Social participation for sustainable and legitimate prioritisation processes: NICE’s experience Santiago, October 2010 Sir Michael Rawlins, Chairman, NICE

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Social participation for sustainable and legitimate prioritisation processes: NICEs experience Santiago, October 2010Sir Michael Rawlins, Chairman, NICEKalipso Chalkidou, Director, NICE InternationalThe NHS in 2010UK parliamentNHS vote every 2 years Secretary of State for Health/Department of Health Primary Care TrustsOther bodies (e.g. Care Quality Commission)NICE10 care doctorsHospitals152 regions across the country Tax-revenue allocation by government with limited co-pays and out-of-pocketguidanceHospitaldoctorsPoints: Public body Administrative Law Devolved powers Secretary of State Money given to NICE would otherwise be used for the direct service provision need to be conscious of this

Consequent obligations and responsibilities Parliament Government Patients Public 21997: Announcing the establishment of NICEThe National Institute's membership will be drawn from the health professions, the NHS, academics, health economists and patient interests. It will need to have access to an appropriate range of skills, including economic and managerial expertise as well as specialist input on specific issues. NICE will create a new partnership between the Government, the NHS and clinical professionalsNICE will offer doctors, nurses and midwives more support than they have had before in making the complex decisions about individual patient care often required in modern health care.It will also inform the decisions of those commissioning care

NICEs featuresOur objectivesIndependence from government, industry and professionals TransparencyInclusiveness and public consultationScientific basis for decisions

Our principlesReduce inappropriate geographical variation Set quality standards for the practice of medicine Encourage innovation in health technologiesPromote efficiency in resource allocation

4Or, why have we survived for so long?INDEPENDENCENICE is an arms length body funded by & accountable to central governmentadvisory committees independent of NICE - indemnity by HMG but with independence over operation & substance of guidance directly issued advice to NHS and public sectorAdvisory committees independent of NICEBut NICE responsible for guidanceChallengesA few well publicised cases where our independence has been challenged - e.g. MS & herceptin

TRANSPARENCYPublish information on organisational structure, staff, membership of committees, policies & methods on websiteSome meetings in public (Board, appeals)Consult on substantive changes to process or methodConsult on all guidance productspublic consultation on products and methods, open meetings, (almost) all evidence available online, communications work Communications work with media

ChallengesBalancing desire for transparency with need for open & honest debate in committees?Handling confidential materialInitial attempts to keep drafts confidential failedAccess to economic models

INCLUSIVENESSRange of stakeholders: health professions, management, industry, patient and carer organisations and researchersInvolved at various levels: Board, Partners Council, Citizens Council, guidance producing committees and consultationsPatient and Public Involvement ProgrammeCommissioned work from professional organisations & research community (eg NCCs at Royal Colleges, & academic TAR groups)ChallengesHandling large numbers of stakeholders Balancing views of different partiesManaging potential conflicts of interest

Centre for Public Health Excellence- public health interventions- public health programmes

Developing NICE guidanceCentre forHealth Technology Evaluation- technology appraisalssurgerydiagnosticsmedical devices

Centre for Clinical Practiceclinical guidelinesquality standardsQOFNICE structureCommunications Patient and public involvement ImplementationR&DTopic selectionInformation systemsNHS Evidence5Stakeholders Patients and CitizensProfessionalsIndustryPayers and ProvidersPopular MediaParliamentPolitical PartiesMinistries of Public Health and of FinanceEU and UK legislators

More than 3,000 external experts, including patients, health professionals, academics, researchers, industry representatives and lay members of the public, offer their time and experience to NICE every year Stakeholder input* Published on NICE web siteTopic referred to NICE*Draft Guideline Public Consultation*Scoping*Dissemination and ImplementationPublication*Development Independent Review of response to public comment*appeallegal challenge7Working with the countrys professionals: the National Collaborating Centres

How does NICE engage with patients and the public?Lay and patient membership of committeesPublic consultationDedicated patient and public involvement unitEngagement in methods and processes developmentCitizens Council and social value guidanceRegular opinion pollsLay versions of all NICE products

Communicating with patientsAll technology appraisals produced in versions for patients and the public, known as Understanding NICE Guidance

Plain-English translation of guidance, not detailed patient information

Includes details of key patient support organisations for further informationIf you are taking a beta-blocker (either on its own or with some other medicine), then you should continue taking it. Your GP may discuss other treatments with you at your next regular visit. If treatment with the beta-blocker is not working, then your GP may suggest trying one of the treatments described above. If it appears that you are suitable for the treatment described in this booklet, but it is not available, you should talk to your local Patient Advice and Liaison Service. If they are not able to help you, they should refer you to your local Independent Complaints Advocacy Service. Its often possible to get less expensive non-branded medicines that are just as good as the branded versions. GPs are recommended to use the non-branded versions when this is possible, to get the best value for money. Seeking Patient Input: which outcomes matter?Case study - Psoriasis

Clinical research and the specialists told us the amount of psoriasis was what most affected the quality of life.Patients told us that the location of the flare-up (e.g. face or joints) was more significant.Assessing value is context-specificOur legal responsibilities on human rights and discrimination The innovative nature of the technology and value added compared to alternatives, especially at the end of life The implications of our guidance on equity and distributive justice

Rawlins, Lancet Oncology, 2007

NICEs Citizens Council13A4R:

Add more about A4R

Also, add some NICE SVJ principlesIndustry as a partnerEngagement in development of methods and processesTopic selection and scoping workshopsSubmission of evidence increasingly reliant on industry reviews for new productsExpert testimonies by professionalsConsultation Appeal and judicial challenge

Technology information, with one record per indication, including mode of action, route of administration, formulation, dose, BNF class, likely comparators and whether the product has been selected for NICE review. Clinical Trial information, with one record per study, including patient population, study design, primary objectives and outcomes. Regulatory information such as status, date of submission, estimated license date, estimated UK availability. Costs and budget impact, including proposed average dose, estimated length of treatment, drug cost range per patient per year/per episode, budget impact. developed and provided by NICENot always easy!

But parliament support is keyWe 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.Jan 2008 UK Parliament Health Select Committee17On the Committee DayERG MembersExperts Members Members Lead Team NICE ChairERG = Evidence Review Group ManufacturersPublic GalleryScreenObservers45 - 55 participantsPublic Recruitment Process for Decision-Making Committees

Managing Vested Interests: Code of Practice for Declaring Interests (NICE 2007)Applies to: NICE employees, NICE Chairman & non-executive board members and their familiesChairs and members of the advisory bodies to NICEExpert advisors testifyingEmployees of organisations contracted by NICE (including academic and professional associations)Is there a personal pecuniary interest?

A personal pecuniary interest involves a current personal payment, which may either relate to the manufacturer or owner of a product or service being evaluated.Example:Any consultancy, directorship, position in or work for a healthcare industry that attracts regular or occasional payments in cash or in kind, both those which have been undertaken in the 12 months preceding the meeting at which the declaration is made and which are planned but have not taken place. Grounds for AppealGround one: The Institute has failed to act fairlybreach of NICEs own process reference to NICE process manual respective paragraphnot related to contentappellants need to show they took steps to address unfairness at the time this aroseGround two: The Institute has formulated guidance which cannot reasonably be justified in the light of the evidence submittedneed to prove that the guidance is obviously and unarguably wrong, illogical, or so absurd that a reasonable Appraisal Committee could not have reached such