| | | | |  | | By David Lim and Lauren Gardner | Presented by the Coalition for Affordable Prescription Drugs (CAPD) | With Katherine Ellen Foley, Alice Miranda Ollstein and Megan Wilson
| | | — CMS elects to limit coverage for Aduhelm, finalizing its proposed decision from January. — Congress is once again delaying a vote on new Covid-response funds. — FDA's external vaccine advisers didn't reach a resolution on how to approach a fall Covid booster campaign. It's Friday. Welcome back to Prescription Pulse. D.C. has learned a lot this week about rabies vaccine protocol. Send tips and feedback 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).
| | A message from the Coalition for Affordable Prescription Drugs (CAPD): A new report finds that rebates do not result in higher drug prices. This new data offers clear evidence refuting drug companies' claims that the rebates PBMs negotiate are to blame for increasing list prices for brand drugs like insulin. Rebates help bring down premiums and out-of-pocket costs for patients. Big Pharma wants Congress to believe rebates are the problem, but don't be fooled: their prices are the problem. Learn more. | | | | | | MEDICARE RESTRICTS ADUHELM COVERAGE TO THOSE IN A CLINICAL TRIAL — The Centers for Medicare and Medicaid Services is largely sticking to its proposed coverage for Aduhelm, a contentious Alzheimer's drug, Katherine and Megan report. The final coverage determination keeps most of the agency's January proposal intact but slightly loosens the trial requirements for drugs like Aduhelm, which was granted conditional approval by the Food and Drug Administration. Medicare will cover the drug for patients in randomized, controlled clinical trials conducted through either FDA or the National Institutes of Health — though CMS doesn't have to approve the study. It also changes the game for future anti-amyloid therapies. Medicare will cover any drug that goes through the traditional approval process for patients in studies, but the studies can be observational, such as an analysis of data from a patient registry. Background: The proposed coverage determination was met with outrage from patient advocacy groups and drug companies , leading to nearly 10,000 submissions during the 30-day public comment period. They argue that CMS is stepping into FDA's regulatory territory by requiring another randomized clinical trial to cover the drug. They say the move would effectively prevent millions of adults living with Alzheimer's from receiving the $28,000-a-year treatment, which is the only one on the market that targets the proteins associated with the disease. The controversy kicked off in June 2021: FDA granted accelerated approval to the drug from Biogen, despite mixed results from the company's two late-stage trials. The decision led to the resignation of three of the agency's external advisory committee on neurological drugs, who voted against approving the drug. The approval hinges on whether the company can conduct a fourth, post-marketing randomized trial. Biogen's next move: Biogen is slated to begin screening patients for its mandated Phase IV Aduhelm trial next month, in addition to the two ongoing Adulhelm trials it is running. One trial is observational, and the other is a continuation of a late-stage clinical trial. CMS has stated that if Biogen's Phase IV trial for FDA meets its criteria, it would cover the drug for patients within that trial. PhRMA is already blasting the decision: "CMS has further complicated matters by taking the unprecedented step of applying different standards for coverage of medicines depending on the FDA approval pathway taken, undermining the scientific assessment by experts at FDA," a PhRMA spokesperson said. "We hope the Administration reconsiders this policy immediately."
| | | | SUBSCRIBE TO NATIONAL SECURITY DAILY : Keep up with the latest critical developments from Ukraine and across Europe in our daily newsletter, National Security Daily. The Russian invasion of Ukraine could disrupt the established world order and result in a refugee crisis, increased cyberattacks, rising energy costs and additional disruption to global supply chains. Go inside the top national security and foreign-policymaking shops for insight on the global threats faced by the U.S. and its allies and what actions world leaders are taking to address them. Subscribe today. | | | | | | | | COVID CREEPS CLOSER TO D.C. POWER CENTERS — Covid infections surged among Washington's most powerful officials this week. Speaker Nancy Pelosi announced her positive test on Thursday after being in close proximity to President Joe Biden in recent days. Sen. Susan Collins (R-Maine) publicized her diagnosis hours after voting to confirm Ketanji Brown Jackson to the Supreme Court. And a handful of Cabinet members and U.S. representatives said they caught Covid after attending Saturday night's Gridiron Club dinner. The rash of positives has jolted official Washington into an uncomfortable realization: As much as everyone wants to be done with Covid, it's not done with us or with Biden's presidency , as POLITICO's Adam Cancryn writes. The question is, are large indoor events like the Gridiron dinner and Biden's health care victory lap wise to hold as the highly contagious BA.2 subvariant spreads? As Lauren writes, it depends . With the wide availability of vaccines and the advent of treatments — along with masks and tests — we're in a different place than even this time last year. Still, individuals' risk thresholds and personal circumstances differ, and no public outing is without some risk of encountering the virus. FDA PANEL DIVES INTO THE BOOSTER UNKNOWN — The U.S. faces a tight, late-spring deadline to accumulate enough data on a Covid-19 vaccine reworked to address new variants, but questions remain about whether and how to tweak the shots' makeup, Lauren writes. At a daylong meeting, FDA's independent vaccine advisers agreed that manufacturers don't have a lot of time to complete clinical trials and get regulatory signoff to make any changes to the vaccines' composition to address different variants in future booster doses. It's also unknown whether future strains will spin off from Omicron, as BA.2 did, or if a fundamentally distinct variant will emerge as Omicron did when it overtook Delta, making strain selection akin to the annual flu vaccine process difficult. Panelists also stressed the need to reach a consensus on what level of vaccine effectiveness will be considered good enough moving forward, as Covid becomes one of several respiratory illnesses that routinely circulates worldwide. FDA: RELAX, TESTS WON'T BE PREEMPTIVELY TAKEN OFF MARKET — Manufacturers of Covid-19 tests marketed under emergency use authorization should not panic if the Public Health Service Act emergency declaration expires, FDA said in a Wednesday update to a frequently asked question document. "Many previous EUA declarations, such as for MERS, Zika, and Ebola, remain in effect; this is especially true for in vitro diagnostic tests," FDA said, noting EUAs are permitted under a separate Federal Food, Drug, and Cosmetic Act authority. "While we have not yet granted full marketing authorization for antigen or serology tests, we are interested in doing so. A de novo submission would be the appropriate pathway for each of those."
| | | | 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. | | | | | | | | SENATE PUNTS VOTE ON NEW COVID FUNDS — Democrats are again postponing an effort to pass legislation that would allow for $10 billion to be spent on Covid-19 therapeutics, vaccines and tests until after the Senate returns from a two-week spring break, Alice reports . Top Biden administration officials have repeatedly warned that a delay in new funding threatens the country's ability to fight the virus and prepare for potential surges and variants. HOUSE DEMS PUT FORWARD MORE DRUG PRICING BILLS AMID BBB STALEMATE — Democrats on the House Oversight Committee introduced a package of three bills Thursday aimed at lowering drug prices as pharmaceutical reforms in the Build Back Better legislation languish in the Senate, Alice reports. The bills, which the committee crafted based on the results of its multiyear investigation into companies' drug pricing practices, already have Senate companions led by Sens. Debbie Stabenow (D-Mich.) and Tina Smith (D-Minn.). They include: — The Discounted Drugs for Clinical Trials Act, which would allow researchers to buy expensive drugs or biologic products at the price it costs to manufacture them — The Pharmaceutical Research and Transparency Act of 2022, which would increase transparency in the costs of clinical trials, which pharmaceutical companies do not currently disclose — The Generic Substitution Non-Interference Act, which would ban pharmaceutical companies from conducting "Dispense-As-Written" campaigns in which health care providers are discouraged from prescribing generic or biosimilar alternatives to brand-name drugs
| | | | A message from the Coalition for Affordable Prescription Drugs (CAPD):   | | | | | | FDA FLOATS OVERHAUL OF DEVICE CYBERSECURITY RECOMMENDATIONS — FDA on Thursday published an overhauled draft guidance on medical device cybersecurity considerations when submitting a premarket submission. The new draft guide, an update to 2018 draft guidance, more explicitly lays out the cybersecurity documents FDA will review when a device premarket submission is sent in for review, according to Kevin Fu, FDA acting director of medical device security. It also eliminates a manufacturer risk tier approach proposed in the former draft guidance in favor of scaling the amount of recommended cybersecurity documentation with a devices' cybersecurity risk. "Cybersecurity is a part of device safety and effectiveness," Fu told POLITICO. "In my view, it'd be difficult to make any kind of security claim if you don't have a sound scientific threat model, followed by cybersecurity risk assessment, which cuts to the clinical risks, and then the software bill of materials, followed by the security architecture and testing." UNANNOUNCED INSPECTIONS STILL ON HOLD — FDA is continuing to announce when it will conduct domestic inspections due to the ongoing Covid-19 pandemic, Judith McMeekin, FDA associate commissioner for regulatory affairs, told the Alliance for a Stronger FDA on Wednesday. "We do announce that for a reason, and it's for safety issues," McMeekin said. "We call in advance to make sure that there are no outbreaks at the facility and/or if there are any safety protocols. So that will continue to remain as we are in the pandemic."
| | | PFIZER TO BUY REVIRAL — Pfizer announced Thursday that it had reached an agreement to buy ReViral, a private company developing antivirals for respiratory syncytial virus, or RSV, in a deal worth up to $525 million.
| | | California is investigating Centene's Magellan Health management of its Medicaid drug program, Kaiser Health News' Samantha Young reports.
| | | Here are some highlights from our colleagues over at AgencyIQ, the regulatory insight platform for FDA. FDA clinical trial diversity guidance close to publication — On Thursday the White House Office of Information and Regulatory Affairs announced it has finished its review of an FDA draft guidance document that is set to make recommendations about "diversity plans to improve enrollment of participants from underrepresented racial and ethnic populations in clinical trials." The long-sought after guidance was first sent to OIRA by the FDA in January 2022. While details about the guidance remain scarce, based on the title it is likely that the FDA will ask companies to develop plans to ensure the representative enrollment of certain populations in their pivotal studies. The guidance comes just as some legislators are seeking to compel companies to do more to encourage diverse clinical enrollment, such as the DEPICT Act sponsored by Reps. Anna Eshoo (D-Calif.), Brian Fitzpatrick (R-Pa.) and Robin Kelly (D-Ill.).
| | | FDA will hold a virtual public meeting on April 19 from noon to 4:30 p.m. EDT to discuss the proposed framework for the reauthorization of its medical device user fee program.
| | A message from the Coalition for Affordable Prescription Drugs (CAPD): A new report finds that rebates do not result in higher drug prices. As Congress debates how to lower the price of insulin, this new data offers clear evidence refuting drug companies' claims that the rebates PBMs negotiate are to blame for increasing list prices for brand drugs. The report also highlights how rebates keep premiums, deductibles, and out-of-pocket costs lower for millions of Americans. Don't be fooled by Big Pharma: their prices are the problem. Learn more. | | | | | | | Follow us on Twitter | | | | Follow us | | | | |
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