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  • l The National Institute for Health and Clinical Excellence(NICE) was established to provide national guidance on thepromotion of good health and the prevention of ill health. NICEguidance is integral to a standards-based healthcare system.

    l NICE issues four types of guidance: technology appraisals,clinical guidelines, public health guidance and interventionalprocedures.

    l Implementation of NICE guidance helps to ensure consistentimprovements in peoples health and equal access to healthcare;however, there are many known challenges to implementing NICEguidance.

    l Key elements to successful implementation are: board supportand clear leadership, provision of a dedicated resource (a NICEmanager), support from a multidisciplinary team, a systematicapproach to financial planning and implementing guidance,and a process to evaluate uptake and feedback.

    l NICE has set up a programme to help support implementation of itsguidance and many practical resources are now available on itswebsite.

    l General implementation tools include a guide to helporganisations implement its guidance, advice on how to changepractice and how to overcome barriers, as well as a forward planner.

    l Guidance-specific implementation tools include slide sets, auditsupport tools, costing tools, implementation advice andcommissioning guides.

    l Other useful resources available on the NICE website are the sharedlearning database with examples of local implementation projectsand the evaluation and review of NICE implementation andevidence (ERNIE) database.

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    What is...? series New title The NHS and HTA

    For further titles in the series, visit:www.whatisseries.co.uk

    Norman Evans BPharmMRPharmS Consultant inPharmaceutical PublicHealth,WandsworthTeaching Primary CareTrust, LondonSalman Rawaf MD PhDFRCP FFPHM Professor andDirector of WHOCollaborating Centre,Department of PrimaryCare and SocialMedicine, ImperialCollege, London

    ImplementingNICE guidance

    Supported by sanofi-aventis

    Date of preparation: April 2009 NPR09/1263

  • IntroductionThe National Institute for Health andClinical Excellence (NICE) was set up as aspecial health authority in April 1999. It wasestablished to provide national guidance onthe promotion of good health and theprevention of ill health in a robust andreliable way. It has grown considerably sinceits establishment and is now the primarysource of clinical standards based on clinicaland cost-effectiveness in England, Wales andNorthern Ireland.

    NICE guidance and clinical guidelines areintegral to a standards-based healthcaresystem. They have a key role in supportingimprovements in service quality. Theperformance of healthcare organisations isbased not just on whether they achievenational targets but, increasingly, on whetherthey are delivering high quality standardsacross a wide range of areas, including NICEguidance. The Care Quality Commission(formerly, Healthcare Commission), in itsannual review of NHS trusts in England,assesses compliance with NICE technologyappraisals and guidance.1,2

    NICE guidance NICE issues four types of guidance.3

    1. Technology appraisalsTechnology appraisals provide guidance onthe use of new and existing technologiesincluding drugs, medical devices andprocedures. They consider the clinical andcost-effectiveness of the technologies.

    The NHS in England and Wales is legallyobliged to provide funding for recommendedtechnology appraisals, usually within threemonths unless advised by NICE that a longerperiod of implementation may be necessary.NHS bodies are responsible for takingwhatever steps are necessary to promote theuptake of recommendations.4

    2. Clinical guidelinesClinical guidelines recommend appropriate

    care and treatment of people with specificdiseases and conditions. They are based onthe best evidence available, taking account ofclinical and cost-effectiveness.

    3. Public health guidanceThe NICE Centre for Public Health Excellencedevelops guidance on the promotion of goodhealth and the prevention of ill health forthose working in the NHS, local authorities,the wider public and voluntary sector. Thereare two types of public health guidance.l Interventional guidance provides

    recommendations on activities providedby organisations to help to promote ormaintain healthy lifestyles; for example,exercise promotion.

    l Programme guidance deals with broaderactivities for the promotion of goodhealth and prevention of ill health; forexample, mental health promotion orstrategies to give up smoking.

    4. Interventional proceduresNICE makes recommendations as to whethera procedure used for diagnosis or treatment issafe enough and works well enough to beused routinely. An interventional procedure isa procedure for diagnosis or treatment thatinvolves making an incision to gain access tothe inside of a patients body or usingelectromagnetic radiation. An example iselectrosurgery (diathermy and coblation) fortonsillectomy, where NICE cautions againstexcessive use of diathermy and highlights theimportance of appropriate training forclinicians and audit of the techniques.5

    NICE guidance is not applicable to allcountries in the UK. The applicability isshown in Table 1.6

    Implementation strategyImplementation of NICE guidance helps toensure consistent improvements in peopleshealth and equal access to healthcare. PuttingNICE guidance into practice benefitseveryone patients, NHS organisations,

    Implementing NICE guidance

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    ImplementingNICE guidance

    Date of preparation: April 2009 NPR09/1263

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    Implementing NICE guidance

    healthcare professionals, public healthpractitioners, policy makers and localauthorities.

    Implementing NICE guidance is aconsiderable challenge. In 2005, the AuditCommission found that only 25% of NHSbodies could verify that NICE technologyappraisals had been implemented withinthree months of publication. The rate ofimplementation of clinical guidelines waseven lower.7

    The implementation of NICE guidance isassociated with many known challenges,including the sheer volume of publishedguidelines, competing priorities, a lack ofresources and a lack of organisational support.Action to support implementation should notfall on any single body, but a broadpartnership needs to be established to sharethe workload. There is no ideal strategy ofintervention that will guarantee effectiveimplementation of all guidance. NICErecognises that implementation is an areawhere the NHS requires a range of supportmechanisms and the organisation hasconsulted widely on how best to achieve this.Implementation appears to be moresuccessful when clear integratedarrangements spanning both primary andsecondary care are developed.

    The reformed Pharmaceutical PriceRegulation Scheme will bring NICE guidanceand NHS policy closer together throughincentive schemes aligning the Quality andOutcomes Framework for general practicewith NICE guidance and Payment by Results.8

    To implement NICE guidance, local healtheconomies need to work together to:

    l Plan in advance for the issue of NICEguidance

    l Ensure that funding and other resourcesare available when needed

    l Develop coherent arrangements forimplementation involving all key playersin the local health economy, coveringresources, training and any infrastructurerequirements

    l Take steps to disseminate and promoteguidance to clinicians

    l Assess the uptake of guidance locally, andidentify and try to overcome any barriersto implementation

    l Take steps to let patients know that theguidance is being implemented.9

    Top-level commitment towards evidence-based practice is at the heart of NICEguidance. Clear leadership helps to promote aculture of improvement in health andhealthcare. Ultimate responsibility forimplementation rests with the chief executivebut is usually devolved to other seniormembers such as the director of public health or medical director. For example,the different guidelines issued by NICE onsmoking10 are fully taken into account bydirectors of public health in the developmentof their local smoking cessation services.

    The board should receive regular reportson implementation, highlighting areas ofnon-compliance.

    Principles ofimplementationSix key elements to successfulimplementation are:

    Date of preparation: April 2009 NPR09/1263

    Country Technology Clinical Interventional Public health appraisals guidelines procedures guidance

    England Yes Yes Yes Yes

    Wales Yes Yes Yes No

    Scotland Yes* No Yes No

    Northern Ireland Yes** Yes Yes No

    * With advice from NHS Quality Improvement, Scotland

    ** With advice from the Department of Health, Social Services and Public Safety, Northern Ireland

    Table 1. Applicability of NICE guidance in the UK6

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    Implementing NICE guidance

    Date of preparation: April 2009 NPR09/1263

    l Board support and clear leadershipl The provision of a dedicated resource (a

    NICE manager)l Support from a multidisciplinary teaml A systematic approach to financial

    planningl A systematic approach to implementing

    guidancel A process to evaluate uptake and

    feedback (audit).9

    The NICE managerA NICE manager co-ordinates theimplementation of NICE guidance andoversees the day-to-day aspects ofimplementation. The work should include:l Horizon scanning and forward planningl Disseminating guidance to relevant

    groupsl Arranging educational eventsl Co-ordinating financial plansl Ensuring effective monitoring and

    feedbackl Producing regular reports for the board.9

    The multidisciplinary teamThe most effective implementation modelshave strong multidisciplinary teams reportingto the board. Often the team will have otherfunctions within the organisation such asclinical governance or audit. The team shouldmeet regularly to consider all new guidanceand identify relevant leads and networks tosupport the implementation of specificguidance. The multidisciplinary team shouldwork to:l Reduce duplication of work across the

    health economyl Ensure compliance with core and

    developmental standards1

    l Ensure effective audit and monitoringarrangements

    l Ensure effective forward planningl Ensure appropriate financial

    arrangements are in place.9

    NICE recommends that multidisciplinaryteams should have no more than 15 membersand include input from:l Nursingl Clinical medicinel Pharmacy/medicines managementl Financel Public health

    l Clinical governance and auditl Commissioning and general

    managementl Patients and the publicl Co-opted members with specific skills as

    necessary.9

    The team should consider ways to co-ordinate work across the healthcarecommunity, particularly where guidancecrosses the primary/secondary care interface.Collaboration reduces duplication andensures a standardised approach to guidance.It also helps to ensure seamless care across the interface. One of the philosophies thatshould be fully understood and adopted bythe team is that any new technology is cost-effective and will reduce the unit cost ofintervention in the long term. Hence, most, ifnot all, initial investments are cost-effective inthe long term.

    A systematic approach to financialplanningClear financial planning is vital to thesuccessful implementation of NICE guidance.The Audit Commissions report on thefinancial implications of NICE guidancerecommends that organisations should aim todevelop a sustainable approach to financialplanning and outlines steps that should betaken when implementing the guidance.7 Afinancial plan should be developed detailingall the activities for the forthcoming financialyear. It should be based on the cost estimatesfor implementing technology appraisals andthe future resource requirements for clinicalguidelines and public health guidance. Theongoing costs of implementing pastguidelines should also be included in the plan(see What is world class commissioning?11 formore information). Comparative costing is anexcellent tool to understand the impact of anew innovation on the health service, thepatient and their family.

    NICE guidance now includes costingtemplates, which can be used to predict costsand savings. The financial impact associatedwith the implementation of a NICEtechnology appraisal can be estimated at localand at national level, and an example (TA 101:Docetaxel for the treatment of hormone-refractory metastatic prostate cancer) is shownin Box 1.12,13

  • Evaluating uptake and feedbackNHS organisations are required by the CareQuality Commission to publish an annualdeclaration on whether they meet corestandards and progress towardsdevelopmental standards. The relevantdomains for NICE are core standard C5 anddevelopmental standard D2.2,9

    Box 2 summarises the process for themanagement of NICE guidanceimplementation by a primary care trust.14

    Practical steps forimplementationNICE has set up a programme to help supportimplementation of its guidance. A wide rangeof practical resources is now available on itswebsite, including financial planning,implementation strategies andcommissioning.15 Some of the advice andsupport is generic and will apply to differenttypes of guidance, while other tools are more specific.

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    Implementing NICE guidance

    Date of preparation: April 2009 NPR09/1263

    Box 1. Implementation of NICE technology appraisal 10112,13

    Case study: NICE technology appraisal (TA) 101 docetaxel for the treatment of hormone-refractory prostate cancer

    Docetaxel (Taxotere, sanofi-aventis) has been recommended as a possible treatment for men with hormone-refractory metastatic

    prostate cancer who are well enough to look after themselves with only occasional assistance. Treatment should be stopped at

    the end of a planned course of up to ten cycles of doctaxel, or earlier if serious side-effects occur or the disease worsens.

    NHS bodies should make funding available within three months. A group should be established as outlined in Box 2, linking in

    with the local cancer network to facilitate implementation of treatment.

    A costing report and template are available to help health communities assess the likely impact of the principal recommendations

    on their local population. The report estimates both national and local impact, based on assumptions about current practice and

    how this might change following implementation. Using a stepwise approach it is possible to arrive at a cost for the local

    population.

    Costing template for docetaxel (TA 101)

    National costing summary: Local costing summary: implementation in England implementation in South-West London*

    Population (males) 24,220,813 700,561

    Estimated new cases of prostate cancer 26,791 618

    Estimated cases of hormone-refractory 10,448 241metastatic prostate cancer requiring treatment

    Estimated current cost of 30,321,054 701,297annual treatment

    Proposed annual cost after 50,295,000 1,160,081implementation of TA 101

    Cost impact of TA 101 19,974,096 458,784

    * Population from all primary care trusts in South West London Cancer Network

    Based on the assumption that: 40% of patients receive prednisolone alone (annual cost: 29/patient); before TA 101, 60% of patients receive mitoxantrone plusprednisolone (annual cost: 4,817/patient); after TA 101, 45% of patients receive docetaxel plus prednisolone (annual cost: 9,065/patient) and 15% receivemitoxantrone plus prednisolone

    NB Costs do not include any hospital-negotiated discounts or other health benefits

  • 6

    General implementation toolsNICE has made available a guide to helporganisations implement its guidance andother national policies as well as to meet the expectations of the Care QualityCommission. It has also published advice on how to change practice, offering practicaladvice to managers and clinicians on how toovercome barriers.16

    NICE has also developed a forwardplanner, which summarises published andforthcoming guidance to help NHS

    organisations plan ahead.17 It explains which sectors are likely to be affected andwhether the guidance will have an impacton work commissioned by the NHS underPayment by Results. It also includesindicative costs for England for guidanceimplementation.

    Guidance-specific implementationtoolsThe following support tools, which relate tospecific guidance, have been developed.9

    Implementing NICE guidance

    Date of preparation: April 2009 NPR09/1263

    Box 2. Process for the management of NICE implementation14

    Quality and clinical governance manager:

    l Receives monthly e-notification from NICE

    l Uploads information onto PCT database

    l Emails NICE database and forward planner to NICE working group, directors and associate

    directors

    l Receives reports from commissioned services on NICE implementation and enters onto

    database

    l Supports NICE working group

    l Prepares reports for risk and clinical governance committee.

    NICE working group:

    l Decides relevance of guidance for PCT

    l Obtains financial appraisal of potential impact of implementation and impact on budgets

    from finance directorate

    l Identifies appropriate lead for each piece of relevant guidance

    l Reports monthly to the risk and clinical governance committee on compliance, exceptions

    and action plans.

    NICE lead:

    l Establishes baseline review of guidance and returns it to quality and clinical governance

    manager

    l Develops action plan if applicable

    l Forms implementation group/ works with LITs

    l Provides exception reports

    l Provides progress reports to NICE working group.

    Risk and clinical governance committee:

    l Oversees the delivery of NICE guidance

    l Receives monthly reports from NICE working group

    l Reports to the board.

    Adapted from Surrey PCTs Policy And Framework For The Implementation of NICE Guidance As A Commissioner OfServicePCT: primary care trust; LITs: local implementation teams

  • 7

    Slide sets

    Slide sets are PowerPoint presentations to support implementation and increaseearly awareness of guidance. They highlightkey messages from the guidance and make suggestions for implementation. The slides can be edited for local use ifrequired.

    Audit support tools

    These consist of audit criteria and datacollection tools to facilitate baselineassessment and to monitor subsequentactivity.

    Costing tools

    These help to assess the financial impact ofimplementing the guidance. They comprise anational costing report and a costing templateto identify local costs and savings (see Box 1for an example).12,13

    Implementation advice

    This signposts support available nationally,highlights relevant resources and offersexamples of good practice. Advice is offered for adaptation at local level ofselected public health and clinicalguidelines.

    Commissioning guides

    These provide support for localcommissioning, including needs assessmentand opportunities for disinvestment.15

    Evaluating the uptake andimpact of NICE guidanceIt is important to know whether guidance isbeing implemented effectively and asexpected. It is necessary to establish howlocal outcomes compare with nationaltrends. NICE has two helpful resources on itswebsite. The shared learning databasecontains real life examples of localimplementation projects, while theevaluation and review of NICEimplementation and evidence (ERNIE) database18 is a source ofinformation on the implementation anduptake of guidance and provides referencesto external reviews, such as those by the CareQuality Commission.

    Conclusion The implementation of NICE guidancepresents formidable challenges to healthcareorganisations. Proper planning is essential forsuccessful adaptation and NICE has nowprovided many tools to help with theimplementation of its guidance.

    In future, it is likely that NICE guidanceand NHS policy will be brought closertogether, possibly aligning with the Qualityand Outcomes Framework of primary carecontracts. It is also likely that the assessmentof NICE compliance will be carried out by theCare Quality Commission.

    References1. Department of Health. Standards for Better Health.www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_4086665 (last accessed 4 March 2009)2. Healthcare Commission and National Institute for Health andClinical Excellence. The role of NICE guidance in the HealthcareCommissions assessment activities.www.cqc.org.uk/_db/_documents/The_role_of_NICE_guidance_in_the_Healthcare_Commissions_assessment_activities_July_2008.pdf (last accessed 28 April 2009)3. National Institute for Health and Clinical Excellence. A guide toNICE. London: NICE, 2005.4. National Institute for Health and Clinical Excellence. The legalimplications of NICE guidance. www.nice.org.uk/niceMedia/pdf/Legal_context_nice_guidance.pdf (last accessed 4 March 2009)5. National Institute for Health and Clinical Excellence.Electrosurgery (diathermy and coblation) for tonsillectomy.www.nice.org.uk/nicemedia/pdf/ip/IPG150guidance.pdf (lastaccessed 30 March 2009)6. Coppell A. Bridging the Gap. Pharm Manage 2008; 2244:: 37.7. Audit Commission. Managing the financial implications of NICEguidance. www.audit-commission.gov.uk/reports/NATIONAL-REPORT.asp?CategoryID=&ProdID=CC53DDFE-42C8-49c7-BB53-9F6485262718 (last accessed 4 March 2009)8. Department of Health. The Pharmaceutical Price RegulationScheme.www.dh.gov.uk/en/Publicationsandstatistics/Publications/DH_091825 (last accessed 30 March 2009)9. National Institute for Health and Clinical Excellence. How toput NICE guidance into practice. A guide to implementation fororganisations.www.nice.org.uk/media/848/D0/HowtoputNICEguidanceintopracticeFINAL.pdf (last accessed 4 March 2009)10. www.nice.org.uk/search/guidancesearchresults.jsp?keywords=Smoking&searchType=guidance (last accessed 28 April 2009)11. Sobanja M. What is world class commissioning? London:Hayward Medical Communications, 2009.12. National Institute for Health and Clinical Excellence. Docetaxelfor the treatment of hormone-refractory metastatic prostate cancer.www.nice.org.uk/guidance/index.jsp?action=download&o=33348(last accessed 11 March 2009)13. National Institute for Health and Clinical Excellence. Costingtemplate and costing report. Docetaxel for the treatment ofhormone-refractory metastatic prostate cancer.www.nice.org.uk/guidance/index.jsp?action=download&o=33354(last accessed 11 March 2009)14. Policy And Framework For The Implementation of NICEGuidance As A Commissioner Of Service.www.surreyhealth.nhs.uk/doc.aspx?id_Resource=610 (last accessed4 March 2009)15. National Institute for Health and Clinical Excellence.Commissioning guides - supporting clinical service redesign.www.nice.org.uk/usingguidance/commissioningguides/ (lastaccessed 30 March 2009)16. National Institute for Health and Clinical Excellence. How tochange practice: understand, identify and overcome barriers to change.www.nice.org.uk/media/D33/8D/Howtochangepractice1.pdf (lastaccessed 4 March 2009)17. www.nice.org.uk/usingguidance/implementationtools/forwardplanner/forward_planner.jsp (last accessed 4 March 2009)18. www.nice.org.uk/usingguidance/evaluationandreviewofniceimplementationevidenceernie/evaluation_and_review_of_nice_implementation_evidence_ernie.jsp (last accessed 4 March 2009)

    Implementing NICE guidance

    Date of preparation: April 2009 NPR09/1263

  • Supported by sanofi-aventis

    Implementing NICE guidance

    Published by Hayward MedicalCommunications, a division ofHayward Group Ltd.

    Copyright 2009 Hayward Group Ltd.All rights reserved.

    8

    What is...? series

    This publication, along withthe others in the series, isavailable on the internet atwww.whatisseries.co.ukThe data, opinions and statementsappearing in the article(s) hereinare those of the contributor(s)concerned. Accordingly, thesponsor and publisher, and theirrespective employees, officersand agents, accept no liabilityfor the consequences of any suchinaccurate or misleading data,opinion or statement.

    Date of preparation: April 2009 NPR09/1263