Pri­vate in­sur­ers de­cline to cov­er Bio­gen's new Alzheimer's drug in es­ca­lat­ing stand­off — re­port

As the fall­out con­tin­ues from the FDA’s con­tro­ver­sial ap­proval of Bio­gen’s new Alzheimer’s drug Aduhelm, some in­sur­ers are re­port­ed­ly un­will­ing to cov­er the high costs as­so­ci­at­ed with the drug.

At least six af­fil­i­ates of Blue Cross Blue Shield across the coun­try have adopt­ed new poli­cies de­scrib­ing Aduhelm as ei­ther “ex­per­i­men­tal” or “in­ves­ti­ga­tion­al,” the Boston Globe re­port­ed Tues­day evening, say­ing the drug falls out­side cov­ered med­i­cines be­cause it re­mains un­der clin­i­cal re­view. The re­port came a day af­ter the Cen­ters for Medicare & Med­ic­aid Ser­vices opened a nine-month re­view process over lim­it­ing cov­er­age of Aduhelm, which is priced at $56,000 per year.

End­points News has reached out to Blue Cross Blue Shield for com­ment, as well as oth­er ma­jor in­sur­ers re­gard­ing their cov­er­age plans, and will up­date ac­cord­ing­ly.

Bio­gen, mean­while, is slam­ming the de­ci­sion. In an emailed state­ment to End­points News, a Bio­gen spokesper­son said the char­ac­ter­i­za­tion of Aduhelm as ex­per­i­men­tal is “in­ac­cu­rate and mis­lead­ing,” and not­ed that on­ly a “very small por­tion” of pa­tients would be af­fect­ed by the plans.

“Typ­i­cal­ly, an ex­per­i­men­tal drug is one that has not yet en­tered clin­i­cal tri­als, where­as an in­ves­ti­ga­tion­al drug is one that is be­ing stud­ied in tri­als but has not yet re­ceived mar­ket­ing ap­proval from the FDA,” spokesper­son Al­li­son Parks wrote. “Aduhelm is ap­proved by the FDA and is nei­ther ex­per­i­men­tal nor in­ves­ti­ga­tion­al.”

It’s not en­tire­ly clear how the in­sur­ers came to their de­ci­sion, nor why they are de­scrib­ing Aduhelm as an ex­per­i­men­tal prod­uct, giv­en its green light by the FDA on June 7. Their lan­guage may be a ref­er­ence to the ac­cel­er­at­ed ap­proval path­way up­on which reg­u­la­tors used to OK Aduhelm, which re­quires a study to con­firm clin­i­cal ef­fi­ca­cy be com­plet­ed by 2030.

His­tor­i­cal­ly, in­sur­ers have cov­ered drugs un­der ac­cel­er­at­ed ap­proval, al­though some have ob­ject­ed to cer­tain ex­pen­sive rare dis­ease med­i­cines. Whether or not in­sur­ers would be will­ing to pay for the drug had been an open ques­tion, how­ev­er, due to Aduhelm’s high price tag. Some in­sur­ers al­so cit­ed neg­a­tive as­sess­ments of the drug to jus­ti­fy their po­si­tions, the Globe re­port­ed.

In a no­tice post­ed by Blue Cross Blue Shield of Min­neso­ta on June 23, the in­sur­er said claims for Aduhelm may be de­nied while the drug re­mains “un­der re­view.” An­oth­er memo from the North Car­oli­na af­fil­i­ate post­ed some­time last month de­scribed its plans in sim­i­lar terms, say­ing it “does not pro­vide cov­er­age for in­ves­ti­ga­tion­al ser­vices or pro­ce­dures.”

The Min­neso­ta group’s “goal is to find the right bal­ance be­tween mak­ing new treat­ments avail­able and guard­ing against un­safe or un­proven ap­proach­es,” it wrote. “While the drug is un­der clin­i­cal re­view, the drug treat­ment is con­sid­ered ex­per­i­men­tal/in­ves­tiga­tive un­til the eval­u­a­tion process has been com­plet­ed.”

It re­mains to be seen how the in­sur­ers’ plans will play out over time or whether their plans will change once the CMS re­view is com­plete. Bio­gen has said it ex­pects about 80% of pa­tients el­i­gi­ble for Aduhelm are cov­ered by Medicare, and pri­vate in­sur­ers are like­ly to fol­low the fed­er­al gov­ern­ment’s lead.

CMS has de­nied on­ly about 3% of claims sub­mit­ted by hos­pi­tals and physi­cians, typ­i­cal­ly do­ing so when the care is, in their opin­ion, “not rea­son­able and nec­es­sary.”

The Globe re­port is the lat­est in an on­go­ing con­tro­ver­sy over the drug, which the FDA OK’ed de­spite a unan­i­mous vote against ap­proval by its own ad­comm. Three of those pan­el ex­perts have since re­signed in protest, with one mem­ber — Har­vard pro­fes­sor Aaron Kessel­heim — call­ing the de­ci­sion “prob­a­bly the worst drug ap­proval de­ci­sion in re­cent U.S. his­to­ry.”

Things have on­ly grown more heat­ed fol­low­ing a re­port from STAT News about a group of Bio­gen em­ploy­ees tasked in ear­ly 2019 specif­i­cal­ly to per­suade the FDA to ap­prove the drug.

The re­port spurred at least two promi­nent De­mo­c­ra­t­ic leg­is­la­tors to call for an in­ves­ti­ga­tion in­to the drug’s ap­proval process, a probe which got un­der­way Tues­day. And in­ter­im FDA chief Janet Wood­cock has asked the HHS in­spec­tor gen­er­al to in­ves­ti­gate her own agency to ex­am­ine the re­la­tion­ships be­tween FDA of­fi­cials and Bio­gen ex­ec­u­tives.

As pub­lic health ex­perts con­tin­ue to crit­i­cize the drug’s ap­proval and call for broad­er re­form, the FDA staff in charge of the OK is stand­ing by their de­ci­sion. Bil­ly Dunn, Pe­ter Stein and Pa­trizia Cavaz­zoni wrote in a JA­MA per­spec­tive Tues­day that Aduhelm is a per­fect fit for the ac­cel­er­at­ed ap­proval path­way de­spite the “com­plex­i­ties” sur­round­ing the drug.

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