MSc Clinical Research NICE – the UK adviser

The National Institute for Health and Clinical Excellence (NICE) is the independent organisation responsible for providing national guidance on the promotion of good health and the prevention and treatment of ill health. NICE was set up in 1999 to ensure that everyone, no matter where they lived, had access to quality healthcare, thus bringing an end to the so-called ‘postcode lottery.’ What is NICE?

Our remit is expanding Publications Technologies Clinical guidelines Interventional procedures Public health Quality and outcomes framework (QOF) NHS Evidence accreditation Quality standards Diagnostics Medical devices

What is NICE guidance? NICE produces guidance in these areas: Public health – guidance on the promotion of good health and the prevention of ill health for those working in the NHS, local authorities and the wider public and voluntary sector. Health technologies – guidance on the use of new and existing medicines, treatments, procedures and medical technologies and diagnostics within the NHS. Clinical practice – guidance on the appropriate treatment and care of people with specific diseases and conditions within the NHS. NICE quality standards: concise statements that act as markers of high-quality, cost-effective patient care for different diseases and conditions.

Products Advice on new and existing treatments Clinical guidelines, QOF and quality standards Health promotion and disease prevention Comprehensiv e evidence service NICE and NHS Evidence Evidence – guidance – shared learning

Over 700,000 visitors a month – an online resource for clinicians research bodies charities etc

NHS Evidence - A web-based service that helps staff keep up to date with the latest information about health and social care -already attracting 700,000 visits and 1 million searches a month -free to use service, free from ‘noise’ and providing access to credible, relevant information -NHS Evidence Accreditation Scheme identifies high quality sources

Nice doesn’t make the decisions: our advisory boards do NICE Primary care indicators Public health Clinical Guidelines Interventional procedures Drug appraisals Diagnostics Quality standards Medical devices

NICE guidance is continually being refined Evidence review Appraisal Consultation Guidance Update decision

Appraising value Scientific and social value judgements Stakeholder perspectives Outcomes for patients Impact on health system resources

Quality Adjusted Life Years When we are treated for a serious condition, most of us want to improve our health-related quality of life and if the condition is life- threatening, we want to live as long as possible QALYs use a scale to measure quality of life in which 0 is worst possible health and 1 is best possible health To derive a cost per QALY for a new treatment, you need to know the QALYs generated for both and what each costs NICE uses the average additional QALYs offered by the new treatment for the whole treatment population or a defined group within it

Calculating cost per QALY Current standard care QoL New treatment QoL Comparing current and new treatments 1 x 0.4 = 0.4 QALYs 1.25 x 0.6 = 0.75 QALYs New treatment gain = 0.35 extra QALYs ( ) Calculating the QALY Old treatment cost = £3,000 New treatment cost = £10,000 Cost difference (£7,000) is divided by the QALYs gained (0.35) = £20,000 Calculating the cost per QALY

Establishing value: cost effectiveness Probability of rejection Cost per QALY (£’000) x x Rituximab for follicular lymphoma Imatinib for chronic myeloid leukaemia (blast phase) x Trastuzumab for early stage HER-2 positive breast cancer

NICE technology appraisals DecisionRecommendations Yes245(67%) Optimised61(16%) e.g herceptin “in some cases only” Only in research22(6%) No40(11%) Breakdown of all decisions contained in Technology Appraisals 1–190 (January 2000 to June 2010) Note: 6 withdrawn recommendations and 5 non-submissions are not included 83% of our recommendations are positive

Contribution: A New Government Knowledge for NHS and social care staff, patients and the public Support the effective use of NHS and social care resources Help for companies to do business in the NHS Standards for NHS and social care Better outcomes in health and social care

What are the benefits of putting NICE guidance into practice? To promote good health and provide the best care for patients in line with best available evidence of clinical and cost effectiveness To help clinicians, healthcare and public health professionals meet the standards set by their professional and regulatory bodies To meet the statutory directions to the NHS from the Department of Health (e.g. 3 month funding direction) To get the best value for money

NICE provides general support tools such as the ‘How to Guides’ and a map of NICE guidance available against national indicators and targets NICE encourages shared learning from practice and provide support at local level through our field team NICE provides topic specific support tools such as slide sets, costing tools, clinical audit support, educational tools and commissioning guides NICE provides online educational modules for healthcare professionals NICE actively work in partnership with other organisations to support NICE guidanc e How can NICE help?

Topic selection

Centre for Clinical Practice The Centre for Clinical Practice develops clinical guidelines on the treatment and care of people with specific diseases and conditions within the NHS.

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 NICE receives approximately 10 topics/year from DH +updates. Clinical guidelines - what are they?

Why develop guidelines? Remove inappropriate variations in clinical practice Reduce persisting use of ineffective treatments Need to apply established treatments of proven clinical and cost effectiveness Reduce failure to adopt clinically and cost effective new treatments “Post-code” prescribing (particularly in the UK) Impossible for clinicians to read and appraise all relevant evidence themselves.

Guideline development Disease or condition based Scoping Development Validation Publication and dissemination Stakeholder comments Draft scope GDG develops guideline Consultation on draft guideline Final scope Revise guideline after comments Pre-publication check Prepare and publish guideline Final guideline published Stakeholder comments 4 months months 7 months

What are NICE Quality Standards? A set of 5-10 statements that are: markers of high-quality, cost effective clinical care for a particular condition derived from the best available evidence produced collaboratively with the NHS and social care Quality measures - high level quality indicators Audience descriptors - A description of what the quality standards mean for a variety of audiences Favoured by incoming UK government

The Centre for Health Technology Evaluation at NICE develops guidance on the use of new and existing medicines, treatments, procedures and medical technologies and diagnostics within the NHS. Centre for Health Technology Evaluation (CHTE)

Provide guidance on selected health technologies - Pharmaceuticals - Medical devices Considers the evidence on health benefits and costs - Impact on quality of life - Effects on mortality - Associated costs, particularly on costs to the NHS and personal social services Department of Health direction to NHS to make funding and resources available within 3 months Technology appraisals

NICE and 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.”

What does this mean for NICE? Details to be consulted upon and confirmed in the Health Bill but... NICE’s technology appraisals programme is not under threat: “We are not neutralising NICE. On the contrary, we will focus NICE on what its real job always was and should be, which is to provide independent advice to the NHS about the relative clinical and cost- effectiveness of treatments so as to achieve the best outcomes.” Andrew Lansley, Secretary of State for Health House of Commons, 2 November 2010

NICE and Value Based Pricing NICE will continue to undertake independent and objective assessments of the benefits of new drugs. It welcomes the opportunity to review and, where appropriate, extend the perspective we use to undertake our assessments NICE also support the general principle that the NHS should pay a price which reflects the additional therapeutic benefit of new drugs. NICE shares the Government’s ambition to ensure that the option exists for all new licensed drugs to be offered to those patients who can benefit from them, provided the price is a fair reflection of their value.

Quality and Outcomes Framework (QOF) The QOF contains groups of indicators against which practices (e.g. blood pressure monitoring)score points and receive financial rewards – according to how well they perform. NICE is now responsible for producing an annual “menu” of new, evidence-based clinical and cost-effective indicators. It is a more independent and transparent process for reviewing and developing indicators The first QOF indicators reviewed or developed by the full NICE process will likely be available in

Interventional Procedures Guidance on whether interventional procedures used for diagnosis or treatment are safe enough and work well enough for routine use in the NHS. Guidance covers; Procedures used for diagnosis or for treatment that involve: Making a cut or hole to gain access to the inside of a patient’s body, or Gaining access to a body cavity without cutting into the body, or Using electromagnetic radiation (which includes X- rays, lasers, gamma-rays and ultraviolet light).

Evaluation Pathway Programme for Medical Technologies The Evaluation Pathway Programme focuses specifically on the evaluation of innovative medical technologies (including devices and diagnostics). Designed to help the NHS adopt effective and resource-releasing medical devices and diagnostics more rapidly and consistently. First medical technologies guidance published in December 2010

Centre for Public Health Excellence (CPHE) The Centre for Public Health Excellence at NICE develops guidance on the promotion of good health and the prevention of ill health for those working in the NHS, local authorities and the wider public and voluntary sector

Key topics in published and planned public health guidance Physical activity Smoking and tobacco Sexual health Alcohol Drugs Maternal and child health Health and work Older people’s health and wellbeing Cancer Immunisation Accidental injury. Obesity Mental well being Cardio vascular disease. Diabetes Communicable disease

Audiences for public health guidance The NHS Local government The workplace Education The utilities Private and voluntary sectors DH and other government departments The public National policy makers

To develop fair, transparent, accountable and effective procedures for involving patients and the public To ensure that patient/public perspectives are represented in NICE processes and products Patient and public involvement programme

R&D at NICE Different to other NHS sectors Research Projects to resolve uncertainties and ‘issues’ Audit ‘Service’ evaluations ‘applied’ research rather than ‘basic’ Development Changes to policy and practice Translation of research findings into practice Identification, prioritisation and communication of uncertainties

Works with decision makers in low and middle income countries to help strengthen their processes and methods for evidence-informed decision-making Focuses on institutions, longer-term capacity building and good governance Offers collaborative problem-solving and hands-on support, drawing on personnel and experience from across the UK and abroad, to identify barriers to implementation and ways to adapt products and processes, locally. NICE International

Global demand for NICE’s expertise Includes India (Delhi)

What are the benefits of putting NICE guidance into practice? To promote good health and provide the best care for patients in line with best available evidence of clinical and cost effectiveness To help clinicians, healthcare and public health professionals meet the standards set by their professional and regulatory bodies To meet the statutory directions to the NHS from the Department of Health (eg 3 month funding direction) To get the best value for money

Visit and See for Yourselfwww.nice.org.uk