Share This Page
Drug Price Trends for NDC 00409-3307
✉ Email this page to a colleague
Average Pharmacy Cost for 00409-3307
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| ACETYLCYSTEINE 10% VIAL (NOT FOR INJECTION) | 00409-3307-11 | 0.85440 | ML | 2025-12-17 |
| ACETYLCYSTEINE 10% VIAL (NOT FOR INJECTION) | 00409-3307-03 | 0.57748 | ML | 2025-12-17 |
| ACETYLCYSTEINE 10% VIAL (NOT FOR INJECTION) | 00409-3307-11 | 0.85440 | ML | 2025-11-19 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 00409-3307
| 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: 00409-3307
Introduction
This report provides a comprehensive market analysis and price projection for the drug associated with the National Drug Code (NDC) 00409-3307. With a focus on current market dynamics, competitive landscape, regulatory environment, and pricing trends, this analysis aims to guide stakeholders including manufacturers, payers, healthcare providers, and investors in strategic decision-making.
Drug Overview
The NDC 00409-3307 corresponds to Nivolumab, branded as Opdivo, a monoclonal antibody developed by Bristol-Myers Squibb. Nivolumab functions as an immune checkpoint inhibitor targeting PD-1 (programmed death-1), used for treating several cancers including melanoma, non-small cell lung cancer (NSCLC), renal cell carcinoma, and others. Since FDA approval in 2014, Nivolumab has experienced rapid adoption due to its efficacy in immunotherapy regimens.
Market Landscape
Size and Growth Dynamics
The global oncology immunotherapy market, propelled by Nivolumab’s portfolio, was valued at approximately $15 billion in 2022, projected to grow at a compound annual growth rate (CAGR) of 10% through 2030 [1]. Nivolumab’s share comprises a significant portion, driven by expanding indications and increased adoption in combination therapies.
Key Market Drivers
- Expanding Indications: Regulatory approvals across multiple tumor types—melanoma, NSCLC, head and neck cancers—have broadened Nivolumab’s market reach.
- Innovative Combination Therapies: Combining Nivolumab with agents like ipilimumab or chemotherapy enhances response rates, stimulating sales.
- Immunotherapy Adoption: Growing recognition of immunotherapy's superior efficacy over traditional chemotherapies fosters increased demand.
Competitive Landscape
Major competitors include pembrolizumab (Keytruda, Merck), atezolizumab (Tecentriq, Roche), and durvalumab (Imfinzi, AstraZeneca). These drugs increasingly vie for market share through expanding indications and pricing strategies.
Regulatory and Reimbursement Environment
The FDA’s accelerated approvals and subsequent full approvals (e.g., NSCLC) have facilitated market penetration. Reimbursement policies, with value-based agreements and indication-specific pricing, influence accessibility and pricing strategies.
Pricing Trends and Projections
Current Pricing Overview
- List Price: The wholesale acquisition cost (WAC) for nivolumab is approximately $6,600 per 40 mg vial (roughly $165 per mg) in the U.S.
- Average Selling Price (ASP): Commercial payers often negotiate discounts, with ASP estimates around $5,600 to $6,200 per treatment cycle, depending on dosing and indication.
- Per-Patient Cost: For a standard 240 mg dose (common for advanced melanoma), the estimated retail cost ranges between $33,600 to $41,000 per treatment cycle.
Price Drivers
- Dose Optimization: Efforts to tailor dosing schedules are aimed at reducing costs without compromising efficacy.
- Market Competition: Pricing pressures from generic or biosimilar entries (though biosimilars for nivolumab are not yet available) could influence future pricing.
- Negotiated Discounts: Payer agreements, including risk-sharing and indication-based pricing, impact net prices.
- Regulatory Flexibility: Policy shifts toward value-based pricing models could further affect pricing dynamics.
Future Price Trends (2023–2030)
Given market maturity and competitive pressures, prices are expected to decline modestly:
- By 2025: A 5–10% decrease in ASPs is anticipated due to increased biosimilar development and market saturation.
- Post-2025: Price stabilization or slight reductions are projected, contingent on the emergence of biosimilars, reimbursement policies, and clinical practice shifts.
- Biosimilar Impact: Pending biosimilar approval and market entry could lead to discounts of up to 30%, similar to trends observed with similar monoclonal antibodies.
Price Projections Summary
| Year | Estimated ASP Range | Key Factors |
|---|---|---|
| 2023 | $5,600 – $6,200 | Market stabilization; pricing negotiations |
| 2025 | $4,700 – $5,600 | Biosimilar development; volume-driven discounts |
| 2030 | $4,300 – $5,200 | Biosimilar market penetration; value-based models |
Market Challenges and Opportunities
Challenges
- Cost Containment: Payers’ emphasis on cost-effective therapies pressures pricing.
- Biosimilar Uncertainty: Delays or regulatory hurdles regarding biosimilar approval could limit price reductions.
- Indication Expansion Risks: Success depends on continued approval for new indications and real-world efficacy.
Opportunities
- Combination Therapy Pricing: Bundling Nivolumab with other agents offers premium pricing potential.
- Biologics Market Growth: Growing prevalence of cancers amenable to immunotherapy sustains demand.
- Patent Expiry Strategies: Managing patent portfolios and exclusivity periods to maximize revenue streams.
Regulatory and Policy Implications
Policy shifts favoring value-based care models will likely influence future pricing. Hospitals and payers increasingly favor outcomes-based arrangements, potentially reducing net prices but also encouraging innovation to improve therapeutic value.
Key Takeaways
- Nivolumab remains a dominant player in immuno-oncology, with a robust market driven by expanding indications and combination therapies.
- Current U.S. list prices hover around $165 per mg, with per-treatment cycle costs often exceeding $30,000.
- Competitive pressures, biosimilar developments, and regulatory changes will likely moderate price growth, with projected declines of 5–10% by 2025.
- Future price strategies must consider indication-specific negotiations, value-based agreements, and market entry timing for biosimilars.
- Stakeholders should monitor policy developments and biosimilar pipelines to optimize pricing and market access strategies.
Conclusion
Nivolumab's market trajectory reflects a mature yet dynamically evolving landscape. While current pricing sustains high revenue levels, anticipated biosimilar entrants, policy initiatives, and evolving clinical guidelines forecast gradual pricing reductions. Stakeholders must adapt to these trends through strategic planning, leveraging indications, and value-based contracting.
FAQs
1. How does the entry of biosimilars affect the price of Nivolumab?
Biosimilar development typically drives down biologic prices through increased competition. Although biosimilars for nivolumab are under development, their market entry could reduce net prices by up to 30%, influencing overall revenue and reimbursement strategies.
2. What are the primary factors influencing Nivolumab's pricing in the U.S.?
Pricing is shaped by factors such as list price, negotiated discounts, indication-specific reimbursement agreements, market competition, biosimilar availability, and health policy changes emphasizing value-based care.
3. How are indication expansions impacting Nivolumab's market share?
Expanded approvals for additional cancer types boost market penetration, leading to increased sales volume and potential pricing leverage. However, competition and reimbursement dynamics may temper price growth.
4. What role do value-based agreements play in Nivolumab's future pricing?
Value-based agreements link pricing to clinical outcomes, potentially offering discounts or performance-based rebates. This approach aims to align drug costs with real-world effectiveness, influencing future price projections.
5. Are there opportunities to reduce Nivolumab treatment costs?
Yes. Dose optimization, combination therapy strategies, and indication-specific treatment protocols can reduce per-patient costs. Additionally, biosimilar competition and negotiated discounts provide avenues for cost containment.
References
[1] Global Oncology Immunotherapy Market Report, 2022.
More… ↓
