Cost per Responder of TAR-200 vs. Other FDA-Approved Novel and Generic Treatments Among Bacillus Calmette-Guérin-Unresponsive High-Risk Non-Muscle Invasive Bladder Cancer With Carcinoma in Situ in the United States
Author(s)
Stephen Williams, MD, MBA, MS, FACS, FACHE1, Sang Cho, PhD2, Laura Morrison, MScPH3, Mukul Singhal, PhD2, Dominic Pilon, MA3, Kayleen Gwyn, PharmD2, Beatrice Libchaber, MA3, Gordon Wong, BA3, Francesca Lee, MScPH3, Urvi Desai, PhD4, Kruti Joshi, MPH2.
1University of Texas Medical Branch Clear Lake, Webster, TX, USA, 2Johnson & Johnson, Horsham, PA, USA, 3Analysis Group ULC, Montréal, QC, Canada, 4Analysis Group, Inc., Boston, MA, USA.
1University of Texas Medical Branch Clear Lake, Webster, TX, USA, 2Johnson & Johnson, Horsham, PA, USA, 3Analysis Group ULC, Montréal, QC, Canada, 4Analysis Group, Inc., Boston, MA, USA.
OBJECTIVES: Despite recent therapeutic progress, available treatment options for patients with Bacillus Calmette-Guérin (BCG)-unresponsive high-risk non-muscle-invasive bladder cancer (BCG-UR HR-NMIBC) with carcinoma in situ (CIS) are sub-optimal. TAR-200, a novel intravesical drug releasing system, was granted United States (US) Food and Drug Administration (FDA) Breakthrough Therapy Designation for this population. An economic model compared the cost-per-responder for US patients with BCG-UR HR-NMIBC with CIS treated with TAR-200 versus other FDA-approved treatments.
METHODS: A 15-month cost-per-responder model was developed from a Medicare payer perspective (2025 US dollars). Patients treated with TAR-200 monotherapy were compared to those treated with pembrolizumab, nadofaragene firadenovec (NF), nogapendekin alfa inbakicept (NAI)+BCG (with and without reinduction), or valrubicin based on published clinical trial data. Model inputs included costs for initial and subsequent treatment, medical visits, and radical cystectomy (RC). Outcomes comprised the total cost per patient achieving and sustaining complete response (CR) for ≥12 months, based on the overall CR rate and digitized Kaplan-Meier curves and swimmer plots for the 12-month duration of response. Patients experiencing non-response were assumed to receive subsequent treatment or undergo an RC.
RESULTS: At 15 months, the proportion of patients achieving and sustaining CR for ≥12 months was 43.5% for TAR-200, 18.8% for pembrolizumab, 21.9% for NF, 26.8% for NAI+BCG (36.6% including reinduction), and 10.1% for valrubicin. The total cost-per-patient achieving and sustaining CR for ≥12 months was $1,892,569 for TAR-200, which resulted in cost savings of $698,262 versus pembrolizumab, $406,840 versus NF, $832,346 versus NAI+BCG, and $1,541,999 versus valrubicin. Considering NAI+BCG reinduction, cost savings of $162,599 per patient achieving and sustaining CR for ≥12 months were observed for TAR-200 versus NAI+BCG.
CONCLUSIONS: TAR-200 demonstrated the highest proportion of patients achieving and sustaining CR for ≥12 months, translating to substantial cost savings per responder compared to other FDA-approved treatments for BCG-UR HR-NMIBC with CIS.
METHODS: A 15-month cost-per-responder model was developed from a Medicare payer perspective (2025 US dollars). Patients treated with TAR-200 monotherapy were compared to those treated with pembrolizumab, nadofaragene firadenovec (NF), nogapendekin alfa inbakicept (NAI)+BCG (with and without reinduction), or valrubicin based on published clinical trial data. Model inputs included costs for initial and subsequent treatment, medical visits, and radical cystectomy (RC). Outcomes comprised the total cost per patient achieving and sustaining complete response (CR) for ≥12 months, based on the overall CR rate and digitized Kaplan-Meier curves and swimmer plots for the 12-month duration of response. Patients experiencing non-response were assumed to receive subsequent treatment or undergo an RC.
RESULTS: At 15 months, the proportion of patients achieving and sustaining CR for ≥12 months was 43.5% for TAR-200, 18.8% for pembrolizumab, 21.9% for NF, 26.8% for NAI+BCG (36.6% including reinduction), and 10.1% for valrubicin. The total cost-per-patient achieving and sustaining CR for ≥12 months was $1,892,569 for TAR-200, which resulted in cost savings of $698,262 versus pembrolizumab, $406,840 versus NF, $832,346 versus NAI+BCG, and $1,541,999 versus valrubicin. Considering NAI+BCG reinduction, cost savings of $162,599 per patient achieving and sustaining CR for ≥12 months were observed for TAR-200 versus NAI+BCG.
CONCLUSIONS: TAR-200 demonstrated the highest proportion of patients achieving and sustaining CR for ≥12 months, translating to substantial cost savings per responder compared to other FDA-approved treatments for BCG-UR HR-NMIBC with CIS.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
EE186
Topic
Economic Evaluation
Disease
Oncology, Urinary/Kidney Disorders