In-vitro diagnostics

26

Jul 2021

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. Read more

16

Jul 2021

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. Read more

12

Jul 2021

MTRC released an update of the syndicated report on reimbursement decisions for IVD tests in 5 EU countries (Belgium, France, Germany, the Netherlands, and Switzerland). The updated report covers 3-year period of 2018-2020. Broader coverage gives a better understanding of the activity of the reimbursement organizations. Read more

07

Jul 2021

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

05

Jul 2021

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). Read more

22

Jun 2021

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. Read more

15

Jun 2021

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. Read more

11

Jun 2021

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. Read more

10

Jun 2021

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. Read more

07

Jun 2021

In 2013, Norway established a framework, “New Method,” for the introduction of innovations into the health care system through either a national or hospital-based health technology assessment. In this framework, all innovations should undergo HTA before being funded. As of June 7, 2021, five HTAs of in-vitro diagnostics are in progress. Read more

28

May 2021

In April 2021, the National Institute for Health and Care Excellence (NICE) published three new Interventional Procedure Guidance (repetitive short-pulse transscleral cyclophotocoagulation for glaucoma, deep brain stimulation for chronic, severe, treatment-resistant obsessive-compulsive disorder in adults, and Melphalan chemosaturation for primary or metastatic cancer in the liver) and two Medtech Innovation Briefings (microINR for anticoagulation therapy and RenalSense Clarity RMS for acute kidney injury), and two clinical guidelines (for atrial fibrillation and chronic pain in over 16s). Read more

27

May 2021

In April 2021, the Austrian Institute for Health Technology Assessment (AIHTA) initiated several new research projects. The projects are related to IVD tests for early detection of colon cancer, telemedical care in diabetes field, health apps, screening methods, consequences of coronavirus pandemic, and other topics. Read more