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News and blog posts

29
Sep 2023

Blog: Project ideas: What HEOR projects are requested by our clients? Part 3

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.
29
Sep 2023

Publication Digest: Gaps in the evidence underpinning high-risk medical devices in Europe at market entry, and potential solutions

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.
29
Sep 2023

Regular update of the Norwegian Laboratory Code System released

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.
28
Sep 2023

Publication Digest: Health Technology Assessment-Informed Decision Making by the G-BA/IQWiG in Germany and NICE in England: The Role of Budget Impact

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.
25
Sep 2023

The pilot phase of the Innovative Devices Access Pathway launched in the UK

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.
22
Sep 2023

Rapid HTAs of four medical devices released in Tuscany

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.
21
Sep 2023

Ongoing HTAs by IACS in Spain in September 2023

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.
19
Sep 2023

Ongoing HTAs in Norway in September 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.