A few days after blasting three next-generation JAK inhibitors to treat rheumatoid arthritis for offering “marginal” clinical benefits over AbbVie’s Humira, drug-cost watchdog Institute for Clinical and Economic Review (ICER) took the unusual step of pulling the report, citing the need to change its methodology. Now, the new draft report on RA drugs is out, and ICER has reversed its negative stance on one of those products: AbbVie’s Rinvoq, the company’s all-important Humira follow-up.
ICER made a few key changes in the new analysis. The reviewers changed their assumptions about how doctors treat RA patients to reflect that when patients fail one drug, they transition to a basket of targeted immune modulators—not to palliative care, as the previous model assumed. ICER also factored in a 16% loss in the efficacy of treatment whenever patients moved from a first-line to a second-line immune modulator.
Instead of analyzing the costs of the medicines over a lifetime, ICER changed the time horizon of treatment to one year. And the new assessment calculated long-term cost-effectiveness of Rinvoq based on an assumed net price that matches the current net price of Humira and that reflects the average discount of the other two JAK inhibitors.
Those changes were enough to bring the cost burden of Rinvoq below ICER’s threshold for cost-effectiveness, which is $150,000 per quality-adjusted life-year (QALY) gained. ICER determined the cost-effectiveness ratio for Rinvoq vs. Humira would be $92,000 per QALY.
ICER still had trouble assessing the other two JAK inhibitors, Pfizer’s Xeljanz and Eli Lilly and Incyte’s Olumiant, though. The agency acknowledged that all of the JAK inhibitors were superior to older drugs when it came to putting patients into remission at 12 weeks. But ICER’s reviewers cited a lack of data—specifically head-to-head data—comparing Olumiant and Xeljanz to other JAK inhibitors or to Humira.
As a result, ICER is no longer suggesting that Xeljanz’s benefits over Humira are just “marginal” as it did in the initial draft, but instead it’s lamenting the inability to fully determine the value of Rinvoq’s rivals. “This is more a limitation of the data than the model and does not inform what clinicians or policymakers would like to know: the most cost-effective choice among the three JAK inhibitors,” according to the new draft report (PDF).
AbbVie did not immediately respond to a request for comment from FiercePharma.
Eli Lilly is currently evaluating whether or not it will provide feedback to ICER on the new report, a spokesperson told FiercePharma in an email. "We remain committed to working closely with ICER to ensure the appropriate and scientifically sound assessment of Olumiant and RA medicines at large," she said.
A spokesperson for Pfizer repeated what the company said after ICER released the first draft of the RA assessment, which is that it would provide feedback that it hopes the agency will use for the final assessment. ICER’s final draft of the report is now scheduled to be published on November 26.
If Rinvoq scores ICER’s final blessing, it could ease the marketing challenge AbbVie is facing—and make it easier for the company to pull in the $2.2 billion in annual sales that analysts are expecting for the product by 2023. Rinvoq’s success is imperative as the $20-billion-per-year Humira starts getting hammered by biosimilar competition.
Safety concerns are already complicating the sales challenge for all three makers of JAK inhibitors. When the FDA approved Rinvoq in August, the green light came with a dreaded black-box warning of an increased risk of malignancy, thrombosis and infections. Xeljanz and Olumiant bear similar warnings.
Because of the delay caused by ICER’s about-face on the original draft report, it has extended the deadline for public comments on the RA report to November 8. One of ICER’s independent appraisal groups will hold a public meeting to discuss the final assessment on December 9.
Editor's note: This story has been updated to include a response from Eli Lilly.