Cancer

Molecular gene profile analysis (Oncotype DX) was evaluated within the "New Methods" framework starting in 2021. On August 26, 2024, the Decision Forum for "New Methods" recommended Oncotype DX to be introduced to predict the benefit of chemotherapy in postmenopausal patients with lymph node-positive, estrogen receptor-positive (ER+), human epidermal growth factor receptor-2 negative (HER2-) early-stage invasive breast cancer.

NICE recently introduced a new centralized approach to prioritizing topics for its guidance and a decision-making body - a prioritization board. In July 2024, the decisions of the prioritization board were first published by NICE. Sixteen topics were prioritized, twenty were not prioritized, and one was withdrawn.

On August 2, 2024, the HAS published positive opinions on the inclusion of targeted high-throughput sequencing of gene panels in the medical management of lung cancer, gastrointestinal stromal tumors, and chronic lymphocytic leukemia in the NABM Nomenclature. This is a consequence of the efforts to disburden the innovation funding budget and clean the List of IVD tests outside the Nomenclature (Liste des actes hors nomenclatures, AHN, i.e., the merged 2023 RIHN List and the Supplementary List funded outside Statutory Health Insurance via the research and innovation budget).

On July 1, 2024, the National Institute for Health and Disability Insurance (INAMI/RIZIV) introduced a new agreement (Convention), which allows permanent reimbursement for molecular biology tests by next-generation sequencing (NGS) in oncology and hemato-oncology. The tests were reimbursed temporarily in the context of the pilot Convention from 2019. Fifty-one new pseudo-nomenclature codes with tariffs were introduced. The pseudocode descriptions specify the indication, while certain biomarkers and reimbursement conditions are mentioned as notes to the code.

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 July 2, 2024, the revised EBM (German Uniform Evaluation Standard) catalog for the third quarter of 2024 was published. The changes introduced mainly concern updating the content of several EBM sections with the respective comments and/or clarifications and introducing the new EBM codes for several companion diagnostics tests, for follow-up and evaluation of the “Kranus Lutera” health app, and for the services provided within the co-funded study on bronchoscopic lung volume reduction in severe pulmonary emphysema using thermal ablation (rp-RL BTVA).

On July 1, 2024, the National Institute for Health and Disability Insurance (INAMI/RIZIV) introduced a new agreement (Convention), which allows permanent reimbursement for molecular biology tests by next-generation sequencing (NGS) in oncology and hemato-oncology. The tests were reimbursed temporarily in the context of the pilot Convention from 2019. Fifty-one new pseudo-nomenclature codes with tariffs were introduced. The pseudocode descriptions specify the indication, while certain biomarkers and reimbursement conditions are mentioned as notes to the code.

On April 3, 2024, NHS England published the 2024/25 Prescribed Specialised Services (PSS) Operational Tool. This Tool is used as a mechanism to identify whether healthcare activity belongs to specialized services using so-called identification rules. Forty-three new service lines were introduced in multiple areas, and eight service lines were amended.

On January 26, 2024, NHS England announced the third round of the Innovation Open Call, funded by the NHS Cancer Programme. All types of late-stage innovations aimed at early detection and diagnosis of cancer are eligible, including medical devices, in-vitro diagnostics, digital health solutions, and AI. Awarded projects will be 100% funded up to the total value of £4 million to produce and evaluate evidence in a real-world setting, supporting adoption and spread by providers, commissioners, and regulators. The application submission will be open on April 8, 2024.

On January 30, 2024, the Institute for the Hospital Remuneration System (InEK) published the list of the requests for innovation funding (NUB) that were submitted by the hospitals in 2023. The medical technologies of cardiovascular, ENT, extracorporeal, gastrointestinal, neuromodulation, and other technology groups obtained positive status 1.

In January 2024, the Ministry of Health and Prevention published the Order in the Official Journal of the French Republic updating the cancer screening programs. The new Order replaces the previous one from September 2006 and specifies the implementation conditions for the organized screening programs for breast, colorectal, and cervical cancers.