Health technology assessment

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. In the second half of 2020, eight new mini-HTA projects of medical technologies were launched in Norway: tissue allotransplantation, pain treatment via neuromodulation, among others.

In November 2020, the National Institute for Health and Care Excellence (NICE) published one new interventional procedure guidance (for swallowable gastric balloon capsule for weight loss), five Medtech innovation briefings (for QuickChange Incontinence Wrap for urinary incontinence in men, Magseed for locating breast cancer lesions, Dexcom G6 for continuous glucose monitoring, and others). Also, one clinical guidance (for acute coronary syndromes) was updated.

In November 2020, Stockholm Region issued a preliminary version of the prospective report for the management of health care up to 2040. The report raised the need for new ways of organizing health care in the Stockholm Region and outlined the increase of standardization and alignment trend, emerge of collaborative governance models, the increase of care structure complexity, etc.

On December 03, 2020, the Swedish Dental and Pharmaceutical Benefits Agency (TLV) published a report on its activities in health economic evaluations of medical technologies in 2020. The significant change is that since 2020 TLV has a permanent assignment to carry out horizon scanning and health economic evaluations of medical technology products as a part of the national orderly introduction framework.

On November 27, 2020, the National Committee for the evaluation of medical devices and health technologies (CNEDiMTS) at the French National Authority for Health (HAS) released a recommendation about the registration of flash self-monitoring glucose system FREESTYLE LIBRE 2 in the LPPR list.

The HTA body of the Tuscany Regional Healthcare issues two types of documents: HTA forms and motivational forms. With a regional decree 19274 of November 24, Tuscany Regional Healthcare has published assessments of twelve medical devices of various therapeutic areas. See the list of evaluated devices in the post from MTRC.

In November 2020, the Swedish Dental and Pharmaceutical Benefits Agency (TLV) launched a theme survey for medical technology products in stroke, focusing on products for diagnostic/assessment in case of suspected stroke. The submissions in relation to this survey will be closed on December 16, 2020

In October 2020, a mini-HTA report was published on “Early method evaluation” (Tidlig metodevurdering). The report proposes a novel type of “early method evaluation” to complement existing national and mini-HTA frameworks in Norway. This new assessment type can be performed before classical HTA. Early Method Evaluation can be used locally at department or hospital levels when new technology/innovation is tested to analyze the impact on patient, staff, finances before reliable evidence from clinical studies became available.

In September 2020, the National Institute for Health and Care Excellence (NICE) published one new interventional procedure guidance (for transcranial magnetic stimulation for auditory hallucinations), one new medical technologies guidance (Axonics sacral neuromodulation system for treating refractory overactive bladder), one new diagnostic guidance (Implantable cardiac monitors to detect atrial fibrillation after cryptogenic stroke) and four Medtech innovation briefings (for Novii Wireless Patch System, t:slim X2 insulin pump and others). Also, three clinical guidance documents were updated.

Belgian Health Care Knowledge Center (KCE) initiated the health services research on facilitators and barriers for e-Health adoption by general practitioners. The project has been started in 2017 and is still ongoing.

The Belgian Health Care Knowledge Center (KCE) is conducting research towards a faster, substantiated decision on the reimbursement of innovative medical products. The project started in 2019 and is still being conducted.

On October 14, 2020, the French National Authority for Health (HAS) announced the ongoing update of the submission file guides to support companies who requested reimbursement for medical devices with a system of machine learning (artificial intelligence).