Sources tell InsideHealthPolicy an international pricing index could have negative consequences on drug pricing legislation expected to be rolled into a year-end spending deal.Such an index, if formally proposed by the Centers for Medicare and Medicaid Services, would complicated a number of […]
Mulcahy: Develop Domestic Solutions to Tackle Drug Prices
RAND Corporation Senior Health Policy Researcher Andrew Mulcahy says the U.S. should find its own solutions for tackling high drug prices and pricing transparency.While referencing drug pricing in other countries can bring about short-term solutions to the problem, Mulcahy writes in an article […]
Column: Cut Wasteful Health Spending
The answer to fixing exorbitant health care spending in the U.S. is not to throw more money at the problem, the author of a recent opinion piece published on USA Today writes, but to cut wasteful spending."We need to examine health care's overpriced services, middlemen and the perverse incentive […]
Gottlieb Talks Expanding Access to High-Cost Therapies
Former Food and Drug Administration Commissioner Scott Gottlieb says opening up patient access to therapies through the Medicare market can play a key role to support a number of patients by implementing a payment-over-time model for high-cost therapies.Gottlieb made the comments during a recent […]
Legislators Added to WHCC2020 Keynote Agenda
U.S. legislators Reps. Seth Moulton and Roger Marshall have been added to the keynote slate for the World Health Care Congress 2020 event, set to kick off March 29 in Washington, D.C.Moulton's speech, according to an email, will be centered around how leaders in Washington can bolster mental […]
HHS Expands Accelerator Network
The Department of Health and Human Services (HHS) is expanding its innovation accelerator network as it welcomes five new accelerators, Fierce Healthcare reports.The new accelerators are Emory University and Georgia Institute of Technology, Plug and Play Tech Center, University of Missouri […]
NICE Post Reflects on Partnership with CMAC
A recent post on the National Institute for Health and Care Excellence (NICE) looks at the partnership between it and the Charity Medicines Access Coalition (CMAC) through which the pair worked to "identify where changes to NHS practices, that NICE can influence, could benefit patients and […]
Article Considers International Pricing Index for More than Part B Drugs
While the Trump administration is exploring an international pricing index for Medicare Part B drugs, the U.S. appears to pay more for Part D drugs than other countries, the authors of a recent Health Affairs blog post write."While international drug price comparisons are challenging, two […]
Should the U.S. Government Get More Involved in Drug Prices?
The U.S. government should look to other economically developed countries with a heavier hand in drug pricing in order to better wrangle drug prices, the authors of a recent article published on The Conversation write.More government involvement in drug prices, however, has gained "little favor" […]
FDA’s Woodcock Outlines Problem Areas of Medical Innovation
Janet Woodcock, director of the Food and Drug Administration's (FDA) Center for Drug Evaluation and Research, had a blunt message for a crowd of roughly 150 researchers on the state of medical innovation in the U.S., according to a Los Angeles Times report: "It's not working, and it won't work in […]
Warren Adds Drug Pricing to Campaign
Democratic Sen. Elizabeth Warren added a health care plan to her presidential campaign, as well as policies to wrangle drug prices, hours before the Sept. 12 presidential debate, InsideHealthPolicy reports.According to the report, the proposed bill, the Affordable Drug Manufacturing Act, would […]
States Taking Action on Drug Prices
Thirty-three states so far this year have passed a record 51 laws to address rising drug prices and affordability, Kaiser Health News reports.According to the report, 28 states passed 45 laws in 2018."Legislative activity in this area is escalating," Trish Riley, National Academy for State […]
Germany as a Model for Drug Pricing Solutions?
With American policymakers working to find solutions to rising drug prices, Germany's model could hold some clues, the author of a recent article published on Harvard Business School's Working Knowledge writes.Germany since 2011 has required pharmaceutical companies justify high price tags for […]
STAT: Pelosi’s Drug Pricing Plan ‘More Aggressive Than Expected’
While House Speaker Nancy Pelosi's plan to slash drug prices is likely to generate support from House progressives, the proposal is "dramatically more aggressive than expected," STAT reports. According to the report, Pelosi's plan would give the government the right of way to negotiate prices on […]
Officials: FDA Developing Guidance on RWD Quality
Two Food and Drug Administration (FDA) officials in an article published in the Clinical Journal of the American Society of Nephrology say the agency is working on guidance regarding real-world data quality issues, according to a Regulatory Affairs Professionals Society (RAPS) report. The authors, […]
Webinar to Spotlight Health Cost-Effectiveness Analysis
A webinar set for tomorrow, Sept. 10, by the CEA Registry will outline how standardized data on cost-effectiveness can be used by policymakers in low- and middle-income countries in health spending decisions. The webinar is set to begin at noon EST. Featured speakers include:Peter Neumann, […]
A Look at California’s Plan to Slash Drug Prices
A recent report by the San Francisco Chronicle offers a look at California Gov. Gavin Newsom's proposal for reducing the state's drug costs. According to the report, the proposal would take over the role of negotiating down drug prices for the some 13 million people on California's Medicaid plan, […]
Report Dives into FDA Regulatory Decision Making
A recent report by STAT offers a deep dive into the world of regulatory decision making inside the Food and Drug Administration (FDA) with a heavy focus on the agency's decisions on Sarepta's Exondys 51 and Vyondys 53. While the FDA gave a green light to Exondys 51 in 2016 on the condition the […]
Article Considers Best Practices for ERP Regulations
A recently article published in Value in Health considers best practices for external reference pricing regulations for countries with expanding healthcare coverage. The authors suggest that policymakers "should consider a set of requirements" when bringing external reference pricing to the […]
ACA Architect Talks Health Law, U.S. Health Care
Managed Care Magazine recently caught up with Ezekiel Emanuel, the architect of the Affordable Care Act, to discuss the health care law and U.S. health care system. While Emanuel defends his work on the ACA, he said there were some components that could use some adjustment. " ... The eligibility […]
PhRMA Takes Aim at Senate Finance Package
While PhRMA says it has been a longtime proponent for boosting affordability and predictability of cost-sharing in Medicare Part D, it says the Senate Finance Committee's latest package is the wrong course of action. PhRMA in a blog post says the committee "has pushed for changes that would upend […]
NICE Chief Dillon to Exit in 2020
The National Institute of Health and Care Excellence's (NICE) chief, Andrew Dillon, recently announced plans to step down in March 2020, Pharmafile reports. According to the report, Dillon has lead NICE since joining the organization in 1999. David Haslam, NICE's chair, said NICE after Dillon's […]
Trump Wants Spravato for Vets
President Donald Trump during the American Veterans National Convention made clear his goal of providing veterans easy, widespread access to Johnson & Johnson's drug for treatment-resistant depression, Spravato, Endpoint News reports. Trump also called on the pharma giant to give away the drug […]
Former FDA Commissioners Encourage Expanded Use of RWE, RWD
Three former chiefs of the Food and Drug Administration (FDA) have called on officials to expand the use of real-world evidence (RWE) and real-world data (RWD) to not only bolster the foundation of evidence for new therapies, but also as a way to drive down health care costs, InsideHealthPolicy […]
HHS Appealing Judge’s Decision on Prices in TV Ads
The Department of Health and Human Services (HHS) is looking to appeal a judge's decision to block the administration's plan to require drug companies include a drug's list price in television ads, FierceHealthcare reports. Officials, according to the report, have argued that the proposal would be […]
Cummings, Sanders Put Pressure on Pharma Companies
Rep. Elijah Cummings and Sen. Bernie Sanders are turning up the pressure against pharmaceutical giants Teva, Mylan and Heritage Pharmaceuticals as policymakers seek answers on generic drug pricing, FiercePharma reports. Cummings and Sanders, according to the report, allege the companies crafted and […]
Podcast Spotlights RWE in Drug Development
A new podcast in a series titled 'Non-binding Guidance' by Ropes & Gray spotlights the use of real-world evidence in the drug development landscape. Ropes & Gray attorneys Kellie Combs and Sarah Blankstein discuss how the pharmaceutical industry has been utilizing RWE in the development […]
FDA’s OCE, Syapse Partner on RWE
The Food and Drug Administration's Oncology Center of Excellence (OCE) and Syapse are joining forces to bolster the use of real-world evidence to leap over hurdles in trials, Endpoints News reports. The partnership comes as the FDA continues to express its support for RWE in the development […]
Report: Trump Administration Moving Forward with International Pricing Index
The Trump administration is moving forward on a proposal that would implement an international pricing index for some drugs covered under Medicare, The Hill reports. According to the report, Seema Verma, Centers for Medicare and Medicaid Services administrator, called the effort a "top […]
Despite Increasing Interest in RWE, Barriers Remain
While regulators have expressed interest in facilitating real-world evidence (RWE) in the drug development pipeline, a number of key obstacles, such as infrastructure and data concerns, remain, according to a PMLiVE report. Drugmaker Pfizer recently was able to lean on data from electronic health […]
