CMS’s New Ruling on Biogen’s Aduhelm Restriction Coverage

The Centers for Medicare & Medicaid Services (CMS) recently issued a final coverage determination for Biogen’s controversial Alzheimer’s drug Aduhelm, limited to subjects enrolled in clinical trials conducted by the National Institutes of Health (NIH).

CMS also emphasized that there is insufficient clinical evidence to demonstrate adequate efficacy for Alzheimer’s patients despite the expedited FDA approval of Aduhelm. In fact, CMS believes that currently there is no single type of Alzheimer’s drug proven to be successful in ameliorating the disease progression and that no clinical trials have shown that the anti-amyloid mAb can provide significant therapeutic benefit to Alzheimer’s patients.

Aduhelm: Controversial New Alzheimer’s Drug Since Approval

In June 2021, the FDA approved Aduhelm, a new drug for Alzheimer’s disease co-developed by Biogen and Japanese pharmaceutical company Eisai. This was the first Alzheimer’s treatment approved since 2003, and the first drug ever shown to mitigate the disease through the removal of amyloid beta peptide (Aβ).

However, since its approval for marketing, there have been a series of controversies, including the FDA’s announcement of restricted uses of Aduhelm and the European Medicines Agency’s (EMA) opposition to its marketing application. In December 2021, Biogen announced that the price of Aduhelm had been reduced from $56,000 to $28,000 per year, a 50% discount, undermining the confidence of medical professionals and the drug user community.

Related Article: EMA Rejects Marketing Authorization Application of Aduhelm

CMS Issues Final Ruling on Coverage Restriction for Aduhelm

CMS first disagreed with the FDA’s assessment and announced in January 2022 that it intends to include Aduhelm in the coverage of Medicare, but only for subjects enrolled in clinical trials conducted by the National Institutes of Health (NIH).

On April 7, 2022, CMS issued its final ruling statement on the population restriction for Aduhelm, which, as predicted by most industry experts, only provides coverage for patients in clinical trials. This result was immediately supported by many clinical experts who believed that the FDA should not have approved Aduhelm in the first place and expected CMS to underline its lack of clinical credibility by not covering Aduhelm therapy at all.

Through CMS’s independent review process, the use of drugs, whether or not they receive expedited FDA approval or other privileged approval, is once again further scrutinized by the Americans. CMS also highlighted in its statement that “medical innovation must include clinical trials that demonstrate benefit to patients,” CMS said in its decision memo.

Drugs from Roche and Eli Lilly Possibly Affected

The ruling of CMS against Aduhelm may also lead to coverage restrictions on other anti-amyloid antibody drugs that are similar to Aduhelm.

Meanwhile, Genentech, a subsidiary of Roche, and Eli Lilly are also working hard to advance the final phase of clinical trials for their anti-amyloid drugs. In particular, Eli Lilly has high expectations for its drug Donanemab, which has also received expedited approval from the FDA, while Genentech has indicated that it will follow the standard review application process to obtain FDA approval and expects to release clinical data in late 2022.

In response to the CMS ruling, Brandy Matthews, the medical launch leader for donanemab, called for an evaluation of monoclonal antibody drugs on an individual basis based on the results of clinical trials, rather than restricting the same line of therapies across the board. “We urge CMS to ensure that its coverage decision does not intentionally or unintentionally limit access to future therapies,” said Matthews.

Is this the End of Biogen’s Turmoil?

Since the marketing approval of Aduhelm in 2021, Biogen originally anticipated sales of tens of billions of dollars, but ended up in a dispute with CMS and a large number of layoffs. The CMS ruling on patient restriction has brought a temporary end to Biogen’s turmoil. 

Still, Biogen strongly disagrees with the ruling statement, arguing that CMS is using a different standard in its review of Aduhelm and compromising the rights of many Medicare beneficiaries. Nevertheless, given that another Alzheimer’s drug candidate in collaboration with Eisai is awaiting market launch, Biogen indicated that internal assessments will be carefully performed and the company will continue to update its decisions.

Written by Aurora Mau/ Translated by Richard Chau

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GeneOnline Team