Med Tech-related technology assessments and clinical guidelines from NICE in January 2021

In January 2021, NICE published two new interventional procedures guidance: Self-expanding implant insertion into the intersphincteric space for faecal incontinence and Minimally invasive radical hysterectomy for early stage cervical cancer.

Interventional Procedure Guidance 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 concluded that evidence on the safety and efficacy of self-expanding implant insertion into the intersphincteric space for faecal incontinence is inadequate in quality and quantity; therefore, this procedure should only be used in the context of research.

Minimally invasive radical hysterectomy for early stage cervical cancer involves removing the uterus, cervix, upper vagina and some lymph nodes, and the robot may be used to assist the procedure. NICE made the following conclusions:

• There are no short-term safety concerns;
• The evidence on efficacy for tumours 2 cm or larger shows that minimally invasive radical hysterectomy has shorter disease-free and overall survival compared with open hysterectomy surgery. Therefore, this procedure should not be used for tumours 2 cm or above;
• The evidence on efficacy for tumours smaller than 2 cm is inconclusive for disease-free and overall survival compared with open hysterectomy surgery. Therefore, for tumours smaller than 2 cm, this procedure should only be used in the context of research;
• Further research, preferably in the form of randomized controlled trials, should describe details of patient selection, tumour histology and size and surgical technique and report overall survival, disease-free survival, tumour recurrence and patient‑reported outcome measures.

Medical technologies guidance 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 January, NICE issued two new medical technologies guidance on the PLASMA system for transurethral resection and haemostasis of the prostate and the VAC Veraflo Therapy system for acute infected or chronic wounds that are failing to heal.

NICE concluded that evidence supports the case for adopting the PLASMA system for bipolar transurethral resection and haemostasis of the prostate.

• Clinical outcomes are comparable with monopolar transurethral resection of the prostate (mTURP), but PLASMA avoids the risk of transurethral resection syndrome and reduces the need for blood transfusion and the length of hospital stay;
• The PLASMA system for prostate resection and haemostasis should be considered as an option for people with symptomatic benign prostatic hyperplasia when surgical intervention is indicated;
• Cost modelling estimates that the PLASMA system is cost saving by £459 per procedure compared with mTURP for hospitals that already use an Olympus platform and £343 for those that do not. This assumes a reduced (2-day) length of stay with PLASMA and that 65% of procedures need a second electrode for haemostasis. Evidence suggests there are reduced readmissions with the PLASMA system compared with mTURP. This would increase cost-saving to £534 for hospitals that already use an Olympus platform and £418 for those that do not.

The VAC Veraflo Therapy system comprises a dressing that covers the wound, attached by tubes to a machine, which delivers the therapy. It uses negative pressure therapy but also slowly introduces cleansing fluid onto the wound bed (wound instillation therapy). NICE concluded that there is not enough good-quality evidence to support the VAC Veraflo Therapy system for routine adoption. Research in the form of a randomized controlled trial is recommended to show clinically meaningful benefits for the VAC Veraflo Therapy system (wound instillation with negative pressure therapy) compared with negative pressure wound therapy alone. A key outcome should be time to wound closure.

MedTech Innovation Briefing is the NICE's advice program 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.

Six MedTech Innovation Briefings were published in January:

• Optilume for anterior urethral strictures – a technology that combines balloon dilation to expand or widen the strictured area, with delivering an anti-proliferative drug (paclitaxel) to reduce stricture recurrence;
• Artificial intelligence in mammography – for support radiologists or other qualified people to interpret mammograms. Five artificial intelligence (AI) technologies for mammography were evaluated - Transpara Mammography, Transpara DBT, HealthMammo Software, ProFound AI for 2D Mammography, and ProFound AI for DBT. The technologies;
• Artificial intelligence for analyzing chest CT images - the software (Veye Chest, icolung, Veolity) which helps radiologists and radiographers to detect abnormalities in chest CT images;
• Natural Cycles for monitoring fertility  - which is the first fertility-awareness app that comes with a basal thermometer and has been CE-marked as a medical device;
• Accuro for guiding epidural or spinal anaesthesia - a handheld ultrasound device used for guiding location, angle, and depth of needle insertion for administering epidural or spinal anaesthesia;
• AcQMap for mapping the heart atria to target ablation treatment for arrhythmias – that displays high-resolution 3D cardiac chamber reconstructions using ultrasound and cardiac electrical activity (measured using electrodes) as a propagation wavefront, and allow for a more targeted approach to ablation therapy, reducing the risk of unnecessary excess tissue ablation. The system can also be used with a novel algorithm – SuperMap, designed to map stable or transient rhythms.

Also, two clinical guidelines were updated in January:

• Suspected cancer: recognition and referral [NG12] - recommendation on when to offer faecal testing for colorectal cancer were amended to include the full list of criteria. Testing with quantitative faecal immunochemical tests  to assess for colorectal cancer is now recommended for offering to adults without rectal bleeding who:
  • are aged 50 and over with unexplained abdominal pain or weight loss, or
  • are aged under 60 with changes in their bowel habit, or iron-deficiency anaemia, or
  • are aged 60 and over and have anaemia even in the absence of iron deficiency;
• Brain tumours (primary) and brain metastases in adults [NG99] - recommendations on surgical cavity radiosurgery and radiotherapy were replaced with the link to the NHS England commissioning policy on stereotactic radiosurgery and stereotactic radiotherapy to the surgical cavity following resection of cerebral metastases.

See the full details 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).