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| | Weekly View June 24, 2022 |
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From the desk of Priya Ranade |
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Next week, join ICER’s President Dr. Steve Pearson, MD, MSc at Fierce Biotech’s Next Gen panel, “What are Cell and Gene Therapies Worth?” Fierce Biotech is hosting a free two-day virtual event from June 29-30.
Register here to attend.
Let’s see what happened this week… |
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How Drug Pricing Can Increase ESG Risks for Pharmaceutical Stocks Morningstar |
Morningstar recently explored how ICER's work supports environmental, social, and corporate governance (ESG) investing. They stated:
"Drug pricing is complex and unclear. Patients rarely fully understand drug prices and can be left with frustratingly large bills. Drug Pricing can potentially limit access to medicines, creating a major environmental, social, and governance risk for pharmaceutical companies and pharma stocks.
Within this ambiguous and complicated pricing background, along with the lack of regulatory oversight on U.S. drug pricing, an independent, private organization—the Institute for Clinical and Economic Review, or ICER—has gained prominence and authority by assessing the cost-effectiveness of drugs." |
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Industry-funded studies on cost-effectiveness often favor pricier drugs, study finds STAT |
New research indicated that one-third of the cost-effectiveness analyses that were conducted by drugmakers reached more favorable conclusions than independently conducted analyses. And industry-sponsored analyses were twice as likely to report that a medicine was cost effective when relying on a commonly used metric to gauge the value of a medication, according to the study published in The BMJ. |
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FDA advisers offer a vote of confidence for gene therapies Boston Globe
Zynteglo Could Be Gene Therapy Test Case For Viability Of Outcomes-Based Contracts – UHC Exec Pink Sheet |
Earlier this month the FDA’s Cellular, Tissue and Gene Therapies adcomm voted unanimously in favor of FDA approving beti-cel as a potential treatment for beta thalassemia. And last week, ICER hosted a public meeting on the comparative clinical effectiveness and value of beti-cel.
During our public meeting, UnitedHealthcare Pharmacy director of emerging therapeutics and outcomes-based contracting Erik Schindler explained, “Prospects for outcomes-based, risk-sharing contracts for cell and gene therapies in general 'are promising, are moving forward, and this is a disease state and condition that if we can’t do it here, we’re probably going to have a problem doing it elsewhere.'”
Click here to watch the public meeting recording. |
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MUST READS Washington ups pressure on PBMs with more aggressive FTC policy, congressional ask for GAO study Healthcare Dive |
PBMs, which negotiate rebates and fees with drugmakers, create drug formularies and reimburse pharmacies for prescriptions, have been facing criticism over their role in rising prescription drug spending from patient advocates, provider and pharmacy groups, federal regulators and politicians. Last week, the Federal Trade Commission voted unanimously to adopt a policy statement to more closely examine fees and rebates paid to PBMs in exchange for preferred coverage for their drugs from payers.
In addition, Republican members of the House Education and Labor Committee asked the Government Accountability Office to study PBMs and their role in the pharmaceutical supply chain, citing concerns about how PBMs are reimbursed for their services and their effect on competition. |
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Medicare could save $3.6B buying generic drugs at Mark Cuban pharmacy’s prices: study The Hill |
According to a new study from researchers at Brigham and Women’s hospital, Medicare could have saved up to $3.6 billion in 2020 if it bought generic drugs at the prices paid by billionaire entrepreneur Mark Cuban’s drug company. The $3.6 billion in savings amounts to 37 percent of the $9.6 billion that Medicare spent on the 89 drugs examined in the study. There were savings to be had on 77 of those drugs, and 12 with no savings. |
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New Senate proposal to lower insulin prices would let drugmakers lock in their current profits STAT |
A bill, introduced Wednesday by Sens. Jeanne Shaheen (D-N.H.) and Susan Collins (R-Maine), proposes a complicated redesign of how insulin products are priced, and what patients pay for them. The proposal could help a minority of patients who use insulin, and Senate leadership is hoping to speed it to a vote this summer. The fix would likely spread costs to all Medicare patients, insurers, and the federal government, without changing how much drug makers make on the medicine.
The bill offers Eli Lilly, Novo Nordisk, and Sanofi an incentive to lower their sticker prices to the actual prices they negotiated with insurers in 2021. Patients who pay the sticker price, then, like uninsured patients, would see their prices fall, if drug makers chose to participate in the voluntary program. Insured patients would have their costs capped at $35 per month, though many patients already pay that amount or less. |
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Senate lawmakers introduce a bill to help the FDA and the U.S. Patent Office coordinate STAT |
A bipartisan group of senators introduced a bill to require the Food and Drug Administration and the Patent & Trademark Office to create a task force to boost coordination. The goal is for the agencies to share information about their respective review procedures, improve communication about scientific trends, make it possible to swap confidential information, and determine whether pharmaceutical companies are providing accurate representations about their products. |
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Novartis loses patent appeal for blockbuster MS drug, opening the door to generic rivals
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