AposHealth (NICE Guidance MTG76.) is a non-invasive device worn on the feet to reduce pain and improve function in patients with knee osteoarthritis. The device consists of a pair of AposHealth shoes with 2 curved pods (pertupods) on the heel and forefoot of each shoe.

AposHealth has been recommended as a cost-saving option to manage knee osteoarthritis in adults when the follow criteria apply:

• non-surgical standard care has not worked well enough and
• a patient’s condition meets the referral criteria for total knee replacement surgery but they do not want surgery

Technologies - Why were these technologies selected for inclusion in the MTFM policy?

NICE Diagnostic and Medical Technology guidance were reviewed for technologies that meet the following three criteria:

Effective - Based on positive NICE guidance that evidences; clinical effectiveness, improved patient recovery & are time releasing

Cost saving within 3 years - NICE modelling demonstrates a net saving in the first 3 years of implementing the technology

Affordable to the NHS - The budget impact should not exceed £20 million, in any of the first three years

Technologies that have reached a good level of widescale adoption and spread and therefore have graduated from HIN support include:

Four technologies that are alternative treatments to transurethral resection of the prostate (TURP) for benign prostatic hyperplasia: 

• Greenlight – this is a surgical device that uses a laser to reduce the size of an enlarged prostate 

• Rezum – this is a surgical device that uses water vapour to destroy excess prostate tissue 

• Plasma System – this is a surgical device that uses electrodes to cut out prostate tissue 

• UroLift – lifts and holds the enlarged prostate tissue away from the urethra, relieving the compression of this organ. 

Three technologies that are an alternative to more invasive procedures: 

• Spectra Optia – is a apheresis and cell collection platform for people with sickle cell disease who require automated red cell exchange 
• XprESS Multi Sinus Dilation System – is a sterile, single-use device treating chronic sinusitis with a dilating balloon.
• Thopaz+ – is a portable digital chest drain system which accurately monitors and records air leak and fluid drainage.

• gammaCore - this is a handheld, patient-controlled, non-invasive vagus nerve stimulator. It is used for preventing and treating cluster headaches
• SecurAcath – a device that secures catheters without requiring sutures or adhesives 
• Heartflow® – a non-invasive personalised cardiac test that reduces the need for unnecessary procedures
• Placental growth factor (PIGF) based testing – tests for early diagnosis of preeclampsia in pregnant women, which if unmonitored, can cause serious complications for mother and baby 

These technologies, while not within the commission for support by HINs are still supported by the MedTech Funding Mandate policy, whereby, they are still excluded from the associated core payment mechanisms or prices within the NHS Payment Scheme 23-25, they are instead chargeable as passthrough items.

Q: Funding - Is additional funding provided to purchase the technologies?

A: The MTFM policy does not provide additional funding for the technologies it supports. Instead, commissioners are responsible for funding MTFM technologies that providers want to use. MTFM funding should form part of a regular contract and commissioning discussions between Finance, Commissioning teams and Clinicians. The MTFM policy criteria ensure that technologies are cost-saving within three years.

Technologies will be added to the mandate on a yearly basis, signalled in the summer, confirmed in Autumn and then available to purchase in the following April.

Q: Mandation - What is mandated by the policy?

A: This policy mandates commissioners to fund these technologies as prescribed by the NHS National Tariff Payment System and in line with local clinician needs and demands.

If a provider wants to utilise a technology then the local commissioner is mandated to fund it. Providers and commissioners should submit a variation to NHS England, using the required template, if they are not following this guidance

Q: Compliance - What is meant by policy compliance?

A: To comply with the Policy, if a provider wants to adopt eligible technologies then their local commissioner will fund the costs of implementing the technologies. If the commissioner does not agree to fund these costs then they will be non-compliant with the Policy.

If a provider/clinical team/clinician does not want to adopt one or more of the technologies then they create inequities in patient access to the technologies compared to NHS patients receiving care in other parts of England.

 The Health Innovation Network’s Quarterly Assurance Reporting process for its commissioners in the NHS England and NHS Improvement Innovation, Research and Life Sciences team will be used as the gold standard for monitoring uptake of the technologies on the policy and will be one of the catalysts for escalation of compliance and adoption.

Contractual Requirements

The NHS Standard Contract requires both commissioners and providers of NHS-funded services to comply, where relevant.*

This builds on existing contractual requirement(s) to have regard for guidance published by NICE.

*where technology is not relevant to the organisation (e.g. services not provided) or if another/alternative treatment is better suited to a patient (based on clinical decision making)

Q: Procurement - How should the technologies on the MTFM policy be procured?

A: Technologies will be available for procurement through the relevant NHS Supply Chain Category Tower framework.