Biogen defends Alzheimer’s drug price amid fury

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“There is no perfect analogue in this space, but we rated Aduhelm to be about 1/3 the level of cancer immunotherapies and about 25% below the average level of psoriasis biologics” such as Humira, she said in an email.

Critics say the comparison would make sense if Biogen had submitted convincing evidence to the Food and Drug Administration that Aduhelm worked in clinical trials, as the makers of Keytruda and Humira have done. But this is not the case.

“Keytruda is an expensive drug, but for patients with non-small cell lung cancer, you have clinical data showing that it improves survival,” said Brian Skorney, analyst at Baird investment bank , who argues that drug regulators should not have approved Aduhelm. “The problem here with Aduhelm’s award is that there is no argument that it is doing for Alzheimer’s patients what Keytruda is doing for cancer patients.”

The FDA approved Aduhelm on June 7 over objections from the agency’s scientific advisory board, including three members who resigned in protest, saying Biogen had failed to demonstrate its effectiveness. One of the most closely watched investigational drugs in recent history, it had generated conflicting results in two late stage clinical trials. In one study, people who received the drug declined 22% slower on average than those who received a placebo. The other trial did not achieve its goal.

Many analysts and scientific experts have been stunned by Aduhelm’s approval, which came under pressure from families of people with Alzheimer’s and their advocates. The FDA cleared the drug under a less common “fast track” for drugs that meet a serious unmet need.

The FDA typically uses this approach when regulators are unsure of a drug’s clinical benefits and rely on another yardstick that suggests it would help patients. In this case, it was Aduhelm’s reduction of a sticky substance called amyloid that clumps together in plaques in the brains of people with Alzheimer’s disease. The reduction, Biogen said this week, is “reasonably likely to predict” that the drug will benefit these patients.

Considering the “unbearable expense” of treating the approximately 6 million Americans with the most common cause of dementia, Biogen estimates that $ 56,000 “reflects the overall value this treatment brings to patients, caregivers and the community. the company, ”Parks said.

Critics, including drug pricing experts, leading scientists, a senior insurance executive and several lawmakers in Washington, vehemently disagree.

They say the evidence that Aduhelm was effective in clinical trials was confusing at best, and the drug is only worth a fraction of $ 56,000, if any. They also say there remains an open question whether removing amyloid plaques from the brains of people with Alzheimer’s disease will slow cognitive decline.

“Based on the evidence we have today, this drug is nowhere near as effective, if it is effective at all,” said Dr Steven Pearson, president of the Institute for Clinical and Economic Review, or ICER, an influential drug from Boston. price watch group.

Pearson’s group recently attempted to calculate a fair price for a hypothetical drug that did not cure Alzheimer’s disease but prevented it from progressing in patients with early symptoms. The ICER concluded that such a drug would be a breakthrough and could cost between $ 50,000 and $ 70,000 per year, based on an estimated annual cost of $ 500 billion to the U.S. healthcare system as a result of this. devastating disease.

But in a May 7 draft report, the watchdog group said Biogen generated “insufficient evidence” that its drug would fit the bill, if the FDA approved it, as the agency did for four weeks. later. In fact, the ICER calculated that Biogen’s drug would deserve an annual price of only $ 2,500 to $ 8,300, based on conflicting results and evidence from clinical trials. that it can cause worrying side effects, including swelling of the brain which usually does not cause severe symptoms.

Many drug companies have charged breathtaking prices for breakthrough new drugs in recent years, including gene therapy from Novartis that costs $ 2.1 million for a one-time treatment for a rare inherited disease. But Skorney, Baird’s analyst, said Biogen may have “pushed a sleeping bear” into charging $ 56,000 for Aduhelm amid widespread skepticism about its effectiveness.

The price tag, he said, could cause Congress to pursue drug pricing reforms, including seeking permission to negotiate drug costs on behalf of the government-funded Medicare program, whose beneficiaries constitute the bulk of patients with Alzheimer’s disease.

Senators Elizabeth Warren, Democrat of Massachusetts, and Bill Cassidy, Republican of Louisiana, this week called on Congress to investigate Aduhelm’s implications for the federal budget. Analysts have predicted that Medicare and its registrants, who pay a share of their prescription drug costs, will spend between $ 5.8 billion and $ 29 billion per year on the drug, which could be more than the federal government spends. for some entire agencies.

Biogen and its Japanese business partner, Eisai, said in a press release Wednesday that they plan to market the drug to 1 to 2 million Americans with mild cognitive impairment, although the drug’s label from the FDA does not limit it to these patients.

Biogen also said it was working with Connecticut-based insurer Cigna and the Veterans Health Administration on “innovative access agreements” for the patients these organizations serve, but Biogen did not provide details. A spokesperson for the Veterans Health Administration said on Friday it could not provide any information immediately. Cigna did not respond to inquiries.

Michael Sherman, chief medical officer of Point32Health, the insurance company formed by the recent merger of Tufts Health Plan and Harvard Pilgrim Health Care, agreed that Aduhelm’s pricing could fuel long-standing appeals to the government to limit drug prices, anathema to pharmaceuticals. industry.

His company, Massachusetts’ second-largest health insurer, is carefully weighing whether to cover Aduhelm because it’s so expensive, and experts consulted by Point32Health have “consistently … been negative about their belief in the effectiveness of the drug. medication, ”Sherman said. in an email.

Biogen, Sherman continued, demonstrated that the current drug approval process “can create a blank check when it approves a drug for which there is no direct competition. The fact that Biogen chose to populate it with an inordinately high number shows this in a way that invites a strong regulatory response. “

Even the Alzheimer’s Association, which enlisted celebrities such as Samuel L. Jackson in a public campaign that lobbied the FDA to approve Aduhelm, broke with Biogen over the price.

Joanne Pike, chief strategy officer for the nonprofit, said Thursday the group recognizes Aduhelm is not a cure, but believes it will benefit patients and lead to better medicines.

“The association does not determine the costs of the drugs, but we want the treatment to be affordable and accessible,” she said. “The price as it stands today is unacceptable.”


Jonathan Saltzman can be reached at [email protected]

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