In-vitro diagnostic tests

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.

On February 24, 2021, NHS England published an update of the Specialized Services Policy Pipeline (covering period November 10, 2020 - February 10, 2021). Two new Clinical Commissioning Policies were added to the work program, and seven new policies were published, including stereotactic ablative radiotherapy, stereotactic radiosurgery and proton therapy. The status of ongoing policies was updated as well.

In February 2021, the National Institute for Health and Care Excellence (NICE) published one new medical technologies guidance (Leukomed Sorbact for preventing surgical site infection) and seven new Medtech innovation briefings (PROPEL sinus implants, URO17 for detecting bladder cancer, Faecal microbiota transplant, DOAC Dipstick for detecting oral anticoagulants, CytoSorb for reducing the risk of bleeding during cardiac surgery, and others).

Healthcare Improvement Scotland develops HTAs and clinical guidelines to support decision-making. In the fourth quarter of 2020, Healthcare Improvement Scotland published assessments of continuous glucose monitoring in pregnant women with type 1 diabetes, endobronchial valves for lung volume reduction in patients with severe emphysema, and other topics.

On February 5, 2021, the French Ministry of Solidarity and Health published the results of the pre-selection of applications submitted in 2020 for participating in the coverage with evidence development programs. Regarding the Health Economic Research Program (PRME), 20 applications regarding various medical technologies were selected, including high throughput genome sequencing analysis in pediatric diagnostics, robotic thoracic surgery during lobectomy or segmentectomy in lung cancer, robotic gastric bypass for morbid obesity, mechanical thrombectomy techniques in the treatment of ischemic stroke, CAR-T cell therapy in the treatment of diffuse large B-cell lymphomas, creation of arteriovenous accesses for hemodialysis - the surgical technique and the endovascular technique, etc. Regarding the national Hospital Program of Clinical Research (PHRC-N), 205 applications were pre-selected.

In January 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 0174 and 0071 with changes to be implemented not later than May 01, 2021. Five new procedure codes related to the areas of men's health, robotic surgery, endoscopy, and orthopedics, as well as three new diagnostic codes, were introduced.

On January 25, 2021, the Norwegian Directorate of e-Health released a regular update of the Norwegian Laboratory code (NLK) system (version 7280.54) and associated tariffs for state and private laboratories to be implemented not later than March 01, 2021. In this update, 63 new codes were introduced. On February 02, 2021, an extra update was issued (version 7280.55) to be implemented not later than April 01, 2021. Five new codes for the analyses of mutated SARS-CoV-2 were introduced in this update.

On January 26, 2021, NHS Accelerated Access Collaborative published the MedTech Funding Mandate policy for 2021/22, which will come into force in April 2021. According to the NHS Long Term Plan, introducing a MedTech Funding Mandate will support getting innovative medical devices, diagnostics, and digital products to patients faster. Four technologies will be supported in 2021/22 - HeartFlow FFRCT, gammaCore, SecurAcath, and PIGF-based testing.

On January 11, 2021, a new version of the Nomenclature of Medical Biology Acts (NABM068) was released. One new code for detecting the genome of the influenza A and B viruses by RT-PCR was introduced.

On January 07, 2021, NHS England published an update of the Specialized Services Policy Pipeline (covering the period October 19, 2020 - December 08, 2020). Two new Clinical Commissioning Policies were added to the work program, and six new policies related to radiotherapy, neurosurgery, pulmonology, and in-vitro diagnostics were published.

The revised EBM (German Uniform Evaluation Standard) catalog came into force on January 1, 2021. The most significant changes include the increase of the reimbursement base rate and the introduction of many new surcharge fees in the area of radiotherapy services.

On December 23, 2020, NHS England and NHS Improvement published the final document for updating the National Genomic Test Directory (Test Directory), as well as other documents supporting the application process for amendments. The deadline for applications submission for 2021/22 Test Directory is January 31, 2021.