New Kaiser analy­sis shows how lim­it­ing price ne­go­ti­a­tions to tar­get­ed drugs may bet­ter fo­cus up­com­ing leg­is­la­tion

As Con­gress con­sid­ers whether to adopt sweep­ing new leg­is­la­tion to low­er pre­scrip­tion drug prices across the board, the Kaiser Fam­i­ly Foun­da­tion is out with a new re­port on Mon­day show­ing how a more tar­get­ed ap­proach on a sub­set of drugs might be a more ef­fi­cient way to save gov­ern­ment funds.

“This analy­sis shows that Medicare Part D and Part B spend­ing is high­ly con­cen­trat­ed among a rel­a­tive­ly small share of cov­ered drugs, main­ly those with­out gener­ic or biosim­i­lar com­peti­tors,” wrote Juli­ette Cuban­s­ki, deputy di­rec­tor of the pro­gram on Medicare pol­i­cy at KFF, and Tri­cia Neu­man, SVP of KFF. “Fo­cus­ing drug price ne­go­ti­a­tion or ref­er­ence pric­ing on a sub­set of drugs that ac­count for a dis­pro­por­tion­ate share of spend­ing would be an ef­fi­cient use of ad­min­is­tra­tive re­sources, though it would al­so leave some po­ten­tial sav­ings on the ta­ble.”

The re­port found that in 2019, 60% of net to­tal Part D spend­ing came from 250 top-sell­ing drugs in Medicare’s Part D pro­gram with one man­u­fac­tur­er and no gener­ic or biosim­i­lar com­pe­ti­tion, which was 7% of all Part D cov­ered drugs.

“For the top 250 drugs, the av­er­age net cost per claim was $5,750, more than twice as much as the av­er­age net cost per claim for the re­main­ing 2,208 drugs with one man­u­fac­tur­er ($2,555), and more than 13 times greater than the av­er­age net cost per claim for all oth­er cov­ered Part D drugs ($422) (pri­mar­i­ly gener­ic drugs),” the analy­sis shows.

In ad­di­tion, the top 50 drugs cov­ered un­der Medicare Part B, rep­re­sent­ing just 8.5% of all Part B cov­ered drugs, ac­count­ed for 80% of to­tal spend­ing in the pro­gram.

“In con­sid­er­ing whether to broad­en these pro­pos­als to fo­cus on all pre­scrip­tion drugs, pol­i­cy­mak­ers may want to con­sid­er whether do­ing so would achieve suf­fi­cient sav­ings to jus­ti­fy the added ad­min­is­tra­tive bur­den and as­so­ci­at­ed costs,” Cuban­s­ki and Neu­man wrote.

De­moc­rats are hop­ing to use sav­ings from ma­jor drug pric­ing re­forms to help pay for an in­fra­struc­ture bill lat­er this year, rather than try to work through stand­alone pric­ing leg­is­la­tion, which would re­quire 60 votes in the Sen­ate.

“I would look for leg­is­la­tion com­ing out of the Sen­ate to be more along the lines of what Sen­a­tor Wyden pro­posed with Sen­a­tor Grass­ley in 2019, which was more mod­est if on­ly in that it didn’t in­clude the ne­go­ti­a­tion pro­vi­sion in HR 3,” Cuban­s­ki told End­points.

Forge Bi­o­log­ics’ cGMP Com­pli­ant and Com­mer­cial­ly Vi­able Be­spoke Affin­i­ty Chro­matog­ra­phy Plat­form

Forge Biologics has developed a bespoke affinity chromatography platform approach that factors in unique vector combinations to streamline development timelines and assist our clients in efficiently entering the clinic. By leveraging our experience with natural and novel serotypes and transgene conformations, we are able to accelerate affinity chromatography development by nearly 3-fold. Many downstream purification models are serotype-dependent, demanding unique and time-consuming development strategies for each AAV gene therapy product1. With the increasing demand to propel AAV gene therapies to market, platform purification methods that support commercial-scale manufacturing of high-quality vectors with excellent safety and efficacy profiles are essential.

Cy­to­ki­net­ics’ ALS drug fails PhI­II, leav­ing the biotech with a sin­gle late-stage prospect

Cytokinetics’ candidate for the muscle disease amyotrophic lateral sclerosis, or ALS, failed a Phase III trial, the Bay Area biotech announced Friday morning.

At a second interim analysis of the trial, an independent review committee recommended that Cytokinetics discontinue its COURAGE-ALS trial for reldesemtiv, as it “found no evidence of effect” compared to placebo on the primary or key secondary endpoints.

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CHMP gives thumbs-up for We­govy use in ado­les­cents, along with nine new drug rec­om­men­da­tions

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended nine drugs for approval this week while also giving thumbs up for six expanded indications, including Novo Nordisk’s approved obesity medication Wegovy for younger people. Wegovy is already approved as an obesity treatment in the EU for adults, and the new indication would allow prescriptions for adolescents aged 12 and older.

Austin biotech Mol­e­c­u­lar Tem­plates lays off more than 100 staffers as pipeline nar­rows

Molecular Templates is ridding itself of a Phase I HER2 asset and fine-tuning its pipeline to focus on three programs and a preclinical Bristol Myers Squibb collaboration. With the narrowed scope on its so-called engineered toxin bodies, the Austin, TX biotech is laying off about half of its staff.

That’s a little more than 100 employees, per an SEC filing. Molecular’s layoffs, approved by its board Wednesday, add to the dozens of pullbacks in the industry in the first three months of 2023.

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Green­Light re­ceives buy­out of­fer; Apol­lomics com­pletes SPAC merg­er

RNA biotech GreenLight Biosciences has been handed an offer for potential acquisition.

GreenLight said in a release that it has received a non-binding “indication of interest” from Fall Line Endurance Fund to acquire GreenLight’s capital stock for $0.60 per share in cash. The release said any potential agreement between the two parties would depend on certain conditions.

Through a special committee, the biotech will evaluate the offer but added there’s no certainty a deal will go forward. GreenLight will also not make any more announcements until a deal comes through or “otherwise determines” a statement is necessary.

TScan Therapeutics' departing CEO David Southwell and CSO/COO Gavin MacBeath

TCR up­start an­nounces CEO ex­it, with CSO now act­ing re­place­ment

A public T cell biotech’s chief executive has decided to leave the company.

TScan Therapeutics said Friday morning that CEO David Southwell stepped down earlier this week, leaving both his chief executive and board member roles. Filling in is Gavin MacBeath, the company’s CSO and COO. He became the acting CEO on Tuesday, and will continue to remain CSO and COO, TScan’s announcement read.

Mathai Mammen, FogPharma's next CEO

Math­ai Mam­men hands in J&J's R&D keys to lead Greg Ver­dine’s Fog­Phar­ma 

In the early 1990s, Mathai Mammen was a teaching assistant in Greg Verdine’s Science B46 course at Harvard. In June, the former R&D head at Johnson & Johnson will succeed Verdine as CEO, president and chair of FogPharma, the same month the seven-year-old biotech kickstarts its first clinical trial.

After leading R&D at one of the largest drugmakers in the world, taking the company through more than half a dozen drug approvals in the past few years, not to mention a Covid-19 vaccine race, Mammen departed J&J last month and will take the helm of a Cambridge, MA biotech attempting to go after what Verdine calls the “true emperor of all oncogenes” — beta-catenin.

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Sen­ate Fi­nance Com­mit­tee lobs more bi­par­ti­san pres­sure on­to PBMs

Congress is honing in on how it wants to overhaul the rules of the road for pharmacy benefit managers, with a Senate Finance Committee hearing Thursday serving as the latest example of the Hill’s readiness to make changes to how pharma middlemen operate.

While pledging to ensure patients and pharmacies “don’t get a raw deal,” Finance Committee Chair Ron Wyden (D-OR) laid out the beginning of what looks like a major bipartisan effort — moves the PBM industry is likely to challenge vigorously.

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Nicklas Westerholm, Egetis Therapeutics CEO

Ac­qui­si­tion talks on­go­ing for Swedish rare dis­ease biotech Egetis, shares up al­most 40%

Shares of the Sweden-based rare disease biotech Egetis Therapeutics skyrocketed on Thursday afternoon as the company said it’s engaged in “ongoing discussion” with external parties regarding a “potential acquisition.”

Egetis confirmed rumors with a statement on Thursday while noting that there is no certainty that a takeover offer will be made.

Nonetheless, the possibility of an acquisition has shot up Egetis’ share price. By the afternoon on Thursday, its stock price was {$EGTX.ST} up over 38%. An Egetis spokesperson told Endpoints News in an email that it has no further comments.

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