1. Implementation of new technologies Dr Keith Cooper Southampton Health Technology Assessments Centre University of Southampton

2. Structure of talk Introduction Background to evidence based decision making for implementing new technologies Example: Machine perfusion preservation vs. cold storage in kidney transplantation

3. 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 B Choice A

4. 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

5. 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?

6. 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)

7. 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)

8. 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 LifePort TM kidney transporter (Organ Recovery Systems), RM3 renal preservation system (Waters Medical Systems)

9. 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%

10. Cost effectiveness model

11. Other model parameters (costs) Parameter Value Storage cost per Kidney: Cold storage (ViaSpan)£262.33 Machine perfusion (LifePort)£736.55 Other costs Transplant cost£16,413 Dialysis cost (per month)£2052 Post transplant cost (month 1-3)£2463 Post transplant cost (month 4-12)£1385

12. Other model parameters (QALY) Quality of life values (age 50 years) Transplant state: 0.75 Dialysis state: 0.63

13. Cost effectiveness results Results using MPT data (Moers 2008) Costs per patient Health benefits (QALYs) Preferred technology Cold storage (ViaSpan)£142,8059.58 Machine perfusion (LifePort)£139,1109.79 Difference£-36950.22Machine perfusion Results using PPART data (Watson 2010) Costs per patient Health benefits (QALYs) Preferred technology Cold storage (ViaSpan)£139,2059.19 Machine perfusion (LifePort)£141,3199.13 Difference£2114-0.06Cold storage

14. 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.

15. 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.

16. 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

17. Thank you!