Introduction:

In 2018, the FDA expanded the approved use of hexaminolevulintate HCl (HAL), marketed in the US as Cysview by Photocure Inc., in conjunction with blue-light cystoscopy (BLC) to include its use in the surveillance of non-muscle-invasive bladder cancer (NMIBC). The clinical benefit, which may also impact the economic burden of NMIBC in terms of further management (follow-up repeated cystoscopies) and treatment(s) (instillations, cystectomy) are unknown. The objective of this analysis was to determine the estimated budget impact to practices that incorporate BLC with HAL for the surveillance of NMIBC in the clinic setting.

Methods:

A budget impact model was developed from the facility perspective assessing projected costs at 2 years for a simulated facility with 50 newly diagnosed bladder cancer patients. Cystoscopy performance inputs were based on existing published literature that have measured the effect of BLC with HAL on both the rate of recurrence and the relative risk of recurrence using blue-light compared to white-light alone. Downstream treatment response assumptions were based on published literature on the response rate to intravesical BCG or intravesical chemotherapy (single postoperative instillation or induction).

Results:

Use of BLC identified 9 additional recurrences over two years compared to WLC alone. Of those recurrences missed in the first year using WLC alone, approximately 1% will progress to a higher tumor grade once identified. Use of flexible BLC for surveillance did not substantially increase costs to the practice, with a net difference (mean reimbursement – mean costs) of $0.76 per cystoscopy over two years.

Conclusion:

From the office/clinic perspective, this model suggests use of flexible BLC for the surveillance of NMIBC does not impact cost per cystoscopy. Additionally, flexible BLC resulted in the identification of 9 recurrences over two years that would otherwise be missed using WLC alone.

Funding: Photocure Inc.