MTRC

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

On September 11, 2024, NHS England published an updated work plan for specialized clinical commissioning policies development. One MedTech-related policy was added to the program on long-term left ventricular assist devices (LVAD) for destination therapy in adults with heart failure. No new policies were published: https://lnkd.in/eA43KtuG

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 September 16, 2024, the National Association of Statutory Health Insurance Physicians (KBV) and the National Association of Statutory Health Insurance Funds (GKV-Spitzenverband) announced that they had reached an agreement in financing negotiations concerning outpatient care: https://lnkd.in/eKPAZeUm

Strategic recommendations on the topic of market access pathways for medical technologies. MTRC is the leading provider of reimbursement analysis 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. MTRC offers a service of development of comprehensive strategies to establish reimbursement and funding for medical technologies in Europe. Multiple situations may call for reimbursement strategy support, for example: 1️⃣ Technology is new and no coding and reimbursement are available 2️⃣ Coding and reimbursement are available, but the tariff is low and does not cover the cost of a device 3️⃣ Coding and reimbursement are available, and the tariff is sufficient, but there are restrictions on the target population for the procedure The reimbursement strategy includes an understanding of the relevant pathways (including innovative payment schemes), stakeholders involved, the process, data and evidence requirements, timelines, and deadlines for applications. With MTRC you can avoid the hassle of contracting multiple vendors by working with a single professional provider of services in the European region. Finally, we 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/eFnbr8NS

In September 2024, the National Institute for Health and Care Excellence (NICE) published one new Interventional Procedures Guidance concerning single-step scaffold insertion for repairing symptomatic chondral knee defects: https://lnkd.in/eTa9bEkw

A cost-effective approach to reimbursement analysis for medical technologies in Europe. MTRC is the leading provider of reimbursement analysis in Europe. Since 2017 we have accomplished 880+ market access and HEOR projects in Europe for more than 220 companies. We specialize in multi-country assessments and have experience with analysis in 34 EU countries. Over the years of practice, MTRC developed a robust analytical and reporting methodology that answers all your key questions. The typical scope of the project includes the following: 1️⃣ procedure and reimbursement codes 2️⃣ payment mechanisms 3️⃣ reimbursement tariffs 4️⃣ policy (coverage) and HTA considerations You can avoid the hassle of contracting multiple vendors by working with a single professional provider of services in the European region. A typical project takes about 4-5 weeks to enable your fast business decisions. Finally, we 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/d8DUyKiF

The French National Authority for Health (HAS) released new recommendations about add-on reimbursement of medical devices and medical aids from the meetings of the National Commission for Evaluation of Medical Devices and Health Technologies (CNEDiMTS) in September 2024. Five recommendations were published concerning the registration or modification of registration conditions/extension of indications for the medical devices in the List of Reimbursable Products and Services (LPPR). Opinions concern endocrine and spine devices, as well as medical aids: https://lnkd.in/eqRzq-Ne

Market access for in-vitro diagnostic (IVD) testing is a challenging field. It includes co-existing frameworks of reimbursement (coding, payment mechanism tariffs), funding (post-reimbursement approval by payers), and health technology assessment (HTA). For most of the Med Tech companies, the starting point for understanding the European market is EU5 countries: England, France, Germany, Italy, and Spain. Despite the single similarity of large populations, these countries are organized completely differently from the market access perspective. On the reimbursement side, England and Spain use a global budget model, while France, Germany and Italy use a fee-for-service model. In both England and Spain, there are national coverage lists of genetic tests. HTA is part of the reimbursement process in France and Germany (partly) and it is a stand-alone process for IVD tests in England, Italy, and Spain. MTRC developed an analytical White Paper with a summary of key market access elements of EU5 countries, including stakeholders, payment mechanisms, innovative payment schemes, funding, and the role of HTA for in-vitro diagnostic tests. Read more and request a White Paper here: https://lnkd.in/eXaE_bKj

On September 18, 2024, the Organization for Outpatient Physician Tariffs (OAAT) AG announced that the comprehensive tariff system, including the TARDOC catalog of individual service tariffs and outpatient flat rates, is now available for review by interested parties. As emphasized by the OAAT AG, the new system has not been approved yet. After the partial approval by the Swiss Federal Council in June 2024, the implementation of the new system was postponed until January 2026: https://lnkd.in/eNiJF8wE