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The MedTech Funding Mandate (MTFM) launched on 1 April 2021 and in its first year, 2021/22, supported four NICE-approved, cost saving technologies which we will continue to support in 2022/23 (supported technologies are reviewed annually to ensure that they meet the policy criteria).

As detailed in the MTFM policy guidance, to be considered for the MTFM 2022/23 policy, technologies needed to be:

Effective: demonstrated through positive NICE Medical Technology Guidance (MTG) or Diagnostic Guidance (DG), published by 30 June 2021.

Cost-saving within three years of implementation: as demonstrated by NICE modelling and published in a NICE resource impact template.

Affordable to the NHS: the NICE budget impact analysis total costs should not exceed £20 million in any of the first three years.

With NICE, the Innovation, Research and Life Sciences (IRLS) team assessed all available MTG and DG guidance to understand which technologies met the criteria. Qualifying technologies are listed below.

The technologies meeting the criteria for inclusion in the MTFM 2022/23 policy are categorised into two themes:

Benign prostatic hyperplasia (BPH) is a common condition in ageing men and others with a prostate (trans women, some non-binary and some intersex people). It is currently treated with the surgical procedure, transurethral resection of the prostate (TURP) which usually requires the patient to stay in hospital for 1 to 3 days. Four less invasive innovations allow patients with BPH to be treated as day cases. Providers will not be expected to implement all four technologies, instead, each would be expected to work with its AHSN and the Getting It Right First Time (GIRFT) Urology Area Networks to understand its technology needs and the potential uptake locally.

Improving the patient experience during procedures technologies are innovative alternatives to otherwise more invasive and costly procedures. Thopaz and Spectra Optia use digital technology to increase efficiency and improve outcomes compared to current procedures and Xpress is a minimally invasive alternative to invasive sinus surgery, thus reducing the risk of complications and improving patient recovery, outcomes and experience

Product

Description and benefits

UroLift

Specialism: Urology: BPH

The UroLift system lifts and holds the enlarged prostate tissue away from the urethra, relieving the compression of this organ. It can be performed under local anaesthesia in an outpatient setting or ambulatory care centre, and the patient can return home the same day without a catheter. NICE guidance MTG58

GreenLight XPS

Specialism: Urology: BPH

The GreenLight XPS vaporises prostatic tissue with a laser. The laser fibre is passed through a cystoscope to photoselectively vaporise the enlarged prostate tissue, leaving a clear urethral channel. GreenLight XPS can be done as a day case procedure, reduces the risk of complications, and allows a quicker return to normal activity. NICE guidance MTG29.

Rezum

Specialism: Urology: BPH

Rezum is a minimally invasive procedure that uses water vapour (steam) to treat BPH. The technology delivers targeted, controlled doses of stored thermal energy in water vapour directly to the region of the prostate gland with the obstructive tissue causing lower urinary tract symptoms (LUTS). Rezum effectively alleviates BPH and patients can be treated as outpatients.

PLASMA system

Specialism: Urology: BPH

PLASMA is a bipolar electrosurgery system for transurethral resection and haemostasis of the prostate. The system uses electrodes to cut out (resect) prostate tissue and stop any local bleeding afterwards (haemostasis), which avoids the risk of transurethral resection syndrome and reduces the need for blood transfusion. This procedure can be done as a day case.

XprESS multi-sinus dilation system

Specialism: ENT: Chronic sinusitis

The XprESS multi-sinus dilation system is a sterile, single-use device for treating chronic sinusitis. Dilation of the XprESS balloon remodels the bony sinus outflow tract by displacing adjacent bone and paranasal sinus structures. This has the potential to reduce the tissue lost compared to traditional functional endoscopic sinus surgery (FESS) procedures.

Thopaz+ portable digital system

Specialism: Thoracic surgery/ Trauma: Portable digital system for managing chest drains

Thopaz+ is a portable digital chest drain system that provides regulated negative pressure close to the patient’s chest and continuously monitors and records air leak and fluid drainage. The system comprises an inbuilt, regulated suction pump with a digital display, rechargeable battery, tubing that connects to any standard chest drain catheter and a Thopaz+ disposable fluid collection canister. Sensors in the system turn the pump on and off to ensure the pressure level set by the healthcare professional is precisely maintained.

Spectra Optia

Specialism: Haematology, transfusion: automated red blood cell exchange in people with sickle cell disease.

The Spectra Optia Apheresis System is an apheresis and cell collection platform for the treatment of sickle cell disease. In a typical exchange procedure, Spectra Optia separates and removes sickle red blood cells from the patient’s blood using continuous flow and centrifugation. These are replaced with healthy red blood cells according to the user-defined software protocol.

 

The following 4 technologies from the 2021/2022 Med Tech Funding Mandate (MTFM) will continued to be supported as part of the 2022/23 MTFM.

Placental Growth factor based testing (PIGF)

Specialism: Women and children’s

PIGF based testing provides fast and accurate diagnosis if PE is suspected, using a simple blood test for placental biomarkers. Blood tests are available from Roche Diagnostics (Roche Elecsys sFlt-1/PIGF Ratio Test) and Quidel Corporation (quidel Triage PIGF test). 

The product is recommended by NICE between 20 weeks and 34 weeks plus six days of gestation. The improved diagnosis allows better ante-natal risk management and provision of appropriate care according to clinical need, with subsequent financial and capacity benefits for the maternity system.

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HeartFlow

Specialism: Cardiology: for use in stable, recent onset chest pain and suspected angina.

A standard coronary CT scan is uploaded to HeartFlow, which produces an FFRCT, and a 3D model of the coronary arteries. Reduces unnecessary invasive angiograms by specifically identifying site and degree of coronary artery block.

Read more

gammaCore

Specialism: Neurology

Patient-handheld medical device that enables self-administering discrete doses of non-invasive vagus nerve stimulation (nVNS) therapy for the treatment of cluster headache. Reduces need for medication, increases self-management.

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SecurAcath

Specialism: IV access: safety device for PICC lines.

Subcutaneous catheter stabilization device with small nickel feet placed just beneath the skin at the insertion site. Reduces need for adhesive dressings, cleaning time and dislodgement rates.

Read more

 

About the policy

 

In 2021/22 the policy will support devices, diagnostics or digital products that:

  • are effective: demonstrated through positive NICE guidance;
  • deliver material savings to the NHS: the benefits of the innovation are over £1 million over five years for the population of England;
  • are cost-saving in-year: NICE modelling demonstrates a net saving in the first 12 months of implementing the technology;
  • are affordable to the NHS: the budget impact should not exceed £20 million, in any of the first three years.

To minimise burden on the NHS at this time, it was agreed that for the first year of the policy only, technologies must have also been previously supported by the Innovation Technology Payment.

The AAC expects hospitals and commissioning organisations to comply with the policy guidance where appropriate. The Mandate directs the NHS to which MedTech innovations are effective and likely to give savings on investment. The NHS Standard Contract will require both commissioners and providers of NHS-funded services to comply, as relevant, with their obligations under, and any recommendations contained in, the MedTech Funding Mandate.

Once the policy becomes effective in April, the NHS Accelerated Access Collaborative (AAC) team will regularly review NICE guidance on medical technologies and diagnostics to identify medical devices, diagnostics and digital products which have been recommended by NICE and are likely to meet the MedTech Funding Mandate criteria in the following year, and highlight these to providers and commissioners.

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