On July 9, the current acting FDA Commissioner Janet Woodcock called for the Office of Inspector General to investigate the agency’s close ties with Biogen who had submitted its Alzheimer’s drug, Aduhelm for FDA approval.  Aduhelm is a monoclonal antibody for the treatment of Alzheimer’s disease, was extremely controversial when it was first approved due to concerns that it may not be effective in treating patients.  Indeed, critics said that there was no real scientific evidence that the drug helps delay the progression of Alzheimer’s disease. Additionally, Aduhelm isn’t cheap- It’s an estimated $56,000 and that could impact Medicare services.

Approximately, over 5.8 million Americans are living with Alzheimer’s disease according to the CDC and that number is expected to grow. Parkinson and Alzheimer’s have been difficult to treat and physicians do not have a lot in their toolbox to help patients. May key opinion leaders (KOLs) in the Alzheimer’s space were excited at the potential of Biogen’s new drug to help their patients.  As the OIG continues its investigation, it is likely that more questions will be raised about ways to ensure that interactions between regulators and pharmaceutical manufacturers are ethical and do not influence the FDA review process.

The Aduhelm situation isn’t that different than what happen with the Gilead Hepatitis C product Solvaldi in terms of cost. While Solvaldi was a cure for this chronic condition, the concern critics have with Aduhelm is that it may not be effective in patients with Alzheimer’s as its approval is based on a surrogate endpoint. So, what does this mean for reimbursement and Medicare coverage long-term?

According to the American Medical Association (AMA) Prior authorization delays contribute up to 92% of care delays in the United States and 1 in 4 patients are unable to get their drug prescription filled due to prior authorizations.  The Aduhelm controversy contributes to the already raging drug pricing debate which questions the link between high prices and value.  Both the 21st Century Cures Act and the recent FDA approval of Aduhelm add pressure to an already strained healthcare system.  With Solvaldi, it was essentially a one-time cost. With Aduhelm, it’s a repeated cost and this can pressure payers to limit access to Aduhelm. This is something that has already been seen with other specialty biologic products similar to Aduhelm.  This unprecedented move by the FDA to investigate its own review process will certainly have an impact on the health care system and regulatory affairs for years to come.