Last updated: July 31, 2025
Introduction
The National Drug Code (NDC) 00406-8960 refers to a specific pharmaceutical product, which, based on available data, is identified as "Tazemetostat" — an oral EZH2 inhibitor used primarily in the treatment of epithelioid sarcoma and certain types of follicular lymphoma. As an innovative therapy with relatively recent FDA approval, understanding its market landscape and pricing trajectory is crucial for stakeholders, including pharmaceutical companies, healthcare providers, insurers, and investors.
This analysis provides a comprehensive overview of the current market dynamics and offers price projections grounded in current data, competitive landscape, regulatory environment, and overarching healthcare trends.
Market Overview
Therapeutic Indication and Clinical Profile
Tazemetostat (brand name Tazverik®) targets EZH2, an epigenetic regulator involved in cancer cell proliferation, representing a novel class of targeted therapy. Its primary indications include:
- Epithelioid Sarcoma (ES): Approved for metastatic or locally advanced cases unamenable to surgery.
- Follicular Lymphoma (FL): Specifically for relapsed or refractory cases in patients with specific genetic mutations (e.g., EZH2 mutations).
The unique mechanism of action positions Tazemetostat as a targeted therapy, with potential applications expanding through ongoing clinical trials in other malignancies.
Market Size & Penetration
The initial market for Tazemetostat is relatively niche, given the rarity of epithelioid sarcoma and specific subtypes of follicular lymphoma.
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Epidemiology:
- Epithelioid sarcoma is rare, with an estimated incidence of approximately 1 per 1 million people annually in the U.S. [1].
- FL is more common, accounting for 20-30% of non-Hodgkin lymphoma cases, with an estimated diagnosed prevalence of approximately 80,000 patients in the U.S.
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Market Penetration:
As of 2023, Tazemetostat has gained modest market share, predominantly among specialized oncology centers. Adoption is gradually expanding with increasing clinical familiarity and ongoing pipeline development.
Competitive Landscape
While Tazemetostat is the first-in-class EZH2 inhibitor approved for these indications, it faces competition from alternative therapies:
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For epithelioid sarcoma:
Surgical resection remains primary; systemic options are limited. Other targeted agents and clinical trials are emerging, but none yet offer directly competing mechanisms.
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For follicular lymphoma:
Multiple agents, including PI3K inhibitors (e.g., idelalisib), monoclonal antibodies (e.g., rituximab), and other targeted therapies, provide alternative options, impacting market share and pricing strategies.
Pricing Dynamics & Trends
Current Pricing
The wholesale acquisition cost (WAC) for Tazemetostat, as listed in the IBM Micromedex database, is approximately $17,500 per month per patient, translating to $210,000 annually for a full course of treatment, depending on dosing and patient-specific factors [2].
This premium pricing aligns with its orphan drug status, novelty, and targeted therapy positioning but is under pressure from payer negotiations and formulary placements.
Factors Influencing Price
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Orphan Drug Designation:
Grants market exclusivity (7 years in the U.S.) which sustains pricing power.
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Manufacturing Costs:
As a small-molecule drug synthesized via complex processes, production costs remain significant but are mitigated by high pricing.
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Market Penetration and Reimbursement Policies:
Payers are increasingly demanding value-based pricing, especially as more data accumulates regarding overall survival benefits and quality of life.
Pricing Trends & Projections
Given the current treatment landscape:
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Short-Term (Next 1-2 Years):
Prices are expected to remain relatively stable, with potential minor adjustments driven by negotiations, discounts, and rebate strategies.
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Mid-to-Long Term (3-5 Years):
Prices may decline modestly (-10% to -20%) as new competitors enter clinical trials, biosimilars or alternatives develop, and payer pressures escalate.
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Impact of Expanded Indications:
Additional approvals could either bolster pricing through increased demand or dilute per-unit revenue if price competition intensifies.
Regulatory & Market Forces
Regulatory Landscape
The FDA’s orphan drug designation confers exclusive marketing rights, incentivizing sponsors to invest in rare disease therapies like Tazemetostat. However, the upcoming expiration of exclusivity in 2030 may lead to increased generic or biosimilar competition, pressuring prices downward.
Market Expansion & Pipeline
Clinical trials are ongoing for additional indications, including:
- Diffuse large B-cell lymphoma
- Solid tumors such as renal cell carcinoma
Successful expansion could elevate demand and permit incremental price adjustments aligned with therapeutic value.
Competitive and Pricing Outlook
| Scenario |
Price Projection (Next 5 Years) |
Comments |
| Conservative |
Maintains current levels (~$17,500/month) |
Limited competition, regulatory stability, moderate payer acceptance |
| Moderate |
Slight decrease (~$15,000/month) |
Increased competition, more aggressive payer negotiations, evolving treatment standards |
| Pessimistic |
Significant decrease (~$12,000/month) |
Entry of biosimilars/biosuperior agents, reduced pricing power, expanded indications |
Overall, a gradual price decline of approximately 20-30% over five years is plausible, barring breakthroughs in clinical efficacy or expanded indications.
Key Takeaways
- NDC 00406-8960 (Tazemetostat) is a targeted, orphan drug primarily treating epithelioid sarcoma and specific lymphomas with current annual prices around $210,000.
- Market growth is modest due to rarity and niche indications but remains stable with potential for expansion as clinical uses broaden.
- Pricing remains high driven by orphan status, unique mechanism, and limited competition but is likely to face moderate downward pressure over the coming years.
- Reimbursement trends will be critical, with payers seeking value-based arrangements to balance innovation costs and clinical benefits.
- Future market landscape hinges on regulatory decisions, pipeline success, and evolving treatment paradigms, influencing both market size and pricing dynamics.
FAQs
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What is the primary therapeutic indication for NDC 00406-8960?
Tazemetostat is indicated for epithelioid sarcoma and certain follicular lymphomas, serving as a targeted epigenetic therapy.
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How does the orphan drug designation impact the pricing of Tazemetostat?
Orphan status grants exclusive marketing rights (7 years), enabling premium pricing due to limited competition and high unmet needs.
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What are the main factors affecting its market penetration?
Rarity of indications, clinical adoption, payer acceptance, and ongoing clinical trials influence uptake.
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Are there upcoming therapies that could disrupt Tazemetostat’s market?
Emerging EZH2 inhibitors and broader epigenetic agents are in development, which could introduce competition over the next 5-10 years.
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How might regulatory changes influence future prices?
Potential expiration of exclusivity rights and approval of biosimilars or generics could lead to significant price reductions.
References
- Fletcher CDM, et al. (2010). WHO Classification of Tumours of Soft Tissue and Bone. WHO Press.
- IBM Micromedex. (2023). Drug pricing and reimbursement data.
- FDA. (2020). Tazemetostat (Tazverik) approved for epithelioid sarcoma.
- Market Research Reports. (2022). Oncology drug market analysts on rare tumor therapies.
- ClinicalTrials.gov. (2023). Ongoing research evaluating expanded uses of Tazemetostat.
This comprehensive analysis facilitates strategic decision-making by providing clear insights into the current and projected market landscape of NDC 00406-8960.
