Market Access Challenges for Novel Therapies for Treatment of Severe Alopecia Areata

OBJECTIVES: Janus kinase inhibitors (JAKi) have been recently approved for treating severe alopecia areata (AA). This analysis explores how identical clinical trial evidence led to differing reimbursement decisions in four European countries.

METHODS: We reviewed Health Technology Assessment (HTA) reports and reimbursement decisions in France, Germany, the UK, and Sweden for baricitinib and ritlecitinib, two JAKi approved for severe AA.

RESULTS: Both JAKi were studied in well-designed placebo-controlled trials in adults (and adolescents for ritlecitinib) with severe AA affecting over 50% of the scalp. They showed high efficacy in hair regrowth after >6 months of treatment, with lash and eyebrow regrowth as secondary endpoints. The countries had varied views on the disease (severe vs. cosmetic), the intervention (lifestyle drug or not), and the outcomes (no quality-of-life improvement). With no clearly defined best standard of care, placebo comparisons were acceptable. HAS (France) recommended reimbursement for both drugs due to high unmet need and efficacy on primary endpoints, despite minor added benefit due to lack of quality-of-life benefit and safety issues. NICE (UK) and TLV (Sweden) recommended against baricitinib due to the lack of quality-of-life improvement, need for long-term use associated with safety concerns, and unacceptable cost-effectiveness. However, ritlecitinib was recommended by NICE and TLV despite limited data, as utility from a vignette study partly captured quality-of-life issue. A conservative estimate for time on treatment decreased uncertainty. Lower drug price decreased cost. All of these made cost-effectiveness achievable. In Germany, both drugs are seen as lifestyle drugs for a cosmetic condition and therefore are not considered for reimbursement.

CONCLUSIONS: Reimbursement decisions for JAKi in severe AA varied despite identical evidence provided, due to differences in disease and outcomes perception and assessment methods. Future JAKi treatments must consider the choice of active comparator as an additional hurdle.