Once in a while, the government prevails against drugmakers. Last Thursday, the Centers for Medicare and Medicaid Services (CMS) decided it would not cover the controversial Alzheimer’s drug, Aduhelm, except in clinical trials, despite the FDA’s approval of the drug. In an opinion piece for Stat News, John N. Mafi and Catherine Sarkisian, professors of medicine at UCLA, explain why it is appropriate that Medicare will only cover the drug for people participating in clinical trials.
Physicians and scientists have applauded CMS’ decision. Aduhelm has unclear benefits and presents huge risks. But, not surprisingly, Wall Street went ballistic on hearing the decision. Biogen threatened to sue CMS. While the cost of the drug is astronomical and reason enough to question whether it should be covered, the danger to people’s health and well-being from taking the drug are real and serious.
No one can argue that Aduhelm is either safe or effective, based on the evidence. More than four in ten people who took the drug ended up with bleeding or swelling in the brain. On top of that, one in fifty people lost their vision permanently. Other dangerous side effects are not yet known.
In addition, clinical trials at best show a possible benefit from the drug and many trials show no improved memory. The possible benefit was determined only in retrospective analysis, where there is a high likelihood of false positives. Moreover, the clinical trials were not conducted on an ethnically or racially diverse population.
Medicare is not allowed to factor in the cost of a drug when deciding whether to cover it. But, it should not pay for a drug that has no proven value and proven risks. The Medicare trust fund is predicted to be insolvent by 2026. At its initial launch price of $56,000, the drug would drive up costs for a Medicare population already struggling to afford needed care. It added $11 to the monthly Part B premium this year. People taking Aduhelm would spend about $6,800 a year, more than a quarter of their typical income, out of pocket.
Those arguing for Medicare’s coverage of the drug falsely claim that it will keep other drugs from being developed. There’s too much money in drug development, and drugmakers know that CMS’ decision is the exception, not the rule. Moreover, CMS has previously opted not to cover an FDA-approved drug.
Thank goodness CMS did not agree to cover Aduhelm at this time. That should lead to a lower Part B premium in the not too distant future.
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