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In-vitro diagnostic tests

11
Jan 2019

New coverage decisions for procedures and tests in Switzerland (KLV/OPre)

Federal Department of Home Affairs (FDHA) released changes in coverage of medical procedures, IVD tests and medical aids in Switzerland. They include extension of coverage for neonatal screening to severe congenital immunodeficiencies, extension of coverage under restrictions for TAVI, gene test for breast cancer, PET, PET / CT, local superficial hyperthermia during tumour treatment, external defibrillator and coverage for sub-urethral tapes for the treatment of stress urinary incontinence in women. Also, changes in the coverage for neonatal screening were introduced.
05
Nov 2018

Safety and efficacy of FebriDx® test in Spain

In the middle of October 2018, the Andalusian Agency for the Evaluation of Health Technologies, AETSA, has published a health technology report in which they have assessed the safety, efficacy and efficiency of FebriDx® test.
10
Sep 2018

Ten new diagnostic codes were added to private reimbursement schedule in England in July 2018

The Clinical Coding and Schedule Development Group develops and maintains procedural and diagnostics nomenclature for private payers in England. In July new codes for aminoglycoside induced deafness testing, Intra-Operative PTH profile, cytokine panels and lymphocyte immunophenotyping, streptococcus pneumoniae by PCR, OCT for cardiology, contract-enhanced ultrasound and faecal immunochemistry test were added to the CCSD Schedule.
23
Aug 2018

The further evaluation of biomarker-based tests in primary breast cancer was commissioned to the Institute for Quality and Efficiency in Health Care (IQWiG) at the beginning of July of 2018

At the beginning of July of 2018, the Federal Joint Committee (G-BA) has commissioned to the Institute for Quality and Efficiency in Health Care (IQWiG) to provide an assessment of potential harm and benefits of biomarker-based tests for or against adjuvant chemotherapy in primary breast to understand its efficacy in comparison with the previous standard examinations in women who do not require chemotherapy due to a low/intermediate risk of relapse. The final report is expected to be released by G-BA at the end of 2018.
05
Jul 2018

Rapid HTA of MammaPrint® test in Belgium

In spring 2018, the Belgian Healthcare Knowledge Center, KCE, has published a rapid HTA report of MammaPrint® test for personalized management of adjuvant chemotherapy decisions in early breast cancer. The report complements evaluation of the clinical utility of the test from the EUNetHTA’s assessment with health economic evaluation in a Belgian context. Estimates show approximate mean chemotherapy-related costs in Belgium of €11 411 without considering sick leave costs and of €15 044 when the latter are included. KCE came to the conclusion that given the uncertainties surrounding the limited data on the clinical utility of MammaPrint®, no reliable incremental cost-effectiveness ratio could be calculated.