Assessments and proposals for access to orphan drugs in Spain.

Assessments and proposals for access to orphan drugs in Spain.

On the occasion of the next World Day for Rare Diseases, February 28, AELMHU demands a change of model for the financing of these drugs in Spain.

According to the definitive data of the 2022 Annual Access Report, they confirm the difficulties suffered by patients with minority pathologies in Spain, since only 43% of the orphan products authorized in Europe are financed in our country.

For the president of AELMHU, María José Sánchez Losada, "innovation is a tangible asset for patients and society, but also a project for the future and for the country", which is why the Association looks with hope at the new developments undertaken by the Ministry, and urges all the agents involved to change the model because thousands of patients and families are waiting for us.

For this reason, and as already raised to the Ministry of Health in a document of recommendations on the occasion of the Preliminary Public Consultation on the Draft Bill amending the Consolidated Text of the Law on Guarantees and Rational Use of Medicines and Medical Devices, the association proposes a battery of proposals in different areas such as:

● The financing and pricing of the MM.HH. and their inclusion in the pharmaceutical provision of the SNS, in order to provide certainty, agility and greater transparency in the processes.

● The evaluation of medicines, to favor consensual solutions that allow for agile information sharing, establish a predictable procedure for the presentation, resolution and reporting of claims, and increase the participation of patients and clinicians.

● Funding linked to clinical outcomes and financial results, stimulating greater transparency and governance, which will make it possible to homogenize the existing territorial disparity and facilitate data collection.

● The Reference Price System, through the exclusion of HM.

● Streamlining access, with new mechanisms that reflect the specificities of rare diseases and orphan drugs, as well as the need to incentivize them, in line with the provisions of the European Regulation on Human Medicinal Products.