When the Institute for Clinical and Economic Review (ICER) first released its draft report on the cost effectiveness of next-generation JAK inhibitors to treat rheumatoid arthritis, it blasted all three—Pfizer’s Xeljanz, AbbVie’s Rinvoq and Eli Lilly and Incyte’s Olumiant—for offering “marginal” clinical benefits at high prices. But just days into the public comment period, ICER took the unusual step of withdrawing the report and admitting the need to completely rethink its approach.
In the latest iteration of ICER’s draft report (PDF), released Tuesday in preparation for a Dec. 9 public meeting, AbbVie and Pfizer come off a bit better than they did before. Still, they and the seven other pharma companies that play in the RA space are unhappy with ICER’s methodology for determining the cost effectiveness of new drugs. The American College of Rheumatology and three patient advocacy organizations also have plenty of bones to pick with the cost-effectiveness watchdog.
In the end, ICER determined that Rinvoq offers “a small to substantial net health benefit” over AbbVie’s older RA drug, Humira, according to a statement. Thus, a value-based price for the drug would be $44,000 to $45,000. Rinvoq’s list price is $59,860, but if AbbVie is offering typical rebates and discounts, ICER said, the drug would end up in the value-based range.
ICER also said that Xeljanz offers a clinical benefit over Humira, but that it lacked the data necessary to assess Olumiant’s usefulness as a treatment. The agency could not calculate value-based price benchmarks for either drug, it said, because of a lack of head-to-head trials comparing them to Humira.
After it pulled its initial cost-effectiveness analysis of JAK inhibitors, ICER’s reviewers made a few key changes to their methodology. Instead of assuming that patients who failed their first-line treatment would be switched to palliative care, they factored in the standard real-world practice of moving those patients to a basket of targeted immune modulators. And rather than analyzing the cost of treatment over a lifetime, they changed the time horizon to one year.
That last change irked several of the pharma companies that were asked to provide feedback on the latest iteration of the report. “A longer time frame, beyond the one-year horizon used in the base case, would be more appropriate for capturing the long-term benefits of disease modifying drugs and the effect of switching seen over the course of long-term treatment,” J&J’s Janssen unit said in a comment that’s included in a separate ICER report (PDF).
“The one-year time horizon leads to misleading results of the model,” Lilly said in a comment. “RA is a chronic progressive disease with expected lifetime use” of disease-modifying treatments, the company added.
ICER responded that it had to use a one-year time horizon because of the uncertainty regarding the long-term impact of drug treatment for RA. The original lifetime horizon didn’t work because it over-emphasized the effect of second- and third-line treatments, it said.
“We explored options for modeling follow-on care to address the concern, but shortening the time horizon appeared to be the most reasonable and policy relevant choice, especially because our focus in this review is to compare the outcomes of initial biologic agents, a focus that gets greatly diffused in a lifetime model,” ICER said.
The drugmakers and patient advocacy organizations had plenty of other suggestions for how ICER could improve its approach to valuing RA drugs. AbbVie pointed out that ICER used only one of the five phase 3 trials of Rinvoq to compute cost effectiveness, and in so doing it excluded certain patient groups, including those who didn’t respond well to older generations of biologic treatments.
Bristol-Myers Squibb, maker of the RA drug Orencia, questioned why Humira was chosen as the only comparator drug when there are other products used in the first-line setting, such as Amgen’s Enbrel. ICER responded that it chose Humira because it was the most commonly used comparator in head-to-head trials of JAK inhibitors.
That said, ICER acknowledges that Humira itself may not be the best benchmark on which to assess the cost effectiveness of newer choices for RA. In October, ICER released a report naming Humira as the worst example of price increases that are not supported by clinical evidence. Therefore, Humira “itself may be priced above commonly cited cost-effectiveness thresholds,” the agency said in Tuesday's statement.
At the Dec. 9 public meeting, ICER plans to bring up the high prices of Humira and the new JAK inhibitors as part of a broader discussion of “what constitutes fair pricing for this class of drugs,” it said.