ICER to Assess Treatments for Ulcerative Colitis, Including Biosimilar Infliximab

The Institute for Clinical and Economic Review (ICER) said this week it will review the comparative clinical effectiveness and value of therapies for ulcerative colitis (UC), including the reference infliximab product from Johnson & Johnson and biosimilar infliximab from Pfizer.

The assessment will be publicly discussed during a meeting of the California Technology Assessment Forum (CTAF) in June 2020, where the independent evidence review panel will deliberate and vote on evidence in the report.

The majority of the drugs that ICER is assessing are approved for UC in the United States. Two of the UC drugs that will be assessed are brand-name infliximab, sold as Remicade by Janssen, a unit of Johnson & Johnson, and the biosimilar infliximab from Pfizer, Inflectra.

ICER will also evaluate vedolizumab (sold as Entyvio by Takeda), in both subcutaneous and intravenous formulations; Takeda is seeking FDA approval for a subcutaneous version of vedolizumab.

ICER will also look at Janssen’s ustekinumab, sold under the name Stelara, which is approved for moderate-to-severe plaque psoriasis, active psoriatic arthritis, and moderately to severely active Crohn disease; the company is also seeking an indication expansion for UC in the United States. Earlier this month, the European Commission cleared Stelara for the treatment of moderate-to-severe UC.

The other drugs to be assessed are reference adalimumab, sold as Humira by AbbVie; golimumab (Simponi, Janssen); and tofacitinib (Xeljanz, Pfizer).

ICER has gained prominence for issuing reports that seek to change the ways in which new prescription drugs are evaluated and priced, and its work is backed by funding from the Laura and John Arnold Foundation. Over the past dozen years or so, ICER has seen a jump in the number of reports that it issues; perhaps not unsurprisingly, this has coincided with an increase in the number of high-cost therapies.

A study published last spring by the Crohn’s and Colitis Foundation found that patients with inflammatory bowel disease, including UC, had a high burden of costs, especially in the first year after the initial diagnosis.

ICER said that it will contact patient groups and clinical experts to gain further insights on the patient perspective and clinical context of treating UC; it will accept open input until September 24 and a draft scoping document will be available September 27.

Infliximab is also part of ICER’s review of therapies for rheumatoid arthritis; CTAF will review that evidence on November 19.