Molecular diagnostics

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.

In July 2024, NHS England issued an updated version of the 2024/25 National Genomic Test Directory, which lists genomic tests commissioned by NHS England via Genomic Laboratory Hubs. A total of 58 new codes (test-indication combinations) were introduced in the Test Directory for cancer, and ten new codes in the Test Directory for rare and inherited diseases.

In July 2024, the National Institute for Health and Care Excellence (NICE) released a report on proposed approaches to the economic evaluation of multi-indication health technologies (MIHTs) developed by the HTA Lab. Examples of MIHTs include circulating tumor DNA tests, polygenic risk scores, and virtual ward platform technologies, which can be used across multiple disease areas or multiple indications. This report proposes approaches that NICE could adopt for future economic evaluations of MIHTs and provides recommendations for implementing the approaches on pilot topics.

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 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.

The revised EBM (German Uniform Evaluation Standard) catalog came into force on October 1, 2023. The most significant changes concern the introduction of the new EBM codes for several IVD tests, prostate-specific membrane antigen (PSMA) positron emission tomography, as well as for stereotactic radiosurgery (SRS) in vestibular schwannomas.

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.

The National Genomic Test Directory lists genomic tests commissioned by NHS England via Genomic Laboratory Hubs. It is updated annually. The applications submitted before April 1, 2024, to add new tests or change existing ones will be considered for implementation on April 1, 2025.

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 revised EBM (German Uniform Evaluation Standard) catalog came into force on July 1, 2023. The most significant changes concern introducing the new EBM codes for several IVD tests, as well as for the cryopreservation of the ovarian tissue.