Just five days after releasing a 145-page draft report suggesting that three next-generation treatments for rheumatoid arthritis would be unlikely to be cost-effective, the Institute for Clinical and Economic Review (ICER) has taken the unusual step of backtracking on its own number crunching.
ICER posted a brief statement on its website saying it is “reevaluating its approach” to the initial report it released on RA drugs, which was primarily aimed at assessing three JAK inhibitors that recently hit the market: AbbVie’s Humira follow-up Rinvoq, Pfizer’s Xeljanz, and Eli Lilly and Incyte’s Olumiant. The first draft suggested that Rinvoq and Xeljanz offer “marginal” clinical benefits and that there isn’t enough data on Olumiant to do a proper cost-effectiveness analysis on it.
This is generally the part of the process where drugmakers weigh in on ICER’s initial conclusions—feedback that the agency uses to develop a revised draft, and then after that a final set of recommendations. But ICER's vice president of communications and outreach, David Whitrap, told FiercePharma that the agency determined in the last few days that it needed to “reevaluate the modeling approach” immediately.
“Through discussions among our internal experts, we believe we have developed an approach to modeling these treatments in a manner that will be more accurate and reflective of real-world medical practice than what we had previously conceived,” Whitrap said in an email. “And instead of waiting until our Revised Evidence Report to make this adjustment, we felt the most appropriate approach in this scenario would be to issue a preliminary revision so that stakeholders and the general public will have more time to react to this improved method.”
In other words, ICER decided to hit rewind and start all over again.
A Lilly spokesperson told FiercePharma the company received an email Tuesday from ICER about the decision to pull the draft report but that it cannot provide further comment. Spokespeople from Pfizer and AbbVie did not immediately respond to requests for comments. A spokesperson for Pfizer said last week that the company intended to provide feedback to ICER that its executives hoped the agency would take into account before finalizing its recommendations on RA drugs.
Perhaps it’s not surprising ICER got some pushback after last week’s release. The first draft report acknowledged that significantly more patients who were taking JAK inhibitors achieved remission or low disease activity after three months than did people taking the old standard of care, methotrexate. But ICER’s reviewers said they didn’t find enough evidence to compare more commonly used combination treatments: methotrexate plus JAK inhibitors vs. methotrexate plus Humira.
Nor did they have enough head-to-head data comparing the new drugs to each other. That led ICER’s reviewers to slap the “marginal” label on Xeljanz and Rinvoq and to shrug their shoulders when it came to Olumiant. Ultimately ICER questioned whether the newer drugs would be cost-effective if they were priced above Humira, which is now facing competition from low-cost biosimilars.
ICER did take a different approach to reviewing the new class of RA drugs than it had back in 2017, when it determined that Humira—the world’s best-selling drug at $20 billion per year—wasn’t worth its price. For this review of JAK inhibitors, ICER said, it focused on how well the drugs did in putting patients into remission at three months. That change was necessary, its reviewers determined, because physicians treating RA generally switch patients to different therapies if they don’t achieve remission or low disease activity at the 12-week mark.
So what additional changes does ICER plan to make to more accurately reflect the real-world treatment of RA? Stay tuned. ICER plans to release a new first draft in the coming days, Whitrap said. Then it will take comments on the report again, issue a revised draft and hold a public meeting to discuss it on November 19 before finalizing its cost-effectiveness analysis.