With Robert King and Megan R. Wilson
CMS SIGNALS COMPROMISE — The top Medicare official tasked with heading CMS’ drug price negotiation group signaled the agency might loosen its proposed requirement to restrict drug companies from disclosing details about the negotiation process.
The pharmaceutical industry raised concern that the floated restrictions on talking about the negotiations amount to a violation of the First Amendment in response to CMS’ initial guidance detailing how it intends to run the program — raising the specter of litigation if the agency did not walk back the requirement.
Meena Seshamani, director of Medicare, indicated in an interview with Robert that CMS is receptive to taking a lighter approach.
“We are looking at it and exploring it. I think we want to be able to set up a transparent program, and we understand these issues around proprietary information,” Seshamani said. “These are things we are continuing to think through.”
Still hiring: Seshamani said the agency is still trying to finish hiring roughly 100 people to staff the CMS drug price negotiation group, which is tasked with selecting 10 drugs for negotiation by Sept. 1.
“Jobs are continuing to be posted, we are continuing to hire,” Seshamani told Robert, adding that CMS is focused on bringing in economists and individuals with industry or clinical experience. “We will have a more comprehensive announcement soon.”
Steve Ubl, CEO of industry trade group Pharmaceutical Research and Manufacturers of America, pointed to letters from Republican lawmakers questioning why CMS needs to hire so many people. That, he says, is a sign that the GOP will consider changes to the drug price negotiation process once the industry can “continue to educate and collect the evidence base around these issues.”
“We don’t think it’s a real negotiation,” Ubl told POLITICO. “It’s more like a negotiation with a gun to your head if the alternative is to be excluded from the Medicare and Medicaid program or pay a tax on the proceeds of the medicine at some exponential level. I think you’ll see over time legislation introduced, oversight conducted.”
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TODAY ON OUR PULSE CHECK PODCAST, your host Katherine talks with Daniel Payne about his report on how hospitals, clinics, patient advocates and state workers are striving to prevent individuals from losing their Medicaid coverage as the program unwinds.
HHS ON SMOKING CESSATION — Biden administration officials said Thursday they plan to launch the first government-wide draft framework for smoking-cessation help for Americans. The framework, part of the Biden cancer moonshot, aims to harmonize smoking-cessation resources available through existing agencies, including the CDC, the FDA and the Department of Veterans Affairs.
“The goal is to coordinate [the resources] and leverage their work across the government,” said Rachel Levine, HHS assistant secretary for health.
Levine stressed that the program would focus on marginalized communities, including people of color and members of the LGBTQ community, who smoke at disproportionately higher rates than other groups. The program will also focus on preventing minors from using e-cigarettes.
“To end cancer caused by tobacco, we have to put into place multiple policies at the federal, state and local level that we know work,” said Erika Sward, assistant vice president of national advocacy for the American Lung Association.
FDA Commissioner Robert Califf noted that his agency is still on track to finalize rules that would ban menthol cigarettes and flavored cigars. The rule is expected this summer. He also said the FDA hopes to propose a rule that would limit the amount of nicotine permitted in cigarettes.
But Califf said that eliminating those products won’t be enough to guarantee more smokers quit. “Here’s what I’m concerned about … we’re gonna take away the menthol and these little cigars and [then] we ask the question, ‘what is the care package for these people when they’re going to quit?’”
Agencies have collaborated on smoking cessation in the past and will likely continue to do so outside the new framework. On Thursday, for example, the FDA and the National Institutes of Health jointly awarded funding for a new Center for Rapid Surveillance of Tobacco, which will help the agencies collect and analyze data faster on the types of tobacco products used nationwide.
COHEN TO LEAD CDC — President Joe Biden plans to name North Carolina Health Secretary Mandy Cohen as the next director of the CDC, three people with knowledge of the matter told POLITICO.
The Washington Post first reported the anticipated appointment. Cohen, an Obama-era health official well known in Democratic policy circles, would replace outgoing CDC chief Rochelle Walensky, who is slated to leave the agency at the end of the month.
ADVOCACY GROUPS TO CMS: REGISTRY IS A BARRIER — Alzheimer’s disease advocates and doctors are frustrated and disappointed that Medicare will cover new treatments granted traditional approval only for patients enrolled in a clinical registry.
On Thursday, CMS said it would still require patient registries for coverage to see how the drugs work in real-world settings. It also said it would develop a nationwide portal where clinicians can enter patient data to ensure coverage is not delayed for treatments gaining traditional approval. The FDA is slated to decide whether to grant Leqembi, an Alzheimer’s treatment from Eisai and Biogen, traditional approval in July. No other drugs in the new class of Alzheimer’s treatments have received traditional approval.
“The bottlenecks will be worse than if there were no registry,” said R. Scott Turner, a neurologist and director of the Memory Disorders Program at Georgetown University. Turner said it would add a time constraint for doctors trying to treat as many patients as possible every day. “It’s unreimbursed effort and time, so who is going to want to do it?”
However, others said it is too soon to say whether the registry will delay or reduce patient access — and it could benefit clinicians in real time as they assess whether their patients are benefiting from a new treatment. “To me, this is serving two important purposes — you’re helping your patients get coverage [for an expensive drug] and that information is going to be available to you as a doctor,” said Diana Zuckerman, president of the National Center for Health Research, a patient advocacy think tank based in Washington.
COST PLUS DRUGS TARGETS HUMIRA — Coherus BioSciences plans to launch its biosimilar version of Humira, AbbVie’s blockbuster treatment for rheumatoid arthritis and other autoimmune disorders, at a massive discount in July, Megan reports.
The injectable medicine, called Yusimry, will have a list price of $995 per carton of two autoinjectors, the company said Thursday, 85 percent cheaper than its brand-name competitor. Coherus will also partner with the Mark Cuban Cost Plus Drug Company, co-founded by the tech billionaire, to offer the drug directly to patients for about $577 per carton of two autoinjectors.
Humira, one of the biggest-selling drugs in the U.S., has been on the market for 20 years without any lower-cost biosimilar competitors. That ended when Amgen launched its biosimilar, called Amjevita, in January. Several others are expected to come onto the market later this year.
The FDA published draft guidance Thursday for drugmakers developing migraine medicines that lays out recommendations for efficacy, trial design, dose selection and other considerations.
The FTC and DOJ released a summary Thursday of their June 2022 two-day workshop on pharmaceutical mergers.
The FDA updated its compliance manual Thursday for inspection and field testing of radiation-emitting electronic products.
The FDA issued hurricane season recommendations Wednesday for medical device manufacturers, urging companies to consider stockpiling materials to avoid disruptions if a storm impacts the supply chain.
