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.”

Clin­i­cal tri­al di­ver­si­ty da­ta show mis­match be­tween en­roll­ment and dis­ease preva­lence, GSK says

A lack of diversity in clinical trials has persisted despite decades of initiatives to try to turn the tide.

In a recent review of 17 years of clinical trials, drugmaker GSK found that there were some mismatches between the demographics of its US-based trials and how prevalent diseases were in those populations.

The results, the company says, will help GSK and others design studies that better represent epidemiological rates within races and ethnicities.

Jean-Paul Clozel, Idorsia CEO (Patrick Straub/Keystone via AP Images)

Idor­si­a's brain bleed drug flunks PhI­II tri­al, a decade af­ter pre­vi­ous flop

Idorsia’s long journey with clazosentan came to an abrupt “unexpected result” Monday morning with a Phase III flop.

The Swiss biopharma said the drug did not meet the main goal of the late-stage REACT study, conducted in the US, Canada and Europe since early 2019.

The 409-patient trial tested the intravenous drug’s ability to prevent complications due to delayed cerebral ischemia following aneurysmal subarachnoid hemorrhage (aSAH), in which blood vessels in the brain narrow and blood accumulates around the brain’s surface, which then dials up the pressure on the brain.

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Kenji Yasukawa, Astellas CEO (Photographer: Akio Kon/Bloomberg via Getty Images)

Astel­las taps chief strat­e­gy of­fi­cer as next CEO to 'go on the ag­gres­sive'

Five years into its big R&D revamp, Astellas says it’s time for a changing of the guard.

Kenji Yasukawa, who took over as president and CEO in 2018, will step down to become chairman of the board in April, making room for Naoki Okamura to take over. Okamura joined the company in 1986 and has served in a variety of finance, business and strategy roles, including most recently as chief strategy officer.

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The Big Phar­ma dis­card pile; Lay­offs all around while some biotechs bid farewell; New Roche CEO as­sem­bles top team; 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.

With earnings seasons in full swing, we’ve listened in on all the calls so you don’t have to. But news is popping up from all corners, so make sure you check out our other updates, too.

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Sen. Ron Wyden (D-OR) (Francis Chung/E&E News/Politico via AP Images)

In­fla­tion re­bates in­com­ing: Wyden calls on CMS to move quick­ly as No­var­tis CEO pledges re­ver­sal

Senate Finance Chair Ron Wyden (D-OR) this week sent a letter to the head of the Centers for Medicare & Medicaid Services seeking an update on how and when new inflation-linked rebates will take effect for drugs that see major price spikes.

The newly signed Inflation Reduction Act requires manufacturers to pay a rebate to Medicare when they increase drug prices faster than the rate of inflation.

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Giovanni Caforio, Bristol Myers Squibb CEO (Nicolas Messyasz/Sipa via AP Images)

Bris­tol My­ers turns at­ten­tion to new prod­ucts in wake of Revlim­id patent loss

Bristol Myers Squibb CEO Giovanni Caforio is shifting his focus to newer products as generic sales continue to gnaw at the company’s blockbuster myeloma drug Revlimid.

Both Revlimid and Abraxane sales took a dive last year thanks to generic rivals, BMS reported in its Q4 and full-year results on Thursday. As a result, Q4 sales dipped 5% and full-year sales remained flat. However, Caforio sees a silver lining — or rather, two of them.

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Rob Davis, Merck CEO

Mer­ck’s Keytru­da nears $21B in sales, dou­bles down on com­bo tri­als

Merck’s cancer immunotherapy Keytruda notched sales of $20.9 billion in 2022, cementing its status as one of the world’s top-selling drugs. However, it’s far from resting on that accomplishment.

Merck executives touted nine ongoing trials in its annual earnings call on Thursday, including five studies in Phase III, for Keytruda (pembrolizumab) in combination with other immuno-oncology drugs. The trials include combinations with Merck’s own developments as well as other pharma companies’ candidates, including its melanoma collaboration with Moderna and its mRNA technology plus Keytruda, aimed at creating a personalized vaccine treatment to reduce the risk of cancer recurrence or death.

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Uğur Şahin, BioNTech CEO (Andreas Arnold/picture-alliance/dpa/AP Images)

BioN­Tech opens new plas­mid DNA man­u­fac­tur­ing fa­cil­i­ty in Ger­many

German mRNA player BioNTech opened the doors to a new manufacturing facility on Thursday, this one just about 75 miles north of its headquarters in Mainz, Germany.

BioNTech announced on Thursday that it has completed the construction of its first plasmid DNA manufacturing facility in Marburg, Germany. The facility will produce materials for mRNA-based vaccines and therapies along with cell therapies.

FDA ap­proves GSK's ane­mia drug with safe­ty warn­ing — af­ter bat­ting back sim­i­lar drugs

GSK has secured the first of four US approvals it’s hoping for this year, as the FDA greenlit daprodustat as a treatment for anemia due to chronic kidney disease.

But the FDA limited the use of the drug, to be marketed as Jesduvroq, to patients who have been receiving dialysis for at least four months and stopped short of approving it for patients not dependent on dialysis — in line with the recommendations of the advisory committee it consulted.

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