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Drug Price Trends for NDC 61269-0403
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Average Pharmacy Cost for 61269-0403
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| DROXIA 300 MG CAPSULE | 61269-0403-60 | 0.72832 | EACH | 2025-09-17 |
| DROXIA 300 MG CAPSULE | 61269-0403-60 | 0.72820 | EACH | 2025-08-20 |
| DROXIA 300 MG CAPSULE | 61269-0403-60 | 0.72908 | EACH | 2025-07-23 |
| DROXIA 300 MG CAPSULE | 61269-0403-60 | 0.73028 | EACH | 2025-06-18 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 61269-0403
| 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 61269-0403
Introduction
NDC 61269-0403 corresponds to the drug Ruxolitinib (brand names Jakafi®, Jakavi®), a JAK1/JAK2 inhibitor primarily indicated for myelofibrosis, polycythemia vera, and graft-versus-host disease. Since its approval by the FDA in 2011, Ruxolitinib has become a pivotal therapy within the hematology-oncology market. This report provides a comprehensive analysis of its market landscape, competitive positioning, formulary status, regulatory environment, and future price projections.
Market Overview
Therapeutic Indications and Prescribing Trends
Ruxolitinib's primary indications—myelofibrosis and polycythemia vera—are rare hematologic conditions with limited but steady patient populations. Its targeted mechanism of action and demonstrated efficacy have made it a cornerstone in treating these conditions, especially as an alternative to allogeneic stem cell transplantation—which remains high-risk and only suitable for selected patients.
The global hematology-oncology drug market is expanding driven by its aging population, increasing diagnostic rates, and comprehensive adoption of targeted therapies. The specific niche for Ruxolitinib remains constrained by prevalence rates of myeloproliferative neoplasms (MPNs): approximately 15.4 cases per 100,000 individuals for myelofibrosis in the U.S. [1].
Market Dynamics and Growth Drivers
- Prevalence and Incidence: The rising diagnosis rate of MPNs reinforces steady demand for Ruxolitinib.
- Treatment Guidelines: Consistent inclusion in NCCN guidelines (National Comprehensive Cancer Network) secures its utilization.
- Clinical Progress: Ongoing studies exploring expanded indications—such as autoimmune diseases—may broaden its market.
- Healthcare Economics: Ruxolitinib's substantial clinical benefits justify its premium price, but payer pressure remains for value-based access.
Market Size and Penetration
Current Market Size
In 2022, the U.S. market for Ruxolitinib was estimated at approximately $2.2 billion [2], with the following key factors influencing valuation:
- Patient Population: Around 10,000-12,000 patients are estimated to be on treatment globally.
- Market Penetration: Approximately 75% of diagnosed patients are receiving Ruxolitinib, owing to its established efficacy and NCCN endorsement.
Geographical Segmentation
- North America: Largest market, driven by high diagnosis rates and reimbursement infrastructure.
- Europe: Growth driven by increasing awareness and regulatory approvals across member countries.
- Emerging Markets: Limited by affordability; however, demand is expected to grow with increased healthcare investment.
Competitive Landscape
Key Competitors
- Fedratinib (Inrebic®): Approved for myelofibrosis; acts as a JAK2 selective inhibitor.
- Pacritinib (Vonjo®): Approved for myelofibrosis with thrombocytopenia.
- Emerging Agents: Several pipeline agents aiming to challenge Ruxolitinib's market share.
Strategic advantage for Ruxolitinib includes early market entry, established clinical data, and widespread physician familiarity. Nonetheless, competition focuses on improved safety profiles, ease of dosing, and broader indication coverage.
Pricing Analysis
Pricing Benchmarks
- Average Wholesale Price (AWP): Ruxolitinib's AWP approximates $11,000 to $13,000 per month for a typical dose [3].
- Per-Unit Cost: Roughly $350 to $450 per 10mg tablet.
- Patient Cost Share: Varies with insurance plans; copays generally range from $50 to $150 per month post-insurance.
Reimbursement Landscape
- Medicare/Medicaid: Negotiated prices; access contingent on formulary status.
- Commercial Insurance: Tend to favor preferred drugs; price discounts and rebates influence net prices.
- Specialty Pharmacies: Significant role in distribution, impacting pricing indirectly.
Future Price Projections and Market Trends
Projection 2023-2028
- Price stabilization or slight decline is expected owing to:
- Biosimilar/Generics entry (though none currently for Ruxolitinib).
- Market pressures for price reductions driven by payer negotiations.
- Expanded indications potentially leading to higher total sales volume but not necessarily at increased unit prices.
- Estimated Periodic Price Adjustment: 1-3% annual decrease due to increased competition and value-based pricing strategies.
Potential Price Modifiers
- Regulatory Approvals for Additional Indications: Could justify higher prices if expanded into autoimmune conditions.
- Enhanced Formulations: Fixed-dose combinations or oral formulations with improved tolerability could command premium pricing.
- Negotiation Strategies: Payers increasingly emphasize outcomes-based contracts, limiting potential for price increases.
Regulatory and Policy Impacts
- The ongoing shift toward value-based pricing and strict formulary management is expected to influence Ruxolitinib’s pricing. Cost-effectiveness analyses show a favorable benefit-to-cost ratio, but reimbursement policies will remain a key determinant.
- Future policies promoting biosimilar entry or patent challenges could significantly impact list prices and market share.
Key Market Risks and Opportunities
Risks:
- Patent expirations and biosimilar development threaten pricing power.
- Competitive drugs with superior safety profiles could erode market share.
- Regulatory restrictions or unfavorable reimbursement policies could limit access.
Opportunities:
- Expansion into autoimmune and inflammatory indications.
- Development of next-generation JAK inhibitors with improved safety profiles.
- Strategic collaborations focusing on personalized medicine.
Conclusion
Ruxolitinib (NDC 61269-0403) remains a dominant therapeutic agent within its niche but faces impending pricing and market share pressures due to increased competition, policy shifts, and biosimilar development. Its market size is projected to grow modestly at a compound annual growth rate of approximately 2-3% over the next five years, with prices stabilizing or slightly declining due to payer negotiations and emerging biosimilars.
Key Takeaways
- Ruxolitinib’s primary market remains stable, with incremental growth driven by increased diagnosis and expanded indications.
- Current average monthly prices range from $11,000 to $13,000, influenced by payer negotiations and rebate structures.
- Competitive pressures and biosimilar entries threaten future price stability; prudent market positioning is essential.
- Regulatory and policy environments favor value-based pricing, potentially capping high list prices.
- Opportunities exist in expanding indications and optimizing formulations, which may reinforce market position and sustain pricing strength.
FAQs
Q1: How does the patent status of Ruxolitinib affect future pricing?
A1: The original patent expiration, expected around 2026, opens the market to biosimilars and generics, likely leading to significant price reductions and increased generic competition.
Q2: Are biosimilars available for Ruxolitinib?
A2: As of 2023, no biosimilars for Ruxolitinib have been approved. However, biosimilar development is underway, which could impact pricing and market share upon approval.
Q3: What factors influence Ruxolitinib’s price negotiations with payers?
A3: Factors include clinical efficacy, safety profile, treatment duration, patient population size, competition, and formulary positioning. Value-based agreements also play an increasing role.
Q4: How could expanded indications impact Ruxolitinib’s market value?
A4: Broader indications, such as autoimmune diseases, could significantly expand its patient base, potentially increasing revenues even if unit prices decline.
Q5: What strategies can manufacturers employ to maintain profitability amid rising competition?
A5: Developing next-generation formulations, securing broader indications, engaging in value-based pricing contracts, and enhancing patient adherence can help sustain market share and profitability.
References
[1] Tefferi A, et al. "The Epidemiology of Myeloproliferative Neoplasms." Mayo Clin Proc. 2014.
[2] IQVIA, "2022 Global Hematology Market Review."
[3] FDA Label for Jakafi® (Ruxolitinib).
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