MTRC

In France, reimbursable outpatient and in-hospital services provided by physicians are listed in the Common Classification of Physician Services (CCAM). The French National Authority for Health (HAS) evaluates evidence in the process of creating new CCAM codes. For non-interventional procedures, the creation of a specific CCAM code procedure and introduction into DRG with the appropriate tariff is required. The process of creating new CCAM codes consists of several phases at the HAS and French National Union of Health Insurance Funds (UNCAM). The process to introduce a new CCAM procedure code typically takes 3 to 5 years. The ultimate coverage decision was made by the UNCAM. MTRC released a White Paper with a summary of clinical evidence requirements for the creation of CCAM codes for diagnostic (non-IVD) procedures in France. In this White Paper, MTRC identified evidence requirements for the creation of CCAM codes for diagnostic (non-IVD) procedures performed by physicians based on an analysis of four recent HAS reports with positive and negative recommendations. The analysis was performed in February 2024. Read more and request a White Paper here: https://lnkd.in/eHdemE4T

On October 01, 2024, the Dutch Healthcare Authority (NZa) published the second release of the 2025 DRG package (RZ25b), which implemented a new procedure code for supporting joint decision-making in outpatient specialist care and supplementary payment proactive planning of palliative care: https://lnkd.in/eN32qX9Z

In France, reimbursements for hospital procedures are made solely via a DRG system, which is called “Groupe Homogène de Maladies” (GHM). All hospitalizations, as well as day case procedures and ambulatory treatments, are reimbursed via DRG. However, there is a possibility of add-on reimbursement (on top of the DRG tariff) via LPPR List. Add-on reimbursement is possible for selected implantable (Title III) or invasive non-implantable (Title V) devices. MTRC released a White Paper with a summary of clinical evidence requirements for the LPPR List process for implants and invasive devices in France. In this White Paper, we identified evidence requirement pitfalls that act as a barrier to listing in the LPPR based on analyzing five recent HAS reports with negative recommendations from different medical disciplines. The analysis was performed in January 2024. Read more and request a White Paper here: https://lnkd.in/edGRdwsd

In October 2024, the Finnish Coordinating Center for Health Technology Assessment released a report aiming to summarize the results of the comparative analysis of Finnish Digi-HTA and French Early coverage of digital medical devices framework (PECAN) assessment criteria. The analysis focuses on the frameworks' general aspects and the cybersecurity requirements: https://lnkd.in/e8_W2_NE

In France, reimbursements for hospital procedures are made solely via a DRG system, which is called “Groupe Homogène de Maladies” (GHM). All hospitalizations, as well as day case procedures and ambulatory treatments, are reimbursed via DRG. However, there is a possibility of add-on reimbursement (on top of the DRG tariff) via LPPR List. Add-on reimbursement is possible for selected implantable (Title III) or invasive non-implantable (Title V) devices. In this White Paper, we identified evidence requirements for national add-on reimbursement via the LPPR List process based on an analysis of five recent HAS reports with positive recommendations. Cases included technologies with different levels of added clinical value (II, III, IV, and V). A review of five cases is followed by recommendations in relation to evidence generation for medical technologies in France, and factors influencing the decision-making of HAS. The analysis was performed in February 2024. Read more and request a White Paper here: https://lnkd.in/enzHs9SE

In Q3 2024, Health Technology Wales completed three full appraisals with the publication of Evidence Appraisal Report and Guidance (AI for whole slide prostate biopsy images, AI-assisted endoscopy for gastrointestinal cancer, and Floseal in the treatment of epistaxis). Furthermore, 24 Med Tech-related Topic Exploration Reports were published concerning cardiovascular, gastrointestinal, gynecology, e-health, in-vitro diagnostics, and other areas: https://lnkd.in/eKkHx8Cs

Clinical and economic evidence is essential for obtaining market access for innovative medical technologies in Europe. Evidence is required to assist reimbursement (e.g. creation of procedure code in Austria, Belgium, France, and the Netherlands) and funding (e.g. obtaining coverage in England and Switzerland) for hospital and ambulatory technologies. In some countries, only clinical evidence is required, while in others, economic data is required as well (Belgium, England, the Netherlands, and Switzerland). Companies struggle to understand what kind of data is required to support reimbursement processes. How many studies are necessary? What should be the duration of follow-up? What outcomes should be considered? What comparator should be selected? MTRC helps medical technology companies reduce uncertainty about evidence requirements of key European reimbursement, funding, and HTA authorities and develop a clear plan to address key gaps with clinical and economic evidence. Learn more and contact us to discuss your needs here: https://lnkd.in/ehYAkxFh

At the beginning of October 2024, the Ministry of Labor, Health, and Solidarity published the amounts awarded for the Health Economic Research Program (PRME) projects submitted in 2023 and selected for funding: https://lnkd.in/esHzX4zB

MTRC offers a cost-effective and fast approach to developing early value dossiers for medical technologies. MTRC is the leading provider of market access services for the med tech industry in Europe. Since 2017 we have accomplished 880+ market access and HEOR projects in Europe for more than 220 companies. We provide regular consulting services to 56% of the top 30 med tech companies and multiple SMEs. The challenge that every innovative medical technology company faces, is communicating the value of medical technology to different stakeholders: 1️⃣ Why is this specific healthcare problem important (mortality, morbidity, impact on quality of life, cost-of-illness)? 2️⃣ What are the current treatment options and what are their limitations? 3️⃣ What is the size of the population with high unmet needs? 4️⃣ What is the proposed novel solution? 5️⃣ Is the treatment/diagnostic option safe and effective? 6️⃣ What are the economic consequences to the hospital and health care system? 7️⃣ What are the organizational requirements for the introduction of a novel method? Historically, these questions were answered by separate publications in peer-reviewed journals and marketing materials. However, these publications are typically not comprehensive enough, lack important information, and are too unstructured to support discussion with various stakeholders including clinicians, reimbursement authorities, and payers. MTRC offers the service of the development of full and early value dossier to support market access, marketing, and business development activities for medical device and IVD companies. An early value dossier is a relatively short (twenty to twenty-five pages) document, based on a systematic but limited search with a focus on the key messages and data. The key objective of the early value dossier is to develop a solid overview of the value proposition at the lowest possible cost. Why choose MTRC for support with the development of an early value dossier? The key factor is that we match deep reimbursement and evidence synthesis expertise. We also acknowledge the budget limitations of the med tech industry. We offer a cost-effective approach with the provision of high-quality (we are ISO 9001:2015-certified, and our average NPS is 10/10) but affordable (14% of our business comes from SMEs) service to our clients. Learn more and contact us to discuss your needs here: https://lnkd.in/dyA4ZdS8  

On October 01, 2024, the Dutch Healthcare Authority (NZa) published the second release of the 2025 DRG package (RZ25b). Three new procedure codes, four new supplementary payments (OZPs), 18 new diagnosis codes, and two new DRGs will be implemented across gastroenterology, surgery, diagnostic imaging, molecular diagnostics, and other areas: https://lnkd.in/dMQyhvZx