Several large payers are waiting on results from the National Coverage Determination.
Add UnitedHealth Group to the list of payers that are hitting pause on a coverage policy for Aduhelm, Biogen’s newly approved Alzheimer’s drug stirred controversy over its clinical findings, and later with its $56,000-per-year price tag.
During an analysts’ call reported by Reuters, UNH Chief Executive Andrew Witty said, “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.”
Witty was referencing CMS’ decision earlier this week to launch a National Coverage Determination for Aduhelm, a review that will examine clinical evidence and take public comments before offering guidance for Medicare coverage. Previously, Humana said through a spokeswoman that it would also wait for guidance from CMS, as it is one of the largest providers of Medicare Advantage plans.
On Monday, Formulary Watch® reported that Blue Cross and Blue Shield plans in Michigan, North Carolina, Pennsylvania, and other states would not cover Aduhelm. On Wednesday, The New York Times reported that the Cleveland Clinic and Mount Sinai will not give the drug to patients.
FDA approved Aduhelm (aducanumab) June 7 amid intense debate and despite unanimous disapprove of the advisory panel that reviewed the evidence. Three panel members quit after the approval.
Of note, the approval came without oversight from a permanent FDA commissioner.
FDA Issues Complete Response Letter for Pz-Cel to Treat Epidermolysis Bullosa
April 22nd 2024Prademagene zamikeracel is a cell therapy designed to incorporate the functional collagen-producing COL7A1 gene into a patient’s own skin cells. The FDA is asking for additional information on manufacturing practices.
Read More
FDA Approves Stelara Biosimilar, Selarsdi
April 18th 2024Alvotech’s Selarsdi (ustekinumab-aekn), a biosimilar referencing Stelara (ustekinumab), gained FDA approval, making it the second ustekinumab biosimilar and second for the company to be given the green light for the American market.
Read More