Cross-national biologic treatment guidelines for FMF: a comparative analysis

Area of Science:

• Rheumatology
• Pharmacoeconomics
• Global Health Policy

Background:

• Familial Mediterranean fever (FMF) is a genetic autoinflammatory disorder requiring long-term management.
• Interleukin-1 (IL-1) inhibitors represent a crucial therapeutic option for patients with refractory or intolerant FMF.
• Variations in healthcare systems may impact access to advanced therapies like IL-1 inhibitors.

Purpose of the Study:

• To evaluate the cross-national accessibility and reimbursement policies for IL-1 inhibitors used in FMF treatment.
• To compare the national treatment guidelines for FMF regarding the use of IL-1 inhibitors.

Main Methods:

• A survey was conducted among rheumatologists and project representatives across multiple countries (n=39) to gather data on biologic DMARD (bDMARD) access and reimbursement.
• National FMF treatment guidelines were systematically searched and retrieved from major scientific databases.
• Analysis focused on key treatment parameters including colchicine resistance, biologic indications, and IL-1 inhibitor availability and coverage.

Main Results:

• National treatment guidelines for FMF were obtained from 11 countries, with seven others referencing EULAR 2016 recommendations.
• Anakinra was available in 29/39 countries and reimbursed in 79.3% of those; Canakinumab was accessible in 23/39 countries and reimbursed in 91.3% of those.
• Eighteen countries implemented additional restrictions on the prescription and reimbursement of bDMARDs for FMF patients, highlighting significant access barriers.

Conclusions:

• Substantial disparities exist globally in the prescription of IL-1 inhibitors for FMF, encompassing variations in national guidelines, drug availability, and reimbursement status.
• Standardization of treatment guidelines and ensuring equitable access to IL-1 inhibitor therapies are critical for improving patient outcomes in FMF management.