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.

At the In­flec­tion Point for the Next Gen­er­a­tion of Can­cer Im­munother­a­py

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

All about Omi­cron; We need more Covid an­tivi­rals; GSK snags Pfiz­er’s vac­cine ex­ec; Janet Wood­cock’s fu­ture at FDA; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

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Merck's new antiviral molnupiravir (Quality Stock Arts / Shutterstock)

As Omi­cron spread looms, oral an­tivi­rals ap­pear to be one of the best de­fens­es — now we just need more

After South African scientists reported a new Covid-19 variant — dubbed Omicron by the WHO — scientists became concerned about how effective vaccines and monoclonal antibodies might be against it, which has more than 30 mutations in the spike protein.

“I think it is super worrisome,” Dartmouth professor and Adagio co-founder and CEO Tillman Gerngross told Endpoints News this weekend. Moderna CEO Stéphane Bancel echoed similar concerns, telling the Financial Times that experts warned him, “This is not going to be good.”

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Pfiz­er, Am­gen and Janssen seek fur­ther clar­i­ty on FDA's new ben­e­fit-risk guid­ance

Three top biopharma companies are seeking more details from the FDA on how the agency conducts its benefit-risk assessments for new drugs and biologics.

While Pfizer, Amgen and Janssen praised the agency for further spelling out its thinking on the subject in a new draft guidance, including a discussion of patient experience data as part of the assessment, the companies said the FDA could’ve included more specifics in the 20-page draft document.

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Janet Woodcock (AP Images)

Janet Wood­cock plots her fu­ture at FDA, with se­nior ad­vi­sor role to fall back on if Califf wins con­fir­ma­tion

Acting FDA commissioner Janet Woodcock has been the face of just about every drug approval decision at the agency since the turn of the century. Since the pandemic began, she’s moved between the top of the drugs center to the head of therapeutics at Operation Warp Speed, leading the drive for work on Covid-targeted mAbs and antivirals.

Looking forward — and pending a quick Senate confirmation to cement Rob Califf’s return to the top of FDA early next year — Woodcock’s role at the agency will again be in flux.

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Richard Pazdur (via AACR)

Ac­cel­er­at­ed ap­proval re­forms need mean­ing­ful con­fir­ma­to­ry tri­al im­prove­ments, pro­fes­sors write in Sci­ence

Outside of Covid-19, 2021 has been the year of the accelerated approval.

Beginning last spring, FDA openly challenged six “dangling” accelerated approvals (hadn’t confirmed their clinical benefit yet), three of which were later pulled by the companies.

Then in June, FDA pulled out the accelerated approval pathway, seemingly out of nowhere, to sign off on Biogen’s controversial Alzheimer’s drug Aduhelm. It hadn’t even been mentioned at the drug’s adcomm.

Lisa Deschamps, AviadoBio CEO

Ex-No­var­tis busi­ness head hops over to a gene ther­a­py start­up — and she's reeled in $80M for a dash to the clin­ic

Neurologist and King’s College London professor Christopher Shaw has been researching neurodegenerative diseases like ALS and collaborating with drugmakers for the last 25 years in the hopes of pushing new therapies forward. But unfortunately, none of those efforts have come anywhere close to fruition.

“So, you know, after 20 years in the game, I said, ‘Let’s try and do it ourselves,’” he told Endpoints News. 

In­cor­po­rat­ing Ex­ter­nal Da­ta in­to Clin­i­cal Tri­als: Com­par­ing Dig­i­tal Twins to Ex­ter­nal Con­trol Arms

Most drug development professionals are familiar with the nerve-racking wait for the read-out of a large trial. If it’s negative, is the investigational therapy ineffective? Or could the failure result from an unforeseen flaw in the design or execution of the protocol, rather than a lack of efficacy? The team could spend weeks analyzing data, but a definitive answer may be elusive due to insufficient power for such analyses in the already completed trial. These problems are only made worse if the trial had lower enrollment, or higher dropout than expected due to an unanticipated event like COVID-19. And if a trial is negative, the next one is likely to be larger and more costly — if it happens at all.

Lan Huang, BeyondSpring CEO

Months af­ter shock­ing in­vestors with lung can­cer win, Be­yond­Spring's lead drug hits road­block at the FDA

BeyondSpring shocked investors in early August after its once-marginal lead drug suddenly showed a lot of promise in a common form of lung cancer. With hopes high, the FDA has now slammed the door on that drug in another indication — does that spell bad news for BeyondSpring’s Cinderella story?

The FDA issued BeyondSpring a complete response letter for its plinabulin in combination with granulocyte colony-stimulating factor (G-CSF) for the prevention of chemotherapy-induced neutropenia, effectively shutting down the drug’s immediate chances at a marketing approval, the biotech said Wednesday.

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