Health technology assessment

In early February 2019, the network of European HTA agencies, EUnetHTA, announced the final report of the project OTCA12 “C-reactive protein point-of-care testing (CRP POCT) to guide antibiotic prescribing in primary care settings for acute respiratory tract infections (RTIs)”.

On January 31st, 2019, the French High Authority for Health (HAS) has published a new assessment of transcatheter aortic valve implantation (TAVI). The objective of this assessment was to clarify the level of requirements of the National Commission for the Evaluation of Medical Devices and Health Technologies (CNEDiMTS) in terms of minimal clinical data to provide for the registration of a new TAVI on the LPPR, for the acceptance of a new indication for a TAVI already registered on the LPPR and for renewal of registration of a TAVI registered on the LPPR.

In late January 2019, the network of European HTA agencies, EUnetHTA, announced the ultimate project plan of the project OTCA20 “Prophylactic or therapeutic use of endoanchoring systems in endovascular aortic aneurysm repair (EVAR/TEVAR).”

In December 2018, the National Institute for Health and Care Excellence (NICE) published one new diagnostic guidance (for tumour profiling tests to guide adjuvant chemotherapy decisions in early breast cancer), two new interventional procedure guidance (for transcutaneous neuromuscular electrical stimulation for oropharyngeal dysphagia in adults and bronchial thermoplasty for severe asthma), and four MedTech innovation briefings.

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.