Alzheimer’s Groups Seek Broad Medicare Coverage for Pricey Drugs

Industry-backed Alzheimer’s advocacy groups are seeking to rally lawmakers and political candidates around their push for Medicare to broaden coverage for Biogen’s expensive drug Aduhelm and others like it.

The Centers for Medicare & Medicaid Services on Thursday said it would increase coverage for patients taking Leqembi, or lecanemab, from Biogen Inc. and Eisai Co., if the Food and Drug Administration grants the product traditional approval.

The FDA is set to decide on Leqembi by July 6. A traditional approval would prompt the CMS to allow for coverage for patients enrolled in a registry that collects real-world information on how the therapy works for them, the Medicare agency said.

The FDA gave accelerated approval of Leqembi in January based on evidence it reduced amyloid plaques in the brain. The agency will grant traditional approval if it decides that results from a phase 3 trial confirm that the drug meaningfully delays the progression of Alzheimer’s disease.

The Alzheimer’s Association said the Medicare agency’s announcement is in line with a commitment the CMS laid out in 2022 when it first announced its would restrict coverage for monoclonal antibodies directed against amyloid for the treatment of Alzheimer’s disease to those patients taking it in clinical trial settings.

The group, which on Thursday called the new registry “an unnecessary barrier” for patients, has made its presence known at Capitol Hill this year, with purple-wearing advocates filling seats at eight different congressional hearings. Most have included testimony from high-ranking health officials in the Biden administration, such as Health and Human Services Secretary Xavier Becerra, and Chiquita Brooks-LaSure, administrator of the Centers for Medicare & Medicaid Services.

Controversial Move

The CMS in February denied a request from the Alzheimer’s Association and other groups to reconsider its coverage restrictions for amyloid-targeting monoclonal antibodies. The 2022 decision followed the FDA’s accelerated approval of Aduhelm, or aducanumab. The controversial move went against the recommendation of an independent panel of experts. Lawmakers from both sides of the aisle criticized the CMS for covering the drug only in clinical trials.

Aduhelm was first priced at $56,000 a year but has since been lowered to $28,000 annually, while the company’s Leqembi drug is $26,500. A study published in the Journal of the American Medical Association estimated that coverage of Biogen’s Leqembi could cost Medicare up to $5 billion a year.

With an independent panel of experts scheduled to meet June 9 to discuss Leqembi, and a final FDA approval decision expected within weeks after, patient advocacy organizations want members of Congress, the White House, and top HHS officials to press for broader coverage of amyloid-targeting monoclonal antibodies.

“It’s kind like appealing to a higher court,” Robert Egge, chief public policy officer at the Alzheimer’s Association, said in an interview.

Clinicians and researchers are pushing back, arguing that the campaigns are misleading the public on CMS coverage policy for these therapies.

Groups like Georgetown’s PharmedOut project, which aims to promote evidence-based prescribing and education on medical product marketing practices, are warning lawmakers of the need for continued study of these therapies. They cite risks of serious side effects, such as brain swelling and bleeding, as well as uncertainty over whether the drugs meaningfully slow the progression of Alzheimer’s disease.

The plans for using a national patient registry is “part of CMS’ mission to help improve the lives of Americans we serve,” Brooks-LaSure said in a press release.

“CMS has always been committed to helping people obtain timely access to innovative treatments that meaningfully improve care and outcomes for this disease,” she said.

‘We Need Some Leadership’

The Alzheimer’s Association has held what Egge called “cheerful protests or indignant rallies” at every CMS regional office this year, and demonstrated at HHS headquarters in Washington on May 24. The group also announced Thursday plans to host rallies in all 50 states throughout Alzheimer’s & Brain Awareness Month in June to push the CMS to change its coverage policy.

The idea is to get Congress, the White House domestic policy council, and people in HHS above the Coverage and Analysis Group paying attention, Egge said. CAG repeatedly told the group that they won’t revisit their decision around coverage.

If the CMS fails to broaden coverage should the FDA grant Leqembi traditional approval, it would mean the CMS policy “is fundamentally broken and needs to be fixed by legislation or other means,” such as the courts, Egge said.

Patient groups are also using public opinion polling as a means to secure champions in Congress for broader coverage. Almost 90% of likely 2024 voters support requiring Medicare to cover the costs of FDA-approved drugs and therapies designed to slow the progression of Alzheimer’s disease, a telephone survey in early May found. Us Against Alzheimer’s, the Alliance for Aging Research, and other Alzheimer’s patient advocacy groups commissioned the poll.

“We need some leadership here. We certainly want the White House to take notice,” Sue Peschin, president and CEO of the Alliance for Aging Research, said in a May 23 media briefing.

Some members of Congress have already committed to taking the CMS to task. Rep. Nanette Díaz Barragán (D-Calif.) has worked on legislation with colleagues from across the aisle, including Rep. Vern Buchanan (R-Fla.) and Rep. John Joyce (R-Pa.).

One bill introduced last Congress, called the Mandating Exclusive Review of Individual Treatments, or MERIT, Act, would require the CMS to issue coverage determinations for individual drugs or biologics, rather than entire classes. A second bill called the Access to Innovative Treatments Act, which Barragán and Joyce reintroduced in April, would create a review process within the CMS for each national coverage determination for drug products. Neither bill got votes in the full chamber.

“The process of FDA approving a drug but having CMS say we’re not going to cover it, it’s not reasonably necessary, is a broken system,” Barragán said in an interview.

Barragán said she’s asked Cathy McMorris Rodgers (R-Wash.), chair of the House Energy and Commerce Committee, to bring up the Access to Innovative Treatments Act. Barragán is also trying to get the heads of the Energy and Commerce health subcommittee—Rep. Anna Eshoo (D-Calif.) and Rep. Brett Guthrie (R-Ky.)—on a call with Brooks-LaSure to press her on Medicare’s coverage decision.

Keeping Patients Safe

The messaging from Alzheimer’s groups is missing the lingering questions on safety and efficacy that surround amyloid-targeting monoclonal antibodies, researchers and clinicians say.

“These drugs don’t have the evidence that Medicare needs for them to be considered reasonable and necessary,” said Judy Butler, a research fellow at PharmedOut. “What they’re doing is trying to keep patients safe and collect evidence at the same time.”

PharmedOut sent a letter to members of Congress on May 22, urging them to not interfere in the CMS coverage determination. PharmedOut Director Adriane Fugh-Berman, along with multiple university professors and researchers, argued in the letter that “FDA’s controversial approval of Leqembi’s predecessor aducanumab (Aduhelm) opened the door for approval of this class of drugs, and left CMS with few alternatives in its efforts to protect patients.”

Lawmakers are “getting one side of this argument, and it’s the industry side,” Fugh-Berman said in an interview. The Alzheimer’s Association, Us Against Alzheimer’s, and the Alliance for Aging Research all receive funding from Biogen and Eisai, as well as Eli Lilly & Co., which is planning to apply for traditional FDA approval of its Alzheimer’s drug donanemab.

Legislation from Congress would “basically curtail CMS independence in making coverage decisions,” said Reshma Ramachandran, a Yale School of Medicine family physician and chair of the Doctors for America’s FDA Task Force.

Lawmakers should “allow the agencies to do their job and do their job properly so that we can ensure that there is continued public trust of these agencies and that they’re not being swayed by others who have a relationship with manufacturers, instead of following the science,” Ramachandran said.