HHS Secretary Xavier Becerra (Andrew Harnik/AP Images)

Medicare does­n't re­duce its 2022 pre­mi­um hike even as use of Bio­gen's Alzheimer's drug is sharply cur­tailed

The prospect of the Cen­ters for Medicare & Med­ic­aid Ser­vices (CMS) pay­ing for Bio­gen’s con­tro­ver­sial Alzheimer’s drug Aduhelm opened up a mul­ti-bil­lion-dol­lar can of worms late last year that CMS now says it won’t right un­til 2023, leav­ing the agency with lit­tle ex­pla­na­tion for ma­jor pre­mi­um and de­ductible in­creas­es for se­niors this year.

Back in No­vem­ber 2021, CMS ex­plained that Medicare Part B will have to in­crease its stan­dard month­ly pre­mi­um — from $148.50 in 2021 to $170.10 in 2022 — in part be­cause of the mas­sive spend­ing that could oc­cur should the agency sign off on a na­tion­al cov­er­age de­ci­sion for Aduhelm, and its $56,000 an­nu­al price tag next year.

Since then, Bio­gen slashed the price of Aduhelm in half, but saw CMS’ re­stric­tive na­tion­al cov­er­age de­ci­sion for Aduhelm fi­nal­ized, mean­ing the amy­loid-tar­get­ed drug will on­ly be used in clin­i­cal tri­als and won’t be cov­ered by com­mer­cial in­sur­ance providers. That os­ten­si­bly means that sales of Aduhelm won’t amount to much for sev­er­al years, and like­ly will nev­er hit those ini­tial $10 bil­lion-plus per year es­ti­mates.

But HHS is stick­ing with those pre­vi­ous­ly an­nounced pre­mi­um hikes and kick­ing the sav­ings can down the road.

HHS Sec­re­tary Xavier Be­cer­ra said in a state­ment last Fri­day that while these Medicare Part B pre­mi­ums for 2022 “should be ad­just­ed down­ward to ac­count for an over­es­ti­mate in costs at­trib­ut­able to the in­clu­sion of new Alzheimer’s drug Aduhelm,” due “to the le­gal and op­er­a­tional hur­dles in ad­just­ing Medicare pre­mi­ums mid­stream in 2022, the re­duc­tion in pre­mi­um costs at­trib­ut­able to Aduhelm will be in­cor­po­rat­ed in­to Medicare pre­mi­ums for 2023 to low­er Part B pre­mi­ums paid by Medicare ben­e­fi­cia­ries.”

Ac­cord­ing to a re­port from the CMS chief ac­tu­ary ear­li­er this month, the price change for Aduhelm and the fi­nal­ized na­tion­al cov­er­age de­ci­sion from CMS mean that “the lev­el and amount of un­cer­tain­ty re­gard­ing the po­ten­tial use of Aduhelm were great­ly re­duced.”

If both of those is­sues had re­solved ear­li­er, the re­port says that the 2022 Part B pre­mi­um would’ve been about $10 less than the cur­rent lev­el, or $160.40.

“It is cer­tain, how­ev­er, that any ad­di­tion­al fund­ing caused by in­clud­ing the un­cer­tain­ty of po­ten­tial Aduhelm costs in the 2022 pre­mi­um will be used to re­duce the nec­es­sary fi­nanc­ing in 2023 and lat­er,” CMS chief ac­tu­ary Paul Spi­tal­nic wrote in a memo.

Some who are fol­low­ing this lat­est move by HHS ques­tioned what CMS is do­ing dif­fer­ent­ly with its ad­di­tion­al in­fo on Aduhelm, while oth­ers won­der if chang­ing how much peo­ple paid this year could set a bad prece­dent.

Paul Gins­burg, a pro­fes­sor of health pol­i­cy at the Uni­ver­si­ty of South­ern Cal­i­for­nia, told the Wash­ing­ton Post, “I could see chaos hap­pen­ing down the road al­most every year where some­one starts a cam­paign to pres­sure the sec­re­tary to low­er the pre­mi­um be­cause some­thing went bet­ter than ex­pect­ed.”

Albert Bourla, Pfizer CEO (John Thys/POOL/AFP via Getty Images)

Pfiz­er CEO un­der fire from UK watch­dog over vac­cine com­ments — re­port

Pfizer CEO Albert Bourla told the BBC last December that he had “no doubt in my mind that the benefits, completely, are in favor” of vaccinating 5- to 11-year-olds for Covid-19. Almost a year later, those comments have reportedly landed him in trouble with a UK pharma watchdog.

Children’s advocacy group UsForThem filed a complaint with the UK’s Prescription Medicines Code of Practice Authority (PMCPA) last year accusing Bourla of making “disgracefully misleading” statements during the BBC interview, including one that “Covid in schools is thriving.” At the time, UK regulators had not yet cleared the vaccine for the 5 to 11 age group, though the vaccine did have a positive opinion from the EMA’s human medicines committee.

FDA tells Catal­ent to fix is­sues at two man­u­fac­tur­ing sites on its own

The CDMO Catalent will have to fix issues at two manufacturing plants in the US and Europe that were subject to inspections by the FDA this summer, giving the company room to correct the issues without facing further regulatory action.

The FDA gave Catalent a “voluntary action indicated” response to two inspections at the contract manufacturer’s site in Bloomington, IN, and Brussels, Belgium. Fixing the issues on its own is a preferable outcome to facing an “official action indicated” response, meaning that an official warning would be sent out or a sit-down with the FDA would be required.

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Sanofi's new headquarters, La Maison Sanofi, in Paris (Credit: Luc Boegly)

Sanofi wel­comes 500 staffers to new Paris HQ af­ter €30M ren­o­va­tion

When Paul Hudson took the helm at Sanofi back in 2019, he promised to reinvent the pharma giant — including its Paris headquarters. This week, the company set up shop in new “state-of-the-art” digs.

La Maison Sanofi, as the new HQ is called, is officially open for business, Hudson announced on Monday. The 9,000-square-meter (just under 97,000-square-foot) space accommodates 500 employees across the company’s government and global support functions teams, including finance, HR, legal and corporate affairs — and it was built with environmental sustainability and hybrid work in mind.

Sta­da to place $50M+ in­vest­ment in a new fa­cil­i­ty in Ro­ma­nia

While Romania may conjure up images of vast mountain ranges and tales of medieval kings, one generic manufacturer has broken ground on a new facility there.

German pharma company Stada said Monday that it has placed a €50 million ($51.9 million) investment into a 100,000 square-meter (1.08 million square-foot) site in Turda, Romania, a city in the Southeast of the country. According to a Stada spokesperson in an email to Endpoints News, the company has developed only 281,500 square feet of the site so far.

Rachael Rollins (Charles Krupa/AP Images)

US seeks jail time for co-CEO of New Eng­land com­pound­ing cen­ter af­ter dead­ly 2012 fun­gal out­break

The US attorney for the district of Massachusetts late last week called on the state’s district court to sentence the former co-owner of the now-defunct New England Compounding Center to 18 months of jail time for his role in the center’s quality deviations that led to more than 100 people dead from a fungal meningitis outbreak.

Gregory Conigliaro was convicted of conspiring with more than a dozen others at NECC to deceive the FDA and misrepresent the fact that the center was only dispensing drugs pursuant to patient-specific prescriptions.

Vac­cine doc­u­ments, young lead­ers and mar­ket tur­moil: End­points' 10 biggest sto­ries of 2022

It’s been a volatile year in the world of biopharma. Market declines reset M&A valuations, and may be beginning to tempt bigger buyers back into dealmaking. Russia’s war in Ukraine disrupted drug sales and clinical trials. A new generation of young biotech leaders emerged in the Endpoints 20(+1) Under 40. And as capital runs dry in a tough environment for raising new funds, companies big and small are taking a look at their headcounts and operations for ways to make it through lean times.

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Tom Riga, Spectrum Pharmaceuticals CEO

Spec­trum im­plodes af­ter a harsh pub­lic slap­down and now a CRL from Richard Paz­dur

The FDA has gone out of its way several times to flatten any expectations for Spectrum’s lung cancer drug poziotinib, including slamming the regulatory door in the biotech’s face four years ago when the their executive crew came calling for a breakthrough drug designation and encouragement from the oncology wing of the FDA.

That stinging early rebuke pointed straight down the path to a corrosive in-house agency review of Spectrum’s attempt to land an accelerated approval for the oral EGFR TKI and a public whipping that included a classic takedown by none other than Richard Pazdur, who slammed the company for “poor drug development” that led to confusion over the dose needed for a slice of NSCLC patients harboring HER2 exon 20 insertion mutations.

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Merck targets vaccine-hesitant parents in its latest 'Why Vaccines' campaign. (Image: Shutterstock)

Mer­ck­'s lat­est 'Why Vac­ci­nes' cam­paign seeks to bet­ter in­form vac­cine-hes­i­tant moms

From Hollywood couple endorsements to targeted equity efforts, Merck has been pushing the value of vaccinations, especially since the Covid-19 pandemic disruption. Now the pharma is turning to a new target — vaccine-hesitant parents, and moms in particular.

Merck’s “Why Vaccines” latest social media and digital campaign spotlights real-life new moms who have questions about vaccinating their children.

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Big Phar­ma's Twit­ter ex­o­dus; Mer­ck wa­gers $1.35B on buy­out; $3.5M gene ther­a­py; 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.

As you start planning for #JPM23, we hope you will consider joining Endpoints News for our live and virtual events. For those who are celebrating Thanksgiving, we hope you are enjoying the long weekend with loved ones. And if you’re not — we’ll see you next week!

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