Health technology assessment

Emilia Romagna Region published a preliminary information report on the LumiHeal™ KLOX system, a topical photo-converter system for the treatment of acute and chronic wounds.

On July 27th, 2018, the European network for HTA has published a rapid assessment of the continuous glucose monitoring (CGM real-time) and flash glucose monitoring (FGM) as personal, standalone systems in patients with diabetes mellitus treated with insulin.

Emilia Romagna Region published a rapid assessment report on the Medtronic’s Heli-FX™ EndoAnchor™ system. The authors concluded that published literature is of poor quality (mainly non-comparative studies) and mostly includes patients with abdominal aortic aneurysm. Data on the use of the device for thoracic aorta aneurysm repair are extremely limited.

In mid-July 2018, the Health Service of the Canary Islands, SESCS, has published a report in which they have assessed the safety, effectiveness and cost-effectiveness of the endoscopic ablation by radiofrequency in antral gastropathy and Actinic proctitis.

In the first half of July, the National Institute for Health and Care Excellence (NICE) published one new Diagnostics Guidance for biomarker tests to help diagnose preterm labour in women with intact membranesand one new medtech innovation briefing for airglove air warming system for venous access.

Three mini-method assessments regarding the magnetic non-radioactive detection system SentiMag Sienna + of sentinel lymph nodes in breast cancer, cough reflex testing and emergency targeted ultrasound implementation were initiated by Oslo University Hospital in June of 2018. All finalized mini-method assessments are published in the National Database for Mini-HTA.

In June of 2018, the Norwegian Institute of Public Health (NIPH) has published a single technology assessment regarding the MicraTM Transcatheter Pacing System (Micra TPS) - a leadless pacemaker produced by Medtronic to reduce the rate of complications following pacemaker implantations through design and novel technology. The objective of the assessment was to investigate the clinical efficacy, safety and cost effectiveness of Micra TPS in patients indicated for single chamber ventricular pacemaker implantation. The results have shown that the current evidence is not sufficient to prove that the Micra TPS gives less complications than standard pacemakers, also the use of Micra appeared not to be cost-effective.

In the second half of June, the National Institute for Health and Care Excellence (NICE) published two new interventional procedure guidance for laparoscopic ventral mesh rectopexy for internal rectal prolapse and MRI-guided focused ultrasound thalamotomy for treatment-resistant essential tremor, and two new medtech innovation briefings for negative pressure wound therapy for closed surgical incision wounds and ocular response analyzer to measure corneal hysteresis.

On 6th of July, 2018, the European network for health technology assessment, EUnetHTA, has opened the public consultation on ‘Horizon Scanning, Topic Identification, Selection and Prioritisation for European Cooperation on HTA – Draft recommendations.’

In April 2018, a national HTA program has been launched in order to re-evaluate benefits presently covered by the mandatory health insurance.

In late June 2018, the Andalusian Agency for Evaluation of Health Technologies, AETSA, has released a report on the efficacy and safety leadless pacemaker.

At the beginning of June 2018, the Health Technology Evaluation Service of the Basque County, OSTEBA, has published an assessment of effectiveness, safety and indications of radiological bone suppression technology for the detection of lung cancer.