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.

Forge Bi­o­log­ics’ cGMP Com­pli­ant and Com­mer­cial­ly Vi­able Be­spoke Affin­i­ty Chro­matog­ra­phy Plat­form

Forge Biologics has developed a bespoke affinity chromatography platform approach that factors in unique vector combinations to streamline development timelines and assist our clients in efficiently entering the clinic. By leveraging our experience with natural and novel serotypes and transgene conformations, we are able to accelerate affinity chromatography development by nearly 3-fold. Many downstream purification models are serotype-dependent, demanding unique and time-consuming development strategies for each AAV gene therapy product1. With the increasing demand to propel AAV gene therapies to market, platform purification methods that support commercial-scale manufacturing of high-quality vectors with excellent safety and efficacy profiles are essential.

Mathai Mammen, FogPharma's next CEO

Math­ai Mam­men hands in J&J's R&D keys to lead Greg Ver­dine’s Fog­Phar­ma 

In the early 1990s, Mathai Mammen was a teaching assistant in Greg Verdine’s Science B46 course at Harvard. In June, the former R&D head at Johnson & Johnson will succeed Verdine as CEO, president and chair of FogPharma, the same month the seven-year-old biotech kickstarts its first clinical trial.

After leading R&D at one of the largest drugmakers in the world, taking the company through more than half a dozen drug approvals in the past few years, not to mention a Covid-19 vaccine race, Mammen departed J&J last month and will take the helm of a Cambridge, MA biotech attempting to go after what Verdine calls the “true emperor of all oncogenes” — beta-catenin.

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Lu­pus drug de­vel­op­ment mar­ket heat­ing up, while FDA links with ad­vo­ca­cy group to fur­ther ac­cel­er­ate re­search

The long-underserved systemic lupus erythematosus (SLE) market is suddenly buzzing with treatment possibilities. Less than two years after AstraZeneca’s approval for Saphnelo — the first new SLE drug in a decade and joining just one other approved in GSK’s Benlysta – the pipeline of potential drugs numbers in the dozens.

Although most are very early stage — Spherix Global Insights estimates five in Phase II/III — the pharma R&D enthusiasm is catching on among doctors, patients and advocacy groups. On Wednesday, the Lupus Research Alliance and the FDA formed a novel private-public partnership called Lupus Accelerating Breakthroughs Consortium (Lupus ABC) to help advance lupus clinical trial success.

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Sen­ate Fi­nance Com­mit­tee lobs more bi­par­ti­san pres­sure on­to PBMs

Congress is honing in on how it wants to overhaul the rules of the road for pharmacy benefit managers, with a Senate Finance Committee hearing Thursday serving as the latest example of the Hill’s readiness to make changes to how pharma middlemen operate.

While pledging to ensure patients and pharmacies “don’t get a raw deal,” Finance Committee Chair Ron Wyden (D-OR) laid out the beginning of what looks like a major bipartisan effort — moves the PBM industry is likely to challenge vigorously.

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Nicklas Westerholm, Egetis Therapeutics CEO

Ac­qui­si­tion talks on­go­ing for Swedish rare dis­ease biotech Egetis, shares up al­most 40%

Shares of the Sweden-based rare disease biotech Egetis Therapeutics skyrocketed on Thursday afternoon as the company said it’s engaged in “ongoing discussion” with external parties regarding a “potential acquisition.”

Egetis confirmed rumors with a statement on Thursday while noting that there is no certainty that a takeover offer will be made.

Nonetheless, the possibility of an acquisition has shot up Egetis’ share price. By the afternoon on Thursday, its stock price was {$EGTX.ST} up over 38%. An Egetis spokesperson told Endpoints News in an email that it has no further comments.

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FDA ap­proves Nar­can opi­oid over­dose re­ver­sal spray for over-the-counter sale

The FDA today approved Emergent BioSolutions’ Narcan brand naloxone nasal spray for over-the-counter sales. The nod was expected and comes on the heels of a unanimous 19-0 advisory committee vote in favor of approval last month.

The move to OTC means the opioid overdose reversal agent will now be available on grocery, convenience and gas stations shelves, as well as potentially for purchase online.

Stéphane Bancel, Moderna CEO (AP Photo/Markus Schreiber)

Mod­er­na so­lid­i­fies deal with Kenya to build mR­NA man­u­fac­tur­ing fa­cil­i­ty

The mRNA player Moderna is further cementing its presence on the African continent.

Moderna announced on Thursday that it has finalized an agreement with Kenya’s government to partner up and bring an mRNA manufacturing facility to the east African nation. The new facility aims to manufacture up to 500 million doses of vaccines annually. Moderna also said the new facility will have the ability to spike its production capabilities to respond to public health emergencies on the continent or globally.

Ivana Magovčević-Liebisch, Vigil Neuroscience CEO

FDA lifts par­tial clin­i­cal hold on Vig­il Neu­ro­science's TREM2 an­ti­body, re­mov­ing dos­ing cap

When Vigil Neuroscience filed its IPO papers in late 2021, the biotech revealed that the FDA had just cleared its Phase I trial — but with a partial clinical hold that limited dosing to under a certain level.

More than a year later, the FDA has lifted the hold.

Vigil is now free to dose VGL101, an antibody targeting TREM2, at levels higher than 20 mg/kg in its ongoing and future clinical trials in patients with adult-onset leukoencephalopathy with axonal spheroids and pigmented glia (ALSP), an inherited condition that affects the brain and spinal cord.

Luke Miels, GSK chief commercial officer

GSK picks up Scynex­is' FDA-ap­proved an­ti­fun­gal drug for $90M up­front

GSK is dishing out $90 million cash to add an antifungal drug to its commercial portfolio, in a deal spotlighting the pharma giant’s growing focus on infectious diseases.

The upfront will lock in an exclusive license to Scynexis’ Brexafemme, which was approved in 2021 to treat a yeast infection known as vulvovaginal candidiasis, except in China and certain other countries where Scynexis already out-licensed the drug.

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