In-vitro diagnostic tests

On August 11, 2021, the Dutch Healthcare Institute (ZIN) published the assessment of Oncotype DX®. The assessment was conducted to confirm whether the test complies with the criteria of "science and practice" to determine if it can be reimbursed under the basic health insurance package. In conclusion, the test can be reimbursed under the basic health insurance package.

In late July 2021, two new COVID-19 antigen tests were added to the Laboratory Test Nomenclature (Laboratoriotutkimusnimikkeistö) in Finland.

In July 2021, the National Institute for Health and Care Excellence (NICE) published one new Interventional Procedure Guidance (inducing and maintaining normothermia using temperature modulation devices to improve outcomes after stroke or subarachnoid hemorrhage) and four new Medtech Innovation Briefings (HealthVCF for detecting vertebral compression fractures on CT scans, trublood-prostate for triaging and diagnosing people with prostate cancer symptoms, AI technologies for detecting diabetic retinopathy, and Acumen IQ sensor for predicting hypotension risk).

In July 2021, the Dental and Pharmaceutical Benefits Agency released two completed health economic evaluations on the cost-effectiveness of the Oncotype DX and ProSigna tests. The evaluation was performed at the request of the Medical Technology Product (MTP) Council. The cost per quality-adjusted life-years for ProSigna is estimated to be 207,000 SEK compared to the stand-alone clinical pathology assessment. The analysis indicates that the use of Oncotype DX provides greater benefit than the alternative, also at a lower cost.

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.