Screening

On December 2, 2024, the Swiss Federal Office of Public Health published the changes that will occur to the Healthcare Benefit Ordinance (KLV/OPre), which determines coverage of medical services in Switzerland. The updates will enter into force on January 1, 2025, and they relate to the list of explicitly evaluated services (Annex 1 of KLV/OPre), outpatient-before-hospital services (Annex 1a), List of Tools and Equipment (Annex 2), and the List of Analyses (Annex 3).

In late October 2024, the Agency for Health Technology Assessment and Tariff System (AOTMiT) published several recommendations concerning the Prenatal Testing Program, specifically on removing alpha-fetoprotein and estriol testing and qualifying the placental growth factor (PlGF) test and free fetal DNA testing (cffDNA) as part of non-invasive prenatal diagnostics.

On August 3, 2024, the Ministry of Labor, Health, and Solidarity published an Order in the Official Journal of the French Republic modifying the national neonatal screening program using laboratory examinations. Starting November 1, 2024, all newborns will be screened for sickle cell disease. Other modifications include organizational changes and modifications related to the timing of blood sample collection.

On August 2, 2024, the French National Authority for Health (HAS) published a report presenting the program for evaluating targeted high-throughput sequencing procedures. The program defined indications for which the technology will be evaluated with a view to its transitioning to regular reimbursement under the Statutory Health

On July 1, 2024, the annual call for proposals to the UK National Screening Committee (UK NSC) was launched. During the call, stakeholders can propose potential new screening topics or modifications of existing screening programs. The deadline for applications is September 30, 2024.

In July 2024, the UK National Screening Committee (UK NSC) released an annual report from April 1, 2023 to March 31, 2024. The report provides a summary of the Committee’s ongoing work and accomplishments, including recommendations regarding the introduction of national population screening programs.

On July 12, 2024, the UK National Screening Committee (UK NSC) announced a new task group for multi-cancer detection (MCD) tests. The group will review different methods for the evaluation of MCDs, from which UK NSC is expected to derive a position statement and develop a roadmap for a possible MCD screening program.

On June 26, 2024, the Norwegian Directorate of Health published its proposal to change the process of including new diseases in newborn screening. The key objective is making the process more dynamic, which requires regulatory and administrative amendments.

On July 1, 2024, the annual call for proposals to the UK National Screening Committee (UK NSC) was launched. During the call, stakeholders can propose potential new screening topics or modifications of existing screening programs. The deadline for applications is September 30, 2024.

On June 19, 2024, the Order SND/606/2024, of June 13, came into force. This Order, among other things, amends Annexes I, II, III, VI, and VII of Royal Decree 1030/2006, of September 15, which establishes the Common Package of Benefits of the National Health System and the procedure for its update. The changes mostly concern in-vitro diagnostics, ENT, pulmonary and airways, cardiovascular, and some other fields.

In June 2024, the National Institute for Health and Care Research (NIHR) in England released three MedTech-related assessments in its Health Technology Assessment (HTA) Journal, which concerned management for non-acute anterior cruciate ligament injury, laparoscopic cholecystectomy, and antenatal/newborn screening programs. HTA Journal publishes research reports on the effectiveness, costs, and broader impact of health technologies for those who use, manage, and provide care in the NHS and informs National Institute for Health and Care Excellence (NICE) guidance.

On June 18, 2024, the Swiss Federal Office of Public Health published the changes that will occur to the Services Ordinance (KLV/OPre), which determines coverage of medical services in Switzerland. The updates will enter into force on July 1, 2024, and they relate to the list of explicitly evaluated services (Annex 1 of KLV/OPre), outpatient-before-hospital services (Annex 1a), List of Tools and Equipment (Annex 2), and List of Analyses (Annex 3).