Account
Prescribing controls on new medicines
Insider Insights

Spain: Increasing prescribing controls on new medicines

01/02/2022

According to data from the Ministry of Health (Ministerio de Sanidad), 65.1% of medicines admitted to reimbursement in 2021 were subject to some sort of restriction on prescribing/dispensing. This compares to 52.8% of drugs in 2020 and 28.2% of drugs in 2011.

Of 548 non-generic medicines admitted to reimbursement in 2021, 39.2% were classified as hospital-use (uso hospitaliario) only, compared to 27.6% in 2020 (and just 15.7% in 2011). A further 59 drugs (10.8%) were classified as hospital diagnosis (diagnóstico hospitalario, requiring diagnosis from a hospital-based physician but which can subsequently be dispensed in the out-patient sector). This is comparable to 2020 when 40 new drugs (10.6%) were subject to hospital diagnosis but up significantly from 2011 when just 17 (3.8%) drugs were subject to this sort of control. Meanwhile another 39 new drugs (7.1%) were subject to an inspection visa (visa de inspección, a form of prior authorisation) which is on a par with 2020 (and 2011).

In total, 764 out of 2,048 new medicines were not granted reimbursement in 2021, corresponding to 37.3% of new medicines. This compares to 32.7% in 2020 and 16.6% in 2011.

Sources:

www.diariofarma.com, “Sanidad se aplica en la financiación selectiva y limitación de dispensación”, 18th January 2022

Stay in the know, subscribe to our newsletter

Be the first to receive exclusive content on the latest from the pharmaceutical and market access sector.