Anktiva shortage: What providers and prescribers need to know in 2026

Anktiva Supply Landscape: A Provider Briefing for 2026

Since its FDA approval in April 2024, Anktiva (nogapendekin alfa inbakicept-pmln) has rapidly become an important treatment option for BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ. ImmunityBio reported 700% year-over-year revenue growth for the drug in 2025, reflecting growing adoption across urology practices and cancer centers.

However, significant supply and access challenges remain — most critically, the ongoing BCG shortage that directly impacts Anktiva's utility. This guide provides urologists, oncologists, and practice administrators with the information needed to navigate these challenges in 2026.

Current Supply Status

Anktiva Availability

Anktiva supply from ImmunityBio has been scaling to meet demand. The drug is not currently listed on the FDA drug shortage database. It is distributed through specialty channels, primarily Cencora (formerly AmerisourceBergen), using the buy-and-bill model.

Key ordering details:

• NDC: 81481-803-01 (single-dose vial)
• Dosage form: 400 mcg/0.4 mL intravesical solution
• WAC: $35,800 per dose
• J-code: J9028 (permanent, effective January 2025)
• Distributor: Cencora — 1-888-711-5469

BCG Shortage: The Critical Constraint

The primary barrier to Anktiva utilization remains the BCG (TICE BCG) shortage. Merck continues as the sole U.S. manufacturer, and supply has been inadequate for several years. Key developments:

• ImmunityBio has characterized the current BCG shortage as "terrible" in corporate communications
• The company's recombinant BCG (rBCG) program has dosed over 570 patients through expanded access at 58 sites
• Over 45,000 rBCG vials were anticipated for U.S. availability in 2025
• A U.S. FDA meeting for rBCG was scheduled for March 2026
• European regulatory submission is also planned

For practices managing limited BCG supply, prioritization of BCG for Anktiva combination therapy in eligible patients represents a clinical and logistical decision that should be made at the institutional level.

Reimbursement and Payer Landscape

Insurance Coverage

Coverage for Anktiva has expanded significantly since the permanent J-code was issued in January 2025. Key payer considerations:

• Commercial insurers: Most major commercial payers have established coverage policies, though prior authorization is uniformly required
• Medicare: Coverage under Part B (physician-administered drug) with appropriate documentation of BCG-unresponsive status
• Documentation requirements: Payers typically require evidence of BCG-unresponsive disease per FDA guidance criteria — persistent/recurrent CIS within 12 months of adequate BCG therapy, or recurrent high-grade Ta/T1 within 6 months of adequate BCG

Financial Support Programs

ImmunityBio offers the CARE program to support provider offices with reimbursement navigation:

• Benefits investigation: Verify patient coverage and requirements
• Prior authorization support: Assistance with submission and tracking
• Claim denial guidance: Payer-specific appeal strategies
• Copay assistance: Eligible commercially insured patients can pay as little as $100 per dose (maximum benefit $25,000)
• Patient assistance program: For qualifying uninsured/underinsured patients
• Contact: 1-877-ANKTIVA (1-877-265-8482) or 833-422-2731, Monday–Friday, 8:00 AM–8:00 PM ET

For detailed reimbursement guidance, providers can access the official ordering and reimbursement resources on the Anktiva HCP website.

Clinical Considerations for Prescribers

Dosing Protocol

The approved dosing regimen for Anktiva with BCG:

• Induction: 400 mcg intravesically with BCG once weekly × 6 weeks
• Assessment: Evaluate response at month 3; second induction course may be given if CIS persists
• Maintenance: 400 mcg with BCG once weekly × 3 weeks at months 4, 7, 10, 13, and 19
• Extended maintenance: For patients with ongoing CR at month 25+, additional courses at months 25, 31, and 37
• Maximum duration: 37 months total

Efficacy Data

From the pivotal QUILT-3.032 trial:

• CIS complete response rate: >62%
• 12-month CR rate: 66% of responders
• 24-month CR rate: 42% of responders
• Bladder preservation: Durable responses support bladder-sparing approaches

Safety Profile

Most adverse reactions are local and consistent with intravesical therapy:

• Common (≥15%): Increased creatinine, dysuria, hematuria, urinary frequency, micturition urgency, UTI, increased potassium, musculoskeletal pain, chills, pyrexia
• Other notable: Fatigue (14%), nausea (14%), irritable bladder (11%), diarrhea (9%), nocturia (7%)
• Serious: Hematuria (3.4%), fatal cardiac arrest (1.1%)
• Systemic exposure: Below limit of quantitation following intravesical administration at the approved dose

Important safety communications: The label includes a warning regarding delayed cystectomy — providers should discuss with patients that the risk of metastatic bladder cancer increases the longer cystectomy is delayed in the presence of persisting CIS. Females of reproductive potential should use effective contraception during treatment and for 1 week after the last dose.

Managing BCG Allocation at Your Practice

Given the ongoing BCG shortage, providers should consider developing institutional protocols for BCG allocation. Considerations include:

• Prioritize BCG-naïve induction patients who have the highest likelihood of response to initial BCG therapy
• Reserve BCG for Anktiva combination therapy in BCG-unresponsive patients who are eligible — this is a patient population with limited treatment options
• Consider BCG-free alternatives for patients who can be treated with Pembrolizumab, Adstiladrin, or intravesical Gemcitabine/Docetaxel
• Track and forecast BCG utilization to maintain adequate supply for patients already on Anktiva maintenance
• Explore the rBCG expanded access program — contact ImmunityBio about eligibility for your practice

Referring Patients for Anktiva Treatment

If your practice does not currently carry Anktiva or lacks BCG supply, consider referring eligible patients to:

• Academic medical centers with urologic oncology programs
• NCI-designated comprehensive cancer centers
• Practices enrolled in the rBCG expanded access program

You can direct patients to MedFinder for Providers as a tool for locating treatment centers with current Anktiva availability.

Expanded Indications on the Horizon

ImmunityBio has submitted a supplemental BLA for Anktiva + BCG in papillary-only BCG-unresponsive NMIBC, supported by long-term disease-free survival data from the QUILT-3.032 trial. Additionally, the company is investigating Anktiva in combination with chemotherapy and checkpoint inhibitors for non-small cell lung cancer (NSCLC).

The European Medicines Agency recommended conditional marketing authorization for Anktiva with BCG in NMIBC CIS, with six BCG strains available in Europe for combination use.

Key Takeaways for Providers

• Anktiva supply is stable and scaling; BCG shortage is the primary access barrier
• Prior authorization is required by all payers — start early and leverage the CARE program
• rBCG expanded access may provide a path to BCG supply for your practice
• Consider institutional BCG allocation protocols that prioritize high-value treatment combinations
• For patients who cannot wait for BCG, discuss BCG-independent alternatives

Related Articles

• How to Help Your Patients Find Anktiva in Stock: A Provider's Guide
• How to Help Patients Save Money on Anktiva: Provider's Guide
• Anktiva Shortage Update: What Patients Need to Know in 2026
• Alternatives to Anktiva