ICER to Review RA Therapies, Including Biosimilar Infliximab

The Institute for Clinical and Economic Review (ICER), a nonprofit organization that produces reports analyzing evidence on the effectiveness and value of drugs, has released a draft scoping document for the assessment of treatments for rheumatoid arthritis (RA).

The new assessment, says ICER, is intended to incorporate data that have emerged since the organization reviewed RA treatments in 2017, including data related to biosimilar infliximab, Inflectra.

While ICER said it will not perform a detailed economic analysis of biosimilars available for the treatment of RA, it will present data on biosimilars. These data will be presented separately from those related to innovator products, given differences present in biosimilars’ clinical study designs and intents relative to those of originator products. ICER says that it will explore the potential health system budgetary impact of biosimilar infliximab over a 5-year time horizon using available information on the potential population eligible for treatment and results from a simulation model for treatment costs.

The organization also notes that it will include information on wasteful or low-value services that can be reduced or eliminated to create additional resources in healthcare budgets for higher-value or innovative services.

ICER’s 2017 review of RA therapies, which focused on 11 drugs (adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, abatacept, rituximab, sarilumab, tocilizumab, baricitinib, and tofacitinib), found that all of these products substantially improve patients’ health outcomes versus conventional disease-modifying antirheumatic drugs (DMARDs). However, these agents’ costs translate into cost-effectiveness estimates that exceed commonly cited thresholds.

Assuming a willingness to pay threshold of $150,000 per quality of life-year (QALY) gained, etanercept given in combination with a conventional DMARD was found to be cost-effective as a first-line therapy. Other drugs, including abatacept (in combination with a DMARD) and tofacitinib were estimated to have higher costs and fewer QALYs gained.

The 2017 report also called for regulatory intervention to curb the rising prices of these agents, which ICER said are “moving further from reasonable alignment with the added benefits to patients.”

Stakeholders are encouraged to submit their comments on the scoping document and on low-value care practices to ICER by May 1, 2019.