Medicare Part B

CMS Proposes to Restrict Medicare Coverage of Aduhelm to Patients in Clinical Trials

In a highly anticipated but not-so-surprising move, CMS on Jan. 11 released a proposed National Coverage Determination (NCD) that would restrict Medicare coverage of Biogen and Eisai, Co., Ltd.’s Aduhelm (aducanumab-avwa) and any other FDA-approved monoclonal antibodies that target beta amyloid plaque for the treatment of Alzheimer’s disease. Industry experts say the coverage proposal — coupled with a recent price cut on Aduhelm — is unlikely to alter commercial payers’ hesitancy toward covering the drug, while one actuary says the decision supports Medicare Advantage plans’ expectations that coverage would be limited.

According to the proposed NCD, which is now open to a 30-day comment period, Medicare would cover the therapies under Coverage with Evidence Development (CED), requiring that patients be enrolled in approved randomized controlled trials that are conducted in a hospital-based outpatient setting. Participants must have a “clinical diagnosis of mild cognitive impairment (MCI) due to AD or mild AD dementia; and evidence of amyloid pathology consistent with AD.” The NCD also would allow coverage of one beta amyloid positron emission tomography (PET) scan per patient as part of the protocol.


Medicare Plans to Cover Aduhelm but With Certain Restrictions

To say that the FDA’s approval of Biogen and Eisai, Co., Ltd.’s Alzheimer’s disease treatment Aduhelm (aducanumab-avwa) on June 7, 2021, garnered an immense amount of attention would seem to be an understatement. That said, the drug has somehow gathered even more notice over the past few months due to multiple developments, with CMS most recently issuing a proposed National Coverage Determination (NCD) on Aduhelm and other monoclonal antibodies that target beta amyloid plaque that will allow Medicare coverage for the therapies but only under certain circumstances. While commercial payers often follow CMS’s lead, it remains to be seen whether that decision — plus a dramatic price cut on Aduhelm — will prompt payers that have declined to cover the therapy to change course.

There is a 30-day public comment period on the proposed NCD, which was published Jan. 11. A final decision is expected on April 11.


News Briefs: CMS Rescinds Most Favored Nation Model | Jan. 13, 2022

CMS issued a final rule on Dec. 29 that rescinded the Most Favored Nation model. The mandatory model would have priced Medicare Part B drugs on the U.S. market based on their prices in certain countries. An interim final rule that was published in November 2020 had been blocked from being implemented on Jan. 1, 2021.

CMS published a proposed rule on Jan. 12 that would rein in direct and indirect remuneration (DIR) fees, which pharmacies have long complained about. The proposal would save consumers about $21.3 billion but cost the federal government $40.0 billion from 2023 through 2032.


Payer Groups Applaud CMS Coverage Decision on Aduhelm

CMS on Jan. 11 issued its long-awaited proposed National Coverage Determination (NCD) for Aduhelm (aducanumab), the Alzheimer’s drug that has been the subject of controversy since the FDA approved it last June. In what officials acknowledged was an unusual decision, CMS said Medicare will cover Aduhelm — and any other FDA-approved monoclonal antibodies that target amyloid plaques — only for people who are enrolled in qualifying clinical trials.

Health insurer trade groups praised the decision, which comes after Aduhelm manufacturer Biogen cut the price of the drug approximately in half in a bid to encourage both provider uptake and payer coverage.


Aduhelm Price Cut May Not Sway Private Payers’ View of Drug

Since the FDA greenlit the Alzheimer’s drug Aduhelm (aducanumab) in July under the accelerated approval program, concerns over the drug’s hefty price tag and overall effectiveness have been mounting. Now, the drug’s manufacturer, Biogen Inc., has cut the price approximately in half. One expert tells AIS Health that the move may cause private insurers to view the drug slightly more favorably, but they’re still likely to impose coverage restrictions on it. And a health plan trade group signaled that it isn’t impressed by the price cut.

After all, the furor surrounding Aduhelm is not all about price. “The clinical evidence that the FDA relied upon when approving the drug had various limitations, and the findings of the two clinical studies were conflicting,” James Chambers, Ph.D., MPharm., an associate professor at the Tufts Medical Center Institute for Clinical Research and Health Policy Studies, tells AIS Health via email.