treatment regimens) Degree of resection (e.g. amount of residual tumour not resected) Disease progression Health-related quality of life Risk stratification Progression-free survival Overall survival Safety Frequency of adverse reactions (classified by System Organ Class) Patient reported adverse reactions Cost-effectiveness Cost per life year gained Cost per QALY gained Healthcare resources Cost of hexaminolevulinate Cost of cystoscopy Cost to adapt specialised equipment (if required) Costs associated with clinical management changes e.g. changes in post-operative management, surgeries avoided, changes in need for tests used after cystoscopy for cancer staging (e.g. CT or MRI). Total Australian Government Healthcare costs Total Cost to the Medical Benefits Schedule (MBS) Total Cost to the Pharmaceutical Benefits Scheme (PBS) Total Cost to other healthcare services Patients with prior resected non-muscle invasive bladder cancer Component Description Patients with prior resected non-muscle invasive bladder cancer, who are Patients undergoing post-operative follow-up or surveillance for disease recurrence with rigid cystoscopy. Urine cytology (proportion of patients) Prior tests (for investigative Imaging (proportion of patients) medical services Flexible cystoscopy (proportion of patients) only) Rigid cystoscopy with resection Blue-light cystoscopy/Photodynamic diagnosis (PDD) with hexaminolevulinate, Intervention as an adjunct to white-light cystoscopy Standard white light rigid cystoscopy Comparator Efficacy/effectiveness Outcomes
treatment regimens) Degree of resection (e.g. amount of residual tumour not resected) Disease progression Health-related quality of life Risk stratification Progression-free survival Overall survival Safety Frequency of adverse reactions (classified by System Organ Class) Patient reported adverse reactions Cost-effectiveness Cost per life year gained Cost per QALY gained Healthcare resources Cost of hexaminolevulinate Cost of cystoscopy Cost to adapt specialised equipment (if required) Costs associated with clinical management changes e.g. changes in post-operative management, surgeries avoided, changes in need for tests used after cystoscopy for cancer staging (e.g. CT or MRI). Total Australian Government Healthcare costs Total Cost to the Medical Benefits Schedule (MBS) Total Cost to the Pharmaceutical Benefits Scheme (PBS) Total Cost to other healthcare services Patients with prior resected non-muscle invasive bladder cancer Component Description Patients Patients with prior resected non-muscle invasive bladder cancer, who are undergoing post-operative follow-up or surveillance for disease recurrence with rigid cystoscopy. Prior tests (for investigative medical services only) Urine cytology (proportion of patients) Imaging (proportion of patients) Flexible cystoscopy (proportion of patients) Rigid cystoscopy with resection Intervention Blue-light cystoscopy/Photodynamic diagnosis (PDD) with hexaminolevulinate, as an adjunct to white-light cystoscopy Comparator Standard white light rigid cystoscopy Outcomes Efficacy/effectiveness
1460-PICO-confirmation.docx