ICER plots ear­ly sci­en­tif­ic ad­vice pro­gram for bio­phar­ma

The In­sti­tute for Clin­i­cal and Eco­nom­ic Re­view (ICER) is look­ing to help the bio­phar­ma in­dus­try with ear­li­er re­views of clin­i­cal work, adding to their cur­rent in­de­pen­dent eval­u­a­tions of the clin­i­cal and eco­nom­ic val­ue of pre­scrip­tion drugs, med­ical tests and oth­er health in­no­va­tions.

David Whitrap

“For some time, ICER has been re­ceiv­ing re­quests from life sci­ences com­pa­nies to help them re­think clin­i­cal tri­al de­sign, so that the tri­als more ad­e­quate­ly mea­sure the types of out­comes that mat­ter most to pa­tients and their fam­i­lies,” David Whitrap, ICER VP of com­mu­ni­ca­tions and out­reach, told Fo­cus.

The idea float­ed is that bio­phar­ma com­pa­nies pay a fee for such a pre-mar­ket or pre-clin­i­cal re­view, though it’s un­clear at this stage what that fee would be or how such a re­view would be con­duct­ed.

“Some in­ter­na­tion­al health tech­nol­o­gy or­ga­ni­za­tions, such as NICE and CADTH, have of­fered this ‘ear­ly sci­en­tif­ic ad­vice’ to in­dus­try for many years with gen­er­al suc­cess. We are there­fore eval­u­at­ing the op­tions to pro­vide a sim­i­lar ser­vice but have not made any de­fin­i­tive plans,” Whitrap said.

Bern­stein biotech an­a­lyst Ron­ny Gal not­ed that the po­ten­tial move for ICER would be a fund­ing shift from their past re­liance on do­na­tions and con­fer­ence or­ga­niz­ing.

“We do not ques­tion ICER staff’s in­tegri­ty, but it is very hard to not grow to like your clients,” Gal said. “This fund­ing mech­a­nism is (re­spect­ful­ly) in­her­ent­ly prob­lem­at­ic for an or­ga­ni­za­tion whose mis­sion is to be­come the fair ar­biter of drug val­ue … It is in­cred­i­bly short­sight­ed of pay­ers (in­clud­ing and es­pe­cial­ly CMS) not to step up and fund ICER. An in­de­pen­dent eval­u­a­tor of drug val­ue is fi­nal­ly get­ting off the ground and you let it be­come fund­ed by Phar­ma?”

But Whitrap re­as­sured that if ICER does pur­sue such a pro­gram, “We would on­ly do so in a man­ner that would pre­serve ICER’s in­de­pen­dence and in­tegri­ty, and on­ly if of­fer­ing the ear­ly ad­vice to man­u­fac­tur­ers would fur­ther our core mis­sion of help­ing all pa­tients achieve ac­cess to high-val­ue care.”

Gal al­so called the idea “a pos­i­tive for the drug in­dus­try” as it will al­low drug de­vel­op­ers “to be the ones to ed­u­cate ICER ear­ly about the mer­it of their drug — they will get to com­pre­hen­sive­ly present their case and gain clar­i­ty as to what da­ta they need to put to­geth­er to ob­tain bet­ter prices.”

Whitrap added: “We’re still eval­u­at­ing all of our op­tions at this point re­gard­ing ear­ly sci­en­tif­ic ad­vice, in­clud­ing how to sup­port the staffing re­quire­ments it would en­tail … any po­ten­tial of­fer­ing in this area would be struc­tured in a way that would safe­guard the in­de­pen­dence of the drug as­sess­ments we con­duct at or around FDA ap­proval.”


First pub­lished here. Reg­u­la­to­ry Fo­cus is the flag­ship on­line pub­li­ca­tion of the Reg­u­la­to­ry Af­fairs Pro­fes­sion­als So­ci­ety (RAPS), the largest glob­al or­ga­ni­za­tion of and for those in­volved with the reg­u­la­tion of health­care and re­lat­ed prod­ucts, in­clud­ing med­ical de­vices, phar­ma­ceu­ti­cals, bi­o­log­ics and nu­tri­tion­al prod­ucts. Email news@raps.org for more in­for­ma­tion.

Author

Zachary Brennan

managing editor, RAPS

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