USA – Medicare will not pay for Biogen’s new Alzheimer’s drug unless prospective patients are enrolled in a clinical trial, the US government has announced, severely limiting the drug’s use.
The final policy, issued by the Centers for Medicare and Medicaid Services, largely confirms a draft proposal issued in January that Biogen and its pharmaceutical industry allies had sought to overturn.
In making its decision, the FDA stated that the clinical trial data supporting the drug, now known as Aduhelm, were insufficient to conclude that treatment is “reasonable and necessary” — a government standard for coverage.
The policy also applies to other drugs that function similarly to Biogen’s if, like Aduhlem, they are approved based on an intermediary measure that predicts but does not prove clinical benefit.
The final policy allows for slightly less stringent coverage if an Alzheimer’s drug similar to Aduhelm is approved based on a direct measure of clinical benefit.
In that case, CMS would pay for treatment in approved comparative studies, which could include data collection through a registry.
The FDA’s decision is the most recent contentious development for Aduhelm, which received contentious FDA approval in June.
Aduhelm is the first medication approved in the United States to slow the progression of Alzheimer’s disease rather than temporarily alleviate some of its symptoms.
However, the evidence gathered by Biogen to support its benefit was contradictory and ambiguous, raising serious doubts among physicians and even some FDA officials about whether Aduhelm actually helps patients.
When Biogen first examined data from Aduhelm’s main two studies in 2019, it concluded that they were likely to fail and halted testing.
However, Biogen revisited the data months later and discovered signs of benefit in one of the two trials, which it used to apply for Aduhelm’s approval.
The FDA’s later convened independent advisers were harshly critical of Biogen’s results and voted decisively against it.
Three members of that committee resigned after the FDA ignored their advice and approved Aduhelm.
Notably, the FDA granted Aduhelm accelerated approval based on its ability to remove a type of protein called amyloid from the brain.
In seeking approval, Biogen emphasized data indicating that Aduhelm slowed the progression of Alzheimer’s disease.
Low sales revenue
Since then, debate among doctors and researchers has raged, weighing on Biogen’s rollout of the drug, which earned only US$1 million in sales in the final three months of last year.
This figure was far lower than what Wall Street analysts had predicted, as it is estimated that approximately 6 million people in the United States have Alzheimer’s disease, and treatment options remain limited.
Medicare, which covers the majority of Alzheimer’s patients in the country, has finalized its policy, refusing to cover Aduhelm outside of a strictly controlled study known as a randomized clinical trial.
In contrast to the draft, CMS included in its definition any trials approved by the FDA or run by the National Institutes of Health, and removed the requirement that those trials take place in hospitals.
Patients must have mild cognitive impairment due to Alzheimer’s disease and evidence of amyloid accumulation in the brain to be eligible for coverage.
Biogen has taken drastic measures in response to Aduhelm’s problems. With meager sales numbers and declining revenue from most of its other products, the company announced in March that it would begin layoffs as part of an effort to cut US$500 million from its annual spending.
Biogen stated in its statement that it is “carefully considering all of its options” as it “further evaluates the business impact of this decision.”
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