Scott Selman, his wife and their restaurant, Club Paris

Covid vac­cines and drugs are free. But for many im­muno­com­pro­mised pa­tients, pro­tec­tion comes at a cost

To tell the truth, Scott Sel­man didn’t mind the pan­dem­ic at the be­gin­ning. He was a soli­tary man who spent his week­ends on home con­struc­tion and gar­den­ing projects, and his week­days at the An­chor­age steak­house his fam­i­ly had owned for three gen­er­a­tions. Al­ways the kitchen and his back of­fice; he could nev­er back­slap and chitchat with the pa­trons like his broth­er, the face of the busi­ness.

He had plen­ty of ex­pe­ri­ence with even greater iso­la­tion. In 2011, Sel­man un­der­went a dou­ble-lung trans­plant af­ter a hered­i­tary dis­ease de­stroyed his own. The im­muno­sup­pres­sants he took to pre­vent re­jec­tion al­so meant he had to wear masks and avoid crowd­ed ar­eas.

When the lock­downs start­ed, “it was like wel­come to the club, every­body,” Sel­man said. “I did the best I could. I’m not a re­al peo­ple per­son any­way, so I didn’t have any, like, emo­tion­al detri­ments.”

But then the pan­dem­ic kept drag­ging. The first waves ebbed, on­ly to give way to Delta, which re­ced­ed in­to Omi­cron. Vac­cines brought lit­tle re­lief. The same im­muno­sup­pres­sants that kept his im­mune sys­tem from de­stroy­ing his lungs al­so kept it from re­spond­ing prop­er­ly to vac­cines.

“Sud­den­ly Omi­cron (came) and it’s su­per con­ta­gious,” he said. “I start­ed get­ting a lit­tle wor­ried.”

So he was ex­cit­ed when his trans­plant team at the Uni­ver­si­ty of Wash­ing­ton called and told him there was a new drug avail­able that might pro­tect him and oth­er im­muno­com­pro­mised against the virus. They just didn’t men­tion how hard it would be to find a dose, how much it would cost, or how head-scratch­ing strange the en­tire thing would be.

“That was the weird­est thing,” Sel­man said af­ter­wards. “And it gets even weird­er.”’

Pro­tec­tion at a cost

For most Amer­i­cans, pro­tec­tion from Covid-19 came free of charge. It was a rare bright spot in Amer­i­ca’s fail­ure-rid­den pan­dem­ic re­sponse: HHS bankrolled the de­vel­op­ment of the coro­n­avirus shots and made them free to every US res­i­dent, ex­pend­ing mil­lions to set up vac­ci­na­tion sites and con­duct out­reach.

But for around 3% of Amer­i­cans, those vac­cines don’t quite work. Sev­en mil­lion Amer­i­cans have ge­net­ic con­di­tions or take can­cer, trans­plant or oth­er drugs that sup­press their im­mune sys­tem. They might get some pro­tec­tion from a shot, or none at all.

Many have spent the past year turn­ing their arms in­to pin-cush­ions, col­lect­ing up to five or more jabs in hopes the next one will fi­nal­ly boost their an­ti­body lev­els. (Of­fi­cial­ly, up to four shots are now au­tho­rized for this group.)

The Trump and Biden White House had a plan for these pa­tients: Evusheld. De­vel­oped by As­traZeneca and backed with over $1.57 bil­lion in HHS funds, Evusheld is sim­i­lar to an­ti­body drugs used to treat Covid-19 but with one tweak: It’s en­gi­neered to stay in the body for around 6 months, mean­ing it could pro­vide long-term pro­tec­tion from the virus.

Af­ter sev­er­al stud­ies, Evusheld was fi­nal­ly au­tho­rized in De­cem­ber. For a sub­set of pa­tients, it rep­re­sent­ed pan­dem­ic de­liv­er­ance.

“I kind of nev­er got to leave my house since my trans­plant,” said Jul­lie Hog­gan, a speech ther­a­pist in the Las Ve­gas sub­urbs who got a kid­ney trans­plant in Jan­u­ary 2020. “Once Evusheld came out, you know, I was hop­ing to get that.”

Like many, though, Hog­gan dis­cov­ered the drug was not easy to find. The gov­ern­ment did not set up a clear na­tion­al dis­tri­b­u­tion plan, as it had with vac­cines. Some med­ical cen­ters got it, oth­ers didn’t. Some, es­pe­cial­ly large trans­plant cen­ters, got it but lim­it­ed ac­cess to on­ly a small sub­set of pa­tients. Some got it but the doc­tors, nurs­es or ad­min­is­tra­tors whom pa­tients called didn’t know and turned them away.

Hog­gan called clin­ics for days search­ing for dos­es for both her­self and a small Face­book group of im­muno­com­pro­mised lo­cals. She was ec­sta­t­ic when one woman fi­nal­ly called back and left a voice­mail say­ing her of­fice had spare dos­es — un­til Hog­gan phoned her and learned how much it would cost: $1,000.

The nurse said “‘We’re hap­py to do it. We’re ready to do it. It’ll be $1,000-a-per­son. Cash,’” Hog­gan re­called. “I was like, Holy crap. And I said that’s an aw­ful lot of mon­ey for a drug that’s sup­posed to be free.”

Hog­gan wasn’t alone. Un­like with vac­cines, the gov­ern­ment doesn’t pay for the cost of ad­min­is­ter­ing Evusheld, on­ly the cost of the drug it­self. That means the im­muno­com­pro­mised can be on the hook for con­sul­ta­tions, fa­cil­i­ty fees and oth­er com­mon hos­pi­tal charges when they get their shot.

Medicare will usu­al­ly cov­er these costs, and there’s a fed­er­al fund for the unin­sured. But pa­tients with pri­vate in­sur­ance can face a wide range of dif­fer­ent fees.

Evusheld’s un­even dis­tri­b­u­tion has on­ly com­pound­ed the is­sue. Be­cause some re­gions have no avail­abil­i­ty and oth­er have sur­plus­es, pa­tients have dri­ven hours over city or even state lines to get dos­es in places that don’t take their in­sur­ance, ac­cru­ing trav­el bills and larg­er med­ical costs.

“Many peo­ple are hav­ing to go out of net­work,” said Rob Re­lyea, a Mi­crosoft en­gi­neer who set up a web­site to track Evusheld dos­es af­ter his own wife, a can­cer pa­tient who had re­ceived B-cell de­plet­ing treat­ment, strug­gled to get ac­cess.

Or they’ve turned to places that don’t take in­sur­ance at all. The nurse that called Hog­gan worked for the lo­cal branch of Concierge MD, a na­tion­al chain of concierge clin­ics that ad­ver­tis­es $999 for Evusheld on its site. Abe Malkin, founder of the chain, de­fend­ed the price, not­ing they of­fer at-home ser­vice and that a nurse has to stay for an hour to watch for ad­verse re­ac­tions, as the FDA rec­om­mends. He added they have since low­ered the price to $799.

“Some of our pa­tients are home-bound, it’s risky for them to trav­el,” he said. “So they’re will­ing to pay a pre­mi­um for them to re­ceive care at home.”

Re­na Con­ti

It’s im­pos­si­ble to tell how com­mon these charges are. Re­na Con­ti, who stud­ies drug and health­care pol­i­cy at Boston Uni­ver­si­ty, said Evusheld and oth­er an­ti­bod­ies have not been on the mar­ket long enough to gen­er­ate that da­ta. But ear­ly work sug­gests the out-of-pock­et costs may be “quite sig­nif­i­cant,” she said.

A woman with a rare kid­ney dis­ease in Los An­ge­les told End­points News she was charged $1,100 for her dose, most of it for a 10 to 15-minute physi­cian con­sult. A trans­plant pa­tient in Vir­ginia said her in­sur­ance was billed $1,100 for her shot, $296 of which they had to pay. Michelle Fontenot, a trans­plant pa­tient in Illi­nois was giv­en an es­ti­mate of $2,890 from one lo­cal hos­pi­tal be­fore get­ting the drug else­where, where she was giv­en a $400 es­ti­mate. (For every pa­tient in this sto­ry, End­points re­viewed copies of med­ical bills and oth­er billing doc­u­ments.)

The prob­lem got worse last month when the FDA rec­om­mend­ed dou­bling the dose of Evusheld, forc­ing many pa­tients to make a sec­ond vis­it. Lisa Brooks, who has an im­mun­od­e­fi­cien­cy dis­ease, paid $250 cash at a clin­ic in Cal­i­for­nia for a first dose. For a sec­ond, she was ini­tial­ly billed $4,549 by Stan­ford Health Care. She would have had to pay just over $1,000 her­self, be­tween what was left of her de­ductible and what was not cov­ered by in­sur­ance.

Af­ter call­ing mul­ti­ple times, she said they low­ered it to $3,069, adding there was an er­ro­neous charge and that they nev­er ac­tu­al­ly in­tend­ed to have her pay any por­tion of the bill. Brooks has worked for med­ical com­pa­nies, and wor­ries about pa­tients with less ex­pe­ri­ence nav­i­gat­ing the sys­tem.

“I’m for­tu­nate to know what I’m do­ing and I’m wor­ried about all the peo­ple that don’t have my ex­pe­ri­ence,” she said. (Stan­ford de­clined to com­ment, cit­ing pa­tient con­fi­den­tial­i­ty.)

Part of the prob­lem, Con­ti ar­gued, is that the US fo­cused all its ef­forts in 2021 on get­ting as many peo­ple vac­ci­nat­ed as pos­si­ble. And in the­o­ry, mak­ing treat­ments free can ac­tu­al­ly dis­in­cen­tivize vac­ci­na­tion.

“It was like yet an­oth­er in­cen­tive to go out and get vac­ci­nat­ed — the po­ten­tial threat of hav­ing very sig­nif­i­cant out-of-pock­et costs,” she said.

Many im­muno­com­pro­mised peo­ple are vac­ci­nat­ed, though. It just didn’t work. They ar­gue the cur­rent fed­er­al pol­i­cy means they’re pay­ing hun­dreds of dol­lars for pro­tec­tion oth­er Amer­i­cans got for free. And they won­der about oth­er im­muno­com­pro­mised peo­ple who don’t have the re­sources to jump through the hoops they did.

“Can you imag­ine if every­one in the coun­try had to pay hun­dreds of dol­lars for a vac­cine?” said the Vir­ginia woman, who asked to re­main anony­mous to avoid up­set­ting her trans­plant team. “It’s re­al­ly the dis­par­i­ty, every im­muno­com­pe­tent per­son gets their pro­tec­tion for free. And I just can’t tell you how pissed off every­one is.”

‘I feel des­per­a­tion’

Sel­man’s trans­plant team was in Seat­tle, so they sug­gest­ed he look on a gov­ern­ment web­site for lo­ca­tions in Alas­ka with dos­es. But on­ly one lo­ca­tion showed up in all of Alas­ka, and it was in Juneau, a city 500 miles away, ac­ces­si­ble on­ly by fer­ry or plane.

He called around, and even­tu­al­ly, a state health of­fi­cial told him there was a site in An­chor­age, a clin­ic called We­ka. Sel­man had nev­er heard of it and the web­site said lit­tle about Evusheld, but his doc­tors told him he need­ed it. So he called and made an ap­point­ment for 10 am the next day.

He pulled up not to a doc­tor’s of­fice, but to the wide-open park­ing lot of a shut-down ho­tel. When he walked in­side, there was a reg­is­tra­tion sign above the check-in desk and signs of­fer­ing var­i­ous treat­ments out­side the guest rooms. A re­cep­tion­ist took down his in­for­ma­tion and told him he would have to pay $550 by cred­it card be­fore he could even be treat­ed. They would then bill his in­sur­ance an­oth­er $950, she ex­plained, and if in­sur­ance didn’t cov­er it, he would have to.

Sel­man thought it sound­ed bizarre — thought the whole thing was bizarre, from the re­pur­posed ho­tel to the up­front cost, to the mys­te­ri­ous ab­sence from the site — but felt he didn’t have a choice but to hand them his Visa. 

“I’m ex­treme­ly sus­cep­ti­ble. I feel des­per­a­tion,” he re­called. “My team said I need to get this. I want to get it be­cause I had ex­haust­ed all my oth­er re­sources and the state has sent me there, so okay.”

Then things got stranger, Sel­man said. Evusheld is au­tho­rized as two shots in the hip, but a nurse gave him the an­ti­body by IV in­fu­sion. Sel­man, def­er­en­tial to doc­tors since they saved his life a decade pri­or, said noth­ing. But af­ter­ward, he said, his trans­plant team called and rep­ri­mand­ed We­ka, who said they hadn’t known and rec­om­mend­ed Sel­man come back in 45 days.

Just weeks lat­er, though, he got a call from a state of­fi­cial say­ing that We­ka had shut down. The of­fi­cial point­ed him to a site at a near­by mall, where he was giv­en the an­ti­body prop­er­ly free of charge. He nev­er heard from We­ka for the $950, but they al­so nev­er re­fund­ed the $550 charge.

A spokesper­son for As­traZeneca said it was “con­cern­ing” that the clin­ic ad­min­is­tered the drug by IV and re­ferred Sel­man’s case to the med­ical af­fairs team for in­ves­ti­ga­tion.

We­ka CEO Crys­tal Her­ring de­clined to dis­cuss We­ka’s pric­ing poli­cies or Sel­man’s case, cit­ing pa­tient con­fi­den­tial­i­ty, even though Sel­man au­tho­rized the com­pa­ny to do so.

She said We­ka would con­duct a re­view of its Evusheld ad­min­is­tra­tion, adding that the com­pa­ny was asked by Alaskan of­fi­cials to set up the site as the Delta wave strained lo­cal hos­pi­tals, forc­ing the com­pa­ny to ramp up and treat many pa­tients in a short pe­ri­od of time. She said they closed in Feb­ru­ary be­cause of dwin­dling de­mand.

“WE­KA was not aware of the po­ten­tial of any billing or treat­ment dis­crep­an­cy of the na­ture de­scribed in your in­quiry,” she said in an email. “How­ev­er, due to the large vol­ume of pa­tients/pro­ce­dures in a short pe­ri­od of time and the tran­si­tion of op­er­a­tions and per­son­nel, it is pos­si­ble that in­for­ma­tion rel­a­tive to said raised con­cerns had not yet reached WE­KA man­age­ment for pro­cess­ing.” A spokesper­son for the Alas­ka De­part­ment of Health did not re­spond to re­peat­ed re­quests for com­ment.

Al­though a pos­si­ble out­lier, Sel­man is not alone, at least when it comes to steep charges. Last month, Derek Eis­nor, a med­ical of­fi­cer at HHS, said on a call with state pub­lic health agen­cies that they had re­ceived re­ports of places “charg­ing sev­er­al thou­sand dol­lars” for var­i­ous an­ti­body drugs.

“Ob­vi­ous­ly, this would be in vi­o­la­tion of our plan­ning pri­or­i­ties,” he said, “which again is to main­tain eq­ui­table ac­cess of all pro­cured ther­a­peu­tics for all Amer­i­cans, re­gard­less of their abil­i­ty to pay.”

Sel­man’s steak­house, Club Paris, held up through the pan­dem­ic well, bol­stered in part by a pair of PPP loans. Lo­cals still come in at night for the pe­tite filet and king crab com­bo, the restau­rant’s spe­cial, as­sured that be­cause it’s Sel­man’s place, the restau­rant is tak­ing the prop­er pre­cau­tions. He was able to weath­er the charges. But life still feels un­cer­tain.

“Every­thing is shift­ing sand. And when you’re im­muno­com­pro­mised, it’s not just in­con­ve­nient,” he said. “It could be death.“

‘We want to get them to you’

Not every state has had a mas­sive scram­ble for Evusheld. Af­ter Hog­gan, the Neva­da trans­plant pa­tient re­ceived the call ask­ing for $1,000 per dose, she wrote an an­gry let­ter to the state health de­part­ment, ask­ing why the drug wasn’t more wide­ly avail­able. To her sur­prise, she got a call just four days lat­er.

“We want to get them to you,” Dave Wuest, ex­ec­u­tive sec­re­tary of the Neva­da Board of Phar­ma­cy, told her. “We just don’t know how to find you.”

With $19 mil­lion in Covid-19 re­lief funds, Wuest and oth­ers soon set up a sys­tem to reach pa­tients like Hog­gan. Any Nevadan can now call a num­ber and be screened for el­i­gi­bil­i­ty for Evusheld or oth­er Covid-19 ther­a­peu­tics and di­rect­ed to a treat­ment site. All costs are cov­ered by the state, in­clud­ing house vis­its for home­bound res­i­dents. Hun­dreds of peo­ple have got­ten Evusheld through the sys­tem, Wuest told End­points.

That in­cludes Hog­gan and her Face­book group. “This is how states should be do­ing it,” she said.

Na­tion­al­ly, though, there’s been lit­tle sign of im­prove­ment. Con­ti, the BU pro­fes­sor, said Con­gress could elim­i­nate the ad­min­is­tra­tive costs pa­tients face by adding it to a list of pre­ven­ta­tive treat­ments that pri­vate in­sur­ers can’t charge for, such as flu shots.

But there’s been no move­ment yet to do so. On the con­trary, Con­gress has stalled on fund­ing on new coro­n­avirus treat­ments, and Biden of­fi­cials now warn they could run out of funds to buy more Evusheld dos­es. Soon, there might not be dos­es even for those who can af­ford to pay.

“I have hopes things are im­prov­ing, but not fast enough,” said Re­lyea, the Mi­crosoft en­gi­neer track­ing Evusheld dos­es. “This should be treat­ed with the same ur­gency as the vac­cine wave.”

The Big Phar­ma dis­card pile; Lay­offs all around while some biotechs bid farewell; New Roche CEO as­sem­bles top team; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

With earnings seasons in full swing, we’ve listened in on all the calls so you don’t have to. But news is popping up from all corners, so make sure you check out our other updates, too.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 158,500+ biopharma pros reading Endpoints daily — and it's free.

Sen. Ron Wyden (D-OR) (Francis Chung/E&E News/Politico via AP Images)

In­fla­tion re­bates in­com­ing: Wyden calls on CMS to move quick­ly as No­var­tis CEO pledges re­ver­sal

Senate Finance Chair Ron Wyden (D-OR) this week sent a letter to the head of the Centers for Medicare & Medicaid Services seeking an update on how and when new inflation-linked rebates will take effect for drugs that see major price spikes.

The newly signed Inflation Reduction Act requires manufacturers to pay a rebate to Medicare when they increase drug prices faster than the rate of inflation.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 158,500+ biopharma pros reading Endpoints daily — and it's free.

Trodelvy notch­es a win in most com­mon form of breast can­cer

Following a promise last year to go “big and fast in breast cancer,” Gilead has secured a win for Trodelvy in the most common form.

The drug was approved to treat HR-positive, HER2-negative breast cancer patients who’ve already received endocrine-based therapy and at least two other systemic therapies for metastatic cancer, Gilead announced on Friday.

Trodelvy won its first indication in metastatic triple-negative breast cancer back in 2020, and has since added urothelial cancer to the list. HR-positive HER2-negative breast cancer accounts for roughly 70% of new breast cancer cases worldwide per year, according to senior VP of oncology clinical development Bill Grossman, and many patients develop resistance to endocrine-based therapies or worsen on chemotherapy.

Raymond Stevens, Structure Therapeutics CEO

Be­hind Fri­day's $161M IPO: A star sci­en­tist, GPCR drug dis­cov­ery and a plan to chal­lenge phar­ma in di­a­betes

What does it take to pull off a $161 million biotech IPO these days?

In Structure Therapeutics’ case, it means having a star scientist co-founder paired with the computational drug discovery company Schrödinger, $198 million in private funding from blue-chip investors, almost six years of research work on G protein-coupled receptors and a slate of oral, small-molecule drugs, with an eye on the huge and growing diabetes and weight-loss market.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 158,500+ biopharma pros reading Endpoints daily — and it's free.

Af­ter 13 years, Ramy Mah­moud steps in­to CEO seat at Opti­nose; Ru­pert Vessey set to ex­it Bris­tol My­ers in Ju­ly

After 13 years as president and COO at Optinose, Ramy Mahmoud has stepped into a new role as its CEO. He is taking the place of Peter Miller, who stepped down earlier this week, though Miller is still staying with the company as a consultant.

In 2010, the two business partners joined Optinose to take it in a new direction, transforming it from a delivery platform to product company. They previously worked together at Johnson & Johnson, when Miller was president at Janssen and Mahmoud headed medical affairs. Miller said after he learned about Optinose, “I did what I always do, which is find people smarter than me to talk with about the idea. And the first person I called was Ramy … and I said, ‘Hey, Ramy, what do you think of this technology?’”

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 158,500+ biopharma pros reading Endpoints daily — and it's free.

Photo: Julia Weeks/AP Images

FDA ax­es re­quire­ment for pos­i­tive Covid test be­fore Paxlovid use

FDA announced today that doctors and pharmacists can now prescribe Paxlovid to patients without a positive test for Covid-19.

CDER Director Patrizia Cavazzoni reissued Paxlovid’s authorization letter Wednesday, saying it has revised the authorization to “no longer require positive results of direct SARS-CoV-2 viral testing.” The EUA now requires instead that adults and kids 12 years of age and older have a “current diagnosis of mild-to-moderate COVID-19.”

Te­va drops out of in­dus­try trade group PhRMA

Following in AbbVie’s footsteps, Teva confirmed on Friday that it’s dropping out of the industry trade group Pharmaceutical Research and Manufacturers of America (PhRMA).

Teva didn’t give a reason for its decision to leave, saying only in a statement to Endpoints News that it annually reviews “effectiveness and value of engagements, consultants and memberships to ensure our investments are properly seated.”

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 158,500+ biopharma pros reading Endpoints daily — and it's free.

Sanofi CFO Jean-Baptiste de Chatillon (L) and CEO Paul Hudson (Romuald Meigneux/Sipa via AP Images)

Sanofi sees downtick in flu sales as it preps for launch of RSV an­ti­body

Sanofi expects its RSV antibody jointly developed with AstraZeneca will be available next season, executive VP of vaccines Thomas Triomphe announced on the company’s quarterly call.

Beyfortus, also known as nirsevimab, was approved in the EU back in November and is currently under FDA review with an expected decision coming in the third quarter of this year. The news comes as the FDA plans to hold advisory committee meetings over the next couple months to review RSV vaccines from Pfizer and GSK.

Christophe Weber, Takeda CEO (Photographer: Shoko Takayasu/Bloomberg via Getty Images)

Take­da fo­cus­es on ‘di­verse’ pipeline prospects on heels of two ac­qui­si­tions

After a whopping $4 billion asset buy from Nimbus Therapeutics, along with a $400 million deal with Hutchmed for a colorectal cancer drug, Takeda executives touted pipeline optimism on its latest earnings call this week.

That’s because the TYK2 inhibitor for psoriasis Takeda is getting from Nimbus, along with the Hutchmed fruquintinib commercialization outside of China, are just two of what it reports are 10 late-stage development programs of promising candidates.