UK cost watchdog drafts guidance against 5 Covid treatments and J&J depression med – Endpoints News

It looks like five Covid treat­ments like­ly won’t make the NICE list this year, the UK’s cost-ef­fec­tive­ness watch­dog re­cent­ly an­nounced, and nei­ther will J&J’s es­ke­t­a­mine.

The coun­try’s Na­tion­al In­sti­tute for Health and Care Ex­cel­lence, which ad­vis­es the Na­tion­al Health Ser­vice, re­leased draft guid­ance on Wednes­day that rec­om­mends against Re­gen­eron’s mon­o­clon­al an­ti­body com­bo Re­gen-Cov (al­so known as casiriv­imab and imde­vimab), GSK’s Xe­vudy (sotro­vimab), and As­traZeneca’s Evusheld (tix­agevimab and cil­gav­imab) due to un­cer­tain­ty over just how ef­fec­tive they are against Omi­cron.

The watch­dog al­so rec­om­mend­ed against Mer­ck’s Lagevrio (mol­nupi­ravir) and Gilead’s Vek­lury (remde­sivir) over cost-ef­fec­tive­ness is­sues. NICE gave a thumbs-down to all five treat­ments in the out­pa­tient set­ting, and Re­gen-Cov and Vek­lury in hos­pi­tal set­tings re­gard­less of the need for sup­ple­men­tal oxy­gen.

“The ev­i­dence for all the treat­ments we’ve looked at is high­ly un­cer­tain be­cause most of the stud­ies were car­ried out be­fore the emer­gence of the now dom­i­nant Omi­cron vari­ant of Covid-19,” He­len Knight, in­ter­im di­rec­tor of med­i­cines eval­u­a­tion at NICE, said in a news re­lease.

The news comes months af­ter the FDA pulled its emer­gency use au­tho­riza­tion for Xe­vudy over da­ta that sug­gest­ed the treat­ment was “un­like­ly to be ef­fec­tive” against the BA.2 sub­vari­ant. Re­gen-Cov is sim­i­lar­ly not au­tho­rized for use any­where in the US due to the spread of Omi­cron.

“We re­main com­mit­ted to test­ing and eval­u­at­ing the ef­fec­tive­ness of sotro­vimab against new vari­ants and shar­ing da­ta with reg­u­la­tors and health au­thor­i­ties, a GSK spokesper­son told End­points News in an email on Wednes­day. “We will con­tin­ue to en­gage with NICE in this on­go­ing Mul­ti­ple Tech­nol­o­gy Ap­praisal with the aim of main­tain­ing ac­cess to sotro­vimab for pa­tients who need it.”

Back in Feb­ru­ary, US reg­u­la­tors warned that Evusheld “may be less ac­tive against cer­tain Omi­cron sub­vari­ants,” but said in an up­date last month that they con­tin­ue to rec­om­mend the pre-ex­po­sure pro­phy­lax­is (PrEP) drug to pre­vent Covid, as “Evusheld still of­fers pro­tec­tion against many of the cur­rent­ly cir­cu­lat­ing vari­ants and may of­fer pro­tec­tion against fu­ture vari­ants.”

NICE says it’s draft­ing sep­a­rate guid­ance on Evusheld in the pro­phy­lax­is set­ting, and ex­pects to have a de­ci­sion in the spring.

Mean­while, the agency rec­om­mend­ed three drugs for use go­ing for­ward, in­clud­ing Pfiz­er’s Paxlovid, Roche’s RoActem­ra (sold as Actem­ra in the US for rheuma­toid arthri­tis) and Eli Lil­ly’s Olu­mi­ant, which hasn’t yet re­ceived a mar­ket­ing au­tho­riza­tion for Covid in the UK.

NICE spec­i­fied that this is mere­ly draft guid­ance, and is sub­ject to change. The agency al­so wel­comed com­ments and ad­di­tion­al ev­i­dence.

“We are ready to work with all the com­pa­nies whose prod­ucts have not been rec­om­mend­ed in this draft guid­ance, and with NHS Eng­land, to ex­plore whether there is scope for any com­mer­cial or oth­er so­lu­tions that could ad­dress the is­sues high­light­ed by the in­de­pen­dent ap­praisal com­mit­tee,” Knight added.

A Mer­ck spokesper­son re­ject­ed the draft guid­ance on Wednes­day, telling End­points in an email that it’s “not un­com­mon for an ini­tial NICE as­sess­ment to be neg­a­tive.”

“We do not be­lieve the draft guid­ance re­gard­ing mol­nupi­ravir (LAGEVRIO) re­flects the clin­i­cal pro­file of LAGEVRIO and the val­ue that may rep­re­sent to NHS. We will con­tin­ue work­ing with NICE as part of the con­sul­ta­tion process,” the spokesper­son said.

“This draft guid­ance does not re­flect the full body of da­ta avail­able, nor is it in line with the broad range of ev­i­dence-based guide­lines from around the world in­clud­ing the Eu­ro­pean So­ci­ety of Clin­i­cal Mi­cro­bi­ol­o­gy and In­fec­tious Dis­ease, the World Health Or­gan­i­sa­tion (WHO), the U.S. Na­tion­al In­sti­tute of Health, and the NICE COVID-19 Rapid Guide­line,” Gilead told End­points.

Re­gen­eron and As­traZeneca did not re­spond to re­quests for com­ment as of press time.

NICE al­so hand­ed down a neg­a­tive draft de­ci­sion for J&J’s Spra­va­to (es­ke­t­a­mine), deal­ing a tough blow to the broad­er hal­lu­cino­gen­ics field. The FDA first ap­proved Spra­va­to in 2019 for treat­ment-re­sis­tant de­pres­sion, and while it isn’t a tra­di­tion­al psy­che­del­ic be­cause it doesn’t act on the same sero­tonin re­cep­tors as LSD or psilo­cy­bin, it can have dis­so­cia­tive ef­fects such as hal­lu­ci­na­tion.

De­spite Janssen’s at­tempts to ap­peal pri­or NICE draft guid­ance, the agency said in a fi­nal ap­praisal doc­u­ment last week that it doesn’t rec­om­mend es­ke­t­a­mine for pa­tients with treat­ment-re­sis­tant de­pres­sion who’ve failed on at least two oth­er an­ti­de­pres­sants.

NICE said in its de­ci­sion:

The com­pa­ny po­si­tioned es­ke­t­a­mine nasal spray for peo­ple who have had at least 3 an­ti­de­pres­sants be­fore, with or with­out an­oth­er treat­ment like lithi­um or an an­tipsy­chot­ic med­i­cine. This is nar­row­er than the mar­ket­ing au­tho­ri­sa­tion, and al­so how clin­i­cal ex­perts ad­vised es­ke­t­a­mine would like­ly be used in NHS prac­tice. The clin­i­cal ev­i­dence at this po­si­tion­ing is un­cer­tain be­cause it on­ly con­sid­ers a small num­ber of peo­ple from the full clin­i­cal tri­al pop­u­la­tion.

In its ap­peal let­ter, Janssen ar­gued ear­li­er this year that NICE act­ed un­fair­ly and ex­ceed­ed its pow­ers, call­ing the ini­tial ap­praisals “un­rea­son­able.”

“The Com­mit­tee recog­nis­es that clin­i­cal un­cer­tain­ties are in­her­ent to clin­i­cal tri­als in men­tal health but pro­vides no ex­pla­na­tion of how (if at all) this sit­u­a­tion has been tak­en in­to ac­count in its de­ci­sion mak­ing,” the let­ter states.