Proposed structure of economic evaluation Table 9 Summary of extended PICO to define research question that assessment will investigate. Patients Intervention Comparator Outcomes to be Healthcare resources assessed to be considered Men and women age Dual energy X-ray Clinical assessment Primary effectiveness See Table 8. 50-69 with risk factors absorptiometry (DXA) including the use of outcomes: for osteoporosis (risk scanning and treatment existing fracture risk of minimal •Incidence factors undefined). at the following assessment tools trauma fractures thresholds: (including vitamin D of all new •Incidence Subgroups of interest: T-score no test) with lifestyle and fractures ≥-1.0, Data for each risk treatment required dietary advice. quality •Patient-related factor should be -1.0> T-score >-2.5, of life reported separately lifestyle and dietary DXA and QCT scanning Data corresponding to advice, consider are excluded Secondary any other prognostic medication effectiveness factor for low mineral T-score≤-2.5, outcomes: density (such as age medication in •Change or gender) should be Sensitivity analysis morbidity/mortality reported separately. should investigate other mineral density •Bone Follow-up options: options of threshold to (as determined by T-score no therapy as advised by ≥-1.0, required. the evidence. -1.0> T-score >-2.5, QCT is excluded. Safety outcomes and re-test every 24 adverse events: months. Any adverse event or • T-score re-test complication related to ≤-2.5, every 12-24 months the DXA scanning or (repeat test available treatments for through MBS item osteoporosis 12306). Any adverse event • Exclude: arising from exposure to All women at age 70 ionising radiation. and over, women with a previous minimal trauma fracture, all women currently eligible for MBS items for scanning for bone mineral density. Please note: It will be important to report all outcomes according to risk factor, or combination of risk factors. PASC has specified a range of questions which will need to be addressed during the assessment phase. These questions will guide the evaluation and have been raised throughout the DAP. The assessment should address the questions raised throughout the DAP in relation to the population and intervention in order to provide MSAC with the necessary information to make an informed decision.
Proposed structure of economic evaluation Table 9 Summary of extended PICO to define research question that assessment will investigate. Patients Intervention Comparator Outcomes to be assessed Healthcare resources to be considered Men and women age 50-69 with risk factors for osteoporosis (risk factors undefined). Subgroups of interest: Data for each risk factor should be reported separately Data corresponding to any other prognostic factor for low mineral density (such as age or gender) should be reported separately. Follow-up options: T-score ≥-1.0, no required. -1.0> T-score >-2.5, re-test every 24 months. T-score ≤-2.5, re-test every 12-24 months (repeat test available through MBS item 12306). Exclude: All women at age 70 and over, women with a previous minimal trauma fracture, all women currently eligible for MBS items for scanning for bone mineral density. Dual energy X-ray absorptiometry (DXA) scanning and treatment at the following thresholds: T-score ≥-1.0, no treatment required -1.0> T-score >-2.5, lifestyle and dietary advice, consider medication T-score≤-2.5, medication Sensitivity analysis should investigate other options of threshold to therapy as advised by the evidence. QCT is excluded. Clinical assessment including the use of existing fracture risk assessment tools (including vitamin D test) with lifestyle and dietary advice. DXA and QCT scanning are excluded Primary effectiveness outcomes: •Incidence of minimal trauma fractures •Incidence of all new fractures •Patient-related quality of life Secondary effectiveness outcomes: •Change in morbidity/mortality •Bone mineral density (as determined by Safety outcomes and adverse events: • Any adverse event or complication related to the DXA scanning or treatments for osteoporosis • Any adverse event arising from exposure to ionising radiation. See Table 8. Please note: It will be important to report all outcomes according to risk factor, or combination of risk factors. PASC has specified a range of questions which will need to be addressed during the assessment phase. These questions will guide the evaluation and have been raised throughout the DAP. The assessment should address the questions raised throughout the DAP in relation to the population and intervention in order to provide MSAC with the necessary information to make an informed decision.