Last updated: February 20, 2026
What is NDC 00472-0242?
NDC 00472-0242 is a proprietary medication known as Yescarta (axicabtagene ciloleucel). It is a chimeric antigen receptor T-cell (CAR-T) therapy approved by the FDA for adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy.
Market Landscape
Indications and Patient Population
Yescarta targets aggressive B-cell lymphomas. The relevant indications include:
- Diffuse large B-cell lymphoma (DLBCL)
- Primary mediastinal large B-cell lymphoma
- High-grade B-cell lymphoma
- DLBCL arising from follicular lymphoma
The total addressable market is primarily adults with relapsed/refractory (R/R) large B-cell lymphoma (LBCL), estimated at approximately 17,000–20,000 patients annually in the U.S. (American Cancer Society, 2022).
Competitive Environment
Yescarta competes with other CAR-T therapies targeting similar indications:
- Kymriah (tisagenlecleucel) by Novartis
- Breyanzi (lisocabtagene maraleucel) by Bristol-Myers Squibb
These therapies differ in manufacturing processes, approval labels, and pricing strategies but collectively dominate the market for R/R LBCL.
Market Penetration
Yescarta achieved approximately 23% of the US CAR-T market share in 2022, with steady growth driven by expanded indications and increasing acceptance in community settings. The shift toward outpatient infusion protocols also broadens its usage.
Regulatory and Reimbursement Trends
CMS and private insurers currently reimburse CAR-T therapies based on the "bundled payment" model. The average wholesale price (AWP) for Yescarta is about $373,000 per treatment dose (FDA, 2022). Reimbursement policies increasingly favor expanded access and outpatient protocols to reduce costs.
Price Projections
Current Pricing Landscape
- Average Wholesale Price (AWP): $373,000 per dose.
- Average Sales Price (ASP): Estimated at $350,000–$370,000 after distributor discounts.
- Net Price after Payer Negotiations: Typically 10-15% lower than AWP, reflecting rebates and discounts.
Future Price Trends
Price trajectories for Yescarta are influenced by:
- Manufacturing costs: Expected to decrease with process innovations and increased production scale. Economies of scale could lower unit costs by 10–15% over five years.
- Market competition: Introduction of biosimilars or alternative therapies could pressure price reductions by 15–20% over the next 3–5 years.
- Regulatory and reimbursement landscape: Shift toward value-based reimbursement models may limit price increases to reflect clinical outcomes.
Projected Price Range (2025-2030)
| Year |
Price Range (USD) |
Notes |
| 2025 |
$330,000 – $370,000 |
Slight decline due to competition and efficiency gains |
| 2028 |
$300,000 – $340,000 |
Further competitive pressures and cost reductions |
| 2030 |
$275,000 – $315,000 |
Market stabilization, biosimilar entry possible |
Revenue Projections
Given current sales volumes, Yescarta's US annual revenue is approximately $1.5–2 billion. With market growth, new indications, and potential price adjustments, revenue could reach:
- 2025: ~$2.2 billion
- 2030: ~$2.5–3 billion
Key Factors Impacting Revenue
- Adoption rate in outpatient settings
- Pipeline expansion for earlier line therapy
- Regulatory decisions on additional indications
Regulatory and Policy Influences
- FDA approvals for broader indications or combination therapies could expand the market.
- CMS reimbursement adjustments tied to outcomes and cost-effectiveness could modify pricing strategies.
- Patent expirations or biosimilar developments, anticipated around 2030, may significantly impact pricing and market share.
Key Takeaways
- NDC 00472-0242 (Yescarta) is a leading CAR-T therapy for R/R LBCL with approximately $373,000 AWP per dose.
- The market is competitive with Kymriah and Breyanzi sharing similar indications.
- Market penetration is solid, with potential for growth through outpatient administration and pipeline expansion.
- Price projections suggest a gradual decline, influenced by competition, cost reduction, and value-based policies.
- Revenue from Yescarta is likely to increase through 2025 and into the late 2020s, contingent on market development and policy measures.
FAQs
Q1: How does the price of Yescarta compare to competing CAR-T therapies?
Yescarta's current AWP (~$373,000) is comparable to Kymriah and Breyanzi, which range from $375,000 to $410,000. Price variances depend on dosing and negotiated discounts.
Q2: What factors could significantly alter future pricing?
Introduction of biosimilars, manufacturing cost reductions, reimbursement model shifts, and regulatory changes could all influence pricing.
Q3: Is there potential for price reductions based on clinical outcomes?
Yes, increasing emphasis on value-based contracts could tie prices to clinical effectiveness, potentially reducing payers' costs.
Q4: How might expanded indications affect revenue projections?
Approval for earlier lines of therapy or other lymphoma types could expand patient volume, boosting revenue despite potential price pressures.
Q5: When are biosimilar entries expected, and how will they impact the market?
Biosimilar development is underway, with regulatory filings anticipated around 2028–2030. Biosimilar competition could lead to substantial price decreases.
References
[1] American Cancer Society. (2022). Cancer facts & figures 2022.
[2] FDA. (2022). Yescarta (axicabtagene ciloleucel) prescribing information.
[3] IQVIA. (2022). Market data for CAR-T therapies.
[4] CMS. (2022). Reimbursement policies for CAR-T therapies.
