IDENTIFYING RECENT TRENDS IN HEALTH TECHNOLOGY ASSESSMENTS FOR CROHN'S DISEASE
Author(s)
Mahendraratnam N, Inocencio TJ, Gaffney J, Agatep BC, Hughes KE
Avalere Health LLC, Washington, DC, USA
OBJECTIVES: To identify the types of coverage recommendations made by key ex-US health technology assessment (HTA) organizations for biologic treatments in Crohn’s disease (CD) and to understand how these organizations interpret evidence to support these recommendations. METHODS: Publicly available HTAs on CD from January 2009 to June 2013 for the following organizations were reviewed: CADTH (Canada), CONITEC (Brazil), HAS (France), IQWiG (Germany), NICE (United Kingdom), PBAC (Australia), and ISCIII (Spain). HTAs were identified using an HTA search engine and were supplemented with separate manual searches for CD-related reports on each HTA organization’s website. When additional context was needed to evaluate the HTA with the most recent recommendations, older HTAs were identified and reviewed. For each organization, the recommendation and corresponding clinical and economic rationales were reviewed and extracted. RESULTS: In total, nine HTAs were reviewed across five organizations; no HTAs on CD from IQWiG or ISCIII were identified. All HTAs endorsed the use of infliximab and adalimumab for CD from a clinical perspective. Recommendations for subpopulations including fistulizing disease, pediatrics, and prior/concurrent corticosteroid use varied. Recommendations were consistent with the host country’s approved labeled indications when appropriate cost thresholds were met, with the exception of PBAC, where adalimumab was additionally deemed appropriate for fistulizing disease, and CONITEC, where certolizumab was not endorsed due to safety concerns. Research gaps identified include the lack of head-to-head trials for adalimumab vs. infliximab and the paucity of long-term clinical and economic evidence. CONCLUSIONS: Infliximab and adalimumab generally received positive endorsements in CD, despite being frequently scrutinized by HTA organizations for their high costs. The expiration of patents and the introduction of biosimilars will likely shift how HTA entities evaluate clinical, economic, and humanistic evidence for biologic treatments for CD in the future.
Conference/Value in Health Info
2014-05, ISPOR 2014, Palais des Congres de Montreal
Value in Health, Vol. 17, No. 3 (May 2014)
Code
HT3
Topic
Health Policy & Regulatory, Health Technology Assessment
Topic Subcategory
Approval & Labeling, Decision & Deliberative Processes, Pricing Policy & Schemes
Disease
Gastrointestinal Disorders, Systemic Disorders/Conditions