Knowledge base
Archived articles from Synergus RWE, kept for reference.
10 articles
Class IIb and III – Clarify Eligibility for 137 (h) prior to submitting NUB in Germany!
In a recent post by G-BA, they reinforced to the hospitals are required to submit a 137(h) application for medical devices of class IIb or III, unless G-BA already has clarified that the product is not eligible. It is…
France: Temporary reimbursement pending results from clinical trial
France offers a pathway called PECT (The Prise en Charge Transitoire ) for temporary reimbursement off valuable and innovative medical devices and services pending completion of ongoing clinical trial. The aim is to…
Medical Device and EU HTA Regulation - Norwegian perspective
Norway has developed a national system with mini-HTA and national evaluations that include medical devices and diagnostics. The system is governed by the 4 regional health companies with the responsibility of specialist…
5 key-steps to unlock the potential for the new attractive reimbursement opportunity in Germany
5 key-steps to unlock the potential for the new attractive reimbursement opportunity in Germany The recent change that was announced in Germany regarding the process for innovation funding will become effective 2020. In…
German reimbursement opportunity for medical devices re-opens 2020 !
A change to the German legislation regarding the introduction of new innovative medical devices have just been implemented as of May 1 st . The new law will be applicable as of 2020. It is not clear how all aspects of…
Managed entry agreements / Coverage with Evidence Development – The new home-run for device, diagnostic and digital health start-ups!?
With the evolving evidence requirements for the introduction of new technologies, I would suggest that we should evaluate how we see a successful journey for a start-up company. Historically, most of the start-ups we…
Synergus analyzed the data and recommendations from 10 latest HTA reports in Sweden
Synergus’ analysis included the 10 latest HTA reports by different national and regional HTA bodies in Sweden. The reports covered various disease areas and technology areas, most of them related to treatment and…
Value-based health care in bariatric surgery
This is a summary of the pilot study regarding the development of a value-based monitoring platform for bariatric surgery in Sweden. Initial analysis of data To understand the relevant outcomes, historical data from…
Stuck in DRG/ZE negotiations in Germany?
Many medical device manufacturers have found themselves caught in a trap where there is a DRG and/or ZE (add-on payment) available for their technology but where the insurance companies refuse to pay this fee. Through…
GKV-Spitzenverband says more high-risk medical devices should be assessed by G-BA in § 137h
Background With the introduction of § 137h SGB V in 2016, the German legislator introduced a systematic early assessment of new medical devices based on high-risk methods in the hospital sector. If a hospital applies…