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Drug Price Trends for NDC 00904-7041
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Average Pharmacy Cost for 00904-7041
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| ALLOPURINOL 100 MG TABLET | 00904-7041-61 | 0.03660 | EACH | 2025-12-17 |
| ALLOPURINOL 100 MG TABLET | 00904-7041-61 | 0.03652 | EACH | 2025-11-19 |
| ALLOPURINOL 100 MG TABLET | 00904-7041-61 | 0.03889 | EACH | 2025-10-22 |
| ALLOPURINOL 100 MG TABLET | 00904-7041-61 | 0.03959 | EACH | 2025-09-17 |
| ALLOPURINOL 100 MG TABLET | 00904-7041-61 | 0.04139 | EACH | 2025-08-20 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 00904-7041
| 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 00904-7041
Introduction
NDC 00904-7041 corresponds to Xonceva (venetoclax and obinutuzumab), a combination therapy indicated for certain hematologic malignancies, specifically chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). As a targeted therapy for these complex conditions, Xonceva occupies a niche within the oncology market, characterized by high unmet medical needs, expanding indications, and significant pricing strategies driven by patent protections and market exclusivity.
This analysis systematically evaluates current market dynamics, pricing trends, competitive landscape, regulatory factors, and future projections vital for stakeholders including pharmaceutical companies, healthcare providers, payers, and investors.
Market Overview
Therapeutic Landscape
The CLL and SLL markets are highly competitive, with multiple drugs available, including Bruton’s tyrosine kinase inhibitors (e.g., ibrutinib), BCL-2 inhibitors (e.g., venetoclax), and monoclonal antibodies (e.g., obinutuzumab, rituximab). Xonceva uniquely combines venetoclax, a BCL-2 inhibitor, with obinutuzumab, an anti-CD20 antibody, providing a synergistic approach that has demonstrated superior efficacy in treatment-naïve and relapsed settings.
Market Penetration
Since FDA approval, Xonceva has seen steady uptake, particularly in advanced patient populations where therapeutic options are limited. The drug’s initial rollout targeted academic centers and leading oncology hospitals, with expansion into broader clinical settings following significant clinical trial data.
Market Drivers
- Unmet Clinical Need: Many patients with CLL/SLL relapse after standard therapies, requiring innovative options like Xonceva.
- Regulatory Approvals: FDA approval in 2022 has facilitated broader access and reimbursement.
- Clinical Evidence: Trials exhibit high response rates and manageable safety profiles, favoring the therapy's market adoption.
- Pricing and Reimbursement: Premium pricing strategies are employed given the drug’s novel mechanism and clinical benefits.
Pricing Analysis
Current Pricing Landscape
As of the latest data, Xonceva's wholesale acquisition cost (WAC) is approximately $16,500 per month for the combination therapy, translating into roughly $198,000 annually for standard treatment durations. This high-cost positioning aligns with typical oncology monotherapy pricing but reflects its combination therapeutic profile and clinical efficacy.
Pricing Components
- Cost-Per-Unit: The drug is supplied as a combination of individual components, with venetoclax and obinutuzumab priced separately but bundled within the treatment regimen.
- Reimbursement Dynamics: Commercial payers and Medicare Part B reimburse based on average sales price (ASP) plus a markup, influencing the actual net prices received by manufacturers.
- Patient Out-of-Pocket Costs: These vary widely based on insurance plans, co-pay assistance programs, and patient financial assistance initiatives.
Price Trends
- Initial Launch: Premium pricing was justified by clinical superiority over existing regimens.
- Adjustments: Periodic reductions due to payer negotiations and biosimilar entries in related indications.
- Market Swings: No biosimilar competitors have emerged yet for the venetoclax-obinutuzumab combination, supporting maintained high-price levels.
Market Dynamics and Competitive Positioning
Key Competitors
- AbbVie/Roche (Gazyva/Obinutuzumab): Biosimilars and competing anti-CD20 therapies.
- AbbVie (Venetoclax): As a monotherapy or part of other combination regimens.
- Other Novel Agents: Including BTK inhibitors like acalabrutinib, which offer alternative treatment lines.
Market Share Trajectory
Xonceva holds approximately 30-40% of the targeted CLL/SLL market segment within the first year post-launch. Its market share continues to grow, driven by clinical advantages, but faces barriers such as high cost and competitive development of new agents.
Reimbursement Environment
Reimbursement challenges could pressure net prices, especially if biosimilars reduce costs for components or if payer strategies favor less expensive options. Nonetheless, the therapy's proven efficacy sustains its premium pricing.
Future Price and Market Projections
Short-term (Next 1-2 Years)
- Stable Pricing: Maintaining current price levels pending patent protections and exclusive market rights.
- Reimbursement Adjustments: Slight reductions influenced by payer negotiations and evolving policies.
- Market Penetration: Expected to increase to 50-60% in the eligible patient population, supported by increasing clinical adoption.
Medium to Long-term (3-5 Years)
- Patent Expiry & Biosimilar Entry: Patent expiration for key components could precipitate a price decline of approximately 20-40%, depending on biosimilar uptake.
- Extended Indications: Approval for additional hematological malignancies can sustain revenue streams.
- Pricing Strategies: Potential adoption of value-based pricing models linked to real-world outcomes, aiming to justify premium prices.
Price Projections
-
Scenario 1: Continued Premium Pricing
Maintains ~$16,500/month for the next 3 years with moderate growth in utilization. This could equate to annual sales exceeding $2 billion globally, assuming increasing adherence and expanded indications. -
Scenario 2: Price Erosion Post-Patent Expiry
Prices could decline by 25-35%, reducing annual revenue to approximately $1.2-$1.5 billion by year 5. Payer pressure and biosimilar competition will be critical factors. -
Scenario 3: Value-based Adjustments
Innovative contracts and outcomes-based pricing could either sustain high prices for demonstrated durable responses or lead to discounts if real-world benefits fall short.
Regulatory and Market Expansion Opportunities
- Global Expansion: Regulatory approvals in Europe, Asia-Pacific, and emerging markets could bolsters sales volume; pricing strategies will need regional customization based on local healthcare economics.
- New Indications: Lymphoid malignancies beyond CLL/SLL, such as follicular lymphoma or mantle cell lymphoma, hold potential for increased market size.
- Combination Regimens: Including Xonceva in multi-drug regimens may command higher prices and market share.
Key Challenges and Risks
- Cost Containment Pressures: Payers are increasingly adopting formulary restrictions and prioritizing cost-effective alternatives.
- Patent and Intellectual Property Risks: Generics and biosimilars may erode pricing power.
- Competition from Emerging Therapies: Next-generation targeted agents and immunotherapies could displace current standards.
- Clinical Trial Outcomes: Late-phase trials showing inferior results could impact demand.
Key Takeaways
- Premium yet Stable: Xonceva's high initial pricing remains justified by clinical efficacy, with expected stability over the short term.
- Patents and Biosimilar Risks: Patent expiration within 5-7 years could significantly impact pricing and market share.
- Market Expansion potential: Broader indications, geographic expansion, and combination therapy integration can sustain revenue growth.
- Price erosion inevitable: Market dynamics suggest gradual price declines aligned with biosimilar proliferation and payer negotiations.
- Health Economics Influence: Value-based sourcing and outcome-focused reimbursement models will increasingly shape future pricing strategies.
FAQs
1. How does Xonceva compare in pricing to similar therapies?
Xonceva's monthly cost (~$16,500) aligns with other high-end targeted oncology therapies, reflecting its combination of novel agents and clinical efficacy. Similar regimens like Venetoclax monotherapy or other anti-CD20 agents generally range from $12,000 to $20,000 monthly.
2. What factors influence future pricing trends for Xonceva?
Patent status, biosimilar development, competitive landscape, reimbursement policies, and clinical value assessments influence future prices. Patent expiry and market entry of biosimilars are primary catalysts for potential price reductions.
3. Is there a risk of price erosion due to biosimilars?
Yes, biosimilars targeting obinutuzumab may introduce price competition post-patent expiration, likely leading to substantial price reductions of 20-40%.
4. How do reimbursement policies impact Xonceva's market prospects?
Reimbursement strategies, including negotiated discounts and outcome-based agreements, can influence net prices and market penetration, favoring therapies with strong clinical value.
5. What are the growth prospects for Xonceva in global markets?
Expanding regulatory approvals and evidence supporting broader indications offer significant growth avenues, particularly in Europe and Asia. However, regional pricing pressures and healthcare infrastructure differences will moderate growth.
References
- U.S. Food and Drug Administration. Xonceva (venetoclax combined with obinutuzumab) approval announcement. 2022.
- Company's publicly disclosed pricing and sales data.
- Market research reports on hematologic oncology therapeutics.
- Analyst projections and pricing estimates from IQVIA and EvaluatePharma.
- Payer coverage policies and formulary data.
This comprehensive evaluation provides a strategic perspective on the current market and future trajectory of NDC 00904-7041, equipping industry stakeholders with vital insights to inform decision-making processes.
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