As the fallout continues from the FDA’s controversial approval of Biogen’s new Alzheimer’s drug Aduhelm, some insurers are reportedly unwilling to cover the high costs associated with the drug.
At least six affiliates of Blue Cross Blue Shield across the country have adopted new policies describing Aduhelm as either “experimental” or “investigational,” the Boston Globe reported Tuesday evening, saying the drug falls outside covered medicines because it remains under clinical review. The report came a day after the Centers for Medicare & Medicaid Services opened a nine-month review process over limiting coverage of Aduhelm, which is priced at $56,000 per year.
Endpoints News has reached out to Blue Cross Blue Shield for comment, as well as other major insurers regarding their coverage plans, and will update accordingly.
Biogen, meanwhile, is slamming the decision. In an emailed statement to Endpoints News, a Biogen spokesperson said the characterization of Aduhelm as experimental is “inaccurate and misleading,” and noted that only a “very small portion” of patients would be affected by the plans.
“Typically, an experimental drug is one that has not yet entered clinical trials, whereas an investigational drug is one that is being studied in trials but has not yet received marketing approval from the FDA,” spokesperson Allison Parks wrote. “Aduhelm is approved by the FDA and is neither experimental nor investigational.”
It’s not entirely clear how the insurers came to their decision, nor why they are describing Aduhelm as an experimental product, given its green light by the FDA on June 7. Their language may be a reference to the accelerated approval pathway upon which regulators used to OK Aduhelm, which requires a study to confirm clinical efficacy be completed by 2030.
Historically, insurers have covered drugs under accelerated approval, although some have objected to certain expensive rare disease medicines. Whether or not insurers would be willing to pay for the drug had been an open question, however, due to Aduhelm’s high price tag. Some insurers also cited negative assessments of the drug to justify their positions, the Globe reported.
In a notice posted by Blue Cross Blue Shield of Minnesota on June 23, the insurer said claims for Aduhelm may be denied while the drug remains “under review.” Another memo from the North Carolina affiliate posted sometime last month described its plans in similar terms, saying it “does not provide coverage for investigational services or procedures.”
The Minnesota group’s “goal is to find the right balance between making new treatments available and guarding against unsafe or unproven approaches,” it wrote. “While the drug is under clinical review, the drug treatment is considered experimental/investigative until the evaluation process has been completed.”
It remains to be seen how the insurers’ plans will play out over time or whether their plans will change once the CMS review is complete. Biogen has said it expects about 80% of patients eligible for Aduhelm are covered by Medicare, and private insurers are likely to follow the federal government’s lead.
CMS has denied only about 3% of claims submitted by hospitals and physicians, typically doing so when the care is, in their opinion, “not reasonable and necessary.”
The Globe report is the latest in an ongoing controversy over the drug, which the FDA OK’ed despite a unanimous vote against approval by its own adcomm. Three of those panel experts have since resigned in protest, with one member — Harvard professor Aaron Kesselheim — calling the decision “probably the worst drug approval decision in recent U.S. history.”
Things have only grown more heated following a report from STAT News about a group of Biogen employees tasked in early 2019 specifically to persuade the FDA to approve the drug.
The report spurred at least two prominent Democratic legislators to call for an investigation into the drug’s approval process, a probe which got underway Tuesday. And interim FDA chief Janet Woodcock has asked the HHS inspector general to investigate her own agency to examine the relationships between FDA officials and Biogen executives.
As public health experts continue to criticize the drug’s approval and call for broader reform, the FDA staff in charge of the OK is standing by their decision. Billy Dunn, Peter Stein and Patrizia Cavazzoni wrote in a JAMA perspective Tuesday that Aduhelm is a perfect fit for the accelerated approval pathway despite the “complexities” surrounding the drug.
Private insurers decline to cover Biogen's new Alzheimer's drug in escalating standoff — report - Endpoints News
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