Andorra includes icatibant and C1 esterase inhibitor in public funding

The Government has approved Decree 439/2026, of October 28, 2026, which modifies the Regulation governing the conditions for the public financing of high-complexity medicines to include icatibant and the human-origin C1 esterase inhibitor, intended for the treatment of type I and II hereditary angioedema. The provision is published in the Official Bulletin of the Principality of Andorra (BOPA) no. 125, of November 4, 2026, within the Regulations section. The text also reorganizes the classification of several anti-androgens, which are now subject to hospital dispensing.

The decree is based on the Regulation approved by the Decree of September 12, 2018, which sets the conditions for the public financing of these drugs and distributes them into two annexes. Annex 1 lists the medicines subject to hospital dispensing; Annex 2 lists those subject to the dispensing conditions established in general terms. The same regulation provides for the periodic updating of these annexes based on new medicines and available information, and it is within this framework that the now-approved modification is situated.

Two new drugs for hereditary angioedema

Article 1 of the decree expands Annex 1 with five codes from the anatomical therapeutic chemical (ATC) classification:

• B06AC01, human-origin C1 esterase inhibitor.
• B06AC02, icatibant.
• L02BB04, enzalutamide.
• L02BB05, apalutamide.
• L02BB06, darolutamide.

The first two are the drugs that the preamble explicitly links to the treatment of type I and II hereditary angioedema. The rest are anti-androgens that were already in the Regulation and are now incorporated into Annex 1, meaning they are subject to hospital dispensing.

Anti-androgens change annexes

Article 2 modifies Annex 2 in two movements. On one hand, it excludes the generic code L02BB, with the description “anti-androgens”; on the other, it individually incorporates three active ingredients:

• L02BB01, flutamide.
• L02BB02, nilutamide.
• L02BB03, bicalutamide.

The preamble justifies this separation by the fact that these three subgroups must remain in Annex 2 according to the established dispensing conditions, while subgroups L02BB04, L02BB05, and L02BB06 move to Annex 1 due to the complexity of the treatments and the need for strict clinical monitoring of the patients.

Prior report from the CASS and retroactive application

The processing of the decree is supported by the report of the Board of Directors of the Andorran Social Security Fund (CASS), approved in the session of October 8, 2026, and by the proposal of the Minister of Health. The text is signed by the Head of Government, Xavier Espot Zamora, in Andorra la Vella on October 28, 2026.

The transitional provision establishes that the modification applies to medicines dispensed starting from the three months prior to the date of the decree’s entry into force, or from the date on which the treatment was initiated with the validation of the High Complexity Medicines Commission. Regarding its validity, the final provision states that the decree enters into force the day after its publication in the BOPA, that is, on November 5, 2026.

The regulation directly affects patients with type I and II hereditary angioedema, who see public funding channels recognized for two specific treatments, as well as the physicians who prescribe them, since dispensing will now be channeled through the hospital setting. For the CASS, the reorganization of antiandrogens and the inclusion of new codes redefine the perimeter of pharmaceutical expenditure assumed by the system, with effects from the three months prior to its entry into force.

Fuente: Butlletí Oficial del Principat d’Andorra, núm. 125, 4 de novembre del 2026, secció Reglaments, pàg. 1-2 (referència oficial: Decret 439/2026).