Last updated: March 5, 2026
What is the Registered Drug?
NDC 62135-0495 is associated with Tisagenlecleucel (Kymriah), a CAR T-cell immunotherapy for relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL) and certain types of non-Hodgkin lymphoma. It is manufactured by Novartis.
Market Overview
Indications and Use Cases
- Approved for pediatric and young adult patients up to 25 years with B-cell ALL refractory or in second or later relapse.
- Approved for adult patients with relapsed or refractory large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma, primary mediastinal large B-cell lymphoma, and transformed follicular lymphoma.
Market Size
- The global market for CAR T-cell therapies is projected to reach $10 billion by 2030 (Grand View Research, 2022).
- The U.S. CAR T-cell therapy market, specifically for cancers treatable with Kymriah, targets approximately 2,500-3,000 patients annually.
Competitive Landscape
- Yescarta (Gilead) is a primary competitor.
- Breyanzi (Bristol-Myers Squibb) also targets similar indications.
- Emerging therapies aim to expand or replace CAR T-cell options.
Adoption Drivers
- Increased approval for broader indications.
- Growing number of patients eligible for treatment.
- Reimbursement policies by Centers for Medicare & Medicaid Services (CMS).
- Clinical data supporting durable remissions and safety.
Pricing Structure
List Price
- The wholesale list price of Kymriah in the U.S. is approximately $475,000 per treatment course.
- Price reflects the cost of cell manufacture, personalization, and administration.
Reimbursement & Payer Policies
- Payers generally reimburse on a case-by-case basis.
- Outcome-based payment models are increasingly common.
- Coverage for pediatric ALL is generally earlier established than for adult NHL.
Cost Trends
- Price stability in recent years.
- Minor adjustments due to manufacturing costs and distribution logistics.
- Pricing for expanded indications remains under negotiation.
Market Dynamics Influencing Price Projections
Clinical Development and Approvals
- Recent approval extensions for additional lymphoma subtypes.
- New clinical trials aim to improve efficacy and safety, potentially impacting future pricing.
- Expanding indications can increase the number of treatments, slightly diluting per-unit cost but increasing overall market share.
Regulatory and Policy Developments
- Cost-effectiveness assessments by health authorities influence future pricing.
- United States has no mandated price reductions; negotiations remain bilateral between manufacturers and payers.
Market Entry of Biosimilars and Competitors
- Limited biosimilar competition due to personalized nature.
- New CAR T therapies entering the market could pressure prices downward.
Manufacturing and Supply Chain
- Complexity of autologous cell therapy drives high production costs.
- Innovations reducing manufacturing costs could lead to lower prices over the medium term.
Pricing Projections (2023-2028)
| Year |
Estimated Average Treatment Price |
Influencing Factors |
| 2023 |
$475,000 |
Stable list pricing; Reimbursement policies enforce consistency. |
| 2024 |
$470,000 |
Slight reductions expected due to operational efficiencies. |
| 2025 |
$465,000 |
Expansion of indications may stabilize gross revenue. |
| 2026 |
$460,000 |
Competitive pressures from emerging therapies. |
| 2027 |
$455,000 |
Cost reductions in manufacturing begin impacting pricing. |
| 2028 |
$450,000 |
Potential impacts from new market entrants and policy adjustments. |
Summary
NDC 62135-0495 (Kymriah) maintains a high price point driven by manufacturing complexity, personalized therapy logistics, and limited competition. Expect marginal price reductions over the next five years influenced by operational efficiencies and competitive dynamics but no significant drop unless new payer negotiations or biosimilar entries occur.
Key Takeaways
- Kymriah's current price stands around $475,000 per course.
- Market size is limited but growing, with expanding indications.
- Price projections indicate slight decreases over five years, approximately 1% annually.
- Pricing is influenced by manufacturing innovations, regulatory changes, and competition.
- Reimbursement policies, especially outcome-based models, play a critical role in market uptake.
FAQs
Q1: How does the price of Kymriah compare with other CAR T therapies?
A: It is generally comparable to Yescarta, with slight variations based on indication and manufacturer policies.
Q2: What factors could lead to larger price reductions?
A: Entry of biosimilars, manufacturing cost reductions, or policy mandates.
Q3: Are there any upcoming regulatory decisions that could impact pricing?
A: Approvals for new indications and outcome-based reimbursement policies are under review and may influence prices.
Q4: How do manufacturing complexities affect treatment costs?
A: Personalized manufacturing increases costs, supporting higher price points; operational efficiencies can reduce this over time.
Q5: What proportion of the treatment cost is covered by insurance?
A: Coverage varies; commercial payers often reimburse fully or partially, with formulary management influencing patient access.
References
[1] Grand View Research. (2022). CAR T-Cell Therapy Market Size, Share & Trends Analysis Report.
[2] Novartis. (2022). Kymriah prescribing information.
[3] Centers for Medicare & Medicaid Services. (2022). Reimbursement policy updates.
