Major changes to P&R process in Spain expected in 2021

Patricia Lacruz, Head of the Dirección General de Cartera Básica de Servicios del Sistema Nacional de Salud y Farmacia (DGCBSF), outlined major changes on 26 November 2020 that will be made to the pricing and reimbursement process in Spain in 2021.

The new changes are expected to be implemented in the second or third quarter of 2021, and represent a significant shift from the current drug evaluation process.

A new network, called the Red de Evaluación de Medicamentos (Pharmaceutical Evaluation Network), will have responsibility for the revised health technology assessment process in Spain. The network will comprise three elements: a therapeutic evaluation group (led by Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) and the autonomous communities), an economic evaluation group (led by DGCBSF and the autonomous communities) and 7 evaluation “nodes” that will serve as expert reviewers appointed by the autonomous communities.

The new network will be responsible for producing therapeutic positioning reports (IPTs). Although IPTs were introduced in 2013 to support pricing and reimbursement decision-making, they have been set back by delays and resistance from the 18 autonomous regions. In respect to selection criteria for the IPT process, the Coordination Group will prioritise new drugs based on key criteria, including: therapeutic position; potential additional clinical benefit relative to existing alternatives; safety profile; new indications. The list provided by the Coordination Group will then be approved by the Comisión Permanente de Farmacia (CPF). The new IPT process will consist of 12 steps and should take a maximum of 90-96 working days.

Another major change is the inclusion of health economic evaluation in the IPT process. The methodology for this will be based on guidelines developed by the Grupo de Evaluación de Novedades, EStandarización e Investigación en Selección de Medicamentos (GENESIS).

MAP will continue to track developments relating to these major changes. Find out more on the Ministry of Health website.

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Published 9. December 2020 in News, News Spain