In-vitro diagnostic tests

On the 19th of September 2019, the Federal Joint Committee (G-BA) concluded on the possible applications and limits of non-invasive molecular genetic tests (NIPT) at the expense of the statutory health insurance (SHI). The decision provides that a NIPT can be used in justified individual cases and after medical consultation.

MTRC has developed three reports on the key market access topics, including innovation funding, health technology assessment and funding frameworks for medical devices. These reports help to understand the relevance of these frameworks to certain types of medical technologies, including in-vitro and in-vivo diagnostics tests. This post provides some key facts about the HTA, funding and innovation payment landscape for in-vitro and in-vivo diagnostics tests in Europe.

The insurance company AOK Saxony-Anhalt concluded that patients are much less frequently prescribed an antibiotic after the examination via a rapid test for a bacterial cause of the infection. In more than 40% of the tested patients, the doctors waived the antibiotics prescription.

The fee negotiations for the coming year are over - the National Association of Statutory Health Insurance Physicians (KBV) and the National Association of Statutory Health Insurance Funds (GKV-Spitzenverband) agreed on an increase in the monetary conversion factor for all medical and psychotherapeutic services in the amount of 1.52 percent. GKV-Spitzenverband and KBV have also agreed to sponsor the video consultations.

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.