Health technology assessment

For the first time in three years, the Institute for Quality and Efficiency in Health Care (IQWiG) received data within the framework of the early benefit assessment of new examination and treatment methods (NUB) with high-risk medical devices according to §137h of Social Code Book (SGB) V. This involves seven invasive therapeutic cardiovascular, pulmonary, neurological, gastrointestinal, and urological procedures.

In 2013, Norway established a framework, “New Method,” for the introduction of innovations into the health care system through either a national or hospital-based health technology assessment. In this framework, all innovations should undergo HTA before being funded. As of June 7, 2021, five HTAs of in-vitro diagnostics are in progress.

On April 29, 2021, the National Institute for Health Research (NIHR) HTA Programme opened NICE Rolling Call for first-stage applications that should meet research recommendations provided by NICE guidance published from 2015 onwards. The first-stage application deadline is September 01, 2021.

In April 2021, the National Institute for Health and Care Excellence (NICE) published three new Interventional Procedure Guidance (repetitive short-pulse transscleral cyclophotocoagulation for glaucoma, deep brain stimulation for chronic, severe, treatment-resistant obsessive-compulsive disorder in adults, and Melphalan chemosaturation for primary or metastatic cancer in the liver) and two Medtech Innovation Briefings (microINR for anticoagulation therapy and RenalSense Clarity RMS for acute kidney injury), and two clinical guidelines (for atrial fibrillation and chronic pain in over 16s).

In April 2021, the Austrian Institute for Health Technology Assessment (AIHTA) initiated several new research projects. The projects are related to IVD tests for early detection of colon cancer, telemedical care in diabetes field, health apps, screening methods, consequences of coronavirus pandemic, and other topics.

On May 10, 2021, NICE announced the update of the evidence standards framework (ESF) for digital health technologies with changes in response to an ESF user survey that ran from October to December 2019. Furthermore, NICE launched a new Office for Digital Health to coordinate its digital health activities and strategic projects and manage collaboration with external partners.

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 Treatment Council (Behandlingsråd) is a new model for assessing treatment methods and health technologies, expected to become fully operational during 2021. On May 4, 2021, the first meeting of the Treatment Council was conducted. Also, the Treatment Council's Secretariat invites all the interested healthcare stakeholders to attend open online information meetings.

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.

The HTA body of the Tuscany Regional Healthcare issues two types of documents: HTA forms and motivational forms. With a regional decree 6462 of April 21, 2021, Tuscany Regional Healthcare has published assessments of six medical devices of various therapeutic areas, including devices for the treatment of vaginal prolapse, cardiovascular conditions, an implant for vocal cord rehabilitation, and a cerebral embolic protective device.

The Treatment Council (Behandlingsråd) is a new model for assessing treatment methods and health technologies, expected to become fully operational during 2021. The first meeting of the Treatment Council is planned to be conducted in May 2021. On April 15, 2021, the method and process frameworks of the Treatment Council (Behandlingsråd) were sent for consultation to the parties who have previously submitted consultation responses regarding these documents.

The National Institute for Health and Care Excellence (NICE) is currently developing health technology assessments concerning eHealth technologies in its Medical Technologies Guidance, Diagnostic Guidance, and Medtech Innovation Briefing programs. As of late April 2021, there are thirteen ongoing assessments.