CMS plans to launch a new drug pay­ment mod­el for state Med­ic­aid pro­grams, the first of po­ten­tial­ly mul­ti­ple pric­ing mod­els un­der Pres­i­dent Don­ald Trump's "most fa­vored na­tion" push that the phar­ma in­dus­try has been close­ly mon­i­tor­ing.

The Cen­ter for Medicare and Med­ic­aid In­no­va­tion (CM­MI) un­veiled the GEN­ER­OUS de­mo Thurs­day af­ter­noon, which state Med­ic­aid pro­grams can opt in­to. States that elect to par­tic­i­pate will be able to pur­chase drugs in the pi­lot pro­gram at prices sim­i­lar to fel­low wealthy na­tions.

The de­mo pro­gram was pub­lished short­ly af­ter Trump and his top health of­fi­cials de­tailed a range of price cuts to the megablock­buster GLP-1 weight loss drugs sold by Eli Lil­ly and No­vo Nordisk. In ex­change for low­er­ing the all-cash price of the drugs di­rect­ly to con­sumers, Medicare will be­gin to cov­er the drugs be­gin­ning next year. The new Med­ic­aid mod­el will al­so be­gin next year, ac­cord­ing to a re­lease from CMS.

The FDA told Bio­haven its study us­ing re­al-world da­ta “would like­ly be in­ad­e­quate to pro­vide sub­stan­tial ev­i­dence of ef­fec­tive­ness” when it was pro­posed, ac­cord­ing to an agency re­jec­tion let­ter for the rare dis­ease drug tro­r­ilu­zole.

Ear­li­er this week, the reg­u­la­tor re­ject­ed Bio­haven’s drug, shut­ting down the com­pa­ny’s sec­ond at­tempt to get ap­proval of a ther­a­py for a neu­rode­gen­er­a­tive dis­ease called spin­ocere­bel­lar atax­ia. In 2023, the FDA re­fused to even re­view Bio­haven’s ap­pli­ca­tion for tro­r­ilu­zole af­ter the drug failed a place­bo-con­trolled tri­al.

The let­ter was post­ed the same week Bio­haven an­nounced its drug was re­ject­ed, mark­ing one of the quick­est turn­arounds for the agency to make a com­plete re­sponse let­ter pub­lic as part of its wider push to share why drugs were not ap­proved.

Gilead’s Trodelvy failed to meet the pri­ma­ry end­point in a Phase 3 tri­al for cer­tain breast can­cer pa­tients, mark­ing an­oth­er set­back for a key drug in Gilead’s can­cer port­fo­lio.

Trodelvy has faced a se­ries of ups and downs as the com­pa­ny has tried to ex­pand its use cas­es.

Gilead said Fri­day that Trodelvy did not im­prove pro­gres­sion-free sur­vival in the Phase 3 AS­CENT-07 study, which com­pared Trodelvy to chemother­a­py as a first op­tion for pa­tients who have re­ceived en­docrine ther­a­py. The study in­clud­ed pa­tients with HR-pos­i­tive/HER2-neg­a­tive metasta­t­ic breast can­cer.

Gilead said the study will con­tin­ue to ex­am­ine the drug’s im­pact on over­all sur­vival, where “an ear­ly trend” in fa­vor of Trodelvy was ob­served, though da­ta were not yet ma­ture.

→ Are you tired of No­vo Nordisk and Pfiz­er, or are you thirsty for more? They’ve even in­fil­trat­ed the top of Peer Re­view as the bick­er­ing gets loud­er and the dol­lar fig­ures swell in