In-vitro diagnostic tests

On July 7, 2021, a Decree which defines the new annual budget of €20 million for breast cancer genomic tests has been published. The Decree describes the access procedure and the requirements for the disbursement of the budget. This Fund will provide “free” access to genomic testing to women from all Italian regions who could benefit from the testing.

In July 2021, the Clinical Coding and Schedule Development (CCSD) working group, which develops and maintains procedural and diagnostics nomenclature for private payers in England, has published Bulletins 0178 and 0075 with changes to be implemented not later than November 01, 2021. No new procedure codes were introduced. Two new diagnostic codes were introduced.

The revised EBM (German Uniform Evaluation Standard) catalog came into force on July 1, 2021. Three biomarker tests in breast cancer, a number of services related to cryopreservation of egg and sperm cells in young cancer patients, new services dedicated to prenatal testing of the fetal rhesus factor, services concerning the delivery of brachytherapy in prostate cancer were introduced.

In June 2021, the National Institute for Health Research (NIHR) in England released six MedTech-related reports in its Health Technology Assessment (HTA) Journal, which concerned tibial nerve stimulation for urinary incontinence treatment, imaging in ophthalmology, in-vitro diagnostics, and eHealth. 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.

In mid-June 2021, 38 new tests, including five COVID-19 antigen tests, were added to the Laboratory Test Nomenclature (Laboratoriotutkimusnimikkeistö) in Finland.

On July 1, 2021, the updated version of the Swiss Services Ordinance (KLV/OPre) came into force. The changes concern the List of explicitly evaluated services (Annex 1 of KLV/OPre), the List of medical aids (Annex 2 of KLV/OPre), and the List of Analyses (Annex 3 of KLV/OPre).

In late May 2021, the Clinical Coding and Schedule Development (CCSD) working group, which develops and maintains procedural and diagnostics nomenclature for private payers in England, has published Bulletins 0177 and 0074 with changes to be implemented not later than August 01, 2021. Five new procedure codes related to diagnostic imaging, ENT, breast reconstruction, and gynecology, and nine new diagnostic codes were introduced.

The Health Sciences Institute in Aragon (IACS) systematically evaluates healthcare technologies and facilitates the promotion of research, effective innovation, and decision-making in health services through knowledge management. Currently, the IACS is working on assessments of efficacy, effectiveness, and safety of intraoperative radiation therapy in breast cancer, determination of preeclampsia biomarkers SFlt-1 and PlGF, treatment of congenital ventricular septal defect by cardiac catheterization, and others.

The National Institute for Health and Care Excellence (NICE) is currently developing health technology assessments concerning in-vitro diagnostics in its Diagnostic Guidance and Medtech Innovation Briefing programs. As of June 08, 2021, there are ten ongoing assessments.

In May 2021, NICE published an impact report on diagnostic pathology, which provides an uptake analysis of several NICE-recommended pathology diagnostics, including high-sensitivity troponin tests, placental growth factor (PIGF)-based tests for suspected pre-eclampsia, faecal immunochemical test (FIT) for colorectal cancer, and others.

In May 2021, the Agency for Health Quality and Assessment of Catalonia (AQuAS) published a report on next-generation sequencing (NGS) for molecular diagnosis and selection of therapeutic targets in oncological diseases. The studies identified present favorable results on the diagnostic efficacy of the NGS-based gene panels; the evidence on the clinical effectiveness of NGS panels remains limited. The authors emphasize the need for further studies.