An­timi­cro­bial re­sis­tance: FDA dis­cuss­es re­im­burse­ment re­forms

Re­im­burse­ment re­forms for an­timi­cro­bial treat­ments could in­clude “a mix of mile­stone pay­ments and sub­scrip­tion fees for de­vel­op­ers of FDA-ap­proved prod­ucts with high eco­nom­ic and clin­i­cal val­ue, tar­get­ed at mul­ti-drug re­sis­tant or­gan­isms and linked to proven clin­i­cal out­comes,” FDA Com­mis­sion­er Scott Got­tlieb said in a speech at Pew Char­i­ta­ble Trusts on Fri­day.

He al­so of­fered the idea of us­ing a “sub­scrip­tion-based mod­el” that could see hos­pi­tals pay­ing a flat rate for ac­cess to a cer­tain num­ber of dos­es of a new an­timi­cro­bial.

Cur­rent­ly, the Cen­ters for Dis­ease Con­trol and Pre­ven­tion (CDC) es­ti­mates that the di­rect cost of an­timi­cro­bial re­sis­tance on the US econ­o­my is $20 bil­lion an­nu­al­ly.

“These sub­scrip­tion fees could be priced at a lev­el to cre­ate a suf­fi­cient re­turn on the in­vest­ment to de­vel­op drugs with a cer­tain pro­file,” Got­tlieb said. “This should have the ef­fect of cre­at­ing a nat­ur­al mar­ket for drugs that meet cer­tain im­por­tant spec­i­fi­ca­tions.”

The FDA is al­so dis­cussing pay­ment pi­lots with oth­er fed­er­al agen­cies, in­clud­ing the Cen­ters for Medicare and Med­ic­aid Ser­vices (CMS), not­ing in­ter­est in do­ing such pi­lots in con­cert with the pri­vate sec­tor as well.

New ap­proach­es to re­im­burse­ment that could be ex­plored might “al­so in­clude new tech­nol­o­gy add-on pay­ments for cer­tain new an­tibac­te­r­i­al drugs that meet crit­i­cal pa­tient and pub­lic health needs,” he said.

Mean­while, ear­li­er this week, the FDA re­leased a new re­quest for in­for­ma­tion (RFI) to ob­tain ex­ter­nal in­put in­to de­vel­op­ing an an­nu­al list of reg­u­la­to­ry sci­ence ini­tia­tives specif­i­cal­ly for an­timi­cro­bial prod­ucts. Part of such a list will be a fo­cus on the “de­lay in avail­abil­i­ty of in­for­ma­tion re­gard­ing the iden­ti­fi­ca­tion and an­tibac­te­r­i­al sus­cep­ti­bil­i­ty of the causal pathogen, when iso­lat­ed.”

Re­spons­es to the RFI will be ac­cept­ed un­til 31 Oc­to­ber 2018.


Im­age: Scott Got­tlieb. SHUT­TER­STOCK

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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