US re­sponds to drug­mak­er­s' IRA coun­terof­fers as Medicare price ne­go­ti­a­tions con­tin­ue

CMS wants fur­ther dis­cus­sions with phar­ma com­pa­nies that are par­tic­i­pat­ing in IRA price ne­go­ti­a­tions, HHS an­nounced on Tues­day.

The agency said it has re­spond­ed to coun­terof­fers pro­posed by all of the par­tic­i­pat­ing man­u­fac­tur­ers, but de­clined to com­ment fur­ther. Ac­cord­ing to CMS’ guide­lines, the agency will now hold up to three ne­go­ti­a­tion meet­ings with the com­pa­nies be­fore ne­go­ti­a­tions end Aug. 1.

Drug­mak­ers have large­ly kept qui­et about the talks. End­points News reached out to par­tic­i­pat­ing com­pa­nies on Tues­day, all of which de­clined to com­ment or did not re­spond.

While many of the com­pa­nies have ar­gued in court that the leg­is­la­tion will harm in­no­va­tion, As­traZeneca CEO Pas­cal So­ri­ot said in Feb­ru­ary that CMS’ ini­tial of­fer was “rel­a­tive­ly en­cour­ag­ing” com­pared with ex­pec­ta­tions. CMS will pub­lish an ex­pla­na­tion for ne­go­ti­at­ed prices by March 1, 2025, and the dis­counts will take ef­fect in Jan­u­ary 2026.

Mean­while, HHS con­tin­ues to tout the IRA as a win for the Biden ad­min­is­tra­tion.

“Now that we are ne­go­ti­at­ing di­rect­ly with phar­ma­ceu­ti­cal man­u­fac­tur­ers to bring down the price of pre­scrip­tion drugs for peo­ple on Medicare, there will be even more sav­ings in the fu­ture,” HHS Sec­re­tary Xavier Be­cer­ra said in a Tues­day news re­lease.

The re­search and ad­vo­ca­cy group Cen­ter for Amer­i­can Progress re­cent­ly pre­dict­ed that net Medicare price re­duc­tions for 30-day sup­plies of the ne­go­ti­at­ed drugs “could range from a low of $30 for in­sulin prod­uct No­voLog Flex­Pen to a high of $6,548 for can­cer drug Im­bru­vi­ca.” No­voLog is made by No­vo Nordisk and Im­bru­vi­ca is sold by John­son & John­son and Ab­b­Vie.

Phar­ma com­pa­nies have made lit­tle progress in their le­gal cam­paign against the IRA. The fed­er­al gov­ern­ment has won two le­gal chal­lenges brought by As­traZeneca and a group of or­ga­ni­za­tions in­clud­ing PhRMA. The lob­by­ing group has filed an ap­peal in Texas. Bris­tol My­ers Squibb, J&J, No­var­tis and No­vo Nordisk pre­sent­ed their cas­es in a joint hear­ing last month in New Jer­sey fed­er­al court.

“There hasn’t been any with­drawals, and I think that that just sig­nals that the ne­go­ti­a­tion pro­gram is func­tion­ing the way that Con­gress in­tend­ed,” Bri­an Net­ter, deputy as­sis­tant at­tor­ney gen­er­al with the De­part­ment of Jus­tice, said dur­ing the hear­ing.