The first 10 drugs that un­der­went gov­ern­ment price ne­go­ti­a­tions in 2023 were pro­ject­ed to save the gov­ern­ment bil­lions of dol­lars. Now, one month since the new pric­ing took ef­fect, the ex­tent to which those sav­ings are trick­ling down to se­niors is­n't as straight­for­ward as it might seem.

Ex­perts tell End­points News that cost sav­ings de­pend not on­ly on how much CMS low­ered the drugs' list prices by ne­go­ti­at­ing with phar­ma com­pa­nies, but al­so on what Medicare plans se­niors are us­ing, how much their pre­mi­ums are in­creas­ing, and a new out-of-pock­et spend­ing cap for se­niors.

Case in point: Eliquis, the blood thin­ner from Bris­tol My­ers Squibb and Pfiz­er, saw a 56% cut in its list price. But there's a wide dis­par­i­ty in what kind of sav­ings flow through to se­niors' pock­ets, ac­cord­ing to a new analy­sis from the law firm DLA Piper, which ad­vis­es life sci­ence com­pa­nies.

No­vo Nordisk’s next-gen meta­bol­ic drug Ca­griSe­ma per­formed bet­ter than the block­buster semaglu­tide at re­duc­ing blood sug­ar and weight in pa­tients with type 2 di­a­betes.

That was the topline re­sult from the lat­est Phase 3 read­out, No­vo re­port­ed Mon­day. The com­pa­ny found that pa­tients who re­ceived the 2.4 mg dosage of Ca­griSe­ma (which com­bines 2.4 mg semaglu­tide with 2.4 mg of ca­gril­in­tide) had a 1.91 per­cent­age-point im­prove­ment in HbA1c lev­els and a 14.2% drop in weight af­ter 68 weeks.

Pa­tients who re­ceived 2.4 mg of semaglu­tide alone had a 1.76 per­cent­age-point im­prove­ment in HbA1c lev­els and 10.2% in weight loss. The end­point im­prove­ments from Ca­griSe­ma were each sta­tis­ti­cal­ly sig­nif­i­cant, No­vo said.

The FDA has start­ed ac­cept­ing pitch­es for drug­mak­ers to par­tic­i­pate in the agency’s PreCheck pro­gram, a new ini­tia­tive aimed to speed up the con­struc­tion of US man­u­fac­tur­ing sites.

The agency said it will se­lect an ini­tial co­hort of fa­cil­i­ties for the pro­gram based on the med­i­cines the site will man­u­fac­ture, the sta­tus of the build­ing’s con­struc­tion, and the site's abil­i­ty to quick­ly pro­duce prod­ucts for the US mar­ket. The FDA will pri­or­i­tize fac­to­ries that will pro­duce “crit­i­cal” drugs for the US, ac­cord­ing to a Sun­day press re­lease.

The agency’s PreCheck pro­gram, an­nounced last Au­gust, is a two-phase ap­proach. The first phase will al­low drug man­u­fac­tur­ers to com­mu­ni­cate with the FDA ear­li­er, be­fore a fa­cil­i­ty is op­er­a­tional, through “pre-op­er­a­tional re­views.” The sec­ond phase will in­volve pre-sub­mis­sion meet­ings be­tween the agency and man­u­fac­tur­ers to re­solve any fac­to­ry-re­lat­ed is­sues.

Eu­ro­pean reg­u­la­tors will soon sign in a new raft of laws that could make drug­mak­ers jump through more hoops to de­lay gener­ic and biosim­i­lar com­pe­ti­tion. And com­pa­nies de­vel­op­ing rare dis­ease and or­phan drugs are like­ly to be great­ly af­fect­ed.

The Eu­ro­pean Coun­cil and Par­lia­ment’s so-called “phar­ma pack­age” in­tro­duces new cri­te­ria that drug­mak­ers must meet to max­i­mize mar­ket ex­clu­siv­i­ty, ex­perts in­ter­viewed by End­points News said. These cri­te­ria are de­signed for phar­ma com­pa­nies to gen­er­ate more val­ue-based ev­i­dence, but in­dus­try is con­cerned they could sim­ply serve as red tape, con­sid­er­ing the cap on ex­clu­siv­i­ty re­mains un­changed for the av­er­age drug.

Cur­rent­ly, new drugs get eight years of da­ta pro­tec­tion fol­lowed by two years of mar­ket ex­clu­siv­i­ty, said Cather­ine Drew, a part­ner at law firm Pin­sent Ma­sons. Com­pa­nies can al­so earn a third year of ex­clu­siv­i­ty if the com­pa­ny se­cures a new in­di­ca­tion that shows ev­i­dence of “sig­nif­i­cant clin­i­cal ben­e­fit.”