Gilead Sciences has priced its covid-19 treat­ment, remde­sivir, at $3,120 for the typ­i­cal U.S. pa­tient with pri­vate in­sur­ance.

Trump ad­min­is­tra­tion se­cures 500,000 cour­ses of drug for hos­pi­tal use

The Washington Post - - FRONT PAGE - BY HANNAH DEN­HAM, YAS­MEEN ABU­TALEB AND CHRISTO­PHER ROW­LAND hannah.den­ham@wash­post.com yas­meen.abu­taleb@wash­post.com christo­pher.row­land@wash­post.com

Gilead Sciences, the maker of the first covid-19 treat­ment found to have worked in clin­i­cal tri­als, remde­sivir, said Mon­day it will charge U.S. hospi­tals $3,120 for the typ­i­cal pa­tient with pri­vate in­sur­ance.

Soon after the an­nounce­ment, the Trump ad­min­is­tra­tion said it had se­cured nearly all of the com­pany’s sup­ply of the drug for use in U.S. hospi­tals through Septem­ber, with a con­tract for 500,000 treat­ment cour­ses, which it will make avail­able to hospi­tals at Gilead’s price.

Other de­vel­oped coun­tries will pay 25 per­cent less than the United States, a dis­count Gilead said re­flects a need to make the drug as widely avail­able as pos­si­ble through­out the world.

The com­pany has li­censed generic man­u­fac­tur­ers to pro­duce the drug for de­vel­op­ing coun­tries, “at a sub­stan­tially lower cost,” the com­pany said.

Gilead’s an­nounce­ment set­tles a lin­ger­ing ques­tion about a drug that has been shown to have a mod­est ben­e­fit but re­mains the only ther­apy au­tho­rized by the Food and Drug Ad­min­is­tra­tion to treat hos­pi­tal­ized pa­tients with covid-19, the dis­ease caused by the novel coro­n­avirus. A clin­i­cal trial spon­sored by the gov­ern­ment showed the drug — in­vented by Gilead but de­vel­oped largely by tax­payer-funded agen­cies — sped up hos­pi­tal re­cov­er­ies by four days. It had no sta­tis­ti­cally sig­nif­i­cant im­pact on sur­vival for covid-19 pa­tients.

Set­ting a price for a novel drug in the mid­dle of a pan­demic posed an un­prece­dented chal­lenge, Gilead said. Cutting four days of hos­pi­tal costs for each pa­tient saves the U.S. health sys­tem $12,000 per pa­tient, the com­pany said. Based on that bench­mark, it sug­gested it could have jus­ti­fied a higher price.

“As with many as­pects of this pan­demic, we are in un­charted ter­ri­tory in pric­ing remde­sivir,'' Gilead’s chair­man and chief ex­ec­u­tive, Daniel O’day, wrote in an open let­ter. “As the world continues to reel from the hu­man, so­cial and eco­nomic im­pact of this pan­demic, we be­lieve that pric­ing remde­sivir well be­low value is the right and re­spon­si­ble thing to do.''

Gilead said it will have spent $1 bil­lion to de­velop and man­u­fac­turer remde­sivir by the end of 2020. Gilead in­vented the drug about 10 years ago when it was search­ing for treat­ments for hep­ati­tis C but did not de­velop it. Later, the drug’s po­ten­tial as an an­tivi­ral for emerg­ing dis­eases was ex­plored through a part­ner­ship with the gov­ern­ment. Tax­pay­ers spent at least $70 mil­lion de­vel­op­ing the drug, ac­cord­ing to ad­vo­cates.

An in­de­pen­dent anal­y­sis last week by the In­sti­tute for Clin­i­cal and Eco­nomic Re­view said Gilead could re­cover its costs by dis­tribut­ing the drug for as lit­tle as $1 to $60 per dose, or $100 to $160 per dose if all of the com­pany’s 2020 costs are taken into ac­count.

Un­der Mon­day’s pric­ing, Gilead set the price at $520 per dose in the United States and $390 per dose in other de­vel­oped coun­tries. Gilead said six doses are re­quired, while the U.S. De­part­ment of Health and Hu­man Ser­vices said it was us­ing an av­er­age of 6.25 vials in its es­ti­mated costs for hospi­tals.

Mem­bers of Congress and con­sumer ad­vo­cates raised con­cerns Mon­day that Gilead could be seek­ing to profit un­fairly on a tax­payer-backed in­ven­tion amid a pan­demic.

“We are in the midst of a full-blown global health cri­sis,” said Rep. Diana Degette (D- Colo.), who chairs the House En­ergy and Com­merce over­sight and in­ves­ti­ga­tions panel. “We need to make sure any treat­ment that has the po­ten­tial to save lives is avail­able to all those who need it, not just those who can af­ford it.”

Rep. Lloyd Doggett (D-tex.) said Gilead had set “an out­ra­geous price for a very mod­est drug, which tax­payer fund­ing saved from a scrapheap of fail­ures.” He crit­i­cized the Trump ad­min­is­tra­tion for not de­mand­ing a lower price in its con­tract for the first 500,000 cour­ses of treat­ment.

“Gilead has priced at sev­eral thou­sand dol­lars a drug that should be in the pub­lic do­main,” said Peter May­bar­duk, ac­cess to medicines di­rec­tor for the non­profit group Pub­lic Ci­ti­zen. “Gilead did not make remde­sivir alone. Pub­lic fund­ing was in­dis­pens­able at each stage, and gov­ern­ment sci­en­tists led the early drug dis­cov­ery team. Al­low­ing Gilead to set the terms dur­ing a pan­demic rep­re­sents a colos­sal fail­ure of lead­er­ship.”

HHS will dis­trib­ute the drug to state health de­part­ments based on the num­ber of hos­pi­tal­ized pa­tients with covid-19, the agency said. State health de­part­ments will then al­lo­cate the drug to hospi­tals based on need — the same process HHS em­ployed for a do­na­tion of 120,000 treat­ment cour­ses of the drug, whose fi­nal al­lo­ca­tion is be­ing shipped on Mon­day.

“To the ex­tent pos­si­ble, we want to en­sure that any Amer­i­can pa­tient who needs remde­sivir can get it,” HHS Sec­re­tary Alex Azar said in a state­ment.

De­mand for remde­sivir soared after the Na­tional In­sti­tutes of Health an­nounced on April 29 that a clin­i­cal trial had shown that hos­pi­tal­ized pa­tients with ad­vanced covid-19 who re­ceived the ex­per­i­men­tal drug recovered faster than sim­i­lar pa­tients who re­ceived a placebo. Two days later, the Food and Drug Ad­min­is­tra­tion, cit­ing those re­sults, ap­proved the drug to treat se­verely ill pa­tients.

Con­firmed coro­n­avirus cases have soared in re­cent weeks, and health of­fi­cials warned on Sunday that the win­dow was clos­ing to stop the spread of the virus. The num­ber of con­firmed cases sur­passed 2.5 mil­lion on Sunday as a crush­ing new wave of in­fec­tions con­tin­ued to bear down through­out the coun­try’s South and West. Across the na­tion, 40,587 new daily cases were re­ported.

Remde­sivir must be ad­min­is­tered in­tra­venously, which has lim­ited its use to hos­pi­tal­ized pa­tients with sig­nif­i­cant covid-19 pro­gres­sion. The com­pany is test­ing an in­haled form, which would al­low pa­tients to use it at home, ear­lier in the dis­ease, when it might have a greater ben­e­fit.

Mean­while, an in­ex­pen­sive steroid has been shown to have a greater ben­e­fit on the death rate for pa­tients in hospi­tals. The 60year-old drug, dex­am­etha­sone, re­duced the risk of death for pa­tients on ven­ti­la­tors by a third and cut the risk of death for pa­tients on oxy­gen by a fifth, ac­cord­ing to a study pub­lished in the Lancet on June 16.

AMR Ab­dal­lah Dalsh/reuters

Lab techs work on remde­sivir in Cairo last week. The drug has been found in a study to speed up hos­pi­tal re­cov­er­ies for covid-19 pa­tients.

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