Background Fingolimod is prescribed in the UK following NICE approval in 2012. In Newcastle, our regional service, high prevalence and subspecialty structures have allowed us to accumulate a large cohort starting fingolimod, with >130 by January 2014.
Objectives 1) to audit prescribing against the European license and NICE guidelines. 2) to evaluate the impact on DMT prescribing, staff interaction and relapse treatment. 3) to describe the rate and reasons for discontinuation.
Methods To permit adequate follow up, we identified the first 100 from a comprehensive database, collecting data on counselling, eligibility, screening, first-dose monitoring, laboratory and ophthalmological surveillance. We evaluated our use of MRI and documentation of relapse and subsequent DMT changes. Causes of discontinuation were recorded.
Results Compliance with EMA advice on risk management was good. Considering eligibility, there was a significant group switching from natalizumab, a circumstance not considered by NICE. Fingolimod was well tolerated, with our few discontinuations related to abnormal bloods, nonspecific symptoms and single cases related to relapse, Ramsay-Hunt syndrome and 2° AV block.
Conclusions Our experience is commensurate with expectations from trials. While the demands of the risk management plan are high, we have complied well, reflecting increasing confidence in managing higher risk DMTs.