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Reimbursement Processes around the World Spain Description of Healthcare System The National Health Service SNS (Sistema Nacional de la Salud) provides healthcare to the Spanish population. It is coordinated and supervised by the Ministry of Health and Consumer Affairs MSC (Ministerio de Sanidad y Consumo). However, since the recent decentralisation of healthcare to the seventeen autonomous regions (Comunidades Autónomas), the MSC focus more on pharmacovigilance, product approvals, cost-containment and long-term policies. The regions are responsible for the healthcare delivery and financing of it. Reimbursement Approval Process When marketing authorization is granted either by the European Medicines Agency (EMEA) or the Spanish Medicine Agency AEMPS (Agencia Espanola del Medicamento y Productos Sanitarios), the Ministry of Health (MSC) initiates a procedure to decide on reimbursement of this new product on the national reimbursement list. The manufacturer is then invited to provide all relevant information to allow the Interministerial Pricing Commission CIPM (La Comisión Interministerial de Precios de los Medicamentos), led by MSC, to make a decision. If the outcome is positive (inclusion in the national reimbursement list), this decision is valid (mandatory) throughout the country. There are three reimbursement categories:
If a reimbursement status is approved, the pricing is decided simultaneously. If the reimbursement decision is negative, the product will be put on the negative list and pricing is free. Decision criteria to grant a reimbursement status include:
After market authorization, the manufacturer first need to go through some administrative tasks with the AEMPS, including getting a national product code, before the Directorate of Pharmaceutical and Health Products DGFPS initiates the procedure for pricing and reimbursement. Each company is free to submit as much documentation as considered necessary to support a positive decision; among these documents there is just a compulsory one “Price application” where the company establishes the desired price as well as the following information:
New product prices are published in the Official Journal (Boletín Oficial del Estado) although are effective as soon as officially communicated to the company.. It should be mentioned that the regions have a degree of freedom to impose their own pharmaceutical price caps or cost-containment targets and free pricing is allowed for new prescription products that do not enter the reimbursement system.According to the Directive 89/105/EEG, the pricing & reimbursement process should not take longer than 180 days. However, various studies in the past years indicated that it is not unusual that it takes the Spanish authorities longer to get to a decision. Although Spanish pharmaco-economic guidelines are available since 1995, these type of studies are not mandatory in the pricing & reimbursement process. Published Spanish pharmaco-economic guidelines are available since 1995. Glossary of Special TermsAATM: Agencia d'Avaluacio de Tecnologia Medica / Catalonian Technology Assessment and Medical Research Agency OSTEBA: Osasunerako Teknologien Ebaluaketa / Basque Health Technologies Assessment Service Reimbursement Organizations/HTA Organizations National: AEMPS (Agencia Espanola del Medicamento y Productos Sanitarios) AETS (Agencia de Evaluacion de Tecnologias Sanitarias) DGFPS (Dirección General de Farmacia y Productos Sanitarios) CIPM (La Comisión Interministerial de Precios de los Medicamentos) Regional: AATM (Agencia d'Avaluacio de Tecnologia Medica) AETSA (Agencia de Evaluacion de Tecnologias Sanitarias de Andalucia) AVALIA-T (Axencia de Avaliación de Tecnoloxías Sanitarias de Galicia) OSTEBA (Osasunerako Teknologien Ebaluaketa) UETS (Unidad de Evaluación de Tecnologías Sanitarias) Suggested Reading
Useful links: Ministry of Health Official Journal Spanish Medicines Agency HTA agency – National HTA agency – Andalucia HTA agency – Basque country HTA agency – Catalonia HTA agency – Galicia HTA agency – Madrid
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