Guide To The Technology Appraisal Process - NICE

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NATIONAL INSTITUTE FOR HEALTH AND CAREEXCELLENCEGuide to the processes of technology appraisalApril 2018AcknowledgementsNICE is very grateful to everyone who contributed to the development of this guide(see section 7).ForewordThe National Institute for Health and Care Excellence (NICE) provides guidance tothe NHS in England on the clinical and cost effectiveness of selected new andestablished technologies. NICE carries out appraisals of health technologies at therequest of the Department of Health and Social Care. Guidance produced by NICEon health technologies is also applied selectively in Northern Ireland and Wales.This document is one of a series describing the processes and methods that NICEuses to carry out technology appraisals. It focuses on the technology appraisalprocesses (and provides an overview for organisations invited to contribute to anappraisal).The documents in the series are: Guide to the processes of technology appraisal (this document). Guide to the methods of technology appraisal. Cancer Drugs Fund technology appraisal process and methods (addendum). Guide to the technology appraisal and highly specialised technologies appealprocess.Organisations invited to contribute to NICE technology appraisals (consultees andcommentators) should read this guide with the other documents listed above. Alldocuments are available on the NICE website.Guide to the processes of technology appraisalPage 1 of 104

1 Introduction1.1 This guide describes the processes, including expected timescales, that NICEfollows when carrying out a technology appraisal. The processes are designedto produce robust guidance for the NHS with appropriate contribution fromstakeholders. This guide should be read with NICE’s guide to the methods oftechnology appraisal.1.2 Technology appraisals are developed by the Centre for Health TechnologyEvaluation in NICE.1.3 The National Institute for Health and Care Excellence (Constitution andFunctions) and the Health and Social Care Information Centre (Functions)Regulations 2013 indicate that NICE may make a technology recommendation: in relation to a health technology identified in a direction by theSecretary of State that relevant health bodies provide funding within a specified period toensure that the health technology be made available for the purposesof treatment of patients.1.4 The Health and Social Care Act 2012 describes NICE’s general duties asfollows: In exercising its functions, NICE must have regard to: the broad balance between the benefits and costs of providing healthservices or of social care in England the degree of need of people for health services or social care inEngland and the desirability of promoting innovation in providing health services or ofsocial care in England.1.5 The Regulations require clinical commissioning groups, NHS England and, withrespect to their public health functions, local authorities, to comply with NICEtechnology appraisal guidance that recommends the relevant health servicebody provides funding within the period specified. When NICE recommends thata treatment be funded by the NHS, the Regulations require that the periodGuide to the processes of technology appraisalPage 2 of 104

within which the health service must comply will be stated in therecommendations as 3 months, except when particular barriers toimplementation within that period are identified (see section 5 on varying thefunding requirement). NICE provides advice and tools to support the localimplementation of its guidance. This includes resource impact tools orstatements for most technology appraisals and additional tools for sometechnology appraisals.1.6 The technology appraisal processes are designed to provide recommendations,in the form of NICE guidance, on the use of new and existing medicines,products and treatments in the NHS. Health technologies referred to NICE’sTechnology Appraisal Programme include: medicinal products medical devices diagnostic techniques surgical procedures or other therapeutic techniques therapeutic technologies other than medicinal products systems of care screening tools.Some of these technologies will also be considered by other programmes withinNICE, such as NICE guidelines, the Medical Technologies EvaluationProgramme, the Diagnostics Assessment Programme or the InterventionalProcedures Programme, or will have medicines and prescribing support fromthe Medicines and Technologies Programme at NICE. This process guiderelates only to technologies appraised through the Technology AppraisalProgramme.1.7 The technology appraisal process is specifically designed to appraise a product,device or other technology, for a single indication. The process normally coversnew technologies (typically, new pharmaceutical products or new licensedindications) and enables NICE to produce guidance soon after the technology isintroduced in the UK. NICE seeks relevant evidence from several sources. Thecompany submits the principal evidence. The evidence review group (ERG), anGuide to the processes of technology appraisalPage 3 of 104

external academic organisation independent of NICE, produces a review of theevidence submission (see sections 3.3.8 and 3.3.9). Consultees provideinformation (see table 1) and selected clinical experts, NHS commissioningexperts and patient experts also give evidence (see section 3.4).1.8 Companies can ask to fast track an appraisal using the fast track process. Theaim of this option is to provide an equally robust but less resource-intensiveappraisal process than the standard appraisal process. NHS England andcommissioners have committed to provide funding for the highly cost-effectivetechnologies recommended in fast track guidance within 30 calendar days ofpublication.1.9 NICE makes the decision on whether the standard or fast track process will beused to appraise a technology. Once published, NICE technology appraisalguidance has the same status, regardless of whether it was produced by thestandard or the fast track process. Any health technologies that are referred toNICE for technology appraisal, such as pharmaceuticals or medical devices,can be fast tracked as long as they fulfil the criteria (see section 2.4.31 –2.4.32).1.10 An appraisal is based on a review of clinical and economic evidence, mainlyprovided by the company, supported by testimonies from patients, healthcareprofessionals and commissioners. Clinical evidence shows how well thetechnology works – the health benefits. The evidence includes the impact onquality of life (for example, pain and disability), and the likely effects onmortality. Economic evidence shows how well the technology works in relationto how much it costs the NHS and whether it represents value for money.1.11 The appraisal committee (see table 1) considers the evidence and decideswhether or not the technology should be recommended as a clinically effectiveand cost-effective use of NHS resources, or whether it should only berecommended for specific groups of people.1.12 The appraisal committee provides its recommendations to NICE in either anappraisal consultation document (ACD) or a final appraisal document (FAD).Normally, the committee produces an ACD only if its preliminaryGuide to the processes of technology appraisalPage 4 of 104

recommendations are substantially more restrictive than the terms of themarketing authorisation (or equivalent, for example, CE marking for devices) forthe technology being appraised or do not recommend use of the technology. Ifthe committee produces an ACD, then NICE invites consultees, commentatorsand the public to comment on it. After considering these comments, thecommittee finalises its recommendations and provides them to NICE in the formof a FAD. The FAD forms the basis of the guidance that NICE issues to theNHS in England.1.13 The NICE technology appraisal process complies with the principlesunderpinning the UK government’s Review of quality assurance of governmentmodels (the Macpherson recommendations). The Director of the Centre forHealth Technology Evaluation is the senior responsible owner with overallresponsibility for assuring the quality of models developed in their areas ofresponsibility. The quality of models is assured through the requirements for thedevelopment of evidence submissions (see NICE’s guide to the methods oftechnology appraisal) and the process used to involve stakeholders in testingthe reliability of models (see section 3.2.11).1.14 NICE is committed to advancing equality of opportunity, eliminating unlawfuldiscrimination and fostering good relations between people who share aprotected characteristic and society as a whole, and to complying fully with itslegal obligations on equality and human rights. NICE's equality schemedescribes how NICE meets these commitments and obligations.1.15 In formulating its recommendations, the appraisal committee will have regard tothe provisions and regulations of the Health and Social Care Act 2012 relatingto NICE. The committee will also take into account NICE’s Social valuejudgements: principles for the development of NICE guidance. This document,developed by NICE's Board, describes the principles NICE should follow whendesigning the processes used to develop its guidance. In particular, it outlinesthe social value judgements that NICE and its advisory bodies, includingappraisal committees, should apply when making decisions about theeffectiveness and cost effectiveness of interventions.Guide to the processes of technology appraisalPage 5 of 104

1.16 Service level agreements are in place to help disseminate NICE technologyappraisal guidance within the devolved administrations in Wales and NorthernIreland.Guide to the processes of technology appraisalPage 6 of 104

Table 1 Participants in the technology appraisal processesAppraisalThe appraisal committee considers and discusses the evidencecommitteefor a technology.The appraisal committee is an independent standing committeethat produces recommendations. NICE recruits committeemembers through open, competitive advertising and appointsmembers initially for a 3-year term. Committee members are from: the NHS lay backgrounds (with an understanding of patientand public perspectives on healthcare issues) academia pharmaceutical and medical devices industries.Full details of how NICE recruits members can be found in therecruitment and selection procedure for advisory bodies.NICE allocates members to 1 of 4 standing committees. Memberswill normally remain in the same committee for the duration of theirmembership. Sometimes members may be needed to join anothercommittee to ensure that the meeting is quorate and that businesscan be done in line with the committee standing orders and termsof reference.Although the committee seeks the views of organisationsrepresenting healthcare professionals, patients, carers, companiesand government, its advice is independent. Names of committeemembers are posted on NICE’s website.See the appraisal committee’s standing orders and terms ofreference.Guide to the processes of technology appraisalPage 7 of 104

Lead teamA lead team, selected from the committee members at the start ofeach appraisal, helps the NICE team prepare a technical report tobrief the committee. The lead team normally consists of3 committee members; 1 focuses on clinical effectiveness; 1 oncost effectiveness and 1 on patient and carer evidence (called thelay lead).The technicalThe technical team consists of the chair or vice chair of theteamcommittee along with the NICE team, which normally comprises ofthe following: the associate director, the technical adviser and thetechnical lead.The technical team will be responsible for considering thecompany evidence submission, ERG critique and submissionsfrom other consultees and commentators. It aims to identify andexplore issues, come to preliminary scientific judgements, andadvise the appraisal committee in its discussion of the evidence.The technical team will seek input from the lead team, the ERGand experts where appropriate.ConsulteesNICE invites consultees to take part in the appraisal. They include: national groups representing patients and carers organisations representing healthcare professionals the company that holds, or is expected to hold, themarketing authorisation for medicinal products, or theequivalent for other technologies the Department of Health and Social Care the Welsh government NHS England as the commissioner for specialisedservices clinical commissioning groups (2 are randomlyselected).Guide to the processes of technology appraisalPage 8 of 104

As part of the scoping process, NICE invites consultees tocomment on draft remits and draft scopes.Consultees can submit evidence and take part in the consultationon the appraisal consultation document (ACD; if produced). Allnon-company consultees can nominate clinical experts and patientexperts to take part in the appraisal. Company consultees canonly nominate clinical experts. Representatives from NHS Englandand clinical commissioning groups invited to take part in theappraisal may also nominate NHS commissioning experts toattend appraisal committee meetings. All consultees have theopportunity to appeal against the final recommendations, or reportany factual errors, in the final appraisal document (FAD).Consultees can also comment on the proposal for reviewing theguidance (see section 6).CommentatorsNICE invites commentator organisations with an interest in thetechnology to take part in the appraisal. They include, but are notrestricted to: relevant comparator technology companies any relevant National Collaborating Centres (groupscommissioned by NICE to develop clinical and socialcare guidelines) and/or the relevant group for publichealth guidance other related research groups (for example, theMedical Research Council and the National CancerResearch Institute) other groups (such as the NHS Confederation, theNHS Commercial Medicines Unit, the ScottishMedicines Consortium, the Medicines andHealthcare products Regulatory Agency, theDepartment of Health and Social Care, SocialGuide to the processes of technology appraisalPage 9 of 104

Services and Public Safety for Northern Ireland andthe Academic Health Science Networks).As part of the scoping process, NICE invites commentators tocomment on draft remits and draft scopes.Commentators can take part in the consultation on the ACD (ifproduced), but NICE does not ask them to submit evidence for theappraisal. Non-company commentator organisations can nominateclinical experts and patient experts to take part in the appraisal.Commentator organisations can only nominate clinical experts.These organisations receive the FAD and have the opportunity toreport any factual errors.Commentators can also comment on the proposal for reviewingthe guidance (see section 6).Clinical expertsThe chair of the appraisal committee selects clinical experts andand patientpatient experts from those nominated by consultees andexpertscommentators; taking into account the NICE policy on declaringand managing interests for NICE advisory committees. Expertsare invited to help clarify issues about the submitted evidence andattend committee meetings. They may be asked to provide advicebefore, during and after committee meetings.NHSNICE invites 2 NHS commissioning experts from those nominatedcommissioningby NHS England and the clinical commissioning groups to helpexpertsclarify issues about the submitted evidence. They may be asked toprovide advice before, during and after committee meetings abouttheir views and experiences of the technology and the conditionfrom an NHS perspective.Cancer DrugsFor appraisals of pharmaceutical products for cancer indications,Fund clinical leadthe clinical lead for the Cancer Drugs Fund, or a nominateddeputy, is invited to submit a statement and attend both the publicand private parts of appraisal committee meetings.Guide to the processes of technology appraisalPage 10 of 104

Evidence reviewThe ERG is an independent (academic) group that reviews thegroup (ERG)company’s evidence submission and may also prepare someadditional analyses. The ERG is normally commissioned by theNational Institute for Health Research’s Health TechnologyAssessment Programme.Decision supportThe DSU is commissioned by NICE to provide a research andunit (DSU)training resource to support NICE's Technology AppraisalProgramme.NICE staffCentre directorThe centre director is responsible for delivering all outputs of theCentre for Health Technology Evaluation. The centre director mustalso ensure that appraisals are carried out in line with thepublished appraisal process and methods.ProgrammeThe programme director is responsible for all aspects of managingdirectorand delivering the appraisal work programme. The programmedirector interacts with the NICE sponsor branch at the Departmentof Health and Social Care and other national bodies, and withhealthcare industry bodies. The programme director is responsiblefor signing off guidance at specific stages of an individualappraisal. The programme director is also responsible for ensuringthat appraisals are carried out in line with the published appraisalprocess and methods.AssociateThe associate director is responsible for developing individualdirectorappraisals within the appraisal programme and has delegatedresponsibility, from the programme director, for approvingdocumentation for consultation at specific stages of an individualappraisal.Guide to the processes of technology appraisalPage 11 of 104

Project managerThe project manager is responsible for planning individualappraisal timelines, ensuring the timelines and process arefollowed, and liaising with consultees, commentators and otherindividuals and organisations contributing to the appraisal.AdministratorThe administrator is responsible for supporting the projectmanager in the planning and management of individual appraisals,including ensuring the timelines and process are followed, andliaising with consultees, commentators and other individuals andorganisations.Technical leadThe technical lead is the analyst responsible for the technicalaspects of the appraisal, including liaising with the ERG, scopingthe appraisal, preparing drafts of guidance and advising theappraisal committee. There may be more than 1 technical lead foran appraisal.Technical adviser The technical adviser is responsible for the technical quality of theappraisal. This involves providing advice on technical issues, andif appropriate, reviewing and quality assuring the work of thetechnical lead. The technical adviser also ensures a consistentapproach is taken across the appraisal programme.CommunicationsThe communications lead is responsible for circulating andleadcommunicating the guidance to appropriate groups within the NHSin England, and to patients and the public.GuidanceThe guidance information services lead is responsible forInformationsupporting the technical lead in scoping the appraisal. Theservices leadinformation services lead gathers information to support theproduction of a draft scope and continues to track key informationthroughout the life cycle of the appraisal to support the work of thetechnical lead.Guide to the processes of technology appraisalPage 12 of 104

Editorial leadThe editorial lead is responsible for ensuring that all guidancedocuments are accurate, clear and consistent. The editorial leadprepares the final versions of the guidance and information for thepublic.PublicThe PIP is the team at NICE that supports and develops publicInvolvementinvolvement across NICE’s work programme. A PIP publicProgramme (PIP) involvement adviser is assigned to each appraisal and supportspublicpatient and carer consultee organisations, their representatives,involvementand individual patients or carers throughout the appraisal. Thisadvisermay include making it easier to attend workshops or meetings,giving advice on completing submissions and statements,consultation responses or other documentation, and nominatingexperts. The PIP public involvement adviser also supports the laymembers of the appraisal committees and supplies the patient andcarer organisations for the ‘Information for the public’ tab of theguidance page of the NICE website.Commercial andThe CMAP will be responsible for managed access activities,Managed Accessincluding the Cancer Drugs Fund and Patient Access SchemesProgrammeLiaison Unit. This team will support commercial engagement(CMAP)between companies and NHS England when a commercial accessagreement or patient access scheme is needed to addressspecific uncertainties within a topic.Resource impactThe resource impact lead works with the technical lead andleadclinical experts to produce guidance-related costing tools. Thetools consist of a resource impact report and template to helporganisations assess the financial impact of implementing NICEguidance. They are published at the same time as the guidanceand are subject to a limited consultation. The resource impact leadalso provides input at the topic selection stage, assessing thepotential financial impact of each topic scoped.Guide to the processes of technology appraisalPage 13 of 104

ImplementationThe implementation adviser provides support from the scopingadviserstage through to post-publication activities, liaising with theinternal NICE teams, development teams and externalorganisations to support the implementation of NICE guidance,including the development of implementation support tools.Pathways leadThe pathways lead is responsible for ensuring there is a processin place for making guidance accessible through NICE Pathways.This includes ensuring that new guidance is included in new orexisting NICE Pathways with agreement from the Centre forHealth Technology Evaluation management team.Adoption leadThe medicines and technologies programme adoption team leadwill work with the NHS to provide a systematic approach to theadoption of new technologies such as pharmaceuticals, diagnosticand monitoring devices, surgical implants and other technologiesthat improve the care given to patients.2 Selecting technologies2.12.1.1OverviewTopic selection is the process for deciding which topics NICE will producetechnology appraisal guidance on. NICE aims to consider all new significantdrugs and indications. Health technologies referred to NICE’s TechnologyAppraisal Programme include: medicinal products medical devices diagnostic techniques surgical procedures or other therapeutic techniques therapeutic technologies other than medicinal products systems of care screening tools.Guide to the processes of technology appraisalPage 14 of 104

2.1.2The topic selection process has been designed to support the technologyappraisal process so that topics chosen will add value and supporthealthcare professionals and others to provide care of the best possiblequality, which offers the best value for money. The steps involved are shownin figures 1 and manages this process on behalf of the Department of Health andSocial Care. NICE can only begin to appraise a technology when it has beenformally referred by the Secretary of State for Health.2.1.4The aims of the topic selection process are to: ensure NICE addresses topics of importance to patients, carers,healthcare professionals, commissioners, providers and public health help make the best use of NHS resources coordinate the selection of topics using a standard selection process make topic selection as rapid as possible to minimise the period ofuncertainty before guidance is issued ensure that all topic selection activities are inclusive, open, transparentand consistently applied ensure that all stages of the process are well documented with clearoperating procedures and responsibilities and that throughout there isclear and visible progress tracking for all topics considered ensure there are appropriate governance structures and arrangementsin place with all relevant parties.2.1.5Most topics are identified by the National Institute for Health ResearchInnovation Observatory at the University of Newcastle. This centre notifiesNICE about key new and emerging healthcare technologies that might besuitable for NICE technology appraisal. It aims to notify NICE of new drugs indevelopment about 20 months before marketing authorisation and of newindications about 15 months before marketing authorisation. These timeframes are to enable NICE to publish guidance as close as possible toproduct launch. They may vary depending on whether the topic is a cancer ornon-cancer indication. Suggestions for technology appraisal guidance on aGuide to the processes of technology appraisalPage 15 of 104

new medicinal product (that has not yet received a marketing authorisation)should be made by the relevant company through UKPharmaScan.Healthcare professionals, researchers and patients can also suggestpotential technologies for NICE to appraise by contacting the NationalInstitute for Health Research Innovation Observatory., filtering and prioritisationTopic selection decisions are based on considering each potential topicagainst elimination and prioritisation criteria. The elimination criteria filter outtopics unsuitable for guidance development through the TechnologyAppraisal Programme. A topic will not be considered if the technology hasnot been granted a marketing authorisation (or equivalent) or if there are noplans for it to receive a marketing authorisation (or equivalent) or if it isidentical to: a topic for which there is published NICE guidance a topic for which NICE guidance is in development a topic currently in the topic selection process a topic that has been considered and eliminated from the topic selectionprocess a topic that has been considered in the last 3 years and not beenprioritised a topic widely accepted and implemented on the basis of existingpublished guidance from the Department of Health and Social Care,Arm’s Length Body or other government departments (excludingnational service frameworks, white papers and planning prioritiesguidance).2.2.2The following topic areas are outside the remit of technology appraisalguidance development at NICE: Population screening – falls under the remit of the UK NationalScreening Committee.Guide to the processes of technology appraisalPage 16 of 104

Vaccination – generally falls under the remit of the Joint Committee onVaccination and Immunisation. However, NICE does considertherapeutic vaccines. HIV technology or therapy – falls under the remit of the British HIVAssociation. However, there may be situations when the Department ofHealth and Social Care considers that a NICE appraisal of an HIVtechnology or therapy would be helpful to the NHS and these will bedealt with on a case-by-case basis. Haemophilia – for technologies that are considered suitable for existingnational procurement processes.2.2.3Topics are not considered unless: there is appropriate evidence, either available or anticipated to beavailable in the near future, to support the appraisal (refer to section 3.3of the guide to the methods of technology appraisal) and the relevant clinical question(s) can be addressed by applying thetechnology appraisal methodology. This may mean excluding topics forwhich technology appraisal guidance would not add value withoutbroader guidelines on the clinical pathway.2.2.4The importance of each topic is considered against prioritisation criteria thathelp the Secretary of State for Health and Social Care decide which topicsshould be referred to NICE for guidance development through theTechnology Appraisal Programme. This includes consideration of thepopulation size, disease severity, resource impact and the value that NICEcould add in carrying out a technology appraisal. The prioritisation criteriaare: Is the technology likely to result in a significant health benefit, takenacross the NHS as a whole, if given to all patients for whom it isindicated? Is the technology likely to result in a significant impact on other healthrelated government policies?Guide to the processes of technology appraisalPage 17 of 104

Is the technology likely to have a significant impact on NHS resources ifgiven to all patients for whom it is indicated? Is there significant inappropriate variation in the use of the technologyacross the country? Is NICE likely to be able to add value by issuing national guidance? Forexample, without such guidance is there likely to be significantcontroversy over the interpretation or significance of the availableevidence on clinical and cost effectiveness?2.2.5Elimination, filtering and prioritisation is done by the consultant clinicaladviser in the topic selection team. It includes seeking expert opinion andengaging with the relevant commissioners, clinical reference group chairs ormembers and national clinical directors when appropriate. The filteringrecommendations are considered by an internal group at NICE and by NHSEngland.2.2.6Summary information on topic progress is published on the NICE website.The list of potential topics is handed over to the technology appraisal scopingteam to develop the draft scopes.2.2.7The National Institute for Health Research Innovation Observatory at theUniversity of Newcastle develops technology briefings for potential appraisaltopics. The briefings, prioritisation recommendations and draft scopes areconsidered by a joint decision-making group made up of NICE, theDepartment of Health and Social Care and NHS England. This group meets(known as decision point 3 [DP3]) to decide the next steps for each topicbeing considered, to ensure the timely production of guidance. The groupconsiders each topic and decides whether it is potentially suitable for NICEappraisal and as a result, whether the scope should be sent out forconsultation.2.2.8Medicinal products

1.7 The technology appraisal process is specifically designed to appraise a product, device or other technology, for a single indication. The process normally covers new technologies (typically, new pharmaceutical products or new licensed indications) and enables NICE to produce guidance soon after the technology is introduced in the UK.

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