1.1. Study Question

“What is the cost-utility of BOTOX 100 U injection and best supportive care (BSC) compared to BSC alone in the management of refractory UI due to OAB from the public payer perspective in Canada?”

(Manufacturer’s Pharmacoeconomic Submission, page 3.²)

1.2. Treatment

OnabotulinumtoxinA (Ona A; Botox) is administered at a recommended dose of 100 U injected into the detrusor muscle, in combination with BSC, which consists of incontinence pads and treatment for adverse events such as skin and urinary tract infections (UTIs).

1.3. Comparators

The economic evaluation submitted by the manufacturer compared Ona A in combination with BSC (incontinence pads and treatment for adverse events such as skin and UTIs) with BSC alone.

1.4. Type of Economic Evaluation

The manufacturer submitted a cost-utility analysis (CUA) as per CADTH’s Guidelines for Economic Evaluations of Health Technologies: CADTH. The analysis takes a ministry of health perspective. The manufacturer also submitted a CUA from the societal perspective.

1.5. Population

The target population for this economic evaluation comprises adult patients with overactive bladder (OAB) with urinary incontinence (UI) that is not adequately managed with anticholinergic medications. This is in line with the Health Canada indication. The baseline patient and disease characteristics for the target population were derived from two phase 3 studies (191622-095 and 191622-520)^4,5 and an Ona A extension trial (191622-096).⁶ Mean age at baseline was 60.4 years.²