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Comparative Cost Analysis of Emerging Intravesical Therapies Vs Radical Cystectomy for BCG-Unresponsive Non-Muscle-Invasive Bladder Cancer
Peter Aziz, M.S.1, Angela P. Monero, M.S.2, Peter Somboonsong, B.S.2, Anthony Khoudary, B.A./M.S.1, Daniel Edwards, DO, FACOS, FACS1.
1Drexel University College of Medicine, Wyomissing, PA, USA, 2Drexel University College of Medicine, Philadelphia, PA, USA.
BACKGROUND: Radical cystectomy (RC) is standard treatment for Bacillus Calmette-Guérin (BCG)-unresponsive carcinoma in situ (CIS). For patients who are ineligible/declining RC, several FDA-approved therapies introduced in the past three years offer improved response rates over older second-line options but at higher cost. These include nadofaragene-firadenovec (Adstiladrin™), nogapendekin alfa (Anktiva™)+BCG, and the gemcitabine intravesical system (Inlexzo™), with efficacy summarized in Table 1. However, the literature lacks cost comparisons with RC. This study assesses the economic burden of these bladder-sparing options relative to RC.
Table 1 - Efficacy Data| Agent | Clinical Response (CR) Rate | CR ≥12 months | CR ≥24 months | Median Duration of Response | Cystectomy-Free Survival |
| AdstiladrinTM | 51% | 46% of responders | — | 9.7 months | 43% at 60 months (CIS) |
| AnktivaTM+ BCG | 62% | 58% of responders | 40% of responders | 26.6 months | 89% at 24 months |
| InlexzoTM | 82% | 51% of responders | — | 25.8 months | — |
METHODS: Using FDA labels and publicly available wholesale acquisition costs, dosing and unit prices for intravesical therapies were obtained (Table 2). A 2-year horizon captured stepwise dosing. Per-patient costs were estimated from a clinically reasonable 2-year treatment sequence (Figure 1).
Table 2- Dosing & Costs| Agent | Dosing (2-Year) | Unit Cost | Estimated 2-Year Cost |
| AdstiladrinTM | 8 doses (q3mo) | ~$60,000/dose | ~$480,000 |
| AnktivaTM (administered with BCG) | 6 induction + ~15 maintenance doses | ~$35,800/dose | ~$751,800*
Note: if a second induction is needed, add ~$214,800
*Excluding BCG unit cost |
| InlexzoTM | 8 induction + ~6 maintenance implants | ~$67,407/device | ~$943,699**
**Excluding procedural costs |
| Radical Cystectomy | One-time procedure | ~$30,000-$40,000 | ~$65,188 (robotic) or $80,376 (open) |
Figure 1—Decision-Tree Analytic Model
RESULTS: Estimated 2-year drug costs were $480,000 for Adstiladrin
TM, $751,800 for Anktiva
TM +BCG, and $943,699 for Inlexzo
TM. Escalation through all three agents reached $2.18 million, with salvage RC adding $30,000-$40,000 in surgical costs. Compared with upfront RC, this pathway was ~62-fold higher; versus 2-year RC care, ~27-fold (open) and ~34-fold (robotic).
CONCLUSIONS: For BCG-unresponsive CIS, sequential bladder-sparing therapies can exceed $2.1 million per patient, far more than upfront RC. Bladder preservation remains important. This comparison highlights the tradeoff between bladder-sparing therapies and RC-related morbidity and quality of life, emphasizing the need to balance cost, outcomes, and patient preferences in shared decision-making.
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