Molecular diagnostics

On May 30, 2022, NHS England and NHS Improvement updated the 2021/22 National Genomic Test Directory for cancer (version 4), which lists genomic tests commissioned by NHS England via Genomic Laboratory Hubs. However, no new codes were introduced.

In May 2022, the National Institute for Health and Care Excellence (NICE) published three new Interventional Procedure Guidance (endoanchoring systems in endovascular aortic aneurysm repair, supercapsular percutaneously assisted total hip arthroplasty for osteoarthritis, personalized external aortic root support using mesh in people with Marfan syndrome), one Medical Technologies Guidance (Sleepio to treat insomnia and insomnia symptoms), and six Medtech innovation Briefings (ViewSite Brain Access System, Granulox for managing chronic wounds, AMBLor for identifying melanomas, Bladder EpiCheck for detecting bladder cancer recurrence, and others). No MedTech-related clinical guidelines were published.

In April 2022, NHS England and NHS Improvement (NHSEI) announced that the timelines for the evaluation of applications to update the National Genomic Test Directory in 2022/23 are currently under review. Previously, NHSEI planned to publish and implement the 2022/23 Test Directory by April 2022. While the timelines are not confirmed, applications can still be submitted.

On April 21, 2022, NHS England and NHS Improvement updated the 2021/22 National Genomic Test Directory (version 3), which lists genomic tests commissioned by NHS England via Genomic Laboratory Hubs. Forty-two new codes (test-indication combinations) were introduced in the cancer field, and fourteen for rare and inherited diseases.

In March 2022, the National Institute for Health and Care Excellence (NICE) published five new Interventional Procedure Guidance (endoscopic balloon dilation for subglottic or tracheal stenosis, intramedullary distraction for lower limb lengthening, endoscopic full thickness removal of gastrointestinal stromal tumors of the stomach, percutaneous insertion of a cystic duct stent after cholecystostomy, and liposuction for chronic lipoedema), four new Medical Technologies Guidance (myCOPD, UroShield, Prontosan for wounds, and 3C Patch for diabetic foot ulcers), one new Diagnostic Guidance (terminated assessment of Freelite assays for multiple myeloma), and six new Medtech Innovation Briefings (Genedrive MT-RNR1 ID System, icobrain for multiple sclerosis, Al for analyzing chest X-ray images, and others). Also, three new clinical guidelines were published, and six were updated.

In February 2022, the National Institute for Health Research (NIHR) in England released six MedTech-related reports in its Health Technology Assessment (HTA) Journal, which concerned biomarkers for assessing acute kidney injury, non-invasive testing for neovascular macular degeneration, decision support tool to prevent falls in older people, endometrial scratch, distal radius fracture, and test for group B Streptococcus. 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 informs National Institute for Health and Care Excellence (NICE) guidance.

In February 2022, the National Institute for Health and Care Excellence (NICE) published two new Interventional Procedure Guidance (stereotactic radiosurgery for trigeminal neuralgia, and microwave ablation for primary or metastatic cancer in the lung), two new Diagnostic Guidance (EarlyCDT Lung for assessing the risk of lung cancer in solid lung nodules, PredictSURE IBD and IBDX to guide treatment of Crohn's disease), and four new Medtech Innovation Briefings (Insides System for managing intestinal failure, d-Nav insulin management app for type 2 diabetes, GaitSmart for personalized exercise rehabilitation, AposHealth for knee osteoarthritis)

In late January 2022, Swedish Medical Technologies Product (MTP) Council issued an updated version of recommendations regarding gene expression analysis for decision-making on the adjuvant breast cancer treatment, initially published in November 2021. The recommendation to the regions remains the same. The changes were only concerned with the clarification of some facts.

In November 2021, the National Institute for Health and Care Excellence (NICE) published two new Interventional Procedure Guidance (percutaneous implantation of pulmonary artery pressure sensors in chronic heart failure and coronary sinus narrowing device implantation for refractory angina), one new Medical Technologies Guidance (Synergo for non-muscle-invasive bladder cancer), one new Diagnostic Guidance (SeHCAT for diagnosing bile acid diarrhea), and four new Medtech Innovation Briefings (clonoSEQ for minimal residual disease, CerebAir for continuous EEG monitoring, 24/7 EEG SubQ for epilepsy, Paige Prostate for prostate cancer). Also, three new clinical guidelines were published, and six were updated.

On November 18, 2021, Swedish Medical Technologies Product (MTP) Council recommended the use of gene expression analysis (Prosigna and OncotypeDX) for decision-making on the adjuvant breast cancer treatment. The technologies have been under evaluation within the Orderly introduction framework since 2020.

In late November 2021, the INeK (Institute for the Hospital Remuneration System) has published the DRG catalog (Fallpauschalen-Katalog) with the list of DRGs and add-on reimbursement categories (ZEs) for 2022. Seven new DRGs and seventeen ZE categories were added to the catalog in 2022.

On July 1, 2021, the updated version of the Swiss Services Ordinance (KLV/OPre) came into force. The changes concern the List of explicitly evaluated services (Annex 1 of KLV/OPre), the List of medical aids (Annex 2 of KLV/OPre), and the List of Analyses (Annex 3 of KLV/OPre).