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News and blog posts

18
Oct 2017

Clinical guidelines and Med Tech-related technology assessments from NICE in the second half of September 2017

In the second two weeks of September, the National Institute for Health and Care Excellence published 2 new and 3 updated clinical, four new Interventional Procedures Guidance (for intramuscular diaphragm stimulation for ventilator-dependent chronic respiratory failure caused by high spinal cord injuries and motor neurone disease, ab externo canaloplasty for primary open-angle glaucoma, high-intensity focused ultrasound for symptomatic breast fibroadenoma), and 3 Medtech innovation briefings (Farco-fill Protect, Caris Molecular Intelligence for guiding cancer treatment and Aptiva for painful diabetic neuropathy).
17
Oct 2017

The French National Authority for Health (HAS) published new set of decisions regarding add-on reimbursement of medical devices and medical aids in September

French National Authority for Health (HAS) released new decisions about add-on and medical aid reimbursement of medical devices from the meetings of the National Commission for Evaluation of Medical Devices and Health Technologies (CNEDiMTS) in September 2017. They include knee and hip prostheses, therapeutic shoes, coronary stents, heart valves, peripheral stents, and balloons.
13
Oct 2017

NHS England released Commissioning through Evaluation Project Report by NICE in relation to the Selective internal radiation therapy (SIRT)

SIRT is not routinely commissioned in England. In 2013 NHS England commissioned an evaluation of SIRT for colorectal liver metastases and intrahepatic cholangiocarcinoma within registry in England, complemented by systematic literature review and de novo economic analysis (Commissioning Through Evaluation). In July 2017, NICE prepared a final report for NHS England, which was made public on 12th of October 2017.
11
Oct 2017

Lack of co-funding of study from the manufacturer puts high-intensity focused ultrasound at risk for exclusion from German social health insurance

German Federal Joint Committee (G-BA) passed directives for co-funded trials to create evidence on two high-intensity focused ultrasound methods that showed potential benefit in the early benefit assessment process in relation to the innovation funding (NUB). Manufacturer refused to cover required contribution to trial costs and thereby risk exclusion of the methods from benefit catalogues in the German social health insurance.
10
Oct 2017

The French National Authority for Health (HAS) published an HTA report of remote monitoring for implantable cardioverter defibrillator systems (ICDS)

At the beginning of August 2017, the French National Authority for Health (HAS) published a health technology assessment of systems for remote monitoring for implantable cardioverter defibrillators (ICD). The aim of this assessment was an update and clarification of arrangements for the provision of implantable cardioverter defibrillator systems (ICDS) to improve the quality of care for patients with ICD and to promote the deployment of effective solutions in the country.
09
Oct 2017

Italian national HTA Programme approved at the State-Regions Assembly

Agreement on the national HTA programme for medical devices has been reached between the central and regional authorities during the last Assembly. The main player in this context will be the Cabina di Regia per l’HTA. The steering committee will produce policy recommendations about the use of the assessed technologies and monitor implementation by procurement organizations. Read about the scope of the framework in our blog post.
06
Oct 2017

Resumption of assessments for two methods in the field of oncology by Joint Federal Committee (G-BA) in Germany

The Joint Federal Committee (G-BA) resumes assessments of methods that have been intermitted due to missing evidence: LDR brachytherapy in localized prostate carcinoma and PET or PET/CT for malignant lymphomas as well as for interim staging in Hodgkin's lymphoma. Studies conducted in the meantime are expected to provide sufficient evidence base for the assessment about the inclusion of the methods into the social health insurance benefit catalogue in Germany.
03
Oct 2017

The Norwegian Directorate of Health has released 2018 version Norwegian Classification of medical, surgical and radiological procedure codes (NCSP, NCMP, NCRP) applicable since January 1, 2018

New procedure codes will be created for stem cell procedures, extracorporeal techniques (including hemodialysis and CO2 removal), surgical interventions, including growth-controlling spinal correction, transposition of peripheral nerve, interventions on veins, and percutaneous image-guided procedures (including code for pressure measurement in coronary arteries and additional code for drug-eluting balloon). Classification will be enabled from January 1, 2018.
02
Oct 2017

Four decisions for medical devices and IVD tests from the meeting of the Norwegian Decision Forum on introduction of innovations in September

On 25th of September, the Norwegian Decision Forum of “New Methods” had a meeting to review several medical technologies and IVD tests. Decisions were made in relation to the introduction of 2 new newborn screening tests, prehospital emergency thoracotomy, aortic valve replacement using sutureless stent Perceval, and digital breast tomosynthesis.
29
Sep 2017

The Federal Joint Committee (G-BA) has prepared the path for a trial of the transcorneal electrical stimulation for retinitis pigmentosa in Germany

After successful trial application by the manufacturer (Okuvision) of a stimulation technology (Okustim), the Federal Joint Committee (G-BA) decided on a trial guideline for a co-funded study defining the key points of the planned study, including type and time period of the study, target population and control intervention. Results from the trial will be evaluated and may lead to reimbursement of the method in both, the inpatient and outpatient sectors.
28
Sep 2017

Timing for start of add-on reimbursement since recommendation from CNEDiMTS for invasive non-implantable devices in France

MTRC has analyzed timing of decision-making (negotiation about price, final ministerial decision and publication of the decision) after recommendation by CNEDiMTS about expected benefit (AS) and added clinical value (ASA) for invasive non-implantable medical devices reimbursed via LPPR list, title V. Since establishment of the title V program, 5 technologies were added to the List (stent retrievers for stroke; peripheral drug-coated balloons). Time from the recommendation by CNEDiMTS until the start of reimbursement varied from 7 to 13 months (9.4 months on average).