ICER Releases Evidence Report on JAK Inhibitors to Treat Rheumatoid Arthritis

— Using adalimumab as the comparator, upadacitinib’s value-based price benchmark is between $44,000-$45,000 per year; at December 9 public meeting, experts will also review the already high prices of adalimumab and other RA treatments when discussing what constitutes fair pricing for this class of drugs —

BOSTON, November 26, 2019 – The Institute for Clinical and Economic Review (ICER) today released an Evidence Report assessing the comparative clinical effectiveness and economic value of JAK inhibitors for treating rheumatoid arthritis (RA). These therapies include upadacitinib (Rinvoq®, AbbVie), tofacitinib (Xeljanz®, Pfizer), and baricitinib (Olumiant®, Eli Lilly).

“Rheumatoid arthritis is a progressively disabling condition, and patients are fortunate to have multiple therapy options that are this effective at slowing disease progression,” said Pamela Bradt, MD, MPH, ICER’s Chief Scientific Officer. “Our evidence review suggests that upadacitinib is modestly more effective than adalimumab, whereas the evidence cannot demonstrate added effectiveness for tofacitinib, and we found no evidence with which to compare baricitinib to adalimumab. Policymakers will need to consider how to judge the value of a new treatment when its direct competitors are not fairly priced to begin with.”

This Evidence Report will be reviewed at an upcoming public meeting of the California Technology Assessment Forum (CTAF), in Oakland, CA on December 9, 2019. The CTAF is one of ICER’s three independent evidence appraisal committees comprising medical evidence experts, practicing clinicians, methodologists, and leaders in patient engagement and advocacy.

Register here to attend the CTAF meeting in person or to watch by live webcast.

A draft version of this report was previously open for a four-week public comment period. Consistent with our model transparency program, ICER was able to use the hēRo3 platform to securely share the economic model with manufacturers to better inform their public comments on this draft report. The updated Evidence Report and voting questions reflect changes made based on comments received from patient groups, clinicians, drug manufacturers, and other stakeholders. Detailed responses to public comments can be found here.

Key Clinical Findings

A head-to-head trial comparing upadacitinib to adalimumab (Humira®, AbbVie) shows that upadacitinib is associated with statistically-significant but modestly higher rates of disease remission and improvement in other important outcomes – evidence that provides moderate certainty that upadacitinib offers a small to substantial net health benefit over adalimumab. Separate evidence provides high certainty that tofacitinib offers a comparable net health benefit to adalimumab, and there is no evidence to compare baricitinib to adalimumab.

When comparing the JAK inhibitors to conventional Disease Modifying Antirheumatic Drugs (cDMARDs), the evidence provides high certainty that both upadacitinib and tofacitinib offer a substantial net health benefit. Evidence is insufficient to compare baricitinib to the cDMARDs.

Key Cost-Effectiveness Findings

ICER’s economic modeling shows that upadacitinib plus a cDMARD achieves marginally higher quality of life than what is achieved with adalimumab plus a cDMARD, at similar costs. Based on this comparison with adalimumab, ICER’s value-based price benchmark range for upadacitinib is between $44,000 and $45,000. This benchmark represents a 25-26% discount off of upadacitinib’s annual list price of $59,860, a suggested discount that is consistent with the rebates we assume the manufacturer is currently offering.

ICER’s value-based price benchmarks suggest a price range, net of any discounts and rebates, that aligns fairly with a treatment’s added benefits for patients over their lifetime. The ranges reflect commonly cited cost-effectiveness thresholds between $100,000 and $150,000 per Quality-Adjusted Life Year (QALY) gained. New interventions introduced at or below these thresholds help maximize health overall, because they do not contribute to affordability concerns and loss of insurance throughout the health system.

Because upadacitinib does not appear to lengthen patients’ lives when compared to adalimumab, ICER did not calculate what price would be needed to reach alternative thresholds based on Equal Value of Life Years Gained (evLYG).

Due to insufficient head-to-head evidence against adalimumab, ICER did not calculate value-based price benchmarks for either tofacitinib or baricitinib.

An Important Note About Using Adalimumab as a Comparator

Despite upadacitinib achieving common thresholds for cost-effectiveness when compared to adalimumab, all stakeholders should remember that ICER’s 2017 review of treatments for rheumatoid arthritis found that adalimumab itself may be priced above commonly cited cost-effectiveness thresholds. In addition, ICER’s 2019 assessment of unsupported price increases found that adalimumab’s price increases since 2017 represent the costliest for the US health system among all prescription drugs, and that these increases were not supported by new important evidence of additional benefit.

About ICER

The Institute for Clinical and Economic Review (ICER) is an independent non-profit research institute that produces reports analyzing the evidence on the effectiveness and value of drugs and other medical services. ICER’s reports include evidence-based calculations of prices for new drugs that accurately reflect the degree of improvement expected in long-term patient outcomes, while also highlighting price levels that might contribute to unaffordable short-term cost growth for the overall health care system.

ICER’s reports incorporate extensive input from all stakeholders and are the subject of public hearings through three core programs: the California Technology Assessment Forum (CTAF), the Midwest Comparative Effectiveness Public Advisory Council (Midwest CEPAC), and the New England Comparative Effectiveness Public Advisory Council (New England CEPAC). These independent panels review ICER’s reports at public meetings to deliberate on the evidence and develop recommendations for how patients, clinicians, insurers, and policymakers can improve the quality and value of health care. For more information about ICER, please visit ICER’s website.