Still Being NICE After 14 Years Dr Bhash Naidoo / Technical Adviser National Institute for Health and Care Excellence (NICE) Centre for Health Technology Evaluation London / United Kingdom bhash.naidoo@nice.org.uk
Apologies Professor Sir Mike Rawlins
NICE established 1999 The National Institute for Health and Care Excellence (NICE) is the independent organisation in the UK responsible for providing national guidance to the NHS and the wider public health community on the promotion of good health and the prevention and treatment of ill health The government has officially launched the National Institute for Clinical Excellence, which is designed to drive the uptake of new technologies Press release, 1999
NICE s Remit (1999) Aim: to reduce variation in the availability and quality of treatments and care (the so called postcode lottery ) NICE guidance to resolve uncertainty about which medicines and interventions work best and which represent best value for money for the NHS and PSS, and the wider public sector
Technology appraisals Guidance on the use of new and existing medicines, treatments and procedures within the NHS Two types of appraisals: o Single Technology Appraisal (STA) o Multiple Technology Appraisal (MTA) Recommendations to be implemented within 3 months Mandatory funding direction Not all new technologies get appraised Formal referral by the Secretary of State for Health (Department of Health) to NICE required
Clinical guidelines - 2001 Broad guidance covering all or specific aspects of the management of a particular condition (the pathway) Incorporates technology appraisals, interventional procedures and other related NICE guidance where appropriate Recommendations advisory only (but can be used to develop standards to assess clinical practice)
National Institute for Health and Clinical Excellence (NICE) - 2005 Public Health Guidance: Recommendations for populations and individuals on activities, policies and strategies that can help prevent disease or improve health. Focus on: a topic (such as smoking), a population (such as schoolchildren) or setting (such as the workplace). Makes recommendation across the public sector (such as education and transport) Local government has a key role in implementation since government reforms to the public health system in England
NICE s remit has expanded Public health Quality standards Medical devices Interventional procedures Quality and outcomes framework (QOF) NHS Evidence accreditation Clinical guidelines Diagnostics Technologies
National Institute for Health and Care Excellence (NICE) 2013 Became a Non Departmental Public Body from 1 April 2013 (no longer a Special Health Authority) NICE will be enshrined in legislation Greater independence from government Board (& Chair) appointed by Secretary of State for Health Remit expanded beyond the NHS to cover social care
Guidance and Standards Public Involvement Programme (H & SC) R&D (part of CHTE) Evidence Search Implementation (H & SC)
The need for NICE 2002-2010: unprecedented 50% increase in funding in real terms: over 100b additional investment NICE needed to ensure additional money is spent wisely with real improvement in outcomes and reduced variation NICE needed to ensure more success in implementing public health measures in order to moderate future healthcare costs 2011-14: 0% (negative) real growth freeze in salaries and capital investment expected efficiency savings and increased productivity NICE needed to identify and stop wasteful activities without harming quality or equity Making a case to HM Treasury as to the value of investing additional resources in health
NICE: the organisation Budget: 1999: 10m 2005: 27m 2010: 74m 2011/12: 70m 570 whole time equivalents directly employed in London, Manchester and Liverpool (2011/12) 88% permanent employees ~2,000 experts physicians, nurses, health economists, clinical epidemiologists, statisticians, lay people- across the UK Copyright 2012-2013 NICE
Core principles of NICE Procedural fairness, methodological rigour and stakeholder buy-in: Transparency: methods, evidence base and decisions are public Independence: insulation from lobbyists and vested interests Inclusiveness: meaningful consultation and broad committee membership Scientific basis: peer review and methods development Timeliness: to meet the needs of decision makers Contestability: appeal mechanisms Conflicts of interest: clear policy for managing vested interests and bias
Assessment and Appraisal ASSESSMENT APPRAISAL Published evidence HEALTHCARE PROFESSIONAL GROUPS PATIENTS AND SERVICE USERS identification, critical appraisal and synthesis of clinical and economic evidence Unpublished evidence; expert input; industry submissions University group or professional association/royal College ACADEMIA POLICY MAKING: evidence, values, UK reality INDUSTRY Standing (or ad hoc) independent advisory committee/expert group NHS; PUBLIC SECTOR
Role of cost effectiveness in NICE guidance Those developing clinical guidelines, technology appraisals or public health guidance must take into account the relative costs and benefits of interventions (their cost effectiveness ) when deciding whether or not to recommend them. (Principle 2, SVJ, NICE 2008) BUT Decisions about whether to recommend interventions should not be based on evidence of their relative costs and benefits alone. NICE must consider other factors when developing its guidance, including the need to distribute health resources in the fairest way within society as a whole. (Principle 3) See: http://www.nice.org.uk/media/c18/30/svj2publication2008.pdf
NICE s cost-effectiveness threshold ( 20,000 to 30,000 per QALY) 1 x Probability of rejection 0 Rituximab for follicular lymphoma x x Trastuzumab for early stage HER- 2 positive breast cancer Imatinib for chronic myeloid leukaemia (blast phase) 10 20 30 40 50 Cost per QALY ( 000)
Factors involved in NICE decision making Costeffectiveness Cost- Effectiveness Extent Extent of of uncertainty & Irreversibility of of decision Legal Legal and and policy policy constraints Making Judgements NICE NICE DECISIONS Other Other social social values: ethics, ethics, equity, equity, rights Practicalities rights of of implementation
Difficult decisions
Recommendations in Technology Appraisal Guidance 1 273 Recommendation 1 March 2000 to 31 January 2013 1 to 31 January STA MTA Total 2013 Yes 66 (58%) 234 (64%) 300 (62%) - Optimised 16 (14%) 68 (19%) 84 (18%) - Only in research 3 (3%) 22 (6%) 25 (5%) - No 29 (25%) 43 (11%) 72 (15%) 2 (100%) TOTAL 114 (100%) 367 (100%) 481 (100%) 2 (100%) STA, single technology appraisal; MTA, multiple technology appraisal NB: 6 withdrawn recommendations and 14 non-submission recommendations have been excluded
End of life The following criteria must be met Short life expectancy (normally <24 months) Extension to life (normally >3 months) Licensed or otherwise indicated for small patient populations Robust evidence to support extension of life
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
Value based pricing - 2014 We will pay drug companies according to the value of new medicines The Coalition: our programme for government, July 2010 the Government would set a range of thresholds or maximum prices reflecting the different values that medicines offer Price premium for disease severity, therapeutic innovation and wider societal benefits Consultation document on VBP, Dec 2010
Social Care challenges for NICE Less developed evidence base and methodologies Not only about health related quality of life Consideration of function and capability as outcomes Private sector delivery as well as the public sector Costs to individuals are important to consider No ICER thresholds for function and capability
Thank you Dr Bhash Naidoo bhash.naidoo@nice.org.uk