As Bio­gen ex­ecs be­moaned the neg­a­tive me­dia cov­er­age around Aduhelm’s ap­proval a month ago, the biotech isn’t gain­ing much trac­tion yet in us­ing its new drug, large­ly due to a lack of in­sur­ance cov­er­age, ac­cord­ing to an earn­ings call Thurs­day.

Man­age­ment in­di­cat­ed that of the near­ly 900 sites that were prepped and ready fol­low­ing Aduhelm’s ap­proval, 325 of those, or about 35%, have com­plet­ed a pos­i­tive phar­ma­cy and ther­a­peu­tics (P&T) re­view or won’t re­quire one. The re­view is a step some hos­pi­tals or health sys­tems take pri­or to us­ing a new drug. Some ma­jor sites, how­ev­er, have said they won’t par­tic­i­pate.

Bio­gen’s top re­search chief Al San­drock al­so said on the call that he wel­comed a for­mal re­view in­to the in­ter­ac­tions be­tween FDA and Bio­gen, as “a bet­ter un­der­stand­ing is good for every­one in­volved.” He al­so of­fered an open let­ter on Thurs­day to “cor­rect some of the mis­in­for­ma­tion” around the ap­proval. For in­stance, San­drock took is­sue with the idea that ad­u­canum­ab’s tri­al re­sults are “post hoc,” al­though the com­pa­ny did stop the tri­als due to fu­til­i­ty. He al­so stressed that the ac­cel­er­at­ed ap­proval path­way, while not­ing that col­lab­o­ra­tion be­tween in­dus­try and reg­u­la­to­ry agen­cies is com­mon, ap­pro­pri­ate and ben­e­fi­cial.

A for­mer se­nior FDA of­fi­cial told End­points that any dis­cus­sion at a con­fer­ence be­tween agency of­fi­cials and a com­pa­ny on an ap­pli­ca­tion’s de­tails or tim­ing, is im­prop­er and should not hap­pen. Both STAT News and NYT al­so con­firmed sep­a­rate­ly that FDA’s neu­ro­science head Bil­ly Dunn met pri­vate­ly at a con­fer­ence to dis­cuss Aduhelm’s ap­pli­ca­tion.

San­drock al­so seemed to blame the con­tro­ver­sy around the Aduhelm ap­proval on neg­a­tive me­dia at­ten­tion. Jay Ol­son, a re­search an­a­lyst at Op­pen­heimer, opened the call’s ques­tion­ing with one about all of the “neg­a­tive me­dia” cov­er­age, which CEO Michel Vounatsos thanked him for ask­ing and said he agreed with.

Vounatsos said he does ex­pect re­gion­al Medicare MAC/Ad­van­tage plans will pro­vide cov­er­age while Medicare’s NCD re­view is on­go­ing. But the NCD will over­ride any of those lo­cal Medicare plan de­ci­sions that are in­sti­tut­ed pri­or to the NCD, said Al­isha Alaimo, pres­i­dent of Bio­gen’s US or­ga­ni­za­tion. That NCD de­ci­sion from CMS isn’t ex­pect­ed for an­oth­er 9 months.

But, ac­cord­ing to one Bio­gen em­ploy­ee, that re­gion­al cov­er­age has not hap­pened yet, and com­mer­cial in­sur­ers have been hes­i­tant to cov­er the new drug. The com­pa­ny said it brought in $2 mil­lion in quar­ter­ly Aduhelm sales, but Vounatsos said to as­sume that a “big chunk” of that $2 mil­lion is in­ven­to­ry and does not re­veal how many pa­tients have been treat­ed.

Bio­gen ex­pects “mod­est” sales in 2021 but did not pro­vide any fi­nan­cial es­ti­mates.

“It’s still ear­ly days,” Vounatsos said. “Over­all, it’s a bit slow­er than what we as­sumed, but we’re mak­ing progress.”

Al San­drock

Alaimo said Bio­gen is mak­ing every ef­fort to get in front of these lo­cal Medicare de­ci­sion mak­ers and there’s a “high lev­el of in­ter­est” in Bio­gen’s pro­gram where it pays for a test that can iden­ti­fy be­ta amy­loid in po­ten­tial pa­tients.

She not­ed that al­though no in­sur­ers have come out with a cov­er­age pol­i­cy yet, so there are no man­dates on find­ing amy­loid be­ta yet, “that’s the ex­pec­ta­tion.” There are sev­er­al ar­eas of the coun­try where ac­cess to amy­loid PET is not avail­able, she said, not­ing that Bio­gen has re­quest­ed PET and CSF tests, but the com­pa­ny is work­ing on gain­ing PET re­im­burse­ment through CMS.

Vounatsos al­so promised that Bio­gen will pub­lish its Phase III tri­al re­sults for Aduhelm in a peer-re­viewed jour­nal. Those da­ta are im­por­tant as some ex­perts are now rais­ing ques­tions about what the FDA re­leased along­side the ac­cel­er­at­ed ap­proval, and as three ad­comm mem­bers have now re­signed from the FDA pan­el.

The Federal Trade Commission has gotten involved in a patent feud over Supernus’ Parkinson’s drug Apokyn, a case the agency said may have ‘‘significant implications” for patients who rely on the drug.

Sage Chemical won the first generic approval for its Apokyn formulation (also known as apomorphine hydrochloride injection) back in 2022. The non-ergoline dopamine agonist is approved to treat Parkinson’s symptoms during “off episodes,” such as difficulty moving, tremors and intense cramping. However, regulators specified that the approval pertained to the generic drug cartridges only, not the injector pen required for administration.

The White House’s Office of Science and Technology Policy (OSTP) last year sought to find ways to better coordinate large-scale clinical trials in the US — as the UK lead by example during the pandemic — especially for these emergency clinical trials.

The lobbying group PhRMA Tuesday called for more clinical trial diversity in underserved areas, including by making participation less of a burden, and expanding eligibility criteria when appropriate.

The FDA on Tuesday released a warning letter sent earlier this month to the Mason, OH-based site of Procter & Gamble Manufactura, raising questions about the list of ingredients on the label and in the electronic filing.

The warning says that for P&G’s over-the-counter Vicks Nyquil Severe Hot Remedy Cold and Flu Plus Congestion, there’s a “mismatched” list of active ingredients between the labeling and the electronic listing file. The listing file for the active ingredients did not match the active ingredients in the electronic file.