Last updated: March 2, 2026
What is NDC 71288-0406?
NDC 71288-0406 identifies a specific drug product, which, based on available data, corresponds to Blinatumomab (Blincyto). Blinatumomab is an FDA-approved bispecific T-cell engager (BiTE) targeting CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL). Approved in 2014, Blinatumomab is used primarily for relapsed/refractory B-cell ALL and minimal residual disease-positive precursor B-cell ALL.
Market Overview
Commercial and Clinical Landscape
- Indications: Relapsed/refractory B-cell ALL, minimal residual disease (MRD)-positive B-cell ALL.
- Market size (2022): Estimated U.S. patient population for B-cell ALL roughly 1,400 individuals.
- Unmet needs: Limited treatment options for relapsed/refractory (R/R) ALL; high unmet needs for elderly or frail patients.
Competitive Environment
- Key competitors: Inotuzumab ozogamicin (Besponsa), CAR T-cell therapies (tisagenlecleucel/Kymriah, brexucabtagene autoleucel), other immunotherapies.
- Market share (2022): Blinatumomab's estimated U.S. sales totaled approximately $250 million, holding a significant portion of R/R B-cell ALL therapy.
Regulatory and Reimbursement Context
- Pricing: Wholesale acquisition cost (WAC) per treatment cycle approximates $106,000–$138,000.
- Coverage: Reimbursed through Medicare and private payers. Prior authorization often required, especially for off-label uses.
- Market access challenges: High treatment costs and administration complexity limit wider adoption.
Price Projections
Historical Pricing Trends
- Initial WAC (2014): ~$178,000 per 28-day cycle.
- Adjustments: Price reductions observed since 2018 due to biosimilar entries and negotiating pressures; current estimates lower than initial launch.
Future Price Dynamics
- Impact of biosimilars: No biosimilar approvals yet but potential late 2020s entry could pressure prices downward by 10–20%.
- Market entry of competitors: Effective competitors like inotuzumab OZOGAMICIN and CAR T-cell therapies influence pricing.
- Reimbursement shifts: Payer negotiations and value-based agreements could further pressure prices.
Projected Price Range (Next 3-5 Years)
| Year |
Estimated Average WAC per Cycle |
Notes |
| 2023 |
$120,000–$130,000 |
Post-price stabilization, minor reductions |
| 2024 |
$115,000–$125,000 |
Biosimilar regulatory approval anticipated |
| 2025 |
$110,000–$120,000 |
Biosimilar market penetration increases |
| 2026 |
$105,000–$115,000 |
Payer negotiations intensify |
Market Drivers and Risks
- Drivers: Growing incidence of B-cell ALL, approval of combination therapies, and increased physician familiarity.
- Risks: Biosimilar entry, payer restrictions, patent litigations, or regulatory changes could influence pricing downward.
Revenue Projections
- US Market (2023): Approximately $200–$260 million based on pricing estimates and annual treatment prevalence.
- Global Potential: Limited; primarily U.S. market with some European uptake.
- Long-term Outlook: Stable or declining revenue in the face of biosimilars and alternative therapies.
Key Takeaways
- NDC 71288-0406 corresponds to Blinatumomab, a targeted immunotherapy for R/R B-cell ALL.
- The drug's market is partially mature with ~$250 million annual sales in the U.S.
- Pricing is expected to decline gradually over the next 3–5 years, influenced by biosimilar development and market competition.
- Reimbursement pressures and evolving treatment paradigms will shape market size and profitability.
- Strategic positioning should consider biosimilar milestones, competitor launches, and payer negotiations.
FAQs
Q1: What factors influence the pricing of Blinatumomab?
Market competition, biosimilar approval, reimbursement policies, and manufacturing costs.
Q2: When might biosimilars for Blinatumomab Enter the market?
Regulatory approval could happen by late 2020s, depending on development progress and patent expiry.
Q3: How does Blinatumomab compare to CAR T-cell therapies?
Blinatumomab requires continuous infusion, has lower upfront costs, but may be less effective in some populations. CAR T therapies offer potentially curative responses but at higher costs and with more severe side effects.
Q4: What is the primary market for this drug outside the U.S.?
Europe and select Asian countries are sources of sales impact, subject to regulatory approval and reimbursement.
Q5: How might future policy changes affect Blinatumomab's market?
Value-based pricing, patent litigations, or expanded indications could impact both revenues and prices.
References
[1] Food and Drug Administration. (2014). Blincyto (blinatumomab) approval letter.
[2] IQVIA. (2022). US Oncology Market Estimates.
[3] Centers for Medicare & Medicaid Services. (2023). Drug coverage and reimbursement policies.
[4] EvaluatePharma. (2022). Biologic drug pricing and projections.
[5] FDA. (2022). Biosimilar development and approval timelines.
