On July 07, 2023, the Ministry of Health and Prevention announced the implementation of the transitional period for innovative technologies following the experiment under Article 51 of the Social Security Financing Act.

In July 2023, the ZIN announced one more project awarded under round 7 of the Promising care subsidy scheme in 2023. Two more projects within this round were awarded at the end of March 2023. The new project relates to bronchial thermoplasty and will last six years.

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, Solà-Morales et al. proposed recommendations for international standards in evaluating the acceptability of data governance practices for real-world data (RWD) and real-world evidence (RWE) in healthcare. Through a literature review and the following Delphi panel with 21 European experts, the authors identified key topics in RWD/RWE data governance, such as data privacy and security, data management and linkage, data access management, and the generation and use of RWE. The resulting refined checklist can assist RWD/RWE users in ensuring the quality and integrity of data governance while complementing data protection regulations.

In July 2023, the National Institute for Health and Disability Insurance (INAMI-RIZIV) significantly updated the process to obtain reimbursement for health apps. More stakeholders, including the industry, can now submit an application to INAMI-RIZIV for temporary or permanent reimbursement. The new process will come into force on October 1, 2023.

At the end of June 2023, the French National Authority for Health (HAS) published a new document with the goal of improving professional practices: Digital medical devices for professional use – Guide on choosing digital medical devices for professional use.

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 13989 of June 29, 2023, Tuscany Regional Healthcare has published assessments of nine medical devices in the cardiovascular, peripheral vascular, diagnostic imaging areas, and surgical procedures.

In late June 2023, the National Institute for Health and Disability Insurance (INAMI-RIZIV) decided to extend reimbursement for molecular biology tests by next-generation sequencing (NGS) for one year until June 30, 2024. NGS in oncology and hemato-oncology are temporarily reimbursed as a pilot under a specific agreement (Convention) with INAMI-RIZIV from 2019.

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 June 2023. Twenty-eight recommendations were published in relation to the registration, modification of registration conditions, and renewal of registration for devices in the List of reimbursable products and services (LPPR). Opinions concern cardiovascular and peripheral vascular, endocrine, ENT, orthopedic, spinal, and surgical devices, as well as medical aids.

We are happy to announce the further expansion of our HEOR Department with Dr. Dharna Gupta, a dentist by training and a Health Economist by profession. Dharna holds a Master of Public Health degree in Health Policy, Economics & Finance from the Tata Institute of Social Sciences, Mumbai, India (2020). Dharna is a public health researcher with expertise in health systems and policy research, costing analysis, health economic modeling, economic evaluations, and value-based pricing in governmental settings. For the past three years, she was part of the HTA team at the Postgraduate Institute of Medical Education & Research, India, where she has worked on health economic models in the field of oncology, policy briefs and treatment guidelines at the state and national levels, and contributed to the educational modules on evidence-based medicine and health economics. If you are interested in learning about our capabilities in evidence synthesis, please, reach out to us to arrange a call to discuss your needs.

On June 29, 2023, the Dutch Healthcare Authority (NZa) published an update of the first release of the DRG package (RZ24a update) because of the request from the Ministry of Health, Welfare and Sport to recalculate the tariffs based on a corrected 2023 price index for material costs.

In June 2023, the National Institute for Health and Care Excellence (NICE) published five new Interventional Procedure Guidance (intraoperative electron beam radiotherapy, minimally invasive fusionless posterior-approach surgery to correct idiopathic scoliosis, endoscopic ultrasound-guided gallbladder drainage, radiofrequency denervation for osteoarthritic knee pain, and Botulinum toxin type A injections into the urethral sphincter), two new Diagnostic Guidance (transperineal biopsy for prostate cancer, and FibroScan for liver fibrosis and cirrhosis), and two Medtech Innovation Briefings (MiraQ cardiac TTFM, Proov Confirm; their development started before April 2023). Also, four clinical guidelines were updated.

On June 30, 2023, the Innovation Committee at the Federal Joint Committee (G-BA) published the decisions, recommending the transfer to standard care for two completed projects. The projects relate to the utilization of emergency care structures in Germany and implementation of patient guidelines for psychosocial therapies for patients with severe mental diseases.