UP­DAT­ED: Am­gen halts some drug dis­counts for safe­ty net hos­pi­tals as SCO­TUS takes on 340B case

Am­gen will soon be the 10th bio­phar­ma com­pa­ny to pull back on of­fer­ing drug dis­counts to con­tract phar­ma­cies of safe­ty-net hos­pi­tals un­der a fed­er­al pro­gram. Like its peers, Am­gen ar­gues that the growth of these con­tract phar­ma­cies has bal­looned in re­cent years and needs to be reigned in.

Be­gin­ning Jan. 3, 2022, Am­gen’s pol­i­cy will on­ly al­low 340B cov­ered hos­pi­tals to des­ig­nate a sin­gle phar­ma­cy lo­ca­tion, with the ex­cep­tion of fed­er­al grantees and con­tract phar­ma­cies whol­ly owned by a 340B hos­pi­tal, or that have com­mon own­er­ship with a health sys­tem.

Am­gen said in a state­ment:

The Com­pa­ny is con­cerned with the well-doc­u­ment­ed is­sues about pro­gram in­tegri­ty aris­ing from ex­pan­sion of con­tract phar­ma­cy arrange­ments in re­cent years.  In the decade since the Health Re­sources & Ser­vices Ad­min­is­tra­tion (HRSA) ex­pand­ed its con­tract phar­ma­cy pol­i­cy, the num­ber of con­tract phar­ma­cy arrange­ments in the 340B pro­gram has grown by a stag­ger­ing 4,000%.  More than 50% of the prof­its gen­er­at­ed by con­tract phar­ma­cies are re­tained by for-prof­it com­pa­nies, di­vert­ing re­sources from fed­er­al grantees and oth­er cov­ered en­ti­ties that pro­vide care to unin­sured and vul­ner­a­ble pa­tients.

The move aligns Am­gen with Eli Lil­ly, Mer­ck, UCB, Sanofi, No­vo Nordisk, Unit­ed Ther­a­peu­tics, No­var­tis, Boehringer In­gel­heim and As­traZeneca. All of the com­pa­nies have cur­tailed their dis­counts to dif­fer­ing de­grees, and some of them have been threat­ened with fines by the Biden ad­min­is­tra­tion and have since tak­en the is­sue of the ad­min­is­tra­tion’s han­dling of the 340B pro­gram to court.

So far those court de­ci­sions have been a mixed bag for in­dus­try.

Wash­ing­ton DC’s dis­trict court hand­ed No­var­tis a clear win ear­ly last month, ar­gu­ing that the Big Phar­ma can place con­di­tions on the sales of drugs dis­count­ed by a fed­er­al pro­gram to con­tract phar­ma­cies, fol­low­ing an Eli Lil­ly win in court ear­li­er in No­vem­ber. But this in­ter­pre­ta­tion was con­tra­dict­ed by an­oth­er de­ci­sion hand­ed down last month in a New Jer­sey dis­trict court, in which No­vo Nordisk and Sanofi were told that they can­not uni­lat­er­al­ly im­pose re­stric­tions on the 340B pro­gram and that their new poli­cies “must cease.”

340B hos­pi­tals are sound­ing the alarm on Am­gen and UCB’s re­cent en­tries in­to this more re­stric­tive space.

“Am­gen’s de­ci­sion to fol­low the path of oth­er drug com­pa­nies in vi­o­lat­ing the fed­er­al 340B law will great­ly mag­ni­fy the harm that these re­fusals are caus­ing for safe­ty-net hos­pi­tals and the pa­tients in need who re­ly on them. Two fed­er­al dis­trict courts have ruled that drug com­pa­nies can­not refuse these dis­counts or im­pose con­di­tions on them, and the ad­min­is­tra­tion and a bi­par­ti­san ma­jor­i­ty of Con­gress strong­ly agree,” 340B Health pres­i­dent and CEO Mau­reen Testoni said in a state­ment.

SCO­TUS on 340B

Mean­while, the US Supreme Court on Tues­day heard oral ar­gu­ments re­lat­ed to an­oth­er 340B dis­pute. This case deals with a rule from 2017 in which CMS said Medicare would re­im­burse some cov­ered out­pa­tient drugs pur­chased through the 340B pro­gram at low­er rates.

Ac­cord­ing to the Com­mon­wealth Fund, the rule re­duced re­im­burse­ments for 340B hos­pi­tals to 22.5% be­low the av­er­age sales price of a drug; and non-340B hos­pi­tals con­tin­ued to be paid 6% above the ASP. The change in pay­ments saved Medicare and ben­e­fi­cia­ries an es­ti­mat­ed $1.6 bil­lion in 2018, but hos­pi­tals claimed that they were un­fair­ly tar­get­ed.

The back and forth be­tween the jus­tices and for­mer so­lic­i­tor gen­er­al Don­ald Ver­ril­li, who ar­gued the case for the hos­pi­tals, cen­tered most­ly on whether CMS could legal­ly set this low­er re­im­burse­ment rate, with sev­er­al jus­tices seem­ing to sup­port Ver­ril­li’s ar­gu­ments, ac­cord­ing to the tran­script.

Michi­gan law pro­fes­sor Nico­las Bagley al­so wrote at the SCO­TUS blog that the jus­tices seemed to back the claim that CMS “over­stepped its au­thor­i­ty when it cut the amount that it paid cer­tain hos­pi­tals for drugs they dis­pensed in their out­pa­tient de­part­ments. None of the jus­tices voiced sym­pa­thy with the gov­ern­ment’s ar­gu­ment that Con­gress had pre­clud­ed ju­di­cial re­view of the ques­tion.”

Ed­i­tor’s note: Ar­ti­cle up­dat­ed with com­ment from Am­gen.

Mar­ket­ingRx roundup: Pfiz­er de­buts Pre­vnar 20 TV ads; Lil­ly gets first FDA 2022 pro­mo slap down let­ter

Pfizer debuted its first TV ad for its Prevnar 20 next-generation pneumococcal pneumonia vaccine. In the 60-second spot, several people (actor portrayals) with their ages listed as 65 or older are shown walking into a clinic as they turn to say they’re getting vaccinated with Prevnar 20 because they’re at risk.

The update to Pfizer’s blockbuster Prevnar 13 vaccine was approved in June, and as its name suggests is a vaccine for 20 serotypes — the original 13 plus seven more that cause pneumococcal disease. Pfizer used to spend heavily on TV ads to promote Prevnar 13 in 2018 and 2019 but cut back its TV budgets in the past two fall and winter seasonal spending cycles. Prevnar had been Pfizer’s top-selling drug, notching sales of just under $6 billion in 2020, and was the world’s top-selling vaccine before the Covid-19 vaccines came to market last year.

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Graphic: Alexander Lefterov for Endpoints News

Small biotechs with big drug am­bi­tions threat­en to up­end the tra­di­tion­al drug launch play­book

Of the countless decisions Vlad Coric had to make as Biohaven’s CEO over the past seven years, there was one that felt particularly nerve-wracking: Instead of selling to a Big Pharma, the company decided it would commercialize its migraine drug itself.

“I remember some investors yelling and pounding on the table like, you can’t do this. What are you thinking? You’re going to get crushed by AbbVie,” he recalled.

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Albert Bourla (Photo by Steven Ferdman/Getty Images)

UP­DAT­ED: Pfiz­er fields a CRL for a $295M rare dis­ease play, giv­ing ri­val a big head start

Pfizer won’t be adding a new rare disease drug to the franchise club — for now, anyway.

The pharma giant put out word that their FDA application for the growth hormone therapy somatrogon got the regulatory heave-ho, though they didn’t even hint at a reason for the CRL. Following standard operating procedure, Pfizer said in a terse missive that they would be working with regulators on a followup.

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A new can­cer im­munother­a­py brings cau­tious hope for a field long await­ing the next big break­through

Bob Seibert sat silent across from his daughter at their favorite Spanish restaurant near his home in Charleston County, SC, their paella growing cold as he read through all the places in his body doctors found tumors.

He had texted his wife, a pediatric intensive care nurse, when he got the alert that his online chart was ready. Although he saw immediately it was bad, many of the terms — peritoneal, right iliac — were inscrutable. But she was five hours downstate, at a loud group dinner the night before another daughter’s cheer competition.

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Not cheap­er by the dozen: Bris­tol My­ers be­comes the 12th phar­ma com­pa­ny to re­strict 340B sales

Bristol Myers Squibb recently joined 11 of its peer pharma companies in limiting how many contract pharmacies can access certain drugs discounted by a federal program known as 340B.

Bristol Myers is just the latest in a series of high-profile pharma companies moving in their own direction as the Biden administration’s Health Resources and Services Administration struggles to rein in the drug discount program for the neediest Americans.

Joaquin Duato, J&J CEO (Photo by Charles Sykes/Invision/AP)

New J&J CEO Joaquin Du­a­to promis­es an ag­gres­sive M&A hunt in quest to grow phar­ma sales

Joaquin Duato stepped away from the sideline and directly into the spotlight on Tuesday, delivering his first quarterly review for J&J as its newly-tapped CEO after an 11-year run in senior posts. And he had some mixed financial news to deliver today while laying claim to a string of blockbuster drugs in the making and outlining an appetite for small and medium-sized M&A deals.

Duato also didn’t exactly shun large buyouts when asked about the future of the company’s medtech business — where they look to be in either the top or number 2 position in every segment they’re in — even though the bar for getting those deals done is so much higher.

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Florida Gov. Ron DeSantis (AP Photo/Wilfredo Lee, File)

Opin­ion: Flori­da is so mAb crazy, Ron De­San­tis wants to use mAbs that don't work

Florida Gov. Ron DeSantis is trying so hard to politicize the FDA and demonize the federal government that he entered into an alternate universe on Monday evening in describing a recent FDA action to restrict the use of two monoclonal antibody, or mAb, treatments for Covid-19 that don’t work against Omicron.

Without further ado, let’s break down his statement from last night, line by line, adjective by adjective.

Amgen's Twitter campaign #DearAsthma inspired thousands of people to express struggles and frustrations with the disease

Am­gen’s #Dear­Asth­ma spon­sored tweet lands big on game day, spark­ing thou­sands to re­spond

Amgen wanted to know how people with asthma really felt about daily life with the disease. So it bought a promoted tweet on Twitter noting the not-so-simple realities of life with asthma and ended the post with a #DearAsthma hashtag, a megaphone emoji and a re-tweet button.

That was just over one week ago and the responses haven’t stopped. More than 7,000 posts so far on Twitter replied to #DearAsthma to detail struggles of daily life, expressing humor, frustration and sometimes anger. More than a few f-bombs have been typed or gif-ed in reply to communicate just how much many people “hate” the disease.

Pfiz­er, Bris­tol My­ers dom­i­nate top 10 pre­dic­tions for the best-sell­ing drugs of 2022

The annual exercise where analysts try and predict which drugs will become blockbusters and make the most money tends to highlight the biggest trends in biopharma R&D. 2022 is no exception.

The team at Evaluate Vantage published its predictions for the top 10 selling drugs for the year — expecting tens of billions of dollars in sales and highlighting an industry-wide focus on certain diseases and indications.

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