Highly active disease and access to disease-modifying treatments in patients with relapsing-remitting multiple sclerosis in Poland.

INTRODUCTION: In Poland, access to second-line disease-modifying treatments (DMTs) for relapsing-remitting multiple sclerosis is limited by reimbursement criteria that require evidence of more aggressive disease compared to the approved indications. MATERIAL AND METHODS: In a retrospective study carried out in DMT clinics across Poland, we asked neurologists to provide patient data on relapses and neuroimaging disease activity. Included were only patients with active disease, defined as one or more relapse and at least one new lesion between starting DMT and the last visit. For patients who had not received DMT, active disease was defined as at least one gadolinium-positive lesion or two or more new T2 lesions and two or more relapses within 12 months. We analysed the proportions of patients eligible for second-line DMTs based on the current reimbursement criteria and based on the broader criteria, which were in line with the approved indications. RESULTS: In total, 48 neurologists provided data for 641 patients (women 64%; mean age 38 years). Of the 641 patients, 610 (95%) received DMTs: 532 first-line and 78 second-line. Of the 532 patients on first-line DMTs, 40 (7.5%) were eligible for second-line treatment based on the current reimbursement criteria, and an additional 126 (23.6%) would be eligible for second-line treatment based on the broader criteria. Of the 31 patients who did not receive any DMTs, one patient was eligible for second-line treatment, and another two patients would be eligible for second-line treatment based on the broader criteria. Moreover, 13 previously treated patients would be eligible for second-line DMTs based on the broader criteria. When extrapolated to the whole of Poland, our study shows that an additional 1,581 patients would be eligible for second-line DMTs if the current reimbursement criteria were to be replaced by broader criteria complying with the approved indications. CONCLUSIONS: An urgent change is required in the reimbursement criteria in order to expand access to second-line DMTs for patients with relapsing-remitting MS in Poland.