Medical devices

New material codes for an implantable sensor for continuous measurement of glucose in interstitial fluid and embolization equipment were added to the List of reimbursable devices of the Belgian National Institute for Health and Disability Insurance (INAMI-RIZIV) in October 2019.

New material codes for extraction catheters were added to the List of reimbursable devices of the Belgian National Institute for Health and Disability Insurance (INAMI-RIZIV) in September 2019.

Domestic use of motor-driven moving splints (continuous passive motion, CPM) after interventions at the knee or shoulder joint remains covered by statutory health insurance. This has been determined by the G-BA (the Federal Joint Committee).

Glioblastoma is an aggressive brain tumor with a low survival rate, usually occurring in late adulthood. The standard treatment consists of surgery, followed by radiation and chemotherapy. The Institute for Quality and Efficiency in Health Care (IQWiG) has examined possible benefits of tumor-treating field (TTF) therapy - new treatment based on electrostimulation in patients with glioblastoma.

Notification to the Belgian Federal Agency for Medicines and Health Products (AFMPS) is a condition for obtaining reimbursement of compulsory medical insurance for implants and invasive medical devices for long-term use. Only devices that meet the notification requirements will be eligible for health care insurance.

On the 7th of May 2019, the new evaluation for bone-anchored prosthesis has been commenced in a framework of New Method, which provides a way for a managed introduction of innovations into Norwegian health care system. The proposal for the assessment was submitted by Oslo University Hospital in order to receive an opportunity to offer this method to achieve overall money saving and medical benefits as nowadays, only conventional prostheses are offered, and patients are sent to Gothenburg to receive the treatment, that is financed by the Norwegian health service.

In France, there is a fast-track pathway, which provides reimbursement within the framework of the prospective medico-economic study, aiming at demonstrating benefits to patients or reduction of expenditure of health care system. On the 19th of April, the French National Authority for Health published two opinions regarding the inclusion of two devices into innovation package - eCLIPS: for treatment of cerebral aneurysm, Nuvaira™ Lung Denervation System for chronic obstructive pulmonary disease and asthma.

The Federal Joint Committee (G-BA) has signed a further contract for scientific monitoring and implementation of a trial study for NYHA III heart failure therapy optimization by means of continuous blood pressure measurement and monitoring using an implanted sensor in the pulmonary artery.

In April 2019, the Ministry of Health, Consumption and Social Welfare announced the update of the common package of benefits of the Spanish national health system with the inclusion of cervical cancer screening, nipple and areola micropigmentation and update of orthoprosthesis catalog.

At the end of April 2019, the network of European HTA agencies, EUnetHTA, published the “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.”

With the regional decree of April 23, 2019, Tuscany Regional Healthcare has published assessments of six medical devices belonging to various therapeutic areas, including a system for monitoring in heart failure, TAVI, glaucoma drainage system, intravascular lithotripsy system.

NHS England is inviting nominations for additions to, and removals from, the high-cost drugs and devices lists for the next national tariff come into effect in April 2020. All submissions must be submitted by May 31, 2019.