László Vécsei, Professor of Neurology and Head of the Neuroscience Research Group, Albert Szent-Györgyi Clinical Center, University of Szeged, Hungary.
Three anti-CGRP mAbs are currently approved for use in Hungary, and we have seen excellent responses in some patients, no response in a small number and a very good response in the rest. However, due to the current cost of treatment, many patients cannot access effective anti-CGRP mAbs in Hungary until reimbursement is granted.
Although reimbursement arrangements have been agreed in 16 European countries, in Hungary reimbursement is still being negotiated and we are faced with a number of challenging issues:
Objective endpoint to measure efficacy: the insurer is looking for objective endpoints to measure efficacy, which is not usual in pain management. Any kind of pain measure is subjective but, at present, pain diary data are not considered sufficient, though no alternative has been proposed.
Several years of long term data: although all required clinical data and comparative data (vs standard of care) in the patient population were included in the reimbursement application, the insurer is looking for several years of long term data. This is not usual, and we do not believe that such data should be required for innovative medicines at the time of the first reimbursement request.
Confusion over anti-CGRP mAbs as preventive therapy or disease modifying therapy (DMT): there seems to be a misunderstanding around this topic. As anti-CGRP mAbs are not DMTs, there should be no need to investigate the effects of treatment on migraine changes after the discontinuation of one year of treatment. Beneficial effects may be seen after treatment discontinuation (as has been seen in clinical studies) but there should be no requirement to look for them.
Reimbursement based on available budget: unfortunately, reimbursement is not being based on how many patients would benefit from therapy or on real world cost efficiency calculations (as happens in Germany), but is being based on the available budget.
The COVID-19 pandemic: COVID-19 is not helping in reimbursement negotiations about anti-CGRP mAbs. As migraine is not considered a life threatening disease, the available budget is being prioritised to patients with COVID-19.
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