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, including the reference infliximab product from Johnson & Johnson and biosimilar infliximab from Pfizer.
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.
Eye on Pharma: BI Cyltezo Partnership; Europe Ustekinumab Launch; Mexico Biosimilar Approval
July 24th 2024Boehringer Ingelheim (BI) partners with GoodRx to offer its unbranded adalimumab biosimilar to patients at an exclusive low price; a new ustekinumab biosimilar launches in Europe; and Mexican officials approve a bevacizumab biosimilar.
Biosimilars in America: Overcoming Barriers and Maximizing Impact
July 21st 2024Join us as we explore the complexities of the US biosimilars market, discussing legislative influences, payer and provider adoption factors, and strategies to overcome industry challenges with expert insights from Kyle Noonan, PharmD, MS, value & access strategy manager at Cencora.
Real-World Study: No Increase in Health Resource Costs After Infliximab Biosimilar Introduction
July 20th 2024Although biosimilars reduce drug purchasing costs for hospitals, it’s unclear whether those savings might be offset by increased health resource utilization following a non-medical switching initiative.
Biosimilars Gastroenterology Roundup for May 2024—Podcast Edition
June 2nd 2024On this episode of Not So Different, we review the biggest gastroenterology biosimilar stories from May 2024, covering new data from conferences and journals on infliximab and adalimumab products that demonstrate positive clinical results and confirm the safety of these biosimilars, as well as the feasibility of switching to them.
Hesitancy in MENA Nations to Adopt WHO Biosimilar Guidelines Hinders Market Development
July 17th 2024The World Health Organization’s (WHO) new guidelines for biosimilar approvals aim to save time and money for manufacturers in the Middle East and North Africa (MENA), but hesitancy among nations to adopt the guidelines is stifling market development of biosimilars.
BioRationality: Time to Get Rid of PBMs if Biosimilars Are to Succeed
July 15th 2024Sarfaraz K. Niazi, PhD, discusses the challenges with pharmacy benefit managers (PBMs) that plague the biosimilar industry and new legislation that attempts to reform their practices and encourage biosimilar adoption.