The federal Medicare program finalized a plan to restrict coverage for Biogen’s Alzheimer’s therapy to patients in certain clinical trials, while offering a road map to cover drugs that show clinical benefit in the disease.
The decision announced on Thursday will effectively prevent most patients with Alzheimer’s disease from receiving Biogen’s Aduhelm. Yet Medicare officials said that the policy would provide broader coverage to future drugs that show a clear clinical benefit in large trials of the disease and get full approval from the Food and Drug Administration.
It’s a blow to Biogen, which has been campaigning for the Centers for Medicare and Medicaid Services to reverse its stance since the initial coverage proposal was announced in January. Analysts at RBC Capital Markets said on Thursday that the news, while in line with expectations, “likely spells the end for Aduhelm.” At the same time, it “leaves a clear door open” for other medications in development. That includes potential new medicines from Eli Lilly and Roche.
The decision strikes a middle ground—keeping a hard line on Aduhelm while creating a path to payment for newer treatments with strong evidence. “Once the drug goes through traditional approval, then anyone is eligible who is a Medicare patient” and meets the drug’s label criteria, said Tamara Syrek Jensen, a director in the Medicare agency’s coverage and analysis group, on a call with reporters.
Medicare officials said the policy will create consistent coverage rules for Alzheimer’s drugs in development with reimbursement linked to the strength of the clinical benefits they show. “This long-term pathway is meant to be nimble and respond to any new drugs in this class that are in in the pipeline that demonstrate clinical benefit,” Lee Fleisher, CMS’s chief medical officer, said. “Our decision creates one standard and predictable pathway for national coverage that applies to every drug in this class.” Read more from John Tozzi and Robert Langreth.
- Biogen called the move “unprecedented,” and said it’s considering its options. The CMS decision “effectively denies all Medicare beneficiaries access to Aduhelm, the first and only FDA-approved therapy in a new class of Alzheimer’s drugs,” it said in a statement. When additional data from this new class of treatments become available, Biogen said it will urge CMS to reconsider Thursday’s decision for all FDA-approved amyloid-beta targeting therapies, Hari Govind reports.
Medicare’s decision is already spurring calls for the Biden administration to lower the program’s largest-ever rate increase this year. The standard monthly premium for Medicare outpatient, or “Part B,” coverage jumped from $148.50 in 2021 to $170.10 this year, in part to shore up contingency reserves in case the program began to cover Aduhelm. The costly drug was first priced at $56,000 a year, but has since been lowered to $28,000.
The $21.60 increase is the largest annual dollar-amount rate hike ever for Part B coverage, while the 14.5% increase is the third-largest percentage increase since 2007, according to the Centers for Medicare & Medicaid Services. Possible Aduhelm coverage accounted for half of the rate hike. But after Biogen lowered the price of Aduhelm to $28,000 in December 2021, HHS Secretary Xavier Becerra directed the CMS in January to review the Part B rate hike. “We are still going through that process,” Beth Lynk, a CMS spokesperson, said during a press briefing on Thursday.
With the decision Thursday to only cover Aduhelm for beneficiaries in qualifying clinical trials, fewer beneficiaries are likely to be eligible for coverage. That projected savings should merit a reduction in the Part B premium, the National Committee to Preserve Social Security and Medicare says. Read more from Tony Pugh.
The Coronavirus Pandemic
Biden Border Move Creates Disarray, New Alliances: A once-obscure border policy created chaos on Capitol Hill this week and showed the increasingly fraught nature of immigration politics, and some unexpected avenues for bipartisan action. Opposition to the White House’s plans to nix a pandemic-related border restriction known as Title 42 derailed a Covid-19 aid measure in the Senate, gummed up an unrelated House vote, and sparked legislation to rebut the move. The change was opposed by moderate Democrats, some of whom face challenging fall elections. Read more from Ellen M. Gilmer.
Pelosi Infection Brings Virus Ever-Closer to Biden: President Joe Biden spent an hour with Nancy Pelosi (D-Calif.) in the two days before she tested positive for Covid, including an embrace and a kiss on the cheek—yet the White House insisted Thursday he doesn’t qualify as a “close contact” of the House speaker. Biden—who just received his second booster dose of the Pfizer vaccine—tested negative on Wednesday. Because he wasn’t deemed to have spent enough time around Pelosi, he won’t follow CDC guidance that close contacts wear a mask for 10 days, his spokeswoman said, Josh Wingrove and Billy House report.
Biden Renews Pre-Covid Standards for Nursing Homes: The Biden administration is reinstating some pre-pandemic training and care requirements for nursing home staff that were temporarily lifted as facilities struggled to respond to the public health crisis. Chief among the newly restored standards is a rule that caps employment for temporary nursing aides to four months at Medicare- and Medicaid-certified facilities unless they complete state-approved training of at least 75 hours. To ensure enough staffing levels early in the pandemic, the Trump administration waived the training requirement. Tony Pugh has more.
- Meanwhile, states from Arizona to Maine are deploying billions of dollars in federal money to hospitals in a desperate attempt to retain and hire overworked health-care professionals facing the threat of another surge in Covid. Pennsylvania hospitals are getting $210 million for bonuses or wage hikes for front-line health workers. Texas approved $378 million to address “critical staffing needs” at nursing homes and home health agencies. Tennessee health-care facilities are receiving $120 million. Read more from Martin Z. Braun and Lauren Coleman-Lochner.
Federal Workers Face New Jab-or-Job Choice: Federal workers will face renewed pressure to get Covid-19 shots or risk losing their jobs under a court ruling. A federal appeals court on Thursday told a trial judge to toss out a challenge to Biden’s vaccine mandate covering 2 million U.S. government civilian employees. The Texas judge had previously blocked the presidential order nationwide. The ruling echoes the U.S. Supreme Court verdict greenlighting Biden’s similar vaccine requirement for all workers in federally funded health-care facilities. Read more from Laurel Brubaker Calkins.
Bills, Industry & Regulation
Lawmakers Seek Public Drug Clinical Trial Cost Report: A group of congressional Democrats including House Oversight and Reform Chair Carolyn Maloney (D-N.Y.), as well as Sens. Debbie Stabenow (D-Mich.) and Tina Smith (D-Minn.), introduced legislation Thursday requiring drug manufacturers to publicly disclose clinical trial costs. The legislation is part of a slew of bills seeking to lower drug costs, the lawmakers said. These bills “target Big Pharma’s manipulative practices in order to strengthen competition, promote innovation, and increase transparency,” Maloney said, Se Young Lee reports.
Insurers’ ‘Gaming’ of ACA Provision Seen Boosting Premiums: An Obamacare provision designed to protect consumers from price gouging in health insurance is instead being manipulated to keep premiums high, driving up the costs for individuals and employers alike. That’s the consensus of U.S. agencies, academics, and employer groups familiar with the Affordable Care Act’s medical loss ratio provision, which requires insurers in the individual and group markets to spend at least 80% of their premium revenue on claims or quality improvement, or refund the difference. Read more from Sara Hansard.
FDA Floats Cybersecurity Guide Makeover for Devices: Medical device makers should use established security frameworks to reduce vulnerabilities through the regulatory process according to new FDA guidance aimed at combating an increase in digital attacks. Manufacturers have until July 7 to weigh in on the FDA’s proposed guidelines for developing secure devices equipped to handle modern cyber attacks. Laying out recommendations for premarket submissions, the draft replaces a guidance document from 2018 and adds exemptions for investigational devices and clarifies document requests. Ian Lopez has more.
J&J’s ‘Texas Two-Step’ Strategy Remains in Doubt: A corporate strategy that gained attention in a Johnson & Johnson spinoff’s bankruptcy continues to face uncertainty despite a refusal to dismiss the Chapter 11 lawsuit. The maneuver, known as the Texas Two-Step because of its reliance on Texas corporate law, involves a company spinning off a unit then transferring its tort liability to it. The spinoff is then put into bankruptcy to manage that liability without putting the assets of the original company into play. A North Carolina bankruptcy judge last week called the stategy into question. Read more from James Nani.
What Else to Know Today
Survey Says Some Black Americans Wary of Researchers: Medical researchers leave a mixed impression on Black Americans, who largely trust their ability to carry out science, while remaining wary of the potential for misconduct and their ability to own up to errors. The Pew Research Center’s latest findings underscore the diversity of experiences and perceptions within the Black community based on age, education level and other factors. They could inform policymakers, drug companies, federal agencies, and scientists as they work to improve diversity in clinical trials and improve equity in research. Jeannie Baumann has more.
Whitmer Sues to Shield Abortion Rights in Michigan: Michigan Gov. Gretchen Whitmer (D) has filed a lawsuit with the state’s Supreme Court asking it to protect abortion rights if the U.S. Supreme Court overturns Roe v. Wade this year. Whitmer is asking the Michigan court to rule that abortions are legal, according to a statement Thursday. She is seeking to secure abortion rights because of a 1931 law on the state’s books that states that abortions are illegal. “A near total abortion ban would rob women of their reproductive freedom and the ability to decide whether and when to have a child,” Whitmer wrote. David Welch has more.
WHO Preparing for Possible Chemical Attacks: The World Health Organization is preparing for potential chemical attacks or accidents in Russia’s Ukraine war, a top official said. “WHO is considering all scenarios and making contingencies for different situations that could afflict the people of Ukraine, from the continued treatment of mass casualties, to chemical assaults,” said Hans Kluge, Europe Director-General for the WHO at a briefing in Lviv. Biden has echoed European leaders’ concern about the possible use of chemicals against Ukrainians, saying there are “real concerns” about an attack. Read more from Andy Hoffman.
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