US law­mak­ers now want to hear from the mid­dle­men PBMs to un­pack their role in drug pric­ing

The US Sen­ate Fi­nance Com­mit­tee is up­ping the ante on the is­sue of drug pric­ing with yet an­oth­er hear­ing — this time with phar­ma­cy ben­e­fit man­agers, the mid­dle­men that ne­go­ti­ate re­bates with drug­mak­ers in ex­change for for­mu­la­ry cov­er­age and the pur­port­ed vil­lains be­hind sky­rock­et­ing list prices (ac­cord­ing to big Phar­ma) in a hear­ing last month.

On Tues­day, Sen­a­tors Chuck Grass­ley and Ron Wyden in­vit­ed ex­ec­u­tives from five PBMs — Cigna, CVS, Hu­mana, Unit­ed­Health’s Op­tum­Rx and Prime Ther­a­peu­tics — to tes­ti­fy on April 3 in the third drug pric­ing hear­ing this year.

Chuck Grass­ley

The first hear­ing in Jan­u­ary fo­cused on in­sulin af­ford­abil­i­ty, while the sec­ond in Feb­ru­ary in­volved sev­en phar­ma­ceu­ti­cal ex­ec­u­tives, who square­ly placed the blame for sky­rock­et­ing list prices on the mid­dle­men, as­sert­ing that they are forced to hike the prices of pre­scrip­tion drugs in re­sponse to high­er re­bates that all-pow­er­ful PBMs ne­go­ti­ate.

Last week, large US PBM Ex­press Scripts $ES­RX shot back, sug­gest­ing the pow­er to low­er drug prices ul­ti­mate­ly lies with the man­u­fac­tur­ers. “We of­ten have asked drug com­pa­nies to sim­ply low­er their prices. In­stead, drug com­pa­nies have elect­ed to in­crease prices and in­crease re­bates. This is the op­tion drug mak­ers have cho­sen for them­selves and for the mar­ket­place,” the com­pa­ny said in a state­ment.

“The PBMs de­fense is of­ten fin­ger point­ing, blam­ing ex­or­bi­tant drug pric­ing on the man­u­fac­tur­ers and tak­ing no re­spon­si­bil­i­ty for the prob­lem. In fact, it is the PBMs who bear a great deal of the blame, and their prac­tices have led to se­vere in­fla­tion of the prices of both gener­ic and brand­ed med­ica­tions. This lim­its ac­cess to need­ed med­ica­tions for pa­tients.  It is our hope that the Com­mit­tee does not let them get away with pass­ing the buck,” said Robert Levin, pres­i­dent of the Al­liance for Trans­par­ent and Af­ford­able Pre­scrip­tions (AT­AP), in an emailed state­ment to End­points News.

The gen­er­al job de­scrip­tion for PBMs is to ad­min­is­ter drug ben­e­fits for em­ploy­ers and health plans and run big mail-or­der phar­ma­cies. But what goes on be­hind closed doors be­tween these firms and drug­mak­ers in terms of ne­go­ti­a­tions re­mains some­what of a mys­tery.

Ron Wyden

“Mid­dle­men in the health care in­dus­try owe pa­tients and tax­pay­ers an ex­pla­na­tion of their role. There’s far too much bu­reau­cra­cy and too lit­tle trans­paren­cy get­ting in the way of af­ford­able, qual­i­ty health care,” Grass­ley and Wyden said in a Tues­day state­ment.

All re­bates are passed through in Medicare and 95%+ on the com­mer­cial side with con­tin­ued ef­forts to move re­bate to sub­si­dize out of pock­et (OOP) costs for high­er uti­liz­ing se­niors at the point of sale, Leerink’s Ana Gupte not­ed. “(E)spe­cial­ly UNH which is now mov­ing their ef­forts from ful­ly in­sured em­ploy­ers in 2019 to self- in­sured com­menc­ing 2020. The large PBMs (CVS, CI (ES­RX), UNH) are al­ready im­ple­ment­ing al­ter­na­tive pay­ment mod­els that re­ly less on re­bates.”

Ear­li­er in the day, Unit­ed­Health said it was ex­pand­ing a change to how it han­dles re­bates from drug­mak­ers by re­quir­ing new em­ploy­er clients to pass the dis­counts on to peo­ple who take the med­ica­tions. The move will ap­ply to em­ploy­ers that ink new con­tracts af­ter Jan 1, 2020, the com­pa­ny said.

At the last hear­ing with phar­ma­ceu­ti­cal ex­ec­u­tives, drug­mak­ers ar­gued in fa­vor of cut­ting re­bates not just for Medicare but al­so on the com­mer­cial side to even the play­ing field for all drug man­u­fac­tur­ers, as suf­fi­cient in­cen­tive to low­er list prices.

“Al­though the phar­ma ex­ecs ex­pressed their pref­er­ence for a po­ten­tial re­bate re­struc­tur­ing to oc­cur in both gov­ern­ment and com­mer­cial sec­tors, we be­lieve any large-scale changes in com­mer­cial will be dif­fi­cult with a di­vid­ed Con­gress and the ex­pect­ed push back from large em­ploy­ers who al­ready pass along re­bates to re­duce costs for their em­ploy­ees,” Gupte said.

George Scangos (L) and Marianne De Backer

Pi­o­neer­ing biotech icon George Scan­gos hands in his re­tire­ment pa­pers — and this time it’s for re­al

George Scangos, one of the all-time great biotech CEOs, says the time has come to turn over the reins one last time.

The 74-year-old biotech legend spent close to three decades in a CEO post. The first was at Exelixis — which is still heavily focused on a drug Scangos advanced in the clinic. The second “retirement” was at Biogen, where he and his team were credited with a big turnaround with the now fading MS blockbuster Tecfidera. And the third comes at Vir, where he traded in his Big Biotech credentials for a marquee founder’s role back on the West Coast, hammering out a Covid-19 alliance with Hal Barron — then R&D chief at GSK — and breaking new ground on infectious diseases with some high-powered venture players.

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FDA re­ports ini­tial 'no sig­nal' for stroke risk with Pfiz­er boost­ers, launch­es con­comi­tant flu shot study

The FDA hasn’t detected any potential safety signals, including for stroke, in people aged 65 years and older who have received Pfizer’s bivalent Covid booster, one senior official told members of the agency’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Thursday.

The update comes as the FDA and CDC investigate a “preliminary signal” that may indicate an increased risk of ischemic stroke in older Americans who received Pfizer’s updated shot.

FDA cuts off use for As­traZeneca’s Covid-19 ther­a­py Evusheld

The FDA has stopped use of another drug as a result of the new coronavirus variants. On Thursday, the agency announced that AstraZeneca’s antibody combo Evusheld, which was an important prevention option for many immunocompromised people and others, is no longer authorized.

The FDA said it made its decision based on the fact that Evusheld works on fewer than 10% of circulating variants.

Evusheld was initially given emergency authorization at the end of 2021. However, as Omicron emerged, so did studies that showed Evusheld might not work against the dominant Omicron strain. In October, the FDA warned healthcare providers that Evusheld was useless against the Omicron subvariant BA.4.6. It followed that up with another announcement earlier this month that it did not think Evusheld would work against the latest Omicron subvariant XBB.1.5.

Jeanne Loring, director of the Center for Regenerative Medicine (Credit: Jamie Scott Lytle)

A stem cell pi­o­neer sent an ex­per­i­ment in­to space. Pa­tients are the next fron­tier

Last July, Jeanne Loring stood on a dirt road surrounded by Florida swampland and watched as a nearby SpaceX rocket blasted into the sky. The payload included a very personal belonging: cell clusters mimicking parts of her brain.

For more than two decades, Loring has been at the forefront of a stem cell field that always seems on the brink of becoming the next thing in medicine, but has been slow to lift off.

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In a win for Re­gen­eron, No­var­tis' sy­ringe for AMD drug de­clared 'un­patentable'

Regeneron has won a patent case against Swiss pharma giant Novartis over the delivery system for its eye drug Eylea.

The US Patent Trial and Appeal Board ruled that Novartis’ pre-filled syringe for injecting its eye medication Lucentis was “unpatentable” and handed the victory to Regeneron and its AMD drug Eylea.

In the initial complaint in 2020, Novartis alleged to the US International Trade Commission that certain pre-filled syringes for the intravitreal injection, and ultimately Regeneron’s delivery system for Eylea, were infringing on Novartis’ patent. Regeneron filed a petition to review Novartis’ claims in 2021.

'Tis the sea­son: GSK ad­dress­es win­ter virus surges with celebri­ty and in­flu­encer vac­cine aware­ness cam­paigns

GSK is rounding up the usual suspects this winter — flu, respiratory syncytial and even shingles viruses — for multiple marketing efforts all aimed at encouraging vaccinations.

Mom influencers take center stage in its “Flu is a Family Affair” campaign to reach family decision-makers or “chief health officers.” GSK is asking them in the digital campaign to take care of themselves, and take the family along, when they go to the pharmacy or doctor’s office for a flu vaccine.

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Bris­tol My­ers claims win with CAR-T ther­a­py Breyanzi in leukemia

Bristol Myers Squibb is looking to expand Breyanzi into more indications — and the pharma’s newest data readout makes progress on that front.

The Big Pharma put out word Thursday that the CAR-T cell therapy met the primary endpoint of complete response rate compared to historical control in a subset of patients with relapsed or refractory chronic lymphocytic leukemia (CLL) that were refractory to a BTK inhibitor and pretreated with a BCL-2 inhibitor.

FDA takes next step in Tor­rent Phar­ma­ceu­ti­cal­s' trou­bled In­dia plant saga, is­sues OAI

The FDA has handed Torrent Pharmaceuticals an official action indicated (OAI) status for a previously inspected manufacturing facility in India.

Torrent Pharma sent a letter to the National Stock Exchange of India earlier this week with word that the manufacturer has received a “communication from the FDA determining the inspection classification as ‘Official Action Indicated’ (OAI)” for one of its sites. An OAI classification from the FDA comes after the agency has completed an inspection and determines if the facility complies with the applicable laws and regulations. Being given an OAI classification means that regulatory or administrative actions will be recommended to Torrent. However, the details on the recommended actions have not been given.

In­vestor 'misalign­men­t' leads to tR­NA biotech's shut­ter­ing

A small biotech looking to carve a lane in the tRNA field has folded, an investor and a co-founder confirmed to Endpoints News.

Similar to Flagship’s Alltrna and other upstarts like Takeda-backed hC Bioscience, the now-shuttered Theonys was attempting to go after transfer RNA, seen as a potential Swiss Army knife in the broader RNA therapeutics space. The idea is that one tRNA drug could be used across a galaxy of disorders and diseases.

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