Emilia Romagna Region published a preliminary information report on the CytoSorb® device, an extracorporeal cytokine adsorber for the reduction of circulating cytokines in the blood stream.

CEO of the MTRC, Dr. Oleg Borisenko will attend the "MedTech Access Leaders Forum" 5-7 of December in Berlin. Please, write to info@mtrconsult.com if you would be interested to arrange a meeting to discuss your market access needs in Europe. 

The Dutch National Health Care Institute considered that application of one-way endobronchial valves for endobronchial lung volume reduction fulfills the criteria of “state of science and practice” for patients with severe emphysema and insufficiency of drug treatment. Therefore, this procedure can be included into a basic package for appropriate indication.

Article “Bariatric surgery versus conservative management for morbidly obese patients in Spain: a cost-effectiveness analysis” published in the “Expert Review of Pharmacoeconomics & Outcomes Research” provides insights about economic outcomes of bariatric surgery in Spain using Markov modeling. Over the 10-year horizon, bariatric surgery led to a cost increment of €9,386 and 1.6 additional QALY (€5,966/QALY) compared with optimal medical management. Over lifetime horizon, surgery led to 0.6 life years and 4.4 QALY gains and €300/patient average cost savings.

Emilia Romagna Region published a rapid assessment report on the cardiac cryoablation catheter (also known as cryoballoon) for atrial fibrillation (AF). The authors concluded that, compared to radiofrequency ablation, cryoablation is not linked to higher effectiveness but presents shorter procedural time.Emilia Romagna Region published a rapid assessment report on the cardiac cryoablation catheter (also known as cryoballoon) for atrial fibrillation (AF). The authors concluded that, compared to radiofrequency ablation, cryoablation is not linked to higher effectiveness but presents shorter procedural time.

A 155-page reimbursement report covers coronary angioplasty (using a plain and drug-coated balloon, bare metal, drug-eluting and bioresorbable stents), mechanical thrombectomy and atherectomy in hospital settings. The analysis covers procedure coding, payment mechanism, reimbursement tariff and policy restrictions. The report provides an overview of reimbursement situation in 11 EU countries including Austria, Belgium, Denmark, England, France, Germany, Italy, the Netherlands, Norway, Sweden, and Switzerland.

Shockwave Medical, the manufacturer of the Coronary Lithoplasty® System for the treatment of calcified coronary artery stenosis, requested a consultation by the Joint Federal Committee (G-BA) to find out whether their device requires an early benefit assessment according to §137h of the Social Code Book V (SGB V). The G-BA decided that the technology is highly invasive and innovative and therefore will need to undergo benefit assessment to be granted innovation funding.

NHS England, Public Health England and Diabetes UK have teamed up with leading companies from the tech sector to fight against obesity and Type 2 diabetes using innovative digital products.

EUnetHTA has published project plan of rapid assessment of TAVI procedure in patients with intermediate risk. Current plan describes the design and methodology of the assessment, list of involved reviewers, stakeholders and timelines of the project. The final report will be prepared till the end of January 2018.

In the first half of November, 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 orthopedic devices (double-mobility cup, meniscal repair system), electrodes for radiofrequency ablation, portable oxygen concentrator, drug–coated balloons and other devices.

We have developed a one-day training in market access for IVD companies, covering essential areas of reimbursement, funding, health technology assessment, the role of clinical and economic evidence, stakeholder engagement. The seminar is based on the in-house expertise and extensive interview program with laboratory experts. During the course, both general aspects of market access and specific pathways for IVD tests in 12 European countries are reviewed. CEO Oleg Borisenko performs seminar on the client’s facility.