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Molecular diagnostics

11
Sep 2024

Favorable coverage decision for molecular gene profile analysis (Oncotype DX) in Norway

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.
20
Aug 2024

NICE proposed approaches for the economic evaluation of multi-indication health technologies

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.
12
Aug 2024

Permanent reimbursement for next-generation sequencing (NGS) in oncology launched in Belgium

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.
09
Jul 2024

Permanent reimbursement for next-generation sequencing (NGS) in oncology launched in Belgium

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.
12
Oct 2023

The revised EBM catalog came into force in Germany in October 2023

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.
29
Sep 2023

Regular update of the Norwegian Laboratory Code System released

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.
24
Jul 2023

Extended reimbursement for next-generation sequencing (NGS) in Belgium

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.