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Delivered every Tuesday and Friday by 12 p.m., Prescription Pulse examines the latest pharmaceutical news and policy. | | | | |  | | By David Lim and Katherine Ellen Foley | With Daniel Payne
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Eli Lilly will cut the list price of insulin by the end of the year. | John Locher/AP Photo | WINNING THE PR BATTLE — Eli Lilly’s announcement that it will cut the list price of its most commonly prescribed insulin product, Humulin, by 70 percent before year’s end was heralded by President Joe Biden and patient advocates as a major concession by the pharmaceutical industry. But drug policy experts say the truth is more nuanced and this week’s announcement reflects a variety of factors, including market pressure from emerging biosimilar manufacturers and generic efforts by generic drugmaker Civica Rx and the state of California. “Insulin makers may see the writing on the wall that high prices can’t persist forever,” said Larry Levitt, executive vice president for health policy at KFF. “Lilly is trying to get out ahead of the pricing pressures and criticism, and look to the public like the good guy.” Biden and lawmakers, including Senate HELP Committee Chair Bernie Sanders (I-Vt.), are pushing other insulin manufacturers to follow Lilly, which said it would cap out-of-pocket payments for insulin products at $35 “at participating retail pharmacies” for those who have private insurance. Priced in: Northwestern University professor Craig Garthwaite said the Lilly move was already priced into its stock value, noting that it is unclear whether the insulin price cuts will decrease the company’s revenue. Lilly CEO David Ricks told the Financial Times the actions won’t impact the company’s 2023 earnings guidance. More pressure coming: Sanders’ office said he plans to introduce legislation soon that would cap the list price of insulin at $20 a vial. IT'S FRIDAY. WELCOME TO PRESCRIPTION PULSE. Peak bloom for D.C.’s cherry blossoms is coming early this year, according to the National Park Service, which estimates the popular Tidal Basin attraction will be at its best from March 22-25. Send news and tips to David Lim (dlim@politico.com or @davidalim) or Katherine Ellen Foley (kfoley@politico.com or @katherineefoley). TODAY ON OUR PULSE CHECK PODCAST, host Krista Mahr talks with Ruth Reader about online therapy company BetterHelp's settlement with the FTC for allegedly sharing customers’ sensitive health data with third parties and why it's another health data warning shot from the FTC.
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An independent nonprofit group has reviewed the effectiveness and value of the Alzheimer’s drug Leqembi. | Eisai via AP | ICER WEIGHS IN ON LECANEMAB VALUE — On Wednesday, the independent nonprofit Institute for Clinical and Economic Review released a report examining the comparative clinical effectiveness and value of Eisai’s early Alzheimer’s disease treatment (lecanemab), which received FDA accelerated approval in January. “Lecanemab has been approved by the FDA and has a list price of $26,500 per year,” the group said in a statement. “ICER has calculated a health-benefit price benchmark (HBPB) for lecanemab to be between $8,900-$21,500 per year.”
| | | | DOWNLOAD THE POLITICO MOBILE APP: Stay up to speed with the newly updated POLITICO mobile app, featuring timely political news, insights and analysis from the best journalists in the business. The sleek and navigable design offers a convenient way to access POLITICO's scoops and groundbreaking reporting. Don’t miss out on the app you can rely on for the news you need, reimagined. DOWNLOAD FOR iOS– DOWNLOAD FOR ANDROID. | | | | | | | | HOUSE OVERSIGHT LAUNCHES PBM INVESTIGATION — The House Oversight and Accountability Committee opened an investigation Wednesday into the business practices of pharmaceutical middlemen, known as pharmacy benefit managers, to examine their effect on patients — the latest in a series of actions targeting the industry, POLITICO’s Megan R. Wilson reports. SENATE FINANCE GOP: DO NOT USE QALYs — Wrangling over how drugs are selected for Medicare price negotiations continues: Senate Finance Committee Republicans are asking CMS and HHS not to use quality-adjusted life years as a metric, which they argue discriminates against rare-disease patients. “With these concerns in mind, we urge your agencies to eliminate the use of QALYs and other similar metrics in federal programs, including in the implementation of the [Inflation Reduction Act’s] price-setting program,” the 10 senators wrote on Wednesday. 340B WATCH — Several members of the Senate HELP Committee chimed in on the federal 340B drug discount program during a Thursday hearing on community health centers, Daniel reports. While many voiced support for the program, others said some entities are misusing it. “There are a lot of abuses of that program,” ranking member Bill Cassidy (R-La.) said, offering a hypothetical of a hospital using it to boost profits but also noting that he believed some providers were using it to serve patients well.
| | | RSV VACCINES FROM PFIZER, GSK GET NOD — Twelve independent experts voted this week that two respiratory syncytial virus vaccine candidates for adults 60 and over were safe and effective based on available data. But the positive recommendations weren’t unanimous, and advisers had several questions they hope to see answered either upon approval or through post-marketing studies. Pfizer’s vaccine: On Tuesday, advisers voted 7-4 with one abstention that data from Pfizer showed its vaccine is safe and 7-4 with one abstention that it was effective. GSK’s vaccine: On Wednesday, the 12-person panel voted unanimously that GKS’s monovalent RSV candidate was effective at preventing lower-respiratory infections against RSV, but voted 10-2 that the vaccine has a good safety profile based on available data.
| | | ANOTHER BIVALENT SHOT FOR KIDS? On Wednesday, Pfizer and BioNTech asked the FDA to authorize emergency use of the Omicron BA.4/BA.5 bivalent Covid-19 vaccine in children as young as 6 months as a fourth shot at least two months after completion of the primary series. The bivalent vaccine is already authorized as a third dose for the population. CALIFF, MARKS TAKE ON OFFIT — Top FDA officials took to the New England Journal of Medicine on Wednesday to push back against vaccine expert Paul Offit’s contention that updated Covid-19 booster shots are best reserved for older adults and those with conditions that put them at high risk for serious illness rather than for young, healthy people. FDA Commissioner Robert Califf and top vaccine regulator Peter Marks argue Offit’s perspective does not account for “key available evidence” that supports vaccinating all eligible people with the bivalent booster shot that targets Omicron subvariants BA.4 and BA.5 as well as the original strain. NOVAVAX IN FINANCIAL TROUBLE — Embattled Covid-19 vaccine maker Novavax told investors on Tuesday that, while it has enough money for the next year, its ability to remain in business depends on pending arbitration with Gavi, the Vaccine Alliance; its capability to bring an updated Covid vaccine to market by the fall; and funding from the U.S. government. “Given these uncertainties, substantial doubt exists regarding our ability to continue as a going concern through one year from the date that these financial statements are issued,” the company said in a press release.
| | | CONCERNS RAISED ABOUT ‘MENTHOL-LIKE’ CIGARETTES — At the annual meeting of the Society for Research on Nicotine and Tobacco in San Antonio this week, researchers and other attendees asked FDA Center for Tobacco Products officials about new ‘menthol-like’ cigarettes, including Camel Crush, Camel Crisp and Newport Non-Menthol cigarettes, for sale in California despite the state’s recent ban on most flavored tobacco products, Katherine reports. Those new products hit California store shelves shortly before the state ban on flavored tobacco products kicked into gear in December. They came to market under the FDA’s substantial equivalence pathway. This pathway authorizes new tobacco products if manufacturers prove they are largely the same as previously authorized products. But researchers say the products could skirt menthol cigarette bans by simply substituting a synthetic component for menthol and are just as easy for consumers to smoke as menthol cigarettes. Brian King, CTP’s director, said the agency was aware of the products but declined to say more. R.J. Reynolds, Newport and Camel’s manufacturer, didn’t immediately respond for comment.
| | | CMS TO BOOST GLUCOSE MONITOR COVERAGE — Starting in April, Medicare will expand its coverage of continuous glucose monitors to include a broader group of patients, CMS announced in an updated final local coverage determination policy issued Thursday.
| | | The New York Times’ Rebecca Robbins explores how Jazz Pharmaceuticals used Risk Evaluation and Mitigation Strategies for its narcolepsy drug to delay rival competition. Elon Musk’s medical device company Neuralink didn’t seek permission from the FDA to start human trials of its brain implant until early 2022, and the agency rejected the application, Reuters’ Rachael Levy and Marisa Taylor report.
| | | The FDA’s Center for Drug Evaluation and Research released its annual report on drug safety priorities. The FDA seeks feedback on a discussion paper on artificial intelligence in drug manufacturing. CMS released its annual update to its drug spending dashboards to include data from 2021: Medicare Part B, Medicare Part D and Medicaid.
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