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.

A new era of treat­ment: How bio­mark­ers are chang­ing the way we think about can­cer

AJ Patel was recovering from a complicated brain surgery when his oncologist burst into the hospital room yelling, “I’ve got some really great news for you!”

For two years, Patel had been going from doctor to doctor trying to diagnose his wheezing, only to be dealt the devastating news that he had stage IV lung cancer and only six months to live. And then they found the brain tumors.

“What are you talking about?” Patel asked. He had never seen an oncologist so happy.

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Serhat Gumrukçu, Enochian BioSciences co-founder (Seraph Research Institute)

LA biotech founder ar­rest­ed, charged in mur­der-for-hire scheme be­hind 2018 death

A biotech founder has been arrested and charged for his role in a murder-for-hire scheme that resulted in the death of a man in Vermont back in 2018.

Serhat Gumrukçu, the co-founder of Enochian BioSciences, was arrested in Los Angeles, where the company is based, according to the Department of Justice. He was charged alongside Berk Eratay of Las Vegas, and a third person, Jerry Banks of Colorado, was previously arrested for kidnapping and allegedly murdering the victim, Gregory Davis.

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Adam Russell, ARPA-H's incoming acting deputy director

NI­H's new, in­de­pen­dent break­through drug ac­cel­er­a­tor ARPA-H gets its first em­ploy­ee

Despite the controversy of housing it in NIH, HHS Secretary Xavier Becerra on Wednesday afternoon formally announced the establishment of the Advanced Research Project Agency for Health (ARPA-H) as an independent entity within the NIH, as HHS had previously stipulated that “NIH may not subject ARPA-H to NIH policies.”

Becerra also announced the appointment of ARPA-H’s inaugural employee, Adam Russell, who will serve as acting deputy director.

FDA spells out the rules and re­stric­tions for states seek­ing to im­port drugs from Cana­da

The FDA is offering more of an explanation of the guardrails around its program that may soon allow states to import prescription drugs in some select circumstances from Canada, but only if such imports will result in significant cost reductions for consumers.

While the agency has yet to sign off on any of the 5 state plans in the works so far, and PhRMA’s suit to block the Trump-era rule allowing such imports is stalled, the new Q&A guidance spells out the various restrictions that states will have to abide by, potentially signaling that a state approval is coming.

ProFound Therapeutics founding team

Flag­ship's lat­est biotech could turn some of the thou­sands of new pro­teins it dis­cov­ered in­to ther­a­pies — and it has $75M to start

Flagship Pioneering, the incubator of Moderna and dozens of other biotechs, says it has landed upon tens of thousands of previously undiscovered human proteins. The VC shop wants to potentially turn them into therapeutics.

Like other drug developers that have turned proteins into therapeutics (think insulin for diabetes), Flagship’s latest creation, ProFound Therapeutics, wants to tap into this new trove of proteins as part of its mission to treat indications ranging from rare diseases to cancer to immunological diseases.

Richard Silverman, Akava Therapeutics founder and Northwestern professor

This time around, Lyri­ca's in­ven­tor is de­vel­op­ing his North­west­ern dis­cov­er­ies at his own biotech

Richard Silverman was left in the dark for the last five years of clinical development of the drug he discovered. The Northwestern University professor found out about the first approval of Lyrica, in the last few days of 2004, like most other people: in the newspaper.

What became one of Pfizer’s top-selling meds, at $5 billion in 2017 global sales before losing patent protection in 2019, started slipping out of his hands when Northwestern licensed it out to Parke-Davis, one of two biotechs that showed interest in developing the drug in the pre-email days, when the university’s two-person tech transfer team had to ship out letters to garner industry appetite.

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Mihael Polymeropoulos, Vanda Pharmaceuticals CEO

Phar­ma com­pa­ny con­tin­ues its FDA law­suit spree, this time af­ter agency de­nies fast-track des­ig­na­tion

Vanda Pharmaceuticals is making a name for itself, at least in terms of suing the FDA.

The DC-headquartered firm on Monday filed its latest suit against the agency, with the company raising concerns over the FDA’s failure to grant a fast track designation for Vanda’s potential chronic digestive disorder drug tradipitant, which is a neurokinin 1 receptor antagonist.

Specifically, Vanda said FDA’s “essential point” in its one-page denial letter on the designation pointed to “the lack of necessary safety data,” which was “inconsistent with the criteria for … Fast Track designation.”

David Ricks, Eli Lilly CEO (David Paul Morris/Bloomberg via Getty Images)

Eli Lil­ly set to in­vest $2.1B in home state man­u­fac­tur­ing boost

Eli Lilly is looking to expand its footprint in its home Hoosier State by making a major investment in manufacturing.

The pharma is investing $2.1 billion in two new manufacturing sites at Indiana’s LEAP Lebanon Innovation and Research District in Boone County, northwest of Lilly’s headquarters in Indianapolis.

The two new facilities will expand Lilly’s manufacturing network for active ingredients and new therapeutic modalities, including genetic medicines, according to a press release.

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Up­dat­ed: US sees spike in Paxlovid us­age as Mer­ck­'s mol­nupi­ravir and As­traZeneca's Evusheld are slow­er off the shelf

New data from HHS show that more than 162,000 courses of Pfizer’s Covid-19 antiviral Paxlovid were administered across the US over the past week, continuing a streak of increased usage of the pill, and signaling not only rising case numbers but more awareness of how to access it.

In comparison to this week, about 670,000 courses of the Pfizer pill have been administered across the first five months since Paxlovid has been on the US market, averaging about 33,000 courses administered per week in that time.