Michel Vounatsos, Biogen CEO (Credit: World Economic Forum/Valeriano Di Domenico)

Bio­gen de­fends slow roll­out of new Alzheimer's drug, crit­i­cizes neg­a­tive me­dia at­ten­tion

As Bio­gen ex­ecs be­moaned the neg­a­tive me­dia cov­er­age around Aduhelm’s ap­proval a month ago, the biotech isn’t gain­ing much trac­tion yet in us­ing its new drug, large­ly due to a lack of in­sur­ance cov­er­age, ac­cord­ing to an earn­ings call Thurs­day.

Man­age­ment in­di­cat­ed that of the near­ly 900 sites that were prepped and ready fol­low­ing Aduhelm’s ap­proval, 325 of those, or about 35%, have com­plet­ed a pos­i­tive phar­ma­cy and ther­a­peu­tics (P&T) re­view or won’t re­quire one. The re­view is a step some hos­pi­tals or health sys­tems take pri­or to us­ing a new drug. Some ma­jor sites, how­ev­er, have said they won’t par­tic­i­pate.

Bio­gen’s top re­search chief Al San­drock al­so said on the call that he wel­comed a for­mal re­view in­to the in­ter­ac­tions be­tween FDA and Bio­gen, as “a bet­ter un­der­stand­ing is good for every­one in­volved.” He al­so of­fered an open let­ter on Thurs­day to “cor­rect some of the mis­in­for­ma­tion” around the ap­proval. For in­stance, San­drock took is­sue with the idea that ad­u­canum­ab’s tri­al re­sults are “post hoc,” al­though the com­pa­ny did stop the tri­als due to fu­til­i­ty. He al­so stressed that the ac­cel­er­at­ed ap­proval path­way, while not­ing that col­lab­o­ra­tion be­tween in­dus­try and reg­u­la­to­ry agen­cies is com­mon, ap­pro­pri­ate and ben­e­fi­cial.

A for­mer se­nior FDA of­fi­cial told End­points that any dis­cus­sion at a con­fer­ence be­tween agency of­fi­cials and a com­pa­ny on an ap­pli­ca­tion’s de­tails or tim­ing, is im­prop­er and should not hap­pen. Both STAT News and NYT al­so con­firmed sep­a­rate­ly that FDA’s neu­ro­science head Bil­ly Dunn met pri­vate­ly at a con­fer­ence to dis­cuss Aduhelm’s ap­pli­ca­tion.

San­drock al­so seemed to blame the con­tro­ver­sy around the Aduhelm ap­proval on neg­a­tive me­dia at­ten­tion. Jay Ol­son, a re­search an­a­lyst at Op­pen­heimer, opened the call’s ques­tion­ing with one about all of the “neg­a­tive me­dia” cov­er­age, which CEO Michel Vounatsos thanked him for ask­ing and said he agreed with.

Vounatsos said he does ex­pect re­gion­al Medicare MAC/Ad­van­tage plans will pro­vide cov­er­age while Medicare’s NCD re­view is on­go­ing. But the NCD will over­ride any of those lo­cal Medicare plan de­ci­sions that are in­sti­tut­ed pri­or to the NCD, said Al­isha Alaimo, pres­i­dent of Bio­gen’s US or­ga­ni­za­tion. That NCD de­ci­sion from CMS isn’t ex­pect­ed for an­oth­er 9 months.

But, ac­cord­ing to one Bio­gen em­ploy­ee, that re­gion­al cov­er­age has not hap­pened yet, and com­mer­cial in­sur­ers have been hes­i­tant to cov­er the new drug. The com­pa­ny said it brought in $2 mil­lion in quar­ter­ly Aduhelm sales, but Vounatsos said to as­sume that a “big chunk” of that $2 mil­lion is in­ven­to­ry and does not re­veal how many pa­tients have been treat­ed.

Bio­gen ex­pects “mod­est” sales in 2021 but did not pro­vide any fi­nan­cial es­ti­mates.

“It’s still ear­ly days,” Vounatsos said. “Over­all, it’s a bit slow­er than what we as­sumed, but we’re mak­ing progress.”

Al San­drock

Alaimo said Bio­gen is mak­ing every ef­fort to get in front of these lo­cal Medicare de­ci­sion mak­ers and there’s a “high lev­el of in­ter­est” in Bio­gen’s pro­gram where it pays for a test that can iden­ti­fy be­ta amy­loid in po­ten­tial pa­tients.

She not­ed that al­though no in­sur­ers have come out with a cov­er­age pol­i­cy yet, so there are no man­dates on find­ing amy­loid be­ta yet, “that’s the ex­pec­ta­tion.” There are sev­er­al ar­eas of the coun­try where ac­cess to amy­loid PET is not avail­able, she said, not­ing that Bio­gen has re­quest­ed PET and CSF tests, but the com­pa­ny is work­ing on gain­ing PET re­im­burse­ment through CMS.

Vounatsos al­so promised that Bio­gen will pub­lish its Phase III tri­al re­sults for Aduhelm in a peer-re­viewed jour­nal. Those da­ta are im­por­tant as some ex­perts are now rais­ing ques­tions about what the FDA re­leased along­side the ac­cel­er­at­ed ap­proval, and as three ad­comm mem­bers have now re­signed from the FDA pan­el.

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

No­vo Nordisk re­mains un­der UK scruti­ny as MHRA con­ducts its own re­view in 'in­cred­i­bly rare' case

The UK’s Medicines and Healthcare products Regulatory Agency is now reviewing Novo Nordisk’s marketing violation that resulted in its loss of UK trade group membership last week. Novo Nordisk was suspended on Thursday from the Association of the British Pharmaceutical Industry (ABPI) for two years after an investigation by its regulatory arm found the pharma broke its conduct rules.

MHRA said on Tuesday that its review of the Prescription Medicines Code of Practice Authority (PMCPA) investigation is standard practice. An MHRA spokesperson emphasized in an email to Endpoints News that the situation with Novo Nordisk is “incredibly rare” while also noting ABPI took “swift and proportionate action.”

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FTC says patent bat­tle over Parkin­son's drug could have 'sig­nif­i­cant im­pli­ca­tion­s' for pa­tients

The Federal Trade Commission has gotten involved in a patent feud over Supernus’ Parkinson’s drug Apokyn, a case the agency said may have ‘‘significant implications” for patients who rely on the drug.

Sage Chemical won the first generic approval for its Apokyn formulation (also known as apomorphine hydrochloride injection) back in 2022. The non-ergoline dopamine agonist is approved to treat Parkinson’s symptoms during “off episodes,” such as difficulty moving, tremors and intense cramping. However, regulators specified that the approval pertained to the generic drug cartridges only, not the injector pen required for administration.

Growth hor­mone from No­vo Nordisk is in short­age over man­u­fac­tur­ing de­lays

Novo Nordisk’s growth hormone Norditropin is in shortage because of manufacturing delays, according to an FDA site that tracks drug shortages as well as the American Society of Health-System Pharmacists’ shortages list.

The FDA has shortages of the drug listed for its 5, 10, 15 and 30 mg doses, while the pharmacists’ group, also known as ASHP, reported shortages of the same doses, except for the 15 mg version.

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PhRMA calls for more di­verse in­fra­struc­ture up­grades to US emer­gency tri­als frame­work

The White House’s Office of Science and Technology Policy (OSTP) last year sought to find ways to better coordinate large-scale clinical trials in the US — as the UK lead by example during the pandemic — especially for these emergency clinical trials.

The lobbying group PhRMA Tuesday called for more clinical trial diversity in underserved areas, including by making participation less of a burden, and expanding eligibility criteria when appropriate.

Mar­ket­ingRx roundup: What could a US Tik­Tok ban mean for phar­ma? Pfiz­er, Lil­ly lead phar­ma March Mad­ness ad­ver­tis­ers

Just as pharma marketers finally make moves into TikTok, the threat of a US ban on the social media channel is now looming. Already banned on federal employee phones by an initial Congressional act, more bills and maybe bans are on the way. With rare bipartisan agreement, lawmakers have introduced legislation that would give the US president the power to ban TikTok (although not mentioned by name) and other foreign-owned technology platforms that represent a security threat to the US.

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Chat­G­PT with phar­ma da­ta de­buts for med­ical meet­ings, be­gin­ning with AACR

What do you get when you combine ChatGPT generative AI technology with specific pharma and clinical datasets? A time-saving tool that can answer questions about medical conference abstracts and clinical findings in seconds in one new application from ZoomRx called FermaGPT.

ZoomRx is debuting a public version of its generative AI product specifically for medical conferences beginning this week for the upcoming American Association for Cancer Research (AACR) annual meeting that runs April 14-19.

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Andy Plump, Takeda R&D chief (Jeff Rumans for Endpoints News)

What kind of PhI­Ib da­ta is worth $4B cash? Take­da’s Andy Plump has some thoughts on that

A few months back, when Takeda caused jaws to drop with its eye-watering $4 billion cash upfront for a mid-stage TYK2 drug from Nimbus, it had already taken a deep dive on the solid Phase IIb data Nimbus had assembled from its dose-ranging study in psoriasis.

Now, it’s rolling that data out, eager to demonstrate what inspired the global biopharma to go long in a neighboring, but new, disease arena for the pipeline. And the most avid students of the numbers will likely be at Bristol Myers Squibb, who will have a multi-year head start on pioneering the TYK2 space with Sotyktu (deucravacitinib) as Takeda makes its lunge for best-in-class status.

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FDA warns Proc­ter & Gam­ble over NyQuil la­bel's in­gre­di­ent list­ings

The FDA on Tuesday released a warning letter sent earlier this month to the Mason, OH-based site of Procter & Gamble Manufactura, raising questions about the list of ingredients on the label and in the electronic filing.

The warning says that for P&G’s over-the-counter Vicks Nyquil Severe Hot Remedy Cold and Flu Plus Congestion, there’s a “mismatched” list of active ingredients between the labeling and the electronic listing file. The listing file for the active ingredients did not match the active ingredients in the electronic file.