Imfinzi + BCG for NMIBC access guide: FDA approval, coding, and buy-and-bill

On May 28, 2026, the FDA approved Imfinzi (durvalumab) in combination with Bacillus Calmette-Guérin (BCG) induction and maintenance therapy for adult patients with BCG-naïve, high-risk non–muscle invasive bladder cancer (NMIBC). It is the first and only immunotherapy combination approved in this setting and the first new treatment option for high-risk NMIBC in years.

The approval is based on the Phase 3 POTOMAC trial, which showed a 32% reduction in the risk of disease recurrence, progression, or death compared with BCG alone. For urology practices and cancer centers, the new indication creates a Part B buy-and-bill therapy that runs alongside intravesical BCG — and raises immediate questions about prior authorization, coding, site-of-care logistics, and reimbursement.

This guide maps what access teams, urologists, and pharmacy directors need to know. It is independent information and not medical advice or reimbursement guidance for a specific patient or plan.

Quick answer

Who this is for

• Urologists and oncology teams treating non–muscle invasive bladder cancer
• Hospital pharmacy directors and cancer center administrators evaluating formulary addition
• Prior authorization and benefit verification specialists processing Part B claims for the new regimen
• Market access teams at AstraZeneca tracking adoption and reimbursement
• Payer medical directors reviewing utilization management criteria for NMIBC

Source standard

Every fact in this guide is sourced from the FDA approval notice dated May 28, 2026, the AstraZeneca press release, the POTOMAC trial publication in The Lancet, the Imfinzi prescribing information revised May 2026, and the AstraZeneca Access 360 reimbursement guide. Always verify current coverage and coding through payer-specific portals and the latest CMS guidance.

What changed and why it matters

Before this approval, the standard of care for BCG-naïve, high-risk NMIBC was transurethral resection of bladder tumor (TURBT) followed by BCG induction and maintenance therapy. Up to 80% of high-risk NMIBC patients experience disease recurrence within five years of BCG treatment, and many eventually require radical cystectomy.

The POTOMAC trial demonstrated that adding one year of durvalumab IV infusions to standard BCG therapy meaningfully reduced disease recurrence. The FDA granted standard review and approved the combination based on the final analysis of POTOMAC.

Key trial results from POTOMAC (presented at ESMO 2025 and published in The Lancet):

• 67 disease-free survival (DFS) events in the durvalumab + BCG arm versus 98 events in the BCG-alone arm
• Hazard ratio 0.68 (95% CI 0.50–0.93; two-sided P = .0154)
• Median time to high-risk event: 14.1 months with durvalumab + BCG vs 8.3 months with BCG alone
• Among patients who underwent cystectomy, median time to surgery: 19 months with durvalumab vs 14.1 months with BCG alone
• Median DFS was not reached for either arm at a median follow-up of 60.7 months

Dosing and administration

The recommended durvalumab dose for patients weighing ≥30 kg is:

• 1,500 mg IV every 4 weeks for up to 13 cycles
• Administered in combination with BCG induction and maintenance therapy
• First infusion: infuse over 60 minutes; if tolerated, subsequent infusions may be administered over 30 minutes
• Treatment should continue until recurrence of high-risk disease, disease progression, unacceptable toxicity, or a maximum of 13 cycles

For patients weighing <30 kg: 20 mg/kg IV every 4 weeks for up to 13 cycles.

Coverage and benefit routing

Durvalumab for NMIBC is administered as an intravenous infusion in a clinic or hospital outpatient setting. This means it routes through the medical benefit (Part B in Medicare), not the pharmacy benefit.

Medical benefit (Part B)

• Route: IV infusion — billed under medical benefit
• Medicare Part B: Covered under the buy-and-bill model. Providers purchase the drug, administer it, and bill Medicare at ASP + 4.5% (or ASP + add-on for providers in certain models)
• Commercial payers: Most cover IV oncology drugs under the medical benefit, but PA requirements, site-of-care edits, and preferred acquisition channel (buy-and-bill vs. specialty pharmacy provider) vary by plan

Prior authorization

Because this is a newly approved indication for an existing drug, expect:

• Most commercial payers to require prior authorization for the NMIBC indication even if Imfinzi was previously on the medical benefit formulary for other cancers
• PA criteria may include confirmation of BCG-naïve status, high-risk NMIBC classification (Ta/T1 high-grade, CIS, or both), and documented TURBT
• Medicare Advantage plans may apply step-edit or site-of-care requirements

Site-of-care considerations

• Hospital outpatient department (HOPD): Most common setting; drug paid at ASP + 4.5% under Part B
• Physician office (POS 11): Also eligible for buy-and-bill reimbursement, but some payers prefer hospital administration for PD-1/PD-L1 agents
• Ambulatory surgery center (POS 24): Less common for immunotherapy infusions; check payer policy

Coding guide

HCPCS / J-code

Imfinzi (durvalumab) has an established J-code. Verify the current code through CMS quarterly HCPCS updates:

Wastage billing

Hospitals billing outpatient claims should use the JW modifier for discarded drug and the JZ modifier when no wastage occurs, per CMS requirements.

Buy-and-bill economics

The Imfinzi NMIBC regimen calls for 13 cycles of 1,500 mg IV over approximately one year. For a drug with an established ASP in the oncology space, the buy-and-bill economics include:

• Per-cycle cost: 1,500 mg at current ASP (check CMS ASP pricing files)
• Total treatment course: Up to 13 cycles
• Wastage: 1,500 mg can be drawn from three 500 mg vials with no wastage, or from a combination of 500 mg and 120 mg vials depending on inventory
• Reimbursement: ASP + 4.5% (non-340B) or 340B ceiling price considerations for eligible entities

Providers should confirm ASP pricing through the quarterly CMS ASP files and verify payer-specific reimbursement rates before initiating the regimen.

Patient assistance and support

AstraZeneca offers patient support through Access 360:

• Phone: 1-844-275-2360
• Services: Benefit investigation, prior authorization support, patient assistance copay programs for commercially insured patients
• Website: www.MyAccess360.com
• Specialty pharmacy: AstraZeneca can direct providers to in-network specialty pharmacy providers for medical benefit drugs

Competitive landscape

Durvalumab + BCG for BCG-naïve high-risk NMIBC enters a competitive landscape:

Keytruda is already approved for BCG-unresponsive NMIBC with carcinoma in situ, but that is a different patient population. The POTOMAC-based Imfinzi approval targets BCG-naïve patients earlier in the disease course. Keytruda is also being studied with BCG in KEYNOTE-676 for the same BCG-naïve high-risk NMIBC population, which could create future competition.

What to monitor

• Formulary decisions: NCCN guidelines update for NMIBC — whether durvalumab + BCG becomes a Category 1 recommendation for BCG-naïve high-risk NMIBC
• PA criteria evolution: As payers adopt the new indication, expect PA criteria to tighten after the initial launch window
• Medicare ASP updates: The ASP for durvalumab may adjust with increased utilization across multiple indications
• Competing therapies: KEYNOTE-676 readout for Keytruda + BCG could shift the treatment landscape
• Real-world adoption: Urology practices may face challenges integrating a systemic IV immunotherapy into a disease setting previously managed with intravesical therapy alone

Sources

• FDA. FDA approves durvalumab in combination with Bacillus Calmette-Guerin for high-risk non-muscle invasive bladder cancer. May 28, 2026. Available at: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-durvalumab-combination-bacillus-calmette-guerin-high-risk-non-muscle-invasive-bladder
• AstraZeneca. IMFINZI (durvalumab) approved in the US in first and only immunotherapy combination for patients with BCG-naïve, high-risk non-muscle-invasive bladder cancer. Press release. May 28, 2026. Available at: https://www.astrazeneca.com/media-centre/press-releases/2026/imfinzi-approved-in-us-for-early-bladder-cancer.html
• POTOMAC trial: Durvalumab in combination with BCG for BCG-naive, high-risk, non-muscle-invasive bladder cancer (POTOMAC): final analysis of a randomised, open-label, phase 3 trial. The Lancet. 2025. Available at: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(25)01897-5/fulltext
• AstraZeneca. IMFINZI (durvalumab) Prescribing Information. Revised May 2026. Available at: https://www.imfinzihcp.com
• AstraZeneca Access 360. IMFINZI Access and Reimbursement Guide. Available at: https://www.myaccess360.com
• Prime Therapeutics. High-Cost Therapy Profile: January 2026. Available at: https://www.primetherapeutics.com/high-cost-therapy-profile-january-2026