OBJECTIVES: Discussions on pricing and reimbursement (P&R) conditions have become increasingly common in Spain due to budget constraints. This research aims to analyze national P&R conditions for innovative pharmaceutical products agreed in the last 5 years to estimate the P&R trends in Spain.

METHODS: We analyzed the number and type of P&R conditions applied to new pharmaceutical products (excluding generics and biosimilars) reimbursed in Spain between June 2017 and May 2022. The Spanish database on products funding (BIFIMED) was used to identify new products reimbursed. Separate analyses were conducted for biologic and orphan products.

RESULTS: We identified 2,008 reimbursed products. A number of approvals stipulated specific P&R conditions; 291 (14.5%) reported ≥ 1 and 105 (5.2%) reported 2-6. Over the 5-year period, there was an increase in the percentage of products with ≥ 1 conditions (12.5% in year 1 vs. 23.9% in year 5) and with ≥ 2 conditions (4.8% in year 1 vs. 12.7% in year 5). The most common conditions were sales follow-up (93.8%; 273/291) and clinical protocols (23.0%; 67/291). Outcomes-based agreements (16.5%; 48/291), price-volume agreements (13.1%; 38/291), and expenditure caps per patient (9.6%; 28/291) were also relatively common. Over the 5-year period, 292 reimbursed products were biologics and 121 were orphan. Up to 42.5% (124/292) of the biologics and 76.0% (92/121) of the orphan products had ≥ 1 condition. The number of biologics and orphans with ≥ 1 condition grew consistently between years 1 and 5: for biologics from 21.7% to 74.4% and, for orphans, from 47.3% to 92.3%.

CONCLUSIONS: The frequency of P&R conditions in Spain has grown consistently over the last 5 years. Over the last year, conditions were applied to almost all orphans and to most biologics. Understanding the conditions applied to other products can help drive P&R negotiation with the Ministry of Health.