SPAIN Law and Practice Contributed by: Lluís Alcover, Eduard Rodellar, Laia Rull and Pablo Mansilla, Faus Moliner
bursement. These arrangements may take vari- ous forms, including caps on the number of units reimbursed by the NHS and charge-backs if pre- defined therapeutic outcomes are not satisfied. Medical Devices Royal Decree 1030/2006 and Ministerial Order SCO/3422/2007 regulate the process of updat- ing the package of benefits provided within the NHS. The rules state that any new technique, technology or process cannot be included in the NHS’s package of benefits unless it con- tributes effectively to the prevention, diagnosis or treatment of diseases; to the maintenance or improvement of life expectancy; to self- resilience; or to the elimination or reduction of pain and suffering. Moreover, an improvement in safety, efficacy, effectiveness, efficiency or use- fulness over other currently available alternatives must be demonstrated. Royal Decree 9/1996, as mentioned in the fore- going, is the relevant legislation for the reim- bursement of specific devices/products for non- hospitalised patients. Under this legislation, the reimbursement of such products must be guided by the same criteria used for medicinal products. 8.4 Cost-Benefit Analyses for Pharmaceuticals and Medical Devices Medicinal Products Spanish law does not make any reference to cost-benefit analyses when it comes to the reimbursement of medicinal products. Howev- er, Article 92 of Royal Legislative Decree 1/2015 includes a reference to “cost effectiveness” as one of the criteria to be considered in reim- bursement decisions. Cost-effectiveness ratios are commonly used in price and reimbursement proceedings, but unlike in other jurisdictions, no official cost-effectiveness threshold (eg, the maximum amount a decision-maker is willing
to pay for a unit of health outcome) applies in Spain. With respect to the type of economic evalua- tion to be performed, Spanish law provides no guidance. However, the Spanish National Health System’s Advisory Committee for Phar- maceutical Financing ( Comité Asesor para la Financiación de la Prestación Farmacéutica del Sistema Nacional de Salud CAPF) has recently published a guideline on this matter, which the MOH has informally confirmed will be used as a reference. In the guideline, it is stated that “Cost- utility analysis (CUA) will be prioritized” and that “In cases where a CUA is not feasible, justifica - tions must be provided, and a cost-effectiveness analysis (CEA) will be conducted” . Finally, in 2024, the MOH launched a public con- sultation for a new Royal Decree pertaining to health technology assessment within the frame- work of the NHS. This legislation, which has not yet been approved, will be the main legislation governing health technology assessment (HTA) in Spain. The first draft of the Royal Decree sub- mitted for public consultation established that economic evaluations of health technologies “will provide useful information for decision-mak- ing… through a robust evaluation that consid- ers the value of the medical technology from the perspective of relative effectiveness, the social value of the medical technology, and the impact on health-related quality of life. This information will identify the efficiency of the new technol - ogy compared to available alternatives, as well as analyse its budgetary impact” . Medical Devices As with medicinal products, Spanish law does not refer to cost-benefit analysis in the regula- tion of the reimbursement of services or tech- nologies other than medicinal products. Royal
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