Health payers–including Medicare and Point32Health–to question Aduhelm pricing and its “reasonable and necessary” use

State’s Sec­ond-Largest Health Insur­er Slams Bio­gen For Cost­ly Alzheimer’s Drug (The Boston Globe):

The state’s sec­ond-biggest health insur­er is threat­en­ing to lim­it or not cov­er Biogen’s new Alzheimer’s drug, accus­ing the Cam­bridge biotech of putting “exces­sive cor­po­rate prof­its” ahead of patients by charg­ing $56,000 a year for the con­tro­ver­sial treat­ment. Michael Sher­man, chief med­ical offi­cer for Point32Health, the insur­ance com­pa­ny formed by the recent merg­er of Tufts Health Plan and Har­vard Pil­grim Health Care, said Bio­gen should cut the cost of the drug called Aduhelm by a fac­tor of rough­ly 10, to $5,400, giv­en the medicine’s ques­tion­able ben­e­fits and poten­tial risks.

Sen­a­tors Call On Con­gress To Exam­ine Expen­sive New Alzheimer’s Drug (STAT):

Sens. Eliz­a­beth War­ren (D‑Mass.) and Bill Cas­sidy (R‑La.) want Con­gress to take a deep­er look at how Biogen’s con­tro­ver­sial and pricey new Alzheimer’s drug, Aduhelm, will affect the Medicare pro­gram, they wrote in a let­ter Wednes­day. The bipar­ti­san duo is press­ing the Sen­ate Finance Com­mit­tee to take on “the vex­ing new ques­tions and chal­lenges that approval rais­es for the Medicare pro­gram and oth­er health pro­grams” the pan­el over­sees, they wrote.

The Letter from Sens. Elizabeth Warren (D‑Mass.) and Bill Cassidy (R‑La.):

Cas­sidy, War­ren Call for Hear­ing on New Alzheimer’s Dis­ease Drug Aduhelm (press release):

… Under the broad label that FDA approved, the drug is avail­able to all Alzheimer’s patients, and the agency did not place lim­its on treat­ment dura­tion sug­gest­ing that patients could remain on the drug indef­i­nite­ly. We are trou­bled by reports that those fac­tors could lead the drug to com­mand “some­where between” the $37 bil­lion we cur­rent­ly spend on Medicare Part B and the $90 bil­lion we cur­rent­ly spend on Medicare Part D. This lev­el of poten­tial new spend­ing, par­tic­u­lar­ly for just one prod­uct with lim­it­ed evi­dence of clin­i­cal effi­ca­cy thus far, tests the program’s resiliency.

… Medicare cov­er­age is lim­it­ed to items and ser­vices that are con­sid­ered “rea­son­able and nec­es­sary” for the diag­no­sis or treat­ment of an ill­ness or injury, fit with­in the scope of a ben­e­fit cat­e­go­ry, and are not oth­er­wise specif­i­cal­ly exclud­ed from cov­er­age. The Cen­ters for Medicare and Med­ic­aid Ser­vices (CMS) … may also need to make deci­sions about cov­er­age for poten­tial ancil­lary ser­vices like amy­loid PET scans. CMS might address these issues under its cur­rent author­i­ties through the issuance of a nation­al cov­er­age deter­mi­na­tion, which could autho­rize cov­er­age with­out restric­tion, lim­it cov­er­age, or delay full cov­er­age pend­ing col­lec­tion of more evi­dence. It might also be pru­dent for Con­gress to make pol­i­cy changes to enable Medicare to move towards val­ue-based pay­ment arrange­ments, which direct­ly con­nect pre­scrip­tion drug pric­ing to clin­i­cal effectiveness.

News in Context:

• Can the con­tro­ver­sial FDA approval of Aduhelm back­fire and delay the dis­cov­ery of actu­al Alzheimer’s treat­ments? (Yes, it can)
• US Sen­a­tor Joe Manchin calls for a new FDA Com­mis­sion­er to replace cur­rent (act­ing) one who “has repeat­ed­ly ignored pub­lic health con­cerns and shown a dere­lic­tion of duty” over opi­oids and aducanumab
• First, do no harm? Six rea­sons to approach anti-amy­loid drug Aduhelm cau­tious­ly, if at all
• Grow­ing back­lash against the FDA approval of unproven Alzheimer’s treat­ment Aduhelm, by Biogen