Cost-Effectiveness Analysis of Pembrolizumab for BCG-Unresponsive Carcinoma in Situ of the Bladder.

Patients with BCG-unresponsive carcinoma in situ (CIS) are treated with radical cystectomy (RCx) or salvage intravesical chemotherapy (SIC). Recently, pembrolizumab was approved for BCG-unresponsive CIS.

We used a decision-analytic Markov model to compare pembrolizumab, SIC (with gemcitabine-docetaxel induction+monthly maintenance), and RCx for patients with BCG-unresponsive CIS who are RCx candidates (index patient 1) or are unwilling/unable to undergo RCx (index patient 2). The model used a US Medicare perspective with a 5-year time horizon. One-way and probabilistic sensitivity analyses were performed. Incremental Cost-Effectiveness Ratios(ICERs) were compared using a willingness-to-pay threshold of $100,000/Quality-adjusted life year(QALY).

For index patient 1, pembrolizumab was not cost-effective relative to RCx(ICER $1,403,008/QALY) or SIC(ICER $2,011,923/QALY). One-way sensitivity analysis revealed that pembrolizumab only became cost-effective relative to RCx with a >93% price reduction. Relative to RCx, SIC was cost-effective for time horizons <5 years and nearly cost-effective at 5 years(ICER $118,324/QALY). One-way sensitivity analysis revealed that SIC became cost-effective relative to RCx if risk of recurrence or metastasis at 2 years was less than 55% or 5.9%, respectively. For index patient 2, pembrolizumab required >90% price reduction to be cost-effective(ICER $1,073,240/QALY). Pembrolizumab was cost-effective in 0% of 100,000 microsimulations in probabilistic sensitivity analyses for both index patients.

At its current price, pembrolizumab is not cost-effective for BCG-unresponsive CIS relative to RCx or SIC. Although gemcitabine-docetaxel is not cost-effective relative to RCx at 5 years, further studies may validate its cost-effectiveness if recurrence and metastasis thresholds are met.

The Journal of urology. 2020 Dec 21 [Epub ahead of print]

Kevin M Wymer, Vidit Sharma, Christopher S Saigal, Karim Chamie, Mark S Litwin, Vignesh T Packiam, Matthew Mossanen, Lance C Pagliaro, Bijan J Borah, Stephen A Boorjian

Department of Urology, Mayo Clinic, Rochester, Minnesota., Department of Urology, David Geffen School of Medicine; University of California, Los Angeles, California., Division of Urologic Surgery, Brigham and Women's Hospital, Boston, Massachusetts., Department of Oncology, Mayo Clinic, Rochester, Minnesota., Department of Health Services Research, Mayo Clinic, Rochester, Minnesota.

Read an Expert Commentary by Bishoy Faltas, MD

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