| | | | |  | | By David Lim and Katherine Ellen Foley | | | | | 
CMS won't reconsider a request to cover some Alzheimer's drugs like Aduhelm. | Biogen via AP | WAITING ON MEDICARE TO CHANGE — The Centers for Medicare and Medicaid Services struck a blow this week against the Alzheimer’s Association and dozens of lawmakers by denying a request to reconsider restrictive Medicare coverage of anti-amyloid Alzheimer’s drugs. “We regret that the decision could not be more favorable,” the agency said in a statement. Medicare said there still isn’t evidence to merit a reconsideration of its decision, which it made after the FDA in 2021 approved Aduhelm, a drug from Biogen. This year, the FDA granted accelerated approval to Leqembi, a new anti-amyloid monoclonal from Eisai and Biogen. The companies have asked the FDA to grant Leqembi traditional approval based on a Phase III trial, which showed the drug modestly slowed cognitive decline — with the risk of some side effects. That new data isn’t enough to sway CMS’ decision, the agency said. The Alzheimer’s Association asked CMS to reconsider its coverage determination in December, and a few dozen lawmakers supported that request earlier this year. The CMS decision on Wednesday means Medicare will still cover only Leqembi and its predecessor, Aduhelm, for patients in FDA or NIH-cleared randomized trials. If Leqembi, or any future anti-amyloid therapy, receives traditional FDA approval, Medicare will cover them for those enrolled in a patient registry. As of January, Biogen was still enrolling patients in its post-marketing trial, but there are no ongoing trials for Leqembi. So for now, eligible patients must pay for the treatments themselves, which cost upward of $26,000 annually. “CMS’s policy to block access to these treatments eliminates people’s options, resulting in continued irreversible disease progression and contributes to greater health inequities,” Joanne Pike, the president and CEO of the Alzheimer’s Association, said in a statement. IT'S FRIDAY. WELCOME TO PRESCRIPTION PULSE. We are excited to see that the National Zoo’s Bird House is re-opening next month — although bird watching can happen anywhere in the DMV when the weather’s nice. Send news, tips and your best bird sightings to David Lim (dlim@politico.com or @davidalim) or Katherine Ellen Foley (kfoley@politico.com or @katherineefoley). TODAY ON OUR PULSE CHECK PODCAST, host Ruth Reader talks with U.S. Surgeon General Vivek Murthy about his desire to help kids who struggle with mental illness and his office’s guidelines for how to support young people's mental health.
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Merck wants to get new patents for its cancer drug, Keytruda. | Seth Wenig/AP Photo | MORE SCRUTINY OF MERCK KEYTRUDA PATENTS? Merck’s efforts to obtain new patents for blockbuster drug Keytruda, which treats multiple types of cancer, should be carefully reviewed by the U.S. Patent and Trademark Office, top progressive lawmakers wrote in a Wednesday letter to USPTO Director Kathi Vidal. A blockbuster drug generates more than $1 billion in revenue annually. “Should the USPTO approve new patent applications for the drug, biosimilar competitors could be shut out of the market until 2036, giving Merck a total period of nearly 35 years of patent protection for Keytruda — monopoly protection that extends well beyond the intent of the Drug Price Restoration and Patent Term Restoration Act (Hatch-Waxman) and the Biologics Price Competition and Innovation Act,” wrote Sens. Elizabeth Warren (D-Mass.) and Bernie Sanders (I-Vt.) and Reps. Katie Porter (D-Calif.) and Pramila Jayapal (D-Wash.). GOP LAWMAKERS PRESS CMS ON USE OF IRA FUNDS — Top Republicans are asking CMS Administrator Chiquita Brooks-LaSure and HHS Secretary Xavier Becerra for more transparency and quarterly updates about how the Biden administration will use $3 billion in Inflation Reduction Act funds allocated to help set up the Medicare drug price negotiation program over the next decade. “By sidestepping regular order and bypassing the standard appropriations process, proponents of the IRA set aside billions in taxpayer dollars with no reporting requirements or tools to prevent waste, fraud, and abuse,” House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-Wash.), House Ways and Means Committee Chair Jason Smith (R-Mo.) and Senate Finance Committee ranking member Mike Crapo (R-Idaho) wrote Wednesday. The lawmakers want updates on projected spending from the fund and how much unused money remains over time so Congress can “as appropriate, adjust the IRA’s statutory spending level.”
| | | | 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. | | | | | | | | CALIFF STUMPS AT DATAPALOOZA — Those fortunate enough to hear FDA Commissioner Robert Califf speak on a regular basis are familiar with the themes from his Health Datapalooza address: lamenting U.S. health outcomes compared to those of other nations, touching on the health burden of smoking, urging better data and evidence generation, referencing his time in Silicon Valley, and so on. The FDA leader warned conference goers on Thursday that more needs to be done to combat “state-sponsored … purposeful misinformation” spread to take advantage of divisions in the U.S. and create more dissension among Americans. “Members of the public are coming to believe that facts don't exist, that all facts are political and therefore a matter of opinion,” Califf said. “I believe this is a view that's increasingly a problem in our society, and if we don't do something about it, I think the outcome is predictable and quite, quite scary.” NEONATAL INCUBATORS MAY RELEASE AIRBORNE CHEMICALS — The FDA told health care providers it is working with manufacturers to further evaluate research that suggests there may be “elevated levels of formaldehyde, cyclohexanone, and other volatile chemicals” from neonatal incubators. The agency said an initial review of existing literature “is inadequate to assess the potential exposure and risk to newborns and providers.” “Currently, the FDA is not aware of any reported adverse events related to the use of neonatal incubators and exposure to these airborne chemicals,” the agency said. Providers should continue to use the incubators, which are critical for newborns who cannot maintain their own body temperature, according to the FDA. FDA WANTS HELP SHAPING FUTURE DEVICE SAFETY OVERSIGHT — The FDA is asking organizations to give input on the development of an active surveillance system for medical devices that uses electronic health data to monitor for potential safety signals from devices used in clinical practice. “The FDA anticipates establishing a contract for the development and execution of a medical device active surveillance system to vendor(s) with the appropriate expertise to design, develop, and run such a system,” a recent request for information says.
| | | MODERNA PLEDGES FREE COVID VACCINES FOR UNINSURED — Moderna executives again said Thursday that the company would launch a patient-assistance program for uninsured individuals to get updated Covid-19 vaccines for free, Katherine reports. The company also said in its 2022 fourth-quarter and year-end earnings call that it expects U.S. demand for Covid vaccines to be 100 million doses this year. In addition, company executives said they plan to ask the FDA for approval of its respiratory syncytial virus vaccine candidate later this year and expect to see it on the market by year’s end or in early 2024. The company is also developing HIV, shingles and herpes vaccines. Moderna using mRNA for personalized preventive medicine: On Wednesday, Moderna said the FDA designated the personalized mRNA cancer vaccine it’s making with Merck as a breakthrough therapy — a classification intended to speed development and review of promising drugs — after it saw positive Phase II data. The vaccine, used with Merck’s Keytruda, is specifically for high-risk melanoma patients. PFIZER’S PRELIMINARY DATA ON INFANT RSV VACCINE — In a presentation to CDC expert advisers Thursday, Pfizer said its maternal RSV vaccine candidate was 81.8 percent effective at preventing severe RSV in infants up to 3 months old and 69.4 percent effective at preventing severe disease up to 6 months old. In a Phase III trial, pregnant individuals received the vaccine late in their terms to generate protection for their infants. Pfizer said Tuesday the FDA had agreed to review its maternal RSV vaccine candidate. The agency’s vaccine experts will review the RSV vaccine for older adults this coming Tuesday.
| | | FDA ISSUES FIRST FINES FOR ILLEGAL VAPE MANUFACTURERS — The FDA’s Center for Tobacco Products said Wednesday it had issued its first civil monetary penalties to four e-cigarette manufacturers for selling unauthorized products, Katherine reports. The agency fined VapEscape, Great American Vapes, The Vapor Corner and 13 Vapor for $19,192, the maximum amount allowed for single violations. According to the agency, it had warned each company that it was selling unauthorized vapes, but the companies failed to pull their products from the market.
| | | Jed Gorlin is the new chief medical officer of America’s Blood Centers.
| | | Top FDA leaders want longer advisory committee meetings that would help influence drug development, not just approval decisions, Pink Sheet’s Sarah Karlin-Smith reports.
| | | The FDA issued a warning cautioning consumers not to buy Delsam Pharma’s artificial eye ointment because it may have bacterial contamination. The FDA will hold a virtual meeting to discuss patient-focused drug development for long Covid on April 25. The FDA will celebrate its 2023 Rare Disease Day on Feb. 27.
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