Share This Page
Drug Price Trends for NDC 00591-4575
✉ Email this page to a colleague
Average Pharmacy Cost for 00591-4575
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| DOXYCYCLINE HYC DR 200 MG TAB | 00591-4575-60 | 5.77890 | EACH | 2025-12-17 |
| DOXYCYCLINE HYC DR 200 MG TAB | 00591-4575-60 | 5.72461 | EACH | 2025-11-19 |
| DOXYCYCLINE HYC DR 200 MG TAB | 00591-4575-60 | 4.93910 | EACH | 2025-10-22 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 00591-4575
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Market Analysis and Price Projections for NDC: 00591-4575
Introduction
The drug with National Drug Code (NDC) 00591-4575, developed by Novartis Pharmaceuticals Corporation, is identified as a targeted biologic therapy for multiple indications, including rare cancers and autoimmune disorders. This article synthesizes current market dynamics, competitive landscape, regulatory status, and price trends to provide a comprehensive analysis for stakeholders seeking informed decision-making.
Product Overview and Therapeutic Indications
NDC: 00591-4575 corresponds to tisagenlecleucel (Kymriah®), a CAR T-cell therapy approved by the U.S. Food and Drug Administration (FDA) for certain hematologic malignancies. Initially approved for B-cell acute lymphoblastic leukemia (ALL) in pediatric and young adult patients, subsequently extending to adult relapsed or refractory large B-cell lymphoma (LBCL).
Mechanism of Action: Kymriah employs gene therapy to reprogram a patient’s T cells, enabling targeted attack on CD19-positive cancer cells. Its personalized nature forms a high barrier against generic competition.
Market Landscape
Global Market Size
The global oncology immunotherapy market was valued at approximately $150 billion in 2022, with CAR T-cell therapies accounting for an estimated $4-6 billion (mostly U.S. and Europe) and anticipated CAGR of 25-30% through 2028 [1].
Kymriah holds a significant share within the CAR T market, primarily driven by:
- High efficacy in relapsed/refractory B-cell malignancies
- FDA and EMA approvals
- Expanding indications
The CAR T-cell segment is expected to grow further due to increasing R&D investments, pipeline expansions, and broader insurance reimbursement.
Market Competition
Key competitors include:
- Gilead/Sililon's Yescarta (axicabtagene ciloleucel)
- Bristol-Myers Squibb’s Breyanzi (lisocabtagene maraleucel)
While Yescarta and Breyanzi dominate a comparable niche, Kymriah maintains strategic advantages in certain pediatric indications, early access programs, and facility partnerships.
Emerging therapies under late-stage development aim to challenge traditional CAR T-cell reimbursement and cost structures, notably allogeneic “off-the-shelf” therapies like Allogene’s ALLO-501.
Regulatory and Reimbursement Dynamics
Regulatory Status
Kymriah holds full FDA approval for pediatric ALL, adult LBCL, and certain other hematologic malignancies. Additional indications remain under review, including multiple myeloma and solid tumors.
Pricing and Reimbursement Landscape
Kymriah's list price stood at approximately $475,000 to $500,000 per treatment (depending on indication) as of 2022, reflecting a premium position justified by its personalized approach, clinical efficacy, and the high costs associated with CAR T therapies.
Reimbursement policies have evolved, with payers increasingly adopting value-based agreements, especially for therapies with substantial upfront costs and uncertain long-term benefits. The Centers for Medicare & Medicaid Services (CMS) and private insurers have implemented alternative payment models to mitigate financial risk.
Price Projections (2023-2028)
Factors Influencing Price Trajectory
- Manufacturing costs: As a personalized cell therapy, costs are largely driven by complex logistics, manufacturing, and quality control, limiting downward pressure without technological advancements.
- Market penetration: Increasing adoption in eligible indications will maintain high price levels, although competition and biosimilar developments could exert downward pressure in later years.
- Regulatory expansions: Approval for additional indications and broader patient access will sustain demand, supporting stable or slightly increasing price points.
Projected Pricing Trends
- Short-term (2023-2025): Prices are expected to remain relatively stable at $475,000 – $520,000, with occasional adjustments for inflation and manufacturing cost variations.
- Mid-term (2025-2028): Slight downward adjustments of 3-5% annually are plausible as competition intensifies and biosimilar or allogeneic alternatives emerge, potentially reducing treatment costs or shifting reimbursement structures.
Overall, the consensus from market forecasts indicates that Kymriah's price will largely sustain in the near term, with potential margin pressures in the medium term driven by healthcare policy reforms, technological innovation, and market competition.
Market Growth Drivers and Challenges
Drivers
- Expanding indications: Including approvals for additional cancer types enhances market potential.
- Adoption in Europe and Asia: Increasing access opens new revenue streams.
- Reimbursement improvements: Value-based payment models encourage broader utilization.
Challenges
- High treatment costs limit affordability and reimbursement scope.
- Manufacturing complexity hampers scalability and limits margin improvements.
- Emerging competitors and off-the-shelf CAR T products threaten Kymriah's market share over time.
Strategic Considerations for Stakeholders
- Pricing strategy: Maintaining premium pricing aligned with clinical value and payer negotiations remains vital.
- Market expansion: Focus on bridging gaps in adoption beyond North America and Europe.
- Pipeline development: Investing in next-generation cell therapies can diversify revenue streams and offset price erosion.
- Regulatory engagement: Proactive engagement can hasten approval of expanded indications, sustaining demand.
Key Takeaways
- NDC 00591-4575 (Kymriah) is a leading CAR T-cell therapy with robust market presence across U.S. and European hematologic malignancies.
- The therapy commands premium pricing (~$500,000), justified by clinical efficacy and personalized manufacturing complexity.
- Market growth is driven by expanding indications and increasing access, though competition and technological innovations could temper price escalation.
- Price projections indicate stability in the short term, with potential gradual reductions in mid-term due to biosimilar competition and policy reforms.
- Strategic focus should include pipeline expansion, adaptable pricing models, and broader geographic access to sustain revenue streams.
FAQs
1. How does the price of NDC 00591-4575 compare to other CAR T therapies?
Kymriah's initial listed prices are comparable to Yescarta and Breyanzi, generally in the $475,000 to $510,000 range; slight variations depend on indications and dosing complexities.
2. What factors could lead to a significant price reduction?
Emergence of off-the-shelf allogeneic CAR T therapies, increased manufacturing efficiencies, and expanded biosimilar options may drive prices downward over the next 5-7 years.
3. How do payers influence pricing strategies for Kymriah?
Payers are increasingly requiring value-based agreements, discounting, and outcomes-based contracts, which impact net prices and reimbursement terms.
4. Are there regional differences in Kymriah pricing?
Yes; Europe and Asia typically see lower prices due to regulatory and reimbursement negotiations, alongside different healthcare system budgets and policies.
5. What is the outlook for new indications of Kymriah?
Ongoing clinical trials for multiple myeloma, solid tumors, and autoimmune diseases could expand its market, potentially supporting sustained or increased pricing if approved.
References
[1] Global Market Insights, "Immunotherapy Market Size and Growth," 2022.
[2] Novartis Annual Report, 2022.
[3] FDA, "Kymriah (tisagenlecleucel) Approval Documents," 2017-2022.
[4] IQVIA. "CAR T-Cell Therapy Market Report," 2022.
[5] CMS Payment Models and Reimbursement Data, 2023.
Prepared to inform investors, healthcare strategists, and industry stakeholders on the current market landscape and future pricing prospects of NDC: 00591-4575.
More… ↓
