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Using evidence to inform healthcare policy and practice: an overview of NICE. Kalipso Chalkidou, MD, PhD NICE International . UK NHS is free, largely, at the point of delivery and all residents are covered First (1948) and argest single payer publicly funded system in the world
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Using evidence to inform healthcare policy and practice: an overview of NICE Kalipso Chalkidou, MD, PhD NICE International
UK NHS is free, largely, at the point of delivery and all residents are covered First (1948) and argest single payer publicly funded system in the world Annual budget of £100 billion Not perfect; universal coverage with fixed resources involves compromises…but it provides a good level of cover Private insurance in the UK approx. 10% and shrinking – privately insured continue to contribute to NHS through general taxation
The NHS in the late 90s… • No quality standards • Lack of guidance for professionals • Unexplained (and unpopular) variation • Unaffordable new technologies
1997 - Government white paper • ‘A new National Institute for Clinical Excellence will be established to give new coherence and prominence to information about clinical and cost-effectiveness.’ • ‘…membership will be drawn from the health professions, the NHS, academics, health economists and patient interests.’ • ‘… need to have access to an appropriate range of skills, including economic and managerial expertise as well as specialist input on specific issues.’
NICE Statutory Instruments – 1999/2005 "Subject to and in accordance with such directions as the Secretary of State may give, the Institute shall perform: such functions in connection with the promotion of clinical excellence, and the effective use of available resources in the health service" Article 3 (functions of the Institute) of the principal Order (March 2005)
The real challenge HAS, July 2007
NICE: who we are • National Institute for Health and Clinical Excellence - established 1 April 1999 • Special Health Authority – part of NHS • Board appointed by Secretary of State for Health • Budget of £60m pa; to reach £100m over next 3 years • ~300 staff directly employed in London and Manchester • ~3,000 experts –physicians, nurses, health economists, clinical epidemiologists, statisticians, lay people- across the UK engaged in NICE guidance development during the year
NHS Evidence NICE structure Information systems Topic selection Communications Implementation Developing NICE guidance R&D Patient and public involvement Centre for Public Health Excellence - public health interventions - public health programmes • Centre for • Health Technology Evaluation • - technology appraisals • interventional procedures • diagnostics • devices Centre for Clinical Practice - clinical guidelines
Evaluating new treatments to decide coverage in NHS • Rational drug use: advice on the optimal use of new medical technologies: • Drugs • Medical devices • Surgical procedures • Negative list of cost-ineffective drugs and devices • Completed around 160 topics - over 400 individual products • NICE-approved drugs free of charge for 85% of population; remaining 15% pay a £7 flat fee per prescription
Setting quality standards for treating disease • Clinical guidelines • Cover whole diseases and conditions – not just individual drugs and interventions • Published around 80 topics – including diabetes, heart disease, depression, infertility and head injuries. Another 40 in development • Plan to cover the major causes of illness in the UK
Helping people stay healthy – balance new technologies and public health • Prevention, aiming to improve health and reduce health inequalities • Exercise, smoking cessation, nutrition, sexual health and substance misuse • Transport and the built environment • Advice to the NHS, local and central government and businesses
Ensuring safe surgery • We review new interventional procedures and tell the NHS about their usefulness and safety • Laser surgery for correcting sight is an example • We can recommend: • Use in clinical studies only • Special measures for gaining patient consent • Safe for general use
NICE guidance • Technology appraisals Drugs, medical devices, diagnostics • Clinical guidelines Care pathways for whole diseases and conditions • Public health guidelines Disease prevention • Interventional procedures Regulating new surgical techniques • Clinical quality standards and the Quality and Outcomes Framework Sentinel indicators of good practice: regulation and P4P • Implementation support Costing tools and commissioning guides
NICE guidance 2000-2008 Public health Interventional procedures Clinical guidelines Technology appraisals Single technology appraisal process
NICE guidance 2009-2011 Quality standards
Technology appraisal recommendations 84% of our advice recommends use… 342 individual recommendations in 160 technology appraisals
How we work • Comprehensive evidence base • Expert input • Independent advisory committees • Genuine consultation • Support for implementation • Regular review
Published evidence Review of Evidence Unpublished evidence??? Academic group: university or professional association Our Decision Making Process HEALTHCARE PROFESSIONAL GROUPS PATIENTS AND CONSUMERS DECISION MAKING SOCIAL VALUE JUDGEMENTS NHS; PUBLIC SECTOR ACADEMIA INDUSTRY • Standing independent advisory committee
NICE decision cycle Appraisal Evidence review Consultation Update decision Guidance
Assessing Cost Effectiveness 1 x Probability of rejection x Rituximab for follicular lymphoma Imatinib for chronic myeloid leukaemia Trastuzumab for early stage HER-2 positive breast cancer x 0 50 10 20 30 40 Cost per QALY (£’000)
A developmental approach 4 parliamentary enquiries: broadly supportive
House of Commons: London Jan 2008 “We conclude that NICE does a vital job in difficult circumstances. The development of more and more health technologies and procedures, alongside rising patient expectations and the ageing population, is going to make it even more difficult in the future. Healthcare budgets in England, as in other countries, are limited. Patients cannot expect to receive every possible treatment. NICE requires the backing of the Government. NICE must not be left to fight a lone battle to support cost- and clinical effectiveness in the NHS.”
2000 Perceptions of NICE 2007
Myths about NICE: “NICE is a rationing body” • Over £1b/yr aggregate extra spending across NHS1 • 0.9%increase in national tariff - DRG equivalent2 • 13% of the total (£4.5b) increase in funding attributed to drugs and NICE recommendations3 • 3 month implementation directive for all technologies • Over 8% of NICE budget forimplementation support4 Sources 1: Department of Health 2006/07; 2: DH 2005/06; 3: King’s Fund 2006/07; NICE 2006/07
Myths about NICE:“NICE denies patients beneficial care” • Breakthrough technologies: Trastuzumab for early breast cancer within 2 weeks of EMEA license • net cost: £100m/yr • Me-too technologies: generic statins • net cost: £8m/yr • Branded simvastatin: additional £500m/yr; • Forthcoming court challenge for encouraging switch • Evidence base uncertain: cox-2 inhibitors not recommended for routine use because of CVD risk • Company appeal against decision rejected (2001) • CVEs prevented?
Rawlins, Lancet Oncology, 2007 Myths about NICE: “NICE only cares about costs” • Our legal responsibilities on human rights and discrimination • The innovative nature of the technology and value added compared to alternatives • The implications of our guidance on equity and distributive justice
Are we making a difference? • Routinely collected national data • Published research • Healthcare Commission reports • Patient surveys • National audits • Informal comments
National inspection results – technology appraisals Self assessment results – NHS Trusts Source: The Healthcare Commission: Annual Health Check
Case study: saving money through generic substitution… • Based on extensive evidence of effectiveness and cost-effectiveness, NICE recommends statins “for primary prevention of cardiovascular disease (CVD) for adults who have a 20% or greater 10-year risk of developing CVD”. • NICE recommends that “therapy should usually be initiated with a drug of low acquisition cost”. • Adherence to NICE guidance on generic substitution for statins, PPIs and antihypertensives would save the NHS more than £200 million annually. (National Audit Office – 2007)
Case study: …to invest in primary prevention • Screening: Framingham 1991 10-year risk equations should be used to assess CVD risk with adjustments for ethnicity and family history • Primary prevention: simvastatin 40mg recommended for adults with 20% or greater 10-year risk of developing CVD • Secondary prevention: initiate on simvastatin 40mg - consider increasing to simvastatin 80mg or a drug of similar efficacy and acquisition cost if total cholesterol >4mmol/l or LDL cholesterol >2mmol/l • Audit level of total cholesterol of 5mmol/l should be used to assess progress in populations or groups of people with CVD • Cost: £35m p.a. – up to 15,000 heart attacks prevented
On our 5th birthday… "NICE may prove to be one of Britain's greatest cultural exports, along with Shakespeare, Newtonian Physics, the Beatles, Harry Potter and the Teletubbies" The Triumph of NICE Richard Smith, Editor BMJ July 2004
On our 10th birthday.. When NICE first started to flex its muscles in 1999, the drugs industry would love to have exported it, preferably somewhere like Mars. Ten years later, the influence of NICE, far from being blunted, is beginning to spread. Its methods and organisational model have become something of a beacon to governments wrestling with the issues of efficacy and fairness in healthcare delivery.” NICE goes global Nigel Hawkes BMJ January 2009
Global influence? Less than 3% of the global market 25% of global market uses UK prices in reference pricing NICE website receives 400,000 unique visitors every month -50% from North America Model of comparative effectiveness agency currently discussed in the US
In the press Top health officials in Austria, Brazil, Colombia and Thailand said in interviews that NICE now strongly influences their policies. “All the middle-income countries — in Eastern Europe, Central and South America, the Middle East and all over Asia — are aware of NICE and are thinking about setting up something similar,” said Dr. Andreas Seiter, a senior health specialist at the World Bank.
Burden of chronic disease and ageing populations Not so different after all… Users’ expectations and the promise of universal coverage and a guaranteed package Finite budgets, low % public spending and resulting inequities of access Policy and practice Growth in health technologies – expanding global market
Drug prices: a key determinant of access in rich and poor countries alike….
In the press Andrew Witty [CEO, GSK] has also signalled his willingness to negotiate on price, in a climate where value for money is increasingly discussed and other countries are contemplating setting up a version of Nice
The demand side is weak • Procedural deficiencies: (perceived) limited transparency; accountability and contestability; inclusiveness and consultation; sound methodological basis • Weak evidence base: low generalisability of evidence of comparative value; limited data on epidemiology and current practice • Insufficient capacity: few health economists, SRs… • Limited ownership of decision-making: weak home-grown prioritisation processes; little ability to drive aid investment and technology adoption based on local priorities
[The Bank] has, since 2007, been building up its activities in the less glamorous but equally vital area of “health systems”. This means getting local bureaucracies to recruit the right staff and deliver the right drugs to the right people at the right times, and knocking the heads of aid agencies together to eliminate gaps and overlaps in coverage.
“The UK’s National Institute for Health and Clinical Excellence (NICE) has established guidelines for the management of most clinical diseases and these have been used by many countries to determine how to allocate resources. The challenge is to adapt the NICE guidelines to the situation and medical practice in the country.” July 2008
Evidence alone is not enough… • Evidence needs to be interpreted with, amongst other things, value judgments • While NICE is committed to the production of useful evidence, we seek always to respect our clients’ values, culture and history • Evidence is often generated during process (especially, perhaps, evidence about values) and NICE values open, inclusive and collaborative processes • Evidence generation through innovative frameworks involving policy makers is an integral part of our work
National Indian Commission on Macroeconomics and Health, 2005 “Disease burden estimations…cost-effectiveness studies of interventions…independent evaluations of programme implementation are examples of the kind of work that needs to be undertaken. In the absence of such capacity, current policy-making is ad hoc and driven by individual perceptions.”