HTA Infrastructure in the UK - NICE

1. HTA Infrastructure in the UK - NICE Richard Devereaux-Phillips Health Technology Assessment - Workshop 2011 20 January, Radisson Blu, Galway

2. Disclaimer Although I am a member of the Appraisals Advisory Committee of the National Institute for Health and Clinical Excellence, the views expressed in this presentation are my own and should not be taken to represent the opinion of either the Committee or of the Institute.

3. Presentation Overview • The NHS and rationing in cultural context • National Institute for Health and Clinical Excellence facts explained and myths dispelled • Recent Developments / Future Scenarios • HEALTH WARNING – It’s a flavour

5. Available to the entire population, comprehensive in its range, free at the point of delivery and first class in its standards • Funded from general taxation

6. What is cost effectiveness? • Technologies can be considered to be cost effective if their health benefits are greater than the opportunity costs measured in terms of the health benefits associated with programmes that may be displaced to fund the new technology. In other words, the general consequences for the wider group of patients in the NHS are considered alongside the effects for those patients who may directly benefit from the technology of interest.

7. Born April 1st 1999

8. “Probably not, but it’s worth a bloody good try.” Frank Dobson, Health Secretary, who established NICE in 1999, when asked whether he thought it would work.

9. The Triumph of NICE “NICE may prove to be one of Britain’s greatest cultural assets along with Shakespeare, Newtonian physics, The Beatles, Harry Potter and the Teletubbies” Richard Smith, Editor. British Medical Journal 2004

10. Why is NICE so important • Unique in its application of health economic data to make coverage / reimbursement recommendations • Implementation is mandatory for Technology Appraisals (to be continued……) • International reach • Seen as the gold standard model or “the least imperfect way of doing an impossible job”

11. What does NICE do • Public Health Guidance (?) • Interventional Procedure Guidance • Clinical Guidelines • Technology Appraisals

12. Technology appraisals Guidance on the clinical and cost effectiveness of specific new or existing medicines and treatments leading to recommendations on the appropriate use of the technology within the NHS.

13. Technology appraisals look at … Pharmaceuticals (for example, beta-interferon for MS) Devices (for example, insulin pumps) Diagnostics (for example, liquid based cytology) Procedures(for example, surgery for morbid obesity) Health promotion tools (for example, patient education models for diabetes)

14. The Department of Health refers technologies for appraisal based on one or more of the following criteria . • Is the technology likely to result in a significant health benefit, taken across the NHS as a whole, if given to all patients for whom it is indicated? • Is the technology likely to result in a significant impact on other health-related Government policies (for example, reduction in health inequalities)? • Is the technology likely to have a significant impact on NHS resources (financial or other) if given to all patients for whom it is indicated? • Is there significant inappropriate variation in the use of the technology across the country? • Is the Institute likely to be able to add value by issuing national guidance? For example, in the absence of such guidance is there likely to be significant controversy over the interpretation or significance of the available evidence on clinical and cost effectiveness?

15. Technology appraisal development process

16. Technology appraisal guidance formats Full guidance (web only) Quick Reference Guide (printed) Information for the public (printed) Assessment report /systematic review of all the evidence (web only)

17. A shorter process, designed for single technologies, with a narrow evidence base Run alongside the process for multiple technology (e.g. drug class) appraisals STA topics are selected through the standard topic selection process, but with fast track facility as well Key principles maintained Transparency, inclusiveness, robust assessment, independent decision making, regular review Single technology appraisal process

18. Minimum timeline of 6 months overall Reliance on standard template company submission Option to skip consultation (i.e. current appraisal consultation document stage) where the Appraisal Committee’s recommendations are consistent with licensed indications Appeal stage retained in every case STA process: elements

19. Publication Appeal (or not) Evidence Review Evidence Submission Preliminary recommendations Committee meeting Mnftr specifies decision problem STA Referral from DH as STA Consultation Review Committee meeting Final guidance [ 27-35 weeks]

20. Guide to the Methods of Technology Appraisal • Describes general methodological concepts underlying appraisal process. • Describes the requirements for those submitting evidence to the Technology Appraisals programme. • Review of the 2004 version of the guide was conducted 2007-8. • An updated version was issued in July 2008.

21. The NICE reference case

22. Consideration of cost effectiveness in decision making • The Institute must take into account the cost-effectiveness of the technology when making recommendations • The Institute does not adopt a precise cost-effectiveness threshold • The ‘threshold range’ represents the opportunity cost of programmes displaced by adopting new technologies

23. The Quality Adjusted Life Year Initial QALY loss due to side effects New treatment Currenttreatment QALYs gained 1 Health-related quality of life 0 Length of life (years)

24. Assessing Cost Effectiveness 1 Probability of rejection 0 50 10 20 30 40 Cost per QALY (£’000)

25. Appraising Cost-Effectiveness Below £20,000/QALY - CE Above £20,000/QALY - CE and other factors The degree of certainty surrounding the calculation of ICERs Change in HRQoL inadequately captured The innovative nature of the technology Above £30,000/QALY as above but much stronger (!) Always give reasons ADDENDUM 2009: ‘Appraising life-extending, end of life treatments’

26. Appraising life-extending, end of life treatments 2009 Supplementary Advice The treatment is indicated for patients with a short life expectancy, normally less than 24 months and; There is sufficient evidence to indicate that the treatment offers an extension to life, normally of at least an additional 3 months, compared to current NHS treatment, and; The treatment is licensed or otherwise indicated, for small patient populations. Plus Estimates of extensions to life are robust … Assumptions in the economic model are plausible and robust

27. Budget impact and pricing • Budget impact • The budget impact of a technology does not determine the Committee’s decision. The Committee will want to be increasingly more certain of the cost effectiveness of a technology as the impact on NHS resources increases. • Pricing • The Committee is not able to make recommendations on the pricing of technologies to the NHS

28. Value Based Pricing The Government view: “We need a system that encourages the development of breakthrough drugs addressing areas of significant unmet need. And we need a much closer link between the price the NHS pays and the value a new medicine delivers, sending a powerful signal about the areas that the pharmaceutical industry should target for development.” “Over the next three years we will be moving towards a new system of pricing for medicines, where the price of a drug will be determined by its assessed value.”

29. Patient Access Schemes “Patient access schemes are proposed by pharmaceutical company and agreed by DH to improve the cost effectiveness of a drug and enable patients to receive access to cost effective innovative medicines” The Pharmaceutical Price Regulation Scheme 2009 between DH and the ABPI

30. Patient Access Schemes Respect the role of NICE Discussed first and agreed in principle by DH & company; NICE to assess impact on cost-effectiveness Full costs to be included in costs considered by Appraisal Cttee Clinically robust, plausible, appropriate and monitorable Operationally manageable without unduly complex monitoring, disproportionate additional costs & bureaucracy. Cumulative administrative burden of such schemes remains manageable for all parties involved in their operation, including front-line NHS staff Consistent with existing financial flows and local commissioning NHS in E&W must be consulted on PASs, in particular where these involve additional data collection beyond that associated with the conventional purchase of medicines

31. NICE Outputs • As at December 2007 • 133 technology appraisals • 248 interventional procedures • 65 clinical guidelines • 7 pieces public health guidance

32. Technology Appraisals1999-2005 • “No” – 19% • “Yes” – 23% • “Yes, but” (major restrictions) – 32% • “Yes, but” (minor restrictions) – 26%

33. NICE Appeals 2000-2007 • 130 technology appraisals published • 47 appeals submitted • 42 allowed • 19 upheld • 23 dismissed

34. Looking forward

35. NICE International Non-profit consultancy providing advice and training to foreign governments and organisations on: The processes of using evidence to inform policy The methods for health technology assessment and clinical and public health guideline development Created in July 2008 to: Address increasing international demand for our expertise Respond to relevant national and international development policies Learn from other countries Enhance our national and international reputation

36. The Darzi reportHigh Quality Care For All (June 2008) Quality and Outcomes Framework (QOF) NICE quality standards Innovative medical devices and diagnostics

37. What is the NICE Evaluation Pathway The Evaluation Pathway Programme focuses specifically on the evaluation of innovative medical technologies (including devices and diagnostics). This programme both complements and operates in conjunction with NICE's existing technology appraisal capacity, which continues to evaluate new pharmaceutical and biotechnology products. The EP programme is designed to help the NHS adopt efficient and cost effective medical devices and diagnostics more rapidly and consistently. The types of products which might be included are medical devices that deliver treatment such as those implanted during surgical procedures, technologies that give greater independence to patients, and diagnostic devices or tests used to detect or monitor medical conditions.

38. Notify a product to the Evaluation Pathway •http://www.nice.org.uk/aboutnice/whatwedo/aboutmedicaltechnologies/notifyaproducttoep.jsp •Or email medtech@nice.org.uk

39. Patient Access Schemes Liaison Unit The use of patient access schemes (PAS) were formalised in January 2009 as part of the PPRS agreement. PPRS states that PASs need to be reviewed to ensure that the burden on the NHS is acceptable and manageable. NICE has been asked by the DH to develop a unit to support them in assessing the feasibility of implementing scheme proposals. NICE are establishing an expert panel responsible for the providing advice on implementing individual PASs.

40. NHS White Paper (July 2010) Quality standards (NHS & social care) NHS Outcomes Framework Firmer statutory footing NIHR And NHS constitution

41. Current and future product line up Social care

42. NICE future

43. A short future of NICE More clinical guidelines QOF indicators Diagnostics evaluation Quality standards

44. Thank you Richard.phillips@medtronic.com +44 7711 046848