Mer­ck joins its peers with plan to cut ac­cess to dis­count­ed drugs for con­tract phar­ma­cies

Back in May, HHS looked like it was tak­ing con­trol of its 340B drug dis­count pro­gram, which re­quires drug­mak­ers to pro­vide mas­sive price dis­counts to hos­pi­tals that treat low-in­come pa­tients.

HHS at the time sent stern let­ters to As­traZeneca, Eli Lil­ly, No­var­tis, No­vo Nordisk and Sanofi for ac­tions they took to lim­it ac­cess to these dis­count­ed drugs, with HHS threat­en­ing steep fines and mak­ing clear that the 340B statute “does not per­mit man­u­fac­tur­ers to im­pose con­di­tions on cov­ered en­ti­ties’ ac­cess to 340B pric­ing, in­clud­ing the pro­duc­tion of claims da­ta.”

Since that let­ter was sent, how­ev­er, HHS has backpedaled and had to de­fend it­self be­fore sev­er­al law­suits. The de­part­ment al­so with­drew an ad­vi­so­ry opin­ion from De­cem­ber “in light of on­go­ing con­fu­sion” about its scope and im­pact, and which said drug­mak­ers are ob­lig­at­ed to de­liv­er cov­ered out­pa­tient drugs to con­tract phar­ma­cies un­der the drug dis­count pro­gram known as 340B.

Now, not on­ly are As­traZeneca and Lil­ly en­gaged in le­gal dis­putes over whether they should be re­quired to pro­vide dis­count­ed drugs to an un­lim­it­ed num­ber of con­tract phar­ma­cies, but Mer­ck is join­ing in on the 340B re­stric­tions, threat­en­ing to with­hold some of the drug dis­counts from hos­pi­tals part­ner­ing with com­mu­ni­ty phar­ma­cies.

Ef­fec­tive Sept. 1, Mer­ck said it will no longer vol­un­tar­i­ly hon­or 340B dis­counts or charge­backs for con­tract phar­ma­cies that have not be­gun to pro­vide 340B claims da­ta, un­less the hos­pi­tal-cov­ered en­ti­ty lacks its own in-house phar­ma­cy and des­ig­nates a con­tract phar­ma­cy of its choice. The move di­rect­ly coun­ters what HHS stip­u­lat­ed in its let­ter from May with re­gard to im­pos­ing con­di­tions and re­quir­ing claims da­ta.

Mer­ck said it set up a vol­un­tary pro­gram last year to try to pre­vent waste, but it did not see a lot of par­tic­i­pants, adding:

We had hoped that 340B cov­ered en­ti­ties would broad­ly em­brace the col­lab­o­ra­tive Mer­ck Pro­gram and the op­por­tu­ni­ty to take mean­ing­ful but time-ef­fi­cient steps to help en­sure pro­gram in­tegri­ty, in­clud­ing steps to pre­vent Med­ic­aid-340B du­pli­cate dis­counts, which are pro­hib­it­ed by the 340B statute. We are par­tic­u­lar­ly con­cerned about these and oth­er statu­to­ry vi­o­la­tions in the con­text of con­tract phar­ma­cy trans­ac­tions.

Hos­pi­tals are cry­ing foul over Mer­ck’s move.

Mau­reen Testoni

Mau­reen Testoni, pres­i­dent and CEO of an as­so­ci­a­tion of hos­pi­tals known as 340B Health, said in a state­ment, “Mer­ck’s threat to with­hold 340B drug dis­counts from hos­pi­tals part­ner­ing with com­mu­ni­ty phar­ma­cies will cause ir­repara­ble harm to safe­ty-net providers and the pa­tients liv­ing with low in­comes they serve. Drug com­pa­nies should not im­pose con­di­tions on hos­pi­tals el­i­gi­ble for 340B dis­counts, in­clud­ing de­mand­ing ac­cess to pa­tients’ drug claims. Mer­ck’s lead­ers should with­draw their threat and con­tin­ue to abide by the law.”

With Mer­ck join­ing the mix of com­pa­nies re­strict­ing their dis­count prices for con­tract phar­ma­cies, sev­er­al up­com­ing court rul­ings will clar­i­fy whether those shifts are le­gal. Oral ar­gu­ments in the As­traZeneca case are set for Sept. 18.

Bio­mark­er 'roadmap­s' and the fu­ture of can­cer R&D; Cur­tain rais­es on #AS­CO22; Pfiz­er, No­var­tis tack­le drug ac­cess; 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.

While this was not a week for earth-shattering news, there were certainly a lot of interesting tidbits. If you found this recap helpful, please recommend it to your friends and colleagues. We’ll see you on the other side of the long weekend.

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Keep­ing pres­sure on Am­gen, Mi­rati draws mixed re­views on lat­est cut of KRAS da­ta

As the close runner-up to Amgen’s Lumakras in the KRAS race, any data cut from Mirati’s adagrasib continues to draw scrutiny from analysts. And the latest batch of numbers from ASCO is a decidedly mixed bag.

While a quick comparison suggests that adagrasib spurred slightly more responses and led to a longer overall survival than Lumakras among a group of non-small cell lung cancer patients, its duration of response appears shorter and the safety profile continues to spark concern.

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Ann is one of ViiV Healthcare's newest spokespeople as the retired school administrator speaks up about her HIV status.

GSK's Vi­iV de­buts next evo­lu­tion in HIV med Dova­to cam­paign with new spokes­peo­ple and new mes­sage

When Ann saw the first TV commercials for HIV medicine Dovato, she didn’t see herself represented. So the 74-year-old retired school administrator who’s been living with HIV since 1998, reached out to GSK’s ViiV Healthcare and asked why not?

Now Ann is one of three people starring in ViiV’s latest Dovato campaign called “Detect This.” The next-step evolution in the branded campaign plays on the word “detect” — often used in describing HIV status under control as undetectable — but in this case, uses the word as a directive for people to understand they can use fewer medicines.

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Switzer­land to de­stroy over 600,000 ex­pired dos­es of Mod­er­na Covid vac­cine

As concerns related to uptake and distribution continue to linger, Switzerland is among the first countries that plans to destroy hundreds of thousands of expired and unused Covid-19 vaccine doses.

The European country said it plans to destroy more than 600,000 doses of Moderna’s Spikevax Covid-19 vaccine as the doses have reached their expiration date.

However, Moderna CEO Stéphane Bancel told the World Economic Forum in Davos, Switzerland that he’s in the process of throwing 30 million doses in the garbage, exclaiming, “We have a big demand problem.”

Lina Khan, FTC chair (Graeme Jennings/Pool via AP Images)

Pile-on over PBMs con­tin­ues with FTC com­ments and a new bi­par­ti­san Sen­ate bill

More than 500 stakeholders sent comments to the FTC on whether the commission should look further into pharma middlemen, known as PBMs, with many of the commenters calling for more federal oversight.

Similar to the critical open comment period in a deadlocked FTC session last February, pharmacies and pharmacy groups are continuing to call out the lack of transparency among the top 3 PBMs, which control about 80% of the market.

Pharma brands are losing their shine with US consumers who are now thinking about the economy and inflation instead of Covid. (Credit: Shutterstock)

Phar­ma brands fade in an­nu­al Har­ris con­sumer vis­i­bil­i­ty poll: Mod­er­na drops off and Pfiz­er dips

As Covid-19 concerns are fading in the US, so is biopharma visibility. The annual Axios Harris Poll survey to determine and rank the 100 most top-of-mind brands in the US finds Moderna, which was No. 3 last year, not on the list at all for 2022, and Pfizer sinking 37 spots.

However, it’s not that Moderna or Pfizer did anything wrong, it’s just that Americans have moved on to other worries beyond Covid.

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HHS Secretary Xavier Becerra (Jacquelyn Martin/AP Images)

HHS fin­ish­es off Trump-era rule that would've erased ba­sic FDA regs with­out fre­quent re­views

HHS on Thursday finalized its decision to withdraw a rule, proposed just before former President Donald Trump left office, that would’ve caused thousands of HHS and FDA regulations to automatically expire if they weren’t reviewed within two years, and every 10 years thereafter.

The decision follows the filing of a lawsuit last March, in which several nonprofits alleged that the outgoing administration planted “a ticking timebomb” for HHS, essentially forcing it to devote an enormous amount of resources to the unprecedented and infeasible task of reviewing thousands of regulations regularly.

Tran­si­tion to new Eu­ro­pean clin­i­cal tri­als in­fo sys­tem starts slow­ly

At the end of January, the European Medicines Agency officially launched its new clinical trials info system (CTIS), although the migration to the new platform has only really just begun, and sponsors have until the end of January 2023 before all initial trial applications must be submitted through CTIS.

Overall, 56 clinical trial applications have been submitted in CTIS during the first 3 months since the launch of the system on Jan. 31, according to new data posted by the EMA. By comparison, about 4,000 new trials are authorized each year across Europe.

Vi­iV Health­care looks to make long-act­ing HIV pre­ven­tion shot ac­ces­si­ble in low- and mid­dle-in­come coun­tries

The Joint United Nations Programme on HIV and AIDS set a lofty goal back in 2019 to end the HIV epidemic by 2030. But according to the World Health Organization, infection rates are not falling rapidly enough to meet that target.

GSK’s ViiV Healthcare thinks it can help change that.

On Friday, ViiV announced that it’s in talks with the UN-backed Medicines Patent Pool (MPP) for patent rights to its cabotegravir long-acting HIV injectable for pre-exposure prophylaxis (PrEP) in low- and middle-income countries.