PHP78 - PRICING AND REIMBURSEMENT REFORMS IN SPAIN – A SYSTEMATIC ANALYSIS OF NATIONAL PRICING DECISIONS BY THE CIPM

Abstract

Following marketing authorization in Spain, new medicines are assessed by the Inter-Ministerial Pricing Commission for Pharmaceuticals (CIPM), which provides reimbursement recommendations with a maximum ex-factory price. For innovative products, pricing is based on international reference pricing, with additional factors including unmet need and budget impact also playing a role. However, this price setting process can be very time-consuming (12-18 months), involving lengthy negotiations. In September 2017, major reforms were announced that included companies only being allowed to submit single price proposals to the CIPM to shorten this process. Since November 2017, CIPM recommendations have been published on a monthly basis. This research aims to systematically analyze all CIPM recommendations to date. Publically-available CIPM decisions were identified from www.msssi.gob.es (10/3/2007-05/29/2018) and the date of EC-approval identified from http://www.ema.europa.eu. 93 recommendations were identified across six monthly reports, 40% (37/93) classified as new originator medicines, 16% (15/93) as new/expanded indications, 27% (25/93) as re-evaluations, and 17% (16/93) as other medicines. 32% (30/93) were for oncology indications. 60% (56/93) were positive and 40% (37/93) were negative recommendations. Positive recommendations rates were broadly consistent across the different classifications: 62% for new originator medicines, 47% new/expanded indications, 56% re-evaluations, and 75% other medicines. However, oncology medicines had a numerically lower positive recommendation rate (47%) than non-oncology ones (67%). The median delay between EC-approval and CIPM positive recommendations was 12.8 months, and was numerically higher for oncology (14 months) than non-oncology indications (12.8 months). Although CIPM decisions are now published publically the underlying rationale is not. Delays between EC-approval and CIPM decisions remain lengthy. CIPM recommendations also subsequently need to be ratified through final funding resolutions as published by the General Directorate of the Basic Services Portfolio and further negotiations with regional/local who are the budget-holders are necessary to gain patient access.