PCN74 Long-Term Cost-Effectiveness of Nadofaragene Firadenovec and Oportuzumab Monatox for Treatment of Bacillus Calmette-Guerin (BCG)-Unresponsive, Non-Muscle Invasive Bladder Cancer (NMIBC)

Abstract

Nadofaragene firadenovec (NADO) and oportuzumab monatox (OPOR) are new treatments for bladder cancer unresponsive to BCG therapy. To evaluate the long-term cost-effectiveness of NADO and OPOR compared with a hypothetical bladder cancer treatment (HT) in BCG-unresponsive NMIBC in 2 patient populations: those with 1) carcinoma in situ (CIS) ± high-grade Ta/T1 and 2) high-grade Ta/T1 alone (Ta/T1). Pembrolizumab (PEM) was also evaluated in CIS, and gemcitabine ± docetaxel (GEM/DOC) in both populations. A semi-Markov model was developed, employing 3-month cycles over a lifetime horizon, from a healthcare sector perspective. Model inputs were obtained through manufacturer- submitted evidence, systematic literature reviews, and clinical expert opinion. NADO price was based on annual PEM price and OPOR price was a manufacturer provided placeholder price. Primary outcomes, discounted at 3% annually, included total costs (TC), quality-adjusted life years gained (QALY), equal value of life years gained (evLYG), and cost/QALY compared to HT. One-way and probabilistic sensitivity analyses were conducted to evaluate uncertainty. For CIS population: NADO had $308,000 TC, 5.17 QALY, 5.26 evLYG, and $151,000 cost/QALY; OPOR had $310,000 TC, 4.69 QALY, 4.73 evLYG, and $382,000 cost/QALY; PEM had $265,000 TC, 5.04 QALY, 5.12 evLYG, and $114,000 cost/QALY, and GEM/DOC had $172,000 TC, 5.88 QALY, 6.00 evLYG, and dominated HT. For Ta/T1 population: NADO had $302,000 TC, 5.52 QALY, 5.64 evLYG, and $93,000 cost/QALY; OPOR had $302,000 TC, 5.23 QALY, 5.32 evLYG, and $123,000 cost/QALY; and GEM/DOC had $165,000 TC, 5.83 QALY, 5.95 evLYG, and dominated HT. Key uncertainty drivers were probabilities of disease progression to MIBC, NMIBC recurrence beyond 12 months and initial treatment efficacy. NADO and OPOR may provide bladder-sparing therapeutic alternatives for BCG- unresponsive NMIBC patients. Pricing of these drugs will determine whether they are cost effective at commonly accepted thresholds.