Spain

On June 30, 2021, the Interterritorial Council of the National Health System has approved the inclusion of real-time continuous glucose monitoring (rt-CGM) systems in the Common Package of Benefits for adult patients meeting certain criteria. The inclusion of rt-CGM devices in the Common Package of Benefits means that these devices are now guaranteed to the defined population nationwide.

The Health Sciences Institute in Aragon (IACS) systematically evaluates healthcare technologies and facilitates the promotion of research, effective innovation, and decision-making in health services through knowledge management. Currently, the IACS is working on assessments of efficacy, effectiveness, and safety of intraoperative radiation therapy in breast cancer, determination of preeclampsia biomarkers SFlt-1 and PlGF, treatment of congenital ventricular septal defect by cardiac catheterization, and others.

In May 2021, the Agency for Health Quality and Assessment of Catalonia (AQuAS) published a report on next-generation sequencing (NGS) for molecular diagnosis and selection of therapeutic targets in oncological diseases. The studies identified present favorable results on the diagnostic efficacy of the NGS-based gene panels; the evidence on the clinical effectiveness of NGS panels remains limited. The authors emphasize the need for further studies.

The Galician Scientific and Technical Advice Unit in Spain (AVALIA-T) systematically evaluates healthcare technologies and provides decision-makers with critically reviewed information about their efficacy, safety, and effectiveness. Currently, the AVALIA-T is working on assessments of ventricular assist devices in pediatric patients with an indication for permanent destination therapy, bronchial thermoplasty for severe acute asthma, effectiveness and safety of epiduroscopy in the treatment of failed back surgery syndrome, and other topics.

The Agency for Health Technology Assessment of Andalusia Autonomous Community in Spain (AETSA) systematically evaluates healthcare technologies and provides decision-makers with critically review information about their efficacy, safety, and effectiveness. Currently, the AETSA is working on assessments of laser-induced heat therapy in epilepsy surgery, stereotactic radiation therapy for the treatment of refractory ventricular tachycardia, implantable Holter monitor with ILink Online technology for prolonged cardiac monitoring, and other topics.

In February 2021, the Health Technology Assessment Agency of the Health Institute Carlos III published the report for the efficacy and safety of robotic spinal surgery compared to manual surgery in spinal fusion.

In November 2020, the General Directorate of Basic Package of National Health System and Pharmacy Services published the Resolution on the agreement of the Commission of Benefits, Insurance, And Financing in relation to the proton therapy technique. The key points of the agreement include the recommendation for the creation of an interdisciplinary committee in each autonomous community to evaluate each specific case of proton therapy and therapeutic indications.

In the middle of 2020, the Galician Scientific and Technical Advice Unit (Unidad de Asesoramiento Científico-técnico, Avalia-T) released a health technology assessment on clinical Effectiveness of newborn screening for inborn errors of metabolism by MS/MS that aimed to update the data collected in the pilot study. It is recommended to define health indicators, optimum and acceptable levels of some process indicators.

On the 9th of July 2020, the Ministry of Health of Spain released a screening guide for Hepatitis C infection as a part of the Strategic Plan for Addressing Hepatitis C in the National Health System. To improve access to screening and link to treatment monitoring, the guide proposes actions such as diagnosing the infection in a single step, training and support activities for health professionals, or a simplification of the models.

In June 2020, the Andalusian Health Technology Assessment Department (AETSA) published an update of the earlier report (2012) on assessment of effectiveness and safety of tumor treating fields (TTF) therapy in glioblastoma.

In February 2020, the Office for Health Technology Assessment (HTA) of Basque Country OSTEBA published an HTA report for efficacy and safety of mechanical thrombectomy (MT) in the treatment of patients with ischaemic stroke beyond 6 hours after onset or with an unknown time of onset. According to the report, the use of MT, together with standard medical treatment (SMT) in such patients, is justified provided that they meet the neuroimaging selection criteria applied to the studies analyzed.

In June 2020, the Agency for Health Quality and Assessment of Catalonia (AQuAS) published an assessment report on the effectiveness and safety of bilateral implantation of non-cochlear hearing implants in Spain.