In-vitro diagnostic tests

In 2013, Norway established a framework, “New Method,” for the introduction of innovations into the health care system through either a national or hospital-based health technology assessment. In this framework, all innovations should undergo HTA before being funded. As of June 7, 2021, five HTAs of in-vitro diagnostics are in progress.

In April 2021, the National Institute for Health and Care Excellence (NICE) published three new Interventional Procedure Guidance (repetitive short-pulse transscleral cyclophotocoagulation for glaucoma, deep brain stimulation for chronic, severe, treatment-resistant obsessive-compulsive disorder in adults, and Melphalan chemosaturation for primary or metastatic cancer in the liver) and two Medtech Innovation Briefings (microINR for anticoagulation therapy and RenalSense Clarity RMS for acute kidney injury), and two clinical guidelines (for atrial fibrillation and chronic pain in over 16s).

In April 2021, the Austrian Institute for Health Technology Assessment (AIHTA) initiated several new research projects. The projects are related to IVD tests for early detection of colon cancer, telemedical care in diabetes field, health apps, screening methods, consequences of coronavirus pandemic, and other topics.

The Galician Scientific and Technical Advice Unit in Spain (AVALIA-T) systematically evaluates healthcare technologies and provides decision-makers with critically reviewed information about their efficacy, safety, and effectiveness. Currently, the AVALIA-T is working on assessments of ventricular assist devices in pediatric patients with an indication for permanent destination therapy, bronchial thermoplasty for severe acute asthma, effectiveness and safety of epiduroscopy in the treatment of failed back surgery syndrome, and other topics.

In April 2021, the Clinical Coding and Schedule Development (CCSD) working group, which develops and maintains procedural and diagnostics nomenclature for private payers in England, has published Bulletins 0176 and 0073 with changes to be implemented not later than August 01, 2021. Four new procedure codes related to men's health and breast surgery and one new companion diagnostic code were introduced.

The revised EBM (German Uniform Evaluation Standard) catalog came into force on April 1, 2021. Two new EBM codes for IVD tests were introduced, and reimbursement conditions for two IVD tests were amended.

Healthcare Improvement Scotland develops HTAs and clinical guidelines to support decision-making. In the first quarter of 2021, Healthcare Improvement Scotland published assessments of targeted screening for early lung cancer in adults at high risk, gammaCore for cluster headache, and other topics, which mostly concern eHealth technologies.

On March 30, 2020, the Dutch Healthcare Institute (Zorginstituut Nederland, ZIN) announced five projects which received a subsidy under the "Subsidy scheme for promising care" in 2021: repetitive transcranial magnetic stimulation and in vivo exposure with response prevention in obsessive-compulsive disorder; MRI-guided laser-induced thermotherapy in glioblastoma; personalized treatment with selective internal radiotherapy in elderly or vulnerable colon cancer patients with liver metastases; structured, multidisciplinary and person-centered intensive care aftercare for patients at risk of health problems; Basophil Activation Test in children with possible IgE mediated cow's milk allergy.

On March 23, 2021, 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 not later than May 01, 2021. NLK system is used for activity-based reimbursement by the Norwegian Health Economics Administration (Helfo) in outpatient settings since 2018.Thirty-four new codes were added in medical biochemistry and medical microbiology areas.

In March 2021, the National Institute for Health Research (NIHR) in England released six MedTech-related reports in its Health Technology Assessment (HTA) Journal, which concerned sacral nerve stimulation and magnetic sphincter augmentation device for fecal incontinence treatment, patch augmentation surgery for rotator cuff repair, in-vitro diagnostics, and eHealth. HTA Journal publishes research reports on the effectiveness, costs, and broader impact of health technologies for those who use, manage, and provide care in the NHS and inform National Institute for Health and Care Excellence (NICE) guidance.

On March 22, 2021, the repository of innovative laboratory tests (RIHN) and the Supplementary list were published. No new codes for IVD tests have been introduced and no codes were removed in the new versions of catalogs.

In the middle of February 2021, the Swedish Dental and Pharmaceutical Benefits Agency (TLV) launched the assessment on the following prognostic platforms for gene diagnostics in breast cancer: Oncotype DX, MammaPrint, ProSigna. The evaluation is planned for the spring of 2021.