Market access is a challenging field. Multiple priorities have to be managed within a limited budget. We would like to share the anonymized outlines of the projects in the HEOR and market access fields commissioned to MTRC to inspire our clients. The next example is the rapid development of value messages to support positioning and marketing activities.

MTRC shares the most relevant and impactful publications in the field of market access and HEOR for medical technologies in Europe through its Publications Digest. In a recent publication, Hulstaert et al. investigated the level of evidence supporting innovative high-risk medical devices (class IIb-III) during their market entry phase. The authors reviewed assessment reports from the Belgian healthcare payer (RIZIV-INAMI) concerning novel implants and invasive medical devices (n=18) available between 2018 and mid-2019 and conducted a literature review on evidence gaps within the European legal and ethical frameworks. The findings highlighted issues with the evidence provided for CE marking, indicating that clinical effectiveness is not ensured by regulatory compliance alone. The study underscored the necessity for improved clinical evidence transparency and alignment with international ethical standards to ensure patient safety and efficacy in the realm of novel medical devices.

In late September 2023, the Norwegian Directorate of e-Health released an updated version of the Norwegian Laboratory Code (NLK) system and associated tariffs to be implemented no later than November 1, 2023. A total of 123 new codes were added, 50 codes were terminated, and 69 codes were amended.

MTRC shares the most relevant and impactful publications in the field of market access and HEOR for medical technologies in Europe through its Publications Digest. In a recent publication, Schaefer et al. assessed the effect of official evaluation criteria, including the role of budget impact (BI), on health technology assessment (HTA) outcomes employed by the Federal Joint Committee (G-BA), Institute for Quality and Efficiency in Health Care (IQWiG) in Germany, and National Institute for Health and Care Excellence (NICE) in England. Analyzing data from 2011 to 2018, the authors underscored the consistent adherence of G-BA/IQWiG and NICE to official evaluation criteria while also revealing an independent influence of BI on HTA outcomes, potentially carrying implications for health policy decisions.

In September 2023, the Skåne University Hospital is working on several HTAs, including evaluations in the cardiovascular, diagnostic imaging, men’s health, neurology and neurosurgery fields

On September 1, 2023, the Institute for Hospital Remuneration Systems (INeK) announced the start of the application process for the innovation funding of the new examination and treatment methods (NUB) for 2024. The Federal Joint Committee (G-BA) reminds applying hospitals about minor changes in application requirements.

On September 5, 2023, the Ministry of Health published the Decree of June 9, 2023, on the adoption of the 2023-2025 National HTA Medical Devices Program.

On September 19, 2023, the Innovative Devices Access Pathway (IDAP) pilot was launched. IDAP program aimed to accelerate the development of cost-effective medical devices and their integration into the UK market. The application window to join the pilot phase is now open to the UK and international commercial and non-commercial developers of innovative health technology. The deadline is October 29, 2023. Eight products will be selected for the pilot phase and receive non-financial support from a team of experts.

The HTA body of the Tuscany Regional Healthcare issues three types of documents: full HTA reports, rapid HTA reports, and motivational forms. With regional decree 19147 of September 6, 2023, Tuscany Regional Healthcare has published assessments of four medical devices in the peripheral vascular and dermatology areas.

In September 2023, the Health Sciences Institute in Aragon (IACS) is working on several HTAs, including evaluations in diagnostic imaging, endocrine, IVD, neuromodulation, orthopedics, peripheral vascular, and some other fields.

On September 12, 2023, an application window was opened to join the NHS Innovation Accelerator (NIA) program in 2024. NIA supports the development of individuals (‘Fellows’) and the spread of their innovation nationally. The deadline for applications is October 22, 2023.

In September 2023, the following method assessments were initiated as a part of a framework for the managed introduction of innovations "New Methods" for cardiovascular, e-health, endocrine, gastrointestinal, IVD, men’s health, neurology and neurosurgery, neuromodulation, robotic surgery, and some other fields.