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Implementation of new technologies Dr Keith Cooper Southampton Health Technology Assessments Centre University of Southampton Structure of talk • Introduction • Background to evidence based decision making for implementing new technologies • Example: Machine perfusion preservation vs. cold storage in kidney transplantation Introduction • Within health care systems there is limited resources and increasing demand on services • Choices need to be made in a fair and equitable manner Choice A Choice B HTA modelling • Health Technology Assessment aims to evaluate health technologies by investigating: – – – – whether the technology works for whom at what cost how it compares with the alternatives • A health technology can be any intervention that improves health and includes – medications, devices, hospital procedures, health promotion activities and diagnostic tests • Health Technology Assessment in the UK is overseen by the NIHR HTA programme – Provides Technology Assessment Reports for NICE NICE (National Institute for Health and Clinical Excellence) • Provides guidance to NHS on new technologies, promote clinical excellence and the effective use of resources within the NHS. • Recommendations are based upon – Clinical evidence: systematic review, meta analyses – Economic evidence: cost effectiveness models • Bases decision-making on Technology Assessment Reports (TARs) and manufacturer submissions • TARs produced by university departments, such as Southampton Health Technology Assessments Centre (SHTAC) • New technologies are most often more effective and more costly – is it good value for money to adopt? NICE decision making – Cost effectiveness • Costs and health benefits are estimated for patients on alternative treatments • Health benefits are in term of Quality Adjusted Life Years – Life expectancy + Quality of life • Compare new treatment with existing treatment(s) • NICE is more likely to recommend a treatment if its cost effectiveness is lower than CE threshold (£30,000 per QALY) Machine perfusion systems and cold static storage of kidneys from deceased donors • NICE technology appraisal guidance [TA165] Published date: January 2009 • Assessment group report by PenTAG, university of Exeter – (Bond, Pitt, Akoh, Moxham, Hoyle, Anderson) What is the best method of preservation for kidneys for transplantation? • Cold storage solutions – the kidney is flushed through with a sterile preservation solution and is kept on ice in a box before transplantation – Marshall's hypertonic citrate (Soltran, Baxter Healthcare) and Belzer UW (Viaspan, Bristol Myers Squibb) • Machine perfusion systems – Machine perfusion systems continuously pump cold preservation solution through the kidney – The LifePortTM kidney transporter (Organ Recovery Systems), RM3 renal preservation system (Waters Medical Systems) Clinical evidence Machine Preservation Trial (Moers, 2008) PPART study (Watson 2010) Cold storage (Viaspan) N= 336 Machine perfusion (Lifeport) N = 336 Cold storage N = 45 Machine perfusion (Lifeport) N = 45 Proportion of delayed graft function following transplant 26.5% 20.8% 56% 58% Proportion of primary non function 4.8% 2.1% 0% 2% Graft survival at 1 year 90% 94% 98% 93.3% Cost effectiveness model Other model parameters (costs) Parameter Storage cost per Kidney: Cold storage (ViaSpan) Value £262.33 Machine perfusion (LifePort) £736.55 Other costs Transplant cost Dialysis cost (per month) Post transplant cost (month 1-3) £16,413 £2052 £2463 Post transplant cost (month 4-12) £1385 Other model parameters (QALY) • Quality of life values (age 50 years) • Transplant state: 0.75 • Dialysis state: 0.63 Cost effectiveness results Results using MPT data (Moers 2008) Costs per patient Health benefits (QALYs) Cold storage (ViaSpan) £142,805 9.58 Machine perfusion (LifePort) £139,110 9.79 Difference £-3695 0.22 Results using PPART data (Watson 2010) Costs per patient Health benefits (QALYs) Cold storage (ViaSpan) £139,205 9.19 Machine perfusion (LifePort) £141,319 9.13 Difference £2114 -0.06 Preferred technology Machine perfusion Preferred technology Cold storage NICE recommendations • The overall costs and benefits associated with kidney transplantation using either machine perfusion or cold static storage were similar. • The Committee recommended that the LifePort kidney transporter be considered as an alternative to cold static storage solutions. • The choice of which to use would depend on clinical and logistical factors within both the retrieval team and transplant centres. NICE – recommendations further research • The Committee considered that it was important for transplant centres to collect standardised and comprehensive data that follow up the outcomes for kidneys stored using different methods. Conclusions • Unclear from current data (2009), whether machine perfusion preferable to cold storage – Depends upon trial data used • Difficult to show difference in clinical outcomes – Large RCT is needed which may not be practical • Other more recent studies have come to different conclusions • Gomez et al 2012 – MP is cost effective • Groen et al 2012 – MP cost saving • Jochmans 2015 (Transplant International) provides excellent overview of current evidence Thank you!