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.

Es­tab­lished in 1992, 340B is a fed­er­al health pro­gram that re­quires phar­ma com­pa­nies to of­fer steep dis­counts on their drugs to hos­pi­tals that treat low-in­come pa­tients. But in the last few years, large phar­mas start­ed set­ting their own re­stric­tions on the bal­loon­ing pro­gram, claim­ing that hos­pi­tals are us­ing an un­lim­it­ed num­ber of so-called “con­tract” phar­ma­cies — an out­side phar­ma­cy not owned by the hos­pi­tal — to ob­tain more dis­counts.

The ad­min­is­tra­tion has strug­gled to deal with what phar­ma com­pa­nies see as a pro­gram that’s grown to al­most 10% of the en­tire US phar­ma mar­ket.

Be­gin­ning March 1, 2022, BMS said it will on­ly rec­og­nize up to two des­ig­nat­ed 340B con­tract phar­ma­cy lo­ca­tions (in­clud­ing one for its block­buster mul­ti­ple myelo­ma drugs like Revlim­id and Po­m­a­lyst) per 340B hos­pi­tal that lacks an en­ti­ty-owned phar­ma­cy. Oth­er sim­i­lar moves have cost hos­pi­tals sig­nif­i­cant­ly in lost sav­ings from the dis­count pro­gram. 

Re­cent court de­ci­sions, while con­flict­ing on how com­pa­nies can pro­ceed with their lim­its on con­tract phar­ma­cies, not­ed that Mass­a­chu­setts-based Bev­er­ly Hos­pi­tal says it lost more than $125,000 in 340B sav­ings since Sanofi’s 340B changes took ef­fect. And, they not­ed, Rochester, NY-based Strong Memo­r­i­al Hos­pi­tal said that No­vo Nordisk and oth­er drug­mak­ers “re­fused to of­fer drugs at the 340B ceil­ing price, re­sult­ing in over­charges of more than $2 mil­lion.”

Ac­cord­ing to Bri­an Reid at Re­al Chem­istry’s week­ly newslet­ter, the Bris­tol My­ers move, as well as oth­er com­pa­nies’ sim­i­lar ones, means that re­stric­tions on 340B pric­ing are now in place for eight of the top 10 best-sell­ing drugs in the US, and six of those re­stric­tions have been im­posed since Dec. 1.

HRSA is work­ing on a new pro­posed rule­mak­ing re­lat­ed to its Ad­min­is­tra­tive Dis­pute Res­o­lu­tion rule, which would es­tab­lish new re­quire­ments and pro­ce­dures for the 340B pro­gram’s process. These pro­ce­dures would set up a method for hos­pi­tals and phar­ma com­pa­nies to re­solve dis­putes.

But pur­suant to a court or­der, HRSA is cur­rent­ly en­joined from en­forc­ing these reg­u­la­tions against Eli Lil­ly.

Mau­reen Testoni, pres­i­dent and CEO of the hos­pi­tal as­so­ci­a­tion 340B Health, said Bris­tol My­ers, the 12th drug com­pa­ny “to vi­o­late the 340B statute,” will “weak­en the health care safe­ty net and harm pa­tients who re­ly on 340B providers for ac­cess to af­ford­able drugs and care while en­rich­ing the com­pa­ny and its stock­hold­ers. In 2020, BMS re­port­ed $42.5 bil­lion in rev­enues, with its can­cer drug Revlim­id ac­count­ing for more than $12 bil­lion.”

Paul Hudson, Sanofi CEO (Cyril Marcilhacy/Bloomberg via Getty Images)

FDA side­lines Paul Hud­son's $3.7B MS drug af­ter es­tab­lish­ing link to liv­er dam­age

One of Sanofi CEO Paul Hudson’s top picks in the pipeline — picked up in a $3.7 billion buyout 2 years ago — has just been sidelined in the US by a safety issue.

The pharma giant put out word early Thursday that the FDA has put their Phase III studies of tolebrutinib in multiple sclerosis and myasthenia gravis on partial clinical hold, halting enrollment and suspending dosing for patients who have been on the drug for less than 60 days. Patients who have completed at least 60 days of treatment can continue therapy as researchers explore a “limited” — but unspecified in Sanofi’s statement — number of cases of liver injury.

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Phar­ma re­acts to post-Roe; Drug­mak­ers beef up cy­ber de­fense; Boehringer, Roche qui­et­ly axe drugs; 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 a reminder, we are off on Monday for the Fourth of July. I hope this recap will kick off your (long) weekend well and that the rest of it will be just what you need. See you next week for a shortened edition!

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Eric Hughes, incoming Teva EVP of global R&D and CMO

Te­va chief raids Ver­tex for his new glob­al head of re­search and de­vel­op­ment

Teva CEO Kåre Schultz has found his new R&D chief and CMO in Vertex’s ranks.

The global generics giant, which has some 3,500 staffers in the R&D group, has named Eric Hughes to the top research spot in the company. He’ll be replacing Hafrun Fridriksdottir, who held the role for close to five years, on Aug. 1.

Hughes hasn’t been at Vertex for long, though. He jumped from Novartis less than a year ago, after heading the immunology, hepatology & dermatology global development unit. Before that, he completed a five-year stint as head of early clinical research for the specialty discovery medicine department in the exploratory clinical & translational research group at Bristol Myers Squibb, according to his LinkedIn profile.

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#BIO22: Man­ag­ing a biotech in tur­bu­lent times. 'There's a per­fect shit­show out there'

On Tuesday, June 14, Endpoints News EIC John Carroll sat down with a group of biotech execs to discuss the bear market for industry stocks and how they were dealing with it. Here’s the conversation, which has been lightly edited for brevity.

Martin Meeson, sponsor opening:

Thank you, John. Hello everyone. My name’s Martin Meeson, I’m the CEO of Fujifilm Diosynth. For those of you who don’t know Fujifilm Diosynth, we operate in the development of clinical and commercial product scale up, we have facilities in Europe and the US, and around about 4,000 employees. We run on average about 150 programs, so when it comes to managing in turbulent times over the last two years, we’ve had quite a lot of experience of that. Not just keeping the clinical pipelines and the commercial pipelines open, but also our response to the pandemic and the molecules that we’ve had within there. One of the phrases that I coined probably about a year ago when we were talking at JP Morgan, was I talked about managing through turbulent times. Well, it’s become the fact that we are not managing and leading through these times, we are managing in them, which is why that’s really the purpose of and the topic that we’ve got today.

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Amgen's taking social media followers around the globe as it introduces the many different

From Tam­pa to Mu­nich, Am­gen’s ‘Places’ cam­paign in­tro­duces its lo­ca­tions around the world

Amgen is taking social media followers around the world with its latest corporate campaign. Called “Places of Amgen,” the twice monthly posts highlight the biopharma’s different offices and sites – and the people who work there.

Each post runs on LinkedIn, Facebook and Instagram with details about the work Amgen does in that location, when it was established, comments from people who work there and other interesting facts. The most recent one about Paris, France, for example, notes that Amgen France last year signed a French association charter committed to the inclusion of LBGT+ people in the workplace.

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Credit: Shutterstock

Bio­haven takes mi­graine cam­paign to pa­tients' Twit­ter feeds, months ahead of Pfiz­er takeover

Two weeks ago, Biohaven hit an all-time high in weekly Nurtec prescriptions. CEO Vlad Coric attributes at least some of that success to a new interactive Twitter campaign that encourages patients to free their feed of potential migraine triggers.

Earlier this month, Biohaven in partnership with Twitter launched the #RelieveYourFeed campaign that allows users to customize their app settings based on their migraine triggers.

Oncologists on Twitter are talking up ASCO studies, health equity and burnout, according to new deep dive research from Harris Poll (via Shutterstock)

What’s been on in­flu­en­tial on­col­o­gist­s' minds? Most­ly AS­CO, but al­so health eq­ui­ty, ac­cord­ing to new Har­ris Poll re­search

Over the past few months, oncologists have been talking a lot about the ASCO conference. Not surprising considering its import and the study data presented, but what may be less expected is the second most talked about topic of health equity.

That’s according to data from The Harris Poll and the new expert network the researcher is building out. While the company has been doing deep data dives into specific health issues or conditions for pharma clients, it’s now monitoring influencer networks of therapy area specialists to find out what experts are really thinking about.

No­var­tis to re­sume the pro­duc­tion of two ra­di­oli­gand ther­a­pies af­ter re­solv­ing qual­i­ty is­sues

Earlier this year, Novartis touted its radioligand as a major piece to counter competition in the cancer space. However, the physical production of its products has had anything but a smooth ride.

In May, Novartis had to suspend production of Lutathera and Pluvicto, its two primary radiotherapies. According to the company, this was done out of an abundance of caution as a result of potential quality issues identified in its manufacturing. The production suspension impacts the commercial and clinical trial supply of the products.

Roche, Pfiz­er top list of ESG lead­ers in pa­tient group­s' view, but many still think phar­mas can do bet­ter

The rise of pharma environmental, social and governance (ESG) efforts in the past two years has been meteoric as investors turn their attention to sustainable funding. However, investors aren’t the only ones watching. Patients are beginning to tune into pharmas’ ESG promises too.

Patient advocacy groups familiar with ESG regard it as an important issue and want to be included in helping pharma companies set ESG policies and targets, according to a new report from PatientView. That’s quite different from what the investment community wants across a variety of Gartner’s defined financial, competitive, strategic and perception goals.