Comparative Effectiveness
PPT Presentation by Gemmen et al reporting on the Patient Registry SIG from ISPOR.
This fact sheet describes awards made by the Agency for Healthcare Research and Quality (AHRQ) in Fiscal Year (FY) 2010 to support trainees who are focusing on comparative effectiveness research. Funding to support these projects was provided through the American Recovery and Reinvestment of 2009.
Variety of White Papers, News, Methods Guides, and Databases to facilitate Comparative Effectiveness.
The AMCP eDossier System is a centralized, secure, web-based platform, that provides qualified health care decision makers the opportunity to easily access, review, and evaluate research to make informed, evidence-based decisions.
A Format for Submission of Clinical and Economic Evidence of Pharmaceuticals in Support of Formulary Consideration. FMCP Format Executive Committee. (Source: Journal of Managed Care Pharmacy, Jan. 2010)
by Cohen et al., who support a pluralistic system of CER analyses with a clearinghouse for systematic reviews conducted by multiple evidence-based practice centers, each uniquely suited to its constituency. (Source: Applied Health Economics & Health Policy: December 2009)
Sign up to receive draft methods.(Source: AHRQ, Nov. 2009)
Each of the three major health care reform bills now before Congress contains a major section establishing the U.S.'s first comparative effectiveness research agency. (Source: GoozNews ~ 28 Sep 2009)
"...the administration considers Baucus’s bill the most promising vehicle for crafting a compromise, because it is less costly than the alternatives approved by four other congressional committees and is the most palatable to influential private stakeholders." (Source: Iglehart JK, NEJM, September 2009)
Welcome to the CEA Registry Blog by the Center for the Evaluation of Value and Risk in Health, Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, Boston, MA. We have developed this blog to encourage interactivity among our users by allowing readers to post comments and questions about the Registry. The forum of this blog ranges from posting brief online updates to more in-depth content, enabling our users to be in-the-know about new developments and resources. We invite all comments and suggestions.
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.
Only 32% of medication studies published in top medical journals compared the effectiveness of existing treatments, and active-comparator trials were less likely than trials with inactive controls to report positive results. (Source: Michael Hochman, MD; Danny McCormick, MD, MPH, JAMA, 2010;303(10):951-958)
Presentation by Badri Rengarajan, M.D., Archimedes
International network of more than 28,000 dedicated people from over 100 countries. We work together to help health care providers, policy-makers, patients, their advocates and carers, make well-informed decisions about health care, based on the best available research evidence, by preparing, updating and promoting the accessibility of Cochrane Reviews – over 4,600 so far, published online in The Cochrane Library.
Presentation by Jean Paul Gagnon, PhD, Health Policy Consultant
By Josh Feldstein. This white paper examines key factors in CER, and makes specific recomendations.
Presentation at ISPOR Europe, Nov. 2011 by Laurent Eckert, PhD, sanofi-aventis R&D, Massy, France
The National Patient Advocate Foundation has launched a comparative-effectiveness research database (PDF) that compiles research funded by the National Institutes of Health and the Agency for Healthcare Research and Quality...The database was launched with information on 224 NIH research projects; a separate database catalogs information on 49 cancer-related comparative-effective research projects funded through the NIH...Also included in the database is information on 352 AHRQ research projects, 72 of which were paid for with stimulus funds. (Source: (1/6, Andis Robeznieks, Modern Physician)
Excellent overview of the use of CER and HEOR
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.
Healthcare has never been more enmeshed in the political moment. Ever since the announcement of Don Berwick to lead CMS, opposition centered around Berwick's supposed desire to ration care. Berwick's supporters argue that care is already rationed arbitrarily by insurers.
CER could significantly stifle innovation," said John A. Vernon, a professor at the University of North Carolina at Chapel Hill and co-author of the study. 'As a result, Americans will live shorter lives in poorer health. Simply put, CER will cause us to produce less health.'...'Comparative effectiveness research would put the brakes on medical innovation and prevent many groundbreaking drugs from ever being invented,' said Robert Goldberg, vice
president of CMPI and co-author of the study."
HHS seeks input on approaches to developing a CER Inventory that capture ongoing and existing CER in the United States. The inventory will be accessible to the public, including patients, clinicians, and policymakers, through a web-based system.
As stakeholders continue to strive for greater value in the US healthcare system, many are calling for more research to inform treatment decisions, particularly for providers and patients choosing between available multiple interventions.(Source: April 2011 American Health& Drug Benefits,Riaz A, et.al.)
Attitudes of employers on comparative effectiveness research.
Why do we expect government to pay for drugs and a whole menu of medical interventions that are no better at securing health than the older alternatives they seek to replace? The burden of evidence must be on innovation to explicitly prove its worth...Without research into the comparative effectiveness of treatments, how can anyone -- payer, provider, or patient -- know what care should be guaranteed, delivered, and reimbursed? (Source:Sam Wainwright, New American Foundation: The New Health Dialogue)
This article examines the structure, process and outcomes of ISPOR task force, comment on the potential impact of the report in the context of comparative effectiveness research, and offer a few observations on the future of this field.
Editorial stating that CER is more than just a topic to debate, the use of this research study in assessing the value of therapeutics has vastly remained undetermined among the majority stakeholders in the industry (Source: Infosys).
Drug/placebo differences are much larger than drug/drug differences. In the latter case much, much larger studies are needed to detect a difference between them. Such studies will cost millions to perform, however, and ultimately result in higher drug prices.
Primer in AJHP by Schumock and Pickard, containing a good basic overview.
AHRQ invites the public to comment on this proposed information collection
This final research report, available in PDF, states that these best practices address critiques from patients, clinicians, policymakers, and others who assert that SRs typically focus on broad populations and, as a result, often lack information relevant to individual patients or patient subgroups.(Source: AHRQ)
Now an analysis of findings from six focus groups commissioned by the Medicare Payment Advisory Commission, or MedPAC, finds that although physicians think comparative effectiveness research studies are a good idea, their support for such studies depends on a number of factors.
It requires a much broader view of the healthcare system so that information will exist about a patient’s outcome as he or she moves from diagnosis to treatment in the healthcare system. (Source: PharmaVOICE - September 2010)
Significant comparative effectiveness research (CER) efforts should be dedicated to understanding the effectiveness of investments across broad determinants of health instead of focusing primarily within the health care domain alone. (Source: JAMA,by Kindig et al)
The National Patient Advocate Foundation (NPAF) has created a new Comparative Effectiveness Research (CER) Database available to the public. The new database compiles comparative studies funded by the National Institutes of Health (NIH) and the Agency for Healthcare Research and Quality (AHRQ). The majority of these reviews are funded through the $1.1 billion in CER funding allocated by the American Recovery and Reinvestment Act (ARRA) which was signed into law in February 2009.
Comparative effectiveness research provided for in congressional healthcare overhaul legislation, can fill in the gaps left by standard clinical trials by pinpointing subpopulations that respond to a particular drug, an expert says. (source: FDANews, Nov. 16, 2009)
Patients can expect significant savings and better outcomes from their prescription medications when health care professionals use comparative effectiveness research, according to researchers at the University of Illinois at Chicago.
Provides public electronic access to a comprehensive database of cost-effectiveness ratios in the published literature. Its goals are to find opportunities for targeting resources to save lives and improve health and to move towards standardization of cost-effectiveness methodology in the field. Housed at Tufts Medical Center, Institute for Clinical Research and Health Policy Studies.
"The proposal to include $1.1 billion for comparative-effectiveness research (CER) in the federal stimulus package encountered a vigorous and well-coordinated backlash. The campaign to gut this funding ultimately failed, but the debate it engendered and the resonance of the opposition's arguments in both lay and policy circles reveal much about the issues that will surround such research and its application in the coming years."
Presentation at ISPOR Europe, Nov. 2011 by Richard Gliklich, MD, President & CEO, Outcome, Cambridge, MA, USA; Newell McElwee, PharmD, MSPH, Exec Director, US Outcomes Research, Merck , North Wales, PA, USA; Donna Messner, PhD, Senior Project Manager, Center for Medical Technology Policy, Baltimore, MD, USA
"The American Reinvestment and Recovery Act gives comparative-effectiveness research (CER) a large boost in funding over the next 2 years. Despite a consensus that better information about the relative effectiveness of different medical interventions is needed to improve the quality and value of care, some view CER with skepticism."
DERP is a collaboration of public entities (the Center for Evidence-based Policy and the Oregon Evidence-based Practice Center) who have joined together to produce systematic, evidence-based reviews of the comparative effectiveness and safety of drugs in many widely used drug classes, and to apply the findings to inform public policy and related activities in local settings
Reform for the National Institute for Health and Clinical Excellence and a switch to value-based pricing are on the agenda as the new coalition government lays out its proposals for the National Health Service. (Source: Pharma Times, May 24, 2010)
Focusing on scientific cooperation in HTA in Europe, thirty four government appointed organisations from the EU Member States, Accession Countries and EEA work together to help developing reliable, timely, transparent and transferable information to contribute to HTAs in European countries. The EUnetHTA Joint Action builds on the achievements of a number of the previous European initiatives including the EUnetHTA Project (2006-2008) and the Pharmaceutical Forum (on relative effectiveness).
First in a series of articles to discuss how to use evidence to arrive at reliable scientific conclusions? (Source Steven Novella, Science-Based Medicine, Nov. 18, 2009)
Evidence-based Medicine Workbook, Finding and applying the best research evidence to improve patient care. (Source: Glasziou, Del Mar, Salsbury, BMJ Books, September 2009)
JMCP Supplement. Includes Ten Commandments for CER, secondary data structures, stat issues, developing collaborative study protocol, and more.
Presentation by David Gregory, Executive Vice President, Presscott Associates
Pharma pricing and market access case study
Master slide deck from Tufts University which covers FDAMA Section 114 and CER
77 page report with definition, criteria, infrastructure, strategic framework, priorities, etc.
Experts believe that comparative-effectiveness research can substantially reduce future health care spending and improve the quality of care. (Source: NEJM, Feb.3,2010)
Designed as a set of high-level questions, the GRACE Principles address good practice for the design, conduct, analysis, and reporting of observational CER studies. These principles may be expanded to provide more detail and/or to address special applications.
Pharmacoeconomics and health outcomes research are playing an increasingly important role in informing clinical development and market access decisions of new innovative medicines. Both disciplines are dealing with the evaluation of the costs and outcomes of healthcare interventions and can be considered as two branches of the same “value for money” tree. (Source: Frontiers Reviews, Dominique J. Dubose)
Full list of available quality of care reports, EBM guides, etc.
Presentation by Kim D. Slocum, President, KDS Consulting, LLC
Comparative effectiveness research (CER) stands out as the intriguing wild card of health care reform. CER compares competing treatments against each other to determine which interventions work best, supplying critical information for medical decision-making and health policy. If CER works as planned, it may be one of the few reform measures to survive into the final health care legislation that has a chance of flattening the cost curve while also improving quality.(Source: University of North Carolina (Chapel Hill) School of Law; University of North Carolina (UNC) at Chapel Hill, Richard S. Saver)
YouTube Video where Academy of Managed Care Pharmacy (AMCP) discusses issues that health plans need to consider to prepare for the eventual arrival of follow-on biologics.
Comparative Effectiveness Research (CER) has been a primary topic of both discussion and legislative debate for the past four Congressional sessions, with both House and Senate resolutions and bills drafted, debated, amended, and ultimately tabled as members tried to arrive at a meaningful way to cultivate the CER-derived evidence base within the U.S.
By Marcial Velasco Garrido, Finn Børlum Kristensen, Camilla
This house believes that the widespread use of comparative effectiveness reviews and cost/benefit analyses will stifle medical innovation and lead to an unacceptable rationing of health care. (Source: The Economist, October 2009)
HHS Secretary Kathleen Sebelius today announced three sets of grants and cooperative agreements totaling nearly $17 million for patient-centered outcomes research (PCOR), or research that compares treatments and strategies to improve health outcomes for patients (Source: US Department of Health and Human Services).
Highlights from an Issue Panel on Perspectives on Comparative Effectiveness Research (CER): Views from Diverse Constituencies, by Birnbaum et al. Different seats in the health-care arena offer a di- verse range of views regarding comparative effectiveness research (CER) and whether it is a catalyst for conflict or for positive change.(Source: ISPOR Connections, Sept/Oct 2010, page 6)
The author relates CER to CBA, and discusses why CER research design is easier to translate into CBA than randomized controlled trials.
This role and how physicians might be involved in comparative-effectiveness research are important considerations. As front-line service providers, physicians have a considerable stake in how comparative-effectiveness research mechanisms are constructed, in leading collegial buy-in to associated processes, and in implementing recommendations through their clinical activities.(Source: February 2011, AMJM)
Health systems around the world are under increasing strain because of the rising prevalence of chronic conditions, including diabetes, heart disease, and asthma. For more than 15 years, disease-management programs (DMPs) have been promoted as a solution to this problem. By carefully coordinating the delivery of high-quality care to patients with chronic conditions, the programs are supposed to enhance the patients’ health, reduce hospitalization rates, and lower treatment costs.
The caliber and stature of this group is a testament to the importance of addressing issues of effectiveness and quality in the healthcare delivered across New England,' stated Steven D. Pearson, MD, MSc, President of ICER. 'We look forward to working with this distinguished council to produce actionable, relevant information for patients, providers and policymakers in New England.'"
Provides an overview and analysis of public funding of CER and the desirability and feasibility of incentivizing additional CER in the private sector.
The purpose of this OHE monograph is to inform and stimulate debate about the way different sorts of evidence and considerations are taken into account in decisions about new health care technologies.
Further investment in and analysis of comparative effectiveness is required for health care reform.
Manufacturers, in more countries, are proposing risk-sharing and value-based schemes more often.
.
Ulf Staginnus, is the creator of HealthEconomics Blog and Head Pricing, Health Economics & Outcome Research, Europe, at Novartis Oncology. He talks about the direct implications of recent European cost-containment measures on the pharmaceutical industry. Watch, and learn why the tough times are here to stay. what industry executives and policy makers alike, must do to reach an innovative and cost-effective agreement.
This issue of PharmacoEconomics is devoted entirely to issues related to comparative effectiveness research ( Source: Pharmacoeconomics, Authors: Howard G. Birnbaum and Paul E. Greenberg).
The Institute of Medicine (IOM) released a new report outlining its recommended standards for systematic reviews of the comparative effectiveness of medical or surgical interventions (see the list of the standards). In developing its standards, the IOM relied on the current methodological evidence and guidance from respected organizations that produce systematic reviews.
It is clear to all informed persons that the nation needs better evidence of what works in health care, and this has propelled comparative effectiveness research (CER) policy developments of late. (Source: Rebecca Singer Cohen, Bryan Luce, Health Affairs Blog, June 30, 2010)
Leela Barham explores whether pharma firms can use value-based pricing (VBP) to improve market access.
This article addresses the influence of growing interest in humanism and comparative effectiveness on health care reform.
The realization that meaningful medical liability reform is critical to controlling health care costs and optimizing quality of care is spreading beyond traditional supporters, as evidenced by Peter Orszag's column.(Source: NYT Opinion Pages)
The objective of this paper is to describe ways that health care reform will affect MCO populations in the future, to examine examples of how MCOs have utilized CER data in the past, and to identify questions that MCOs will have to address as they integrate CER into future decision making.
The objective of this paper is to describe some of the impact, both positive and negative,
that CER may have on the pharmaceutical industry.
Article is critical about the dissemination of information for comparative effectiveness.
Leela Barham explores the potential for patient access schemes (PAS) to help companies achieve market access.There has been a rise in the number of patient access schemes (PAS), or risk-sharing schemes, in the UK and other countries. They are “simply a response to uncertainty,” says Jim Furniss, director, market access solutions at Bridgehead International Ltd. That uncertainty is two-fold—about the benefits of a product in real-life use and about budget impact. (Source:eyeforpharma, August 10, 2010)
This is a presentation by Janice Haigh at Market Access Europe 2010 that took place March 2-3, 2010.
With increasing frequency in Europe, and now starting to show up in the US, biopharma companies and payers are entering into agreements to provide some form of risk sharing or price protection as new drugs are adopted into formularies. (Source: eyeforpharma, August 10, 2010)
Presentation by Sheldon Greenfield, MD, Health Policy Research Institute, University of California, Irvine, November 17, 2010
AHRQ outlines guide for comparative effectiveness research just released!
Intends to improve the transparency, consistency, and scientific rigor of this work, which consists of systematic reviews of existing research on effectiveness, comparative effectiveness, and comparative harm of different health care interventions. (Source: AHRQ)
ISPOR Special Interest Group & Task Force Forum
A pioneering scheme designed by government to impose a money-back guarantee on pharmaceutical companies if their drugs did not adequately treat patients has failed to provide any clear conclusions more than seven years after it was launched.
Article on the early formation of NICE
NEHI, an independent nonprofit national network for health innovation, proposed a national strategy for disseminating comparative effectiveness research (CER) findings that would be led by the newly created Patient-Centered Outcomes Research Institute (PCORI)
The HMO Research Network (HMORN) is uniquely positioned to conduct Comparative Effectiveness Research (CER). The 2009 health care reform debate; Recovery Act legislation and funding mandates; the Institute of Medicine (IOM) report of Initial National Priorities for Comparative Effectiveness Research and other forces have all worked to focus attention on CER as never before.(Source: Poster Abstracts from 16th Annual Research Network Conference, March 21-24, 2010)
Comparative effectiveness research (CER) may be defined informally as an assessment of available options for treating specific medical conditions in selected groups of patients. In this context, the most prominent features of CER are the various patient populations, medical ailments, and treatment options involved in any particular project.(Source:AJOM, Volume 123, Issue 12, Concato, J. et. al)
Presentation at ISPOR Europe, Nov. 2011, by Marc L. Berger, M.D., Executive Vice President & Senior Scientist, Life Sciences, OptumInsight, New York, NY, USA
Xcenda's Managed Markets consultants discuss how manufacturers are revamping their approach to managed care messaging to increase their products' market opportunity. Key points for their presentation include impact of payer environment, building value props throughout the life cycle, and communicating this message with respect to FDAMA Sect. 114. (Source: Xcenda, April 20, 2010)
Presentation at ISPOR Europe, Nov. 2011, by Michael Drummond, MCom, DPhil, Professor of Health Economics, Centre for Health Economics, University of York, Heslington, York, UK
Healthcare sector participants in the US and worldwide offer a rich diversity of views on comparative effectiveness research (Source: Pharacoeconomics, Nellesen et al.)
Dan Ollendorf, MPH, ARM , is 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.
This 50-page special report contains insider information from three leading experts in DM analytics. They review key principles in calculating ROI, how to establish metrics for evaluating DM programs, and common mistakes in measuring ROI. They also share some relevant case studies for comparison.There is a fee to order this report.
During recent discussions, it has been argued that stratified cost-effectiveness analysis has a key role in reimbursement decision-making and value-based pricing (VBP). It has previously been shown that when manufacturers are price-takers, reimbursement decisions made in reference to stratified cost-effectiveness analysis lead to a more efficient allocation of resources than decisions based on whole-population cost-effectiveness analysis. However, we demonstrate that when manufacturers are price setters, reimbursement or VBP based on stratified cost-effectiveness analysis may not be optimal. (Source:Neil Hawkins and David A. Scott, Health Economics. 2011(June):20;6)
Rethinking Randomized Clinical Trials for Comparative Effectiveness Research: The Need for Transformational Change. (Source: Various authors, Annals of Internal Medicine, Aug. 4, 2009)
Presentation from Clifford Goodman, PhD delivered at the National Comparative Effectiveness Summit, Oct. 13, 2011
Selecting quality of care and resource use measures is an important and challenging task for organizations striving to improve the quality of health care in their communities. This Decision Guide is designed to inform readers about the most critical issues to consider when selecting and adopting such performance measures.
GfK HealthCare, one the largest providers of fully integrated custom health care marketing research in the world, announced today the undertaking of a first-ever research study aimed at examining the UK's National Institute for Health and Clinical Excellence (NICE) as a model producer of Health Technology Appraisals (HTA), and its impact on decision making in ex-UK health care systems. (Source: The Medical News, July 21, 2010)
Four major content areas for which abstracts were solicited from scientists across the United States included: (1) study design, (2) data collection, (3) statistics and analytic methods, and (4) policy issues and applications. The symposium proceedings are published in a supplement to the June 2010 issue of the journal Medical Care. A printed copy of the supplement is available free of charge through the AHRQ Publications Clearinghouse.
This presentation contains: Policy context of NICE, NICE methods, Are devices different?, The role of randomised trials, When do we have sufficient evidence?, Impact of NICE guidance
A range of initiatives from private payers to drive a tighter link between evidence comparisons and treatment decisions.(Source: PharmExec.com, by Edward Tuttle, Anita Chawla, Dave Nelleson,Justin Works)
Peter Mansell explains how multiple stakeholders are analyzing data to make their own determinations of medicine value.
Advocates of CER often say their goal is to find and encourage what is best for patients, and certainly CER can be used in this way. But when the data gathered is used by government agencies to lower spending - such as by favoring older, cheaper drugs over newer, more expensive ones, as has been the case in Britain - the priority becomes the financial bottom line, not the best interests of the patient."
PowerPoint Presentation by Dr. Joe Jackson,Applied Health Outcomes Research at Thomas Jefferson University. Proponents of Comparative Effectiveness Research (CER) hope to challenge conventional thinking in evidence-based medicine, observational research design, patient-centered aspects in medical care, and health plan design applications such as Accountable Care Organizations. Inertia in healthcare practices and multiple chronic diseases will test the veracity of Comparative Effectiveness applications. This presentation covers history, context, governmental players, targets of CER including chronic illness, policy issues, stakeholders, and ACO issues.
Presentation delivered by Joe V. Selby, M.D. at the National Comparative Effectiveness Summit, Oct. 12, 2011
This is a paid report from ISR reports. Data is generated from 30 respondents, all of whom have responsibility for formulary decision-making at their organizations. Data highlights that US payers desire more data from randomized controlled trials that utilize a comparator product(s), not just a placebo.
Use of Comparative Effectiveness Research in Drug Coverage and Pricing Decisions: A Six-Country Comp
This issue brief comparatively examines the use of CER across six countries—Denmark, England, France, Germany, the Netherlands, and Sweden. With CER gaining traction in the United States, these international experiences offer insights and potential lessons.
Policymakers often use the research these organizations generate to determine the content of publicly provided health benefits—for example, to decide whether a new drug should be covered under regional or national formularies. Other uses include negotiating pricing arrangements with drug companies or designing “value-based” cost-sharing arrangements, wherein patients pay more out-of-pocket for drugs deemed less effective than their alternative.
Interview covering trends and major challenges in HEOR.
The new value-based pricing strategy will radically overhaul the way medicines are paid for. Once the PPRS scheme has run its course by 2014, grug prices will be set according to the value the medicines provide. The White Paper also proposes changes to the role of NICE (National Institute of Clinical Excellence) and structural shifts in the way that budgets are managed – with 80% of control being handed over to GP’s. (Source: InPharm.)
Value-Based Purchasing and Comparative Effectiveness Research:
Why the Pharmaceutical, Biotechnology, and Medical-Surgical Device Industries Should Embrace the Coming Market Evolution. (Source: MarCom Group International, Inc.)
In February 2012, the National Health Council held its annual Voluntary Health Leadership Conference in San Diego, California. Joe Selby, MD, MPH, Executive Director of the Patient-Centered Outcomes Research Institute, was interviewed by the NHC about how better information gleaned through comparative effectiveness research can lead to better health decisions.
Insight into the reasons for choosing one type of comparative effectiveness research study design over another. (Source: 5/24, National Pharmaceutical Council: E.V.I.dently Today)
