Christine Wilson and Noah Phillips

Open sea­son on PBMs but FTC votes against dig­ging in­to their an­ti-com­pet­i­tive prac­tices fur­ther

The abus­es of phar­ma­cy ben­e­fit man­agers were on full dis­play Thurs­day but the Fed­er­al Trade Com­mis­sion failed in ad­vanc­ing a mo­tion (2-2) to study these phar­ma mid­dle­men in more depth, which could lead to wider in­ves­ti­ga­tions.

FTC com­mis­sion­ers Noah Phillips and Chris­tine Wil­son vot­ed against con­duct­ing an FTC study on PBMs, claim­ing that it was not de­signed to study the com­pet­i­tive ef­fects of the PBMs, and it’s not clear this study would re­veal any­thing about pa­tients’ out-of-pock­et costs, ac­cord­ing to Phillips.

Wil­son added that she does think it’s use­ful to look in­to man­u­fac­tur­er re­bates, and she’s con­fi­dent there can be a da­ta-dri­ven ap­proach. But she not­ed that many of com­plaints against PBMs “are base­less,” ac­cord­ing to the PBMs, and that the mid­dle­men have not im­pact­ed in­de­pen­dent phar­ma­cy mar­gins, and have not led to a de­crease in in­de­pen­dent phar­ma­cies.

Lina Khan

Mem­bers of Con­gress have in­tro­duced leg­is­la­tion to ex­am­ine the PBM in­dus­try, and “to be clear, I sup­port an FTC analy­sis of this in­dus­try,” Wil­son said. “If there’s an­ti-com­pet­i­tive con­duct, I want to know about it.” But she said it’s not the FTC’s role to pick win­ners and losers, and there needs to be an ob­jec­tive de­sign to the study to pro­duce a da­ta-dri­ven re­port.

Lament­ing the failed vote, FTC chair Lina Khan, who vot­ed in fa­vor of it, added, “We have a re­al moral im­per­a­tive to act, this in­quiry is long over­due.”

FTC com­mis­sion­er Re­bec­ca Slaugh­ter, who al­so vot­ed for the study, stressed that “there isn’t one per­fect PBM study, and let’s not make the per­fect the en­e­my of the very, very im­por­tant.”

“Two mem­bers of the FTC just let the worst ac­tors in the mar­ket off the hook. Af­ter hear­ing hours of tes­ti­mo­ny by com­mu­ni­ty phar­ma­cists and pa­tients, all of whom paint­ed the same shock­ing pic­ture about PBM abuse, and not a sin­gle wit­ness there to de­fend the PBM in­dus­try, it is in­ex­plic­a­ble that two mem­bers of the com­mis­sion could vote against the study. Their de­ci­sions could not pos­si­bly have been based on what was heard to­day,” B. Dou­glas Hoey, CEO of the Na­tion­al Com­mu­ni­ty Phar­ma­cists As­so­ci­a­tion, said in a state­ment.

A pair of House Re­pub­li­cans, Rep. Bud­dy Carter (GA), a phar­ma­cist, and Rep. John Rose (TN) kicked off the open pub­lic hear­ing pri­or to the vote, call­ing on the FTC to use its pow­ers to ob­tain new da­ta from PBMs, and shine a light on their abu­sive prac­tices.

Re­bec­ca Slaugh­ter

While rail­ing against the mid­dle­men for their “take-it-or-leave-it” ap­proach­es, the con­gress­men al­so called out the PBMs’ non-trans­par­ent fee in­creas­es that have dri­ven away com­mu­ni­ty phar­ma­cies.

Khan not­ed that she’s seen two ma­jor trends — pa­tients are pay­ing more for drugs, in­clud­ing the ones nec­es­sary for sur­vival, and in some cas­es are forced to ra­tion their med­i­cines. The oth­er trend is that small, lo­cal and fam­i­ly-owned phar­ma­cies have been van­ish­ing at a high rate, and these places can be in­sti­tu­tion­al for help­ing their com­mu­ni­ties and proved to be more nim­ble in vac­ci­nat­ing peo­ple in some cas­es dur­ing the pan­dem­ic, as with West Vir­ginia.

The FTC has re­ceived com­plaints that peo­ple are dri­ven to more ex­pen­sive drugs by PBMs too, es­pe­cial­ly with the rise of bi­o­log­ics, Khan not­ed.

The three largest PBMs — CVS Care­mark, Ex­press Scripts and Op­tum­Rx — dom­i­nate their com­pe­ti­tion, con­trol­ling al­most 80% of the PBM mar­ket, and en­gage in nu­mer­ous games to tilt the field to their ad­van­tage, such as by claw­ing back mon­ey af­ter drugs are dis­pensed, in­cen­tiviz­ing pa­tients to switch to their own spe­cial­ty phar­ma­cies, or to ma­nip­u­late prices to make more prof­its, those tes­ti­fy­ing claimed.

Lee Hertz

The Na­tion­al Com­mu­ni­ty Phar­ma­cists As­so­ci­a­tion raised con­cerns at Thurs­day’s hear­ing around how PBMs are both “ver­ti­cal­ly in­te­grat­ed up­stream with Aet­na, Cigna, Unit­ed­Health and the Blues and down­stream with phar­ma­cies,” which al­lows them to ex­ploit “their da­ta plat­forms to en­gage in myr­i­ad un­fair meth­ods of com­pe­ti­tion against phar­ma­cy com­peti­tors which re­sult in in­creased costs to pa­tients,” said NC­PA Gen­er­al Coun­sel Matt Seil­er.

Lee Hertz, di­rec­tor of an­a­lyt­ics at Quest An­a­lyt­ics Group, who works close­ly with PBMs and phar­ma­cies ex­plained to End­points News how PBMs are al­so us­ing “lim­it­ed dis­tri­b­u­tion” drugs that are a sub­set of these spe­cial­ty drugs, adding:

The idea be­hind them is that a pro­duc­er has not yet re­leased the item to broad dis­tri­b­u­tion and has ‘Se­lect­ed’ spe­cif­ic PBM spe­cial­ty phar­ma­cies to car­ry them. Then non-se­lect­ed PBMs have to pur­chase from those se­lect­ed. The price of the item may be high­er or low­er than oth­er spe­cial­ty items in nor­mal dis­tri­b­u­tion. Be­cause they are gen­er­al­ly new­er items, you could say they are ‘more ex­pen­sive.’ In most guar­an­teed price deals, LDD items are ex­empt from price dis­count and re­bate guar­an­tees. This clas­si­fi­ca­tion is of­ten ma­nip­u­lat­ed to af­fect the ag­gre­gate guar­an­tees of the agree­ment. Re­bates are the big is­sue. SRx [spe­cial­ty pre­scrip­tion] re­bates are get­ting close to [$]2,000 per brand script.

A rur­al New Mex­i­co phar­ma­cist al­so told the FTC that PBMs ma­nip­u­late pa­tient co-pays to make phar­ma­cies look like “bad guys” in ad­di­tion to of­fer­ing re­im­burse­ments that are so low it’s “out of con­trol.” Oth­ers tes­ti­fy­ing not­ed that they’re of­ten re­im­bursed less than what they paid for the med­ica­tion.

“PBMs at their worst take a sledge­ham­mer to pa­tients and drug prices,” an­oth­er phar­ma­cist said.

But the PBMs have got­ten so large that it re­mains un­known how like­ly it is, or how quick­ly they can be reigned in.

In the mean­time, phar­ma­cists’ hor­ror sto­ries with PBMs flood­ed the hear­ing.

A Sacra­men­to-based phar­ma­cist told the FTC that con­tracts with PBMs are not ne­go­tiable. Phar­ma­cies do not get any say in rates or fees, and for the pre­scrip­tions they do dis­pense, the claw­backs from PBMs are un­pre­dictable.

None of the com­ments in the open hear­ing came from PBMs or those ad­vo­cat­ing on be­half of the PBMs.

The Phar­ma­ceu­ti­cal Care Man­age­ment As­so­ci­a­tion, which rep­re­sents PBMs, did not re­lease a PR on the FTC vote but an­nounced a new ad cam­paign that “calls at­ten­tion to the work phar­ma­cy ben­e­fit man­agers, PBMs, do to pro­duce a seam­less ex­pe­ri­ence at the phar­ma­cy counter for pa­tients, while al­so work­ing to im­prove over­all health out­comes.”

2023 Spot­light on the Fu­ture of Drug De­vel­op­ment for Small and Mid-Sized Biotechs

In the context of today’s global economic environment, there is an increasing need to work smarter, faster and leaner across all facets of the life sciences industry.  This is particularly true for small and mid-sized biotech companies, many of which are facing declining valuations and competing for increasingly limited funding to propel their science forward.  It is important to recognize that within this framework, many of these smaller companies already find themselves resource-challenged to design and manage clinical studies themselves because they don’t have large teams or in-house experts in navigating the various aspects of the drug development journey. This can be particularly challenging for the most complex and difficult to treat diseases where no previous pathway exists and patients are urgently awaiting breakthroughs.

Christian Itin, Autolus CEO (UKBIO19)

Au­to­lus tips its hand, bags $220M as CAR-T show­down with Gilead looms

The first batch of pivotal data on Autolus Therapeutics’ CAR-T is in, and execs are ready to plot a path to market.

With an overall remission rate of 70% at the interim analysis featuring 50 patients, the results set the stage for a BLA filing by the end of 2023, said CEO Christian Itin.

Perhaps more importantly — given that Autolus’ drug, obe-cel, is going after an indication that Gilead’s Tecartus is already approved for — the biotech highlighted “encouraging safety data” in the trial, with a low percentage of patients experiencing severe immune responses.

Dipal Doshi, Entrada Therapeutics CEO

Ver­tex just found the next big ‘trans­for­ma­tive’ thing for the pipeline — at a biotech just down the street

Back in the summer of 2019, when I was covering Vertex’s executive chairman Jeff Leiden’s plans for the pipeline, I picked up on a distinct focus on myotonic dystrophy Type I, or DM1 — one of what Leiden called “two diseases (with DMD) we’re interested in and we continue to look for those assets.”

Today, Leiden’s successor at the helm of Vertex, CEO Reshma Kewalramani, is plunking down $250 million in cash to go the extra mile on DM1. The lion’s share of that is for the upfront, with a small reserve for equity in a deal that lines Vertex up with a neighbor in Seaport that has been rather quietly going at both of Vertex’s early disease targets with preclinical assets.

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Rami Elghandour, Arcellx CEO

Up­dat­ed: Gilead, Ar­cel­lx team up on an­ti-BC­MA CAR-T as biotech touts a 100% re­sponse rate at #ASH22

Gilead and Kite are plunking down big cash to get into the anti-BCMA CAR-T game.

The pair will shell out $225 million in cash upfront and $100 million in equity to Arcellx, Kite announced Friday morning, to develop the biotech’s lead CAR-T program together. Kite will handle commercialization and co-development with Arcellx, and profits in the US will be split 50-50.

Concurrent with the deal, Arcellx revealed its latest cut of data for the program known as CART-ddBCMA, ahead of a full presentation at this weekend’s ASH conference — a 100% response rate among patients getting the therapy. Investors jumped at the dual announcements, sending Arcellx shares $ACLX up more than 25% in Friday’s morning session.

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WIB22: Am­ber Salz­man had few op­tions when her son was di­ag­nosed with a rare ge­net­ic dis­ease. So she cre­at­ed a bet­ter one

This profile is part of Endpoints News’ 2022 special report about Women in Biopharma R&D. You can read the full report here.

Amber Salzman’s life changed on a cold, damp day in Paris over tiny plastic cups of lukewarm tea.

She was meeting with Patrick Aubourg, a French neurologist studying adrenoleukodystrophy, or ALD, a rare genetic condition that causes rapid neurological decline in young boys. It’s a sinister disease that often leads to disability or death within just a few years. Salzman’s nephew was diagnosed at just 6 or 7 years old, and died at the age of 12.

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Ahead of ad­comm, FDA rais­es un­cer­tain­ties on ben­e­fit-risk pro­file of Cy­to­ki­net­ic­s' po­ten­tial heart drug

The FDA’s Cardiovascular and Renal Drugs Advisory Committee will meet next Tuesday to discuss whether Cytokinetics’ potential heart drug can safely reduce the risk of cardiovascular death and heart failure in patients with symptomatic chronic heart failure with reduced ejection fraction.

The drug, known as omecamtiv mecarbil and in development for more than 15 years, has seen mixed results, with a first Phase III readout from November 2020 hitting the primary endpoint of reducing the odds of hospitalization or other urgent care for heart failure by 8%. But it also missed a key secondary endpoint analysts had pegged as key to breaking into the market.

Ab­b­Vie slapped with age dis­crim­i­na­tion law­suit, fol­low­ing oth­er phar­mas

Add AbbVie to the list of pharma companies currently facing age discrimination allegations.

Pennsylvania resident Thomas Hesch filed suit against AbbVie on Wednesday, accusing the company of passing him over for promotions in favor of younger candidates.

Despite 30 years of pharma experience, “Hesch has consistently seen younger, less qualified employees promoted over him,” the complaint states.

Scoop: Gilead ter­mi­nates ear­ly-stage FLT3 tri­al in sol­id tu­mors

Gilead chopped a Phase Ib dose escalation study in recent days, with an update to the federal trials database saying the premature termination followed an “internal safety assessment.”

The IV-administered FLT3 agonist, dubbed GS-3583, was being tested as a monotherapy in 13 patients with advanced solid tumors. The goal of the trial was to find out what dose to test in a Phase II, or maximum tolerated dose.

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Susan Galbraith, AstraZeneca EVP, oncology R&D, at EUBIO22 (Rachel Kiki for Endpoints News)

As­traZeneca’s Su­san Gal­braith high­lights twin wins for the can­cer drug pipeline at SABCS, as oral SERD ex­cels

It’s a good time to be the head of R&D for oncology at AstraZeneca. And no one gets that quite like Susan Galbraith.

Today, Galbraith is at the San Antonio Breast Cancer Symposium, highlighting the data on two key drugs in the cancer pipeline: mid-stage results for its oral SERD camizestrant among patients after one line of therapy, and the AKT drug capivasertib, wrapping the Phase III. Both fall neatly into the range of successes, beating out fulvestrant in hormone receptor-positive, HER2-negative breast cancer.

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