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From the desk of Priya Ranade |
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| For more than 17 years, ICER has been active in developing methods for evidence assessment. Every few years, we intentionally revisit our methods and processes for conducting value assessments -- also known as our Value Assessment Framework (VAF). We view the VAF as the backbone of our rigorous, transparent evidence reports that, within a broader mechanism of stakeholder and public engagement, will help the United States evolve toward a Health care system that provides fair pricing, fair access, and a sustainable platform for future innovation. This week, we released a set of proposed changes to our VAF, beginning in 2024. These proposals are based on ICER’s experience in methods development for health technology assessment (HTA) reports in the US, benchmarking with HTA agencies around the world, and input from stakeholders across the US health system. ICER is accepting public comment on these proposals through June 30th.
Areas with proposed changes include:
- Clinical trial diversity ratings and other methods adaptations related to health equity.
- Cost-effectiveness scenarios related to potential effects of Medicare drug price negotiation.
- New methods to ensure that cost-effectiveness analyses done according to a modified societal perspective have “non-zero” inputs for impacts on productivity for the patient and caregivers, even when direct data are lacking.
We last updated our Value Assessment Framework in 2020. |
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Let's see what else happened this week... |
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| ICER planning changes to assessments for IRA, diversity, other factors BioCentury |
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| Opinion I lost 40 pounds on Ozempic. But I’m left with even more questions. The Washington Post |
Last year, ICER published an obesity management Final Evidence Report on subcutaneous semaglutide (Wegovy, Novo Nordisk), liraglutide (Saxenda, Novo Nordisk), phentermine/topiramate (Qsymia, Vivus Pharmaceuticals), and bupropion/naltrexone (Contrave, Currax Pharma). We found that semaglutide used for weight loss would achieve common thresholds for cost-effectiveness if priced between $7,500 – $9,800 per year; the current annual net price is $13,618. |
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| Bernie Sanders says price of Alzheimer’s treatment is unconscionable, calls on HHS to take action CNBC |
| Sen. Bernie Sanders on Wednesday called on the U.S. Health and Human Services Department to take action to ensure seniors can afford the Alzheimer’s treatment Leqembi. Sanders, who chairs the Senate Health Committee, in a letter to HHS Secretary Xavier Becerra called the $26,500 annual price tag for Leqembi set by drugmakers Eisai and Biogen “unconscionable.”
Earlier this year, we released our Final Evidence Report assessing the comparative clinical effectiveness and value of Leqembi. ICER analyses suggested the treatment would achieve common thresholds for cost-effectiveness if priced between $8,900 – $21,500 per year. |
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| MUST READS
Merck sues US government to halt Medicare drug price negotiation Reuters |
Merck sued the U.S. government on Tuesday, seeking an injunction of the drug price negotiation program contained in the Inflation Reduction Act (IRA), which it argues violates the Fifth and First Amendments to the U.S. Constitution. This is the first attempt by a drugmaker to challenge the law, which the pharmaceutical industry says will result in a loss of profits that will force them to pull back on developing new treatments. The Biden administration's drug pricing reform aims to save $25 billion annually by 2031 through price negotiations for Medicare. |
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| ‘We don’t agree’ on drug pricing policy, FDA chief tells biotech leaders STAT
Califf criticizes insurers for doing too little on drug research STAT |
| Robert Califf, the Food and Drug Administration chief, told a crowd of biotech leaders on Wednesday that drug costs needed fixing. “We don’t agree,” said Califf, referring to a conversation he had backstage with Ted Love, the new chair of the Biotechnology Innovation Organization. “I think the prices of drugs are too high in the U.S.”
The FDA Commissioner also suggested Medicare or states should pay less for drugs that reach market under accelerated approval. ICER recommend a similar approach in our 2021 White Paper on strengthening the accelerated approval pathway: “Another reimbursement-driven approach to addressing cost concerns, while also enhancing incentives for confirmatory evidence, would be to regulate pricing at the time of accelerated approval and limit pricing to the marginal or average cost of producing and delivering the drug. This price ceiling would stay in effect until confirmatory evidence is produced.”
Separately, Califf also called on private insurers to chip in on conducting post-approval clinical research on drugs. |
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| More states embrace drug price boards to curb health costs Axios |
More states are pushing their own plans to lower drug costs, viewing it as an extension of efforts to set payment rates for utilities, transportation and other essential services. Colorado, one of the states to create a state prescription drug affordability board (PDAB), is rolling out a dashboard this week that will show which drugs are the likeliest to have price caps. |
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| Women more likely than men to skip or delay medications due to cost, CDC report finds NBC News |
| Women are more likely than men to skip, delay or take less medication than was prescribed because of cost, the Centers for Disease Control and Prevention reported. The finding came from the CDC’s National Health Interview Survey, an annual survey in which tens of thousands of people in the U.S. are asked questions about their health-related experiences.
It found that in 2021, 9.2 million adults ages 18 to 64 — about 1 in 10 — reported skipping, delaying or using less medication than prescribed over the past year to save money. Women led men when it came to this nonadherence: 9.1% versus 7%. |
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| OTHER HEADLINES
- Endpoints News: FDA to import versions of common cancer drug to alleviate shortage
- STAT: Sen. Cassidy wants to put a stop to FDA delays in drug review process
- Pink Sheet: PBM Reform: Vertical Integration, Specialty Drug Tracking Among Differences In House v. Senate Bills
- Bloomberg Law: Drug Safety Fears Spur Pentagon Plan to Test Widely Used Meds
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Want to work for a fast-paced, mission-driven organization? Look no further! ICER is looking to expand our team, which includes a diverse set of clinicians, researchers, and policy experts. |
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