Photodynamic versus white light-guided treatment of non-muscle invasive bladder cancer: a study protocol for a randomised trial of clinical and cost-effectiveness

IntroductionBladder cancer is the most frequently occurring tumour of the urinary system. Ta, T1 tumours and carcinoma in situ (CIS) are grouped as non-muscle invasive bladder cancer (NMIBC), which can be effectively treated by transurethral resection of bladder tumour (TURBT). There are limitations to the visualisation of tumours with conventional TURBT using white light illumination within the bladder. Incomplete resections occur from the failure to identify satellite lesions or the full extent of the tumour leading to recurrence and potential risk of disease progression. To improve complete resection, photodynamic diagnosis (PDD) has been proposed as a method that can enhance tumour detection and guide resection. The objective of the current research is to determine whether PDD-guided TURBT is better than conventional white light surgery and whether it is cost-effective.Methods and analysisPHOTO is a pragmatic multicentre randomised controlled trial (open parallel group, non-masked and superiority trial) comparing the intervention of PDD-guided TURBT with standard white light resection in newly diagnosed intermediate and high risk NMIBC within the UK National Health Service setting. Clinical effectiveness is measured with time to recurrence. Cost-effectiveness is assessed within trial via the calculation of incremental cost per recurrence avoided and incremental cost per quality-adjusted life per year gained over 3 years and over long term through a modelling exercise over patients’ lifetime.Ethics and disseminationFormal ethics review was undertaken with a favourable opinion, in line with UK regulatory procedures (REC reference number: 14/NE/1062). If reductions in time to recurrence is associated with long-term patient benefits, the cost-effectiveness evaluation will provide further evidence to inform adoption of the technology. Findings will be shared in lay media such as patient and charity forums and will be presented at key meetings and published in academic literature.Trial registration numberISRCTN84013636.

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Cost‑effectiveness analysis of hexaminolevulinate (Hexvix®) guided cystoscopy in Non‑Muscle Invasive Bladder Cancer patients (NMIBC) in Italy

Farmeconomia Health economics and therapeutic pathways ◽

10.7175/fe.v15i3.944 ◽

2014 ◽

Vol 15 (3) ◽

Author(s):

Craig Bennison ◽

Stephanie Stephens ◽

Giario Natale Conti

Keyword(s):

Bladder Cancer ◽

Cost Effectiveness ◽

Incremental Cost ◽

Bladder Tumour ◽

Cost Effective ◽

Sensitivity Analyses ◽

Invasive Bladder Cancer ◽

Base Case ◽

Muscle Invasive Bladder Cancer ◽

Muscle Invasive

OBJECTIVE: To estimate the incremental cost‑effectiveness of hexaminolevulinate (Hexvix®) + Blue Light (H+BL) cystoscopy (compared to white light cystoscopy only) when used at initial transurethral resection of the bladder tumour (TURBT) for patients diagnosed with non‑muscle invasive bladder cancer (NMIBC) in Italy.METHODS: A cost‑effectiveness model has been developed to estimate the incremental cost‑effectiveness of introducing H+BL at initial TURBT for patients diagnosed with NMIBC in Italy. The model consists of two parts: 1) a short term decision tree which estimates the outcome of the initial diagnostic procedure, and 2) a Markov cohort model which is used to estimate long term outcomes through extrapolation based on data and assumptions about patient management, the natural history of the disease and the empirical efficacy of H+BL in improving diagnosis detection and reducing recurrence. Cost‑effectiveness results are expressed as incremental costs per QALY gained. Univariate and probabilistic sensitivity analyses are conducted to test the robustness of the model to changes in inputs and assumptions.RESULTS: Base case results suggest that Hexvix® is a dominant strategy when used in the resection of NMIBC. Hexvix® is expected to be associated with 0.070 incremental QALYs, with cost savings of € 435 per patient. Sensitivity analyses suggest that the cost of Hexvix® and the relative risk of recurrence in intermediate and low risk groups are key drivers in the model. Probabilistic analyses indicate that Hexvix® is expected to be cost‑effective in >99% of iterations, assuming a willingness to pay threshold of € 25,000 per QALY.CONCLUSION: In conclusion, Hexvix® is expected to be a cost‑effective strategy when used in the resection of NMIBC in Italy.

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