Health technology assessment

In early 2019, the Memorandum of Understanding was signed to support HTA in Ireland, Scotland, and Wales. The Memorandum of understanding establishes a collaborative approach to the identification and assessment of new health technologies between Health Information and Quality Authority Ireland, Health Technology Assesment Group Ireland, Health Technology Wales, and the Scottish Health Technology Group. These bodies assess and give guidance on health technologies within their national healthcare systems.

In late March 2019, the Italian Ministry of Health has published a new document on medical device governance. The document presents the guidelines for a new governance of medical devices, which aims at the efficient allocation of the NHS resources, the sustainability of innovation, the strengthening of supervision and the transparency of actions and reports concerning the procurement and use of medical devices.

In March 2019, the National Institute for Health and Care Excellence (NICE) published two new interventional procedure guidance (for Barnett Continent Intestinal Reservoir (modified continent ileostomy) to restore continence after colon and rectum removal and high-intensity focused ultrasound for symptomatic benign thyroid nodules), and three new MedTech innovation briefings (for system for ruling out coronary artery disease in people with symptoms of stable coronary artery disease, medical imaging software tool for kidney stone evaluation, incision management system for closed surgical incisions).

Norway established in 2013 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. Currently, 13 ongoing mini-HTA projects are conducted in Norway: robotic-assisted procedures, microwave ablation, and tonsillectomy devices, among others.

In early February 2019, the network of European HTA agencies, EUnetHTA, announced the final report of the project OTCA16 “Bioresorbable Stents for the Treatment of Cardiovascular Indications (coronary artery disease).” In early February 2019, the network of European HTA agencies, EUnetHTA, announced the final report of the project OTCA16 “Bioresorbable Stents for the Treatment of Cardiovascular Indications (coronary artery disease).”

On the Interterritorial Council that took place March 4th, 2019, the Working Plan for the Spanish Network for Health Technology Assessment was agreed and published. The working plan includes 22 health technology assessment reports, 7 monitoring studies, 9 clinical practice guidelines, and 1 evidence-based product.

In Finland, the Health Care Services Selection Council is responsible for making recommendations regarding the research, treatment and rehabilitation methods. Currently, PALKO is working on the only one assessment related to medical technologies - surgical treatment of lumbar intervertebral disc herniation. In final report, the Council would conclude whether the procedure is a part of publicly funded services or not.

In Norway, the mini-HTA for magnetic technology (Magseed) for breast lesions was released in February of 2018. The method was determined as efficient, safe and was recommended to be introduced as part of the clinical routine in the hospital.

In early 2019, the Norwegian Institute of Public Health (NIPH) has published a health technology assessment report regarding the hyperbaric oxygen therapy for osteonecrosis. The results have shown that the efficacy and safety evidence of the procedure is too uncertain for now, and its economic evidence is also very limited. Further controlled, prospective studies are recommended.

In January 2019, the National Institute for Health and Care Excellence (NICE) published six new interventional procedure guidance, three medical technologies guidance, and three new MedTech innovation briefings for liver function capacity test, a functional electrical stimulation (FES) integrated cycling system used to start muscle contraction to stimulate trunk and limb muscles in people with spinal cord injury, laser shoe attachment used as a walking aid and is designed to help prevent freezing of gait in people with Parkinson's disease.

In October of 2018, the Dental and Pharmaceutical Benefits Agency (TLV) has published a completed health economic evaluation regarding the clinical efficacy and cost-effectiveness MiniMed 670G in comparison to MiniMed 640G device. TLV concluded that the use of the MiniMed 670G can increase the patients’ quality of life due to reduced concern for hypoglycemia, increased comfort, fewer complications and also lead to potential cost benefits.

In early February 2019, the entity that performs health technology assessment for medical devices in Italy, AGENAS, has called for the voluntary contribution of the clinical experts and/or reviewers, as well as for the participation of the manufacturers for announced that they’re working on several HTA projects on different medical devices and procedures, including bariatric surgery, continuous glucose monitoring, Elecsys®sFlt-1/PlGF test and others.