Cost Effectiveness Analysis of Nadofaragene Firadenovec for the Treatment of High-Risk, BCG–unresponsive, NMIBC from a US Third-Party Payer Perspective

(UroToday.com) The 2024 American Society of Clinical Oncology (ASCO) annual meeting featured a session on bladder cancer, and a presentation by Dr. Min Yang discussing a cost effectiveness analysis of nadofaragene firadenovec for the treatment of high-risk, BCG–unresponsive, non-muscle invasive bladder cancer from a United States third-party payer perspective. Bladder cancer is the second most common cancer in the urinary tract in the United States, with 75% restricted to the superficial layers of the bladder and termed as non-muscle invasive bladder cancer. For decades, BCG has been the standard of care for high risk non-muscle invasive bladder cancer patients, however, bladder preserving treatments are limited after BCG failure. Nadofaragene firadenovec, an interferon-alfa-2b encoding gene therapy, is approved for the treatment of high-risk BCG-unresponsive non-muscle invasive bladder cancer with CIS with or without papillary tumors (CIS ± Ta/T1):

This study presented at ASCO 2024 assessed cost-effectiveness of nadofaragene firadenovec compared to pembrolizumab from a United States third-party payer perspective.

A Markov model was developed to estimate total costs, quality adjusted life years, and corresponding incremental cost per quality adjusted life year ratios over a lifetime time horizon for patients treated with nadofaragene firadenovec or pembrolizumab. In the absence of head to head data comparing nadofaragene firadenovec to pembrolizumab, the model population was based on phase 3 trial for nadofaragene firadenovec (data cut: July 8, 2019) and included adult patients (mean age of 71.0 years; 11.7% female) with high-risk, BCG unresponsive non-muscle invasive bladder cancer with CIS ± Ta/T1.¹ Pembrolizumab data was informed by the published KeyNote-057 trial (data-cut: May 25, 2020).² The model consisted of 7 mutually exclusive health states with a three-month model cycle:

• Non-muscle invasive bladder cancer disease-free
• Non-muscle invasive bladder cancer recurrence
• Muscle invasive bladder cancer
• Metastatic disease
• Cystectomy
• Post-cystectomy
• Death

Drug costs, adverse events costs, and health state associated medical costs were included and discounted at 3% annually. The nadofaragene firadenovec and pembrolizumab prices were informed by 2023 United States pricing compendia.

Compared to pembrolizumab, nadofaragene firadenovec resulted in an incremental cost per quality adjusted life year of $123,725 per quality adjusted life year gained. The incremental cost was $24,194 (nadofaragene firadenovec: $374,280; pembrolizumab: $350,086) and the incremental quality adjusted life year was 0.196 (nadofaragene firadenovec: 4.560; pembrolizumab: 4.364). The cumulative drug acquisition and administration costs for nadofaragene firadenovec and pembrolizumab were $181,134 and $141,954 respectively, and adverse event costs were $248 and $2,749 and medical costs associated with health states were $192,898 and $205,382, respectively. The incremental cost per quality adjusted life year ratios for nadofaragene firadenovec remained cost-effective across a majority of the sensitivity analyses and simulations.

Written by: Zachary Klaassen, MD, MSc – Urologic Oncologist, Associate Professor of Urology, Georgia Cancer Center, Wellstar MCG Health, @zklaassen_md on Twitter during the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, Chicago, IL, May 31^st – June 4^th, 2024  

References:

1. Boorjian SA, Alemozaffar M, Konety BR, et al. Intravesical nadofaragene firadenovec gene therapy for BCG-unresponsive non-muscle-invasive bladder cancer: A single-arm, open-label, repeat-dose clinical trial. Lancet Oncol. 2021 Jan;22(1):107-117.
2. Balar AV, Kamat AM, Kulkarni GS, et al. Pembrolizumab monotherapy for the treatment of high-risk non-muscle-invasive bladder cancer unresponsive to BCG (KEYNOTE-057): An open-label, single-arm, multicenter, phase 2 study. Lancet Oncol. 2021 Jul;22(7):919-930.