Med Tech-related technology assessments and clinical guidelines from NICE in July 2022

In July 2022, NICE published two Interventional Procedures Guidance (IPG):

• Transcatheter tricuspid valve annuloplasty for tricuspid regurgitation;
• Transcatheter tricuspid valve leaflet repair for tricuspid regurgitation.

IPG is developed for most of the novel interventional procedures entering the English market. The program focuses solely on clinical evidence. Recommendations may vary from "for research only" to "for use with standard arrangements for clinical governance, consent, and audit." Recommendations are not binding, although they are followed by providers and commissioners.

NICE made recommendations depending on the clinical indications::

• For people with severe and symptomatic tricuspid regurgitation, evidence on the efficacy of both transcatheter tricuspid valve annuloplasty and leaflet repair is limited in quantity and quality. Evidence on its safety shows there are serious but well-recognized complications. Therefore, these procedures should only be used with special arrangements for clinical governance, consent, and audit or research;
• For people with mild or moderate tricuspid regurgitation, evidence on the safety and efficacy of both transcatheter tricuspid valve annuloplasty and leaflet repair is inadequate in quantity and quality. Therefore, these procedures should only be used in the context of research.

The Diagnostic Guidance (DG) program focuses on evaluating innovative medical diagnostic technologies to ensure that the NHS can adopt clinically and cost-effective technologies rapidly and consistently.

In July 2022, NICE published one new DG on PLGF-based testing to help diagnose suspected preterm pre-eclampsia. NICE recommended the following placental growth factor (PLGF)-based tests, used with standard clinical assessment, to help decide on care (to help rule in or rule out pre-eclampsia) for people with suspected preterm (between 20 weeks and 36 weeks and six days of pregnancy) pre‑eclampsia:

• DELFIA Xpress PLGF 1-2-3;
• DELFIA Xpress sFlt-1/PLGF 1-2-3 ratio;
• Elecsys immunoassay sFlt-1/PLGF ratio;
• Triage PLGF Test.

BRAHMS sFIT-1 Kryptor/BRAHMS PLGF plus Kryptor PE ratio is not recommended for routine use in the NHS. Further research is needed to show the accuracy of this test when using specified thresholds. NICE concluded that PLGF-based testing might particularly benefit groups at higher risk of severe adverse pregnancy outcomes, such as people from African, Caribbean, and Asian family backgrounds.

The MedTech Innovation Briefings (MIBs) is the advice program of NICE for innovative technologies. It provides an overview of clinical effectiveness, safety, and cost. It does not offer formal guidance, and it, therefore, does not provide any recommendations. The four new MIBs published in July 2022 are:

• ProciseDx point-of-care platform for inflammatory bowel disease (IBD), a point-of-care platform with four different assays for measuring C‑reactive protein, fecal calprotectin, and levels of infliximab and adalimumab. It is used for monitoring levels of inflammation and therapeutic response to infliximab and adalimumab in IBD;
• RespiraSense for continuously monitoring respiratory rate, which is motion-tolerant, so it can monitor respiratory rate while a person is walking or changing body position;
• Lenus COPD Support Service for remotely managing chronic obstructive pulmonary disease (COPD), using the combination of data from patient-reported outcomes, medical and wearable devices, and clinical records;
• Cyanoacrylate glue for hernia mesh fixation limits trauma to surrounding tissues. The innovative applicators are used for precise, accurate adhesive placement.

Five clinical guidelines were updated in July 2022:

• Melanoma: assessment and management - new and updated recommendations were made on genetic testing, staging, surgery for stages 0 to III melanoma, anticancer treatment for people with stage III and IV melanoma, and follow-up;
• Urinary tract infection in under 16s: diagnosis and management;
• COVID-19 rapid guideline: hematopoietic stem cell transplantation;
• COVID-19 rapid guideline: managing COVID-19;
• Pneumonia in adults: diagnosis and management – NICE reinstated this guideline, which was temporarily withdrawn in May 2020 because of the COVID-19 pandemic, and plans to update it.

See the full details for guidance here and for MIBs here.

This news is just one of about 300 market access news collected by our team in the subscription services "HTA Alerts" and "Reimbursement Alerts" every two weeks from more than 80 organizations. Access our paid subscription services to stay on top of all developments specifically for your products in Europe (reimbursement news) and globally (HTA news). First EU issues of both newsletters are available for download free-of-charge.

Not ready for a subscription service? Subscribe to our free-of-charge newsletter delivered every second week to get updates about key reimbursement developments in Europe (10-12 news every two weeks).