An early analysis of the cost-effectiveness of a diagnostic classifier for risk stratification of haematuria patients (DCRSHP) compared to flexible cystoscopy in the diagnosis of bladder cancer

Abstract

BackgroundUrothelial bladder cancer (UBC) is the 5th most common cancer in Western societies. The most common symptom of UBC is haematuria. Cystoscopy the gold standard for UBC detection, allows direct observation of the bladder, but is expensive, invasive, and uncomfortable. This study examines whether an alternative new urine-based diagnostic test, the DCRSHP, is cost-effective as a triage diagnostic tool compared to flexible cystoscopy in the diagnosis of UBC in haematuria patients.MethodsA model-based cost-utility analysis using cost per quality adjusted life year and life year gained, parameterised with secondary data sources.ResultsIf the DCRSHP is targeted at haematuria patients at lower risk of having bladder cancer e.g. younger patients, non-smokers, then it can be priced as high as £620, and be both effective and cost-effective. Sensitivity analysis found that DCRSHP is approximately 80% likely to be cost-effective across all willingness to pay values (for a QALY) and prevalence estimates.ConclusionThis analysis shows the potential for a non-invasive test to be added to the diagnostic pathway for haematuria patients suspected of having UBC. If the DCRSHP is applied targeting haematuria patients at low risk of UBC, then it has the potential to be both effective and cost-effective.

Integrating Early Economic Evaluation into Target Product Profile development for medical tests: advantages and potential applications

“…This approach could be used within TPPs to estimate the maximum price or minimum diagnostic accuracy at which a test remains cost-effective given a certain WTP threshold. See (12;15–18;20) for examples. Sensitivity analysis —In the absence of a clear WTP threshold, sensitivity analysis could be used to identify ranges of minimal test properties, while exploring changes in cost-effectiveness results due to altering one or more model parameters. See (14;15;19) for examples.…”

“…This approach could be used within TPPs to estimate the maximum price or minimum diagnostic accuracy at which a test remains cost-effective given a certain WTP threshold. See (12;15–18;20) for examples.…”

The role of URO17™ biomarker to enhance diagnosis of urothelial cancer in new hematuria patients—First European Data

“…This is usually performed during the first encounter that the patient has with the urology service, resulting in a significant number of patients unnecessarily undergoing both radiation exposure and invasive procedures, which can lead to further complications such as urinary tract infections 10,11 . These cases of unnecessary investigations for bladder cancer result in significant costs, estimated to be over £100 million annually in the UK alone 12 …”

“…10,11 These cases of unnecessary investigations for bladder cancer result in significant costs, estimated to be over £100 million annually in the UK alone. 12 Following treatment for diagnosed bladder cancer, follow-up by means of cystoscopic surveillance is required for many years. For non-muscle-invasive bladder cancer (NMIBC), the 3 year total costs per person for surveillance alone are estimated to be over £4500, with additional costs for any recurrence or progression.…”

“…A need for an inexpensive diagnostic test or screening tool has been expressed repeatedly. 7,12,16 In 2008, there were six urine-based biomarkers FDA cleared/approved for the surveillance of bladder cancers which were reviewed by Herman et al, but these were all found to have sensitivities equal to or only slightly greater than cytology alone. 17 In 2013, Casadio et al investigated cell free DNA in urine samples as a potential biomarker.…”