Med Tech-related technology assessments and clinical guidelines from NICE in April 2024

The National Institute for Health and Care Excellence (NICE) develops Interventional Procedures Guidance (IPG) for most 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.

In April 2024, NICE published two new IPGs:

• Lymphovenous anastomosis during axillary or inguinal node dissection for preventing secondary lymphoedema;
• Epidermal radiotherapy using rhenium-188 paste for non-melanoma skin cancer.

For lymphovenous anastomosis, NICE made different recommendations depending on clinical indications:

• For adults with breast cancer, lymphovenous anastomosis during axillary dissection for preventing secondary lymphoedema can be used in the NHS while more evidence is generated. It can only be used with special arrangements for clinical governance, consent, and audit or research;
• For adults with other cancers, more research is needed on lymphovenous anastomosis during axillary or inguinal node dissection to prevent secondary lymphoedema. This procedure should only be done as part of a formal research study, and a research ethics committee needs to have approved its use.

NICE recommended epidermal radiotherapy using rhenium-188 paste for non-melanoma skin cancer to be used only in research. NICE concluded that there are no major safety concerns and that the evidence of efficacy is promising. However, the evidence is limited because most of the studies are retrospective and are small, even though non-melanoma skin cancer is a common condition. Also, the calculation of how much rhenium-188 paste to use and the treatment margin around the tumor to use are not standardized for this procedure. It is also unclear how the procedure compares with other treatments.

Medical Technologies Guidance (MTG) evaluates new, innovative medical devices and diagnostics. It looks at medical technologies that deliver treatment, like those implanted during surgical procedures, give greater independence to patients, or detect or monitor medical conditions.

In April 2024, NICE issued two new MTGs on the following technologies:

• GaitSmart rehabilitation exercise programme for gait and mobility issues comprises digital gait assessment (with GaitSmart sensor-based digital technology that monitors limb movement) followed by personalized rehabilitation exercises (with vGym app). NICE assessed the GaitSmart program in older people at risk of falling and those referred for knee or hip replacements (as part of pre-operative and post-operative rehabilitation). NICE made different recommendations depending on clinical indications: For adults at risk of falls, it can be used to treat gait and mobility issues in the NHS while more evidence is generated; For adults having hip or knee replacements, more research is needed on the GaitSmart program to treat gait and mobility issues before or after surgery;
• Kurin Lock is recommended to be used in the NHS to reduce contamination in blood culture collection in emergency departments with high blood culture contamination rates while more evidence is generated.

Health Technology Evaluations (HTE) are the new type of NICE guidance that uses the Early Value Assessment (EVA) approach to provide rapid conditional recommendations on promising health technologies that have the potential to address unmet national needs. NICE evaluates the available evidence to determine if earlier patient and system access in the NHS is appropriate while further evidence is generated.

In April 2024, NICE published HTE on digital technologies to deliver pulmonary rehabilitation programmes for adults with chronic obstructive pulmonary disease (COPD) and made the following recommendations:

• myCOPD can be used in the NHS while more evidence is generated to deliver pulmonary rehabilitation programs for adults with COPD who cannot have or do not want face-to-face pulmonary rehabilitation. The company (my mhealth) must confirm that agreements are in place to generate the evidence (according to the evidence generation plan published by NICE) and contact NICE annually to confirm that evidence is being generated and analyzed as planned. NICE may withdraw the guidance if these conditions are not met. At the end of the evidence generation period (3 years), the company should submit the evidence to NICE in a form that can be used for decision-making. NICE will review the evidence and assess if the technology can be routinely adopted in the NHS;
• More research is needed on the following five digital technologies: Active+me REMOTE, Clinitouch, Kaia Health COPD, Rehab Guru, and Wellinks. Access to these technologies should be through company, research, or non-core NHS funding, and clinical and financial risks should be appropriately managed;
• SPACE for COPD is awaiting appropriate regulatory approval, so it is not included in the recommendations at this time.

Furthermore, NICE updated two clinical guidelines:

• Endometriosis diagnosis and management (NG73) with new and updated recommendations on treatment of endometriosis when fertility is a priority;
• Twin and triplet pregnancy (NG137) with new and updated recommendations on screening for and preventing preterm birth.

See the full details here.

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