In-vitro diagnostic tests

The report includes all published reimbursement decisions for IVD tests in 2018 in European countries with established frameworks for out-patient reimbursement laboratory tests (Belgium, France, Germany, Netherlands, Switzerland).

On March 7, 2019, the Nomenclature was updated. The update brought changes in chapter V of Nomenclature, regarding the creation of new codes, deletion, and modification of existing codes. Changes mainly related to the in-vitro diagnostic testing.

The Clinical Coding and Schedule Development (CCSD) group develop and maintains procedural and diagnostics nomenclature for private payers in England. New diagnostic codes concern circulating tumor DNA profile for the different type of cancers, myriad Prolaris test, PET Scan with florbetapir, etc. and a procedure code for robotic-assisted radical hysterectomy and lymphadenectomy. The codes are introduced with a recommended adoption date being the 1st of May 2019. The documents also contain a list of textual changes in codes and an updated list of unacceptable combinations of codes.

In Finland, the Health Care Services Selection Council is responsible for making recommendations regarding the research, treatment and rehabilitation methods. Currently, PALKO is working on the only one assessment related to in-vitro diagnostics - screening for a Serious Combined Immune Deficiency (SCID) from newborn heel. In final report, the Council will conclude whether the procedure is a part of publicly funded services or not.

On February 5, 2019, the Federal Department of Home Affairs (FDHA) decided that in case of suspected infection or fever of unknown origin, positron emission tomography (TEP) will be considered mandatory services. Also, percutaneous electrical stimulation of the posterior tibial nerve (PTNS) was approved for incontinence indication. Furthermore, the reimbursement amounts relating to incontinence and ostomy materials will be reduced. List of Analyses was also updated.

In early February 2019, the network of European HTA agencies, EUnetHTA, announced the final report of the project OTCA12 “C-reactive protein point-of-care testing (CRP POCT) to guide antibiotic prescribing in primary care settings for acute respiratory tract infections (RTIs)”.

In December 2018, the National Institute for Health and Care Excellence (NICE) published one new diagnostic guidance (for tumour profiling tests to guide adjuvant chemotherapy decisions in early breast cancer), two new interventional procedure guidance (for transcutaneous neuromuscular electrical stimulation for oropharyngeal dysphagia in adults and bronchial thermoplasty for severe asthma), and four MedTech innovation briefings.

In December of 2018, the completed mini-method assessment for targeted deep sequencing panel for patients with varying types of hematological neoplasia was released by the Norwegian Institute of Public Health (NIPH). The method was determined as safe and efficient and was recommended to become a part of routine clinical practice.

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.

The Clinical Coding and Schedule Development Group develops and maintains procedural and diagnostics nomenclature for private payers in England. In October, one new diagnostic code.

Adding the MammaPrint® to the standard risk assessment in patients with early-stage breast cancer has not demonstrated health gains compared to the current way of determining whether a patient needs chemotherapy. Dutch National Health Care Institute has concluded that the test is not eligible for reimbursement from the basic insurance package.

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.