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

In May 2021, NICE published five Interventional Procedures Guidance (IPG):

• Ex-situ machine perfusion for extracorporeal preservation of lungs (ex-vivo lung perfusion) for transplant;
• Transvaginal laser therapy for stress urinary incontinence;
• Transvaginal laser therapy for urogenital atrophy;
• Electrohydraulic lithotripsy for difficult-to-treat bile duct stones;
• Permanent His-bundle pacemaker implantation for treating heart failure.

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 recommended ex-situ machine perfusion for extracorporeal preservation of lungs (ex-vivo lung perfusion) for transplant with standard arrangements for clinical governance, consent, and audit, concluding that evidence on the safety and efficacy is adequate.

NICE concluded that evidence on transvaginal laser therapy for stress urinary incontinence and transvaginal laser therapy for urogenital atrophy does not show any short-term safety concerns. However, evidence on the long-term safety and efficacy is inadequate in quality and quantity. Therefore, these procedures should only be used in the context of research. Further research should report long-term safety and efficacy outcomes, the type of laser and energy used, treatment protocols, and patient selection, including age, menopausal status, and severity of stress urinary incontinence. NICE encourages further research into transvaginal laser therapy for stress urinary incontinence and for urogenital atrophy.

NICE concluded that evidence on the efficacy of electrohydraulic lithotripsy for difficult-to-treat bile duct stones is adequate. However, evidence of its safety is limited in quantity. Therefore, this procedure should only be used with special arrangements for clinical governance, consent, and audit or research. The procedure should only be done in specialized centers with experience in managing difficult-to-treat bile duct stones.

Permanent His-Bundle pacemaker implantation for treating heart failure received "only in the context of research" recommendation because the evidence on the safety and efficacy is inadequate in quality and quantity. This is a technically challenging procedure, and experience in cardiac electrophysiology is needed. It should only be done in specialized centers with experience in cardiac pacing. Further research should be in the form of randomized controlled trials or registry data.

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 May, NICE issued one new MTGs on UroLift for treating lower urinary tract symptoms of benign prostatic hyperplasia.

NICE concluded that the evidence supports adopting the UroLift System for treating lower urinary tract symptoms of benign prostatic hyperplasia in the NHS because it relieves lower urinary tract symptoms, avoids risk to sexual function, and improves the quality of life. The guidance further states that the UroLift System is a minimally invasive procedure and should be considered as an alternative to transurethral resection of the prostate (TURP) and holmium laser enucleation of the prostate (HoLEP) as a day case or outpatient procedure for people who are 50 years and older with a prostate volume between 30 and 80 ml.

UroLift System is likely to be cost-saving compared with standard treatments because of reduced length of stay and procedure time. Over five years, if done as a day-case procedure, UroLift is estimated to save, per person:

• £981 compared with bipolar TURP;
• £1,242 compared with monopolar TURP;
• £1,230 compared with HoLEP.

Compared with transurethral water vapor therapy using Rezum, cost savings for UroLift are uncertain and depend on whether flexible cystoscopy is used before the procedure and the number of implants needed for UroLift. The additional implants needed when UroLift is used for obstructive median lobe treatment mean that there may be additional costs when compared with Rezum.

NICE also updated two MTGs:

• HeartFlow FFRCT for estimating fractional flow reserve from coronary CT angiography, initially published in 2017, to reflect 2021 costs. NICE made the following new conclusions: based on the current evidence and assuming there is access to appropriate CCTA facilities, using HeartFlow FFRCT may lead to cost savings of £391 per patient; by adopting this technology, the NHS in England may save a minimum of £9.4 million by 2022 by avoiding invasive investigation and treatment;
• Parafricta Bootees and Undergarments to reduce skin breakdown in people with or at risk of pressure ulcers, initially published in 2014, to include evidence from two new published studies of Parafricta. NICE concluded that Parafricta Bootees and Undergarments show potential to reduce the development and progression of skin damage caused by friction and shear in people with, or at risk of, pressure ulcers. However, more evidence for their effectiveness in clinical practice is needed to support the case for routine adoption of Parafricta Bootees and Undergarments in the NHS.

MedTech Innovation Briefing (MIB) 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.

Two new MIBs were published in May:

• Axonics sacral neuromodulation system (SNM) for overactive bladder and faecal incontinence - that needs less frequent surgical replacement than the comparable non-rechargeable device currently used as standard care;
• KODEX-EPD for cardiac imaging during ablation of arrhythmias - a non-fluoroscopic 3D cardiac imaging and navigation (mapping) system used during ablation of cardiac arrhythmias.

Furthermore, three clinical guidelines were updated in May. The updates were only related to pharmacological treatment:

• Heavy menstrual bleeding: assessment and management;
• Headaches in over 12s: diagnosis and management;
• Epilepsies: diagnosis and management.

See the full details here.

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