Opin­ion: The drug pric­ing deal is­n't re­al­ly a vic­to­ry for Dems, or a loss for PhRMA. But it could be a har­bin­ger of change

Al­though House and Sen­ate De­moc­rats have fi­nal­ly cracked their Mis­sion: Im­pos­si­ble to al­low the fed­er­al gov­ern­ment to ne­go­ti­ate some drug prices, the ne­go­ti­a­tions will in­clude so few drugs and have so many stip­u­la­tions at­tached that the end re­sult may be more of a drop in the ocean than the mon­soon that drug price ne­go­ti­a­tions could’ve been.

Con­gress is wait­ing for a CBO score be­fore of­fi­cial­ly vot­ing, but ear­ly es­ti­mates point to about $100 bil­lion in drug pric­ing sav­ings over ten years from the deal. That’s ba­si­cal­ly the equiv­a­lent of what the phar­ma in­dus­try spends on DTC mar­ket­ing over a decade. Or about five years of what phar­ma com­pa­nies spend on mar­ket­ing to health care pro­fes­sion­als.

The Medicare ne­go­ti­a­tions deal is al­so com­pli­cat­ed by ex­ten­sive lim­i­ta­tions — it’s on­ly for ex­pen­sive Medicare Part D and B drugs, 10 to start, the drugs must have no gener­ic/biosim­i­lar com­peti­tors, and the ne­go­ti­a­tions can on­ly start post-ex­clu­siv­i­ty, or 9 years af­ter the launch of small mol­e­cule drugs and 13 years for bi­o­log­ics. It’s un­clear what kind of dent, if any, the deal will make on drug prices over the longer term, or for those out­side of Medicare.

“CMS will de­ter­mine the fi­nal price, based on cri­te­ria that are rather pro-in­dus­try – thus it seems more of a no­tice-and-com­ment rather than ac­tu­al ne­go­ti­a­tion,” Bern­stein biotech an­a­lyst Ron­ny Gal wrote in a re­cent in­vestor note. “Our ear­ly im­pres­sion is that the net im­pact is pos­i­tive for phar­ma stocks.”

Mean­while, in­dus­try group PhRMA, which suc­cess­ful­ly flood­ed Capi­tol Hill with 20 lob­by­ists for every sen­a­tor, is once again disin­gen­u­ous­ly cry­ing foul. This is typ­i­cal of PhRMA, which of­ten makes a big, pub­lic stink about al­ready-lim­it­ed bills while wa­ter­ing them down fur­ther be­hind closed doors.

And phar­ma com­pa­nies, fa­mous for hir­ing teams of lawyers to find loop­holes in com­plex statute, will sure­ly nav­i­gate their way around at least some of the ne­go­ti­a­tions, or po­ten­tial­ly forge deals to bring more in­nocu­ous com­pe­ti­tion to mar­ket more quick­ly so as to avoid any ne­go­ti­a­tions at all.

But these side ef­fects (pun in­tend­ed) of the ne­go­ti­a­tions deal might ac­tu­al­ly be a good thing. And al­though the num­bers might be a drop in the ocean, and the ne­go­ti­a­tions them­selves slant­ed in phar­ma’s fa­vor, the deal still dis­rupts the woe­ful­ly in­ad­e­quate sta­tus quo.

Rachel Sachs, a law pro­fes­sor at Wash­ing­ton Uni­ver­si­ty in St. Louis who stud­ies drug pric­ing and in­no­va­tion, said she didn’t think com­pa­nies po­ten­tial­ly bring­ing in more com­pe­ti­tion pri­or to the gov­ern­ment ne­go­ti­a­tions start­ing “would be a bad out­come, from a pol­i­cy per­spec­tive, par­tic­u­lar­ly if we end up with more than one com­peti­tor to dri­ve down prices. It might al­so cut down on the need for some pay-for-de­lay or cit­i­zen pe­ti­tion re­form.”

Pe­ter Bach

Oth­er drug pric­ing ex­perts like Pe­ter Bach have al­so come out in fa­vor of the deal’s abil­i­ty to ne­go­ti­ate prices post-ex­clu­siv­i­ty, rather than when the drugs launch, the lat­ter of which is typ­i­cal in Eu­ro­pean coun­tries.

“Fo­cus­ing on drugs that have logged years on the mar­ket means there will be more (and in many cas­es clear) ev­i­dence of how well drugs work. Rarely true at launch,” he wrote. “This is where the mon­ey is.”

And Bach in­sist­ed to me that is the right step and tar­get­ing the right prob­lem:

So much mon­ey is in the top ex­pen­di­ture drugs that fo­cus­ing there — and thus us­ing ne­go­ti­at­ing re­sources ef­fi­cient­ly — makes sense. I know the push and pull of pol­i­tics and n[um­ber] of drugs and stuff makes for good the­atre, but my ques­tion is where are we com­pared to where we were 5 years ago when no­body knew what a re­bate was or that the biosim­i­lar mar­ket was de­signed to fail or that long mo­nop­o­lies were not just a lit­tle long, they were gen­er­a­tions long.

Ul­ti­mate­ly, if De­moc­rats are able to shep­herd their ne­go­ti­a­tions deal across the fin­ish line (and they’re ex­pect­ed to), the net ef­fect won’t be in­stan­ta­neous sav­ings or the col­lapse of the bio­phar­ma in­dus­try, but per­haps an sign­post on the way to­ward a more sus­tain­able path.

Pfiz­er lays off em­ploy­ees at Cal­i­for­nia and Con­necti­cut sites

Pfizer has laid off employees at its La Jolla, CA, and Groton, CT sites, according to multiple LinkedIn posts from former employees.

The Big Pharma confirmed to Endpoints News it has let go of some employees, but a spokesperson declined to specify how many workers were impacted and the exact locations affected. Earlier this month, the drug developer had confirmed to Endpoints it was sharpening its focus and doing away with some early research on areas such as rare disease, oncology and gene therapies.

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Late Fri­day ap­proval; Trio of biotechs wind down; Stem cell pi­o­neer finds new fron­tier; Biotech icon to re­tire; 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.

I hope your weekend is off to a nice start, wherever you are reading this email. As for me, I’m trying to catch the tail of the Lunar New Year festivities.

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Filip Dubovsky, Novavax CMO

No­vavax gets ready to take an­oth­er shot at Covid vac­cine mar­ket with next sea­son plans

While mRNA took center stage at yesterday’s FDA vaccine advisory committee meeting, Novavax announced its plans to deliver an updated protein-based vaccine based on new guidance.

Vaccines and Related Biological Products Advisory Committee (VRBPAC) members voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all future vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

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CBER Director Peter Marks (Susan Walsh/AP Images)

FDA ad­vi­so­ry com­mit­tee votes unan­i­mous­ly in fa­vor of bi­va­lent Covid shots re­plac­ing pri­ma­ry se­ries

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all current vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

The vote marks an effort to clear up confusion around varying formulations and dosing schedules for current primary series and booster vaccines, as well as “get closer to the strains that are circulating,” according to committee member Paul Offit, professor of pediatrics at the Children’s Hospital of Philadelphia.

Jake Van Naarden, Loxo@Lilly CEO

Lil­ly en­ters ripe BTK field with quick FDA nod in man­tle cell lym­phoma

Eli Lilly has succeeded in its attempt to get the first non-covalent version of Bruton’s tyrosine kinase, or BTK, inhibitors to market, pushing it past rival Merck.

The FDA gave an accelerated nod to Lilly’s daily oral med, to be sold as Jaypirca, for patients with relapsed or refractory mantle cell lymphoma.

The agency’s green light, disclosed by the Indianapolis Big Pharma on Friday afternoon, catapults Lilly into a field dominated by covalent BTK inhibitors, which includes AbbVie and Johnson & Johnson’s Imbruvica, AstraZeneca’s Calquence and BeiGene’s Brukinsa.

Post-hoc analy­sis: EMA's CHMP re­jects Ipsen's po­ten­tial drug for rare ge­net­ic dis­ease

The European Medicines Agency’s Committee for Medicinal Products for Human Use on Friday rejected Ipsen Pharma’s potential treatment for a rare genetic disease known as fibrodysplasia ossificans progressiva (FOP), which causes extra bone to form outside the skeleton.

The EMA said on its website that it could not draw any firm conclusions on the benefits of the French biopharma’s Sohonos (palovarotene), which selectively targets the retinoic-acid receptor gamma (RARγ), “as the applicant’s conclusion was based on a post-hoc analysis which was neither scientifically nor clinically justified and pre-specified study objectives were not met.”

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FDA ap­proves an­oth­er in­di­ca­tion for Keytru­da, this time in the ad­ju­vant NSCLC set­ting

Merck’s blockbuster cancer treatment Keytruda has been handed another indication by the FDA.

The US regulator announced on Thursday that it has approved Keytruda to serve as an adjuvant treatment for non-small cell lung cancer (NSCLC), which is its fifth indication in NSCLC and 34th indication overall.

According to a Merck release, the approval is based on data from a Phase III trial, dubbed Keynote-091, which measured disease-free survival in patients who received chemotherapy following surgery. The data from Merck displayed that Keytruda cut down on the risk of disease recurrence or death by 27% versus placebo.

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.