In-vitro diagnostic tests

On March 1, 2023, Belgian National Institute for Health and Disability Insurance (INAMI-RIZIV) updated three Articles of the Nomenclature related to in-vitro diagnostics. Twelve new codes concerning clinical biology, molecular biology for infections, and genetics were implemented.

MTRC shares the most relevant and impactful publications in the field of market access and HEOR for medical technologies in Europe through its Publications Digest. In a recent publication, Horgan et al. completed a survey of the status of Next-Generation Sequencing (NGS) in Europe and globally. Based on the feedback from 62 experts, a framework for implementation of the NGS is proposed along with in-depth discussion about current aspects of demand-and supply-side issues, governance and strategy, clinical standardization, awareness and education, equipment used, reimbursement and funding.

In February 2023, the National Institute for Health and Care Excellence (NICE) published two new Interventional Procedure Guidance (transvenous obliteration for gastric varices, biodegradable spacer to reduce rectal toxicity during radiotherapy for prostate cancer), one new Health Technology Evaluation (guided self-help digital cognitive behavioural therapy), and two new Medtech Innovation Briefings (LIVERFASt, and Ambu aScope 4 RhinoLaryngo). Also, one new clinical guideline was published, and one was updated.

On February 23, 2023, the Innovation Committee at the Federal Joint Committee (G-BA) published the decisions, recommending the transfer to standard care for another three completed projects. The projects relate to preventing the family risk of colorectal carcinoma, shared decision-making in the hospitals, and digitally supported drug therapy management.

In February 2023, the National Institute for Health and Disability Insurance (INAMI-RIZIV) announced the completion of a pilot project for gene expression profiling (GEP) tests in early-stage breast cancer, which ran from 2019. The pilot showed significant benefits, and INAMI-RIZIV launched a reimbursement for certain tests under the specific agreement (GEP convention) with healthcare providers.

In February 2023, the Clinical Coding and Schedule Development (CCSD) working group, which develops and maintains procedural and diagnostics nomenclatures for private payers in England, published Bulletins 188 and 084 with changes to be implemented no later than March 23, 2023. Five new procedure codes (concerning interventional radiology, robotic surgery, and radiotherapy) and one new diagnostic code were introduced.

On January 27, 2023, the Swiss Federal Office for Public Health announced the update of Annex 3 of the Health Care Benefit Ordinance (KLV/OPre), which contains the list of reimbursed IVD tests (List of Analyses). Two new tests on Monkeypox virus check will be introduced in March 2023.

In February 2023, it was announced that the Basque Office for Health Technology Assessment (OSTEBA) initiated several HTAs, including evaluations in the e-health, radiology, nephrology and urology, cardiovascular, IVD, obstetrics and gynecology, diagnostic imaging, radiotherapy, neurovascular, ENT, interventional radiology, surgical procedures, and some other fields.

On January 31, 2023, the Order approving Addendum 11 to the National Convention for Laboratory Directors was published in the Official Journal of the French Republic. The Addendum implements financial measures provided for by the Social Security Financing Act – reduces the reimbursement tariffs for the tests registered in the main reimbursement catalog for IVD tests in France Nomenclature of Medical Biology Acts (NABM).

On January 24, 2023, the Swedish National Board of Health and Welfare recommended introducing a national screening program for spinal muscular atrophy (SMA) in newborns. It will identify children with a homozygous deletion in the SMN1 gene and 1–3 copies of the SMN2 gene. SMA testing must be included in the existing newborn screening (so-called PKU test). The launch of the new screening program is expected in the summer of 2023.

On January 23, 2023, the Norwegian Directorate of e-Health released an updated version of the National Laboratory code (NLK) system and associated tariffs for state and private laboratories to be implemented no later than March 1, 2023. Twenty-four new codes were added, 179 codes were changed, and 23 codes were terminated.

In January 2023, the National Institute for Health and Care Excellence (NICE) published four new Interventional Procedure Guidance (percutaneous image-guided cryoablation of peripheral neuroma, laparoscopic insertion of a magnetic ring, transcutaneous electrical stimulation of the trigeminal nerve, and trabeculectomy with a biodegradable collagen matrix implant ), two new Diagnostic Guidance (devices for remote monitoring of Parkinson's disease, MRI-based technologies for assessing non-alcoholic fatty liver disease), and three new Medtech Innovation Briefings (PredictSURE IBD, Ambu aScope 4 Broncho, and Aquablation robotic therapy). One MedTech-related clinical guideline was updated.