The cost-savings are particularly noteworthy given prior evidence of blue light imaging enhancing the efficacy of diagnostic cystoscopy.
Incorporating blue light cystoscopy (BLC) with hexaminolevulinate hydrochloride (HCl) into diagnostic cystoscopy may result in cost savings, according to an analysis published in the Canadian Journal of Urology.1
The cost-effectiveness analysis showed that use of BLC with hexaminolevulinate HCl in conjunction with white light at the time of initial transurethral resection of bladder tumors (TURB) lowered costs by $4,660 over 5 years compared with use of white light cystoscopy alone. The investigators also observed that patients receiving BLC had a lower overall cancer burden compared with those receiving white light alone.
For their study, the investigators used TreeAge Pro 2011 software to create a probabilistic decision tree model based on base case scenario cost and utility estimates. The model projected that use of BLC with hexaminolevulinate HCl as an adjunct to white light would cost $25,921 over 5 years compared with $30,581 for patients receiving white light alone at first TURB.
The potential cost-savings are noteworthy, considering that previous studies have already shown how detection of non-muscle invasive bladder tumors has been improved when BLC with hexaminolevulinate HCl is incorporated into diagnostic cystoscopy.
For example, a multicenter, comparative phase 3 study from Daneshmand et al assessed BLC in 304 patients under surveillance who were at high risk of bladder cancer recurrence.2 In this single-arm trial, all patients received hexaminolevulinate HCl instillation prior to cystoscopy. All patients received white light cystoscopy followed by BLC at their initial study visit. Patients with suspicious lesions were then referred to the operating room for a second study visit where they received repeat white light cystoscopy followed by BLC.
An independent pathology consensus panel assessed specimens of all suspicious lesions after the lesions were biopsied or resected. The primary end point of the trial was the proportion of cases in which only BLC detected a histologically confirmed malignancy. The investigators also assessed the false-positive rate, carcinoma in situ detection, and additional tumors detected only with blue light cystoscopy.
The surveillance study visit led to 103 of 304 patients being referred. Of these patients, 63 had confirmed malignancy, including 26 with carcinoma in situ. In 20.6% (n = 13) of the 63 patients, recurrence was detected with blue light flexible cystoscopy but not with white light (P <.0001). Of these 13 cases, 5 were carcinoma in situ.
At the second study visit, carcinoma in situ was confirmed in 26 (41%) of 63 patients through the operating room examination. In 34.6% (n = 9) of the 26 cases, only BLC detected the carcinoma in situ (P <.0001). BLC also led to the discovery of additional malignant lesions in 46% (n = 29) of the 63 patients.
For white and blue light cystoscopy, the false-positive rate was 9.1%. During the surveillance visits, there were 12 adverse events (AEs); however, none of the AEs was serious.
“Office-based blue light flexible cystoscopy significantly improves the detection of patients with recurrent bladder cancer and it is safe when used for surveillance. Blue light cystoscopy in the operating room significantly improves the detection of carcinoma in situ and detects lesions that are missed with white light cystoscopy,” the investigators wrote in their study conclusion.
Hexaminolevulinate HCl, under the tradename Cysview, is approved by the FDA for use in the cystoscopic detection of non-muscle invasive papillary cancer of the bladder among patients suspected or known to have lesion(s) on the basis of a prior cystoscopy.3 For more on BLC with hexaminolevulinate HCl, read our article by Daniel C. Parker, MD, which includes a real-world workflow for incorporation of BLC into clinical practice.
1. Garfield SS, Gavaghan MB, Armstrong SO, et al. The cost-effectiveness of blue light cystoscopy in bladder cancer detection: United States projections based on clinical data showing 4.5 years of follow up after a single hexaminolevulinate hydrochloride instillation. Can J Urol. 2013;20(2):6682-6689.
2. Daneshmand S, Patel S, Lotan Y, et al. Efficacy and safety of blue light flexible cystoscopy with hexaminolevulinate in the surveillance of bladder cancer: a phase III, comparative, multicenter study. J Urol. 2018;199(5):1158-1165. doi: 10.1016/j.juro.2017.11.096
3. FDA Prescribing Information Highlights: Cysview (hexaminolevulinate hydrochloride), for Intravesical Solution (For bladder instillation only). https://bit.ly/33oPN8z. Accessed August 4, 2020.