Presentation (CTI)

OBJECTIVES: Coeliac disease (CD) is a chronic autoimmune condition managed by a strict, lifelong gluten-free diet (GFD). As pharmacological interventions for CD emerge, securing reimbursement may face potential hurdles due to the need to demonstrate value over an effective, non-pharmacologic lifestyle therapy. This research aimed to identify potential reimbursement challenges for CD drugs, draw parallels from Health Technology Assessment (HTA) reports of drugs for analogous conditions where lifestyle, non-pharmacologic therapy is a primary comparator, and propose strategies to address these challenges.
METHODS: A comprehensive review of published HTA reports from agencies in England, Canada, and France was conducted, focusing on drugs for obesity (Semaglutide) and insomnia (Daridorexant). These conditions were selected for their similarity to CD, where lifestyle-based, non-pharmacologic therapies serve as comparators in HTA evaluations. The analysis identified common factors influencing reimbursement decisions and evidence requirements (clinical/economic). These insights informed the anticipation of challenges specific to CD drugs.
RESULTS: Potential reimbursement challenges for CD drugs were identified across four main areas: (1) Demonstrating value over existing management (i.e., proving superior efficacy and cost-effectiveness versus GFD), (2) addressing long-term safety concerns, (3) substantiating the budget impact for a large patient population, and (4) capturing quality of life benefits effectively in traditional health economic models.
CONCLUSIONS: In conclusion, navigating the complex reimbursement landscape for emerging CD drugs requires a robust strategic approach. Key strategies to address identified challenges include integrating therapy with specialist multidisciplinary services, conducting comprehensive long-term clinical and economic studies (prioritizing quality of life, complication rates, and nutritional status), highlighting broader societal and economic benefits, engaging actively with patient groups and clinicians, and exploring innovative pricing models. Ultimately, demonstrating clear value beyond existing dietary management, and adopting comprehensive strategies learned from analogous conditions, will be critical for achieving successful market access.