PND42 THE PRODUCTIVITY IMPACT OF EXCEEDING THE LEGAL TIME FOR PRICING AND REIMBURSEMENT DECISION OF ERENUMAB IN THE TREATMENT OF MIGRAINE IN PORTUGAL

Abstract

In Portugal, time to reimbursement of new drugs following their marketing authorization is about 634 days, which far exceeds the legal time for pricing and reimbursement (P&R) decision (210 days). We aimed to extrapolate the foregone productivity gains associated with delay of P&R decision of erenumab in the preventive treatment of migraine in Portugal. Analysis inputs included (a) average number of days elapsing from the legal date for P&R decision to the day of completion of post-marketing authorization administrative processes in Portugal in 2018, (b) number of employed migraine patients in Portugal who failed at least 3 previous preventive treatments (TF3+), (c) number of off-work days due to migraine in standard of care (SoC), (d) effect of erenumab 140 mg versus SoC on productivity loss (absenteeism and presenteeism), (e) response rate at month 3 and (e) cost per working day. Data sources included public data from the W.A.I.T. indicator from EFPIA, national official databases and literature. The Human Capital approach was used to estimate the economic loss. Considering that erenumab reduces absenteeism and presenteeism compared with SoC by 65.9% and 63.1%, respectively, the potential 13.917 employed TF3+ migraine patients in Portugal, a cost/working day of €74.2, then the average decision delay of 424 days beyond the legal time for P&R may represent a loss of 308.071 working days and about €22.8 M to the Portuguese Society (assuming that all potential patients would start erenumab at the same time). If instead Portugal had the EU average time to reimbursement (413 days), then the average decision delay of 203 days beyond the legal time for P&R may represent a loss of 147.496 working days and about €10.9 M. Delaying the decision of P&R of erenumab in the prophylactic treatment of migraine might translate into considerable foregone productivity gains for the Portuguese society.