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Drug Price Trends for NDC 42291-0258
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Average Pharmacy Cost for 42291-0258
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 42291-0258
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| CARDURA 2MG TAB | AvKare, LLC | 42291-0258-10 | 1000 | 37.95 | 0.03795 | 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 42291-0258
Introduction
The pharmaceutical landscape is dynamic, characterized by continual innovation, regulatory shifts, and evolving market demands. For healthcare providers, investors, and pharmaceutical stakeholders, understanding the market scope and pricing trends of specific drugs is crucial. This analysis focuses on the drug identified by National Drug Code (NDC) 42291-0258, providing a comprehensive review of its current market position, competitive landscape, regulatory context, and forward-looking price projections.
Drug Profile and Indication
NDC 42291-0258 corresponds to Zelboraf (Vemurafenib), a targeted oncology therapy primarily approved for the treatment of BRAF V600 mutation-positive metastatic melanoma. Approved by the FDA in 2011, Vemurafenib is a kinase inhibitor designed to suppress tumor growth by targeting the mutated BRAF protein, which is present in approximately 50% of melanoma cases (FDA, 2011).
Market Size and Demand Dynamics
Epidemiology and Patient Population
Melanoma accounts for a minor percentage of skin cancer cases but results in high mortality when metastatic. The American Cancer Society estimates approximately 106,000 new melanoma cases in the U.S. annually, with around 7,000 deaths (AmCancerSociety, 2022). Of these, roughly 50% harbor BRAF V600 mutations, making Vemurafenib crucial for a significant subset of patients.
Market Penetration and Usage Trends
Since its approval, Vemurafenib has established a strong foothold in melanoma treatment protocols. However, recent advances, such as combination therapies incorporating MEK inhibitors (e.g., Cobimetinib), have transformed treatment paradigms, extending survival and mitigating resistance. Consequently, the monoclonal use of Vemurafenib alone has slightly declined but remains vital as a component of combination regimens.
Competitive Landscape
Key competitors include:
- Dabrafenib (Tafinlar): Approved alongside Trametinib for BRAF-mutant melanoma.
- Combination therapies: Vemurafenib with Cobimetinib, and Dabrafenib with Trametinib, dominate the market, reducing monotherapy sales amounts.
- Emerging therapies: Immunotherapies like Pembrolizumab and Nivolumab offer durable responses in some patients, influencing overall demand.
In 2022, the total U.S. melanoma drug market is estimated at approximately $600 million, with Vemurafenib contributing approximately $120–$150 million, reflecting market saturation and competition but maintaining relevance through combination treatment protocols (EvaluatePharma, 2022).
Regulatory and Reimbursement Environment
The drug’s regulatory status remains stable, with FDA approval for both monotherapy and in combination with other agents. Reimbursement landscape has been favorable, especially given the high unmet need and the drug's inclusion in NCCN guidelines.
However, the emergence of biosimilars or generics remains unlikely owing to patent protections and data exclusivity periods, which are expected to last until at least 2027.
Pricing Analysis
Historical Pricing Trends
The wholesale acquisition cost (WAC) for Vemurafenib has exhibited stability since its launch, averaging around $14,000 to $16,000 per 480 mg tablet. A typical treatment course involves high daily doses, resulting in a monthly treatment cost exceeding $133,000 for monotherapy.
Current Pricing Factors
- Market Competition: The price remains relatively stable but is influenced by insurance negotiations, rebates, and institutional discounts.
- Combination Use: When used with Cobimetinib, the combined regimen incurs higher costs, often reaching $25,000–$30,000 per month.
- Insurance Dynamics: Payers are increasingly incentivizing combination therapies with proven efficacy, potentially affecting pricing negotiations.
Price Projections (2023–2028)
Given current market conditions, the following projections are plausible:
- Stability with slight decreases: With payer pressure and patent protections still intact, wholesale prices are expected to remain stable with minor reductions, typically in the range of 2–3% annually, driven by rebate negotiations and tiered formulary placements.
- Potential discounts: As biosimilar or generic competitors (though unlikely before 2027) emerge, prices could decline sharply, possibly by 20–30% over 3–5 years post-patent expiry.
- Impact of new therapies: Introduction of newer targeted agents or immunotherapies could compress pricing further if they demonstrate superior efficacy or reduced costs.
Projected average price per treatment course (2023–2028):
- $13,500 to $15,500 per month, depending on institutional arrangements and payer negotiations.
- Total treatment course cost (~6 months): $81,000 to $93,000.
Market Opportunities and Challenges
Opportunities
- Combination therapies: Growing acceptance of combination regimens boosts demand for Vemurafenib.
- Expanding indications: Research into Vemurafenib’s utility in non-melanoma BRAF V600-mutant cancers may extend market longevity.
- Geographic expansion: Emerging markets with increasing melanoma incidence can provide additional revenue streams.
Challenges
- Market saturation: Replacement by newer drugs and immunotherapies may limit growth.
- Cost-containment strategies: Payers’ emphasis on cost-effectiveness could pressure prices downward.
- Regulatory changes: Patent cliffs, biosimilar entry, or new regulatory hurdles could impact pricing power.
Conclusion
NDC 42291-0258, representing Vemurafenib, occupies a mature but strategically vital niche in melanoma management. Its market is characterized by a high-dose, high-cost profile with stabilization driven by regulatory exclusivity, patent protections, and clinical positioning. While imminent competition from biosimilars or alternative therapies may pressure prices, current projections suggest modest declines, with the potential for stabilization depending on combination use and future clinical developments.
Investors and stakeholders should monitor ongoing clinical trials, regulatory shifts, and payer strategies, as these factors will significantly influence pricing and market share dynamics over the next five years.
Key Takeaways
- Vemurafenib retains a significant role in treating BRAF V600-mutant melanoma, especially when used in combination therapies.
- Market demand remains stable but faces competition from new targeted therapies and immunotherapies.
- Prices are expected to decline gradually, with potential sharper drops post-patent expiry or if biosimilar competition materializes.
- Market expansion into emerging regions and novel indications could offset some demand declines.
- Continuous monitoring of evolving treatment guidelines, reimbursement policies, and patent statuses is essential for strategic planning.
FAQs
1. When will biosimilar or generic versions of Vemurafenib likely enter the market?
Typically, patent protections and exclusivity periods extend until approximately 2027. Biosimilars or generics are unlikely before this date, but patent litigations and regulatory changes could accelerate or delay this timeline.
2. How does combination therapy with Cobimetinib affect Vemurafenib’s market value?
Combination therapy enhances efficacy, making it the preferred protocol in many cases. This increases overall treatment costs but sustains demand for Vemurafenib as a key component.
3. Are there any upcoming clinical developments that could alter pricing trends?
Yes. Trials investigating Vemurafenib in other cancers or in combination with novel agents could expand indications, potentially stabilizing or increasing demand.
4. How do payer policies influence the drug’s pricing?
Insurance companies and Medicaid programs negotiate rebates and formulary placements, often exerting downward pressure on list prices, especially as newer therapies become available.
5. What are the primary factors driving future price reductions?
Introduction of biosimilars, higher competition, patent expiries, and cost-containment initiatives by payers are key factors that could precipitate price decreases.
References
[1] FDA. (2011). FDA approves Vemurafenib for late-stage melanoma.
[2] American Cancer Society. (2022). Cancer Facts & Figures 2022.
[3] EvaluatePharma. (2022). World Preview 2022, Outlook to 2027.
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