Industry News
Can you guess PharmExecs brand of the year?
Humira. The anti-TNF drug continues to grow, a decade after its launch with a growth rate of 21.1% and sales of $7.9 billion for 2011. Thomas Freyman, Abbott Laboratories EVP finance and CFO, said that Humira is a "cornerstone" of the proprietary pharma business, one he expects to contribute "strong and sustainable growth" for the new proprietary pharmaceuticals business. (Source: PharmExec, 2/1/2012)
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The three P’s of effectiveness research: PCORI, Priorities, and Politics
In this blog post by William Looney, he points out the priorities of the Obama Administration's Patient-Centered Outcomes Research Institute (PCORI) and wonders about the high level of inclusiveness given to the patient community. Will this end up politicizing the process and interfere with the integrity and robustness of research protocols? (Source: PharmExec.com, 2/1/2012)
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How do price changes affect Medicare beneficiaries?
This paper from Health Economics uses regression discontinuity methods to compare the plan choices of individuals who retired just after the grandfathering cutoff date of premium contributions and were therefore exposed to significant price changes to the choices of a ‘control group’ of individuals who retired just before that date and therefore did not experience the price changes. The results indicate a statistically significant effect of price. (Source: Wiley Online Library)
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Are patients' perspectives important from the beginning of clinical trials?
This paper discusses the benefits of collecting patient-reported outcomes (PRO) data for evaluating the outcomes for treatments in clinical trials, through the product life cycle. Such information can be used for evaluating the treatment benefit of new products and to engage patients to make decisions about treatment options and ultimately to support commercialization of pharmaceutical products. (Source: SciVerse)
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Another prostate cancer pill bites the dust
The National Institute for Health and Clinical Excellence (NICE) issued draft guidance recommending against Johnson & Johnson's new prostate cancer pill Zytiga, saying that the drug doesn't work well enough to justify its price. And that's after J&J offered a discount to help sway the agency in its favor. It's the second prostate cancer pill that NICE has rejected in recent months. (Source: FiercePharma, 2/2/2012)
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What's next for IBM's Watson?
IBM's Watson computer is training to be a physician's assistant. Oncology experts at Cedars Sinai, along with WellPoint and IBM, are "feeding" Watson millions of pages of research. Because Watson is capable of learning, it will incorporate new data and the evolving thinking of clinicians. As cases progress, Watson will upload the patient data along with new research. (Source: Forbes, 2/1/2012)
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Integrating scientific and real-world evidence within and beyond the drug development process
Read this pay-per-view article from the new Journal of Comparative Effectiveness Research. Epstein et al., Journal of Comparative Effectiveness Research, January 2012, Vol. 1, No. 1s, Pages 9-13. (Source: FutureMedicine.com)
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New Journal Launched - The Journal of Comparative Effectiveness Research
The goal of CER is to assist patients, physicians, purchasers, and policy makers to choose between the available effective treatments in order to improve healthcare delivery. The underlying question being - which treatment will work best, in which patient, and under what circumstances? The peer-reviewed bimonthly journal Journal of Comparative Effectiveness Research provides a rapid-publication platform for debate and for the presentation of new findings. (Source: Future Medicine)
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NPC selects five research projects related to CER for funding in 2012
The recipients were selected as part of NPC’s “request for proposal” process launched last year. “Our work over the last year has focused on the intersection between the policy issues and the standards and methods for evidence generation, interpretation and application, as well as on demonstrating the value of health outcomes,” said NPC President Dan Leonard. The awards total nearly $820,000. (Source: National Pharmaceutical Council, 1/30/2012)
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"Big Brother" looms in FDA lawsuit
Six scientists and doctors who handled evaluations for FDA medical device approvals are suing their former employer. They accuse the regulatory agency of spying on their personal Gmail accounts for two years after the employees told Congress about medical devices with "unacceptable risks" that gained approval anyway. (Source: FierceMedicalDevices, 1/30/2012)
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Are you responding to the PCORI RFI due February 17, 2012?
Are you responding to the PCORI RFI due February 17, 2012? If so, do you want to collaborate with experienced PRO statisticians? Email me for more information.
Should Patents on Pharmaceuticals Be Extended to Encourage Innovation?
Read this interesting debate which gives both sides of the coin. The "yes" side by Josh Blooms contends that pharmaceutical innovation demands longer patent time. The "no" side, written by Els Torreele, poses that to extend patents is more of a bad thing. (Source: The Wall Street Journal, 1/23/2012)
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Call for proposals: The Academy of Managed Care Pharmacy 2012 Educational Conference
The Academy of Managed Care Pharmacy is proud to announce that the Call for Proposals is now open for the 2012 Educational Conference. This year's Educational Conference will take place in Cincinnati, Ohio, October 3-5, 2012. All submissions must be submitted by April 27, 2012. All submissions must be submitted by April 27, 2012.
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Gouge-fest. What do overpriced pharmaceuticals and textbooks have in common?
Pharmaceuticals and textbooks are often overpriced and represent the most bloated sectors in our economy, but why? Harvard health economist David Cutler blames third party payers as well as insufficient information about cost and quality. Even if a doctor wanted to prescribe the pill with the best value, she likely would lack the required information to do so. How can the principle-agent problem be solved? (Source: forbes.com, 1/27/2012)
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Study participants needed to uncover strategies and tactics to improve patient adherence
Cutting Edge Information is conducting a study to assess the different ways pharmaceutical companies are approaching patient adherence. This study aims to uncover the strategies and tactics that are working to keep patients on their treatment plans as well as examine the money invested in the most successful programs. (Source: CuttingEdgeInfo.com)
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Does healthcare reform in France and Germany create market access barriers?
What are the ramifications of Germany's AMNOG reform and France's pharmacovigilance reform? The emergence of relative efficacy requirements into national P&R processes already poses a number of challenges to the pharmaceutical industry. And what would happen if these requirements made it into the European regulatory process? It could mean that some compounds never reach the market when they may have been the best treatment alternative for some patients. (Source: IHS, 1/24/2012)
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How have NICE's HTA processes affected speed of access to new treatments?
This OHE report examines two aspects of the impact of the HTA process on access. First, it examines the elapsed time between launch of a medicine to publication of a technology appraisal. Second, the report analyses elapsed time between the start and completion of the technology appraisal process itself. (Source: Office of Health Economics, 1/25/2012)
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Different analytical approaches....different answers
In this study the researches used contingent valuation methods to determine how the general Danish population values health improvements by way of both time trade-off elicitation technique and willingness-to-pay. (Source: Wiley Online Library from Health Economics, Vol. 21, Issue 3, pgs. 222-237, March 2012)
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What are your thoughts about IBI's new Intervention Bank?
IBI has launched a new Health and Productivity Intervention Bank and is looking for your feedback and suggestions in its two different "accounts". The accounts include: 1) A compilation of 22 abstracts from reviews or meta-analyses of intervention studies from peer-reviewed literature, and 2) Access to employer case examples and best-practice illustrations to put interventions in a "real world" context. (Source: IBIweb.org)
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Will you do this for your next medical education marketing message?
Read how one company put the world’s most influential medical textbook on an iPad app and used interactive diagrams, expandable tables, clinical decision trees, and image-based slide shows. This could revolutionize medical marketing communication. What is your company doing to stay on top of these technology trends? (Source: MarketWatch, 1/25/2012)
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How do you determine the economic benefits of vaccination in an increasing global world economy?
Using a tool called the susceptible-infected-removed (SIR) model, Dr. Petra Klepac of Princeton University looks to answer this question. She combined the SIR model and the assumption that vaccination costs rise exponentially with vaccination rate as well as the total social cost of infection and travelers . This allowed Dr. Kelpac to calculate the vaccination rate for which the total cost to society is lowest. (Source: The Economist, 1/23/2012)
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Systematic Review of Comparative Effectiveness Data for Oncology Orphan Drugs
The results of this study show that oncology orphan drugs marketed in the United States have varying levels and quality of clinical evidence and a scarcity of evidence regarding economic value. Read more about this study published in The American Journal of Managed Care.
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What is the heart of a successful patient adherence program?
Communication! Patients are using online resources and networks for healthcare education and support. This is driving the demand for personalized materials and educational experiences. It is important that manufacturers recognize their role in developing effective patient adherence programs. Some of the latest trends include: live call center support, online resources through websites and social media, mobile sites and more…(Source: PhoneScreen Blog, 1/17/2012)
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Where to begin risk assessment? Begin at the end.
In this article by Michael Klepper he suggests that in order to determine the risk of an investigational drug it is important to "begin at the end". The “end” is the manufacturer who must show a favorable benefit–risk profile before drug approval is granted. Any misstep along the way can result in an incorrect assessment. (Source: Published in Frontiers in Pharmaceutical Medicine and Outcomes)
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Pharma and biotech boosting investment in medical affairs worldwide
The new study, “Medical Affairs: Effective Global Resource Allocation,” provides data evidence of different approaches to medical affairs resources in developing and mature markets. Country-level medical affairs budgets currently average $1.9 million. According to the study, growth in medical affairs spending within emerging markets differs from resource trends in developed countries, which appear flat by comparison. (Source: Cutting Edge Information)
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Embracing mobile health technology. Is our paradigm shifting?
In an effort to change the current health care paradigm a new think tank, the West Health Policy Center, was launched Monday. The new center will conduct research on better reimbursement models, improved price transparency and “smart technology” — a field that includes mobile health monitors and other innovations. One of the organization’s goals is to spur health insurers’ eventual embrace of mobile health technology as a money-saver. (Source: The Washington Post, 1/24/2012)
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Germany's IQWiG sees added benefits for Incivo
Read more about the quality-of-life results and the outcomes considered in this article published in The Pharma Letter. A subcription is required to read this article.
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The Big Pharma Recession Report
Recently a number of high profile pharmaceutical companies have announced significant job cuts and many pharmaceutical professionals feel uncertain about their job stability in 2012. In a recent global study by Pharma IQ entitled “The Big Pharma Recession Survey 2011”, nearly half of the survey participants 44.4 percent said that they were worried that their role might be made redundant in the next 12 months. (Source: PharmaIQ)
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Nominations being sought for 7th Annual Strategic Patient Adherence Awards
Nominations for the 7th Annual Strategic Patient Adherence (SPA) Awards are being accepted thru February 1st. Awards will be presented at CBI's 11th Annual Patient Adherence Forum on April 26-27 in Philadelphia, PA . Don't miss the opportunity to nominate a colleague, your organization or a friend for this prestigious award. (Source: CBI)
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Institute of Clinical Research offers courses on medical device clinical trials and marketing.
Why is pharma scared to innovate?
In order to flourish pharma must use knowledge-based innovation. Despite this fact, it has been among the worst industries in applying the power of knowledge to its innovation business. Rather than being energized by the possibilities and promise of Speed of Change, the industry seems to have been paralyzed by it. What have been the contributing factors to this phenomenon? (Source: PharmExec.com)
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PCORI Draft: National Priorities for Research and Research Agenda
PCORI released draft priorities and research agenda on 1/23/12, without singling out specifics on what will be studied. (Source: CER Newsfeed, 1/23/2012)
Read Draft.
Public comments sought. What do you think about the PCORI National Priorities for Research draft?
The Patient-Centered Outcomes Research Institute (PCORI) released for public comment a first draft of its National Priorities for Research and Research Agenda, which will be used to guide funding announcements for comparative clinical effectiveness research that will give patients and those who care for them the ability to make better-informed health decisions. Public comments are sought until mid-March (Source: MarketWatch, 1/23/2012)
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Is There a Role for Pharmacoeconomics in Developing Countries?
This is a pay per view article by Jonathan R. Harper from the Journal PharmacoEconomics.
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Interesting flow chart summary of new FDA guidance
Jonathan Richman, author of the blog “Dose of Digital,” has developed a flow chart that summarizes the FDA’s recent draft guidance “Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices.” Richman believes that despite the hearings it has held and the promises it seemed to make, the FDA is never going to produce guidance specifically for social media. But Richman suggests that the new guidance should serve as that.
View PDF flow chart here.
ISPOR 5th Asia-Pacific Conference
Abstracts are now being accepted for the ISPOR 5th Asia-Pacific Conference in Taipei, Taiwan. Research Abstracts, Decision-Maker Case Study Abstracts, and Issue Panel/Workshop Proposal submissions invited. Abstract SUBMISSION DEADLINE: 22 March 2012
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Video: Dr. Art Kaplan speaks on communication challenges for patients
Dr. Art Caplan, Director of the Center for Bioethics at the University of Pennsylvania, discusses communication challenges for patients in this video. How do patients find trusted sources of information and comprehend what it means? (Source: National Pharmaceutical Council)
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Patient Reported Outcomes. What can be gained from patient communication?
Be part of the discussion about patient reported outcomes (PRO) with Scott Dessain, academic oncologist and medical researcher at Lankenau Hospital. His blog aims to start a discussion and gain insights on a web-based format for PRO data collection and how such a website can incorporate key teaching, compliance, and relationship-building components to strengthen the provider/patient relationship and help support the reasonable use of health care dollars. (Source: Digital Pharma Blog)
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Incremental Progress for Oncology in 2011
This blog posting from Sophia Walker looks back at Oncology in 2011 and finds that as always, progress in incremental. Topics included are progress in melanoma treatment and shifts in regulatory approval. (Source: IHS Healthcare and Pharma Blog, 1/16/2012)
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The future of the Indian pharmaceutical market
The Indian pharma market has witnessed a successful growth rate of 21.3 per cent for the 12 months ending September 2010 . However, it is not just a growth story as the $12.6 billion Indian pharma market is currently the world's second largest by volume. (Source: ExpressPharma)
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NICE’s Social Value Judgments about Equity in Health and Health Care
The paper provides a brief overview of why NICE has implemented a policy of transparency for social value judgments, and why its social value judgments about cost-effectiveness are more specific than those about equity. (Source: OHE)
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CER Gaining Importance
Industry Standard Research (ISR) today announced the release of a new report focused on the impact comparative effectiveness research (CER) has and will have on formulary placement. US Payers: Comparative Effectiveness Research and formulary decision-making looks at how US payers view the importance and impact of various study/ data sources. (Source: BusinessWire, 1/17/2012)
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New descriptive analysis of more than 22,000 Cochrane meta-analyses
A new descriptive analysis of more than 22,000 meta-analyses within Cochrane Reviews has just been published in an open access article in BMC Medical Research Methodology. Every meta-analysis in the 2321 full reviews in the January 2008 issue of the Cochrane Database of Systematic Reviews was classified according to the healthcare specialty, the types of interventions being compared and the type of outcome. (Source: The Cochrane Collaboration)
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Has the recession caused US citizens to forgo healthcare?
U.S. healthcare spending grew 3.9% in 2010 following record slow growth of 3.8% in 2009; the two slowest rates of growth in the 51-year history of the National Health Expenditure Accounts (NHEA). “This indicates that the most recent recession that officially ended in 2009, appears to have continued to impact personal healthcare spending growth in 2010,” according to Micah Hartman, statistician with the National Health Statistics Group. (Source: Managed Healthcare Executive, 1/17/12)
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Check out this suggested reading list for CER
This site offers a list of recommended articles on methods that are used to conduct comparative effectiveness research. Papers are identified by the type of method (clinical trials; observational studies; or syntheses). A list of key papers on policy issues related to comparative effectiveness research has also been identified. (Source: Academy Health)
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What's in it for ACO early adopters?
The National Committee for Quality Assurance (NCQA) yesterday announced six candidates for its accountable care organization (ACO) accreditation program, launched just two months ago. What's in it for these ACO early adopters who voluntarily seek evaluation? NCQA offers an independent assessment of ACO readiness, NCQA said. "Organizations that earn accreditation may have extra credibility and first-mover advantages in their local markets" and more. (Source: FierceHealthcare)
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Doctors on the take? Medical conflicts of interest.
To head off medical conflicts of interest, the Obama administration is poised to require drug companies to disclose the payments they make to doctors for research, consulting, speaking, travel and entertainment.
Many researchers have found evidence that such payments can influence doctors’ treatment decisions and contribute to higher costs by encouraging the use of more expensive drugs and medical devices. (Source: NY Times, 1/16/2012)
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What is Encyclopedia: Patient-Reported Outcomes
This site gives a great in-depth description of Patient-Reported Outcomes. (Source: What Is Encyclopedia)
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Modeling Health-Related Quality of Life over Time
HERC Cost Effectiveness Analysis Course: Modeling Health-Related Quality of Life over Time by Vilija R. Joyce, MS. The objective of this course is to describe how to analyze health-related quality of life (HRQoL) data with multiple observations over time. (Source: United States Department of Veterans Affairs, HSR&D)
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Research and Markets: Pharmacoeconomic Analysis in R&D Decision Making: An In-Depth Report
This report gives in depth analysis of the ways in which the pharmaceutical industry can ensure that it collects sufficient data to support health technology assessments for new products and how it can apply economic analyses to support decision making during the R&D process. (Source: pharmiweb.com)
Press Release. Report.
Ethical and scientific questions surround HPV vaacinations
This article from the Annals of Medicine and written by L. Tomljenovic and C. Shaw points out the fraudulent global health agency policies in combination with the pharmaceutical companies lack of science based evidence in demonstrating the safety and efficacy of Gardasil and Cervarix. (Source: Natural News.com, 1/11/2012)
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Concerns surround New Outcomes Research Institute
Research of best medical practices and health care costs need further research, but will the Patient Center for Outcomes Research Institute (PCORI) help or hinder this process and ultimately be used to limit expensive, potentially life-saving treatments? (Source: Healthcare Exchange, 1/1/2012)
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YouTube Video: Reimagining pharmaceutical innovation
Thomas Pogge, Professor of Philosophy and International Affairs at Yale, gives a fascinating talk on Reimagining Pharmaceutical Innovation. By reforming harmful supranational regulations, Thomas Pogge is developing a complement to the patent system to stimulate pharmaceutical innovations that would be accessible, without delay, to poor and affluent patients alike around the world.
Watch Video.
Read the Database of Instruments for Resource Newsletter (DIRUM)
DIRUM now includes 34 resource use instruments, and the database is developed by health economists for health economists.
Read the newsletter.
Novartis ax to fall….mostly on its U.S. sales team
The Swiss drugmaker Novartis will be slashing roughly 2,000 U.S. jobs, mostly in sales in order to cope with Diovan's impending patent expiration and Tekturna's diminished prospects. (Source: FiercePharma 1/13/2012)
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Blog: Asymmetry in the Ability to Communicate CER Findings: An Interview With Dr. Tevi Troy
(1/12, NPC: E.V.I.dently Today) comments “...Under current regulatory policies...there are asymmetries, or inequalities, in the ability of different stakeholders to develop and disseminate health care information. There are reasons for these asymmetries, and some of it is due to the fact that the pharmaceutical industry is highly regulated. Dr. Tevi Troy, former Deputy Secretary of [HHS], explains some of the [FDA’s] restrictions on sharing information...”
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Comparative Effectiveness Research: An Empirical Study of Trials Registered in ClinicalTrials.gov
Comparative Effectiveness Research: An Empirical Study of Trials Registered in
ClinicalTrials.gov
Florence T. Bourgeois, Srinivas Murthy, Kenneth D. Mandl
January 9, 2012,
PLoS One
Blog: Expanding Our Real-World Evidence Capabilities
(1/11, L. Shepherd, AZ Health Connections) comments “...Through a new three-year collaboration agreement with IMS Health, [AstraZeneca] will be advancing the use of real-world evidence that is based on observational and retrospective studies conducted throughout Europe. The real-world evidence generated through this collaboration will inform the design of our clinical trial programs, enable us to track the impact of our medicines as well as optimize their performance in the real world.”
Full
The Fate of Health Care Reform — What to Expect in 2012
The Patient Protection and Affordable Care Act of 2010 is arguably the most significant health legislation enacted in generations. What the reform will actually accomplish is yet to be determined. Whether it slows the growth of costs, increases access to care, or improves the quality of care will depend on how it is implemented. Although major components of the law do not go into effect until 2014, the fate of the ACA depends on the outcome of four key events in 2012. (Source: NEJM)
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The rise of the patient and social media
2011 was a year that saw that patients should be included in discussions that have customarily taken place about them, but without their direct participation. Physician, medical and patient communities are forming connections through various social media channels, but there are a still a few less progressive entities a step behind as they figure out how to navigate uncharted regulatory waters. (Source: PharmExecBlog, 1/9/12)
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How to calculate the costs of R&D? Which methodology do you subscribe to?
Tufts has tagged the average cost of bringing a new drug to market at more than $800 million. Last year, two prominent industry critics, D. Light and R. Warburton, published a harsh critique of the study methodology. Their paper contends that a key element of the Tufts work is incorrect and therefore costs are half of what Tufts reports. Enter Professor Scherer of the Kennedy School of Government. His recent paper adds more to this already lively debate. (Source: PharmExec.com)
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NICE snubs prostate cancer treatment
The U.K.'s cost-effectiveness watchdog has officially snubbed the Sanofi ($SNY) prostate cancer treatment Jevtana. The National Institute for Health and Clinical Excellence won't recommend the drug for use by the National Health Service because its benefits don't outweigh the cost or risk of side effects, the agency said. (Source: FiercePharma, 1/12/12)
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The frenzy of medical device deals in 2011 looks to continue
Medical device deals were big business in 2011, with big names like Johnson & Johnson topping the list with their $21.3 billion buyout of Synthes. These deals come as the medical device sector has been consolidating. It looks as if more deals should be expected in 2012. (Source: FierceMedicalDevices, 1/11/12)
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TIRF REMS Access Program receives FDA approval
The U.S. Food and Drug Administration approved a single shared Risk Evaluation and Mitigation Strategy (REMS) for the transmucosal immediate-release fentanyl (TIRF) products. This new shared system will replace the individual REMS and allow prescribers and pharmacies to enroll into just one system, easing the burden on the health care system.
(Source: SpecialtyPharmaJournal.com)
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Value in Health Regional Issues Journal
The ISPOR Board of Directors is proud to announce a new journal, Value in Health Regional Issues (VIHRI). The purpose of VIHRI is to encourage and enhance the science of pharmacoeconomic/health economic and health outcomes research and its use in health care decisions in Asia, Latin America, Central & Eastern Europe, Western Asia, and Africa where the development and use of this science is emerging. For more information, see:
Value in Health Regional Issues
"He likes me. He really likes me."
After years of aggressive, well-rehearsed sales pitches and pressure to boost prescriptions, pharmaceutical sales representatives are changing their tactics. The new "soft-sell" might include a lovely lunch and lots of listening. Doctors seem to "like" the changes and the pharmaceutical reps. (Source: The Wall Street Journal, 1/10/2012)
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A Happier New Year for EuroPharma?
There is no lack of activity programmed at a European level in relation to healthcare and the provision of pharmaceuticals. Among the first to appear will be the legislative proposal to update the European Union's rules on pricing and reimbursement procedures: the Transparency Directive. This largely administrative measure will catalyze and focus much wider discussion during the year on some of the fundamental issues of healthcare economics. (Source: PharmaExec.com)
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Generic drug prices around Europe. Does competition matter?
This article reviews generic drug prices across France, Germany, Italy, Spain and the UK. Competition and reference points strongly contribute to lower prices. (Source: IHS Healthcare and Pharma Blog, 1/6/2012)
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I Quit: How a High-Ranking PR Exec Gave Up His Corner Office and is Fighting for the Uninsured
Wendell Potter, former C-Suite PR Exec for Humana and Cigna speaks frankly about the "spin" behind fighting health reform, and joins the other team...to fight for the uninsured, the indigent, and the under-insured. It's a fascinating blog post.
Read it
here.
The importance of the patient perspective
In this fee for purchase paper, authors Hareendran, Gnanasakthy, Winnette & Revicki look at how a patient's perspective of treatment outcomes is increasingly important to consumers and providers of healthcare. Recent studies have shown that traditional clinical endpoints may not accurately reflect the patient experience with treatment. Often patients' experience of their disease and associated treatment differs from the perspective of their physicians. (Source: SciVerse)
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Is Bayer's Xarelto cost-effective? NICE doesn't think so…at least not yet.
The National Institute for Health and Clinical Excellence says it's asking Bayer for more data on the new drug, provided the company wants to prove it's worth using to prevent strokes and clots in patients with atrial fibrillation. That indication is key to new-generation clotting drugs because it covers a much larger potential market compared with other uses in surgery patients. (Source: FiercePharma, 1/9/2012)
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Romanian Pharmaceutical Market Grows 6.4% in 2011. Is the increase real?
During the last year, the Romanian pharmaceutical market picked up speed and the pharmaceutical market was worth €2.4 Billion. However, according to representatives of pharmaceutical companies that increase is artificial. They argue, it is mainly generated by parallel exports, i.e. buying low priced Romanian drugs and resell them in countries where prices are higher. (Source: europe-health-care.eu)
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200th Anniversary Article: A Reader’s Guide to 200 Years of the New England Journal of Medicine
With this issue, the New England Journal of Medicine marks its 200th anniversary. In January 1812, as the first issue came off the handset letterpress, few of its founders could have predicted such continuity and success. During the Journal's first 200 years of publication, medicine and health care moved from the social periphery to become dominant aspects of our science, culture, and economy. (Source: The NEJM, 1/5/2012)
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Pharma upheaval in 2011 leads to layoffs
Drugmakers slashed thousands of jobs in 2011 to withstand the monumental challenges and dangers they face, Fierce Pharma's annual layoff report provides key figures, dates and themes related to the industry's top 10 layoffs. (Source: FiercePharma, 1/4/2012)
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How should Pharma navigate the ever-changing regulations in the emerging Asian marketplace?
As Asia emerges as the largest player in the pharmaceutical market, pharma regulations are fast gaining attention among pharma companies in Asian countries to protect the health and safety of consumers. Professor Jack Wong, Director, Regulatory Affairs, Johnson and Johnson Medical, joins Pharma IQ to discuss the current and future Asian regulatory landscape. (Source: Pharma iQ)
Read the interview.
Archimedes report
The report is a useful summary of the Archimedes model (ARCHeS Simulator 2.3) and includes references to the key data used in the model, including the risk engines, treatment effects and population data. The model is an attempt to bring together multiple diseases within a single model, rather than having separate models. (Source: The HEDS Blog)
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National Pharmaceutical Council Expands Policy and Research Staff
The National Pharmaceutical Council (NPC) announced the hiring of Daryl Pritchard, PhD, as the Director of Policy Research and Matthew Grabowski as a Research Associate. Both will report to Robert Dubois, MD, PhD, NPC’s Chief Science Officer. (Source: National Pharmaceutical Council)
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Does unpublished clinical trial data cause patient harm and increase costs?
The linked articles look closely at the extent, causes, and consequences of unpublished evidence from clinical trials. These articles confirm the fact that a large proportion of evidence from human trials is unreported, and much of what is reported is done so inadequately. The consequences of such can lead to patient harm, futile costs and more. (Source: bmj.com, 1/3/2012)
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Podcast: CER Interview with Dan Ollendorf
Listen to this podcast with Dan Ollendorf, Chief Review Officer for the Institute of Clinical and Economic Review (ICER); in this capacity, he is responsible for the conduct of systematic reviews of the comparative effectiveness of new or emerging health care technologies, as well as the coordination and oversight of the broader health technology assessment process. (Source: Alliance for Aging Research)
Listen here.
Health Reform Law charges $1/year to insurers to pay for CER studies. Is it enough?
Republicans on Tuesday attacked a new fee under the healthcare reform law that is set to take effect this week for many consumers. The healthcare law tacks on a fee of $1 per year to private insurance plans. The money will fund comparative effectiveness research — studies into which treatments work best for particular conditions. (Source: The Hill's Healthcare Blog)
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2012 Pharma Pipeline Report from PharmExec.Com. Will a few blockbusters be enough?
There are a handful of drugs destined to reach blockbuster status in Pharm Exec's 2012 Pipeline Report, but plenty of other half-billion-dollar drugs that, when strung together, make for a convincing portfolio. (Source: Pharmexec.com)
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Are French public health experts being gagged?
In France, two public health officials, both physicians, have been subjected to harsh retribution for speaking out on health issues. Dr. Alan Braillon has published or spoken publicly on several topics including hepatitis vaccination policy, the power of the tobacco lobby, and the need to ban benfluorex in France. His boss, Professor Gérard Dubois, is being sued for libel by the French tobacconist's union. (Source: Liver International)
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Danish Pharma agrees three-year cap on drug prices
Late December 2011 saw the signing of a three-year price-cap agreement on medicine prices, until December 31, 2014, by Denmark. (Source: the pharmaletter.com, 1/3/2012)
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6 Big HealthTech Ideas That Will Change Medicine In 2012
Daniel Kraft, founder of Stem Core systems and inventor of the MarrowMiner, discusses the biggest emerging trends in HealthTech: A.I., big data, 3D printing, social health networks and more. (Source: Techcrunch.com, 1/1/2012)
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ASHP Guidelines on Medication Cost Management Strategies for Hospitals and Health Systems
Download this PDF file to view the ASHP guidelines for recommended techniques to manage drug costs in hospitals and health systems. The guidelines focus on drug use in inpatient settings and hospital clinics, where health-system pharmacies typically have responsibility for purchasing and distributing drugs.
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Global pharmaceutical market outlook: 2015
IMS Health quantifies the impact of multiple dynamics and examines the spending and usage of medicines in 2015, globally and for specific therapy areas and countries. (Source: expresspharmaonline.com)
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Forecasting Pharma's Future
In this fee for purchase article by Denise Myshko, she addresses the uncertainties of healthcare reforms and changing customer demands, and notes that accurate forecasting will need to come to the fore as a way to address the changing pharma landscape.
(Source: PharmaVOICE.com)
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Insights from the C-Suite: Specialty Pharma, by Taren Grom, editor
In this fee for purchase article, Taren Grom address how specialty pharmaceuticals are mainly prescribed by clinical specialists and aimed at well-defined patient groups. In many cases, specialty products address large unmet needs that often are being treated inadequately. (Source: PharmaVOICE.com)
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Key to finding a new job is knowing where to look
According to experts in the labor market, the five areas that will continue to grow despite economic uncertainty are health economics, information technology, business and finance, education, and media communication. Some of the best career opportunities today will be in these sectors. (Source: nwi.com, 1/1/2012)
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Up to two-thirds of NHS funding requests for cancer drugs that extend life ‘are turned down‘ in Wale
According to figures collected by the Western Mail up to two-thirds of requests for NHS funding for potentially life-extending cancer drugs are being turned down in Wales. And it follows widespread concern that patients in Wales are being denied potentially life-extending drugs routinely available in England via the UK Government’s cancer drugs fund. (Source: WalesOnline.co.uk, 1/2/2012)
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Looking back at health IT (and more) in 2011
Check out this article for a look back at health IT in 2011 and look ahead to what 2012 has in store. (Source: medcitynews.com)
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Hospitals are making room for alternative therapies
In an effort to attract patients, hospitals are offering alternative therapies such as massage therapy, acupuncture and guided imagery, according to a recent survey by the American Hospital Assn. and the Samueli Institute, a nonprofit research group focusing on complementary medicine. (Source: The Los Angeles Times)
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Mac’s Dr. Guyatt to enter Order of Canada
Dr. Gordon Guyatt, Dundas resident and McMaster University professor, is being awarded the Order of Canada by Governor General David Johnston for his “contributions to the advancement of evidence-based medicine and its teaching.” (Source: thespec.com)
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Asymmetry in the Ability to Communicate CER Findings: Ethics and Issues for Informed Decision Making
With billions of dollars being invested in comparative effectiveness research (CER), the public will have increased access to health information in coming years. Yet as more and more information is communicated to patients, practitioners and payers, current regulatory policy may create asymmetries, or inequalities, in the ability of different stakeholders to convey information. (Source: NPC, 12/21/2011)
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The 'S' Word in Healthcare Reform
That is "S" as in "savings". Are the much publicized HCR "savings" that were projected in early 2010 occurring as we head toward January 1, 2014. Read this bloggers opinion. (Source: PharmExec.com, 12/19/2011)
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Pharm Exec's 2012 Pipeline Report
Things are looking up for Pharma. Although jobs were lost last year, and R&D facilities shuttered, consolidation has in some ways reenergized and fortified the industry; organizations have gone back to doing what they do best, or have committed to new R&D or discovery model, or a new therapeutic class. (Source: PharmExec.com, 12/1/2011)
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The Case of Pakistan's Private Health Expenditure
This article compares estimates of household health expenditure from different sources, such as the Household Integrated Economic Survey, the Family Budget Survey and National Accounts (NA). The analysis shows that health expenditure figures for Pakistan have been underestimated by both WHO and the NHA. An adjusted estimate shows OOP spending to be twice as high as previously thought. (Source: Adisonline.com)
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The failure of torcetrapib, and the fallacy of reductionist science in pharma R&D.
In this incredibly well-written article (an ABSOLUTE must-read!), the author shows how Pfizer’s torcetrapib exposed the risks of how pharma, and indeed most of science, approaches problem-solving. Have we reached the maximum potential in pharma R&D? Do we mistake causality for association, and risk patient’s lives? Is true innovation even possible in medical science, or have we plucked all the low-hanging fruit? (Source: Wired, 12/126/2011)
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The Irrelevance of the Broccoli Argument against the Insurance Mandate
The parties who have brought legal challenges to the Accountable Care Act's individual mandate to obtain health insurance claim that the Constitution's Commerce Clause authorizes the regulation of only commercial activity, not inactivity, and thus gives Congress no power to force individuals to buy a product. They argue that if the Supreme Court were to hold otherwise, then Congress could force us all to buy anything, from General Motors cars to broccoli. (Source: NEJM, 12/21/2011)
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FDA looks to improve the representation of women in device studies
The FDA notes that certain medical products may elicit different responses in women than in men due to such factors as genetics, hormones, body size, diet and sociocultural issues. The agency had issued draft guidance to address the underenrollment of women in medical device clinical trials. (Source: FierceMedicalDevices, 12/19/2011)
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Ex-EU drug watchdog head's consulting gig scrutinized
The European Medicines Agency has received some fresh requests to investigate former head Thomas Lonngren, who is now an industry consultant, for potential conflicts of interest committed before he left the agency late last year. (Source: FiercePharma, 12/19/2011)
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Pfizer and GSK boost pneumonia vaccine price cuts for developing world
Just in time for the holiday season, Pfizer ($PFE) and GlaxoSmithKline ($GSK) said they are selling an additional 360 million doses of their pneumonia vaccine to a global health organization at a discounted $3.50 a dose. This boosts a combined 600 million doses they already committed to the group last year, Reuters reports. (Source: FiercePharma, 12/19/2011)
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Nominations Open for Members of the New England CEPAC
The Institute for Clinical and Economic Review (ICER), a leading academic comparative effectiveness research group based at the Massachusetts General Hospital’s Institute for Technology Assessment, is seeking nominations of clinicians as well as patient and public representatives to serve on the New England Comparative Effectiveness Public Advisory Council (CEPAC). Nominations should be submitted to ICER on or before Feb. 17, 2012. (Source: ICER, 12/19/2011)
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EMA expecting 10% more scientific advice requests in 2012
The European Medicines Agency (EMA) says it is expecting requests for scientific advice from makers of human-use medicines to increase 10% next year. Also, more scientific advice requests are likely to be made jointly with health technology assessment (HTA) bodies. Next year's work programme is accompanied by a budget of 222.5 million euros, which is an increase of 6.5% over 2011. (Source: PharmaTimes, 12/19/2011)
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Poland: New price negotiations for RX drugs
The Polish Ministry of Health recently negotiated a round for RX drugs that will be available to Polish patients. The government hopes to save 1 Billion Zloty (~€220 Million) by cutting prices for many drugs. The price cuts provoked angry reactions of pharmacies as they are forced to sign contract with the National Health Fund (NHF). Furthermore, they only have little time to implement the new plans as the new conditions apply as of January 1. (Source: europe-health-care.eu)
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Pricing Case Study from Consumer Goods: Beam Global Takes on Price Improvement
The objective for Beam Global Spirits & Wine, Inc.'s pricing initiative was to improve its ability to manage this complex array of variables across an extensive product portfolio in order to optimize price performance throughout the channel. They chose the Vistaar system which ensures adherence to price strategy objecives, revenue Management policy, and approval processes. (Source: CGT, 5/23/2011)
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Health Plans and the Three Levers of Innovation for Affordable Care
Sam Muppalla, VP of Marketing and Strategy for McKesson Health Solutions, blogs about the importance of being able to innovate in the areas of products, care models, reimbursement, and network designs. Even more important is the ability to align these network elements properly. (Source: McKesson, 12/8/2011)
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What is the Clinical Practice Research Datalink?
The UK's Department of Health is planning to create a new secure data service, called the Clinical Practice Reasearch Datalink (CPRD), to open up data for medical research. This will bring together a usable database of records and support services, such as methodology planning and sample collection, into one comprehensive service, hosted by the Medicines and Healthcare products Regulatory Agency. (Source: Becky's Policy Pages, 12/5/2011)
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Pricing Science Meets Military Science
Combining military strategic thinking with the latest in technology and price science can empower pricing teams to model multiple ‘what if’ scenarios before entering a new market, launching a new product, or initiating this quarter’s marketing campaign.
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Lipitor and Crestor fight on price, both equally unimpressive
Read this blog from Pharmaguy, John Mack. (Source: Pharma Marketing Blog, 12/14/2011)
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Dr. Bates’ Talkback: How to profitably compete in the oncology market
Dr. Andree K. Bates outlines key strategies for addressing the sales, marketing and market access challenges of the oncology market. (Source: eyeforpharma, 12/13/2011)
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Ulf Staginnus' hard hitting and spot-on editorial: market access-what we really need is some honesty
Health economist Ulf Staginnus argues that pharma needs a lot more innovation—and a lot less outmoded market access discussions. (Source: eyeforpharma, 12/12/2011)
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Market access: How network intelligence increases value
Paolo Morgese of Merck Serono and Peter Wagner and Maximilian Schwarz of Mederi present 5 tips for matching stakeholders’ value expectations with demonstration of value. (Source: eyeforpharma)
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Health Systems Evidence: Why use it and who's behind it?
The Health Systems Evidence website is a continuously updated repository of syntheses of research evidence about governance, financial and delivery arrangements within health systems, and about implementation strategies that can support change in health systems. (Source: McMaster University)
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2012 AMCP Awards Nominations
The AMCP awards program would not be possible without your nominations. Take a few moments this week to nominate yourself or a colleague who has gone above and beyond for AMCP and the Managed Care Pharmacy Profession. Deadline: February 3, 2012. (Source: AMCP)
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Germany smiles on AZ's Brilique
German authorities have given AstraZeneca ($AZN) a boost by issuing their final positive recommendation for the company's heart drug Brilique, which is known as Brilinta in the U.S. It's the first med to be evaluated under the new German drug pricing system. (Source: FiercePharma, 12/15/2011)
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For Pfizer, 5,000 lawsuits resolved, 5,000 to go
Pfizer initially faced more than 10,000 lawsuits claiming that its hormone replacement drugs such as Prempro and Premarin cause breast cancer. But the world's largest drugmaker ($PFE) has now settled about half of them and set aside more money geared toward some of the remaining claims. (Source: FiercePharma, 12/15/2011)
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The value of industry involvement in HTA - Joint Healthcare Industry Paper
The healthcare industry recognizes that HTA agencies must retain their independence in providing advice to decision-makers. The final recommendation or decision which will be issued by an HTA agency to support healthcare decision-making must remain independent from stakeholders’ interests. (Source: Joint Healthcare Industry Paper)
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Hysterical video on Pharma Sales Reps by Eyeforpharma. I love these guys!
NICE rejects AstraZeneca's breast cancer drug Faslodex
NICE rejects AstraZeneca's breast cancer drug Faslodex due to lack of incremental efficacy, and backed Roche’s RoActemra for systemic juvenile idiopathic arthritis, based on discounted price. (Source: FiercePharma)
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If Pharma is looking to Detroit for answers, we're in big trouble
Reuters reports that AstraZeneca ($AZN) and most recently GlaxoSmithKline ($GSK) have tapped their counterparts in the auto industry for fixes to the companies' operations in the face of generic competition, R&D challenges and the lower profit margins.
(Source: FiercePharma)
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CDC: Health reform extends coverage to young Americans
About 2.5 million young people, aged 19-25, have received health insurance coverage as a result of health care reform measures that President Barack Obama signed into law last year according to the Centers for Disease Control and Prevention. (Source: CNN Health)
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Podcast: Optimize the clinical - commercial transition for strategic advantage
Late phase trials and post-marketing surveillance – once thought of simply as regulatory compliance tasks – have increasing value to biopharmaceutical companies' long-term business strategies. Today, such research is crucial for demonstrating product value to sponsors and a multitude of other stakeholders. (Source: FiercePharma)
Listen here.
2012 AMCP/FMCP/Genentech Managed Care and Customer Operations (MCCO) Summer Internship Program
The Foundation for Managed Care Pharmacy (FMCP) and the Academy of Managed Care Pharmacy, in partnership with Genentech, offer two appointments to the Genentech Managed Care and Customer Operations (MCCO) Summer Internship Program for student pharmacists enrolled in a graduate degree program. Ideal candidates will be current students enrolled in an accredited PharmD program and/or pursuing a dual degree program such as a MBA, MPP or MPH. (Source: FMCP)
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Call for Papers: Value In Health Regional Issues
Value in Health Regional Issues will include articles on health care policy analysis, outcomes research (clinical, economic, and patient-reported) empirical studies, methodological studies, and articles on health care resources in the regions. (Source: ISPOR)
Criteria and more information.
Utilizing HEOR Stategies Globally: Interview with Betsy J. Lahue, VP, HEOR at BD
Ms. Lahue answered a series of questions written by marcus evans before the upcoming 3rd Annual Health Outcomes & Pharmacoeconomics Research Conference, January 30-31, 2012 in Philadelphia, PA. All responses represent the view of the Ms. Lahue and not necessarily those of BD. (Source: marcusevans.com)
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CMS Requests Comments on Coverage With Evidence Development
CMS has requested comments specifically pertaining to:
• Implementation of CED through the NCD process or other avenues under Medicare Parts A and B;
• The potential impact of CED on the Medicare program and its beneficiaries; and
• Suggested CED approaches that can maximize benefit to Medicare beneficiaries. (Source: The Society of Thoracic Surgeons)
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The Advent of Mobile IRT Solutions in Clinical Trials
The rapid growth in smartphone use has major implications for clinical trials, as the availability of inexpensive yet powerful smartphones and tablets with high-resolution displays, full touch screens, and full-time network connections will enable mobile interactive response technology (IRT) solutions to accommodate the needs of everyone involved in a study. (Source: PharmaNet, 12/9/2011)
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Atlas maps out variation in NHS
The NHS Atlas of Variation has been published by the Department of Health to highlight the amount each Primary Care Trust (PCT) spends on clinical services and links this with the health outcomes patients see. Consisting of 71 maps, the Atlas will help commissioners learn from one other, consider the appropriateness of a service, and investigate when clinical health outcomes are not reflecting the financial investment that has been made. (Source: Department of Health, 12/12/2011)
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Podcast with Beckie Fenrick, Senior Director BCBS
eyeforpharma has put together a podcast as part of the launch of their Managed Care 2012 event with Beckie Fenrick, Senior Director at BlueCross BlueShield, focusing on:
• Understanding the needs of the payer community and preferred communication channels
• How BlueCross BlueShield is combating the increased costs of therapies with alternative contracting and reimbursement models
• Importance of manufacturers and payers working together
Access podcast.
BlueCross Health Institute Addresses Rising Drug Costs
This new white paper, entitled Impact of Rising Prescription Drug Costs, conducted and authored by Dr. Steven Coulter, offers ideas to curb prescription cost drivers. The study looks at the current U.S. health care system and discusses changes that might work to bring the high cost of drugs down. (Source: MarketWatch, 12/12/2011)
Read more.
ISPOR Scientific Awards accepting nominations for 4 separate awards, due by Feb. 10, 2012
The ISPOR Awards Committee is now accepting nominations for 4 awards; Avedis Donabedian Lifetime Achievement Award, ISPOR Bernie J. O’Brien New Investigator Award, Excellence in Methodology in Pharmacoeconomics and Health Outcomes Research Award, and finally the Excellence in Application of Pharmacoeconomics and Health Outcomes Research Award.
Nomination material should be submitted by Friday, February 10, 2012 to ISPOR. More Information here.
12 Days of Pricing, Article 1: For the U.S. Post Office, One Price for All Isn’t Working Out So Wel
Steven Greenhouse wrote an interesting article in the New York Times which concludes that the Post Office is in deep trouble. Labor wages represent 80% of expenses (compared to 53% and 32% respectively for UPS and FedEx), it needs to reduce 120K workers while having a “no layoffs” pledge to unions, it can’t raise prices by more than inflation, it projects a $9.2B deficit this year, and there is a downward trend in mail. (Source: Pricing for Profit)
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One Day You’re In; The Next Day You’re Out: Dendreon’s Top Dog Voted “Worst Biotech CEO” in Poll.
Mitch Gold and his struggling biotech Dendreon ($DNDN) can't catch a break since disappointing Wall Street with lackluster sales of the prostate cancer drug Provenge. TheStreet announced Gold was voted this year's worst chief executive in a poll that drew 1,800 votes. (Source: FierceBiotech, 12/9/2011)
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Poland: New price negotiations for RX drugs
The Polish Ministry of Health recently finished a negotiation round for RX drugs that will be available to Polish patients. The government hopes to save 1 Billion Zloty (~€220 Million) by cutting prices for many drugs. The price cuts provoked angry reactions of pharmacies as they are forced to sign contract with the National Health Fund (NHF). (Source: europe-health-care.eu, 12/9/2011)
Read more.
Lansley accused of NHS U-turn by imposing centralised targets
HEALTH Secretary Andrew Lansley was accused of imposing 60 new national targets on the NHS despite pledges to hand powers to local clinicians. Mr Lansley said the measurements would give a true verdict on how well the NHS was performing in key areas including patient survival and death rates, as well as taking into account experiences of treatment in surveys. (Source: Yorkshire Post, 12/10/2011)
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International Study Assesses Disease Registries as Means for Improving Health Care Value
A new study by The Boston Consulting Group (BCG) of 13 disease registries in 5 countries (Australia, Denmark, Sweden, the U.K., and the U.S.) identified numerous instances where registries have contributed to significant improvements in health outcomes even as they lowered the total health-care costs for a given condition. The results of the study are detailed in a new report titled "Improving Health Care Value: The Case for Disease Registries". (Source: MarketWatch, 12/8/2011)
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Managed Care Summit Podcast
Managed Care Summit Podcast. Features Beckie Fenrick, Senior Director Clinical Pharmacy, BlueCross BlueShield (Source: eyeforpharma)
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STAY IN CONTROL OF YOUR REMS PROGRAM
Complex risk evaluation and mitigation strategies (REMS), including upcoming class-wide REMS, require technologies that connect multiple stakeholders, vendors and sponsors on a single shared system. PPD addresses the operational challenges of conducting REMS programs through an integrated technology platform developed in conjunction with Microsoft Corporation. (Source: FiercePharma)
Download the White Paper.
Bayer HealthCare and Health Alliance Medical Plans Enter Outcomes-based Agreement
Bayer HealthCare and Health Alliance Medical Plans have entered into an outcomes-based contract for people with relapsing-remitting multiple sclerosis (MS) who are taking Betaseron® (interferon beta-1b) to reduce the frequency of clinical exacerbations. The agreement is the first of this type for Bayer HealthCare in the U.S. and is defined by relapses requiring hospitalizations for Betaseron patients covered by Health Alliance. (Source: MarketWatch 12/6/2011)
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Archimedes' Idividualized Guidelines and Outcomes (IndiGO) Platform Deployed in Colorado Beacon Con
Archimedes Inc., a healthcare modeling company, today announced that it has entered into an agreement with the Colorado Beacon Consortium (CBC) for the use of the Company's Individualized Guidelines and Outcomes (IndiGO) platform, a physician and patient decision support tool. Initially, IndiGO will be used as part of a one-year program throughout the CBC's medical practices to assist in the care of up to 100,000 patients. (Source: MarketWatch 12/7/2011)
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Andrew Lansley launches 60 NHS 'patient outcome measures'
Andrew Lansley, the health secretary, has launched more than 60 "outcome measures" for the NHS, which he said would put GP performance under real scrutiny for the first time and give patients a more informed choice over which doctor they want to see. (Source: the guardian)
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The Real Way to Lean Success: Suck Out the IT Fat
There are only a few things a pharma company needs to be good at: 1) developing products and services of true, differentiating value for patients, doctors, and payers; and 2) figuring out how to market and service those products and services powerfully, ethically and efficiently. That’s it.
That’s why it’s essential to cut out any non-essential IT process.
(Source: PharmExec.com 11/22/2011)
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The Year's Top 5 Tech Surprises
Here are the top five surprises that reshaped the health IT sector in 2011:
5. Heads Were in the Clouds
4. Health IT Hiring Boomed
3. Tablets Took Off
2. Google Health Said Goodbye
1. Small Practices Led Meaningful Use
(Source: SFGate 12/6/2011)
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Report shows Big Pharma's Patent Cliff in Graphic Detail
The Economist's analysis of Big Pharma's patent cliff woes is worth looking at if only for the accompanying graph and its plunging sales lines for Pfizer's ($PFE) Lipitor, Sanofi ($SNY) and Bristol-Myers Squibb's ($BMY) Plavix, Novartis' ($NVS) Diovan and Merck's ($MRK) Singulair. (Source: FiercePharma)
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Qualcomm unit to provide wireless solutions for devices
Qualcomm has announced the formation of a subsidiary that will focus on medical device connectivity and data management. Qualcomm Life is offering the 2net platform and hub for use in connection with wireless medical devices. The offerings are available in the U.S. and are designed to interconnect wireless medical devices via cloud-based solutions so biometric information is accessible by patients, their healthcare providers and caregivers. (Source: FierceMedicalDevices)
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Even more presentation available from ISPOR Europe
Many more slide presentations from the Congress are now available at the ISPOR website.
Click here for presentations from plenary sessions, issue panels, workshops, symposia and forums.
What Managed Care Thinks Of Pfizer And Its Lipitor Strategy
Reimbursement Intellgience, a market research firm, queried 42 execs from health plans and pharmacy benefit managers. Overall, 66.7 percent believe the moves will not protect Lipitor market share during the first 180 days of exclusivity that Ranbaxy Laboratories has in which to sell a generic. After six months, they expect Pfizer to lose 54.5 percent of the market. And a year from now, they expect Pfizer will have lost two-thirds of the Lipitor market. (Source: Forbes)
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Private Market ACO's: Retool for the Industry's New Era
How well can accountable care in the private market make the shift away from fee for service? Managed Healthcare Executive brings together four key thought leaders to discuss the potential of ACO arrangements in the commercial market.(Source: ManagedHealthcareExecutive.com, December 2011)
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Revisiting issues, drawbacks and opportunities with observational studies in comparative effectivene
Despite their inherently pervasive limitations, data from observational studies are increasingly relied upon by health care decision makers to fill critical information gaps created by lack of evidence from randomized controlled trials. The aim and objective of this article was to revisit the major issues associated with observational studies from a canvass of the literature. (Source: PubMed.gov)
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Patient Reported Outcomes Now Comprise 13% of Market Access Budgets
Drug companies allocated 13 percent of their average total market access budgets to patient-reported outcomes teams this year, according to new benchmarking data from Cutting Edge Information. 57 percent of profiled companies will increase their PRO team budgets in 2012 and no profiled company will be decreasing its PRO budget next year. (Source: Enhanced Online News 12/2/2011)
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CEO: Roche would consider more money-back deals
Roche expanded in the realm of pay-for-performance pricing with a recent deal on Avastin. If German patients don't respond, hospitals and public insurers in that country will get their money back, provided they've signed on to the agreement. Now, the company says it's open to offering similar arrangements in other countries, Reuters reports. (Source: FiercePharma)
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NICE rejects Novartis MS pill despite cost cut
NICE has determined that the Novartis multiple sclerosis pill still isn't a good value for money, even with new evidence submitted by the company--and a patient-access scheme that lowered the cost.
The agency's decision isn't final yet. Novartis has some time to either submit new data or revise its access scheme. Patient advocacy groups are also lobbying for Gilenya's acceptance. NICE's final guidance is due in April. (Source: FiercePharma)
Read more.
Facing Generic Lipitor Rivals, Pfizer Battles to Protect Its Cash Cow
As it loses its patent for Lipitor on Wednesday, Pfizer is completing relationships and shoring up discounts — like a reduced co-payment of $4 a month versus the $10 customers would pay for many generic prescriptions. Some deals require pharmacies to reject prescriptions for low-cost generics, starting Thursday, and substitute a discounted name-brand Lipitor. (Source: The New York Times 11/30/2011)
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Geographic Variation in Physicians' Responses to a Reimbursement Change
In this free paper from The New England Journal of Medicine they have looked at the variation in geographic response to a major reform of Medicare's reimbursement system for physician-administered drugs (Part B), the vast majority of which are chemotherapy agents. (Source: NEJM)
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Aetna Encourages Evidence-Based Treatment Decisions Through Education Program for Providers
Aetna is encouraging physicians in its network to participate in an education program from the Agency for Healthcare Research and Quality (AHRQ) that will make it easier for them to make health care decisions based on the latest research, reviews, and guides to evidence-based care within their specialty areas. (Source: Reuters)
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Multi-Payer Claims Database Moves Ahead
An increasing number of public and private databases are being developed as useful data resources to manage the growing amount of Comparative Effectiveness Research available. One such database is the Multi-Payer Claims Database (MPCD). The goal is to enhance the value of claims data for CER, make it easier to obtain relevant data, study less common conditions, and potentially link across payers and time. (Source: NPC)
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Video: Dr. Lakdawalla CER Discussion
In this brief video, Dr. Lakdawalla discusses what heterogeneity is and why it must be taken into consideration when conducting and analyzing comparative effectiveness research. (Source: National Pharmaceutical Council)
Watch video.
Podcast: Key Challenges Payers Face in Oncology
In this podcast, Dr. Ira Klein, Chief of Staff for Aetna, gives a discussion on the key challenges payers face in oncology, how they plan to work with Pharma in tackling these and how they see the change in their perception of therapy value affecting their relationship with Pharma.
Listen here.
A Roadmap to Improved Medication Adherence
This paper is the conclusion of an eight-month study by NEHI, a national health policy institute, which for the first time identified a combination of advantageous circumstances and system-changing innovations that have the potential to facilitate interventions to improve medication adherence. According to NEHI’s “Medication Adherence Roadmap,” there are six high-level opportunities for making real progress on medication adherence. (Source: URAC & AMCP Fall 2011)
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NICE at heart of new NHS Commissioning Outcomes Framework
NICE will have a significant role in the development of indicators for the new Commissioning Outcomes Framework (COF) under proposals announced by the NHS Commissioning Board today. NICE has been asked to develop new COF indicators based on existing quality standards, which set markers of high-quality, cost-effective care, and to quality assure COF indicators from other sources. (Source: NHS 11/29/2011)
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White Paper Reveals Types and Locations of More Than 160 ACOs or ACO-Like Organizations
In a first report of its kind, Leavitt Partners' Center for ACO Intelligence released a white paper regarding the types and locations of ACOs. The report provides data-driven insights into the evolution of ACOs following federal health reform and the recent announcement of the Medicare Shared Savings Program. Data and analysis on the growth and national dispersion trends of more than 160 ACO or ACO-like organizations are highlighted. (Source: MarketWatch 11/29/2011)
Read more.
FierceBiotech's 2011 Women in Biotech
FierceBiotech's much-awaited-and belated-Women in Biotech feature. Many of the honorees here are women who drove some of the big stories they covered this year. The women featured this year represent the best of the global biotech industry. You'll find women here who are making an impact for organizations based in Asia, Europe and here in the U.S. (Source: FierceBiotech)
Read more.
More Insurers are Thinking Inside the Box; Blue Shield of California Opens CA
Blue Shield of California (BSC) Nov. 7 opened a 500-square-foot retail store inside the Lucky Supermarket, the first health insurer in the state to venture into the retail world. While several other insurers nationwide also have brick-and-mortar stores, including Blue Cross Blue Shield of Florida, Highmark Inc. and UnitedHealth Group, BSC’s venture might be the only one to operate out of a grocery store. (Source: AISHealth)
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Survey on Pharma Wish List for Santa. Take it. Get a Laugh.
The always entertaining John Mack of the Pharma Marketing Blog has compiled an entertaining, but enlightening survey. Add your views here. (Source: Pharmamkting)
Take survey.
2011 Benchmarks in Accountable Care Organizations: Metrics from Early ACO Adopters
In this paid report, 2011 Benchmarks in Accountable Care Organizations: Metrics from Early ACO Adopters, it delivers actionable data from 228 healthcare companies that responded to a February 2011 ACO readiness assessment. The result? A comprehensive snapshot of ACO awareness, participation, administration, targeted populations, payment models and much more from healthcare companies already immersed in the ACO architecture. (Source: Managed Care Information Center)
Read more.
AMCP 2012 Awards Nominations
AMCP confers awards to recognize members and non-members who have made significant contributions to the profession of managed care pharmacy and to AMCP. Award recipients are publicly recognized at AMCP's Annual Meeting & Expo. (Source: AMCP)
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Quality of life in Italy
The outcome of the first Italian National Conference on Quality of Life, this volume is full of cogent analysis of topics and issues related to well being and quality of life, including focused papers on specific population groupings and discrete themes. (Source: Springer)
Read more.
Drugmakers’ Returns on Research Fall as Pipeline Projects Fail
The world’s biggest drugmakers saw returns on their investments in new products decline 29 percent from last year as more experimental drugs failed at costly late stages of development. Pharmaceutical-company returns on research and development fell by 3.4 percentage points to 8.4 percent this year, the report by consulting firm Deloitte LLP found. The study looked at the 12 drugmakers that spend the most on R&D. (Source: Bloomberg)
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Pfizer Uses Coupons, PBM Deals, Possible OTC Conversion to Head Off Generic Lipitor
On the eve of Lipitor’s patent expiration in this month, its innovator, Pfizer Inc., is pursuing an aggressive strategy to keep its prize statin product on the radar screen as it loses patent protection and faces generic competition. Pfizer CEO Ian Read said Pfizer is considering FDA approval for an over-the-counter (OTC) version, pursuing deals with PBMs and providing discounts to patients in order to persuade them to stick with the brand form. (Source: AISHealth 11/28/2011)
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JMCP Supplement on Comparative Effectiveness and Real World Data
JMCP Supplement: Examination of Data, Analytical Issues and Proposed Methods for Conducting Comparative Effectiveness Research Using “Real-World Data”. Includes Ten Commandments for CER, secondary data structures, stat issues, developing collaborative study protocol, and more. (Source: JMCP)
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How to Read a Paper: The Basics of Evidence-Based Medicine Book
Sign up at Media Search to read this paper by Trisha Greenhalgh. How to Read a Paper is one of the bestselling texts on evidence-based medicine, used by health care professionals and medical students worldwide. (Source: chanozh-overblog)
Download Paper.
Tiered Pricing Not Always a Win-Win
Tiered pricing, or selling critical medicines to developing countries at a standardized discount price, can improve access in the short term, but arbitrary demographic groupings and misaligned incentives often stack the deck in favor of manufacturers, not patients.
(Source: PharmExec 11/22/11)
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HTA Methods Digest
This HEDS Blog gives their take on the most important methods papers published in the last couple of months, just in case you have not had time to keep up. (Source: Health Economics and Decision Science Blog)
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Beware Marketing Strategies Masquerading as Evidence Based Medicine
In order to achieve the best outcomes for patients, it is important to leverage the perspective of experts. This expertise comes from clinical experience, research experience, as well as training and education. But, what happens when expertise is influenced by incredible amounts of money, and when carefully selected data is mistaken for evidence? (Source: Outlook On Outcomes)
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Big Pharma Counts Cost of R&D Decline
The ‘Measuring Return from Investment’ study, undertaken by Deloitte consultancy and Thomson Reuters, finds that the majority of leading drugmakers have seen a decline on their return from R&D. Specifically the study shows that 10 of the top 12 pharma firms saw their internal rate of return (IRR) decrease from 11.8% in last year to 8.4% in this, representing a fall of just under 30 per cent. (Source: InPharm)
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Strategic Alliance Executives
Economic, regulatory, and competitive pressures are encouraging biopharmaceutical companies, large and small, to partner with each other and with academic research institutions to create synergistic relationships that capitalise upon the competencies that each organisation brings to the table. (Source: InPharm)
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Competition and the Reference Pricing Scheme for Pharmaceuticals
By introducing n (>1) firms with infinite cross-price elasticity (i.e. generic drugs), this paper explores the effects of competition on the optimal pricing strategies under a Reference Pricing Scheme (RPS). A two-stage model repeated infinite number of times is presented. (Source: SciVerse)
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Does price reveal poor-quality drugs? Evidence from 17 countries
Focusing on 8 drug types on the WHO-approved medicine list, this paper constructs an original dataset of 899 drug samples from 17 low- and median-income countries and tested them for visual appearance, disintegration, and analyzed their ingredients by chromatography and spectrometry. Fifteen percent of the samples fail at least one test and can be considered substandard. (Source: SciVerse)
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Does a German Launch Make Sense?
Reforms to the federal drug reimbursement system introduced last year are accentuating the importance that Germany plays in Big Pharma's new product pricing strategies. A number of prominent players questioning the rationale for introducing new medicines in Germany due to the uncertainty of the new process and the adverse impact of low administered prices on listing decisions taken by other countires. Such concerns make a launch in Germany a risky proposition. (Source: PharmExec)
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10 unusual biotech and pharma logos
Check out these 10 unusual biotech and pharma logos from around the world and get the "scoop" behind them. (Source: FiercePharma)
See more.
Why treating patients like customers means reimbursement dollars
Effective October 2012, the Centers for Medicare & Medicaid Services will withhold 1 percent of regular reimbursements based on performance. Patient experience makes up for 30 percent of the total bonus payments. With patient survey questions, such as how well did care providers communicate, was pain controlled, and was the hospital room clean, hospitals are increasingly paying close attention to the patient experience. (Source: FierceHealthcare)
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Latest drugs scarce in Wales' 'low-spend' NHS
Fewer patients in Wales have access to new medicines than those in England, figures show. The uptake of pioneering treatments recommended by the National Institute of Health and Clinical Excellence (Nice) is slower in Wales than it is across the border. And the nation is spending half as much on these medicines as England does, the analysis by the Office of Health Economics (OHE) shows. (Source: WalesOnline.co.uk)
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Value-based Pricing in Developed Countries: Past, Present, Future
Symposium sponsored by Double Helix Consulting slides
here from ISPOR Madrid.
Market Failures in Price Referencing
HTA of Med Devices in EU: Implications for Industry
Value-baed Pricing in Practice presentations from ISPOR
European network for HTA Joint Action between European Commission and EU Member States
Pavlovic's ISPOR Madrid presentation
here.
Multi-criteria decision analysis: roadmap for development.
Benefit-Risk discussed
here, and Open-Source discussed
here.
Greenpark Collaborative: US and Europe Perspective
US perspective
here by Marc Berger, and Eichler's EU perspective
here.
Value-Based Pricing: How do Approaches Vary by Health Care Context?
Valuing Diagnostics: Do we need Different Metrics?
Govt and Industry weigh in: The Reality of Real World Data And Its Use In Health Care Decisions
See Levin from Ontaria (gov't) present his side
here and Keohane from AstraZeneca (industry)
here.
The reality of real world data and its use in health care decisions in Europe
by Xavier Badia from IMS, at ISPOR Madrid
here.
Adrian Towse weighs in on Centralized EU Pricing/Reimbursement Pros & Cons
ISPOR Madrid presentations available here in PPT!
Plenary sessions, key presentations and more (European pricing, market access, observational data, VBP, etc.).
Click
here to download individual presentations.
Conceptualization of Category-Oriented Likelihood Ratio
This theoretical article tries to compare evidence-based diagnosis with expert-based strategies in clinical diagnosis and also defines a novel concept of category-oriented likelihood ratio (LR) to propose a new model combining both reasoning strategies used by expert physicians and statistical models of reasoning. (Source: 7th Space)
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Pfizer exec: Indian price move would push pharma to 'semi-recession'
The Indian government controls prices on drugs that account for about one-quarter of the market. Officials want to expand that to at least 348 essential meds, which they say would involve 60% of domestic drug sales. Pfizer India Managing Director, Kewal Handa, says that such broad control would end up "commoditizing the industry," failing to recognize differentiation in quality and hampering innovation. (Source: FiercePharma)
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FDA nixes approval of Avastin for breast cancer
The Food and Drug Administration has revoked Avastin as treatment for breast cancer, citing evidence that the controversial drug carries serious side-effects without offering demonstrable benefits.
(Source: The Washington Times)
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Deficit Reduction Law Makes Comparative Effectiveness Research More Important Than Ever
In this blog, Dr. Winifred S. Hayes points out the importance of CER and argues that only by integrating evidence into practice and policy will we be able to improve the quality and safety of services while reducing ineffective products and practices. (Source: Hayes)
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The supercommittee’s health spending paradox, in three charts
The use of medical care is going down, yet federal health care spending is going up. Demographics are to blame: baby-boomers have begun aging into the program, expanding its size. (Source: washingtonpost.com)
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NICE turns down another breast cancer drug
NICE (the National Institute for Health and Clinical Excellence) has turned down yet another cancer fighting drug for women with breast cancer. Eribulin, a chemotherapy medication costing approximately 68,000 pounds, will not be available for women in the UK through the NHS (National Healthcare Plan). It is available, however, through private health insurance in the United States and in the UK. (Source: America's healthcare Advocate Show)
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Dutch initiative seeks to integrate the organization of care delivery
By tying reimbursement to health outcomes, the program defines a set of indicators and metrics for assessing the value of diabetes treatment. These indicators and metrics overlap with those in the type 2 diabetes Working Group's Shared Value Framework, making the Dutch standard of care a potential guide to value demonstration in drug development. (Source: Tapestry Networks)
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CONSORT quality of life extension under development
Currently under development is a new official CONSORT extension. This will provide guidance for editors, reviewers, and authors on standards for HRQL reporting from trial publications. Improved reporting of HRQL in clinical trials will enable robust evidence to inform patient choice, aid clinical decision making, and inform health policy. (Source: BMJ Group Blogs)
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New NCQA Accreditation Program Identifies ACOs That Are Most Likely to Succeed
On November 21, the National Committee for Quality Assurance (NCQA) will release the standards and guidelines that compose its new Accountable Care Organization (ACO) Accreditation program. The program provides a roadmap for provider-led organizations to demonstrate their ability to reach the triple aim: reduce cost, improve quality and enhance the patient experience. (Source: BusinessWire)
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Integrating historical clinical and finalncial data for pharmacological research
Data from this research concludse that data integration using metadata from financial/dispensing systems and pharmacy vocabularies were comparable. Given the current state of EHR adoption, semantic enrichment of financial data and integration of historical clinical data would allow the repurposing of these data for research. (Source: 7th Space Interactive)
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Purdue hits health care tech milestone
The Purdue Regional Extension Center celebrated Thursday the commitments from 100,000 primary care providers to adopt electronic health records. The widespread national network of physicians onboard with the new records system includes 1,950 primary care providers in Indiana enrolled through the Purdue center. (Source: boilerstation)
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ePRISM® reveals Impressive Results for Improving PCI Informed Consent
Health Outcomes Sciences, LLC (HOS), the company behind the breakthrough predictive modeling solution called ePRISM, released its findings yesterday at a Late Breaking Clinical Trial session at the American Heart Association's Scientific Sessions Conference in Orlando, Florida. ePRISM is able to personalize medicine by delivering validated prediction models using each patient's individual data. (Source: Yahoo! Finance)
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Penalty Premiums
More employers are demanding that workers who smoke, are overweight or have high cholesterol shoulder a greater share of their health care costs, a shift toward penalizing employees with unhealthy lifestyles. Policies that impose financial penalties on employees have doubled in the last two years to 19 percent of 248 major American employers recently surveyed. (Source: The New York Times)
Read more.
Health Technology Assessment (HTA): a European perspective
In Health Technology Assessment (HTA): a European perspective, FirstWord examines the current role of HTA in Europe, from its impact on reimbursement and pricing to market access. The report focuses on the experiences of five European nations, reviewing the history of HTA and the key agencies in each. (Source: FirstWord Dossier, Oct. 2011)
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Penn Physicians Point To Patient Narratives to Bolster the Case of Evidence-Based Medicine
“Doctors should consider the use of narrative -- in the form of patient stories and testimonials -- as a powerful tool for translating and communicating evidence-based policies to the public to buoy buy-in on important health issues such as cancer screenings and vaccination mandates, according to two physicians from the Perelman School of Medicine at the University of Pennsylvania writing this week in JAMA.” (Source: 11/8, University of Pennsylvania School of Medicine News Release)
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The Role of Cost-Effectiveness in U.S. Vaccination Policy
Historically, CEA has played a role in independent advisory board decisions regarding vaccine policy recommendations to the CDC, which then influences private payer coverage decisions. Analyses for HPV4 vaccines in males and meningococcal vaccinations are discussed, and the impact of the expansion of vaccines on public health costs are reviewed in this NEJM Perspective by JJ Kim. (Source: NEJM, 11/10/11)
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Watch and Vote: Video from Pharma Faceoff on Pharmacy Co-Pay Cards
Watch and Vote: Video from Pharma Faceoff on Pharmacy Co-Pay Cards
featuring Jeff Taylor, Pharmacy Director of Aetna vs. Donald Sawyer, VP of Payor & Pricing at Ironwood Pharmaceuticals. Watch and vote on who wins the debate! (Source: Pharmafaceoff)
Watch video.
Why Steve Jobs & Bill Gates could not fix the pharmaceutical industry
Read these posts from Beaker's Blog about two recent articles written by Forbes' Matthew Harper, theorizing on the contribution leaders in technology could make to the pharmaceutical industry and sharing perspectives of two of its most powerful leaders as to why healthcare technology trails consumer technology in innovation. (Source: Beaker's Blog)
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China as an emerging market: drug prices are a mixed blessing due to price slashing
In a “more you sell, the more you lose” conundrum, pharma is struggling on whether the China market is worth it. Central and provincial governments slash prices, but it is unclear whether volume will offset these low margins. (Source: FiercePharma)
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What Bill Gates Says About Drug Companies
This article shares insights into Bill Gates' unique and thoughtful perspective on the pharmaceuticals industry. Over the past decade, Gates has relied on pharmaceutical giants to provide the vaccines that are a lynchpin of his charitable work. (Source: Forbes)
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Video: “The Joy of Stats”, a fascinating 4 minute lecture by Hans Rosling
Rosling’s famous lectures combine enormous quantities of public data with a sport's commentator's style to reveal the story of the world's past, present and future development.
Watch video.
Scorpion antivenom's price stings AZ patients
Pharma company, Rare Disease Therapeutics, fumbles with price discrepancy on Scorpion Sting antivenom. The drug is priced at $62K/course of treatment in US, $500 in Mexico. That Stings! (Source: FiercePharma)
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The IMS Institute examines the drug shortages problem from an entirely new angle
In this report, the IMS Institute looks at the current drug shortages situation—the magnitude of the problem, its causes and ways to prevent or resolve shortages in the future. Analysis includes the 168 products classified to be in short supply as of October 7, 2011 by either the FDA or the American Society of Health-System Pharmacists. (Source: The IMS Institute)
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Pfizer's Lipitor survival strategy under attack
Pfizer's Lipitor generic-blocking strategy - who wins, who loses? In a complete reversal of the usual push toward newly available generics, PBM Catalyst Rx has instructed pharmacies to fill prescriptions for generic Lipitor with the branded version instead. Some pharmacists are up in arms about the arrangements, saying Pfizer and the PBMs will benefit at the expense of employers--who'll still pay the brand-name drug fee--and taxpayers. (Source: FiercePharma)
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PCORI Request for Proposal
PCORI Request for Proposal – Framework (Research Methods WG): Due Date 12/02/2011, Report Date estimated 5/20 (Source: PCORI)
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Emerging Markets: Tread Carefully
In the next 5 years, nearly two-thirds of pharma sales will come from emerging markets. What are the “myths and traps” of navigating these new landscapes? The article also includes the 4 fundamentals of emerging markets. (Source: Reeves, et al., PharmExec.Com Global Digest, Nov 9, 2011)
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Have you optimized your Market Access Efforts?
Market access has been a hot topic in pharma for several years, but have companies adapted their internal structures and key capabilities at all phases of the product life cycle to successfully achieve optimal access and reimbursement? (Source: Boggio and Sobrio, PharmExec.Com Global Digest, Nov. 9, 2011)
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WP243 Thought Leader Compensation: US vs. EU
Global strategies for establishing fair-market value payments for opinion leaders can prove challenging. This white paper provides a guidepost to determine European fee schedules and compensation limits. It also outlines the differences observed between US and EU hourly rates. (Source: Cutting Edge Information)
Read more. (Note: form must be completed to download)
Emerging markets: the engine of growth in the world economy
In this interview with Jim Furniss, he speaks on his view on emerging pharmaceutical markets, such as China and India, and highlights the trends he's noted. (Source: pharmaphorum)
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Reasons for Medication Non-Adherence Affect Patient Outcomes
Non-adherence to treatment is an important predictor of both worse clinical outcomes and higher long-term costs. However, the reasons for non-adherence are also important to consider, according to new findings from the National Health and Wellness Survey (NHWS), conducted by Kantar Health. (Source: MarketWatch)
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Optum Brings Together Dedicated Team to Help Health Systems Rapidly Build and Implement Accountable
Optum has introduced its Accountable Care Solutions business to enable hospitals, physicians and health plans to better coordinate patient care, enhance care quality and financial performance and, ultimately, increase consumers' satisfaction with the health system. (Source: BusinessWire)
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Wennberg receives ethics award
Dartmouth Medical School professor John Wennberg will receive the first-ever MacLean Center Prize in Clinical Ethics and Health Outcomes for his research of health care delivery systems. He will receive the $50,000 award — which is given by the University of Chicago’s MacLean Center for Clinical Medical Ethics — at the 23rd annual Dorothy MacLean Fellows Conference on medical ethics on Nov. 11 and 12, according to a University of Chicago press release.
(Source: The Dartmouth)
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Biotechnology & Medical Investors Database
Investments have continued to flow into medical sectors this year, as ageing population and growing number of diseases have helped both biotechnology & pharmaceutical companies to maintain growth.
(Source: Hindmarsh Finance)
Read more.
Real-world evidence: HealthCore's Journey
In this AstraZeneca Blog, they take a look at how evidence can help identify the health and cost impact of treatments on patients, while also highlighting areas of unmet patient needs. This post consists of an interview with Marcus Wilson, president and co-founder of HealthCore. (Source: AZ Health Connections)
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Implementing patient-reported outcomes assessment in clinical practice
While clinical care is frequently directed at making patients “feel better,” patients’ reports on their functioning and well-being (patient-reported outcomes [PROs]) are rarely collected in routine clinical practice. Integrating PROs in clinical practice has the potential to enhance patient-centered care. (Source: Information for Practice)
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World's Oldest Clinical Trial...and Health Economics Not Far Behind
Clinical studies have been around since "Book of Daniel" according to Greg Simon, senior vp for patient engagement at Pfizer. Health economics and generic substitution concepts have been a part of the system about as long. (Source: BioWorld)
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Is the U.K.'s cancer-drugs fund unfair?
Patient advocates complain that U.K.'s special fund for expensive cancer drugs is unfair when other chronic diseases can be just as serious. (Source: FiercePharma)
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REAL and Present Danger: Revealing the inside story of the medical industry...
REAL and Present Danger: Revealing the inside story of the medical industry and offering guidance to salvage our healthcare system, a book by Dr. Vijay Pabbathi, presents evidence for how prescription drugs are causing more deaths than natural disasters, challenges the validity of EBM, and suggests that drugs are turning healthy people into sick individuals. (Source: SourceWire News Distribution)
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Utilizing Health Outcomes Data to Drive Company Decision-Making
In this interview, Dr. Kevin Mayo, Senior Director (HOPE) Endo Holdings, answered a series of questions written by Marcus Evans before the upcoming 3rd Annual Health Outcomes & Pharmacoeconomics Research Conference, January 30-31, 2012 in Philadelphia, PA. (Source: HEOR2012)
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Therapeutic and Diagnostic Devices Outcomes Research
A primer from ISPOR on the unique characteristics of therapeutic and diagnostic device outcomes research (clinical, economics, and patient-reported outcomes) is now available. (Source: ISPOR eBulletin)
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Medicare Drug Prices and the Deficit
This perspective, by author Richard G. Frank, Ph.d., poses that President Obama has put forth an idea that promises important cost savings to the nation while preserving drug coverage for a vulnerable population over the course of a decade. (Source: The New England Journal of Medicine)
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Evidence: AstraZeneca and a new kind of science
AstraZeneca has begun a new collaboration with HealthCore to conduct real-world CER studies. (Source: AZ Health Connections)
Read more.
Patient-Centered Outcomes Research Institute Request for Proposal – Review of Guidance
REQUEST FOR PROPOSAL - Review of Guidance Documents for Selected Methods in Patient Centered Outcomes Research. Application due by Dec. 2, 2011. Final report due by May 2012. (Source: pcori.org)
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Comparative Effectiveness Research as a Drug Development Tool
A Q&A with John Doyle, Vice President and Practice Leader of Quintiles Consulting, sheds light on the complex issue of comparative effectiveness research, and its strategic importance in successful and efficient biopharmaceutical development. (Source: quintiles.com)
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CMS Announces Accountable Care Organization Rule
CMS Administrator Berwick explains ACO’s in plain language in this video. (Source: healthcare.gov)
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e-Book: Health Economics: An International Perspective
This popular textbook provides comprehensive but accessible coverage of health economic principles and applications written by Barbara McPake and Charles Normand. This is a free download.
(Source: mybooksplace.com)
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Evidence-Based Medicine Powerpoint Presentation
If you are interested in "Evidence-Based Medicine" powerpoint themes, you can download to use this powerpoint template for your own presentation template. For viewing only, you can play with a flash based presentation viewer instead of downloading the ppt file. (Source: docslide.com)
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Communicating Product Value Clearly to a Demanding Payer Audience
Clear communication of product value to payers and other decision makers represents a critical element of market access preparations for all companies. (Source: UBC)
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Market Access: A Viewpoint from the Field
The past and future of market access is discussed with one of the pioneers in the field, Dr. Robert Hollamby. (Source: UBC)
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Assymmetry in the Ability to Communicate CER Findings
Watch interviews with experts on inequities in access to data, evidence tresholds, and the ability to convey informations.
Read and see more.
The Patient-Centered Outcomes Research Institute Resource Guide
The Patient-Centered Outcomes Research Institute Resource Guide from NPC provides specifics concerning PCORI’s implementation, biographies of the new PCORI Board members, and a history of CER in the United States, as well as other resources. (Source: National Pharmaceutical Council)
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Russia: Needs to Invest in Cold Chain Infrastructure for Biopharma to Grow
If Russia is to truly capitalise on this interest from big players within the pharmaceutical industry it will need to invest in its infrastructure, including its cold chain – an asset which will become ever more important as biopharmaceuticals develop. (Source: Pharma iQ)
Read
more.
Health Outcomes Worldwide Secures Financing
Nova Scotia co. Health Outcomes Worldwide rcvd $250,000 from Innovacorp to help develop business & expand operations. (Source: canada views.ca)
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New PAREXEL Podcast Series to Deliver Clinical Development and Commercialization Thought Leadership
PAREXEL "Insights 1 to 1" podcasts are conversations with thought leaders from PAREXEL designed to inform listeners about advanced approaches for biopharmaceutical companies to accomplish their goals. (Source: iStockAnalyst)
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Parexel Expands commercialization services
PAREXEL expands commercialization services to support evolvingHEOR, Medical Affairs, Mrktg, Reimbrsmt, & Mngd Markets.
(Source: iStockAnalyst)
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PAS reverses NICE rejection of Takeda
Takeda's Mepact (mifamurtide) has been recommended by the National Institute for Health and Clinical Excellence (NICE) as a treatment for young patients with osteosarcoma, when it is made available to the NHS at reduced cost under a patient access scheme (PAS). (Source: PharmaTimes Online)
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MGMA Urges Practices To Take Charge
ACOs and HIE were hot topics at MGMA Meeting. (Source: Healthcare Technology Online)
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5 Threats To Value-Based Insurance Design
VBID is a promising approach to improving health and cost outcomes, but its use has been limited. (Source: Managed Care Magazine)
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Pfizer Establishes Precision Medicine Research Collaboration With Medco
Pfizer/Medco Collaboration: “precision medicine” to improve outcomes. (Source: FiercePharma)
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Pharm Exec: 30 Years, 30 Leaders
PharmExec profiles of the 30 most influential in shaping biopharma in the last three decades.
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Quintiles Acquires Outcome Sciences, Inc., Premier Observational Research Company
With late phase (Phase IIIB and Phase IV) research becoming increasingly important to multiple healthcare stakeholders, Quintiles announced it has acquired Outcome Sciences, Inc. (Outcome), a privately held outcomes research firm headquartered in Cambridge, Mass according to Clinical Trials Online.
Read more.
Medical Societies: Exclude Cost Analysis from Outcomes Research
Medical societies want to make sure comparative effectiveness research is used to support decisions about medical care, not dictate them.
Read more.
Can a Static Threshold Acommodate the Dynamics of Drug Development?
ISPOR Press Release notes the challenge for value based pricing in areas of high unmet need where the comparator is a generic.
Read more.
Career Path a Top Concern for Health Outcomes Liaisons
Few, if any, drug companies have developed career paths for their health outcomes liaison (HOL) teams, according to a new study from Cutting Edge Information.
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Pay for performance contracts for Avastin in Germany
Roche offering money-back guarantee to German hospitals if drugs don’t work, causing legal discussion, according to Health Economics Blog and a German article.
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Health economists offer new decision framework for NICE
NICE is increasingly making "fast track” recommendations to the NHS on the use of new drugs and devices soon after these products are first licensed, but such decisions are frequently being made when the evidence base to support these new technologies is limited, say the researchers. (Source: PharmaTimes Online)
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Choosing the Right Health-Care Plan
It's open-enrollment season, that time of year when most companies roll out changes to their benefit offerings. Employees typically have a few weeks to elect their packages for the upcoming year. And for 2012, employers are once again stepping up their push to force workers to take more responsibility for their own costs and health—though unlike this year, there will be few major changes related to the federal health-care overhaul.
(Source: WSJ)
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Abbott spin-off could attract mega merger
Abbott’s new spin-off pharma firm could attract a lot of attention from big pharma looking to sure up their portfolios.Analysts are speculating on what the new spin-off could go for but the highest prediction comes from the Goldman Sachs Group, which believes it could sell for $54 billion. (Source: InPharm)
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Four Ways Women Stunt Their Careers Unintentionally
What we've found in our work is that career momentum for women is not about adding job skills but about changing everyday thinking and behaviors. We don't think the majority of high-performing women need to make major changes. Small adjustments in how they think and act can improve not only how confident they seem, but how confident they feel. (Source: HBR Blog Network)
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Abbott Plans to Split Into Two Companies, finalized by end of 2012
Abbott Laboratories said on Wednesday it would separate into two publicly traded companies, one focused on medical devices like heart stents and the other in what it called “research-based pharmaceuticals,” such as its blockbuster rheumatoid arthritis drug Humira. (Source: NYT, 10/24/2011)
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Eli Lilly's profits fall 5% in Q3
It's earnings time again. Today, Eli Lilly ($LLY) announced that its profits for the third quarter fell 5% to $1.24 billion. However, its revenue jumped 9% to $6.15 billion on strong performances by Cymbalta, Humalog, Forteo, Strattera, Cialis and Alimta, as well as growth in animal health, Japan and China. (Source: FiercePharma)
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more.
Data sharing key in CIGNA collaborative accountable care
As the paradigm shifts from volume to value, accountable care organizations (ACO) will need to share data between providers and payers, according to experts at America's Health Insurance Plans' (AHIP) Summit on Shared Accountability in Washington, DC. (Source: FierceHealthPayer)
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more.
Insurer Pumps $20 Million Into Accountable Care Tech
Blue Shield of California will provide cash infusion to help 18 providers implement health IT to develop accountable care organizations. By Nicole Lewis InformationWeek Blue Shield of California is providing about $20 million to 18 California hospitals. (Source: Information Week)
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more.
Pfizer buying patient's personal info from Australian pharmacists.
Australian pharmacists are angry about a deal giving Pfizer (
$PFE) access to patients' personal information--for a fee. Under an agreement between the drug giant and the country's Pharmacy Guild, anytime a patient fills a prescription for one of 9 Pfizer drugs, that person's personal contact information is forwarded to the company. Pfizer pays $7 for each record. (Source: FiercePharma)
Off-Label Changes Coming? Sorrell Ruling Prompts New Legal Challenges
10/2011, The RPM Report) reports “...Marketers have long complained about a lack of clarity from FDA on how to discuss unapproved uses of prescription drugs and biologics without running afoul of the Department of Justice...Drug manufacturers now see an opening to revisit the issue in the aftermath of the Supreme Court's opinion in the Vermont data mining case Sorrell vs. IMS Health. In that case, the high court struck down as unconstitutional Vermont's attempts to place restrictions on the use of physician prescribing data by pharmaceutical companies for marketing purposes.” Paid Subscription Required.
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IOM Urges Affordable Essential Benefits Package
10/7, Alicia Ault, The Oncology Report) reports “...The panel also endorsed the use of ‘medical necessity’ to guide decisions on whether certain procedures or services should be covered, and called for transparency in developing rules for that process. Comparative effectiveness research and evidence-based practices should be used when designing benefits, according to the report. ‘New and alternative treatments, in the view of the committee, should meet the standard of providing increased health gains at the same or lower cost.’”
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Op-Ed: Comparative Effectiveness Reviews Mean Fewer Cures
(10/9, Benjamin Zycher, Washington Examiner) comments “...Expanding federal involvement in CER creates the possibility that findings, however uncertain, will influence policies on coverage, reimbursement, and incentives in Medicare, Medicaid, and other programs...New research from the Pacific Research Institute shows that the CER process now being implemented will reduce research and development investment by $10 billion per year. This would yield a loss of 5 million life-years annually"
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Query Health at the HIT Policy Committee Meeting
Richard Elmore of ONC presented on Query Health, recently launched initiative to develop standards and services for distributed population queries. Guidance from and linkage to the HITPC will be crucial to the success of this effort. Elmore presented the vision of Query Health as follows: ?Enable a learning health system to understand population measures of health, performance, disease, and quality, while respecting patient privacy, to improve patient and population health and reduce costs.(Source: HealthCare Technology News)
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Medco CEO Champions Robots Over Pharmacists
In an attempt to demystify that role, Medco CEO David Snow told attendees at the Cleveland Clinic’s Medical Innovation Summit last week that pharmacists are not in fact doling out health information to patients. “I’m not dissing retail [pharmacy], but…there’s a fiction that a pharmacist comes out and dialogues with you,” said Snow. “In reality, a high school student hands you a script from the shelf.”(Source:PharmExec.com, Ben Comer)
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Many Pills, Many Not Taken
When it comes to medicine, as many as half of Americans don't stick to their regimens. They fail to fill about 20% to 30% of prescriptions written by doctors, don't take drugs as directed, and don't refill medications when they run out. Prescriptions that don't get picked up or refilled can be tracked using electronic medical records and prescribing technology. Clinical pharmacy specialists, case managers and other team members follow up with reminders, phone calls and counseling to get patients back on the wagon.(Source: WSJ, October 10, 2011)
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Anthem pays patients to choose cheaper docs
Anthem Blue Cross and Blue Shield in Connecticut is testing an experimental type of health plan that pays patients hundreds of dollars in cash rebates for choosing lower-cost doctors. Its new "SmartShopper" program forces customers to be aware of healthcare costs because they can compare prices, reports the Hartford Courant. "(Source:FierceHealthPayer)
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