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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 l.jpg

Using evidence to inform healthcare policy and practice: an overview of NICE

Kalipso Chalkidou, MD, PhD

NICE International

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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

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The NHS in the late 90s… residents are covered

  • No quality standards

  • Lack of guidance for professionals

  • Unexplained (and unpopular) variation

  • Unaffordable new technologies

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1997 - Government white paper residents are covered

  • ‘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.’

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NICE Statutory Instruments – 1999/2005 residents are covered

"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)

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The real challenge residents are covered

HAS, July 2007

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NICE: who we are residents are covered

  • 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

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NHS Evidence residents are covered

NICE structure

Information systems

Topic selection



Developing NICE guidance


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

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Evaluating new treatments to decide coverage in NHS residents are covered

  • 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

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Setting quality standards for treating disease residents are covered

  • 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

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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

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Ensuring safe surgery public health

  • 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

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NICE guidance public health

  • 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

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NICE guidance 2000-2008 public health

Public health

Interventional procedures

Clinical guidelines



Single technology appraisal process

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NICE guidance 2009-2011 public health

Quality standards

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Technology appraisal recommendations public health

84% of our advice recommends use…

342 individual recommendations in 160 technology appraisals

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How we work public health

  • Comprehensive evidence base

  • Expert input

  • Independent advisory committees

  • Genuine consultation

  • Support for implementation

  • Regular review

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Published evidence public health

Review of Evidence

Unpublished evidence???

Academic group: university or professional association

Our Decision Making Process











  • Standing independent advisory committee

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NICE decision cycle public health








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Assessing Cost Effectiveness public health



Probability of rejection


Rituximab for follicular lymphoma

Imatinib for chronic myeloid leukaemia

Trastuzumab for early stage HER-2 positive breast cancer








Cost per QALY (£’000)

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A developmental approach public health

4 parliamentary enquiries: broadly supportive

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House of Commons: London Jan 2008 public health

“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.”

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2000 public health

Perceptions of NICE


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Myths about NICE: public health“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

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Myths about NICE: public health“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?

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Rawlins, Lancet Oncology, 2007 public health

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

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Are we making a difference? public health

  • Routinely collected national data

  • Published research

  • Healthcare Commission reports

  • Patient surveys

  • National audits

  • Informal comments

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National inspection results – technology appraisals public health

Self assessment results – NHS Trusts

Source: The Healthcare Commission: Annual Health Check

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Anti-hypertensives public health

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Case study: saving money through generic substitution… public health

  • 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)

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Statin uptake public health

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Case study: …to invest in primary prevention public health

  • 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

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In the press public health

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On our 5 public healthth 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

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On our 10 public healthth 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

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Global influence? public health

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

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In the press public health

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.

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Burden of chronic disease and ageing populations public health

Not so different after all…


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

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Vol 372, Aug 23, 2008 countries alike….

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In the press countries alike….

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

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The demand side is weak countries alike….

  • 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

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[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.

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“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

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Evidence alone is not enough… 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.”

  • 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

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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.”

Thank you kalipso chalkidou@nice org uk l.jpg
Thank you!