MedTech-related technology assessments and clinical guidelines from NICE in October 2022

Interventional Procedures Guidance (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.

In October 2022, NICE published two new IPGs and made the following conclusions:

• Evidence on the safety and efficacy of YAG laser vitreolysis for symptomatic vitreous floaters is inadequate in quality and quantity. Therefore, this procedure should only be used in the context of research;
• Evidence on the safety of transcutaneous electrical stimulation of the supraorbital nerve for treating and preventing migraine is adequate and raises no major concerns. Evidence on efficacy and recommendations differ depending on clinical indications:
  • The evidence for treating an acute migraine attack is adequate but for treating subsequent attacks is limited in quality and quantity. So, for treating acute migraine, this procedure should only be used with special arrangements for clinical governance, consent, and audit or research;
  • The evidence for preventing migraine is inadequate in quality. So, for preventing migraine, this procedure should only be used in the context of research.

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 October 2022, NICE published one MTG on Magtrace and Sentimag system for locating sentinel lymph nodes for breast cancer. NICE recommended Magtrace and Sentimag as an option to locate sentinel lymph nodes for breast cancer in hospitals with limited or no access to radiopharmacy. Further data collection is recommended to monitor the number of additional sentinel lymph node biopsies done in each hospital after the technology is adopted in clinical practice.

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.

Three new MIBs published in October 2022:

• O2matic PRO 100 for optimizing oxygen treatment in respiratory conditions. The device measures blood oxygen saturation (SpO2) and automatically adjusts the flow of oxygen to the person to achieve and maintain a target SpO2;
• Daylight for treating generalized anxiety disorder in adults. Daylight is an automated personalized self-help program that delivers therapeutic content based on the principles of cognitive behavioral therapy (CBT). People can access Daylight using a smartphone app;
• Signatera for detecting molecular residual disease from solid tumour cancers. Signatera is a blood-based assay that measures circulating tumor DNA (ctDNA) in people with solid tumors, including colorectal, breast, bladder, renal, and lung cancer. ctDNA is a type of cell-free DNA (cfDNA) that can suggest the presence of cancer cells.

One clinical guideline was published in October 2022 for osteoarthritis in over 16s diagnosis and management, which provides recommendations on diagnosis, information and support, non-pharmacological and pharmacological management, follow-up and review, referral for joint replacement, and arthroscopic procedures.

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

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