Health technology assessment

In January 2019, the Austrian HTA body Ludwig-Boltzmann Institute (LBI) has published the update of their decision support document (DSD) 103, which concerns the wearable cardioverter-defibrillator (WCD) therapy in primary and secondary prevention of sudden cardiac arrest in patients at risk. The authors state that further research is necessary for the development of reliable conclusions.

In December 2018, the Andalusian Agency for Evaluation of Health Technologies, AETSA, has released a report on the effectiveness and safety of electrical stimulation of peripheral nerves for treating chronic refractory pain.

In November of 2018, the completed mini-method assessment for decompression due to entrapment neuralgia for patients with chronic pain in the neck, shoulders, and head was released. The method was determined as poorly documented and was not recommended to be introduced as a part of the routine clinical practice.

Two mini-method assessments regarding intraepidermal nerve fiber density in skin biopsy and neurovascular structure-adjacent frozen-section (NeuroSAFE) during robot-assisted laparoscopic prostatectomy (RALP) were initiated by Oslo University Hospital in December of 2018. All finalized mini-method assessments are published in the National Database for Mini-HTA.

In late December 2018, the European HTA agency, EUnetHTA, announced the final report of the project OTCA06 - “Transcatheter aortic valve implantation (TAVI) in patients at intermediate surgical risk.”

In December of 2018, the completed mini-method assessment for targeted deep sequencing panel for patients with varying types of hematological neoplasia was released by the Norwegian Institute of Public Health (NIPH). The method was determined as safe and efficient and was recommended to become a part of routine clinical practice.

In late December 2018, the European HTA agency, EUnetHTA, announced the ultimate project plan of the project OTCA19 - “Screening for osteoporosis in the general population.”

At the beginning of December 2018, the HTA entity of the Region of Tuscany has released a list of the upcoming assessments of the medical devices. Assessments include among others Impella ventricular assist device from Abiomed, Endocuff Vision colonoscope from Olympus, VascuFlex® Multi-LOC multiple stent delivery system from B Braun.

In mid-November, 2018, the European HTA agency, EUnetHTA, published the ultimate project plan of the assessment on “Custom-made or customizable 3D printed implants and cutting guides versus non-3D printed standard implants and cutting guides for improving outcome in patients undergoing knee, maxillofacial, or cranial surgery”.

In mid-November, 2018, the Catalan Agency for Quality and Healthcare Evaluation, AQuAS, published their evaluation of bilateral cochlear implants in children and adults. The authors provided a list of criteria a patient has to fulfil in order to have a cochlear implant prescribed.

In October, the National Institute for Health and Care Excellence (NICE) published one new interventional procedure guidance for selective internal radiation therapy for unresectable primary intrahepatic cholangiocarcinoma, one updated medical technologies guidance endoluminal stent graft system designed for treating aneurysms and dissections of the thoracic aorta and one new medical technologies guidance for a titanium implant intended for use in people with chronic sacroiliac joint pain and three new medtech innovation briefings for device used for babies and children up to 30 kg who need mechanical ventilation, gammaCore for cluster headache and system that delivers warmed and humidified respiratory gases, including at high-flow rates.

In October of 2018, the Norwegian Institute of Public Health (NIPH) has published a single technology assessment regarding the external ultrasound stimulation - Exogen™ in the treatment of femoral or tibial non-union. The objective of the assessment was to evaluate the efficacy, safety and health economic documentation for EXOGEN™ compared to surgical treatment for the management of patients with non-union of a fracture. The results have shown that the present documentation does not give evidence to assess the clinical or cost-effectiveness of EXOGEN™ for the treatment of non-union fractures compared to surgery.