TABLE 3.

Strategies to Minimize BCG Use During Shortages

Avoid BCG in patients with low-risk disease. Intravesical chemotherapy is the first-line option for patients with intermediate-risk NMIBC. Utilize alternative intravesical chemotherapy rather than BCG for patients who would normally receive BCG as a second-line therapy for intermediate-risk NMIBC. For high-risk NMIBC, high-grade T1 and CIS patients undergoing induction therapy should be prioritized for full-strength BCG. If not available, then employ reduced 1/2 to 1/3 dose. If the BCG stocks available for maintenance therapy for NMIBC patients, attempt 1/3 dose BCG and limit doses to 1 year. During a BCG supply shortage, do not utilize maintenance therapy and limit induction BCG to BCG-naive patients with high-risk disease. If no BCG is available, then physicians should consider mitomycin for induction and maintenance up to 1 year. Other options include gemcitabine, valrubicin, epirubicin, docetaxel, sequential gemcitabine/docetaxel, and/or mitomycin. Patients with high-risk features who after shared decision making are not willing to accept alternative intravesical agents should be offered initial radical cystectomy. When a 1/2 to 1/3 dose is used, maximize resources by treating multiple patients in the same day to avoid wasting BCG; coordinate with pharmacy prior to split dosing.

BCG, bacillus Calmette-Guerin; CIA, carcinoma in situ; NMIBC, non-muscle invasive bladder cancer.

At the time of this writing, it is still unclear how split-vial dosing of BCG will be billed. The AUA is currently working with the Centers for Medicare & Medicaid Services (CMS) to determine the next step. Therefore, it is important for physicians to discuss with the insurance company prior to split dosing.

Adapted from American Urological Association.²⁰