AUA 2020: Cost-Effectiveness of Maintenance BCG for Intermediate and High Risk Non-Muscle Invasive Bladder Cancer

( Most patients newly diagnosed with bladder cancer have non-muscle invasive disease (NMIBC). For patients with intermediate or high-risk NMIBC and those with carcinoma in situ (CIS), adjuvant treatment with BCG is guideline-recommended on the basis of proven benefits in disease recurrence. BCG is administered with both induction and maintenance phases.  While guidelines support the use of maintenance BCG (mBCG) for intermediate and high risk non-muscle invasive bladder cancer (NMIBC), in an era of BCG shortage, careful consideration of the relative efficacy and toxicity of maintenance therapy is warranted. In a podium presentation at the American Urologic Association Virtual Annual Meeting, Vidit Sharma, MD, and colleagues presented results of a comprehensive cost-effectiveness analysis comparing mBCG to no-mBCG in patients with NMIBC following initial induction BCG.

The authors assembled a Markov model to compare the cost-effectiveness of mBCG to no-mBCG after induction BCG for intermediate/high-risk NMIBC from a US Medicare perspective. Details of the model are highlighted in this figure below.

Important transition probabilities including five-year recurrence, progression to MIBC, metastasis, mortality, and toxicity rates were extracted from meta-analyses and randomized trials. A literature review similarly provided utility values for health states. The authors performed univariable and multivariable sensitivity analyses. A willingness to pay threshold of $100,000 per quality-adjusted life-year (QALY) was considered cost-effective.

With a 5-year time horizon, mean costs per patient were $13,949 and $12,858 for mBCG and no-mBCG, respectively. Quality-adjusted life years were the same in both strategies (4.104 QALYs), as a result, no-mBCG was the dominant strategy. 


On univariable sensitivity analysis, mBCG became cost-effective if the absolute reduction in five-year recurrence was >41.1% or the reduction in progression was >3.2%.  


Utilizing 1/3rd dose mBCG resulted in marginal decreases in cost with mean 5-year costs per patient of $13,229. 1/3rd dose mBCG resulted in 4.103 QALY’s compared to 4.104 QALYs for no-mBCG, again supporting no-mBCG as the dominant strategy. 

On univariable sensitivity analysis, 1/3rd dose mBCG became cost-effective if the absolute reduction in 5-year recurrence was >25.1% or the reduction in progression was >1.3%. 

Neither full-dose mBCG (ICER $527,919) nor 1/3rd dose mBCG (ICER $247,766) were cost-effective, even if the probability of mBCG toxicity was reduced to 0.

Finally, the authors performed multivariable sensitivity analyses using 10,000 Monte-Carlo microsimulations. In this analysis, mBCG was cost-effective in 13% of microsimulations while 1/3rd dose mBCG was cost-effective in 32% of microsimulations supporting the overall analysis.

While reliant on modeling rather than direct comparative data, the authors found that neither full dose mBCG nor 1/3rd dose mBCG appears cost-effective for intermediate/high-risk NMIBC based on reported efficacy and toxicity data. Thus, the utilization of limited BCG resources should be prioritized for induction treatment.

Presented by: Vidit Sharma, MD, Mayo Clinic, Rochester, MN

Written by: Christopher J.D. Wallis, Urologic Oncology Fellow, Vanderbilt University Medical Center, @WallisCJD on Twitter at the 2020 American Urological Association (AUA) Annual Meeting, Virtual Experience #AUA20, June 27- 28, 2020