The approval in the United States of Biogen’s Alzheimer’s drug on June 7 has already generated controversy. But, far from calming down, it has been feeding in recent months. A race full of obstacles to which, now, a new one is added.
The Centers for Medicare and Medicaid Services (the federal agency of the United States Department of Health and Human Services) have issued the first draft of what the coverage of this drug will be like. A proposal that represents a new blow for the pharmaceutical company, since it contemplates the coverage only for patients who are enrolled in clinical trials.
A position that the company completely rejects. In a statement, Biogen notes that the proposal almost completely eliminates coverage of Aduhelm – the name of the drug – for beneficiaries of Medicare health insurance.
The consultant Evaluate Pharma warns that “the draft is so restrictive that, assuming it is implemented, it could lead to Aduhelm register practically no income in the short term“.
In fact, Evaluate has already lowered the sales forecast for this drug to 211 million euros in 2022 due to the uncertainty about the coverage decision by the United States health insurance program.
The moment the US drug regulatory agency (FDA) issued its authorization for the Alzheimer’s drug, an obstacle course began for Biogen.
The efficacy of the drug was questioned. and, later, different investigations were initiated on the process that had been followed until its approval.
The first of these investigations was announced just 20 days after the authorization of the drug against Alzheimer’s (Aduhelm). It was launched by the legislators of the United States themselves.
“We have serious concerns about the high price of Aduhelm and the process that led to its approval despite doubts about the drug’s clinical benefit,” the House Oversight and Reform Committee said in a statement at the time. Reuters.
Later, Acting FDA Commissioner Janet Woodcock asked the Office of the Inspector General for an independent investigation into Biogen’s drug authorization. She alleged that there were contacts between officials from the regulatory agency and the company prior to the decision that could have occurred outside of the normal process.
Also the high price set by Biogen was controversial: 46,000 euros a year ($56,000). An amount that the laboratory has been forced to lower in half with the aim of “improving patient access” to it.
In fact, doctors in the country are barely prescribing this treatment for Alzheimer’s. This is made clear by the latest accounts published by Biogen: in the third quarter, it invoiced only 258,000 euros ($300,000) from Aduhelm sales.
And it is not only in the United States that it is encountering obstacles. Also in the UnionEuropean. By the end of 2021, the European Medicines Agency (EMA) denied authorization marketing agreement for Biogen’s Alzheimer’s drug.
A decision that the laboratory does not share either. In fact, he announced the request for a review of the reasons why the approval of his drug has been rejected.
That is, there are still two chapters to close in the history of Aduhelm. On the one hand, to find out if the EMA changes its position and, on the other, to know the final decision on the coverage of this drug, which, predictably, will be known in April.