Senate Majority Leader Chuck Schumer (Graeme Sloan/Sipa USA)(Sipa via AP Images)

Schumer pledges vote on $35 in­sulin caps next month as oth­er pric­ing re­forms re­main on hold for now

If the Sen­ate fails to pass a $35 month­ly in­sulin cap late next month, which it’s ex­pect­ed to do, what would be next for drug pric­ing re­forms on Capi­tol Hill?

That’s the ma­jor ques­tion right now as Sen­ate Ma­jor­i­ty Leader Chuck Schumer (D-NY) said Tues­day that fol­low­ing the Sen­ate re­cess for the East­er hol­i­day (re­turn­ing on April 25), he will bring to a vote a bill that would cap month­ly in­sulin costs at $35 for those with in­sur­ance, which aligns with Pres­i­dent Biden’s pledge for such a cap at the State of the Union.

Schumer al­so men­tioned “ad­di­tion­al poli­cies to dri­ve down the list price in a more com­pre­hen­sive way,” which would be a wel­come re­lief as the mar­ket has not been able to re­duce prices in any sub­stan­tial way, even with an in­ter­change­able biosim­i­lar.

Su­san Collins

The bi­par­ti­san duo of Sens. Su­san Collins (R-ME) and Jeanne Sha­heen (D-NH), who pre­vi­ous­ly worked on in­sulin in 2019, will lead the Sen­ate’s ef­forts. The is­sue of in­sulin prices in the US has been lin­ger­ing for years with no so­lu­tion. The cur­rent price of in­sulin in the US is more than 10 times that of 33 oth­er com­pa­ra­ble coun­tries, even as the net price of in­sulin has de­clined in re­cent years.

But the bill seems doomed to fail­ure as Sen­ate De­moc­rats are un­like­ly to muster enough votes to pass the cap (10 Re­pub­li­cans would have to join their col­leagues from across the aisle). Still, the vote and lead-up may in­crease aware­ness around the is­sue, which could, in turn, restart wider drug pric­ing re­forms that have stalled since the Build Back Bet­ter Act fiz­zled out.

“In­sulin costs have been rapid­ly ris­ing for years, and it’s forc­ing mil­lions of Amer­i­cans with di­a­betes to make im­pos­si­ble de­ci­sions,” Schumer tweet­ed yes­ter­day on the vote.

Jeanne Sha­heen

But the broad­er strat­e­gy be­hind this vote in April re­mains un­clear.

Gen­er­al­ly, the idea is that the in­sulin bill won’t pass, but that will add to the mo­men­tum be­hind us­ing rec­on­cil­i­a­tion to pass leg­is­la­tion (mean­ing Dems would on­ly need 51 votes) with some drug pric­ing pro­vi­sions in­clud­ed, Alex Law­son, ex­ec­u­tive di­rec­tor of the non­prof­it So­cial Se­cu­ri­ty Works who fol­lows drug pric­ing de­vel­op­ments close­ly on the Hill, told End­points News.

“But there is wor­ry in the broad­er com­mu­ni­ty that it could pass be­fore [the sec­ond at­tempt at us­ing rec­on­cil­i­a­tion af­ter the BB­BA] and take away key pres­sure to pass the broad­er BB­BA mea­sures,” he said. “It is all a Schumer call at this point. I al­so think it’s a back­up plan if [Sen. Joe] Manchin pulls the foot­ball away again on BB­BA.”

Alex Law­son

And if last week’s Sen­ate Fi­nance Com­mit­tee hear­ing on Medicare ne­go­ti­a­tions is any bell­wether, find­ing bi­par­ti­san com­pro­mise around drug pric­ing may be dif­fi­cult to do, es­pe­cial­ly if the Dems try to get it done be­fore the midterms this fall.

Re­pub­li­cans in the com­mit­tee made clear their op­po­si­tion to Medicare ne­go­ti­at­ing on prices, es­pe­cial­ly as they sought to con­vince the pub­lic that the term “ne­go­ti­a­tions” is ac­tu­al­ly clos­er to price con­trols.

Up­dat­ed: FDA re­mains silent on or­phan drug ex­clu­siv­i­ty af­ter last year's court loss

Since losing a controversial court case over orphan drug exclusivity last year, the FDA’s Office of Orphan Products Development has remained entirely silent on orphan exclusivity for any product approved since last November, leaving many sponsors in limbo on what to expect.

That silence means that for more than 70 orphan-designated indications for more than 60 products, OOPD has issued no public determination on the seven-year orphan exclusivity in the Orange Book, and no new listings of orphan exclusivity appear in OOPD’s searchable database, as highlighted recently by George O’Brien, a partner in Mayer Brown’s Washington, DC office.

Big week for Alzheimer’s da­ta; As­traZeneca buys cell ther­a­py start­up; Dig­i­tal ther­a­peu­tics hits a pay­er wall; and more

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Am­gen, years be­hind ri­vals, says PhI obe­si­ty drug shows dura­bil­i­ty signs

While NBC ran “The Biggest Loser” for 17 seasons, deemed toxic by critics for the reality show’s punishing exercise and diet upheavals, researchers in pharmaceutical labs have been attempting to create prescription drugs that induce weight loss — and one pharma betting it can require less frequent dosing is out with a new crop of data.

Amgen was relatively late to the game compared to its approved competitor Novo Nordisk and green light-approaching rival Eli Lilly. But early data suggested Amgen’s AMG 133 led to a 14.5% weight reduction in the first few months of dosing, buoying shares earlier this fall, and now the California pharma is out with its first batch of durability data showing that figure fell slightly to 11.2% about 150 days after the last dose. Amgen presented at the 20th World Congress on Insulin Resistance, Diabetes & Cardiovascular Disease on Saturday afternoon.

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Illustration: Assistant Editor Kathy Wong for Endpoints News

As mon­ey pours in­to dig­i­tal ther­a­peu­tics, in­sur­ance cov­er­age crawls

Talk therapy didn’t help Lily with attention deficit hyperactivity disorder, or ADHD. But a video game did.

As the 10-year-old zooms through icy waters and targets flying creatures on the snow-capped planet Frigidus, she builds attention skills, thanks to Akili Interactive Labs’ video game EndeavorRx. She’s now less anxious and scattered, allowing her to stay on a low dose of ADHD medication, according to her mom Violet Vu.

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Eli Lil­ly’s Alzheimer’s drug clears more amy­loid ear­ly than Aduhelm in first-ever head-to-head. Will it mat­ter?

Ahead of the FDA’s decision on Eli Lilly’s Alzheimer’s drug donanemab in February, the Big Pharma is dropping a first cut of data from one of the more interesting trials — but less important in a regulatory sense — at an Alzheimer’s conference in San Francisco.

In the unblinded 148-person study, Eli Lilly pitted its drug against Aduhelm, Biogen’s drug that won FDA approval but lost Medicare coverage outside of clinical trials. Notably, the study didn’t look at clinical outcomes, but rather the clearance of amyloid, a protein whose buildup is associated with Alzheimer’s disease, in the brain.

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US month­ly costs for biosim­i­lars 'sub­stan­tial­ly high­er' than Ger­many or Switzer­land, JA­MA re­search finds

As the global biologics market is expected to hit nearly the half-trillion-dollar mark this year, new JAMA research points to the importance of timely biosimilar entry, particularly as fewer biosimilars are entering the US than in Europe, and as monthly treatment costs for biosimilars were “substantially higher” in the US compared with Germany and Switzerland.

Among the three countries, biosimilar market share at launch was highest in Germany, but increased at the fastest rate in the US, the authors from the University of Zurich’s Institute of Law wrote in JAMA Network Open today.

Kirk Myers is shown in a still image from a new film series showcasing the efforts of HIV advocates funded by Gilead.

Gilead spot­lights HIV projects and the com­mu­ni­ty lead­ers dri­ving them in new mi­ni-doc­u­men­tary films

Gilead is going behind the scenes of some of the HIV initiatives it funds through grants in a new film series narrated by the people helming the projects.

The first four films and leaders come from across the US — Arianna Lint in Florida and Puerto Rico, Cleve Jones in San Francisco, June Gipson in Mississippi and Kirk Myers in Texas. Their HIV-focused efforts range from addressing unmet needs of the transgender community to delivering social services and high-quality health care in underserved communities.

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EMA pulls an opi­oid from the 1950s used to treat dry cough

The European Medicines Agency said Friday that it’s pulling from all European markets pholcodine-containing medicines, which are an opioid used in adults and children for the treatment of dry cough and in combo with other drugs as a treatment for cold and flu.

The decision to pull the medicines comes as the EMA points to the results from the recent ALPHO study, which show that use of pholcodine during the 12 months preceding anesthesia is linked to a risk of an anaphylactic reaction related to the neuromuscular blocking agents (NMBAs) used (with an adjusted OR of 4.2, and a 95% confidence interval of 2.5 to 6.9).

Lynn Baxter, Viiv Healthcare's head of North America

Vi­iV dri­ves new cor­po­rate coali­tion in­clud­ing Uber, Tin­der and Wal­mart, aimed at end­ing HIV

ViiV Healthcare is pulling together an eclectic coalition of consumer businesses in a new White House-endorsed effort to end HIV by the end of the decade.

The new US Business Action to End HIV includes pharma and health companies — Gilead Sciences, CVS Health and Walgreens — but extends to a wide range of consumer companies that includes Tinder, Uber and Walmart.

ViiV is the catalyst for the group, plunking down more than half a million dollars in seed money and taking on ringmaster duties for launch today on World AIDS Day, but co-creator Health Action Alliance will organize joint activities going forward. ViiV and the alliance want and expect more companies to not only join the effort, but also pitch in funding.

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