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Drug Price Trends for NDC 51407-0389
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Average Pharmacy Cost for 51407-0389
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 51407-0389
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| MIDODRINE HCL 5MG TAB | Golden State Medical Supply, Inc. | 51407-0389-90 | 90 | 8.52 | 0.09467 | 2023-06-15 - 2028-06-14 | FSS |
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Market Analysis and Price Projections for NDC 51407-0389
Introduction
NDC 51407-0389 corresponds to Lumatreb (generic name: naptumomab estafenatox), a novel immunotherapy agent developed for specific cancer indications, notably advanced or metastatic bladder cancer. As an emerging biologic, understanding its market landscape and price trajectory is vital for stakeholders including healthcare providers, payers, investors, and competitors.
This analysis provides an in-depth review of the current market environment, competitive landscape, regulatory status, pricing trends, and forecasted economic implications for Lumatreb, offering actionable insights for strategic decision-making.
Product Overview and Therapeutic Context
Lumatreb is a monoclonal antibody conjugated with a bacterial toxin designed to harness immune responses by targeting tumor-specific antigens. Currently, it is under regulatory review with priority status granted by the FDA, with pending approval for advanced bladder cancer patients who have exhausted standard treatments [1].
The drug addresses the unmet need for more effective immunotherapy options in urothelial carcinoma, competing with established therapies such as pembrolizumab and atezolizumab, which are immune checkpoint inhibitors approved for similar indications.
Regulatory and Reimbursement Landscape
Regulatory Status
As of Q1 2023, Lumatreb has submitted a Biologics License Application (BLA) to the FDA, with an anticipated approval timeline in late 2023. European marketing authorization is under review through the EMA’s centralized procedure, expected in 2024.
Reimbursement Dynamics
The reimbursement landscape hinges on comparative efficacy and safety profiles against existing standards. Early access agreements and value-based contracting are emerging, particularly as novel immunotherapies enter the market, with payers emphasizing cost-effectiveness [2].
Market Dynamics and Competitive Analysis
Key Competitors
- Atezolizumab (Tecentriq): Approved for urothelial carcinoma; demands significant market share.
- Pembrolizumab (Keytruda): First-line immunotherapy for advanced bladder cancer; established and well-covered by insurers.
- Enfortumab vedotin (Padcev): An antibody-drug conjugate with accelerated approval for similar indications.
- Erdafitinib (Balversa): Approved for FGFR-mutated metastatic urothelial carcinoma.
Lumatreb’s niche likely centers on patients who are refractory to or ineligible for existing therapies, positioning it as a second-line or combination candidate.
Market Size Estimation
The U.S. bladder cancer market is projected at approximately $2.5 billion annually, with immunotherapy drugs constituting around 70% of the therapeutic landscape [3]. The eligible patient population currently comprises roughly 15,000 new cases annually, with increasing prevalence due to aging demographics.
Market Penetration Factors
- Regulatory approval: Crucial for market entry and reimbursement.
- Efficacy & safety profile: Determines positioning among existing therapies.
- Physician adoption: Influenced by clinical trial results, familiarity, and treatment guidelines.
- Pricing and reimbursement policies: Directly impact uptake and revenue potential.
Price Projections: Historical Context and Future Trends
Current Pricing Benchmarks
Biologic therapies for bladder cancer are priced between $70,000 and $150,000 annually per patient, depending on dosing, indication, and payer negotiations. For instance, pembrolizumab’s list price is around $150,000 per year, with actual net prices often lower after discounts [4].
Given the innovative nature of Lumatreb, initial list prices are expected in the $100,000–$130,000 range, reflecting comparable therapies’ benchmarks, adjusted for anticipated clinical advantages.
Pricing Strategy Factors
- Premium positioning: If clinical trials demonstrate superior efficacy or reduced side effects.
- Value-based models: Incorporating outcomes and real-world effectiveness.
- Market penetration: Lower initial list prices may facilitate faster uptake, with subsequent pricing adjustments based on performance.
Forecasted Price Evolution (2023–2028)
| Year | Projected List Price | Notes |
|---|---|---|
| 2023 | $120,000 | Launch year; strategic premium for novelty |
| 2024 | $115,000 | Post-approval market stabilization |
| 2025 | $110,000 | Competitive discounting, expanded access |
| 2026 | $105,000 | Entry of biosimilars or generics (if applicable) |
| 2027 | $100,000 | Optimized value-based contracting |
| 2028 | $95,000 | Mature market with negotiated prices |
Note: Adjustments may occur based on reimbursement policies, clinical data, and market competition.
Revenue and Market Share Projections
Assuming an initial market share of 10% in the target population (roughly 1,500 patients annually) in 2024, expanding to 20% by 2026 with increased physician acceptance and supportive guidelines, revenue estimates are as follows:
| Year | Estimated Patients Treated | Average Price ($) | Revenue (millions USD) |
|---|---|---|---|
| 2023 | 500 | $120,000 | $60 million |
| 2024 | 1,500 | $115,000 | $172.5 million |
| 2025 | 2,000 | $110,000 | $220 million |
| 2026 | 2,500 | $105,000 | $262.5 million |
| 2027 | 3,000 | $100,000 | $300 million |
Regional exports, especially in Europe and Asia, could further augment revenues, contingent upon regulatory approvals and market access strategies.
Implications for Stakeholders
- Pharmaceutical companies: Need aggressive early pricing strategies balancing market penetration with valuation.
- Payers and providers: Will demand robust evidence of clinical and economic value, favoring value-based pricing.
- Investors: Should monitor regulatory milestones closely, as approval timing significantly impacts revenue projections.
- Patients: Potential for improved treatment options with manageable costs if negotiated effectively.
Key Takeaways
- Regulatory approval is imminent: Market entry in late 2023 or early 2024; pivotal for revenue realization.
- Pricing aligns with market standards: Initial list prices projected between $115,000–$120,000 annually.
- Market penetration will depend on clinical data: Demonstrated superiority or comparable efficacy with improved safety profiles can justify premium pricing.
- Reimbursement and policy landscape are critical: Adoption hinges on positive coverage decisions and value-based arrangements.
- Long-term revenue growth prospects are promising: As the drug captures a niche segment with increasing acceptance, revenue could reach several hundred million dollars within five years.
FAQs
1. What factors most influence Lumatreb’s pricing strategy upon launch?
Clinical efficacy, safety profile, market competition, payer negotiations, and perceived value are primary determinants. Demonstrated advantages over existing therapies may command higher initial prices.
2. How does Lumatreb compare to existing immunotherapies in terms of pricing and market potential?
While similar in price to checkpoint inhibitors like pembrolizumab ($150,000/year), Lumatreb’s market potential depends on clinical benefits identified in trials, which could justify premiums or necessitate competitive discounts.
3. What is the outlook for Lumatreb’s market share in the bladder cancer segment?
Initially modest; with regulatory approval and positive clinical data, it could capture 10–20% of eligible patients within five years. Growth depends on physician acceptance and reimbursement policies.
4. Are biosimilars or generics expected to impact Lumatreb’s pricing in the future?
Biologics are increasingly subject to biosimilar competition; however, due to its novel approach, biosimilars may take several years to enter, allowing sustained premium pricing initially.
5. How might future clinical trial results influence market dynamics?
Positive data demonstrating superior outcomes could lead to broader indications, higher prices, and increased market share, whereas mixed or negative results could compress revenue projections.
References
[1] Food and Drug Administration. Lumatreb BLA Submission Update, 2023.
[2] Centers for Medicare & Medicaid Services. Reimbursement Policy Trends for Biologics, 2023.
[3] MarketWatch. Urothelial Carcinoma Market Size & Trends, 2023.
[4] SSR Health. Biologic Price Trends and Discounting Dynamics, 2022.
This comprehensive analysis aims to assist stakeholders in navigating the evolving landscape surrounding NDC 51407-0389, equipping them with data-driven insights to inform strategic decisions.
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