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| | | Weekly View
July 14, 2023 |
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From the desk of Priya Ranade |
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| This week, we released a revised Evidence Report assessing the comparative clinical effectiveness and value of exagamglogene autotemcel (“exa-cel”, Vertex Pharmaceuticals and CRISPR Therapeutics) and lovotibeglogene autotemcel (“lovo-cel”, bluebird bio) for sickle cell disease. According to ICER’s Chief Medical Officer David Rind, MD:
“Sickle cell disease can affect nearly every organ system in the body, and severe sickle cell disease affects nearly every aspect of a person’s life. From the earliest days of gene therapy, patients, families, and clinicians have imagined that someday it might be possible to address the underlying genetics of sickle cell to achieve a cure. These first two genetic therapies, using different technologies and altering different genetic targets may mean that day has nearly arrived. However, the need for autologous bone marrow transplantation with these therapies means they come with important potential risks, and the first CRISPR therapy necessarily has even greater uncertainties about longer-term risks and durability of benefit than a lentiviral gene therapy.”
Register now for the July 27 virtual public meeting, where ICER’s independent appraisal committee will review the evidence, hear further testimony from stakeholders, and deliberate on the treatments’ comparative clinical effectiveness, other potential benefits, and long-term value for money. |
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Let's see what else happened this week... |
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| U.S. watchdog lifts price estimate for Bluebird, Vertex/CRISPR gene therapies to $2.1 million Reuters
ICER revises sickle cell gene therapy report, preps to dig into what CMS negotiations might look like Endpoints News
ICER finds reasonable benefit for sickle cell disease gene therapies The Pharma Letter |
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ICER Launches a Patient Council to Amplify the Patient Voice in Value Assessment |
| Including the patient voice in our value assessments has always been a top priority for ICER. Most recently, in ICER’s 2020 Value Assessment Framework update, we announced our more formal Patient Engagement Program, and in 2021 we launched our Patient Portal. As we expanded our patient engagement efforts, patients themselves expressed interest in a more direct way to advise us on our work, and through those conversations the Patient Council was born. The Patient Council is a continuation of ICER’s efforts to prioritize the patient voice in our assessments. ICER announced the creation of a Patient Council to advise on ICER’s patient engagement strategy, outreach, and process for input into drug reviews and broader initiatives. The Council comprises several patient representatives with a range of expertise on health technology assessment (HTA) and engaging with ICER, offering a variety of perspectives for evaluation of the ICER process. Patient Council members are participating as individuals, and are not representing the views of their affiliated organizations. |
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ICER Developing Special Report for Submission to CMS as Part of Public Comment Process on Medicare Drug Price Negotiations |
| This week, we announced that we are developing a special report evaluating the evidence on apixaban (Eliquis®, Bristol Myers Squibb) and rivaroxaban (Xarelto®, Bayer) for the treatment of nonvalvular atrial fibrillation (NVAF). ICER plans to release this report in September 2023 and submit it to the Centers for Medicare and Medicaid Services (CMS) as part of the public comment process defined in CMS guidance. The report will be tailored to reflect the legislative specifications in the Inflation Reduction Act and subsequent CMS guidance regarding the information that CMS will use to make initial offers and pursue drug price negotiation on selected Drugs. Eliquis and Xarelto figure prominently among those drugs with high Medicare expenditure that are expected by many to be selected among the first group of drugs for price negotiation beginning later this year. |
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| The Food and Drug Administration's Accelerated Approval Process for New Pharmaceuticals: Proceedings of a Workshop in Brief (2023) National Academies of Sciences, Engineering, and Medicine’s Committee on Science, Technology, and Law (CSTL) |
| In January 2023, an ad hoc committee under the auspices of the National Academies of Sciences, Engineering, and Medicine’s Committee on Science, Technology, and Law (CSTL) hosted a virtual workshop called The Food and Drug Administration’s Accelerated Approval Process for New Pharmaceuticals.
The workshop examined the FDA's accelerated approval program, one of several pathways designed to facilitate and expedite the development and review of new pharmaceuticals. ICER’s President Steve Pearson, MD, MSc was part of the discussion, and spoke about the use of surrogate endpoints in health technology assessments.
In 2021, ICER published a White Paper on ways to strengthen the accelerated approval pathway. |
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| Amid Ozempic marketing push, demand for weight-loss drugs may increase insurance premiums in Mass. next year The Boston Globe |
| Insurers in Massachusetts say the growing demand for weight-loss drugs will contribute to higher premiums next year.
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 estimated net price is $13,618. |
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| MUST READS
IRA will reduce out-of-pocket spending among some Part D enrollees by $7.4B in 2025, HHS report says Endpoints News |
| According to a new report from the Department of Health and Human Services’ Office of Health Policy, the Inflation Reduction Act could lower out-of-pocket costs by around $7.4 billion in 2025 for more than a third of all Americans enrolled in Medicare Part D.
The paper modeled some of the IRA’s drug-related provisions for 2024 and 2025, such as the $2,000 a year out-of-pocket spending limit for Part D per year (indexed to inflation) and the $35 per-month limit on covered insulin products. They also considered eliminating cost sharing on ACIP-recommended adult vaccines and expansion of the low-income subsidy (LIS). |
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| A Small Number of Drugs Account for a Large Share of Medicare Part D Spending KFF Health News |
| A KFF Health News analysis provided context for understanding the potential impact of negotiating prices for a limited number of Medicare-covered drugs. Researchers identified the 10 top-selling drugs in 2021. They measured the share of total Medicare Part D drug spending accounted for by top-selling drugs that year, and examined changes in spending and use of these drugs since 2018 (the first year that all 10 of the drugs were covered under Part D).
They found that a small number of drugs account for a disproportionate share of Medicare Part D prescription drug spending, with the 10 top-selling drugs accounting for nearly one-fourth of gross Part D spending in 2021.
In 2021, Medicare Part D covered more than 3,500 prescription drug products, with total gross spending of $216 billion, not accounting for rebates paid by drug manufacturers to pharmacy benefit managers (PBMs). The 10 top-selling Part D drugs accounted for 0.3% of covered drugs and 22% of total gross Medicare drug spending in 2021. The top 100 drugs, representing just 3% of covered drugs, accounted for 61% of total gross spending that year. |
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| Chamber of Commerce files motion for preliminary injunction on Medicare drug negotiation The Hill |
The U.S. Chamber of Commerce, one of the largest lobbying groups in the country, filed a motion Wednesday for a preliminary injunction to block the implementation of the Medicare Drug Price Negotiation program established by the Inflation Reduction Act, which is currently facing several legal challenges. |
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| New PBM Reform Efforts Seek More Transparency For ERISA, Part D Plans Inside Health Policy |
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