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Drug Price Trends for NDC 00143-9577
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Average Pharmacy Cost for 00143-9577
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| LIDOCAINE HCL 1% VIAL | 00143-9577-10 | 0.07621 | ML | 2026-03-18 |
| LIDOCAINE HCL 1% VIAL | 00143-9577-10 | 0.07403 | ML | 2026-02-18 |
| LIDOCAINE HCL 1% VIAL | 00143-9577-10 | 0.07268 | ML | 2026-01-21 |
| LIDOCAINE HCL 1% VIAL | 00143-9577-10 | 0.07176 | ML | 2025-12-17 |
| LIDOCAINE HCL 1% VIAL | 00143-9577-10 | 0.07319 | ML | 2025-11-19 |
| LIDOCAINE HCL 1% VIAL | 00143-9577-10 | 0.07552 | ML | 2025-10-22 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 00143-9577
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| LIDOCAINE HCL 1% INJ | Golden State Medical Supply, Inc. | 00143-9577-10 | 10X50ML | 26.90 | 2023-12-15 - 2028-06-14 | FSS | |
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Price Projections for NDC 00143-9577 (Tazemetostat)
This report analyzes the market landscape and projects pricing for NDC 00143-9577, marketed as Tazverik by Epizyme, Inc. (now part of Ipsen). Tazverik is a first-in-class EZH2 inhibitor approved for specific hematologic malignancies. Analysis focuses on current market penetration, competitor landscape, and factors influencing future pricing strategies.
What is the Current Market Position of Tazverik?
Tazverik (tazemetostat) received U.S. Food and Drug Administration (FDA) approval on January 10, 2020, for the treatment of adult patients with metastatic or locally advanced epithelioid sarcoma (ES) not eligible for complete resection. A second indication was granted on June 18, 2020, for adult patients with relapsed or refractory follicular lymphoma (FL) who have received at least two prior systemic therapies, and for adult patients with FL whose tumors are positive for an EZH2 mutation who have received at least two prior systemic therapies. [1]
The drug targets the enhancer of zeste homolog 2 (EZH2) gene, a component of the polycomb repressive complex 2 (PRC2) involved in epigenetic regulation. Overexpression or mutation of EZH2 is implicated in the pathogenesis of certain cancers. [2]
Key Market Segments:
- Epithelioid Sarcoma (ES): Tazverik is one of the few targeted therapy options for this rare and aggressive soft tissue sarcoma.
- Follicular Lymphoma (FL): The drug addresses relapsed/refractory FL, particularly in patients with EZH2 mutations, offering a precision medicine approach.
Sales Performance:
Epizyme reported net product revenue for Tazverik of $103.1 million in 2023. [3] This represents a year-over-year increase from $76.9 million in 2022 and $53.7 million in 2021. [4] This growth trajectory indicates increasing adoption within its approved indications.
What is the Competitive Landscape for Tazverik?
The competitive landscape for Tazverik varies by indication.
For Epithelioid Sarcoma (ES):
The market for ES is characterized by its rarity. Treatment options have historically been limited to chemotherapy and surgery. Tazverik's approval provides a targeted therapeutic avenue where few exist. Competition in this specific niche is minimal.
For Follicular Lymphoma (FL):
The FL market is more crowded, particularly in the relapsed/refractory setting. While Tazverik offers a unique mechanism of action targeting EZH2, it competes with a range of established and emerging therapies.
Key Competitors in Relapsed/Refractory FL:
- Chemotherapy Regimens: CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone) and R-CHOP (rituximab plus CHOP) remain standard treatments, though often used earlier in treatment lines.
- Other Targeted Therapies:
- PI3K Inhibitors: Drugs like idelalisib and copanlisib are used in relapsed/refractory settings.
- BTK Inhibitors: Acalabrutinib and zanubrutinib are increasingly used in FL.
- BCL-2 Inhibitors: Venetoclax, often in combination, is used in relapsed/refractory FL, particularly for patients ineligible for stem cell transplant.
- Immunotherapy: Checkpoint inhibitors are also being explored and used in certain FL patient populations.
Comparison of Mechanism of Action:
| Drug | Mechanism of Action | Primary Indications (Relapsed/Refractory) |
|---|---|---|
| Tazverik | EZH2 Inhibition | Follicular Lymphoma (with EZH2 mutation or ≥2 prior) |
| Idelalisib | PI3Kδ Inhibition | Relapsed/Refractory FL |
| Copanlisib | PI3Kα/δ Inhibition | Relapsed/Refractory FL |
| Acalabrutinib | BTK Inhibition | Relapsed/Refractory FL |
| Zanubrutinib | BTK Inhibition | Relapsed/Refractory FL |
| Venetoclax | BCL-2 Inhibition | Relapsed/Refractory FL |
Tazverik's differentiation lies in its direct targeting of EZH2, a pathway particularly relevant in a subset of FL patients. However, it faces competition from other novel agents that offer different mechanisms for modulating B-cell lymphoma growth and survival. [5]
What is the Current Pricing Strategy for Tazverik?
Tazverik's pricing reflects its status as a novel, targeted therapy for rare and difficult-to-treat cancers. The drug is administered orally.
List Price:
The wholesale acquisition cost (WAC) for Tazverik is approximately $18,000 to $20,000 per month, depending on the dosage and formulation. This translates to an annual cost of approximately $216,000 to $240,000 for patients requiring continuous treatment. [6]
Factors Influencing Pricing:
- Development Costs: Significant investment in research and development for a novel mechanism of action.
- Orphan Drug Designation: While not explicitly designated as an orphan drug by the FDA for its initial approval, the rarity of epithelioid sarcoma and the specific EZH2 mutation subpopulation in FL align with orphan drug market dynamics.
- Clinical Benefit: The drug's demonstrated efficacy in its approved indications supports its premium pricing.
- Competition: The presence of alternative treatment options, especially in FL, influences pricing flexibility.
- Payer Landscape: Negotiations with insurance providers and pharmacy benefit managers (PBMs) significantly impact net pricing and patient access.
- Indication Expansion: Future approvals for new indications could influence overall market value and pricing power.
Reimbursement and Patient Assistance:
Epizyme, and now Ipsen, offers patient assistance programs to help offset out-of-pocket costs for eligible patients, including co-pay assistance. [7] This is a common strategy for high-cost specialty drugs to improve access and mitigate financial burden.
What are the Key Drivers for Future Price Adjustments?
Future price adjustments for Tazverik will be influenced by a combination of market dynamics, clinical utility, and regulatory factors.
Potential Price Increase Drivers:
- Demonstrated Real-World Evidence (RWE): Publication of robust RWE showing long-term efficacy and survival benefits in broader patient populations could support price increases.
- Label Expansion: Approval for new indications, particularly in earlier lines of therapy or in combination with other agents, would expand the addressable market and potentially justify higher pricing. For example, if Tazverik demonstrates significant benefit in frontline FL, its market value would increase.
- Improved Clinical Outcomes: Clinical trials showing improved progression-free survival (PFS) or overall survival (OS) compared to existing standards of care in specific patient subgroups could bolster pricing power.
- Limited Therapeutic Alternatives: If competing therapies face safety concerns or withdrawal, Tazverik's position as a relatively safe and effective option could allow for price adjustments.
- Inflationary Pressures: Annual price increases to account for inflation are a common practice in the pharmaceutical industry, although subject to increasing payer scrutiny.
Potential Price Decrease or Stabilization Drivers:
- Increased Competition: The entry of new EZH2 inhibitors or other novel agents with similar or superior efficacy/safety profiles in the same indications could put downward pressure on prices.
- Generic Competition: While not immediately foreseeable for a novel targeted therapy, the eventual loss of market exclusivity for related drug classes could influence overall pricing expectations.
- Payer Restrictions and Value-Based Pricing: Increased pressure from payers for evidence of value for money, potentially leading to outcomes-based contracts or preferred formulary placement tied to specific clinical results, could limit price increases.
- Safety Concerns: Emergence of significant, previously unrecognized safety issues could necessitate price reductions or impact market adoption.
- Biosimilar Competition (for related biologics): While Tazverik is a small molecule, the broader landscape of oncology treatments is seeing increased biosimilar adoption, which can influence payer negotiations for other drug classes.
What is the Projected Price Range for Tazverik in the Next Five Years?
Projecting precise drug prices is complex due to dynamic market and payer influences. However, based on current trends and anticipated market evolution, a projected price range can be established.
Assumptions:
- Continued market penetration in current indications.
- No significant unforeseen safety issues emerging.
- Moderate pace of new competitor entry.
- Annual price adjustments in line with pharmaceutical industry norms (e.g., 4-7% per year for inflation and value adjustments), tempered by payer negotiations.
- Potential for minor label expansions, but no blockbuster indication shifts within the five-year window.
Projected Price Range (Annualized Cost in USD):
| Year | Low Estimate (Annualized) | High Estimate (Annualized) | Notes |
|---|---|---|---|
| 2024 | $225,000 | $248,000 | Current pricing base adjusted for modest inflation and market growth. |
| 2025 | $235,000 | $263,000 | Continued inflationary adjustments, potential minor price optimization based on initial payer outcomes data. |
| 2026 | $245,000 | $279,000 | Incremental price increases, potential minor benefit from early RWE supporting value proposition. |
| 2027 | $255,000 | $296,000 | Sustained modest price growth, subject to increased payer scrutiny and potential competitor pressure. |
| 2028 | $265,000 | $315,000 | Pricing reflects cumulative inflation, potential for modest price increases if significant RWE demonstrates superior value or new indications. |
This projection assumes that the net price (after rebates and discounts) will remain a significant factor, and actual out-of-pocket costs for patients will vary based on insurance coverage and patient assistance programs. The upper end of the range accounts for more aggressive price increases driven by strong clinical data or market exclusivity, while the lower end reflects more constrained pricing due to competitive pressures or payer negotiations.
The acquisition of Epizyme by Ipsen in November 2022 may also influence pricing strategies, potentially aligning Tazverik with Ipsen's broader portfolio and pricing structures for specialty oncology drugs. [8]
Key Takeaways
- Tazverik (NDC 00143-9577) is a targeted therapy for epithelioid sarcoma and follicular lymphoma, with 2023 net revenue of $103.1 million.
- Its competitive landscape is characterized by limited direct competition in ES and a more crowded field in relapsed/refractory FL, where it faces PI3K inhibitors, BTK inhibitors, and BCL-2 inhibitors.
- The current list price is approximately $18,000-$20,000 per month, translating to an annual cost of $216,000-$240,000.
- Future price increases are contingent upon robust real-world evidence, label expansions, and demonstrated superior clinical outcomes.
- Downward price pressure may arise from increased competition, payer restrictions, and potential safety concerns.
- Projected annualized costs for Tazverik over the next five years range from approximately $225,000 to $315,000, reflecting annual inflationary adjustments and market dynamics.
FAQs
-
What are the specific EZH2 mutations that make a patient a good candidate for Tazverik in Follicular Lymphoma? The FDA approval for Follicular Lymphoma specifies patients with tumors positive for an EZH2 mutation, and also includes patients with relapsed or refractory FL who have received at least two prior systemic therapies, regardless of mutation status. The specific mutations are generally those affecting the functional domain of the EZH2 enzyme. [1]
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How does Tazverik's oral administration impact its market positioning compared to intravenous competitors? Oral administration offers significant advantages in terms of patient convenience, reduced healthcare resource utilization (fewer clinic visits), and potential for home administration. This can improve patient adherence and satisfaction, positively influencing market adoption, especially when compared to intravenous chemotherapy or targeted agents.
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What is the estimated market size for epithelioid sarcoma in the U.S.? Epithelioid sarcoma is a rare cancer. Incidence estimates vary, but it accounts for a small fraction of all soft tissue sarcomas, which themselves have an incidence rate of roughly 1 in 100,000 people annually. This rarity underscores the high unmet need and justifies specialized therapeutic pricing. [2]
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Are there ongoing clinical trials for Tazverik in combination therapies? Yes, ongoing clinical trials are investigating tazemetostat in combination with other agents for various hematologic malignancies and solid tumors. Results from these trials, particularly if demonstrating synergistic efficacy or improved safety profiles, could lead to future label expansions and impact its market value. [9]
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What is the expected patent protection timeline for Tazverik? The patent landscape for novel drugs is complex, involving compound patents, method-of-use patents, and formulation patents. While specific expiry dates can vary and may be subject to legal challenges, typical patent protection for small molecule drugs can extend for approximately 20 years from the filing date, with potential for extensions. The U.S. compound patent for tazemetostat was filed in 2008, suggesting a general expiry around 2028, with potential extensions. [10]
Citations
[1] U.S. Food & Drug Administration. (2020, January 10). FDA approves tazemetostat for epithelioid sarcoma. Retrieved from FDA Press Release
[2] Epizyme, Inc. (2023). Form 10-K Annual Report. Securities and Exchange Commission.
[3] Ipsen. (2024, February 22). Ipsen announces Full Year 2023 Results. Retrieved from Ipsen Investor Relations
[4] Epizyme, Inc. (2023, February 28). Epizyme Reports Fourth Quarter and Full Year 2022 Results. Retrieved from [Epizyme Investor Relations Archives] (Note: Access to specific archived press releases may require direct search on the company's historical investor relations pages or financial data providers).
[5] National Cancer Institute. (n.d.). Follicular Lymphoma Treatment (PDQ®)–Health Professional Version. Retrieved from NCI PDQ
[6] (Information synthesized from industry pricing databases and market analysis reports for specialty oncology drugs. Specific WAC data can fluctuate.)
[7] Epizyme, Inc. (n.d.). Tazverik Patient Support Programs. Retrieved from [Tazverik Website] (Note: Specific program details are often found on the drug's official patient website).
[8] Ipsen. (2022, November 3). Ipsen completes the acquisition of Epizyme. Retrieved from Ipsen Press Release
[9] ClinicalTrials.gov. (n.d.). Search of ClinicalTrials.gov for "tazemetostat combination". Retrieved from ClinicalTrials.gov
[10] (Patent information synthesized from public patent databases such as USPTO and EPO. Specific patent numbers and expiry dates can be complex and subject to ongoing legal interpretation. General information regarding patent term dates is used here for projection basis.)
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