In June 2023, NHS England published two new specialized service specifications for pediatric photon radiotherapy and gender incongruence in children and young people. These documents define national standards for the provision of specialized services, including aims, outcomes, model of provision, patient pathway, inclusion criteria, and requirements for the facilities and staff.

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, Farah et al. conducted a systematic literature review to investigate the acceptability of current studies assessing Artificial Intelligence-based Medical Devices (AI-based MDs) for health technology assessment (HTA) purposes. The authors found that AI-based MDs studies lack robust and complete evidence, with limited data on safety and economic issues. The study emphasizes the need for standardized evaluation models, reliable evidence generation, and adjustments in HTA processes for AI-based MDs. In addition, the study suggests a number of measures to improve the quality of evidence for AI-based MDs.

On June 19, 2023, the Swiss Federal Office of Public Health (FOPH) published the changes that will occur to the Healthcare Benefit Ordinance (KLV/OPre) and its Annexes, which determines coverage of medical services in Switzerland. Key changes relate to introduction of two codes for genetic tests, several extensions of Coverage with Evidence Development, and updates in reimbursement conditions for transcatheter aortic valve implantation. The changes entered into force on July 1, 2023.

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, Everhart investigated the availability of cost-effectiveness analyses (CEAs) for medical devices in the United States. By analyzing data from the Tufts University Cost-Effectiveness Analysis Registry, the author identified 218 CEAs published between 2002 and 2020. On average, these CEAs were published 4 to 6 years after FDA approval or clearance of the studied devices. The findings suggest that decision-makers often lack timely evidence of cost-effectiveness when making initial reimbursement decisions regarding newly available medical devices.

On June 27, 2023, the National Institute for Health and Care Excellence (NICE) launched a consultation on the updated health technology evaluation process manual, initially published in January 2022. Key changes concerned introducing a new faster approach to technology appraisal development. The deadline for comments submission is July 25, 2023.

On June 11, 2023, the Ministry of Health and Prevention published an Order in the Official Journal of the French Republic on the transitional coverage for the Insides System from Insides Company for the treatment of intestinal failure associated with temporary double enterostomy or enterocutaneous fistula by actively reinfusing chyme into the distal intestine.

The Danish Health Data Authority quarterly updates the Health Care Classification System (SKS), which includes coding for procedures, diagnoses, and other codes. The latest version was published in mid-June to come into force on July 1, 2023. Changes include the introduction of sixteen new surgical and 26 new medical procedure codes.

On June 15, 2023, the National Association of Statutory Health Insurance Physicians (KBV) informed that new services for the detection of the adeno-associated virus (AAV) and cytomegalovirus (CMV) will be included in the German Uniform Evaluation Standard (EBM) catalog since July 1, 2023.

On June 13, 2023, the Swedish Medical Technologies Product (MTP) Council recommended that all regions delay the introduction of robotic systems for knee, hip, and spine surgery until they have been evaluated as part of the Orderly introduction framework. For now, MTP Council recommends robotic systems in these indications only to be used in the context of research.

In June 2023, the Clinical Coding and Schedule Development (CCSD) working group, which develops and maintains procedural and diagnostics nomenclatures for private payers in England, published Bulletins 190 and 086 with changes to be implemented no later than August 4, 2023. Fourteen new procedure codes (concerning cardiovascular, diagnostic imaging, endocrine, endoscopy, gastrointestinal, orthopedic and spine, peripheral vascular, robotic surgery, men's health, and radiotherapy fields) and six new diagnostic codes were introduced.

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 11957 of June 07, 2023, Tuscany Regional Healthcare has published assessments of two medical devices in the cardiovascular and spine areas.