The nonprofit Institute for Clinical and Economic Review on Wednesday released a new report highlighting the ways in which payers are generally ensuring fair access to prescription drugs, even when based on a set of criteria set by the nonprofit.
While noting the lack of transparency hindered the report’s results, ICER said that the ‘great majority’ of payer policies in the formularies evaluated are structured in a way to support many key elements of how ICER defines ‘fair access.’
The report, which ICER called ‘an exploratory analysis intended to chart a roadmap for future research,’ dug into a list of 28 drugs considered ‘fairly priced’ by ICER and the cost-containment org reviewed how fairly different payers covered the drugs. The list (see below) includes three seemingly expensive new drugs: Novartis’ $1.6 million Zolgensma treatment for spinal muscular atrophy, and Kymriah, its $475,000 cancer drug, and Kite’s $373,000 Yescarta.
Then ICER looked into data from the largest formularies and coverage policies among 15 of the largest commercial payers (by covered lives) in the US, including CVS Health (Aetna) and Express Scripts. The available coverage policies on these drugs were evaluated to determine whether they meet a set of ‘fair access’ criteria, including patient cost sharing, clinical eligibility criteria, restrictions on prescriber qualifications, and step therapy (i.e. trying less expensive options before ‘stepping up’ to drugs that cost more).
Overall, the number of drug-formulary policies meeting ICER’s ‘fair access’ criteria was very high, although in some cases the policy wasn’t available. There was also very high concordance across all 15 formularies and for the list of drugs on fair access criteria for clinical eligibility criteria, step therapy, and prescriber restrictions.
‘Because overall concordance with the fair access criteria was so high, there is little variation across drugs by which to explore correlation with features of the drug, drug class, or condition,’ the report said. ICER also revealed that coverage policies made by six payers were changed following discussion of the report’s draft results.
But the findings for one drug, Genentech’s Hemlibra, ‘stands out,’ ICER said, adding:
The single drug with notably lower rates of concordance across cost sharing, clinical eligibility criteria, and step therapy, is emicizumab for hemophilia A. This is one of the most expensive drugs among those in this assessment, and it is used chronically, unlike the one-time CAR-T and gene therapy treatments that round out the most expensive drugs in this list. Emicizumab is also a drug for which there are alternative treatments, albeit treatments that are more expensive on an annual basis. Therefore, it may not be surprising that the utilization management of emicizumab is more restrictive than for other drugs in this assessment.
In its conclusion, ICER again pointed to the limitations of the available data around drug pricing as a reason for the report’s lack of completeness.
‘This assessment has been presented as much as a sign of the limitations in the evidence available to us – and to the public – as it has a report that can give important insights into the current status of insurance coverage for drugs in the US. As such, it is likely to fully satisfy no one,’ the nonprofit added. But it also made clear: ‘Payers should be accorded credit where credit is due: the evidence available and the limitations of our research effort leave many questions, but the great majority of payer policies in the formularies evaluated are structured in a way to support many key elements of fair access.’
While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.
Stéphane Bancel, Moderna CEO
Even as public health officials remain guarded about their comments on the likelihood Omicron will escape the reach of the currently approved Covid-19 vaccines, there’s growing scientific consensus that we’re facing a variant that threatens to overwhelm the vaccine barricades that have been erected.
Stéphane Bancel, the CEO of Moderna, one of the leading mRNA players whose quick vault into the markets with a highly effective vaccine created an instant multibillion-dollar market, added his voice to the rising chorus early Tuesday. According to Bancel, there will be a significant drop in efficacy when the average immune system is confronted by Omicron. The only question now is: How much?
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Reshma Kewalramani, Vertex CEO (Vertex via YouTube)
Vertex claimed its second early-stage win of the fall Wednesday, announcing positive results in a small study on a genetically defined form of kidney disease.
The 16-patient, Phase II trial focused on patients with focal segmental glomerulosclerosis, a rare disease where kidneys are unable to filter blood properly. Over 13 weeks on an experimental pill, the level of protein in the patients’ urine fell by an average of 47.6%.
In a first, China has featured insulin in its centralized drug procurement program — but the bulk order comes at a sizable cost for multinational pharma players.
Novo Nordisk, Sanofi and Eli Lilly were among eight companies, domestic and foreign, whose insulin products won tenders from the Chinese public hospital system. In exchange, the drugs’ prices were cut, on average, by 48%, saving the medical institutions a collective $1.4 billion on the first batch of 210 million doses, according to state media.
Paul Hudson, Sanofi CEO (Cyril Marcilhacy/Bloomberg via Getty Images)
Paul Hudson has spotlighted vaccines, immunology and dermatology as some of the top R&D focuses at Sanofi. His latest deal brings all of them together.
The French pharma giant isn’t sharing any financial details about the buyout of Origimm, a low-profile, private Austrian biotech whose technology promises to identify antigens causing skin disease and build vaccines against them. Their lead candidate targets acne vulgaris.
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Philip Dormitzer, new GSK global head of vaccines R&D
GlaxoSmithKline has appointed Philip Dormitzer, formerly chief scientific officer of Pfizer’s viral vaccines unit, as its newest global head of vaccines R&D, looking to leverage one of the leading minds behind Pfizer and BioNTech’s RNA collaboration that led to Covid-19 jab Comirnaty, the British drug giant said Tuesday.
Dormitzer had been with Pfizer for a little more than six years, joining up after a seven-year stint with Novartis, where he reached the role of US head of research and head of global virology for the company’s vaccines and diagnostics unit.
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In another setback for Biogen, the big biotech lost its appeal to revive a patent for the once-blockbuster drug Tecfidera, marking a likely conclusion to the case.
The US Court of Appeals for the Federal Circuit issued the ruling Tuesday morning, saying Biogen failed to satisfy the ‘written description’ requirement for patent law. As a result, Mylan-turned-Viatris will be able to sell its multiple sclerosis generic without fear of infringement and Biogen will have to find a new revenue driver elsewhere.
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After years as the top spending pharma TV advertiser, AbbVie’s Humira brand finally downshifted earlier this year, ceding much of its marketing budget to up-and-coming sibling meds Skyrizi and Rinvoq. However, now Humira is back on TV with ads for another condition — Hidradenitis suppurativa (HS).
The chronic and painful skin condition results in lumps and abscesses caused by inflammation or infection of sweat glands, most often in the armpits or groin. Humira was first approved to treat HS in 2015 and remains the only FDA-approved drug for the condition. Two TV ads both note more than 30,000 people with HS have been prescribed Humira.
https://endpts.com/whats-fair-new-icer-report-shows-payers-generally-ensuring-fair-access-to-drugs/
