In-vitro diagnostic tests

The Clinical Coding and Schedule Development (CCSD) group develops and maintains procedural and diagnostics nomenclature for private payers in England. New procedure codes concern injection eustachian tuboplasty, extracorporeal shockwave therapy for carpal tunnel syndrome, robotic-assisted laparoscopic excision of recto-vaginal endometriosis, and diagnostic codes for alpha-melanocyte stimulating hormone, NK cell inhibition panel, XR whole spine, and others. The codes are introduced with a recommended adoption date being the 1st of February 2020. The documents also contain a list of textual changes in codes, unacceptable combinations, and inactivated codes.

In Sweden, the Centre for Assessment of Medical Technology (CAMTÖ) leads the development of HTA cooperation in the healthcare region Uppsala-Örebro. In September 2019, CAMTÖ released an HTA report on PD-L1 positivity tested by McAb SP263 to guide immune checkpoint therapy in non-small-cell lung cancer. No safe conclusions could be drawn, but the wide range of positivity rates implies the difficulties in the standardization of PD-L1 expression and the need for better predictive biomarkers.

In November 2019, the two new mini-method assessments for ankyloglossia and rapid testing for chlamydia and gonorrhea were initiated by Oslo University. After the completion of the assessment procedure, the final reports would be available via a mini-HTA database.

In October 2019, the National Institute for Health and Care Excellence (NICE) published one new interventional procedure guidance (for midcarpal hemiarthroplasty for wrist arthritis) and two new MedTech innovation briefings (for superDimension Navigation System to help diagnostic sampling of peripheral lung lesions and MR-proADM test for use with clinical deterioration scores in cases of suspected infection).

The New Therapies (NT) Council provides comments on medical technology products and methods that are evaluated within the framework of the Dental and Pharmaceutical Benefits Agency (TLV) medical technology assignment. In October 2019, the NT Council recommended the use of FoundationOne CDx comprehensive genomic profiling test as support for the drug treatment choice in the context of clinical studies as there is a great need for knowledge and validation.

In September 2019, the Andalusian Health Technology Assessment Department (AETSA) has released an assessment report regarding the evaluation of epigenetic profiling to classify cancer of unknown primary (EPICUP). It was observed that people received empirical therapy without considering the results of EPICUP had a three times higher risk of dying compared to those with specific treatment of the location of the primary tumor, adjusting due to possible confounding factors.

In September 2019, the French High Authority for Health released an assessment report for analysis on DNA chips (ACPA) in different types of oncological conditions to determine its place in comparison with more conventionally used techniques. The ACPA allows to detect a large number of copy number of variations at the whole genome level, ploidy abnormalities, and heterozygosity losses; it is of interest as a cytogenetic technique with some specific advantages among existing technologies.

The Clinical Coding and Schedule Development (CCSD) group develops and maintains procedural and diagnostics nomenclature for private payers in England. New procedure codes concern scar revision, robotic-assisted thymectomy, prophylactic oophorectomy/ hysterectomy, percutaneous electrical nerve stimulation, delivery of fraction of proton beam therapy for non-ocular adult tumors and diagnostic codes for myriad breast and ovarian cancer panel 101 test, clinical exome sequencing MPLA test, and others. The codes are introduced with a recommended adoption date being the 1st of February 2020. The documents also contain a list of textual changes in codes and inactivated codes.

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.