The NHS Long Term Plan committed to the development of the MedTech Funding Mandate, later consulting on the policy in December 2019. The Mandate’s launch was delayed from April 2020 due to Covid-19.
The policy is effective from 1 April 2021 and the Accelerated Access Collaborative (AAC) is responsible for identifying innovations for the policy, supported by input from various stakeholders.
The 2021/22 Mandate will apply to devices, diagnostics, and digital products that:
• Are effective as demonstrated through a positive NICE MTG or DG.
• Deliver material savings to the NHS – over £1m over five years for the population of England.
• Are cost-saving in-year – deliver a net saving in the first 12 months of being implemented (this was retained in light of the ongoing pressures the NHS faces)
• Are affordable to the NHS – the budget impact should not exceed £20m in any of the first three years.
A fifth criterion, that products previously supported through the ITT/ITP programmes will be eligible, is in place only for the 2021/22 Mandate.
The technologies that meet the five criteria are:
• placental growth factor based testing (PlGF) – a diagnostic test to help rule out pre- eclampsia (Triage PlGF test and the Elecsys immunoassay sFlt-1/PlGF ratio)
• SecurAcath – for securing percutaneous catheters
• HeartFlow FFRCT – for estimating fractional flow reserve from coronary CT angiography
• gammaCore – a handheld device which alleviates the symptoms of severe cluster headaches by stimulating the vagus nerve
• From 1 April 2022, technologies not previously supported by the ITT/ITP may be covered by the Mandate.
• Technologies will need a demonstrate a net saving across a three-year period (rather than in-year savings).
• Technologies that have their MTG or DG published up to and including the 30 June 2021 will be reviewed to identify products that:
• Are effective as demonstrated through a positive NICE MTG or DG.
• Are cost-saving within three years.
• Are affordable to the NHS – the budget impact should not exceed £20m in any of the first three years.
The MedTech Funding Mandate policy will be published annually in December following a review and feedback improvement cycle which will become effective on 1 April the following year.
• NICE Medtech Guidance MTG and NICE Diagnostic Guidance DAP will be reviewed throughout the year and a list of technologies that meet the Mandate’s criteria will be published on the Accelerated Access Collaborative - AAC webpage before the end of July.
• Technologies already covered will be assessed to determine if any should be removed.
• The policy document publication schedule for 2021/22 to 2023/24 is as follows:
• MedTech Funding Mandate policy for 2021/22 – January 2021
• MedTech Funding Mandate signalling document for 2022/23 – July 2021
• MedTech Funding Mandate for 2022/23 – December 2021
• MedTech Funding Mandate signalling document for 2023/24 – July 2022
• MedTech Funding Mandate policy for 2023/24 – December 2022
• NICE resource impact templates for the four technologies selected for 2021/22 estimate that without implementation or continued use of these technologies, the cost of care would be around £323m over five years.
• By implementing them, the cost of care reduces to £298m over five years, a saving of around £25m over five years.
The Mandate does not directly fund the technologies included in the policy; NHS-funded care providers are to be reimbursed by their commissioner. This is unlike the Innovation Technology Payment - ITT/ITP programmes which have been directly funded by directly reimbursing the supplier. However, under the Standard Contract signed between care providers and payers in NHS England, there is an obligation for them to have regard to NICE guidance. To understand more about this and understand the obligations from an NHS Business Manager, please view our youtube session with NICE and MedTech Evaluations.
As for the move away from activity-based funding and to blended payments, this would affect the first year of the Mandate with activity and cost to be agreed between providers and commissioners and added to the fixed payment.
Risk share agreements can be used to even out any imbalance of costs and savings between organisations and to encourage implementation. NHS England and Improvement’s Pricing team are developing a collaboration work platform to share educational tools for the management of risk sharing – details of which will be shared when launched.
Legacy ITT/ITP reporting
• Once funding responsibility for technologies transfers to local commissioners on 1 April 2021, the collection of uptake data via the Innovation Technology Payment ITT/ITP programmes will cease.
Monitoring compliance
• The AAC will continue to work with product suppliers and NHS Supply Chain to track the uptake of technologies covered by the Mandate.
• Uptake data will be included in the Accelerated Access Collaborative scorecard and monitored through the Accelerated Access Collaborative Board.
• MedTech Funding Mandate Consultation report
• Guidance for NHS commissioners and providers of NHS funded-care 2021/22
Since 2010, Device Access has supported over 40 Devices successfully through various NICE programmes including MedTech Guidance (MTG).
We are also an official accredited NICE MedTech Early Technical Assessment - NICE META tool facilitator, and since 2014 a licence holder from NHS England of over 1 Billion electronic hospital individual patient records.
This allows us to give you professional guidance about evidence gaps and requirements for successful NICE approval, as well as understand how patients are treated today the volumes of patients who would benefit from the introduction of new treatments, Nationally and by each individual hospital.
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