Interventions of Interest:

  • nadofaragene firadenovec (Adstiladrin®, FKD Therapies Oy and FerGene)
  • oportuzumab monatox (Vicineum®, Sesen Bio)

Bladder cancer is the most common cancer involving the urinary system and usually presents with blood in the urine (hematuria). Overall, bladder cancer is the sixth most common cancer in the United States (US), with approximately 80,000 new cases each year and 17,700 deaths.

An independent appraisal committee determined current evidence is adequate to demonstrate that nadofaragene firadenovec and oportuzumab monatox provide a net health benefit over best supportive care, but that the evidence is inadequate to enable a clear comparison of these treatments to each other or to other active treatments.

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Nadofaragene firadenovec has received a fast track and breakthrough therapy designation from the FDA.

Final Documents

ICER’s Chief Medical Officer David Rind, MD, MSc stated:

“For many patients with BCG-unresponsive NMIBC, there are limited interventions available that preserve the bladder…While our review of the evidence suggests that both nadofaragene firadenovec and oportuzumab monatox may provide benefits for patients, more rigorous trials are needed. The lack of a placebo or active comparator in pivotal trials, though meeting FDA guidance, leaves clinicians, patients, and other stakeholders with significant uncertainty around comparative benefits and the magnitude of those benefits. Even if the therapies are approved based on the current evidence, prospective head-to-head trials are needed that compare treatments and assess patient-important outcomes. Manufacturers should commit to setting prices that are commensurate with the added benefits of these new therapies compared to lower-cost clinically appropriate regimens.”