Medical devices

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.

The French National Authority for Health (HAS) regularly publishes new decisions about add-on reimbursement for medical devices. The decisions made in December 2018 concern various types of devices (orthopedic, neurostimulators, drug-coated balloon and others). The decisions were brought for ten (10) medical devices.

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 late October 2018, Assobiomedica, the body that represents the companies that operate in the medical device sector, published the fourth edition of the document “Public policies for the purchase of medical devices.”

On November 7, 2018, the Italian Ministry of Health announced the document which should serve as a tool for the acquisition of medical devices through tenders.

On 7th of November, 2018, the Italian Ministry of Health announced that the technical standards for magnetic resonance and its use are updated.

On November 1, 2018, the European network for Health Technology Assessment, EUnetHTA, has announced that the patient groups’ input is required for a new Collaborative Assessment on a medical device for high-risk soft tissue sarcoma. The consultation is opened until November 30, 2018.

On October 26, 2018, the French High Authority for Health (HAS) has announced that the composition of the National Commission for the Evaluation of Medical Devices and Health Technologies (CNEDiMTS) has been renewed.

On October 26, 2018, the European Network for Health Technology Assessment has published the final report of femtosecond laser-assisted cataract surgery (FLACS) for the treatment of age-related cataract. The authors of this report are a group of experts from the Italian region of Emilia Romagna, together with Health Austria (Gesundheit Österreich, GÖG).

In July of 2018, the Dental and Pharmaceutical Benefits Agency (Tandvårds-Läkemedelförmånsverket, TLV) has updated the product group codes for consumables for better understanding the range of the products. Editorial changes to the codes' descriptions were implemented. Seven new groups for stomach products, plates and bags of different types, which are especially intended for children have been included in the classification.

On the 5th of June of 2018, Dental and Pharmaceutical Benefit Agency (Tandvårds- och läkemedelsförmånsverket, TLV) has published a decision regarding inclusion of number of Verifine blood lancets produced by Mediq Sverige AB for diabetic patients to monitor the blood glucose levels into the list of pharmaceutical benefits with the price of SEK 23 per package.