Lina Khan (Saul Loeb/Pool via AP)

FTC wants to know: How are PBMs af­fect­ing drug af­ford­abil­i­ty and ac­cess?

Fol­low­ing the Fed­er­al Trade Com­mis­sion’s de­ci­sion to not, at least ini­tial­ly, dig deep­er in­to phar­ma mid­dle­men known as PBMs, the com­mis­sion is now seek­ing com­ments on ways that these mas­sive, ver­ti­cal­ly in­te­grat­ed PBMs are af­fect­ing drug af­ford­abil­i­ty and ac­cess.

PBMs — led by the big 3 of Unit­ed­Health’s Op­tum­Rx, CVS Care­mark, and Cigna’s Ex­press Scripts con­trol­ling al­most 80% of the mar­ket — gen­er­al­ly make their mon­ey by man­ag­ing pre­scrip­tion drug ben­e­fits on be­half of pri­vate health in­sur­ers, Medicare Part D drug plans, large em­ploy­ers, and oth­er pay­ers. But the PBMs al­so fig­ure out ways to tilt the mar­ket in their fa­vor, as the FTC not­ed how the largest PBMs are ver­ti­cal­ly in­te­grat­ed with health in­sur­ance com­pa­nies and spe­cial­ty phar­ma­cies, “giv­ing them fi­nan­cial in­cen­tives to steer pa­tients to use their af­fil­i­at­ed ser­vices.”

The FTC says it’s con­tin­u­ing to look in­to a va­ri­ety of PBM busi­ness prac­tices, among them whether pa­tients are be­ing forced to sub­sti­tute dif­fer­ent pre­scrip­tion drugs to max­i­mize PBM re­bates and fees, or steered away from un­af­fil­i­at­ed phar­ma­cies and meth­ods of dis­tri­b­u­tion and to­ward PBM-af­fil­i­at­ed spe­cial­ty, mail-or­der, and re­tail phar­ma­cies.

For ex­am­ple, Janssen’s metasta­t­ic prostate can­cer drug Zyti­ga (abi­raterone or Xyti­ga) costs $10,000 as a brand name drug, but came to mar­ket in 2019 as a $450 gener­ic. Still, some health plans and PBMs on­ly cov­er the brand name ver­sion, or in some cas­es, tak­ing the gener­ic would be sig­nif­i­cant­ly more ex­pen­sive than tak­ing the brand.

While not­ing that many in­de­pen­dent phar­ma­cies com­ment­ed at the pri­or FTC hear­ing about how PBM con­trac­tu­al terms are con­fus­ing, un­fair, opaque, and ar­bi­trary, FTC staff are al­so look­ing in­to:

  • The im­pact of PBM re­bates and fees on net drug prices to pa­tients, em­ploy­ers, and oth­er pay­ers, as well as for­mu­la­ry de­sign and pa­tients’ abil­i­ty to ac­cess drugs.
  • PBMs’ use of po­ten­tial­ly un­fair, de­cep­tive, or an­ti­com­pet­i­tive con­tract terms and all re­lat­ed prac­tices when cal­cu­lat­ing phar­ma­cy re­im­burse­ments and dis­burse­ments.
  • PBMs’ use of oth­er po­ten­tial­ly un­fair, de­cep­tive, or an­ti­com­pet­i­tive prac­tices, in­clud­ing au­dit pro­vi­sions; phar­ma­cy net­work de­sign and ex­clu­sions; use of gag claus­es, con­fi­den­tial­i­ty claus­es, and non-dis­par­age­ment claus­es; and oth­er po­ten­tial­ly un­fair pro­vi­sions.
  • Po­ten­tial con­flicts of in­ter­est and an­ti­com­pet­i­tive ef­fects aris­ing from hor­i­zon­tal and ver­ti­cal con­sol­i­da­tion of PBMs with in­sur­ance com­pa­nies, spe­cial­ty phar­ma­cies, and providers.

“The Re­quest for In­for­ma­tion will en­able agency staff to study a wide ar­ray of PBM busi­ness prac­tices and is­sues and will help in­form the agency’s pol­i­cy and en­force­ment work,” the FTC said, not­ing that the com­ment pe­ri­od will be open un­til April 25.

On the Con­gres­sion­al end, drug pric­ing and PBM re­forms have gen­er­al­ly stalled out­side of a sin­gle pro­vi­sion to add a $35 cap on co-pays for in­sulin.

In­sulin has been one of the most prob­lem­at­ic ar­eas for high ex­pens­es over the years, as the list price for in­sulin con­tin­ues to sky­rock­et, even if what pa­tients are pay­ing out of pock­et with in­sur­ance has stayed slight­ly up. Those with­out in­sur­ance, how­ev­er, would still pay full price. Many with in­sur­ance now pay more than $600 just for a 40-day sup­ply of in­sulin.

Sen­ate ma­jor­i­ty leader Chuck Schumer of New York said there would be a vote on the in­sulin cap in March.

Tim Van Hauwermeiren, argenx CEO

Ar­genx pur­chas­es $100M+ FDA pri­or­i­ty re­view vouch­er from blue­bird bio

Argenx’s Vyvgart is due for a speedy review at the FDA, thanks to a $102 million priority review voucher (PRV).

The Netherland-based biotech picked up the PRV from bluebird bio, the companies announced on Wednesday. PRVs shorten a drug’s FDA review period from 10 months to 6 months, though they often sell on the open market for around $100 million each.

Argenx plans on using the express ticket on efgartigimod, its neonatal Fc receptor (FcRn) blocker marketed as Vyvgart for adults with generalized myasthenia gravis (gMG). While Vyvgart won its first approval last December for the chronic neuromuscular disease — which is characterized by difficulties with facial expression, speech, swallowing and breathing — CEO Tim Van Hauwermeiren said in a news release that he plans to “be active in fifteen disease targets by 2025.”

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

Up­dat­ed: As­traZeneca jumps deep­er in­to cell ther­a­py 2.0 space with $320M biotech M&A

Right from the start, the execs at Neogene had some lofty goals in mind when they decided to try their hand at a cell therapy that could tackle solid tumors.

Its founders have helped hone a new approach that would pack in multiple neoantigen targets to create a personalized TCR treatment that would not just make the leap from blood to solid tumors, but do it with durability. And they managed to make their way rapidly to the clinic, unveiling their first Phase I program for advanced tumors just last May.

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Ei­sai’s ex­pand­ed Alzheimer’s da­ta leave open ques­tions about safe­ty and clin­i­cal ben­e­fit

Researchers still have key questions about Eisai’s investigational Alzheimer’s drug lecanemab following the publication of more Phase III data in the New England Journal of Medicine Tuesday night.

In the paper, which was released in conjunction with presentations at an Alzheimer’s conference, trial investigators write that a definition of clinical meaningfulness “has not been established.” And the relative lack of new information, following topline data unveiled in September, left experts asking for more — setting up a potential showdown to precisely define how big a difference the drug makes in patients’ lives.

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Illustration: Assistant Editor Kathy Wong for Endpoints News

Twit­ter dis­ar­ray con­tin­ues as phar­ma ad­ver­tis­ers ex­tend paus­es and look around for op­tions, but keep tweet­ing

Pharma advertisers on Twitter are done — at least for now. Ad spending among the previous top spenders flattened even further last week, according to the latest data from ad tracker Pathmatics, amid ongoing turmoil after billionaire boss Elon Musk’s takeover now one month ago.

Among 18 top advertisers tracked for Endpoints News, only two are spending: GSK and Bayer. GSK spending for the full week through Sunday was minimal at just under $1,900. Meanwhile, German drugmaker Bayer remains the industry outlier upping its spending to $499,000 last week from $480,000 the previous week. Bayer’s spending also marks a big increase from a month ago and before the Musk takeover, when it spent $16,000 per week.

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Vi­a­tris with­draws ac­cel­er­at­ed ap­proval for top­i­cal an­timi­cro­bial 24 years lat­er

After 24 years without confirming clinical benefit, the FDA announced Tuesday morning that Viatris (formed via Mylan and Pfizer’s Upjohn) has decided to withdraw a topical antimicrobial agent, Sulfamylon (mafenide acetate), after the company said conducting a confirmatory study was not feasible.

Sulfamylon first won FDA’s accelerated nod in 1998 as a topical burn treatment, with the FDA noting that last December, Mylan told the agency that it wasn’t running the trial.

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Emily Leproust, Twist Bioscience CEO

Twist Bio­science’s 'fac­to­ry of the fu­ture' in Ore­gon could de­liv­er with com­pet­i­tive pric­ing, SVB Se­cu­ri­ties says

The synthetic DNA manufacturer Twist Bioscience has given a peek behind the curtain to several analysts into its “factory of the future” as well as insight into the cost structure, workflow and technology at the site.

The 110,000-square-foot manufacturing site in the city of Wilsonville, OR, just south of Portland, which was announced back in 2020, will double Twist’s production capacity and bring around 400 jobs to the area.

Paul Hudson, Sanofi CEO (Romuald Meigneux/Sipa via AP Images)

Sanofi and DN­Di aim to elim­i­nate sleep­ing sick­ness in Africa with promis­ing Ph II/III re­sults for new drug

The Drugs for Neglected Diseases initiative (DNDi) and Sanofi today said that their potential sleeping sickness treatment saw success rates of up to 95% from a Phase II/III study investigating the safety and efficacy of single-dose acoziborole.

The potentially transformative treatment for sleeping sickness would mainly be targeted at African countries, according to data published today in The Lancet Infectious Diseases medical journal. The clinical trial was led by DNDi and its partners in the Democratic Republic of the Congo (DRC) and Guinea, with the authors noting:

Lil­ly's Covid-19 mAb no longer au­tho­rized due to Omi­cron sub­vari­ants, FDA says

The FDA on Wednesday announced that Eli Lilly’s Covid-19 drug bebtelovimab is no longer authorized to treat Covid-19 because of the rising numbers of two new subvariants that the drug does not work against.

The Centers for Disease Control and Prevention last week published new estimates that the combined proportion of Covid-19 cases caused by the Omicron subvariants BQ.1 and BQ.1.1 are greater than 57% nationally, and already above 50% in all individual regions but one.

Digital render of CPI's Medicines Manufacturing Innovation Centre in Glasgow, Scotland (Image: uk-cpi.com)

CPI opens the doors to a new $100M+ man­u­fac­tur­ing fa­cil­i­ty in Scot­land

A manufacturing site that has received interest and investments from large pharma companies and the UK government is opening its doors in Scotland.

The manufacturer CPI (Centre for Process Innovation) has opened a new £88 million ($105 million) “Medicines Manufacturing Innovation Centre” in Glasgow, Scotland, to accelerate the development of manufacturing tech and solve longstanding challenges in medicine development and manufacturing.