UnitedHealth Group (UNH) - Get UnitedHealth Group Incorporated Report is seeking guidance from Medicare and physicians as the country's biggest health insurer tries to develops policies to cover Biogen's (BIIB) - Get Biogen Inc. Report new Alzheimer’s disease treatment, Aduhelm.
At last check, shares of the Minnetonka, Minn., company were up 1.3% to $420.02, while Biogen, Cambridge, Mass., was down 6.7% to $328.38.
The Food and Drug Administration approved Aduhelm last month, the first new treatment for Alzheimer’s disease in nearly two decades.
Separately, the Cleveland Clinic and Mount Sinai Health System in New York said they wouldn’t administer the drug to patients amid a debate about the drug’s effectiveness and whether the FDA followed missteps in approving the treatment, the Wall Street Journal reported.
"There’s still a lot of information that we need to be able to make really clear decisions, and I think we’re not the only ones in that regard looking for greater clarity in this arena,” Chief Executive Andrew Witty said, according to a transcript of an earnings called with analysts.
Richard Migliori, United Healthcare's chief medical officer, told analysts "we are encouraged to see meaningful progress being made against this devastating disease and advances in its treatment."
"We are continuing to develop our clinical policy as well as our ultimate position on coverage," he said, "but in doing so we’re looking forward to getting the guidance that we need from Medicare, and also looking at the continually contributing clinical outcomes that are coming from -- the clinical evidence that comes from the ongoing clinical trials."
Most importantly, Migliori said, "we’re looking for the advice from those expert, professional organizations, the physicians who have committed their careers to helping people with this devastating disease."
UnitedHealth posted stronger-than-expected first-quarter earnings on and raised its full year profit forecast.
The approval of Aduhelm, which will cost $56,000 a year, has been marred by controversy. In November, scientific advisers to the FDA recommended rejection of the drug and three members of the advisory panel resigned over the approval.
Last week, the FDA approved changes to the product information for Aduhelm, so the label says the drug has not been studied in treating later stages of the disease and should be given to patients with "mild cognitive impairment or mild dementia stage of disease."
One day later, Acting FDA Commissioner Janet Woodcock asked in a letter to the Office of the Inspector General to investigate how agency staff interacted with Biogen prior to the drug's approval.
On Tuesday, FDA officials who signed off on the approval defended their position in a letter to the medical journal JAMA Internal Medicine, Barron's reported.
"In weighing the benefits vs the risks of aducanumab, we considered that Alzheimer’s disease leads to irreversible loss of memory, cognition, and ability to function in daily activities,” the authors wrote.
“In listening sessions, we heard from patients and their families about the devastating toll the disease has taken and their desire for a treatment to stop or delay functional losses."