Health Ministry updates reference prices for funded medications

The Ministry of Health has updated the reference price system for medications funded by the National Health System through Order SND/1053/2026, of October 1, published in the Official State Gazette on Wednesday, October 7, 2026 (no. 249, Sec. I, page 131952). The regulation establishes the new sets and reference prices for 2026, revises previously fixed prices, and removes sets that no longer meet the required criteria. Signed by Minister Mónica García Gómez, the order takes effect the day following its publication.

The reference price system is provided for in Article 98 of the consolidated text of the Law on Guarantees and Rational Use of Medicines and Medical Devices, approved by Royal Legislative Decree 1/2015, of July 24, and has become an essential tool for controlling pharmaceutical expenditure. Its regulatory development is detailed in Royal Decree 177/2014, of March 21, whose Article 5.1 entrusts the head of the Ministry of Health to annually establish new sets and revise prices, following a report to the Government’s Delegated Commission for Economic Affairs.

The last update occurred with Order SND/1118/2025, of October 6, and the procedure for the new order began on April 10, 2026. During its processing, hearings were granted to the health administrations of the autonomous communities, the managing entities of pharmaceutical benefits, laboratories and distributors, and consumer and user associations.

New sets and price revision

Annex 1 lists the sets of presentations dispensable in pharmacies with an official medical prescription or dispensing order, along with their industrial reference price and their reference RRP (VAT included). Sets F514 to F528 are newly created.

Annex 2 contains the sets of hospital-use medications and presentations in clinical packaging, with the industrial reference price for each presentation. Sets P206 to P216 are new, and no new sets have been created for clinical packaging.

For informational purposes, Annex 3 details the reference price of each set (PRC), the presentation whose cost/treatment/day (CTD) determined it, and the defined daily doses (DDD) used in the calculation, in addition to identifying sets formed by the existence of a biosimilar medication.

Exemptions, essential and strategic medications

To ensure the supply of essential medicines—those considered as such by the World Health Organization—the order does not review the reference price of certain presentations included in the sets. The measure is supported by Royal Decree 177/2014 and Directive 89/105/EEC, and has the endorsement of the State Attorney’s Office report reference 1891/2018, dated September 14.

The entry into force of Law 7/2025, of July 28, which creates the State Public Health Agency, modified article 98 and empowered the Interministerial Commission on Medicine Prices, with the participation of the autonomous communities, to exempt certain drugs from the system or apply a reference price increase coefficient to them. For strategic medicines recognized by the Spanish Agency for Medicines and Health Products, that body may revise their prices upward based on reasoned grounds.

Annex 8 identifies the presentations that have been exempted from the system:

• OKEDI 75 mg, powder and solvent for prolonged-release injectable suspension.
• OKEDI 100 mg, powder and solvent for prolonged-release injectable suspension.
• EYLEA 114.3 mg/ml injectable solution, 0.263 ml vial.
• EYLEA 114.3 mg/ml injectable solution in a 0.184 ml pre-filled syringe.

Deletions, galenic innovations, and entry into force

Annex 4 lists the 21 reference sets deleted due to unforeseen circumstances: F72, F88, F114, F221, F302, F339, F366, F428, F435, P90, P96, P99, P101, P105, P119, P175, P178, S28, S56, S73, and S92. The reasons cited are the existence of a single marketed presentation, the absence of a marketed medicine other than the original and/or its licenses, or a modification in the coding of the route of administration.

Annex 5 contains the presentations declared as galenic innovations of therapeutic interest excluded from the system, including those of INSTANYL, with an exclusion period valid until November 29, 2026. Annex 6 lists the presentations for which no set was formed according to article 3.2 of the royal decree, and annex 7 lists the presentations included in the pharmaceutical benefit whose effectiveness had not occurred by April 10, 2026.

The update directly affects public pharmaceutical expenditure and the price paid by patients for funded medicines by reorganizing the sets and adjusting their reference prices. Against the order, which exhausts administrative remedies, a contentious-administrative appeal may be filed within two months before the Contentious-Administrative Chamber of the National Court or, optionally, a request for reversal within one month before the Minister of Health.

Source: Official State Gazette, no. 249, of October 7, 2026, Sec. I. General provisions, page 131952 (official reference: BOE-A-2026-20825).