The health system in the country
Spain has a universal national health system (NHS) mainly funded by taxes. The Spanish NHS is organised in two levels, national (represented by the Spanish Ministry of Health, MoH) and regional (represented by the regional MoH in each of the 17 autonomous communities in Spain). An Interterritorial Council (CISNS, Spanish acronym) is the governance body that makes the final decision about market access to new health technologies at a national level. The CISNS comprises the Health Minister of Spain plus the highest hierarchy level of the 17 regional MoHs. Further details of the Spanish health system can be found in the series of Health Systems in Transition.
A roadmap for new technologies
There are two separate health technology assessment (HTA) processes: one for medicines, and one for other health technologies (such as medical devices).
Assessment of other health technologies
RedETS is the acronym for the Spanish Network of Agencies for Assessing National Health System Technologies and Performance. When a new non-drug health technology seeks access to the Spanish NHS, a commission (led by the Spanish MoH and with regional authorities’ participation) requests RedETS to produce a report, which usually includes an economic evaluation of the new technology. RedETS follows the paper by Lopez-Bastida et al. (2010) as a reference methods guideline for economic evaluations. The commission receives the report from RedETS, assesses the intervention, and makes a recommendation to the CISNS, i.e. the inter-regional Spanish council (CISNS), which makes the final decisions that are then formally adopted and implemented by the MoH.
Assessment of medicines
After the European Medicines Agency marketing authorisation or approval, a government commission (CIPM, Spanish Acronym), with representatives from the Spanish MoH, other national ministries, and regional governments, is the decision-maker for reimbursement of new medicines. The primary input for CIPM’s decisions is provided by the Spanish HTA agency for pharmaceuticals (Agencia Española de Medicamentos y Productos Sanitarios, AEMPS).
This primary input takes the form of the so-called therapeutic positioning reports (“Informe de Posicionamiento Terapeutico” or IPT). IPTs were created in 2013 to inform Spanish MoH’s decisions about the value and access to new technologies and included the evaluation of clinical effectiveness and safety; since 2020, IPTs are supposed to incorporate an economic evaluation of the new drug, although the percentage of IPTs currently including economic evaluations remains low. The Spanish Network for the Economic Evaluation of medicines (REvalMed, Spanish Acronym) follows the methods guideline created in 2017 by the GENESIS group (part of the Spanish hospital pharmacy association (Sociedad Española de Farmacia Hospitalaria, SEFH).
The CIPM decides on the reimbursement of the new drug with input from AEMPS. AEMPS also suggests a price for the drug, which is discussed by the CIPM.
The standard process to evaluate pharmaceutical products gives a narrow time window of 10 days for REvalMed to conduct the economic evaluation of the new drug, which can have an impact on the quality of the assessment. In addition, the composition of REvalMed is controversial: only two out of 143 experts are health economists. REvalMed has recently reached out for some external experts in economic evaluations, but it is unclear how the provision will be addressed. Increasing the participation of patients as active stakeholders is another aspect that has been raised.
The methods guidelines in use have been criticised, as they are not considered complete from a health economic perspective (for instance, it does not include clear recommendations about the modelling). Overall, there is also a general agreement that the process has to be updated.
Next steps for the Spanish HTA
The Royal-Decree Law (passed in 2012) that required that economic evaluations and budget impact analyses should be taken into account represented the seeds for a healthy HTA process in Spain. Through the introduction of economic evaluations in the IPTs, and the creation of REvalMed, the Spanish Government is watering those seeds for a promising HTA process to grow. For Spain to crop a healthy HTA system, and with a long-term view, we envisage two main steps.
The first step is to consolidate the process. For this purpose, it is essential that the Government incorporates the provision of an independent body that can carry out the appraisal process and act as a referee of the economic evaluation (which is not a new claim, see for example our blog about ‘HispaNICE’)
The second step is to identify the long-term objectives and to design a road map towards it. This could allow the Spanish system, still in its initial stages, to learn from the mistakes of the well-established HTA systems and address the limitations that have been repeatedly flagged in those. For example, we can think of moving to a framework that incorporates outcome measures beyond health or health-related quality of life, such as wellbeing; to incorporate treatment effects that fall outside the healthcare sector; and to incorporate distributional considerations that can reflect equity aspects. Those steps probably pull in opposite directions, but both are attainable.
Bernal-Delgado E, García-Armesto S, Oliva J, Sánchez Martínez FI, Repullo JR, Peña-Longobardo LM, Ridao-López M, Hernández-Quevedo C. Spain: Health system review. Health Systems in Transition, 2018;20(2):1–179. Pages 21-22
López-Bastida, J., Oliva, J., Antonanzas, F., García-Altés, A., Gisbert, R., Mar, J. and Puig-Junoy, J., 2010. Spanish recommendations on economic evaluation of health technologies. The European Journal of Health Economics, 11(5), pp.513-520.