In December, HAS published a set of decisions about add-on reimbursement of medical devices that were evaluated by the National Commission for Evaluation of Medical Devices and Health Technologies (CNEDiMTS). These decisions concern respiratory prostheses for total laryngectomy, mandibular advancement devices, some cardiovascular devices (transcutaneous bioprosthetic aortic heart valve, ventricular assist device, etc.) and other devices.

In the first half of January, the National Institute for Health and Care Excellence (NICE) published five new Medtech innovation briefings for in vitro diagnostic test for determining breast cancer subtypes, point-of-care creatinine tests before contrast-enhanced imaging, plasma EGFR mutation tests for adults with locally advanced or metastatic non-small-cell lung cancer, smartphone otoscope and sequencing panel for solid tumour cancers in children .

The Institute for Quality and Efficiency in Health Care (IQWiG) has analyzed the applications for approval of clinical trials at the Berlin Ethics Committee. The share of randomized controlled trials (RCTs) had risen to 86% in 2013. This trend is assumed to be an early response to increasing international legal regulations of medical devices requiring manufacturers to present higher standards of evidence.

The Clinical Coding and Schedule Development Group develops and maintains procedural and diagnostics nomenclature for private payers in England. In November new codes for allergy diagnostics, diagnostic profiles for certain diseases and detection of antibodies against Chlamydia were added to the CCSD Schedule.

A 62-page reimbursement report covers mechanical thrombectomy for stroke. The analysis covers procedure coding, payment mechanism, reimbursement tariffs and policy restrictions in 11 EU countries including Austria, Belgium, Denmark, England, France, Germany, Italy, the Netherlands, Norway, Sweden and Switzerland.

Article “Cost-effectiveness analysis of bariatric surgery for morbid obesity in Belgium” published in the “Journal of Medical Economics” provides insights about economic outcomes of bariatric surgery in Belgium using Markov modeling. Over the 10-year horizon, bariatric surgery led to a cost increment of €3,788 and 1.4 additional QALY (€2,809/QALY) compared with optimal medical management. Over lifetime horizon, surgery led to 1.1 life years and 5.0 QALY gains and €9,332/patient average cost savings.

Since January 1, 2018, responsibility for managing the product regulations for medical devices is transferred from the Norwegian Directorate of Health to the Norwegian Medicines Agency.

The program will cover the period of 2018-2025 and will focus on improvement of provision of health care services, introduction of innovations and other aspects of health care system. Overall budget of the program is 4.7 bln. euros. The program can create a window of opportunity for financing of innovative equipment and devices in Russia.

A 104-page reimbursement report covers percutaneous, thoracoscopic and open in adjunction to heart surgery ablations in hospital settings. Radiofrequency, cryo and microwave ablation sources were considered. The analysis covers procedure coding, payment mechanism, reimbursement tariffs and policy restrictions in 11 EU countries including Austria, Belgium, Denmark, England, France, Germany, Italy, the Netherlands, Norway, Sweden and Switzerland.

The Clinical Coding and Schedule Development Group develops and maintains procedural and diagnostics nomenclature for private payers in England. In November new codes for reconstruction of breast, open adnexectomy, transoral laser microsurgery and surgical correction of hallux valgus were added to the CCSD Schedule.

The Department of Home Affairs (EDI) in Switzerland decided upon the coverage with evidence development (CED) of two types of positron emission tomography as well as stereotactic radiotherapy (photons) of exudative age-related macular degeneration. The status is given to contested medical services for a specific period which is extended until evidence is complete.

The new Diagnosis Related Group (DRG) system, called “LKF system” in Austria came into effect on January 1st 2018. It is used for the reimbursement, documentation and cost data collection of inpatient and day case services in Austrian hospitals. Compared to the last version, the LKF system for 2018 includes two newly established procedure groups (Oncological Immunotherapy and Transcranial Magnetic Stimulation) as well as several new procedures and changes in the association of procedures to specific groups. See details in the MTRC report.