Out-of-pocket cap will increase the net price of insulin, CBO tells Senate bill sponsors – Endpoints News

2022-09-17 03:35:25 By : Ms. Mickey Zhu

A bill that would cap out-of-pock­et in­sulin costs for the in­sured at $35 per month re­mains in lim­bo as the Con­gres­sion­al Bud­get Of­fice told the two Sen­ate spon­sors of the bill that it will like­ly in­crease net prices for in­sulin, and will in­crease pre­mi­ums for com­mer­cial health in­sur­ance and Medicare Part D.

The com­ments from the CBO may spell the end for the bill, which is ef­fec­tive­ly a Band-Aid for a seg­ment of the phar­ma mar­ket that has bal­looned in re­cent years, dri­ving many to ra­tion their life-sav­ing drug.

“Spend­ing for in­sulin and oth­er phar­ma­ceu­ti­cal prod­ucts would in­crease, CBO es­ti­mates, be­cause over­all med­ica­tion use would in­crease in re­sponse to low­er cost-shar­ing re­quire­ments,” CBO di­rec­tor Phillip Swagel wrote to Sens. Jeanne Sha­heen (D-NH) and Su­san Collins (R-ME) on Fri­day. “Some use of in­sulin might al­so shift to new­er and more ex­pen­sive in­sulin prod­ucts. In­creased spend­ing for phar­ma­ceu­ti­cal prod­ucts would re­sult in in­creased spend­ing for health care over­all.”

Three drug­mak­ers con­trol the more than $20 bil­lion in­sulin mar­ket — Eli Lil­ly, No­vo Nordisk, and Sanofi — as 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.

Both Lil­ly and Sanofi pre­vi­ous­ly told End­points News that they sup­port the Sen­ate bill. And Sanofi re­cent­ly an­nounced it would match the $35 per month cap for some of its in­sulins.

Mean­while, in March, the US House of Rep­re­sen­ta­tives passed (by a vote of 232-193) gen­er­al­ly the same month­ly in­sulin cap along par­ty lines. But the CBO has since said that the Sen­ate bill would cost the fed­er­al gov­ern­ment $23 bil­lion over the next decade, which came to about dou­ble what the House ver­sion would cost.

While both the Sen­ate and the House bills ef­fec­tive­ly cut what many of those who re­ly on in­sulin to stay alive will pay at the phar­ma­cy counter, nei­ther one hits the prices set by the phar­ma man­u­fac­tur­ers, nor does it help those who are unin­sured.

If you work in cancer biomarker and target research, chances are you use data from The Cancer Genome Atlas (TCGA) to help you make discoveries. This comprehensive and coordinated effort helps accelerate our understanding of the molecular causes of cancer through genomic analyses, including large-scale genome sequencing. TCGA covers 33 types of cancer with multi-omics data, such as RNA-seq, DNA-seq, copy number, microRNA-seq, and others. Detailed analyses of individual TCGA datasets, as well as pan-cancer meta-analysis, have revealed new cancer subtypes with important therapeutic implications. A key value here is the TCGA metadata.  TCGA samples include extensive clinical metadata for diverse cancers. However, inconsistent terminology and formatting limit the utility of these data for pan-cancer analyses.

The first slice of data has arrived from a dose escalating study of Intellia’s in vivo CRISPR treatment for hereditary angioedema, and it’s a promising first step toward a potential once-and-done therapy.

The CRISPR crew at Intellia $NTLA reported Friday morning that six HAE patients treated with either the low 25 mg dose or the high 75 mg dose of NTLA-2002 experienced a 65% and 92% mean reduction in plasma kallikrein. The low-dose group experienced a 91% reduction in HAE attacks after the drug was used to knock out the KLKB1 gene in liver cells.

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Although “pay-for-delay” agreements and other egregious generic-blocking tactics may be in the rearview mirror, a new report from the nonprofit I-Mak explains how companies are still looking to protect the next generation of blockbusters with piles of new patents.

While some industry insiders point to a broken system that incentivizes these dozens and dozens of new patents — on average there are 74 granted patents on each of America’s 10 top-selling drugs — drugmakers have filed more than 140 patent applications on average per drug, and about two-thirds of those filings came after the approval.

While Moderna has been focused on building out its manufacturing apparatus in North America, Europe and Africa, the company appears to be turning toward Japan for its next act.

According to a report from Nikkei Asia, Moderna CEO Stéphane Bancel said the company would like to build a facility in Japan as well as centralize all processes, including manufacturing, into a single facility.

While no other details on the manufacturing site were offered, such as location and timing, Bancel said the site would ideally manufacture vaccines for Covid-19, flu and other diseases. Endpoints News reached out to Moderna to get more details on the matter but they did not respond by press time.

The Department of Health and Human Services is taking the next step in its campaign to encourage Covid-19 vaccinations. The new fall “We Can Do This” ads move past the initial message to get a vaccine and asks Americans — especially people aged 50 and older — to get an “updated vaccine.”

Updated or bivalent boosters are the newer Pfizer-BioNTech and Moderna vaccines that add Omicron BA.4 and BA.5 components to the original vaccine — the CDC and HHS both recommended the shots earlier this month.

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GSK now has dozens more Zantac lawsuits to contend with.

Plaintiffs on Wednesday filed 88 suits against GSK in Delaware court on behalf of more than 7,000 claimants who allege the popular ranitidine heartburn products caused a range of cancers. Pfizer, Boehringer Ingelheim and Sanofi, which owned Zantac rights at various points in time, were also named in the suit, in addition to Thermo Fisher’s Patheon Manufacturing Services.

WARN notices in California have shed light on some of the inner workings of biotech and pharma — and newly unveiled notices point at two of the industry’s largest players.

AbbVie and Bristol Myers Squibb separately notified the state earlier this week that they plan on letting go 360 employees combined by the end of November — almost 100 at AbbVie and the rest from Bristol Myers.

AbbVie did not respond to repeated attempts for clarification from Endpoints News.

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Illinois-based pharma company Akorn, which filed for bankruptcy back in 2020, has now agreed to pay $7.9 million to resolve allegations that it caused Medicare to pay false claims related to generic drugs that had already transitioned to OTC products.

As part of the settlement, the DOJ said Akorn admitted to delaying its conversion of certain generics — the NSAID pain drug diclofenac, and the antihistamines olopatadine and azelastine — from prescription-only to OTC status.

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While CMS drug price negotiations won’t actually kick off until 2026, a group of more than two dozen Republican senators is already raising questions about how this new law will be implemented.

The partisan law (all Democrats in the House and Senate voted for it, and all Republicans voted against it) includes not only Medicare price negotiations but mandatory inflation-related rebates that will begin next year, as well as million-dollar fines for noncompliance.

Bioscience & Technology Business Center The University of Kansas Lawrence, Kansas

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