Com­pared to avoid­ance, Aim­mune's peanut al­ler­gy treat­ment an im­prove­ment over DB­V's prod­uct — ICER

Peanut al­ler­gy treat­ments from spar­ring drug­mak­ers — Aim­mune and DBV Tech­nolo­gies — are in­cre­men­tal­ly ben­e­fi­cial, but their long-term cost-ef­fec­tive­ness will be de­ter­mined by the price at which they are even­tu­al­ly mar­ket­ed, ICER said in a draft re­port pub­lished on Tues­day, which con­clud­ed us­ing as­sumed prices that the lat­ter’s prod­uct, Vi­askin Peanut, was far less of an im­prove­ment over peanut avoid­ance, com­pared to AR101.

Akin to NICE in the UK, ICER is an in­de­pen­dent body that an­a­lyzes the cost-ef­fec­tive­ness of drugs and oth­er med­ical ser­vices in the Unit­ed States. Un­like NICE, though, ICER is not gov­ern­ment-af­fil­i­at­ed, but its de­ter­mi­na­tions are in­creas­ing­ly be­com­ing in­flu­en­tial with pay­ers.

For now, peanut al­ler­gies are man­aged by avoid­ance, but the threat of ac­ci­den­tal ex­po­sure can­not be nul­li­fied. Aim­mune’s AR101 and DBV’s Vi­askin Peanut are set to be the pi­o­neer­ing peanut al­ler­gy treat­ments ap­proved by the FDA, but there is “sig­nif­i­cant un­cer­tain­ty about the long-term risks and ben­e­fits” for both ther­a­pies, as each has been stud­ied in place­bo-con­trolled one-year clin­i­cal tri­als, ICER said, not­ing that da­ta from the ex­ten­sion tri­als are sparse.

An FDA ap­proval de­ci­sion for AR101 is ex­pect­ed in Jan­u­ary 2020, while DBV is ex­pect­ed to sub­mit its mar­ket­ing ap­pli­ca­tion lat­er in 2019. The so far un­tapped mar­ket is ex­pect­ed to grow to $4.5 bil­lion in 2027 glob­al­ly, ac­cord­ing to Glob­al­Da­ta.

Aim­mune $AIMT ef­fec­tive­ly leapfrogged DBV $DB­VT when the lat­ter re­scind­ed an ap­pli­ca­tion to mar­ket Vi­askin Peanut patch last year in re­sponse to FDA con­cerns about the state of man­u­fac­tur­ing and qual­i­ty con­trol da­ta sub­mit­ted.

Since nei­ther ther­a­py has been ap­proved yet, ICER con­duct­ed its analy­ses us­ing price as­sump­tions, based on an­a­lyst mod­els, which project AR101 will cost be­tween $5,000 and $10,000 for the first six months of use, and $300 to $400 per month af­ter and that Vi­askin Peanut will cost more than $6,000 for a year’s sup­ply.

Based on these es­ti­mates, ICER as­sumed a place­hold­er cost for AR101 at $350 per month ($6,595 for months 1-6 in­clud­ing clin­i­cal vis­its for dose es­ca­la­tion; $4,200 per year there­after). For Vi­askin Peanut, the in­sti­tute as­sumed a place­hold­er cost of $6,500 per year. That works out to AR101 cost­ing $84,000 over a life­time, and Vi­askin Peanut cost­ing $56,000 over a life­times, ICER said.

“Rel­a­tive to our AR101 pric­ing as­sump­tions based on our con­ver­sa­tions with Aim­mune, we had con­ser­v­a­tive­ly as­sumed the low­er end of the com­pa­ny’s com­mu­ni­cat­ed pric­ing range of $5,000 for the up-dos­ing phase and $5,000 per year there­after ($415/month) – so $7,500 for the first year. All-in, the first year costs ICER us­es for its analy­sis are high­er by about 16%,” Stifel’s Derek Archi­la wrote in a note.

For Vi­askin Peanut, ICER’s as­sumed an­nu­al cost of ther­a­py is 20% high­er than Stifel’s $5,000 as­sump­tion, he added.

ICER based its cost-ef­fec­tive­ness cal­cu­la­tions on qual­i­ty-ad­just­ed-life-years (QALYs), a mea­sure of the state of health of a per­son or group in which the ben­e­fits — in terms of length of life — are ad­just­ed to re­flect the qual­i­ty of life.

Treat­ment with AR101 re­sult­ed in 0.63 in­cre­men­tal QALYs, while treat­ment with Vi­askin Peanut came up rel­a­tive­ly short, re­sult­ing in 0.22 in­cre­men­tal QALYs — when com­pared to no im­munother­a­py treat­ment over a life­time, ICER’s analy­sis sug­gest­ed.

“These ben­e­fits are due to im­proved sub­jec­tive qual­i­ty of life de­spite the rel­a­tive rar­i­ty with which se­ri­ous events oc­cur. The ul­ti­mate val­ue of these prod­ucts will be de­ter­mined by the prices that are set by the man­u­fac­tur­ers and their long-term ef­fec­tive­ness,” ICER con­clud­ed.

While in­for­ma­tive, the re­port is not con­clu­sive, part­ly be­cause a one-year time­frame may not re­flect the en­tire ben­e­fit of a ther­a­py that pro­vides in­creas­ing ef­fi­ca­cy over time such as AR101 or Vi­askin peanut, and no qual­i­ty of life da­ta (good or bad) was fac­tored in­to this analy­sis, Archi­la said.

ICER did ac­knowl­edge that one of the lim­i­ta­tions of its analy­sis is that it as­sumed the util­i­ty of the two peanut al­ler­gy ther­a­pies on the ba­sis of ex­ist­ing da­ta on food al­ler­gies, but not specif­i­cal­ly the peanut al­ler­gy pa­tient pop­u­la­tion, due to “the pauci­ty of pref­er­ence-weight­ed health-re­lat­ed qual­i­ty of life es­ti­mates in food al­ler­gy pa­tients and their care­givers.”

ICER’s as­sess­ment is “pre­ma­ture” and the in­sti­tute’s frame­work does not take in­to ac­count the bur­den care­givers car­ry, in terms of mak­ing ther­a­peu­tic de­ci­sions or mak­ing out-of-pock­et costs for treat­ment, a DBV spokesper­son wrote in an email to End­points News.

“We dis­agree with ICER on many as­pects of its over­all method­ol­o­gy, as well as the tim­ing of this re­port. Be­cause the ICER mod­el re­lies on health eco­nom­ic mea­sure­ments…for which there are no pub­lished da­ta/ev­i­dence for peanut-al­ler­gic pa­tients [as there are no ap­proved FDA-ap­proved treat­ments], we be­lieve the draft re­port find­ings were dri­ven by in­ac­cu­rate clin­i­cal out­comes and cost in­puts…We be­lieve the lack of FDA-ap­proved ther­a­peu­tic op­tions for peanut al­ler­gy and as­so­ci­at­ed ab­sence of health state util­i­ty and long-term treat­ment da­ta, com­bined with pa­tient het­ero­gene­ity, pre­cludes an ac­cu­rate and re­li­able cost-ef­fec­tive­ness as­sess­ment, in­clud­ing by ICER.”

End­points has al­so con­tact­ed Aim­mune for com­ment.


Im­age: Shut­ter­stock

John Hood [file photo]

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