The Reimbursement Status of Ustekinumab Across HTAs: A Global Perspective

Author(s)

Kunal Shastri, MSc1, Kerise Clarke, MSc2, Bo Ren Long, MsC2, Margaret H. Ainslie-Garcia, MSc2.
1Fresenius Kabi SwissBioSim GmbH, Eysins, Switzerland, 2EVERSANA, Burlington, ON, Canada.
OBJECTIVES: Health technology assessment (HTA) agencies assess the economic value and impact of new therapies to inform reimbursement. Ustekinumab is an effective and safe IL-12/IL-23 inhibitor indicated for the treatment of plaque psoriasis (PsO), psoriatic arthritis (PsA), Crohn’s disease (CD), and ulcerative colitis (UC). However, data has shown that the reference product is associated with a high cost. This study assessed the HTA reimbursement decisions of ustekinumab’s reference product across all adult indications.
METHODS: The NAVLIN database was used to assess the reimbursement decisions in the following countries: Australia, Canada, France, Ireland, Italy, Scotland, Sweden, and England. In countries where data was not accessible through NAVLIN, a literature search was performed to fill in data gaps (e.g., reports and peer-reviewed publications). The HTA decisions were split into three categories: full reimbursement (according to label), partial reimbursement (e.g., based on disease severity), and do not recommend.
RESULTS: CD and UC were fully reimbursed for all countries. Five countries reported a partial recommendation for PsO: four restrictions based on severity (Australia, Canada, France, and England) and one recommendation requiring failure of previous biologic treatment (Sweden). In Canada, reimbursement of reference product ustekinumab for the treatment of PsA was not recommended due to lack of cost-effectiveness. Among the remaining seven countries, ustekinumab was partially recommended by four HTAs for the treatment of PsA. Partial recommendations were based on disease severity (Australia), and requirement for previous biologic therapy (Scotland, Sweden, and England). Several reports indicate biosimilars have expanded reimbursement status in PsA (Canada) and related indications (UK) following their entry into the market.
CONCLUSIONS: Reimbursement decisions for reference product ustekinumab vary in PsO and PsA. As decisions are largely influenced by cost-effectiveness, use of lower cost ustekinumab biosimilars may help to improve patient access to therapies.

Conference/Value in Health Info

2025-05, ISPOR 2025, Montréal, Quebec, CA

Value in Health, Volume 28, Issue S1

Code

HPR153

Topic

Health Policy & Regulatory

Topic Subcategory

Reimbursement & Access Policy

Disease

SDC: Gastrointestinal Disorders, SDC: Systemic Disorders/Conditions (Anesthesia, Auto-Immune Disorders (n.e.c.), Hematological Disorders (non-oncologic), Pain)

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