TAR call-off contract Scope of Work, Templates

NICE TAR Protocol template guide 1. Introduction 1.1 In order to support the National Institute for Health and Clinical Excellence s (NICE) preferred methods 1 a protocol template for Technology Assessment Reports (TARs) is made available electronically to the TAR Teams, which should be used for all TARs commissioned. The contents of the template will be reviewed at each annual TAR contract review and teams informed of any revisions to ensure that the most recent version of the template is used. 2. Background 2.1 Since NICE is the primary customer, meeting the particular needs of the Appraisal Committee (AC) members should be paramount. Consequently, the report template (supporting document C) has been structured to provide the AC with the information it needs to underpin its discussions and decisions and to provide appropriate information for other stakeholders. Similarly, the protocol template has been revised (supporting document B). The intention is that any protocols prepared for NICE should meet the requirements of the final scope of the appraisal given that the final scope will have been informed by the comments from attendees at the scoping workshop 2. 3. Reviewing manufacturers economic submissions 3.1 NICE requires that TAR teams should undertake the necessary tasks to allow them to form an independent view of the cost-effectiveness of the technology. As a minimum, and subject to consultees complying with NICE s timelines and advice on the presentation of models, this should include reviewing existing literature on costeffectiveness and assessing the clinical validity, reasonableness of assumptions and the data used in the economic models submitted by the manufacturers. If the TAR team judge that the existing economic evidence is not robust, then further work should be undertaken, either by adapting what already exists or developing a denovo model, although it is likely that in these situations de-novo independent modelling will yield the most robust results. In situations where the TAR team judge that there is limited evidence of effectiveness, a review of the cost-effectiveness literature and the industry model will still be necessary. 3.2 However, it is also recognised that this can be achieved in a number of ways, depending on the completeness and robustness of the existing evidence. In NICE s view, the first step would be for the TAR team to assess what is already available that is, review the literature and the economic submissions from the manufacturers. Reviewing the economic submissions of the manufacturers will always mean that the TAR team will need to examine each model and, as a minimum, satisfy themselves that it has face validity from a clinical perspective, that the assumptions are reasonable and that the data used to populate the model is appropriate. So it is anticipated that there will always be a need to 'deconstruct' the model. 3.3 The next step would be for the TAR team to make a judgement as to whether, in their view, the existing evidence is sufficient and if not, what further work is necessary. This further work may mean developing their own de novo model or adapting the models already available. Even if a published economic evaluation or an industry model is used, NICE require the TAR team to submit a copy of the executable economic model used together with their assessment report. This should be accompanied with a technical description of any modifications made to the third party model to explore assumptions, including programming code. 3.4 When the TAR team have considered their options, at the earliest opportunity, they should discuss their proposed approach with the relevant NICE Associate Director or Technical Advisor. 4. Revised Format 4.1 Mindful that the protocol will be displayed on the NICE website, some of the administrative information included in the protocol, will be submitted separately so it will not appear on the website. 4.2 The following template is intended to be a guide for drafting the protocol. The major headings (i.e. those numbered) are a specific and fixed requirement. The titles of suggested sections in bullet points are a list of issues that should be considered, but the order and exact wording of the headings should not be considered prescriptive. 1 Guide to the Methods of Technology Appraisal. NICE (June 2008) Section 5 2 Guide to the Methods of Technology Appraisal. NICE (June 2008) Section 1.3.1

4.3 A detailed description of the standard methodology proposed is not being sought in sections 5 or 6. The purpose of these sections is to provide information which is project-specific. So, where possible, standard methodologies should be covered by reference to validated methods sources such as CRD s guidance for undertaking reviews in health care: Systematic Reviews (3rd Edition), 2008 or, perhaps, by the use of some standard sentences. Presently, there are no agreed standard sentences. Therefore some suggestions have been included in {italics}. However, their inclusion is not mandatory.

Technology Assessment Report commissioned by the NIHR HTA Programme on behalf of the National Institute for Health and Clinical Excellence Protocol Guide Please date (e.g. xx April 2009) 1. Title of the project 3 : The title should reflect the one used in the NICE scoping document. 2. Name of TAR team and lead Details of the lead Name, Post held, Official address, Telephone number and extension Fax number, E-mail address 3. Plain English Summary 4 This summary should contain between 200 and 400 words and be easily understandable by a wider, non-expert audience and is intended to help them understand what your report will aim to do. There should be sufficient detail to inform anyone unfamiliar with the specialised vocabulary of your specific discipline. Please explain specialised technical terms and acronyms and avoid discipline-specific jargon. (More detail on writing for public consumption is available from the Plain English Campaign and a free downloadable guide, designed specifically for the Health Sector, can be found at: http://www.plainenglish.co.uk/files/medicalguide.pdf) 4. Decision problem 5 The decision problem should be derived from the final scope. So this section should explain how the intended analysis will address the framework and any issues identified in the final scope and would include: Purpose of the decision to be made Clear definition of the intervention (e.g. licensed indications, dosages being considered) Place of the intervention in the treatment pathway(s) Relevant comparators Population and relevant sub-groups Key factors to be addressed (e.g. clinical and cost outcomes, further considerations, problematic factors) Areas of agreement at the scoping workshop that are outside the scope of the appraisal and therefore do not require any detailed assessment (e.g. key factors for which evidence is already accepted). 5. Report methods for synthesis of evidence of clinical effectiveness A detailed description of the standard methodology proposed, is not being sought. Where possible this should be covered by reference to validated methods sources such as Centre for Reviews & Dissemination (CRD):CRD s guidance for undertaking reviews in health care: Systematic Reviews (3rd Edition), 2008 or the Cochrane methods or the use of standard or equivalent sentences (some suggestions in {italics} below). The purpose of this section is to give information which is project-specific. For example: Describe the range of typical patients, normal clinical circumstances, clinically relevant outcomes and comparison with relevant comparators. The analysis will include both measures of both relative and absolute effectiveness, appropriate measures of uncertainty and data from all relevant studies. 3 this will appear on the HTA Programme website and appropriate research registers 4 this will be used on the HTA Programme website and for any appropriate research registers 5 this will appear on the HTA Programme website and appropriate research registers

Include information on: TAR call-off contract Scope of Work, Templates Search strategy {Refer to Appendix 9.1 for details of the sources to be searched and the draft search strategy for MEDLINE. No language restrictions will be applied to the search strategy.} Types of studies included (e.g. just RCTs or observational studies in the absence of RCTs) Inclusion and exclusion criteria {Based on the above inclusion/exclusion criteria, study selection will be made independently by two reviewers. Discrepancies will be resolved by discussion, with involvement of a third reviewer when necessary.} Sub-groups to be examined Outcomes to be examined (consider developing a hierarchy of outcomes) Data extraction strategy {Data will be extracted independently by two reviewers using a standardised data extraction form (see Appendix 9.2). Discrepancies will be resolved by discussion, with involvement of a third reviewer when necessary.} Quality assessment strategy {The quality of the individual studies will be assessed by one reviewer, and independently checked for agreement by a second reviewer. Any disagreements will be resolved by consensus and if necessary a third reviewer will be consulted. The quality of the clinical effectiveness studies will be assessed according to criteria based on CRD s guidance for undertaking reviews in health care: Systematic Reviews (3rd Edition), 2008 6 } Methods of analysis/synthesis Methods for estimating qualify of life {The time horizon of our analysis will be a patient s lifetime in order to reflect the chronic nature of the disease. The perspective will be that of the National Health Services and Personal Social Services. Both cost and QALY will be discounted at 3.5%.} 6. Report methods for synthesising evidence of cost-effectiveness Again, the purpose of this section is to give information which is project-specific, so where possible, refer to validated methods sources rather than give detailed descriptions of the standard methodologies. {The quality of the cost-effectiveness studies will be assessed according to the Guidelines for authors and peer reviewers of economic submissions to the BMJ 7.} Including details of the methods for: identifying and systematically reviewing published cost-effectiveness studies evaluation of costs and cost-effectiveness, which may include development of a de novo economic model. 7. Handling the company submission(s) {All data submitted by the manufacturers/sponsors will be considered if received by the TAR team no later than XXXX. Data arriving after this date will not be considered. If the data meet the inclusion criteria for the review they will be extracted and quality assessed in accordance with the procedures outlined in this protocol. Any economic evaluations included in the company submission, provided it complies with NICE s advice on presentation, will be assessed for clinical validity, reasonableness of assumptions and appropriateness of the data used in the economic model. If the TAR team judge that the existing economic evidence is not robust, then further work will be undertaken, either by adapting what already exists or developing a de-novo model.} 6 The full text is available from http://www.york.ac.uk/inst/crd/pdf/systematic_reviews.pdf. 7 Drummond MF, Jefferson TO. Guidelines for authors and peer reviewers of economic submissions to the BMJ. BMJ 1996;313:275 83.

Any commercial in confidence data taken from a company submission, and specified as confidential in the check list, will be highlighted in blue and underlined in the assessment report (followed by an indication of the relevant company name e.g. in brackets). 8. Competing interests of authors Please confirm that there are none or give details. 9. Appendices 9.1. Draft search strategy 9.2. Data extraction form Additional information that is needed by NETSCC, HTA and NICE. Please send this as a WORD document when you submit your protocol to Htatar@soton.ac.uk. Details of TAR team Please give details of members of the Team Surname, Forename, Title Post held, Specialty Organisation, Telephone number and extension E-mail address Please indicate to whom you wish all correspondence to be addressed e.g. {All correspondences should be sent to the lead/senior reviewer, the main reviewer and the project administrator.} Timetable/milestones Please confirm the date that you will submit: Progress report (to NETSCC, HTA who forward it to NICE within 24hr) Assessment Report (simultaneously to NICE and NETSCC, HTA) V1 January 2005 V2 March 2006 V3 April 2009 V4 Amended October 2009