The rollout of Biogen Inc’s Alzheimer’s drug is hitting new roadblocks as some large hospitals decide not to use it. And, many health insurers await coverage terms from Medicare, before setting their own policies. UnitedHealth Group CEO Andrew Witty said the payer needs to see more data on Aduhelm, Biogen’s controversial Alzheimer’s drug, before it will cover it. During UnitedHealth’s July 15 earnings conference call, Mr. Witty addressed Aduhelm coverage, noting that while he understands members and their families are hoping for coverage progress, there are too many unknowns.
- Time to wait: UnitedHealth said it is awaiting guidance on coverage from the Centers for Medicare and Medicaid Services, which runs the healthcare program for Americans aged over 65. UnitedHealth sells private Medicare Advantage plans.
- Fruitful guidance: CMO Richard Migliori, MD, said UnitedHealth will be looking toward experts, professional organizations and physicians for guidance. “We are continuing to develop our clinical policy as well as our ultimate position on coverage, but in doing so, we’re looking forward to getting the guidance that we need from Medicare, and also looking at the clinical evidence that comes from the ongoing clinical trials” said Dr. Migliori.
- Thoughtful decision: “I think this has some way to go before we get to clarity so I wouldn’t guide you to expect very rapid decision making on this,” UNH Chief Executive Officer Andrew Witty said during a conference call with analysts.
- Approval: The U.S. Food and Drug Administration approved Aduhelm (aducanumab) for the treatment of Alzheimer’s, a debilitating disease affecting 6.2 million Americans. Aduhelm was approved using the accelerated approval pathway, which can be used for a drug for a serious or life-threatening illness that provides a meaningful therapeutic advantage over existing treatments.
- Under trial: Under the accelerated approval provisions, which provide patients suffering from the disease earlier access to the treatment, the FDA is requiring the company, Biogen, to conduct a new randomized, controlled clinical trial to verify the drug’s clinical benefit. If the trial fails to verify clinical benefit, the FDA may initiate proceedings to withdraw approval of the drug.