This article was originally published in FierceHealthcare.
While it has been over a month since the FDA announced its controversial decision to approve Biogen’s Alzheimer’s drug, Aduhelm, payers have been slow to make any decisions—and for good reason.
While the excitement around the approval is undeniable given the long-overdue unmet need for Alzheimer’s patients, there are still many questions stemming from the therapy’s stated efficacy and the FDA’s waffling over the label’s indication and usage section. With CMS’s recent move to open a National Coverage Determination (NCD) analysis, many payers will likely delay their initial reviews even further or use interim policies until CMS makes its final coverage decision in nine months.
And since Medicare is expected to shoulder most of the financial burden—senior citizens make up the majority of patients living with Alzheimer’s—there needs to be a high level of certainty about the drug’s clinical benefit. As a result, we may see a more restrictive NCD with respect to Aduhelm.
Of the few policies we’ve seen written to date (in draft or final version), some payers are excluding the product as “investigational and not medically necessary,” and others are covering the product with stringent prior authorization requirements that reflect the inclusion and exclusion criteria from the clinical trials.
The policies are also requiring routine MRIs before the seventh and 12th infusions, an additional consideration contributing to the cost for the patient and the system. While routine monitoring is common for patients dealing with chronic disease states, the burden of monitoring these patients could contribute to nonadherence and, therefore, denial of reauthorization.
What’s more, blocking access may not be an option for many payers outside of self-insured employers. Certain states and federal agencies do not allow for the exclusion of most FDA-approved treatments. Some payers will be required to bear the costs of this new treatment.
What can we expect moving forward?
As it stands, Aduhelm is in Phase IV of the clinical research process. Phase IV studies, which typically involve thousands of people, look at drugs that have already been approved by the FDA. The drugs are available for healthcare providers to prescribe to patients, but questions—about the drug itself and the FDA’s intentions—still need to be answered.
Some are considering the approval of Aduhelm a rallying cry for debating the FDA’s evaluation of therapies. As a pharmacist, I can see both sides of the debate. On one side, patient advocacy groups representing Alzheimer’s patients and their families say any new therapy showing any amount of benefit should be approved.
And if you’ve ever witnessed someone decline from Alzheimer’s, as I have, then you can understand the argument. But many experts warn that fast-tracking the drug without showing solid clinical benefit could set a dangerous precedent, making payers the regulators of utilization based on questionable clinical benefit.
Time will tell if there is a real clinical benefit to Aduhelm with Biogen’s confirmatory trials and with its use in the broader population. In the meantime, we wait. We wait to see if CMS creates a national coverage policy to set guidance on reimbursement. We wait for payers to create their own policies. We wait to see the results of the federal investigation as to whether interactions between Biogen executives and FDA officials during the review process violated FDA rules, which could undermine the public confidence in the approval.
We look forward to learning whether Aduhelm’s effect on brain plaque associated with Alzheimer’s actually benefits patients, especially since other manufacturers have molecules in clinical trials that work similarly. If clinical results show that Aduhelm truly makes an impact on the disease itself, a little competition is always healthy for drug pricing and may even bring down the cost.