Presentation (CTI)

OBJECTIVES: This study aimed to evaluate how treatments for inflammatory or immune-mediated conditions with perceived “cosmetic” manifestations such as alopecia areata, rosacea, vitiligo, and acne vulgaris are evaluated by health technology assessment (HTA) agencies and reimbursed by public payers in Europe and Canada.
METHODS: Guidelines from HTA agencies in Canada [CDA-AMC, INESSS], England [NICE], Scotland [SMC], France [HAS], and Sweden [TLV] were reviewed. HTA submissions and recommendations for therapies treating rosacea, alopecia areata, vitiligo, and acne vulgaris were evaluated. Public reimbursement status was assessed.
RESULTS: Most HTA guidelines did not explicitly specify inclusion or exclusion of therapies for review except for INESSS which stated therapies for cosmetic or aesthetic purposes will not be reviewed. Reimbursement submissions and recommendations varied across HTA bodies. While HAS issued positive reimbursement recommendations for treatments in all disease areas, others such as TLV were more restrictive, issuing negative recommendations for the same therapies targeting both acne and alopecia areata. NICE appraisals were not available for most therapies. NICE issued a positive recommendation for only one of the two alopecia areata therapies approved by HAS, has yet to review therapies for rosacea, and has pending recommendations for vitiligo and acne vulgaris. CDA-AMC, INESSS and the SMC have recommended reimbursement for select therapies targeting these conditions. Specifically, INESSS has reviewed and recommended therapies for rosacea and acne but has not reviewed therapies for alopecia. Negative HTA recommendations were attributed to missing or insufficient data, lack of QoL data, uncertainty regarding clinical meaningfulness, limitations in trial design and analysis, and cost-effectiveness. Access and public reimbursement varied creating inequities within Canada and Europe.
CONCLUSIONS: This study identifies high variability in HTA submissions and reimbursement decisions for immune-related dermatological conditions perceived as cosmetic. The resulting inequalities in access to therapies for such conditions increases the unmet need in these patient populations.