FDA pins an­oth­er 'break­through' badge on Ab­b­Vie's vene­to­clax; Ex­press Scripts bats back at drug­mak­ers on pric­ing

Ab­b­Vie $AB­BV has col­lect­ed a fifth break­through ther­a­py des­ig­na­tion for vene­to­clax as it climbs the block­buster moun­tain with the apop­to­sis drug. The lat­est en­dorse­ment from the FDA cov­ers vene­to­clax’s first-line use, in com­bi­na­tion with obin­u­tuzum­ab, in chron­ic lym­pho­cyt­ic leukemia. Hav­ing just filed its sN­DA, the com­pa­ny is ex­pect­ed to ben­e­fit from an ex­pe­dit­ed re­view soon.

→ Last week, var­i­ous high pro­file, glob­al drug­mak­ers placed the blame for high out-of-pock­et pa­tient costs in the Unit­ed States on the mid­dle­men — phar­ma­cy ben­e­fit man­agers — as­sert­ing that they are forced to hike the prices of pre­scrip­tion drugs in re­sponse to high­er re­bates that all-pow­er­ful PBMs ne­go­ti­ate at a hear­ing with US law­mak­ers. On Wednes­day, the largest US PBM — Ex­press Scripts $ES­RX — shot back, sug­gest­ing the pow­er to low­er drug prices ul­ti­mate­ly lies with the man­u­fac­tur­ers. “We of­ten have asked drug com­pa­nies to sim­ply low­er their prices. In­stead, drug com­pa­nies have elect­ed to in­crease prices and in­crease re­bates. This is the op­tion drug mak­ers have cho­sen for them­selves and for the mar­ket­place,” the com­pa­ny said in a state­ment, prais­ing Lil­ly’s $LLY de­ci­sion ear­li­er this week to re­lease an au­tho­rized gener­ic of its block­buster Hu­ma­log in­sulin, car­ry­ing a 50% dis­count to the brand­ed ver­sion. “We are in dis­cus­sions with Eli Lil­ly about Hu­ma­log au­tho­rized al­ter­na­tive, and if the net cost is low­est for plans, we will add it to our Flex For­mu­la­ry.”

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