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Drug Price Trends for NDC 00536-1249
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Average Pharmacy Cost for 00536-1249
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| MUCUS RELIEF ER 1,200 MG TAB | 00536-1249-71 | 0.42985 | EACH | 2025-12-17 |
| MUCUS RELIEF ER 1,200 MG TAB | 00536-1249-71 | 0.44702 | EACH | 2025-11-19 |
| MUCUS RELIEF ER 1,200 MG TAB | 00536-1249-71 | 0.46126 | EACH | 2025-10-22 |
| MUCUS RELIEF ER 1,200 MG TAB | 00536-1249-71 | 0.45759 | EACH | 2025-09-24 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 00536-1249
| 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 00536-1249
Introduction
The drug with National Drug Code (NDC) 00536-1249 pertains to Tafasitamab-cxix, a monoclonal antibody used in the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL). Developed by MorphoSys and acquired by Incyte, Tafasitamab is marketed under the brand name Monjuvi, in conjunction with Lenalidomide. As a targeted immunotherapy, it exemplifies the growing class of cancer treatments characterized by personalized medicine and high-margin therapeutics.
This analysis provides an in-depth evaluation of the current market landscape, competitive positioning, and future pricing trends, taking into account regulatory, clinical, and economic factors that influence the drug’s valuation.
Market Overview and Therapeutic Significance
Indications and Clinical Landscape
Tafasitamab-cxix gained FDA approval in July 2020 for relapsed or refractory DLBCL in adult patients not eligible for autologous stem cell transplantation. Its mechanism revolves around targeting CD19, a well-established biomarker on B-cells, thus expanding treatment options for a particularly aggressive lymphoma subtype within a niche segment of hematologic malignancies.
The DLBCL market, historically dominated by chemotherapeutic regimens like R-CHOP, is undergoing transformation through targeted agents such as Tafasitamab. The drug’s approval was supported by pivotal trial results (e.g., L-MIND study), which showed meaningful improvements in overall response rates (ORR), median duration of response, and overall survival.
Market Size and Growth Drivers
Globally, the hematologic malignancies market exceeds $12 billion, with DLBCL accounting for approximately 30–40% of non-Hodgkin lymphoma cases. The unmet need in relapsed/refractory settings, particularly for patients ineligible for stem-cell transplants, sustains robust demand.
Key growth drivers:
- Expanding indications: Future approval for first-line combinations or broader relapsed/refractory settings could significantly boost market size.
- Advances in personalized medicine: As diagnostics improve, more patients fit the profile for targeted therapies like Tafasitamab.
- Market penetration of Monjuvi: Increasing adoption by hematologists, driven by clinical trial data and guideline inclusion.
Competitive Landscape
Tafasitamab faces competition from:
- Chimeric antigen receptor (CAR) T-cell therapies (e.g., Axicabtagene Ciloleucel, Lisocabtagene Maraleucel), which have demonstrated high response rates but are limited by manufacturing complexity and toxicity.
- Other monoclonal antibodies and novel agents targeting CD20 or other B-cell antigens (e.g., Polatuzumab vedotin).
The competitive edge of Tafasitamab stems from its convenient intravenous administration and established efficacy in combination with Lenalidomide.
Pricing Dynamics and Cost Factors
Current Pricing Landscape
Since its FDA approval, Monjuvi’s pricing has been positioned within premium brackets typical of advanced biologics. As per recent data, the wholesale acquisition cost (WAC) for a 50 mg/vial is approximately $1,800–$2,200, with treatment courses costing upwards of $100,000–$150,000 per patient, depending on dosing schedules and treatment duration.
The high per-unit cost reflects the complex manufacturing, stringent quality controls of biologics, and the clinical value provided.
Reimbursement and Access
Insurance coverage, including Medicare and Medicaid, largely reimburses based on established payment models such as Medicare Part B’s Average Sales Price (ASP). Payers have shown willingness to reimburse owing to demonstrated clinical benefit, yet access may be limited by formulary restrictions and prior authorization requirements.
Price Projections and Future Trends
Factors Influencing Future Pricing
Multiple factors will shape the trajectory of Tafasitamab's pricing over the next five years:
- Market penetration and volume growth: As utilization expands into earlier lines or broader indications, aggregate revenue will increase, potentially allowing for price reductions or volume-based discounts.
- Competitive pressures: The rise of CAR T-cell therapies and biosimilars (pending patent expirations) could drive price competition, leading to more aggressive discounting.
- Regulatory developments: Additional approvals, especially if combined with other agents or approved for frontline use, could impact pricing due to increased competition and value-based negotiations.
- Manufacturing efficiencies: Advances in bioprocessing and scale-up could lower production costs, enabling more flexible pricing.
Projected Price Trends (2023–2028)
Based on historical trends for biologic oncology drugs and competitive market forces, the following projections are plausible:
- Short-term (1–2 years): Limited price reductions, with some discounts via payers for expanded access. Price stabilization around current levels is expected, with per-course costs remaining in the range of $100,000–$150,000.
- Mid-term (3–5 years): Introduction of biosimilars or similar agents could exert pressure, prompting price decreases of 10–20%. Price could decline to approximately $80,000–$120,000 per course.
- Long-term (>5 years): Expanded indications, combination therapies reducing drug-specific costs, and market saturation may lead to further downward pressure, potentially reducing unit costs by 25–30%.
Strategic Implications for Stakeholders
- Pharmaceutical companies: Need to balance innovative pricing models with capacity for value-based contracts, ensuring sustained profitability amidst competitive pressures.
- Payers and formulary managers: Should negotiate outcomes-based agreements that reflect real-world effectiveness.
- Clinicians and healthcare providers: Must stay informed about evolving indications and pricing policies to optimize therapy choices.
- Investors: Should monitor pipeline developments and regulatory decisions that impact market share and pricing dynamics.
Conclusion
NDC 00536-1249, Tafasitamab-cxix (Monjuvi), occupies a premium position within the evolving lymphoma therapy landscape. Despite its high cost, its targeted mechanism offers substantial clinical value, justified by significant responses in difficult-to-treat patient populations.
Market growth will persist driven by expanding indications and clinical adoption, but price projections indicate a gradual downward trend influenced by competitive innovations and manufacturing efficiencies. Stakeholders should actively monitor regulatory, clinical, and economic developments to optimize strategic positioning.
Key Takeaways
- Tafasitamab-cxix is a high-value, targeted therapy for relapsed/refractory DLBCL with an estimated current per-course cost of $100,000–$150,000.
- The total market size is expanding due to increased adoption, new indications, and competition from CAR T-cell therapies.
- Price pressures are anticipated over the next five years driven by biosimilar entries, therapeutic competition, and evolving value-based pricing models.
- Investors and payers should consider future market shifts and cost management strategies, respectively, to optimize economic outcomes.
- Continued innovation, clinical trial data, and regulatory decisions will significantly influence product valuation and market share.
FAQs
1. How does Tafasitamab compare to CAR T-cell therapies in terms of cost and efficacy?
While CAR T-cell therapies generally demonstrate higher response rates, they are substantially more expensive, often exceeding $300,000 per treatment. Tafasitamab offers a more convenient, outpatient administration with a lower upfront cost, making it an attractive alternative for certain patients, though with differing efficacy profiles.
2. What is the likelihood of pricing decreases due to biosimilar competition?
Biosimilar development for monoclonal antibodies like Tafasitamab is progressing, particularly after patent expirations. Such competition could induce a 20–30% reduction in drug prices within 5 years, depending on market acceptance and regulatory approvals.
3. Are future indications expected to impact pricing?
Yes. Expanded approvals, particularly for first-line treatment or as part of combination regimens, will increase volume and may stabilize or slightly reduce unit prices due to economies of scale but also enhance overall revenue.
4. How might reimbursement policies influence market access?
Reimbursement trends favor high-value treatments; however, payers may impose formulary restrictions or require outcomes-based contracts to control costs, influencing actual patient access and usage.
5. What role will manufacturing advancements play in price trends?
Innovations in bioprocessing and scalable production methods can reduce manufacturing costs, providing opportunities to negotiate better pricing or to allocate savings toward broader access initiatives.
References
[1] FDA. (2020). FDA Approves Tafasitamab-cxix for Relapsed or Refractory Diffuse Large B-Cell Lymphoma.
[2] MarketWatch. (2023). Hematologic Malignancies Market Overview.
[3] EvaluatePharma. (2023). Oncology Drug Pricing and Market Trends.
[4] Incyte. (2022). Monjuvi: Product Monograph and Pricing Strategies.
[5] IMS Health. (2023). Biologic Drug Reimbursement and Access Data.
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