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.”

A new era of treat­ment: How bio­mark­ers are chang­ing the way we think about can­cer

AJ Patel was recovering from a complicated brain surgery when his oncologist burst into the hospital room yelling, “I’ve got some really great news for you!”

For two years, Patel had been going from doctor to doctor trying to diagnose his wheezing, only to be dealt the devastating news that he had stage IV lung cancer and only six months to live. And then they found the brain tumors.

“What are you talking about?” Patel asked. He had never seen an oncologist so happy.

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Ted White, Verrica Pharmaceuticals CEO

'Hands may be tied': FDA slaps Ver­ri­ca with 3rd CRL due to prob­lems with con­tract man­u­fac­tur­er

The FDA has rejected Verrica Pharmaceuticals’ skin disease treatment for a third time — and once again the contract manufacturer is to blame.

The biotech emphasized that the only deficiency in the complete response letter is related to a general reinspection of the CMO, Sterling Pharmaceuticals, and has nothing to do specifically with its drug-device; the rest of the NDA is good to go.

CEO Ted White said the company is “extremely disappointed,” but will keep working toward approval.

(Credit: Shutterstock)

Cracks in the fa­cade: Is phar­ma's pan­dem­ic ‘feel good fac­tor’ wan­ing?

The discordant effects of the Covid-19 pandemic on pharma reputation continues. While the overall industry still retains a respectable halo from its Covid-19 quick response and leadership, a new patient group study reveals a different story emerging in the details.

On one hand, US patient advocacy groups rated the industry higher-than-ever overall. More than two-thirds (67%) of groups gave the industry a thumbs up for 2021, a whopping 10 percentage point increase over the year before, according to the PatientView annual study, now in its 9th year.

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Co­pay coupons gone wrong, again: Pfiz­er pays al­most $300K to set­tle com­plaints in four states

Pfizer has agreed to pay $290,000 to settle allegations of questionable copay coupon practices in Arizona, Colorado, Kansas, and Vermont from 2014 to 2018.

While the company has not admitted any wrongdoing as part of the settlement, Pfizer has agreed to issue restitution checks to about 5,000 consumers.

A Pfizer spokesperson said the company has “enhanced its co-pay coupons to alleviate the concerns raised by states and agreed to a $30,000 payment to each.”

Delaware court rules against Gilead and Astel­las in years-long patent case

A judge in Delaware has ruled against Astellas Pharma and Gilead in a long-running patent case over Pfizer-onwed Hospira’s generic version of Lexiscan.

The case kicked off in 2018, after Hospira submitted an Abbreviated New Drug Application (ANDA) for approval to market a generic version of Gilead’s Lexiscan. The drug is used in myocardial perfusion imaging (MPI), a type of nuclear stress test.

Taye Diggs (courtesy Idorsia)

Idor­sia inks an­oth­er celebri­ty en­dors­er deal with ac­tor and dad Taye Dig­gs as Qu­viviq in­som­nia am­bas­sador

Idorsia’s latest Quviviq insomnia campaign details the relatable dad story of a well-known celebrity — actor and Broadway star Taye Diggs.

Diggs stopped sleeping well after the birth of his son, now more than 10 years ago. Switching mom-and-dad nightly shifts to take care of a baby interrupted his sleep patterns and led to insomnia.

“When you’re lucky enough to be living out your dream and doing what you want, but because of something as simple as a lack of sleep, you’re unable to do that, it felt absolutely — it was treacherous,” he says in an interview-style video on the Quviviq website.

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Belén Garijo, Merck KGaA CEO (Kevin Wolf/AP Images for EMD Serono)

Mer­ck KGaA pumps €440M in­to ex­pand­ing and con­struct­ing Irish man­u­fac­tur­ing fa­cil­i­ties

The area of Ireland famous for Blarney Castle and its cliffsides along the Atlantic Ocean is seeing Merck KGaA expand its commitment there.

The German drug manufacturer is expanding its membrane and filtration manufacturing capabilities in Ireland. The company will invest approximately €440 million ($470 million) to increase membrane manufacturing capacity in Carrigtwohill, Ireland, and build a new manufacturing facility at Blarney Business Park, in County Cork, Ireland.

Rep. Katie Porter (D-CA) (Michael Brochstein/Sipa USA/Sipa via AP Images)

House Dems to Sen­ate lead­er­ship: Quick­ly move a rec­on­cil­i­a­tion bill with drug price ne­go­ti­a­tion re­forms

Twenty House Democrats, including Reps. Katie Porter of California and Susan Wild of Pennsylvania, are calling on Senate leaders to move quickly with a reconciliation bill (meaning they only need a simple majority for passage) with prescription drug pricing reforms, and to include adding new authority for Medicare to negotiate drug prices.

They also called on the Senate to specifically follow suit with the House passage of a $35 per month insulin cap (as Senate Majority Leader Chuck Schumer’s deadline for a vote on that provision has come and gone), and to cap Medicare Part D costs at $2,000 per year for seniors.

Phillip Gomez, SIGA CEO

UP­DAT­ED: On the back of SIGA Tech­nolo­gies' win with the FDA, the mon­key­pox virus sees the com­pa­ny spring­ing to fur­ther ac­tion

As the cases of monkeypox now sit at well over 100 worldwide and have spread to multiple continents, the orders for any type of vaccine against monkeypox are seeing nations and medical bodies looking to get their hands on anything and everything. And now SIGA Technologies seems to be getting in on the action.

According to Euronews, SIGA Technologies, a pharmaceutical company that is focused on providing medical countermeasures to biological and chemical attacks, is now in talks with several European authorities looking to stockpile its antiviral that can counter monkeypox. The drug known as tecovirimat or Tpoxx was approved by the FDA in 2018 as a vaccine for smallpox but was approved by the European Medicines Agency to also act against monkeypox, cowpox and complications from immunization with vaccinia.