Decision Makers and Decision-Making Processes Diagram
Figure 1. HTA process for decision making related to the national catalogue of services in Spain . The central and regional governments request HTA evaluations to the national and regional agencies (Steps 1a and 1b). The ISCIII and regional agencies collaborate to produce the required HTA information (Step 2). The ISCIII produces the HTA report and submit it to the Interterritorial Council (Step3). The Interterritorial council decides about the inclusion or exclusion of technologies in the national catalogue (Step 4). The decision of the Interterritorial council is implemented by the central and regional governments (Step 5).
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 decentralization 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.
The Spanish Constitution of 1978 authorized the decentralization of the National Health System (NHS) from the central government to the Autonomous Communities (Comunidades Autónomas). Between 1981 and 2002, the management of the NHS was transfer from the National Health Institute (Instituto Nacional de la Salud-INSALUD) to regional health services managed independently by 17 autonomous communities and 2 autonomous cities. The NHS is coordinated by the National Health System Interterritorial Council (Consejo Interterritorial del Sistema Nacional de Salud), which contains representatives from all the regional health services, and is presided by the Minister of Health. Under this structure, public health care insurance coverage is provided for >99.5% of the population.
The Interterritorial Council approves the national cataloge of services that are must be provided by all regional health services (cartera de servicios communes). The catalogue of is divided into sections including primary care, specialized care, supplemental care, and pharmacy. The NHS is funded through general taxation. The central government provides financial support to each region based on population and demographic criteria.
The passage of the Law of Cohesion and Quality of the National Health System in May, 2003 initiate a further reform of the Spain’s health system. The purpose of this law was to improve the country’s provision of health services, access to care, and quality of care. These revised regulations mandate that inclusion of new technologies in the national catalogue would consider the efficacy, cost, efficiency, effectiveness, safety, and therapeutic utility of the different alternatives.
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DECISION-MAKERS AND INFLUENCERS
Central and regional governments are the main decision makers in the Spanish NHS pricing, coverage and reimbursement decisions. The level of involvement of the central and regional governments in the decisions varies depending on the type of technology evaluated and the level of coverage (i.e. national or regional level). The central government maintains the responsibility related to pharmaceutical pricing and reimbursement. Decisions related to the content of the national catalogue of services are responsibility of the Interterritorial Council. And decisions related to regional additions to the national catalogue of services and management of the regional health services are responsibility of the regional governments.
There are three different HTA levels in the country: 1) national level for common benefit package excluding pharmaceuticals, 2) national level for pharmaceuticals, and 3) regional level.
At the national level, the National Health System Interterritorial Council is responsible for defining the benefit package of the National Health System. The Council is composed by representatives of the national and autonomous regions governments. HTA is required when incorporating new techniques, technologies or procedures, or when excluding those already provided, in the national common benefit Packaged. The evaluation is done by the Ministry of Health (Ministerio de Sanidad y Consumo) thought the ISCIII in collaboration with the regional HTA agencies (Real Decree 1030/2006). The HTA must include information about cost, efficacy, efficiency, effectiveness, safety and health care utility of the technology. The proposal of inclusion of new technologies that could significantly increase health expenditures also requires approval by the Fiscal and Financial Policy Council (Consejo de Politica Fiscal y Financiera Financial).
The HTA for pharmaceuticals has a different process than that the HTA of other health care technologies. The law differentiates HTA for pharmaceutical price regulation and for decisions related to reimbursement of pharmaceuticals by the national health service (Law 29/2006)
The Ministries of Health, Economy (Ministerio de Economia y Hacienda) and Industry (Ministerio de Industria, Turismo y Comercio) propose the prices for pharmaceuticals to the the national government cabinet (Consejo de Ministros) that has the final responsibility for setting pharmaceutical prices. The Interministerial Comission for Pharmaceutical Prices (Comisión Interministerial de Precios de los Medicamentos) includes representation of the Ministries of Health, Ecomony (Ministerio de Economia y Hacienda) and Industry (Ministerio de Industria, Turismo y Comercio). The Comission proposes the prices for pharmaceuticals to the the national government cabinet (Consejo de Ministros) that has the final responsibility for setting pharmaceutical prices. The Spanish Medicine and Health Products Agency (Agencia Española de Medicamentos y Productos Sanitarios) prepares a report about the therapeutic utility of pharmaceuticals that must be considered by the Comission when proposing pharmaceuical prices. The Agency is in the process of establishing a HTA system for evaluation of pharmaceuticals.
The Ministry of Health has the responsibility for deciding reimbursement of pharmaceuticals by the National Health Service. According to the Law 29/2006, the reimbursement decision must consider the following: a) severity, duration and sequels of the diseases for which the drug is indicated; b) therapeutic and social utility of the drug; c) rationalization of public drug expenditures; d) alternatives for the indications targeted by the drug; and e) the novelty of the drug.
The decision-making process at the regional level is decided by each region. The participation of the HTA organizations in the decision-making process is also regulated at the level of the Autonomous Community. The regional organizations collaborate with the national agency and support the decision-making process at the regional level.
HEALTH TECHNOLOGY ASSESSMENT
A national HTA agency (Instituto de Salud Carlos III-ISCIII) and several HTA organizations in the autonomous regions (Comunidades Autonomas) coexist in the country. Central and regional governments work together with the SCIII. The ISCIII was created under the Health Act of 1986 as an autonomous public institution attached to the Spanish Ministry of Health, which proposes and develops guidelines related to health care. The main objective of the ISCIII is the collaboration and support of research and technological development through its many centers and regional agencies, including HTA, in health care. The ISCIII provides HTA reports to the Inter-territorial Council, the ultimate decision maker for benefit policy.
The government reorganization of 2004 attached all public research organizations, among them the ISCIII, to the new Ministry of Science and Innovation, although its scientific-technical support functions to Health Authorities was maintained through reference centers such as: National Microbiology Center; National Environmental Health Center; National Epidemiology Center; National Public Health School and ISCIII.
The Autonomous Communities also can establish HTA organizations (agencies or services). The functions and processes of these HTA organizations are regulated at the level of the Autonomous Community, and there is not a national standard. Typical of these organizations functions include HTA, irmproving rational use and suppoting the decision-making process at different levels of the national health system. Currently, there are seven regional HTA agencies/services in existence in Spain. The seven agencies include:
- Agencia de Evaluación de Tecnologías Sanitarias de Andalucía
- Instituto Aragonés de Ciencias de la Salud
- Agència d'Avaluació de Tecnologia i Recerca Mèdiques de Catalunya
- Axencia de Avaliación de Tecnoloxías Sanitarias de Galicia
- Agencia Laín Entralgo de Madrid, Unidad de Evaluación de Tecnologías Sanitarias, Comunidad de Madrid
- OSTEBA, Osasun Teknologien Ebaluazioko Zerbitzua, País Vasco
- Servicio de Evaluación del Servicio Canario de Salud
Additionally, other autonomous communities also have units for planning and advice on decision making that could include some level of HTA evaluation. Each regional HTA agency or service is responsible for producing information on the efficacy, effectiveness, safety and efficiency of new health technologies.
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REIMBURSEMENT AND PRICING 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 Inter-Ministerial 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:
- 100% reimbursement for hospital pharmaceuticals
- 90% reimbursement for pharmaceuticals for the management of chronic illnesses (e.g. diabetes, asthma and epilepsy)
- 60% reimbursement for the majority of prescription-only pharmaceuticals
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 price is determined by the manufacturer (“free pricing”).
Decision criteria to grant a reimbursement status include:
- The severity of the disease
- The therapeutic value and efficacy of the product
- The price of the product
- The budget impact for the SNS compared to corresponding products
Pricing Approval Process
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:
- Cost per day compared with equivalent products in Spain
- Price of the product in other EU countries
- Sales forecast
- The overall cost of R&D, production cost, etc.
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.
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The law requires HTA to consider the efficacy, cost, efficiency, effectiveness, safety, and therapeutic utility of the different alternatives. But there are not national or regional guidelines related to data requirements for HTA. The data used in each HTA evaluation is decided case by case by the HTA agencies.
- NHS: National health service
- HTA: Health technology assessment
- INSALUD: Instituto Nacional de la Salud
- MSC: Ministerio de Sanidad y Consumo / Ministry of Health and Consumer Affairs)
- SNS: Sistema Nacional de la Salud / National Health Service (NHS)
Reimbursement Organizations/HTA Organizations
- AEMPS (Agencia Espanola del Medicamento y Productos Sanitarios)
Spanish Medicines Agency
- AETS (Agencia de Evaluacion de Tecnologias Sanitarias)
National Health Technologies Assessment Agency
- DGFPS (Dirección General de Farmacia y Productos Sanitarios)
Department within ministry of health responsible for pharmaceutical products
- CIPM (La Comisión Interministerial de Precios de los Medicamentos)
Interministerial commission responsible for the price negotiations with pharmaceutical manufacturers.
- AATM (Agencia d'Avaluacio de Tecnologia Medica)
Catalonian Technology Assessment and Medical Research Agency
- AETSA (Agencia de Evaluacion de Tecnologias Sanitarias de Andalucia)
Andalusian Health Technologies Assessment Agency
- AVALIA-T (Axencia de Avaliación de Tecnoloxías Sanitarias de Galicia)
Galician Health Technologies Assessment Agency
- OSTEBA (Osasunerako Teknologien Ebaluaketa)
Basque Health Technologies Assessment Service
- UETS (Unidad de Evaluación de Tecnologías Sanitarias)
Madrid’s Technologies Assessment Unit within the Agency Laín Entralgo
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- ÖBIG (2006). Surveying, Assessing and Analysing the Pharmaceutical Sector in the 25 EU Member States. Available at: http://ec.europa.eu/comm/competition/mergers/studies_reports/oebig.pdf
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Law 29/2006, July 26, of rational use of medicines and health products. Available at: http://www.agemed.es/actividad/legislacion/espana/general.htm (Spanish).
- Real Decree 1030/2006, September 15, establishing the common catalogue of services of the NHS and the procederes for its actualization. Available at: http://www.msc.es/profesionales/prestacionesSanitarias/CarteraDeServicios/docs/CarteraDeServicios.pdf (Spanish).
AUTHORS & CONTRIBUTORS:
Enrique Seoane-Vazquez PhD, Assistant Professor Ohio State University, Columbus, OH, USA
Hans Middlehoven PhD , F. Hoffmann – La Roche Ltd., Basel, Switzerland
Jose-Manuel Rodriguez Barrios PharmD, MPH, MSc, Health Economics Reimbursement Manager, Medtronic, Iberia, Madrid, Spain
Sheryl Szeinbach BS, MS, PhD, RPh, Professor, College of Pharmacy, Ohio State University, Columbus, OH USA
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