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

To examine cross-national accessibility and reimbursement policies for IL-1 inhibitors in FMF treatment and compare national guidelines.

As part of the Clinical Practice Strategies (CLiPS) project, data on biologic DMARD (bDMARD) access and reimbursement were collected through questionnaires distributed to paediatric and adult rheumatologists and national representatives of the project. CLiPS representatives from non-responding countries were contacted via email. National FMF treatment guidelines were retrieved from PubMed, MEDLINE, Scopus and Google Scholar searches without language restrictions. Analysis focused on colchicine resistance, intolerance, adverse events, biologic indications and IL-1 inhibitor availability.

We examined 39 countries and obtained national guidelines from 11. Country representatives indicated the use of EULAR 2016 recommendations as their guidelines in seven further countries. Anakinra was available for colchicine-resistant FMF treatment in 29 of 39 countries and covered by national health insurance in 23 of these 29 (79.3%). Canakinumab was accessible in 23 of 39 countries, with reimbursement in 21 of 23 (91.3%). Eighteen countries imposed additional prescription and reimbursement restrictions for bDMARDs in FMF patients.

Significant multi-country disparities exist for the prescription of IL-1 inhibitors in FMF, with variations in national guidelines, drug availability and reimbursement. Standardized treatment guidelines and equitable access to therapies are essential to improve patient care.