In an unusual move, ICER rescinds draft report on JAK drugs for rheumatoid arthritis to revise its modeling approach
Two years ago, the Institute for Clinical and Economic Review (ICER) admonished AbbVie for overpricing the best-selling drug in the world — Humira — along with the raft of rival drugs approved for rheumatoid arthritis. On Wednesday, the influential cost-effectiveness watchdog rescinded its draft report on the new crop of JAK inhibitors, saying it was revisiting the modeling approach it employed in the analysis published in late September.
The review encompassed Eli Lilly’s baricitinib (branded as Olumiant), Pfizer’s tofacitinib (sold as Xeljanz) and AbbVie’s recently approved upadacitinib (christened Rinvoq).
In the draft report, published September 26, ICER sought to evaluate the cost-effectiveness of the three JAK inhibitors versus the established anti-TNF Humira (known chemically as adalimumab) — but found it could only make the comparison with the new AbbVie treatment, due to a paucity of comparator data on the other two JAK treatments.
“Our base-case findings suggest that upadacitinib provides marginal clinical benefit in comparison to adalimumab, at higher costs. Together, these outcomes translate into cost-effectiveness estimates that exceed commonly cited cost-utility thresholds,” the reviewers wrote. “Results from the indirect modeling comparison of tofacitinib to adalimumab suggest that for the marginal benefit tofacitinib offers, prices for this drug much higher than the price of adalimumab may not be justified.”
Then, on Wednesday, ICER issued a brief statement suggesting it was reevaluating the modeling approach used in the draft evidence report. A new draft report will be published in the coming days, the agency said.
The unusual move comes at a time when ICER is, in any case, reassessing its methods. In December, the institute is expected to update the framework that underpins its evidence reports on new drugs and other health care interventions. ICER last updated its value assessment framework in June 2017, and also created a fresh approach to evaluating ultra-rare orphan drugs in November 2017.
In July, the agency in its review of Duchenne muscular dystrophy treatments acknowledged it had used significantly higher price estimates for two therapies in its models — versus the estimates used in their draft report in May. When queried by Endpoints News, ICER suggested the numbers used in the May report were incorrect.
Akin to NICE in the UK, ICER is an independent body that analyzes the cost-effectiveness of drugs and other medical services in the United States. Unlike NICE, though, ICER is not government-affiliated, but its determinations are increasingly gaining traction with payers.
Each of the drugs reviewed in the rescinded report belong to a family of medicines called Janus kinase (JAK) inhibitors — which have been plagued with safety concerns. Named after the two-faced Roman God Janus, the family consists of four enzymes: JAK1, JAK2, JAK3 and TYK2, which are associated with cytokine receptors on the surface of cells and form part of a pathway involved in inflammatory and immune responses.
Pfizer’s JAK1/JAK3 inhibitor — Xeljanz — has been blighted by regulatory restrictions after the higher dose of the blockbuster drug was found to be associated with the risk of blood clots and death. Lilly’s $LLY JAK1/JAK2 Olumiant, meanwhile, was initially rejected by the US agency due to safety concerns — only to eventually secure approval for the lower dose. Lilly’s partner, Incyte $INCY, elected to walk away from co-funding the drug’s development as fears about the benefit-risk profile of the class of drugs accumulated. In August, AbbVie’s $ABBV JAK1 upadacitinib was cleared by the FDA for rheumatoid arthritis with a black box warning.