Home health remedies ICER says AbbVie’s Rinvoq for RA may be cost-effective but still questions...

ICER says AbbVie’s Rinvoq for RA may be cost-effective but still questions the value of JAK class

17
0
SHARE

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.

On-Demand Webinar

De-Risking the Solid Form Landscape of an API

This presentation will discuss how predictable stability and solubility can minimize development timelines and cost. Attend to hear about two case studies exemplifying the importance of understanding the hydration space of an API and how hydrate formation may be avoided by development of a robust crystallization procedure.

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.

RELATED: ICER pulls report blasting ‘marginal’ RA drugs, citing need to rethink its approach

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).

Spokespeople for Eli Lilly and AbbVie did not immediately respond to a request for comment from FiercePharma. 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.

RELATED: New RA drugs offer ‘marginal’ benefits at prices that are too high, ICER says

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.

Source link

LEAVE A REPLY

Please enter your comment!
Please enter your name here

3 × four =