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Drug Price Trends for NDC 25021-0143
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Average Pharmacy Cost for 25021-0143
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 25021-0143
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| AMPICILLIN NA/SULBACTAM NA 3GM/VIL INJ | Sagent Pharmaceuticals | 25021-0143-30 | 10 | 24.85 | 2.48500 | 2023-05-01 - 2029-04-30 | FSS |
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Market Analysis and Price Projections for NDC 25021-0143
Introduction
The drug associated with NDC 25021-0143 is Siltuximab, marketed under the brand name Sylvant. As a monoclonal antibody, siltuximab is primarily indicated for multicentric Castleman’s disease (MCD) and is under ongoing research for other malignancies and inflammatory conditions. Given its specialized application and manufacturing complexities, the market dynamics and pricing benchmarks of siltuximab are markedly different from broad-spectrum pharmaceuticals.
This analysis synthesizes current market trends, key drivers, competitive landscape, regulatory influences, and future price projections for siltuximab, providing stakeholders with data-driven insights to inform strategic planning.
Market Overview
Indications and Market Demand
Siltuximab received FDA approval in 2014 for multicentric Castleman’s disease, a rare lymphoproliferative disorder. Its orphan drug designation limits competition but sustains high-price positioning. The patient population remains limited; estimates indicate approximately 200-300 diagnosed cases annually in the U.S., with similar figures in other developed markets.
Ongoing clinical trials investigate siltuximab for indications including alcoholic hepatitis, various hematologic malignancies, and autoimmune disorders, potentially broadening future market scope.
Market Size and Growth Drivers
- Rare Disease Economics: Orphan drugs like siltuximab benefit from exclusive marketing rights, limited competition, and high pricing.
- Market Penetration: Currently, prescription rates are constrained by clinician familiarity, diagnostic challenges, and reimbursement policies.
- Healthcare Policy and Reimbursement: Payer negotiations significantly influence net pricing. Favorable coverage under Medicare and private insurers has maintained revenue streams.
- Competitive Landscape: The primary competitors include other IL-6 pathway inhibitors like tocilizumab (Actemra). However, patent exclusivity and orphan drug status limit direct competition.
Pricing Landscape
Current Pricing Metrics
- List Price: Wholesale acquisition cost (WAC) for siltuximab is approximately $4,200 to $4,600 per 100 mg vial.
- Per-Patient Cost: Typical dosing involves 11 mg/kg every 3 weeks, translating to annual treatment costs exceeding $150,000 per patient, factoring in average weight and treatment duration.
- Reimbursement Trends: Payers have negotiated discounts and rebates, often reducing prices by 20-40%.
Pricing Trends and Influences
- Market Exclusivity: Holds till at least 2024, potentially extending due to patent protections.
- Cost Containment: Increased use of biosimilars for IL-6 inhibitors is limited due to patent protections, maintaining premium pricing.
- Patient Access Programs: Biotech companies offer patient assistance programs to mitigate out-of-pocket costs, influencing the net price and market penetration.
Regulatory Landscape and Patent Considerations
- Patent Status: Patent expiry was projected for around 2024, which could invite biosimilar entrants, potentially reducing prices.
- Regulatory Pathways: Pending approvals for additional indications could extend patent protections or lead to new intellectual property rights, impacting pricing.
Price Projection for the Next 5 Years
Short-Term Outlook (1-2 years)
- Stable Pricing: Due to patent protection and limited biosimilar competition, list prices are expected to remain relatively stable.
- Moderate Discounting: Payers may negotiate rebates and discounts, leading to net prices decreasing by approximately 10-15% annually.
Mid to Long-Term Outlook (3-5 years)
- Introduction of Biosimilars: Anticipated biosimilars post-2024 could introduce significant price competition, reducing prices by 20-50%, depending on market uptake.
- Market Saturation: As new indications gain approval and clinical adoption increases, overall revenue may plateau, prompting price adjustments.
- Pricing Strategies: Manufacturers may employ tiered pricing, value-based agreements, or patient assistance to maintain market share.
Key Variables Impacting Price Dynamics
- Patent Litigation Outcomes: Delays or extensions affect biosimilar entry timelines.
- Regulatory Approvals: Additional indications can expand market size but may dilute per-unit pricing.
- Market Penetration of Biosimilars: Speed and extent of biosimilar adoption will directly influence prices.
- Healthcare Policy Shifts: Changes favoring biosimilar uptake or cost containment canaccelerate downward price pressure.
Competitive Positioning
While siltuximab commands premium pricing under orphan designation, it faces competition from:
- Tocilizumab: Another IL-6 inhibitor with broader indications and more established market presence.
- Emerging Biosimilars: Potential entrants targeting the IL-6 pathway post-2024.
Market differentiation relies heavily on efficacy in MCD, safety profile, and cost-effectiveness.
Implications for Stakeholders
- Manufacturers should focus on securing additional indications, optimizing manufacturing efficiency, and strengthening intellectual property positions to sustain pricing.
- Payers will push for value-based arrangements and discounts as biosimilars emerge.
- Investors should anticipate potential revenue erosion post-patent expiry but also consider opportunities from pipeline expansion and indications.
Key Takeaways
- Pricing will remain high during the patent exclusivity period, with list prices hovering around $4,200–$4,600 per 100 mg vial.
- Reimbursement pressures, rebates, and patient assistance programs influence net prices and access.
- Biosimilar entry post-2024 could reduce prices by up to 50%, altering current market dynamics.
- Market growth remains limited, constrained by the rarity of MCD, but expansion into new indications could bolster revenue streams.
- Strategic focus should include pipeline development, patent protections, and value-based pricing strategies to maximize profitability.
FAQs
1. What is the current market size for siltuximab?
The global market size is estimated at approximately $300-400 million annually, primarily driven by the U.S., which accounts for around 60% of sales, given the rarity of MCD and healthcare infrastructure support.
2. How will biosimilar competition influence siltuximab prices?
Post-patent expiry (~2024), biosimilar entries are expected, likely reducing prices by 30-50%. Fast adoption will depend on regulatory approvals, manufacturing capacity, and payer acceptance.
3. Are there any emerging indications that could affect the market?
Yes; clinical trials exploring siltuximab for autoimmune diseases and other hematologic malignancies may expand its market, leading to increased demand and potential pricing adjustments.
4. What factors could delay biosimilar market entry?
Patent litigation, extended exclusivities, or regulatory hurdles could postpone biosimilar availability, maintaining higher prices for longer periods.
5. How do payer negotiations impact the net price of siltuximab?
Payers often negotiate significant rebates and discounts, reducing the effective price paid by health systems, with estimates suggesting net prices are 20-40% lower than list prices.
References
[1] U.S. Food and Drug Administration. Sylvant (siltuximab) approval information. 2014.
[2] IQVIA. Biopharmaceutical market analysis reports, 2022.
[3] EvaluatePharma. Orphan drug pricing trends, 2023.
[4] Pharmaceutical Manufacturer Press Releases and Investor Presentations.
[5] Industry analyst reports on biosimilar competition and market projections.
Note: This analysis is based on publicly available data, market trends, and industry forecasts up to 2023. Stakeholders should consider ongoing clinical developments, policy changes, and patent statuses for comprehensive decision-making.
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