In-vitro diagnostic tests

Health Information and Quality Authority (HIQA) develops national HTA guidelines to support decision-making in Ireland. In the third quarter of 2021, Health Information and Quality Authority published three reports in relation to in-vitro diagnostics, including newborn bloodspot screening, tests for hepatitis C and SARS-CoV-2.

In August 2021, the National Institute for Health and Care Excellence (NICE) published three new Interventional Procedure Guidance (magnetic resonance therapy for knee osteoarthritis, laparoscopic removal of uterine fibroids with power morcellation, hysteroscopic mechanical tissue removal for uterine fibroids), and six new Medtech Innovation Briefings (PLASMA system with button electrode, Immunoscore, MMprofiler, Patient Status Engine, lung texture analysis, Colli-Pee). Also, five clinical guidelines were published.

In August 2021, NHS announced rolling out genetic testing for monogenic diabetes and placental growth factor (PLGF) testing to rule out pre-eclampsia. These decisions are made in line with the NHS Long Term Plan committed to increasing access to genomic testing, improving diabetes care across the country, and investing in cutting-edge technologies.

On August 17, 2021, the National Institute of Public Health released a rapid HTA report on the evaluation of PD-L1 assays in urothelial carcinoma commissioned by the Ordering Forum. This assessment does not provide any conclusions on the effectiveness of various treatment strategies in the treatment of urothelial carcinoma in adults.

On August 19, 2021, the Dental and Pharmaceutical Benefits Agency has announced the withdrawal of the assessments of the MammaPrint and EndoPredict tests for various reasons.

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.