Insurers put squeeze on Biogen Alzheimer’s drug

CALL IT THE first big shot across Biogen’s bow in what may become a multi-billion-dollar war in which the hopes of millions for a way to hold back the ravages of Alzheimer’s disease are colliding with the uncertain benefits of a new drug and the explosion of already sky-high health care costs its widespread use would drive. 

The Cambridge-based pharmaceutical company has been riding high since its new treatment for Alzheimer’s disease, aducanumab, was approved last month by the Food and Drug Administration. It is the first approved drug designed to attack the Alzheimer’s disease process, not just its dementia symptoms. 

But the approval was one of the most controversial in the agency’s history, with an FDA advisory panel that reviewed the evidence opposing approval and lots of other experts questioning whether the drug is actually effective. With a price tag of $56,000 a year for the treatment, which is administered via monthly intravenous injections, widespread use of the treatment will depend on insurers’ willingness to cover its cost — and the first signs of insurer revolt are now in the air.

The Globe reports that six state affiliates of insurance giant Blue Cross Blue Shield say they will not cover the drug’s cost because they believe it is still experimental or has not been shown to deliver any “clinical benefit.” With Alzheimer’s overwhelmingly targeting older people, the bulk of the drug cost would fall to Medicare to cover, but lots of patients, the Globe says, would “rely on secondary private insurance for other costs associated with Aduhelm,” the brand name for aducanumab. 

Medicare’s decision about whether to cover the drug — which will have a far greater impact than those of private insurers — may not come for nine months, the Globe reports. 

The drug’s approval is a tortured tale of zigzagging decisions, with the heavy lobbying power of the country’s pharmaceutical industry looming over the spectacle. Two Phase 3 trials designed to test the drug’s effectiveness were terminated early when aducanumab appeared to show no benefit. But Biogen subsequently said further analysis of data from one of the trials showed a high dose of the drug could slow cognitive decline by about four months over an 18-month period. 

That set the stage for the FDA’s consideration of approval of its use. The agency ruled on June 7 that there were enough grounds to sanction the drug’s use. 

The decision sent Biogen’s stock soaring 38 percent on the day of the ruling — and it was hailed by patient advocates who are desperate for any measure that can hold back the relentless march of Alzheimer’s. But critics slammed the decision as an ill-informed move that will add billions of dollars to US health care costs, while offering false hope, but little actual benefit, to Alzheimer’s patients and their families.

The Boston-based health news website STAT reported late last month that Biogen worked a “back channel” at the FDA to push hard for the agency’s consideration of the drug. The FDA’s own acting director has now called for an investigation into its approval of the drug, acknowledging the questions raised about Biogen’s influence on the process. 

Three members of the FDA drug advisory panel that urged against approval of aducanumab resigned in protest following the agency’s decision to contravene their recommendation. One of them, Aaron Kesselheim, a professor at Harvard Medical School in the division of pharmacoepidemiology, called it the “worst drug approval in recent US history” in his resignation letter.