UnitedHealthcare Won’t Cover Aduhelm; Biogen CEO to Step Down

UnitedHealthcare considers Aduhelm unproven and not medically necessary for treating Alzheimer’s disease.

The Centers for Medicare & Medicaid Services’ (CMS) decision to provide only limited coverage for Biogen’s Aduhelm (aducanumab-avwa) to treat Alzheimer’s disease is having far-reaching impacts.

UnitedHealthcare said in an updated Medical Drug Benefit Policy that patients taking Aduhelm must be in an approved clinical trial. The drug is “unproven and not medically necessary for the treatment of Alzheimer’s disease due to insufficient evidence of efficacy.”

In addition, Biogen CEO Michel Vounatsos will step down and the company will significantly reduce commercial infrastructure supporting Aduhelm.

In early April, CMS confirmed that Medicare will only cover Aduhelm for patients in specific clinical trials. In its final Medicare national coverage determination (NCD), CMS said FDA-approved monoclonal antibodies to treat Alzheimer’s disease may only be covered in a randomized controlled trial conducted under an investigational new drug application.

Because of the CMS decision, Biogen will “substantially eliminate its commercial infrastructure supporting Aduhelm, retaining minimal resources to manage patient access programs, including a continued free drug program for patients currently on treatment in the US,” the company said in a news release.

But Biogen expects to continue funding certain regulatory and R&D activities for Aduhelm, including the continuation of the EMBARK re-dosing study and the initiation of the phase 4 post-marketing requirement study, ENVISION.

“Additional actions regarding Aduhelm may be informed by upcoming data readouts expected for this class of antibodies, as well as further engagement with the FDA and CMS,” Biogen said.

Vounatsos will continue in his role until a successor is appointed, according to the company.

“It has been an honor to lead this outstanding company during such a challenging period and to work closely with so many dedicated and talented colleagues. I am very proud of Biogen’s unparalleled capabilities in neuroscience, a complex field with tremendous unmet medical need, and of the novel medicines and benefits we have brought to patients,” Vounatsos said.