Healthcare Expands Advanced Therapies for Spanish Patients

Spanish health authorities have today approved a plan to expand advanced therapies available to Spanish patients in need, establishing mechanisms and organisation to ensure equal rights and access regardless of their location.

The new plan updates and expands the initial Advanced Therapies programme approved by the Ministry of Health and the autonomous communities in 2018. It initially focused on the then-novel CAR-T therapy—genetic modification of immune cells to attack tumours—and has treated over 2,000 citizens nationwide, primarily those with blood cancers (lymphomas, leukaemias, and myelomas), as well as individuals with rare diseases.

Over the next three years, the plan will include innovative medicines and procedures offered by the programme's medical and research machinery, such as gene therapies—modifying, replacing, or inactivating defective genes to prevent or treat diseases—cellular therapies—treatments, often with stem cells, genetically modified or not—and tissue therapies, which are innovative procedures for restoring tissues like tendons, bones, nerves, intestines, or heart valves, among others. The aim is to encompass the numerous medicines and procedures, in addition to CAR-T, authorised and funded by public healthcare since 2018 or potentially incorporated in the short and medium term.

The strategy adopts measures to adapt the current advanced therapies infrastructure to include other innovative medicines and ensure that these new treatments, both old and new, continue to reach any patient in need equally across Spain.

A fundamental element of this structure is the network of reference centres accredited by the National Health System (SNS), where candidate patients are treated, therapies administered, and sometimes medicines manufactured. Currently, there are 28 centres nationwide, which will now need to expand to include references for new procedures. These can be national reference centres for therapies requiring high specialisation and case concentration, or regional when treatments are more generalised.

The care model is based on developing common clinical protocols for each advanced medicine, guiding patient selection, treatment administration, and subsequent clinical follow-up. Similarly, to ensure uniformity in case evaluation and complex situations, the plan includes expert groups at both regional and national levels to analyse treatment requests requiring additional assessment and issue technical reports guiding clinical decision-making with uniform criteria.

The new plan also strengthens the role of public research in developing new therapies, emphasising the importance of SNS hospitals and academic centres designing and manufacturing non-industrial advanced medicines, especially where no commercial alternatives exist.

To ensure this objective, a procedure called hospital exemption is regulated, allowing the clinical use of advanced therapy medicines developed within the hospital environment, always under medical supervision and for specific needs. This exceptional access pathway enables public medical centres to apply innovative treatments to patients while generating clinical and scientific evidence that may contribute to future authorisation for commercialisation.