|Clara MacKayPrincipal Adviser, Health, Consumers' Assn
|1.||NICE has inappropriately considered individual treatments in isolation from alternative treatment options or previous NICE guidance.
||The Institute receives commissions from the Department of Health and the National Assembly for Wales which define the nature of the topic. A more detailed exposition of this commission is circulated to consultees for comment, in the form of a scoping document. If it appears that the topic or scope is inappropriate, consultees may use this opportunity to so advise the Institute.
|2.||NICE should ensure that evidence relating to clinical effectiveness is relevant to experience and priorities of healthcare professionals and patients.
||NICE consults with and seeks evidence from health professionals and patients/carers during the development of its appraisals and new guidelines. As a national organisation we do this through the groups that represent these stakeholders at a national level.
|3.||NICE should put systems into place to amend guidance before the planned expiry date where necessary.
||A system is already in place. It is referred to in "A Guide to the Technology Appraisal Process". Page 16 point c. This guide is one from a series of 5 published by NICE, and is available on the NICE web site.
|4.||NICE must ensure it has systems in place to respond to issues and questions raised by health professionals and patients about its guidance.
||The Institute has such systems in place.|
The Institute responds to organisations representing health professionals or patients and individual patients and health professionals via letters, e-mails, fax and telephone.
In addition, the covering letter to each piece of guidance invites those who receive it to provide direct feedback to the Institute's Chief Executive.
|5.||Urgent need for NICE to be more transparent about the appraisal processappraisal methodologies should be made public along with the details about the basis on which decisions have been taken.
||Appraisal methodology is and has always been in the public domain.Individual guides have been produced, following consultation, for each of the stakeholder groups. These guides are sent to individual groups at the start of a piece of work and are published on the NICE web site
|6.||Resources should be made available to support patient contributions.
||NICE introduced a payment of £400 per group in the appraisal programme last year.|
The Institute funds the National Guidelines and Audit Patient Involvement Unit which provides advice on patient/carer involvement and support and training for patients and carers involved in guideline and audit development.
The Institute is extending the remit of this unit to cover the technology appraisals programme.
|7.||NICE should be much clearer at the outset of an appraisal about what exactly it is trying to evaluate and following that a great deal more explicit and open about the methodology it is using.
||The Institute already does this.|
When producing a clinical guideline or appraisal it is important that the topic it covers is clearly defined, and meets the brief provided by the Department of Health and the National Assembly for Wales. This ensures that the appropriate evidence is considered and that the guideline is produced in a timely manner. This is referred to as scoping the guideline.
The Institute consults on the scope of each appraisal and guideline with those patient, professional and manufacturers groups who are stakeholders.
The final scope is then published on the Institute's website (www.nice.org.uk).
|Dr Martin Duerdenpart time GP.Dr Duerden is listed as an editorial board member of the D&TBDecember 2001.
|8.||Dr Duerden repeats points made by both the D&TB and Helen Marlow regarding:|
Sibutramine & Orlistat
|Please cross-refer to responses made to issues raised by the D&TB and others (Paper 1) and Helen Marlow's evidence below.
|9.||No mechanism for feedback or appeal from within the NHS.
||Feedback: The Institute actively seeks feedback on its work and has systems in place to provide responses (point 4 above).|
The Institute has commissioned three pieces of work. Two sets of market research: on the dissemination of guidance and identifying the wants and needs of stakeholders regarding information on NICE and its processes.
In addition the Institute has launched substantial and independent formal research into the implementation of its work. This is the York University project, which is led by Professor Trevor Sheldon. It will report in summer 2002.
The Institute agrees that it would be appropriate for the NHS organisations that act as formal consultees in its appraisals to be able to appeal. It is consulting on an amendment to the current procedure.
|Wednesday 23 January 2002||
|Helen MarlowePharmaceutical Advisor, Croydon HAEditorial Board Member Drug and Therapeutics Bulletin
|10.||NICE guidance may take the narrow focus on a drug rather than the broader therapeutic aspects of treatment.
||The Institute produces both clinical guidelines and technology appraisals. Both are appropriate in individual circumstances.
|11.||NICE guidance on PPIs for dyspepsia does not consider or comment on use of these drugs in patients on non- steroidal anti-inflammatories who have not had a GI bleedalthough this is a common use for the drugs.
||Cross refer to Paper 1|
|12.||Recommendations can appear to contradict the health technology assessmentmay be good reasons but not clear in the guidance.
||The assessment report does not interpret the evidence: this is the role of the Appraisal Committee. The assessment report is only one part of the evidence they consider.
|13.||Quality of critical appraisals of clinical trials used from HTA reports is variable.
||The assessment reports are subject to the six quality checks referred to by Mr Dillon at the hearing on 30 January. Any errors which do survive and which are brought to the attention of the Institute will be corrected.
|14.||HTA reports can contain unpublished data which has not been subject to the same scrutiny as peer reviewed publication process.
||The assessment reports draw on published and unpublished evidence. The authors consider whether unpublished evidence submitted is of sufficient quality to form part of their report. Assessment reports are then subject to the six quality checks, including peer review.
|15.||NICE does not appear to have a robust declaration of interests procedure. In particular material interests of those involved in the development of guidance should be declared at the time guidance is published.
||Appendix E (NICE memorandum) is a copy of the code of conduct for the Institute. All of the Institute's staff and committee members abide by this code. Members and employees must inform the Chief Executive of the Institute at any time of any changes in their personal interests. Full declarations of interest (personal and non-personal) are made at least annually and these are available to the public.|
In addition for every agenda item at their meetings, committee members declare their interests. If a member has an interest that precludes them from taking part in the appraisal or guideline topic under discussion, they are excluded from participating further in that appraisal or guideline. The minutes of each committee meeting, which include the names of the members who attended and their declaration of interests, are available on the NICE website. Those preparing submissions, those giving evidence to the Committee (appraisals) and those developing the guideline (guideline development groups) also declare their interests.
|16.||. . . front line staff and policy makers are not consulted in the drafting of NICE Appraisals.
||This is not true.|
The Institute consults with two health authorities for each appraisal. This will be extended to primary care organisations after April 2002. In addition the Institute consults with the organisations representing health professionals, and for appraisals starting after 6 February 2001 consultation documents are published on the NICE web site and provide an opportunity for direct feedback to NICE.
|17.||. . . in addition NHS has no right of appeal against NICE guidance.
||See point 9 above.|
|18.||There is no opportunity for the NHS to provide practical feedback to NICE about how its guidance is being received and implemented in practice.
||The Institute actively seeks feedback on its work and has systems in place to provide responses (points 4 and 9 above).
|19.||Ms Marlowe expresses a number of views on SIGN suggesting that the SIGN Guidelines follow a better a more open development process, are more inclusive (patients) and are better presented (language ie directional language rather than vague language in NICE guidance) than NICE appraisals.
||The Institute is in contact with SIGN with a view to developing joint projects.|
SIGN only produces clinical guidelines, whereas NICE produces both technology appraisals and clinical guidelines. It is inappropriate to compare the NICE appraisal process with a clinical guideline development process.Healthcare professionals produce SIGN clinical guidelines. Patients are involved through one consultative "national open meeting", which occurs after the professional groups have formed their guideline recommendations. SIGN guidelines do not incorporate economic analysis/cost effectiveness.
NICE clinical guidelines are produced by multi-disciplinary groups that involve both healthcare professionals and patients throughout the development process. NICE guidelines also incorporate cost effectiveness in their decision-making.Presentation of NICE clinical guidelines and SIGN clinical guidelines follow a similar structure of linking the evidence to recommendations.
|Dr CrayfordDeputy Director Public Health and Chairman Prescribing Committee
|20.||NICE has a standard of cost effectiveness which is £30,000 per QALY (v).
||This is not true. See general points above.
|21.|| In many cases, therefore the true effectiveness of a medicine cannot be assessed at the time of launch when there has been little or no use in a "natural" clinical setting.
||The Institute uses appropriate modelling in order to reach its conclusions.
|22.||When discussing his concerns about the variability of assessment groups stated"to be fair NICE themselves acknowledged that at recent board meetingsthey themselves have been talking about the difficulties in recruiting enough high calibre individuals in these centres to do these assessments."
||This was discussed, by the Institute's Board, in the context of concerns about the capacity of the assessment centres.
|23.||Factual errors have occurred in all the appraisals we have been involved in (assessment reports).
||Where factual errors are identified, the Institute corrects them.
|24.||NICE's own estimates of a predicted annual increase in NHS budgets of £93 million.
||The Institute's estimate is that it is in excess of £200 million.
|Campaign for Effective and Rational Treatment (CERT)written evidence
|25.26.||Extremely lengthy and flaw ridden appraisal process.|
The NICE process as it stands can add up to three years before a drug becomes available for use. The lengthy and flawed appraisal process,
|The Institute's process has been extensively reviewed (during 2000), in conjunction with its stakeholders. It is fair, open and inclusive. The methodologies used by the Institute compare favourably with (and indeed are based on) best international approaches.|
An appraisal usually takes around 12 months. Any extensions are carefully considered before they are approved and they are always explained to consultees.
|and the inevitable round of appeals that occur following problematic NICE decisions, only serves to limit the availability of vital new therapies.
|27.||Whole appraisal process is extremely laborious taking at least 11 months, experts have commented that some appraisals of existing therapies could be made in an afternoon by those who understand field of medicine and evidence from clinical studies
|28.||NICE has little or no flexibility in assessing the effectiveness of a treatment regime over existing therapies.
||The Institute carefully scopes each appraisal. This scope is the subject of consultation with all stakeholders. Scopes include identification of the comparators to be used in the appraisal
|29.||NICE's use of health economics is fundamentally flawed by the organisation's apparent inability to understand data presented by stakeholders.
||The Institute is advised by the leading health economists in the United Kingdom. There are no circumstances in which a submitted economic model would be beyond the understanding of those who advise the Appraisal Committee.
|30.||Method by which NICE accepts evidence and suitability of stakeholders appears arbitrary.
||The processes for accepting evidence and identifying stakeholders are identified in publicly available documents and are on the Institute's web site. There are two series of publications, both produced after consultation:|
One series describes the Technology Appraisal Process and contains a Guide to the Appraisal process, a Guide to Appellants, Guidance for Patient/Carer Groups, Guidance for Healthcare Professional groups and Guidance for Manufacturers and Sponsors.
The second series supports the Guidelines Development Process and proves information for the public and the NHS, Stakeholders and National Collaborating Centres, and Guideline Development Groups.
The Institute consults on the stakeholders it invites to join in its appraisals.
|31.||Systematic failures in the administrative ethos of NICE.
||We would be grateful if CERT would provide the Institute with its evidence of systematic failures. If administrative failures do exist we will rectify them.
|32.||At the moment a single expert is recruited to NICE to advise an Appraisals Committee & other individuals with no experience in the specific clinical area.How is the expert identified?
||This is not true. |
Usually four experts nominated by the patient body consultees and two of the experts nominated by professional / clinical body consultees are invited to inform the Appraisal Committee with written perspectives, and to attend the Appraisal Committee.
Information on appointment of experts is publicly availablesee publications listed in point 31 above Page 11 of A Guide to the NICE Appraisal Process, (publication 1 from a series of 5available from the NICE web site), describes the process of selection.
|33.||Other problems relate to the Appraisal Committee trying to interpret clinical trials in an area that is not their specialityrather than having expertise in the area being appraised.
||The Appraisal Committee is advised by clinical experts and those familiar with the interpretation of clinical trials evidence. The generic nature of the Committee enables the widest possible set of perspectives to be brought to bear on the evidence.
|34.||Unplanned & unexplained delays in appraisals critique of herceptin.
||This issue is dealt with in Paper I.|
|35.||What NICE is looking for in the cancer field is whether a patient is going to live at least an extra three months.
||Each technology is appraised individually and there are no cut-off points for either clinical or cost effectiveness.
|36.||Cox IIsseveral patient groups invited to submit to NICE never received a letter.
||As a part of inviting stakeholder to participate in an appraisal, consultees receive a letter that requires them to sign a form and return it to the Institute. Unless they do so they are not consultees in the Appraisal.
|37.||NICE extended the scope of the appraisal on verteporfin to include people with a diagnosis that is outside the current licensed indications, despite assurances that treatments would only be considered in relation to their licensed indications. This was not discussed with stakeholders during the consultation rounds. Needless to say the input into the appraisal by stakeholders would have been different if this off label indication had been raised.
||This is not true.|
Firstly the Institute's appraisal will establish the clinical and cost effectiveness of photodynamic therapies for age-related macular degeneration (AMD) relative to current practice and in relation to their licensed indications and in order to produce guidance to the NHS in England and Wales.
The scope for this appraisal was subject to consultation with all stakeholders, therefore it incorrect to suggest that it was not discussed with them, or to imply that they were not and are not aware of its content. In addition, it has been published on the NICE web site since August last year.
The scope identifies the boundaries for the collection of evidence to inform the appraisal, and valuable evidence may be missed if the evidence collection was restricted to the licensed indications of a single product.
|38.||NICE appraisal process appears to lack any quality control to prevent errors in the assessment report or the draft guidance.
||The quality control measures which have been put in place have been described elsewhere.
|39.||Health technology groups Commissioned to produce evaluation reports are paid only around £14,000, therefore the bulk of the work is conducted by less experienced staff rather than experts.
||The NHS R&D commissions these groups and they receive at least double the figure quoted.
|40.||Assessments are carried out by a limited number of units comprising health economists with little or no input from the clinical community.
||The process of assessment was described to the committee. Assessment reports are commissioned from six UK universities with a full range of relevant skills.
|41.||Independence. Many of its (NICE) staff have come from the Department of Health and this wholesale importing of personnel can only lead to a culture that follows the "Whitehall party line"work of independent personnel would be welcome by NICE.
||None of the Institute's staff are currently civil servants and only one member of the Institute's staff has previously been employed as a civil servant.|
NICE does not recognise the culture described by CERT. Guidance produced by NICE is developed by independent personnel.
|42.|| CERT calls for the active recruitment of senior personnel from overseas, the industry and non department health aligned academia.
||The Institute's Board includes:|
A professor of clinical pharmacology and consultant physician
A professor specialising in digestive disease research
2 patient representatives
1 senior academic
1 member with a business background
1 public health doctor
1 pharmacologist (recruited from Industry)
2 NHS managers
and the Institute's team are reflective of the wider expertise you would expect.