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.

Pfiz­er’s Doug Gior­dano has $500M — and some ad­vice — to of­fer a cer­tain breed of 'break­through' biotech

So let’s say you’re running a cutting-edge, clinical-stage biotech, probably public, but not necessarily so, which could see some big advantages teaming up with some marquee researchers, picking up say $50 million to $75 million dollars in a non-threatening minority equity investment that could take you to the next level.

Doug Giordano might have some thoughts on how that could work out.

The SVP of business development at the pharma giant has helped forge a new fund called the Pfizer Breakthrough Growth Initiative. And he has $500 million of Pfizer’s money to put behind 7 to 10 — or so — biotech stocks that fit that general description.

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BiTE® Plat­form and the Evo­lu­tion To­ward Off-The-Shelf Im­muno-On­col­o­gy Ap­proach­es

Despite rapid advances in the field of immuno-oncology that have transformed the cancer treatment landscape, many cancer patients are still left behind.1,2 Not every person has access to innovative therapies designed specifically to treat his or her disease. Many currently available immuno-oncology-based approaches and chemotherapies have brought long-term benefits to some patients — but many patients still need other therapeutic options.3

President Donald Trump (left) and Moncef Slaoui, head of Operation Warp Speed (Alex Brandon, AP Images)

White House names fi­nal­ists for Op­er­a­tion Warp Speed — with 5 ex­pect­ed names and one no­table omis­sion

A month after word first broke of the Trump Administration’s plan to rapidly accelerate the development and production of a Covid-19 vaccine, the White House has selected the five vaccine candidates they consider most likely to succeed, The New York Times reported.

Most of the names in the plan, known as Operation Warp Speed, will come as little surprise to those who have watched the last four months of vaccine developments: Moderna, which was the first vaccine to reach humans and is now the furthest along of any US effort; J&J, which has not gone into trials but received around $500 million in funding from BARDA earlier this year; the joint AstraZeneca-Oxford venture which was granted $1.2 billion from BARDA two weeks ago; Pfizer, which has been working with the mRNA biotech BioNTech; and Merck, which just entered the race and expects to put their two vaccine candidates into humans later this year.

Is a pow­er­house Mer­ck team prepar­ing to leap past Roche — and leave Gilead and Bris­tol My­ers be­hind — in the race to TIG­IT dom­i­na­tion?

Roche caused quite a stir at ASCO with its first look at some positive — but not so impressive — data for their combination of Tecentriq with their anti-TIGIT drug tiragolumab. But some analysts believe that Merck is positioned to make a bid — soon — for the lead in the race to a second-wave combo immuno-oncology approach with its own ambitious early-stage program tied to a dominant Keytruda.

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UP­DAT­ED: Es­ti­mat­ing a US price tag of $5K per course, remde­sivir is set to make bil­lions for Gilead, says key an­a­lyst

Data on remdesivir — the first drug shown to benefit Covid-19 patients in a randomized, controlled trial setting — may be murky, but its maker Gilead could reap billions from the sales of the failed Ebola therapy, according to an estimate by a prominent Wall Street analyst. However, the forecast, which is based on a $5,000-per-course US price tag, triggered the ire of one top drug price expert.

A low-pro­file biotech bests Re­gen­eron in high-pro­file patent suit

For nearly a decade now, the low-profile Cambridge biotech Kymab has been battling in US, UK, Japanese and Australian courts with the biotech behemoth Regeneron.

Regeneron has turned itself into a $70 billion company off of a platform of transgenically humanized mice they can use to make antibodies for anything from Ebola to colorectal cancer. The technology took decades and billions to build, 20 years from the company’s founding to the first approved drug. And the company guards and touts it zealously, breaking their production process down into various branded components — Velocimmune, Velocigene, Velocimouse and four other Velocis — and sometimes suing would-be copycats. In 2014, most notably, they sued two Pfizer-backed entities for patent infringement.

Credit: AP Images

Covid-19 roundup: BAR­DA sup­ports Op­er­a­tion Warp Speed with big $628M con­tract to ser­vice Amer­i­ca's vac­cine pro­duc­tion needs

Another BARDA contract designed to service America’s Covid-19 vaccine needs has been deployed.

The White House-led initiative designed to bankroll development to bring a vaccine to the American public by this fall — Operation Warp Speed — has via BARDA handed a meaty contract to the maker of an FDA-licensed anthrax vaccine to open up its manufacturing apparatus to shore up production of Covid-19 vaccines.

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FDA de­lays de­ci­sion on No­var­tis’ po­ten­tial block­buster MS drug, wip­ing away pri­or­i­ty re­view

So much for a speedy review.

In February, Novartis announced that an application for their much-touted multiple sclerosis drug ofatumumab had been accepted and, with the drug company cashing in on one of their priority review vouchers, the agency was due for a decision by June.

But with June less than 48 hours old, Novartis announced the agency has extended their review, pushing back the timeline for approval or rejection to September. The Swiss pharma filed the application in December, meaning their new schedule will be nearly in line with the standard 10-month window period had they not used the priority voucher.

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Bull­ish biotech mar­ket pro­pels Pli­ant to $144M IPO — as No­var­tis pro­vides a $10M boost

After pharma partner Novartis boosted its IPO with a $10 million private placement, Pliant Therapeutics has wrapped its journey to the Nasdaq on a high note.

Pliant had penciled in a $86 million raise back in May. But as has become the norm in recent months, that initial number has turned out to be a mere placeholder, making way for the final haul of $144 million.

The South San Francisco biotech did so by pricing at $16, the high end of the range, while bringing the number of shares offered up to 9 million.