In-vitro diagnostic tests

In order to diagnose pre-eclampsia in pregnancy, two new markers were included in the EBM catalog in early October 2019. The statutory health insurances then will take over the costs for the determination of the PIGF concentration and the sFlt-1 / PIGF quotient. In addition, another tumor marker for ovarian cancer will be included in the EBM.

In August 2019, the Norwegian Institute of Public Health (NIPH) has released a single technology assessment report for molecular profiling panel – Prosigna aimed to investigate its prognostic accuracy, clinical and cost-effectiveness in patients with breast cancer. It was outlined that it is uncertain to what extent Prosigna contributes prognostic information that turns into better clinical results; conclusions about the cost-effectiveness of Prosigna cannot be made due to the lack of existing information.

In mid-August 2019, the network of European HTA agencies, EUnetHTA, announced the final plan of the project OTCA22 “Clinical utility of Point-of-care Tests (POCT) D-Dimer and Troponin.”

The seminar includes overview of topics of reimbursement, funding, payment mechanisms for IVD tests in hospital, day case and out-patient settings, health technology assessment, innovation funding, role of clinical and economic evidence, stakeholder engagement. Data from 10 EU countries are used. The seminar is available as a pre-recorded on-demand webinar or full presentation in Acrobat PDF.

The Clinical Coding and Schedule Development (CCSD) group develop and maintains procedural and diagnostics nomenclature for private payers in England. New procedure codes concern hip replacement, endoscopic ablation, multiple arthroscopic operations on the ankle, collagen paste for closing an anal fistula and diagnostic codes for tests for next generations sequencing molecular intelligence, and others. The codes are introduced with a recommended adoption date being the 1st of November 2019. The documents also contain a list of textual changes in codes, inactivated codes, and an updated list of unacceptable combinations of codes.

Laboratory examinations that can predict whether a patient will receive therapeutic benefits from “personalized” drug treatment or from so-called "molecular companions diagnostics" can be promptly and flexibly reimbursed using the new specific procedure from July 1, 2019.

In July 2019, the National Institute for Health and Care Excellence (NICE) published one new diagnostics guidance for therapeutic monitoring of TNF-alpha inhibitors in rheumatoid arthritis, two new interventional procedure guidance (for transurethral laser ablation for recurrent non-muscle-invasive bladder cancer and ultrasound-guided high-intensity transcutaneous focused ultrasound for symptomatic uterine fibroids), and one new MedTech innovation briefing for HemaClear for bloodless surgical field during limb surgery.

Educational modules include an overview of key stakeholders, money flow, payment model for IVD tests in the ambulatory sector, the process of creation of reimbursement for novel IVD tests. Overviews are available for France, Germany, Italy, Switzerland. Overviews are available as presentations in Acrobat PDF.

In late July 2019, the report of the project OTJA10, titled “Stool DNA testing for early detection of colorectal cancer” was published on the website of the European Network for HTA (EUnetHTA).

With the preventive program for pregnant women, "Hello Baby," premature births and infection-related birth complications should be minimized. Now, the program has been established nationwide: 60 health insurance companies offer to their approximately 6.5 million insured since July 1, 2019, the additional tests contained therein.

The HTA center of Swedish Västra Götaland region has published a report for gene expression profiles to guide adjuvant chemotherapy in luminal, HER2-negative breast cancer. It was concluded that withholding adjuvant chemotherapy in breast cancer patients with intermediate clinical risk of recurrence and low/intermediate risk according to a gene expression assay, compared with providing chemotherapy, probably results in little or no difference in overall survival within nine years and can probably not exclude a small increased risk of recurrence.

The test for severe combined immunodeficiencies (SCID) is part of neonatal screening since July 1, 2019, in Germany. At the beginning of July 2019, the Swedish National Board of Health and Welfare (Socialstyrelsen) has stated that health care should offer screening for the severe combined immunodeficiency (SCID) as approximately two or three children per each year can be diagnosed and treated for the fatal disease with the test available.