Meeting date: 24 April 2014 Agenda item: 8 Paper number: SHTG 14-16 Title: Purpose: SHTG primary submission process FOR INFORMATION Background The purpose of this paper is to update SHTG members on developments surrounding SHTG s Primary Submission Process (PSP). Action required SHTG is asked to note the continuing progress and provide feedback on the first draft of the submission template.
Situation The purpose of this paper is to update SHTG members on developments surrounding SHTG s Primary Submission Process (PSP). In recent weeks, progress has been made in; a) establishing the necessary information required for inclusion within PSP submission templates, and b) identifying potential topics for assessment during the pilot phase. Background In December 2013, SHTG endorsed the PSP subgroups proposals for the PSP pilot process. The proposals covered the following key phases of the pilot process; registration of technology for assessment with the Health Innovation Portal, onward referral to the PSP, assessment of the submission, and summary and dissemination of subsequent SHTG advice. It was agreed by SHTG that the next stage would be to develop more detailed PSP documentation, and to identify potential topics/devices for testing the process during the pilot. Assessment A draft manufacturer submission template is provided in Appendix 1 for consideration by SHTG. The template is at an early stage of development, and has been created based on work we have undertaken in collaboration with EUnetHTA, and also after having met with manufacturers of devices that may be suitable for assessment during the PSP pilot period. Ultimately, a guidance document for manufacturers will be provided alongside the submission template, yet the next stage is to establish whether the content of template is suitably comprehensive without being onerous. It is hoped that feedback from stakeholders and also from manufacturers who go through the imminent pilot process will help to fine-tune the content of the submission template. An update on the aforementioned work streams that have contributed to the development of the draft template is provided as follows; EUnetHTA is a network of government appointed organisations that produce or contribute to health technology assessment (HTA) in Europe, established to create an effective and sustainable network for HTA across Europe. We are currently working in collaboration with EUnetHTA on their Work Package 7 (WP7) programme, the objectives of which are; Strand A - to support the collaboration on new technologies and to contribute to reducing duplication of work by exchanging information on and developing tools to facilitate evidence generation, and Strand B - to exchange information on current assessments of new health technologies. The completion of these objectives will enable the creation of a comprehensive EUnetHTA submission template for medical devices. Healthcare Improvement Scotland (HIS) are partners of WP7 and have carried out data collection and synthesis in relation to Strand A and Strand B. This has involved, amongst other things, assessing and comparing the medical device templates used by HTA bodies in other countries. These comparisons were then used to help develop the draft EUnetHTA submission template where, most recently, HIS have been contributing to the amendment of the template. In addition to the above, we have been working closely with Scottish Lifesciences Association colleagues to identify medical devices that may be suitable for assessment during the PSP pilot phase. So far, we have met with the manufacturers of five different devices, across a broad spectrum of healthcare solutions from haemoglobin sprays to specialist catheters for use during heart transplants. We have presented our proposed PSP File Name: 14-16 SHTG primary submission process Version: 1.0 Date: 30 September 2014 Produced by: Secretariat Page: 2 Review date: n/a
process to the manufacturers and common across all these meetings was the enthusiasm with which our proposed PSP has been met. This has been particularly reassuring and has highlighted the important role we have to play in the link between the medical device industry and the use of their products within NHSScotland. A key distinction between the various devices is their stage of development, ranging from prototypes to those that are already used within other European countries. Owing to the embryonic stage of our PSP process, this represents a welcome distinction which may help to ensure that we are able to manage our workload effectively. Recommendation SHTG is asked to note the continuing progress and provide feedback on the first draft of the submission template. Produced by: Secretariat Page: 3 Review date: n/a
APPENDIX 1 Draft PSP submission template for manufacturers Please complete all sections of the template. The text in italics is intended to help illustrate the required information under each heading. Completed forms to be returned to: TBC 1. Health problem and use of the technology Description of disease or health condition for which technology will be used Provide an overview of the disease or health condition for which the technology is being considered. Definition of the disease or health condition. Describe the known causes or risk factors for developing the disease or health condition. Describe the natural course of the disease or health condition, including reference to any prognosis factors that may affect this natural course. Effects of disease Describe the symptoms of the disease or health condition. Comment on the burden of disease and describe which aspects of the burden of disease are targeted by the technology, i.e. are expected to be improved by the use of the technology. Include an estimate of prevalence and/or incidence for the disease or health condition (including recent trends). Target population Define target population and provide a justification for the target population. Estimate size of target population (assuming different from overall prevalence/incidence figures for population). Please provide evidence for the estimates. File Name: 14-16 SHTG primary submission process Version: 1.0 Date: 30 September 2014 Produced by: Secretariat Page: 4 Review date: n/a
Current clinical management of the disease or health condition Describe the clinical pathway of care that includes the proposed use of the technology. Describe the technologies currently used in the clinical pathway, for which the proposed technology is an alternative. Further detail surrounding comparator technologies is requested in Section 2. Describe any issues relating to current clinical practice, including any uncertainty about best practice. Describe the proposed new pathway of care which would incorporate the new technology if the technology was adopted by the NHS. Describe how the introduction of the new technology would impact upon the requirement for new resources, alternative use of existing resources, or a reduction in resource requirements (e.g. staff, tests/investigations, facilities etc.) 2. Description and use of the technology Manufacturer Name of applicant Manufacturer details (name, contact details, company number, legal status and whether a subsidiary) Sites where the device is manufactured Distributer details (to include name, contact details, company number, legal status and whether a subsidiary) Technology Name of device (full name in UK and, if different, in other countries worldwide) Class of the device Summarise the phase of development of the technology Provide details of the licence status of the technology detailed in the submission, including dates of granted or expected marketing approval. Where available, provide copies of relevant regulatory approval documents (e.g. CE mark certificate). Does the technology have regulatory approval outside Europe? If so, please provide details. Produced by: Secretariat Page: 5 Review date: n/a
Current use of technology and comparator(s) Use of the technology under review If the technology has been launched, please provide information on its use both in the UK and worldwide. List of supporting documents relating to the above: The brochure, model or presentation of the device (summary of characteristics) Letter of support for use of product, i.e. from clinicians, or evidence of use/approval in other countries If the technology has not been launched in the UK provide the anticipated date of availability in the UK. Use of comparator technologies If applicable, state the alternatives to the technology, for the indication(s) under assessment. Provide a justification for the choice of each of the comparators. Describe the variations in use of the comparators across countries/regions/settings, if any. 3. Clinical effectiveness Identification and selection of clinical effectiveness studies Present details of literature search used to identify studies to support clinical effectiveness evidence for the technology. Where possible; State the date of the search and any date limits applied Give details of the search strategy used and which databases were searched Present study inclusion and exclusion criteria If possible, please provide a flow chart showing the number of studies identified and excluded. The PRISMA template may be used: http://www.prismastatement.org/statement.htm Produced by: Secretariat Page: 6 Review date: n/a
Details of clinical effectiveness studies Present details of all studies used as evidence. For each study identified please state the following (data may be presented in tables). 1. Study title 2. Study reference and references for linked publications (including author and dates) 3. Registration number and name of trial registry 4. Conflicts of interest 5. Dates of study 6. Study location 7. Study objective (s) 8. Study design (RCT, randomisation method, blinding etc. If study was not an RCT, include how participants were allocated) 9. Study population (method of recruitment, selection criteria, exclusion criteria) 10. Treatment plan (dose, method of administration, timing and duration of administration) 11. Comparator (if usual care, please describe what this constitutes) 12. Follow-up procedures 13. Main outcome measure (if this uses a scale, state how it was validated) 14. Secondary outcome measures 15. Methods of analysing the results Where the evidence (indirect comparison, meta-analysis etc.) has been carried out, please record the methods used to carry out the evidence synthesis. Please also present the key results from the evidence synthesis below. (http://www.eunethta.eu/sites/5026.fedimbo.belgium.be/files/direct%20and%20indirect%20compariso ns.pdf may provide further guidance useful for completing this section). Produced by: Secretariat Page: 7 Review date: n/a
Clinical effectiveness study results In addition to the above, for each study identified please present the key clinical effectiveness results that will be used to support the clinical effectiveness of the device. Consider the following details when presenting the results Main outcome measure - effect size (+ 95% CI), statistical test (+ p value) Secondary outcome measures - effect size (+ 95% CI), statistical test (+ p value) Ongoing and unpublished studies For each study please state the following information if available: Study description Study results Study quality if this is possible to assess. For on-going studies, publication date For unpublished studies: reasons for non-publication Generalisability and consistency of studies in relation to proposed clinical situation Provide a summary of the strengths and limitations of the clinical-evidence base of the technology. Consideration should be given to the following; General characteristics of study populations and geographic and clinical setting of studies, how these might differ from the proposed target population General characteristics of the interventions examined and how they compare to those in routine use. Comparators used. Describe whether they reflect the most appropriate comparators in clinical practice in Scotland. The outcome measures, and whether this represents a comprehensive list. Conclusions on clinical effectiveness Based on the information provided above, provide a concluding statement regarding the clinical effectiveness evidence highlighting the clinical benefit from the technology. Produced by: Secretariat Page: 8 Review date: n/a
4. Safety Identification and selection of safety studies For the technology under consideration, and the comparator(s), list any additional studies in this safety section which were not included in the clinical effectiveness section. In doing so, provide details of identification and selection of studies in the same way as presented for the clinical effectiveness studies. Results of the studies (safety-specific information) Present the safety outcomes in the clinical studies. Where possible, consideration should be given to the following; For the technology under consideration, the number (and %) of patients requiring permanent or temporary discontinuation of treatment for each study providing safety data. For the technology under consideration, and the comparator, present the total events, frequency of occurrence (as a %), relative risk and 95% CI reported in each of the clinical studies. Categorise the adverse events by frequency and severity, and system order class. Are there any patient subgroups that are more likely to be harmed through use of the technology? If so present the data for these groups, separately. Describe all adverse events and outcomes associated with the technology in national regulatory databases such as those maintained by the MHRA and FDA. Study quality and generalisability of safety results Provide information surrounding the quality and relevance of the safety outcomes presented. Consideration should be given to the following; Were definitions given of reported adverse effects? How were adverse effects data collected: prospective/routine monitoring, spontaneous reporting, patient checklist/ questionnaire/diary; systematic survey of patients? Did investigators report on all the likely important or serious adverse effects? Are the safety data relevant for clinical practice in NHS Scotland? Safety risk management Comment on whether there is a need to manage the use of the technology, or to monitor the use of the technology to minimise the potential risks to safety If relevant, describe any changes made to the marketing authorisation since the initial authorisation as a result of safety issues. Describe any other harms that have come to light after granting of the marketing authorisation or that have been identified outside of the clinical trial context. Produced by: Secretariat Page: 9 Review date: n/a
Conclusions on safety Based on the information provided above, provide a summary statement relating to the safety evidence surrounding the technology. Include the following; What are the most important risks? What are the main differences between the technology and the comparator(s)? Are any patient groups more likely to be at risk? Describe the factors that may affect safety outcomes, e.g. clinician training, patient behaviour etc. 5. Health economics Published economic literature Please provide details of published economic studies used to support the use of the technology. Consideration should be given to the information requirements set out in Section 3 surrounding the identification, selection, description and results of relevant studies. De novo economic evaluation The purpose of the PSP is to provide submitting manufacturers the opportunity to present their own economic evaluation surrounding the use of their technology. As such, please provide details of the economic analysis below under the following broad headings. Overview of the Economic Evaluation Provide a description of the design of the economic evaluation. Define the decision problem to be addressed. This will require a definition and justification of the technologies being compared and the relevant patient group(s). Type of Economic Evaluation Describe the type of economic evaluation (e.g. cost-effectiveness analysis, cost-utility analysis, costminimisation analysis, cost-consequence analysis, or cost-benefit analysis). Justify the choice of economic evaluation. Produced by: Secretariat Page: 10 Review date: n/a
Comparator used in the economic analysis The comparator(s) for the economic analysis is likely to be the same as specified within the previous sections of the template. Provide details of the comparator(s) within the economic analysis. Please note that relevant comparators for inclusion in the economic analysis are those that are considered to be in routine use or represent best practice in NHS Scotland, and therefore are the technologies that are most likely to be replaced if the technology under review is recommended for use. Perspective of economic analysis Describe the perspective of the economic analysis. The perspective on outcomes should be all direct health effects. The perspective adopted on costs should be that of the NHS in Scotland and social work. If the inclusion of a wider set of costs or outcomes is expected to influence the results significantly, reasons for their inclusion should be clearly stated. Time Horizon for the Economic Evaluation State the time horizon for estimating the relative cost-effectiveness of the technology. The time horizon should be sufficiently long to reflect any differences in costs or outcomes between the technologies being compared. Role of Expert Opinion Where data from studies are insufficient to provide values for relevant variables, and such values can be obtained from expert opinion, then expert opinion will be considered as a valid source of evidence. Provide details of the expert opinion garnered to support the economic evaluation. Consider the extent of the expert opinion in relation to both the relative clinical outcomes and the costs of the technology and the comparator. Relative outcomes All the relevant clinical literature relating to the technology under evaluation will have been included in the previous sections of the submission template. For use in the economic analysis, summarise the key clinical outcomes that will be used to inform the economic analysis. Where clinical trial data have been combined, for example where there is no head to head evidence between the technology under review and the comparator, described the methods used and the key findings. For example, where indirect comparisons, systematic reviews, or network meta analyses have been carried out. Produced by: Secretariat Page: 11 Review date: n/a
Relative costs Costs should relate to resources that are under the control of the NHS in Scotland and social work where differential effects on costs between the technologies under comparison are possible. Please provide details of the cost data included within the economic evaluation. Consideration should be given to the following; Technology costs including those of the relevant comparators. Costs of resources associated with the use of the technology (e.g. staff costs, consumables etc.) Source of cost data (including the evidence used to estimate quantity and value of resources used) Discounting Present the discount rate applied to outcomes and costs. Results of health economics Present the key results from the economic evaluation. Consideration should be given to the graphical representation of clinical and cost-effectiveness data to support its effective communication and interpretation. Present the results of any sensitivity analysis used to test areas of uncertainty. Summary of health economic evaluation Based on the information provided above, provide a summary statement relating to the health economic evidence surrounding the technology. 6. Conclusion Summary of submission In no more than 6 bullet points summarise the key points to support the use of the technology within NHS Scotland Produced by: Secretariat Page: 12 Review date: n/a