The cost-effectiveness watchdog Institute for Clinical and Economic Review (ICER) said two years ago that rheumatoid arthritis drugs like AbbVie’s top-selling TNF inhibitor Humira aren’t worth their high prices. But now, with several new options on the market, ICER's gone in for another round of number-crunching.
The verdict? ICER figures three next-gen drugs—including AbbVie's Humira followup Rinvoq—are unlikely to be cost-effective if they’re priced higher than Humira, judging by the clinical trial data now available, at least.
ICER made that determination in a draft report (PDF) now open for comment till Oct. 24. The final analysis could complicate what's already been a challenging launch for the three drugs, which form the JAK inhibitor class: Pfizer’s Xeljanz, Eli Lilly and Incyte’s Olumiant and AbbVie’s Rinvoq.
A spokesperson for Pfizer said the company intends to provide feedback to ICER and hopes the organization will take it into account before finalizing its recommendations. AbbVie and Lilly did not immediately respond to requests for comment from FiercePharma.
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ICER said in its report that in addition to looking at prices, it focused on the ability of the drugs to put RA patients into remission at three months, or at least to tamp down their symptoms to the point where they’re classified as “low disease activity.”
That’s because the proliferation of new RA drugs has changed how physicians treat the disease, and patients who don’t get significant relief after three months are usually switched to a different immune-modulating therapy.
ICER’s reviewers found that “substantially greater” numbers of patients taking JAK inhibitors achieved remission or low disease activity at 12 weeks than did those taking older drugs like methotrexate alone. But when they compared combinations of methotrexate with either JAK inhibitors or Humira, they didn’t find enough data to be able to say definitively that there was much of a difference in symptom improvement at three months.
Therefore, they concluded AbbVie’s Rinvoq provided only “marginal clinical benefit” over Humira, which is set to face biosimilars in 2023. Rinvoq’s list price is $59,000, and ICER estimated that after discounts the price would come to $44,035. But even then the cost of Rinvoq would exceed $150,000 per quality-adjusted life year gained, which is ICER’s threshold for cost-effectiveness.
As for Pfizer’s Xeljanz, its benefits over Humira are also marginal, and “prices for this drug much higher than the price of [Humira] may not be justified," the report stated. Olumiant, meanwhile, is only approved for use in people who've failed on a TNF inhibitor like Humira. That made it difficult to do a comprehensive cost-effectiveness analysis on the drug, ICER said.
What’s more, ICER did not have enough evidence to compare the three JAK inhibitors to one another, because the “clinical trials had somewhat different patient populations, primary endpoints, timing of assessments, and timing of allowable switching to alternative therapies,” the report said.
If any of the makers of JAK inhibitors has the most to lose from ICER’s critique, it’s likely AbbVie. Analysts are expecting Rinvoq to rack up $2.2 billion in annual sales by 2023. But even that won’t be enough to make up for the drop in revenues expected as the $20 billion-per-year Humira starts losing ground to biosimilar competition.
AbbVie is already facing one big marketing hurdle with Rinvoq: safety concerns. The FDA slapped a black-box warning on the product citing an increased risk of thrombosis, malignancy and infections, despite the fact that thrombosis didn’t emerge as a concern during the pivotal clinical trials. It’s similar to a warning on the labels for Xeljanz and Olumiant, though—a strong signal that the FDA has serious concerns about the safety of JAK inhibitors in general.