CMS, patient groups at odds over new Alzheimer’s drug

Delivered every Tuesday and Friday by 12 p.m., Prescription Pulse examines the latest pharmaceutical news and policy.

Jan 18, 2023 View in browser   By Katherine Ellen Foley, Lauren Gardner and David Lim Driving the Day The cost of the new Alzheimer's drug, Leqembi, may be out of reach for many Americans. | AP Photo TO COVER OR NOT TO COVER: THAT IS THE QUESTION — For the second time in two years, government officials and public health advocates are grappling with how to make a newly approved Alzheimer's drug affordable for millions of desperate patients, Katherine reports. Unless or until the Centers for Medicare and Medicaid Services changes its coverage decision that only patients in trials can get Leqembi, a new drug with an annual $26,500 price tag, paid for by Medicare, the treatment may remain out of reach financially for many Americans. Eisai and Biogen, the drug's developers, have no plans for further trials. The Alzheimer's Association, the powerful advocacy group, is in the process of a full-court press to meet with every lawmaker in the House and Senate, urging them to pressure CMS to change its decision, while a host of smaller advocacy groups argue against the drug's widespread distribution because trial data show that its modest benefits for early-stage patients don't outweigh the risks of severe side effects. CMS is in the midst of responding to a formal request to reconsider coverage for Leqembi and similar Alzheimer's drugs in the pipeline, though it's not clear when the agency will make a final decision. IT'S WEDNESDAY. WELCOME TO PRESCRIPTION PULSE. It wouldn't be a new year without new metro delays around the Capitol, would it? Send tips, feedback and commuting tips to David Lim (dlim@politico.com or @davidalim), Lauren Gardner (lgardner@politico.com or @Gardner_LM) or Katherine Ellen Foley (kfoley@politico.com or @katherineefoley). TODAY ON OUR PULSE CHECK PODCAST, Krista Mahr talks with Megan Messerly about the Biden administration's plans to expand the testing of bathroom wastewater from international flights to detect Covid variants and other pathogens — a practice that administration officials and public health experts see as part of a revolution in biosafety infrastructure and a critical plank of national security in the post-pandemic era. Listen to today's Pulse Check podcast Coronavirus The CDC reported that its vaccine safety surveillance system flagged a possible link between a Covid-19 booster and strokes in people 65 and older but downplayed the potential risk. | Scott Olson/Getty Images FDA, CDC DISCLOSE STROKE INQUIRY — A vaccine safety surveillance system flagged a possible link between the Pfizer-BioNTech messenger-RNA bivalent Covid-19 booster and strokes in people 65 and older, but the FDA and the CDC said Friday they don't believe the signal represents a true risk based on data from other systems. Information gathered by the Vaccine Safety Datalink, which scans electronic health records from a dozen health care systems nationwide, "raised a question of whether" stroke risk was elevated in the 21-day period post-vaccination vs. 22 to 44 days post-vaccination, the CDC and the FDA said in a statement posted online. But a similar signal wasn't detected with Moderna's bivalent booster, which also uses mRNA technology, and none of the other federal vaccine side-effect reporting systems have identified it, leading regulators to continue recommending the shots for older adults. Pfizer and BioNTech said in a statement that "there is no evidence to conclude that ischemic stroke is associated with the use of the companies' COVID-19 vaccines." KESSLER DEPARTING — Former FDA Commissioner David Kessler is stepping down this week as President Joe Biden's top Covid-19 science official, capping two years of work shepherding the federal government's vaccine and therapeutic response to the pandemic, POLITICO's Adam Cancryn reports.   STEP INSIDE THE WEST WING: What's really happening in West Wing offices? Find out who's up, who's down, and who really has the president's ear in our West Wing Playbook newsletter, the insider's guide to the Biden White House and Cabinet. For buzzy nuggets and details that you won't find anywhere else, subscribe today.     In the Courts FDA RESPONDS TO ABORTION PILL LAWSUIT — The FDA has asked a federal court to reject a lawsuit challenging its 2000 approval of mifepristone — one of two drugs used in medication abortion — arguing it would harm the public interest and the anti-abortion groups that filed the lawsuit lack standing. The suit, filed in November, charges that the FDA exceeded its authority when it approved the drug 22 years ago and seeks an immediate suspension of the agency's approval. "Allowing Plaintiffs to supplant FDA's considered judgment with cursory and baseless allegations of harm would undermine the administrative framework that Congress designed for the regulation of pharmaceutical drugs," the agency said in the filing. Danco Laboratories, maker of the name-brand abortion pill Mifeprex, moved to join the suit on Friday in support of the FDA's approval. In Congress HARRIS TO LEAD HOUSE FDA SPENDING PANEL — Conservative Rep. Andy Harris (R-Md.) will take the gavel of the House Appropriations Committee's panel governing Agriculture Department and FDA spending, he said in a statement. "I am excited for the opportunity to work with the FDA to ensure the safety and efficacy of the latest developments in drug and medical device research, as well as food safety," said Harris, a practicing anesthesiologist. Harris was known for his skepticism of masks at the height of the pandemic and reportedly said on a radio show in 2021 that he'd prescribed ivermectin, an animal dewormer, as a Covid treatment. POLITICO previously reported that Harris took on an unpaid job overseeing part of a clinical trial for a Covid treatment by a drug company whose leader had longstanding ties to the congressman. Eye on the FDA HHS OIG: FDA NEEDS BETTER IT CONTRACT MANAGEMENT — An audit of the FDA's acquisition of information technology contracts by the HHS Office of Inspector General concluded that while certain aspects "were not conducted with applicable" regulations and policies, the agency generally follows federal regs and rules. A review of five FDA orders worth $23.6 million found that FDA contracting officers did not always properly designate a contracting officer's representative, complete required contractor performance evaluations, document all "key contracting decisions" or include a required "acquisition strategy statement in the orders' acquisition plans." MEDICAL DEVICES ABBOTT WINS FDA APPROVAL FOR NEW TAVI SYSTEM — Abbott announced Tuesday it received FDA approval for its Navitor transcatheter aortic valve implantation system for the treatment of patients with severe aortic stenosis— a blocking or narrowing of the aortic valve in the heart — at high or extreme risk for open-heart surgery. Industry Intel MODERNA REPORTS HIGH EFFICACY FOR RSV SHOT IN OLDER ADULTS — Moderna said Tuesday that an interim analysis of a late-stage clinical trial for its respiratory syncytial virus vaccine in older adults met its primary endpoint, Katherine reports. The analysis of the company's Phase III early results showed that the vaccine had an efficacy rate of more than 80 percent for lower respiratory infections from RSV with two or more symptoms. The trial is ongoing, but the company plans to ask the FDA to approve the vaccine in the first half of this year. Pharma in the States NJ GOVERNOR LEGALIZES SOME OTC CONTRACEPTIVES — On Friday, Gov. Phil Murphy signed legislation allowing individuals to acquire birth control without a doctor's prescription, POLITICO's Caroline Petrow-Cohen reports. The new state law permits pharmacists in New Jersey who complete a training program approved by the N.J. Board of Pharmacy and the State Board of Medical Examiners to distribute self-administered oral, transdermal and vaginal contraceptives over the counter. Individuals seeking OTC birth control will also be required to fill out an annual questionnaire to evaluate patient risk factors determined by the CDC. New Jersey is now the 17th state, plus Washington, D.C., to enact such a law. Pharma Moves Mark Newsom, the founder of the consulting firm Health Evaluations, has returned to CMS as a technical director to work on Medicare Advantage policy in the Medicare Drug and Health Plan Contract Administration Group. Quick Hits As the Biden administration scales up efforts to screen international travelers for Covid-19 variants and other potential health concerns, the CDC is in talks with some airports to monitor wastewater accumulated in-flight, Krista Mahr writes for POLITICO. For The New York Times, Pam Belluck profiles the 96-year-old Étienne-Émile Baulieu, the French scientist behind mifepristone. Document Drawer Rep. Brett Guthrie (R-Ky.) and 14 other Republican House cosigners introduced a bill that aims to end the Covid-19 public health emergency. The FDA published draft guidance for industry on optimizing cancer treatment dosages for patients.   JOIN TUESDAY TO HEAR FROM MAYORS AROUND AMERICA: 2022 brought in a new class of mayors leading "majority minority" cities, reshaping who is at the nation's power tables and what their priorities are. Join POLITICO to hear from local leaders on how they're responding to being tested by unequal Covid-19 outcomes, upticks in hate crimes, homelessness, lack of affordable housing, inflation and a potential recession. REGISTER HERE.       Follow us on Twitter David Lim @davidalim Lauren Gardner @Gardner_LM Katherine Ellen Foley @katherineefoley   Follow us

To change your alert settings, please log in at https://www.politico.com/_login?base=https%3A%2F%2Fwww.politico.com/settings This email was sent to rouf@idiot.cloudns.cc by: POLITICO, LLC 1000 Wilson Blvd. Arlington, VA, 22209, USA Please click here and follow the steps to unsubscribe.