A COST-CONSEQUENCE ANALYSIS OF NOGAPENDEKIN ALFA INBAKICEPT-PMLN (NAI) IN COMBINATION WITH BACILLUS CALMETTE-GUÉRIN (BCG) VERSUS TAR-200 FOR BCG-UNRESPONSIVE NON-MUSCLE INVASIVE BLADDER CANCER WITH CARCINOMA IN SITU±PAPILLARY DISEASE (NMIBC CIS)
Author(s)
Ruchika Talwar, MD, MMHC1, Scott C. Flanders, BS, MHA, PhD2, Emily Matthews, MA3, Mike Dolph, MSc4, Connie Ly, MPH3, Vikas Jangra, PhD5.
1Vanderbilt University Medical Center, Nashville, TN, USA, 2ImmunityBio, Inc., Culver City, CA, USA, 3Cytel Inc., Toronto, ON, Canada, 4Cytel, Calgary, AB, Canada, 5Cytel Inc., Toronto, Canada, Calgary, AB, Canada.
1Vanderbilt University Medical Center, Nashville, TN, USA, 2ImmunityBio, Inc., Culver City, CA, USA, 3Cytel Inc., Toronto, ON, Canada, 4Cytel, Calgary, AB, Canada, 5Cytel Inc., Toronto, Canada, Calgary, AB, Canada.
Presentation Documents
OBJECTIVES: Bladder cancer ranks as the 6th most common cancer overall in the US, with approximately 75% cases being NMIBC. Although intravesical BCG remains the standard of care, many patients experience relapse or develop BCG-unresponsive disease. Newly FDA approved treatment options in this population offer the ability to quantify the costs and benefits across outcomes. A cost-consequence analysis was developed comparing NAI+BCG vs. TAR-200 on costs per complete response (CR) at 12-months using data from the respective, QUILT-3.032 and SunRISe-1 clinical trials.
METHODS: The target population in the model were US adults diagnosed with NMIBC CIS who were unresponsive to BCG treatment [5+2]. A multi-state Markov model with a 3-week cycle length was used, with clinical inputs informed by results of the respective single-arm clinical trials evaluating both FDA approved treatments. CR was based on results from a matched-adjusted indirect comparison (MAIC) using six matched baseline characteristics: age, sex, ECOG, prior BCG instillations, race, and tumor stage. The analysis was conducted from a US Medicare perspective, considering drug acquisition of therapies and administration, healthcare resource utilization, radical cystectomy, and mortality.
RESULTS: Following the MAIC, NAI+BCG and TAR-200 had 12-month CR rates of 49.6% and 45.9%, respectively. Over the assessed 15-month horizon, NAI+BCG and TAR-200 had total costs of $617,958 and $761,883, respectively. The cost-per-patient achieving and sustaining CR for 12 months was lower ($1,245,139) for NAI+BCG compared to TAR-200 ($1,660,515), representing $415,376 in incremental cost savings per responder to the Medicare system. Cost reductions were driven by drug acquisition and administration. Sensitivity analyses using non-MAIC adjusted CR showed consistency with the base case results.
CONCLUSIONS: These results demonstrate that NAI+BCG offers an improvement in complete response rates for BCG‑unresponsive NMIBC CIS patients, with a lower cost per sustained responder outcome within a Medicare population.
METHODS: The target population in the model were US adults diagnosed with NMIBC CIS who were unresponsive to BCG treatment [5+2]. A multi-state Markov model with a 3-week cycle length was used, with clinical inputs informed by results of the respective single-arm clinical trials evaluating both FDA approved treatments. CR was based on results from a matched-adjusted indirect comparison (MAIC) using six matched baseline characteristics: age, sex, ECOG, prior BCG instillations, race, and tumor stage. The analysis was conducted from a US Medicare perspective, considering drug acquisition of therapies and administration, healthcare resource utilization, radical cystectomy, and mortality.
RESULTS: Following the MAIC, NAI+BCG and TAR-200 had 12-month CR rates of 49.6% and 45.9%, respectively. Over the assessed 15-month horizon, NAI+BCG and TAR-200 had total costs of $617,958 and $761,883, respectively. The cost-per-patient achieving and sustaining CR for 12 months was lower ($1,245,139) for NAI+BCG compared to TAR-200 ($1,660,515), representing $415,376 in incremental cost savings per responder to the Medicare system. Cost reductions were driven by drug acquisition and administration. Sensitivity analyses using non-MAIC adjusted CR showed consistency with the base case results.
CONCLUSIONS: These results demonstrate that NAI+BCG offers an improvement in complete response rates for BCG‑unresponsive NMIBC CIS patients, with a lower cost per sustained responder outcome within a Medicare population.
Conference/Value in Health Info
2026-05, ISPOR 2026, Philadelphia, PA, USA
Value in Health, Volume 29, Issue S6
Code
EE159
Topic
Economic Evaluation
Disease
SDC: Oncology