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.”

Bio­mark­er 'roadmap­s' and the fu­ture of can­cer R&D; Cur­tain rais­es on #AS­CO22; Pfiz­er, No­var­tis tack­le drug ac­cess; 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.

While this was not a week for earth-shattering news, there were certainly a lot of interesting tidbits. If you found this recap helpful, please recommend it to your friends and colleagues. We’ll see you on the other side of the long weekend.

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Keep­ing pres­sure on Am­gen, Mi­rati draws mixed re­views on lat­est cut of KRAS da­ta

As the close runner-up to Amgen’s Lumakras in the KRAS race, any data cut from Mirati’s adagrasib continues to draw scrutiny from analysts. And the latest batch of numbers from ASCO is a decidedly mixed bag.

While a quick comparison suggests that adagrasib spurred slightly more responses and led to a longer overall survival than Lumakras among a group of non-small cell lung cancer patients, its duration of response appears shorter and the safety profile continues to spark concern.

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Switzer­land to de­stroy over 600,000 ex­pired dos­es of Mod­er­na Covid vac­cine

As concerns related to uptake and distribution continue to linger, Switzerland is among the first countries that plans to destroy hundreds of thousands of expired and unused Covid-19 vaccine doses.

The European country said it plans to destroy more than 600,000 doses of Moderna’s Spikevax Covid-19 vaccine as the doses have reached their expiration date.

However, Moderna CEO Stéphane Bancel told the World Economic Forum in Davos, Switzerland that he’s in the process of throwing 30 million doses in the garbage, exclaiming, “We have a big demand problem.”

Ann is one of ViiV Healthcare's newest spokespeople as the retired school administrator speaks up about her HIV status.

GSK's Vi­iV de­buts next evo­lu­tion in HIV med Dova­to cam­paign with new spokes­peo­ple and new mes­sage

When Ann saw the first TV commercials for HIV medicine Dovato, she didn’t see herself represented. So the 74-year-old retired school administrator who’s been living with HIV since 1998, reached out to GSK’s ViiV Healthcare and asked why not?

Now Ann is one of three people starring in ViiV’s latest Dovato campaign called “Detect This.” The next-step evolution in the branded campaign plays on the word “detect” — often used in describing HIV status under control as undetectable — but in this case, uses the word as a directive for people to understand they can use fewer medicines.

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Tran­si­tion to new Eu­ro­pean clin­i­cal tri­als in­fo sys­tem starts slow­ly

At the end of January, the European Medicines Agency officially launched its new clinical trials info system (CTIS), although the migration to the new platform has only really just begun, and sponsors have until the end of January 2023 before all initial trial applications must be submitted through CTIS.

Overall, 56 clinical trial applications have been submitted in CTIS during the first 3 months since the launch of the system on Jan. 31, according to new data posted by the EMA. By comparison, about 4,000 new trials are authorized each year across Europe.

Covid-19 roundup: CDC study shows good pro­tec­tion from mR­NA boost­er plus J&J's sin­gle-dose vac­cine; White House launch­es test-to-treat Paxlovid site

Concerns about rare but life-threatening blood clots have limited the use of J&J’s Covid-19 vaccine — once pitched as the only one-shot option in the mix — with the FDA cutting it off except in limited circumstances. Yet there’s some good news for those who did receive it: A single booster dose of an mRNA vaccine for recipients of a single priming dose of Ad26.COV2.S (the J&J vaccine) provided protection close to that of a three-dose mRNA vaccine regimen.

Nassim Usman, Catalyst Biosciences CEO

Af­ter $60M Ver­tex deal, group of Cat­a­lyst share­hold­ers claims biotech could’ve sold as­sets three years ago

Catalyst Biosciences was down to five employees in March, and the biotech needed to do something after two rounds of layoffs, a nixed collaboration and a culling of its hemophilia program.

In came Vertex, with $60 million to buy up the South San Francisco biotech’s preclinical complement drugs, which target the system that bridges the body’s innate and adaptive immune response and a class most known for Ultomiris and Soliris. The deal includes CB 2782-PEG, the dry AMD drug that Biogen no longer wanted in March.

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Lina Khan, FTC chair (Graeme Jennings/Pool via AP Images)

Pile-on over PBMs con­tin­ues with FTC com­ments and a new bi­par­ti­san Sen­ate bill

More than 500 stakeholders sent comments to the FTC on whether the commission should look further into pharma middlemen, known as PBMs, with many of the commenters calling for more federal oversight.

Similar to the critical open comment period in a deadlocked FTC session last February, pharmacies and pharmacy groups are continuing to call out the lack of transparency among the top 3 PBMs, which control about 80% of the market.

Pharma brands are losing their shine with US consumers who are now thinking about the economy and inflation instead of Covid. (Credit: Shutterstock)

Phar­ma brands fade in an­nu­al Har­ris con­sumer vis­i­bil­i­ty poll: Mod­er­na drops off and Pfiz­er dips

As Covid-19 concerns are fading in the US, so is biopharma visibility. The annual Axios Harris Poll survey to determine and rank the 100 most top-of-mind brands in the US finds Moderna, which was No. 3 last year, not on the list at all for 2022, and Pfizer sinking 37 spots.

However, it’s not that Moderna or Pfizer did anything wrong, it’s just that Americans have moved on to other worries beyond Covid.

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