Steve Pearson, ICER president (Jeff Rumans for Endpoints News)
The Institute for Clinical and Economic Review on Tuesday morning released its latest on ‘unsupported’ drug price increases for seven top treatments, and how even after rebates and other concessions, these increases cost the US health system an additional $1.67 billion, including almost $1.4 billion from AbbVie’s Humira alone.
The authors of the report winnowed down a list of the top 250 drugs with the largest US net sales revenue in 2020 to just 10 drugs and assessed whether there was even the potential for evidentiary support to back the price increases.
Overall, the report notes that net price increases for the drugs reviewed ‘were mostly lower than in prior years’ of creating the report, and ‘year-over-year price increases have slowed considerably since ICER began assessing Unsupported Price Increases’ in 2017. ICER said it’s ‘encouraged to see this moderation of price increases and to be part of the milieu in which this moderation has occurred, but also notes that some drugs continued to have unsupported price increases with very large impacts on US spending.’
While this year’s $1.67 billion total is larger than the $1.2 billion estimate from seven drugs with unsupported price increases seen in last year’s report, ICER acknowledges that ‘this is due, in greatest part, to the $1.4 billion increase in spending due to unsupported net price increases for’ Humira, the best-selling drug of all time. And while Humira’s net price has increased by almost 30% in the US over the past four years, its price in Europe has declined due to biosimilar competition.
In evaluating whether Humira had new clinical evidence to support its continued price increases, the report notes, ‘Of the 54 references submitted by the manufacturer, seven articles were duplicates, and 23 articles were excluded because they did not meet our UPI review criteria … Of the remaining 24 articles, 18 presented previously known information about adalimumab, while the remaining six studies were considered low quality.’
And interestingly, many of the drugs on this year’s list were not included in last year’s report.
As far as the three drugs of the final 10 that were not selected, ICER added:
The three drugs assessed that did have new important positive clinical evidence were Venclexta (venetoclax, AbbVie), Cimzia (certolizumab pegol, UCB), and Entresto (sacubitril/valsartan, Novartis); the evidence used to justify Entresto’s price increase was the same evidence used to justify its prior year’s price increase. Importantly, however, ICER’s determination that new evidence exists for these three treatments should not be interpreted to mean that the new evidence justifies the level of price increase; a full cost-effectiveness assessment was not conducted.
For years, paper-based processes and individual point solutions dominated the clinical research landscape, and patient participation in clinical trials was largely an in-person engagement. But when the COVID-19 pandemic took a stronghold, traditional clinical trial methods emerged as inadequate, putting clinical trials and the life sciences industry at a crossroads. Practically overnight, the industry had to rapidly shift to decentralized clinical trial methods, while maintaining data quality and regulatory compliance.
Chiquita Brooks-LaSure (Photo by Caroline Brehman/CQ Roll Call via AP Images)
Although sales of Biogen’s expensive new Alzheimer’s drug have been anemic since the approval in June, the prospect of CMS eventually paying for it opens up a billion-dollar can of worms, and already has the agency defending some premium and deductible increases for seniors.
CMS explained late Friday that Medicare Part B will have to increase its standard monthly premium — from $148.50 in 2021 to $170.10 in 2022 — in part because of the massive spending that could occur should the agency sign off on a national coverage decision for the drug, known as Aduhelm, and its $56,000 annual price tag next year.
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Al Sandrock (Biogen via Youtube)
Two years after Al Sandrock jumped from CMO to the top post in R&D — and just months after the hyper-controversial approval of the experimental Alzheimer’s drug aducanumab (Aduhelm) — Sandrock is planning to step out of his long career at Biogen.
Late Monday evening the big biotech put out word that Sandrock, a longtime fixture in the company after a 23-year stint, is hitting the exit.
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Shao-Lee Lin, Acelyrin CEO
When Acelyrin closed its Series A late last year, it was met with little fanfare. The biotech had only two employees, the former R&D chief and CBO of Horizon Therapeutics, and didn’t even disclose the size of the raise. Westlake Village BioPartners, an LA-based VC firm and lead investor, proved the most noteworthy aspect of the announcement, having spawned from ex-Amgen R&D head Sean Harper and ex-Kleiner Perkins life sciences director Beth Seidenberg.
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Demand for life science real estate is surging in China — and one of Asia’s largest investment groups is rising to the call.
CBC Group — the startup engine that recently lured in Merck’s former R&D chief Roger Perlmutter — is joining forces with Netherlands Pension provider APG Asset Management to launch a new Asia-Pacific healthcare platform and China-focused life science venture.
The fund, dubbed CBC China Life Science Infrastructure Venture (CLSIV), completed a first close of $500 million to provide ‘best-in-class facilities’ for research in China. CBC describes it as the vehicle by which the platform, CBC Healthcare Infrastructure Platform (CBC HIP), will operate.
Glen de Vries (Patrick T. Fallon/AFP via Getty Images)
Glen de Vries, the co-founder of the clinical IT software giant Medidata Solutions, died in a plane crash last week.
Emergency crews found the wreckage of a Cessna 172 in a wooded area in northern New Jersey on Thursday. De Vries was an instrument-rated private pilot, though authorities have not yet said who was piloting the plane. He was with his flight instructor Thomas Fischer, 54, and the plane was headed to Sussex Airport from Essex County Airport in Caldwell. He had started his private pilot training with Fischer in February 2016. Fischer opened the flight school with his wife Jodi in March 2012.
To Amanda Wagner, the past two years or so she’s spent at Immunitas feels like a microcosm of her entire career up to now.
Trained in neuroscience and equipped with an MBA, Wagner’s 16-year biopharma career could be split into a first half in R&D and a second in corporate finance and business development. She was consulting for the Longwood Fund in 2019 when the VC firm pulled her aside to talk about a new immuno-oncology company it was incubating.
Millions of people stuck at home during the pandemic took on do-it-yourself home projects. Now Merck wants them to turn the tables on themselves and get back to self-care.
The ‘Do it For Yourself’ campaign encourages people to pay attention to potential lung cancer symptoms such as prolonged unexplained cough or continuous shortness of breath.
While health checks dropped precipitously during the pandemic, cancer screenings were especially hard hit. Screenings for lung cancer, which is the leading cause of cancer deaths in the US, decreased by 50% in 2020, said Kristen Drake, Merck executive director, global communications.
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Kala Pharmaceuticals continued their transition to a commercial-stage biotech late last year with its second OK after a long slog through the clinic. Now the biotech’s execs are turning to M&A to grow the company.
The Watertown, MA eye-focused biotech announced its acquisition of private ocular biotech Combangio this morning. Combangio, a California biotech which has remained under the radar, was in the middle of developing a secretome therapy — and had recently finished a Phase Ib trial, enrolling 8 patients with persistent corneal epithelial defect, or PCED with positive results.
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