Biogen’s pricey Alzheimer’s drug spurs biggest increase in Medicare premium

USA – The federal government has announced a significant increase in Medicare premiums, blaming the pandemic but also citing “uncertainty” about how much it may be forced to pay for a costly and controversial new Alzheimer’s drug.

The 14.5 percent increase in Part B premiums will raise monthly payments for those with the lowest income from US$148.50 this year to US$170.10 in 2022. It is the largest dollar increase in history, as well as one of the largest percentage increases in recent years.

The Centers for Medicaid and Medicare (CMS) officials said that Aduhelm was responsible for roughly half of the increase in Part B premiums.

Though the CMS is still deciding how it will cover Aduhelm under Part B, the agency stated that the possibility of paying for Aduhelm at all necessitated “additional contingency reserves.”

Medicare is a federal health insurance program that serves over 62 million people, the majority of whom are 65 and older.

Part B premiums are calculated based on income. Individuals making US$500,000 or more per year, and joint filers earning US$750,000 or more per year, will pay US$578.30 per month for coverage in 2022.

Medicare Part B covers physician services, outpatient hospital services, certain home health services, medical equipment, and certain other medical and health services not covered by Medicare Part A, such as medications prescribed by doctors.

Even if Medicare covers Aduhelm on a national level, Biogen may face pressure to lower its price by 95% to meet the Institute for Clinical and Economic Review, (ICER) benchmark for balancing health benefits and costs.

Aduhelm’s controversial case

The Food and Drug Administration approved Aduhelm in June, in one of the most contentious decisions in its history, based on the drug’s ability to remove a toxic protein from the brains of Alzheimer’s patients rather than its effect on cognition.

The decision is contentious because the trial evidence on the latter point was contradictory, with one trial finding a benefit and the other finding none. The FDA’s outside advisers advised against Aduhelm’s approval, but the agency overruled them.

Biogen must conduct a confirmatory trial to show that people taking Aduhelm decline more slowly than those given a placebo in order for the drug to remain on the market. However, the company has nine years to do so.

Aduhelm has struggled commercially in the absence of a firm Medicare decision on coverage. Biogen recently announced that sales between July and September, the drug’s first full quarter on the market, totaled only US$300,000.

The low sales revenues imply that only a few hundred patients have received the drug to date. Analysts on Wall Street predicted third-quarter sales of US$16 million.

CMS plans to release a proposed coverage decision in January, followed by a final version in April.

Meanwhile, as the product has been used outside of clinical trials, concerns about Aduhelm’s side effects, particularly brain swelling, have grown.

Biogen is currently investigating the death of a 75-year-old patient who died after experiencing brain swelling as a result of treatment. It’s unclear whether Aduhelm was responsible for the swelling or the patient’s death.

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