In-vitro diagnostic tests

At the beginning of June 2018, the Federal Department of Home Affairs published an update of the Services Ordinance (Ordinanza sulle prestazioni, OPre). This update concerns many different fields, including the list of laboratory tests.

Two mini-method assessments regarding brachytherapy for esophageal cancer and targeted gene deep-sequencing panels were initiated by Oslo University Hospital in May of 2018. All finalized mini-method assessments are published in the National Database for Mini-HTA.

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.

New recommendations for cervical cancer screening will focus on how we ensure that all women have the opportunity to participate in screening and on the use of HPV tests.

The list of the laboratory tests is based on the Services Order (Ordinanza sulle Prestazioni, OPre) of the September 29th, 1995; the latest update is in force since January 1st, 2018. The list contains the services whose costs are covered by the obligatory healthcare insurance (assicurazione obbligatoria delle cure medico-sanitarie, AOMS). With the latest update, there are 1931 tests on this list. See the list of the January 2018 modifications in Italian here. See the full list of current laboratory tests in Excel format (in French, German and Italian) here. Subscribe to our newsletter delivered every second week not to miss important reimbursement information.

The Clinical Coding and Schedule Development Group develops and maintains procedural and diagnostics nomenclature for private payers in England. In April new codes for continuous glucose monitoring, vestibular and quantitative sensory testing were added to the CCSD Schedule.

In mid-April 2018, the Galician HTA body, Avalia-T, has published a rapid evaluation report on screening of fetal trisomies 21, 18 and 13 by non-invasive prenatal testing. The report was done within EUnetHTA framework.

The Clinical Coding and Schedule Development Group develops and maintains procedural and diagnostics nomenclature for private payers in England. In February new codes for genetic tests and immunological tests for infections were added to the CCSD Schedule.

According to the recommendation of the National Board of Health and Welfare (Socialstyrelsen), hospitals and clinics should not offer screening for prostate cancer with PSA tests with or without other supplementary tests before tissue sampling. The recommendation is based on that the benefit of screening for prostate cancer with PSA tests does not outweigh the negative effects on a population level.

The Clinical Coding and Schedule Development Group develops and maintains procedural and diagnostics nomenclature for private payers in England. In January new codes for Anti C1Q antibodies, soluble CD25, umbilical Cord Ph Level and several genetic tests were added to the CCSD Schedule.

Ninety-two new codes have been implemented, including protein fractions and reproductive medicine tests.

In the first half of January, the National Institute for Health and Care Excellence (NICE) published five new Medtech innovation briefings for in vitro diagnostic test for determining breast cancer subtypes, point-of-care creatinine tests before contrast-enhanced imaging, plasma EGFR mutation tests for adults with locally advanced or metastatic non-small-cell lung cancer, smartphone otoscope and sequencing panel for solid tumour cancers in children .