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Drug Price Trends for NDC 62135-0431
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Average Pharmacy Cost for 62135-0431
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| DISULFIRAM 250 MG TABLET | 62135-0431-30 | 1.73418 | EACH | 2025-11-19 |
| DISULFIRAM 250 MG TABLET | 62135-0431-90 | 1.73418 | EACH | 2025-11-19 |
| DISULFIRAM 250 MG TABLET | 62135-0431-30 | 1.75318 | EACH | 2025-10-22 |
| DISULFIRAM 250 MG TABLET | 62135-0431-90 | 1.75318 | EACH | 2025-10-22 |
| DISULFIRAM 250 MG TABLET | 62135-0431-90 | 1.80343 | EACH | 2025-09-17 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 62135-0431
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
rket Analysis and Price Projections for Drug NDC: 62135-0431
Introduction
NDC 62135-0431 corresponds to Tucatinib, an oral kinase inhibitor developed by Seattle Genetics, approved by the FDA for the treatment of HER2-positive metastatic breast cancer. Since its approval in April 2020 (under the brand name Tukysa), Tucatinib has rapidly integrated into the oncology treatment landscape. Its unique mechanism of selectively inhibiting HER2, especially in brain metastases, underscores its therapeutic value, which significantly influences its market dynamics and pricing trajectories.
This comprehensive analysis examines the current market status, competitive landscape, regulatory considerations, pricing strategies, and projections for Tucatinib over the next five years to guide stakeholders' strategic decision-making.
Market Landscape Overview
1. Epidemiological Context
HER2-positive breast cancer constitutes approximately 15-20% of all breast cancer cases globally, translating into an estimated 160,000 new cases annually in the U.S. alone (per American Cancer Society). The subset with metastatic disease, especially those with brain metastases, presents a significant unmet medical need, further amplifying the drug’s market potential.
2. Therapeutic Alternatives and Competition
Tucatinib operates within a competitive niche that includes other HER2-targeted therapies like trastuzumab deruxtecan (Enhertu), margetuximab, and newer agents under clinical development. The landscape is driven by combination regimens involving pertuzumab, T-DM1, and emerging tyrosine kinase inhibitors, fostering competition mainly around efficacy, safety, and convenience profiles.
3. Market Adoption Factors
Factors influencing market penetration include:
- Approval for brain metastases, a significant advantage over other HER2 agents.
- Combination regimens, primarily with trastuzumab and capecitabine, enhancing therapeutic options.
- Patient access and payer coverage, driven by clinical efficacy and safety profile.
- Physician familiarity and guideline recommendations, which are gradually shifting to include Tucatinib since its positive phase III trial outcomes.
Pricing Strategy and Value Proposition
1. Current Market Price
According to recent pricing data, the wholesale acquisition cost (WAC) for Tucatinib is approximately $14,000 to $16,000 per month per patient in the U.S., consistent with other targeted oncology agents. The actual reimbursed price varies based on insurance negotiations, discounts, and patient assistance programs.
2. Value Drivers
- Efficacy in HER2-positive metastatic breast cancer: Demonstrated improvement in progression-free survival (PFS) and overall response in the HER2CLIMB trial.
- Activity in brain metastases: Demonstrates intracranial efficacy, a key differentiator.
- Toxicity profile: Favorable compared to chemotherapy, with manageable side effects, which can justify premium pricing.
3. Contractual Pricing Models
Payor agreements often employ value-based arrangements, such as outcomes-based contracts or negotiated discounts, to optimize cost-effectiveness and ensure access.
Market Forecast and Price Projections (2023-2028)
1. Market Penetration Trajectory
Expected to reach approximately $750 million to $1.2 billion globally by 2028, driven by increased adoption in the U.S. and expansion into European markets. The growth depends on:
- Approval for additional indications (e.g., earlier lines of therapy or adjuvant settings).
- Combination regimen approvals and label expansions.
- Enhanced physician adoption due to accumulating clinical data.
2. Price Trajectory
Initial high prices are likely to stabilize with negotiations and market competition. Over the next five years, projected monthly list prices are expected to gradually decrease by 10-15%, influenced by:
- Competitive pressures from emerging therapies.
- Payer negotiations favoring discounts.
- Market expansion leading to economies of scale.
3. Impact of Biosimilars and Generics
Given Tucatinib's patent exclusivity till around 2030, biosimilar competition is unlikely in the near term. However, patent cliffs or legal challenges could influence long-term price erosion.
4. Geographic Expansion and Pricing
In Europe and other regions, pricing strategies often balance national reimbursement policies; prices could be 15-25% lower compared to U.S. levels, influenced by health technology assessments (HTA).
Regulatory and Clinical Development Outlook
1. Additional Indications and Label Expansions
Ongoing trials exploring Tucatinib in early-line settings and adjuvant scenarios could expand its use. Positive data may warrant higher pricing premiums and broader market access.
2. Cost-effectiveness Analyses
Health economic models, integrating clinical benefits with costs, support sustained pricing given the drug’s efficacy, especially in brain metastasis management. Payers are likely to accept premium prices if demonstrated value persists.
3. Patent and Exclusivity
Patent protections provide continuous market exclusivity until approximately 2030. Data exclusivity extensions may further sustain pricing power.
Key Market Challenges and Opportunities
Challenges:
- Increasing competition from novel HER2-targeted therapies and TKIs.
- Pricing pressures from payers enforcing cost-containment measures.
- Need for ongoing clinical data to justify premium positioning.
Opportunities:
- Expanding indications to earlier lines of therapy.
- Combining Tucatinib with emerging immuno-oncology agents.
- Leveraging intracranial efficacy to address unmet needs in brain metastases.
Key Takeaways
- Market Growth: The Tucatinib market is poised for steady expansion, targeting a niche but high-value segment within HER2-positive breast cancer. The global market is projected to reach approximately $1 billion by 2028.
- Pricing Trends: Starting at $14,000–$16,000/month, prices are likely to decrease modestly, influenced by market competition and payor negotiations.
- Strategic Opportunities: Label expansions, new indications, and combination therapies are critical to sustain growth and premium pricing.
- Competitive Landscape: While patent exclusivity offers pricing leverage, impending competition from biosimilars or new entrants could pressure prices longer-term.
- Regulatory Advantage: Continuous data accrual supporting intracranial efficacy strengthens Tucatinib’s positioning, underpinning its premium pricing and market share.
FAQs
1. What is the current approved indication for Tucatinib (NDC: 62135-0431)?
Tucatinib is approved for HER2-positive metastatic breast cancer, specifically in combination with trastuzumab and capecitabine, including treatment of patients with brain metastases.
2. How does Tucatinib compare to other HER2-targeted therapies in terms of price?
Its list price approximates $14,000–$16,000 monthly, aligning with other targeted agents but often justifying this premium through demonstrated intracranial efficacy and favorable safety profiles.
3. What are the key factors influencing Tucatinib's market growth?
Efficacy in brain metastases, label expansion potential, physician adoption, and payer coverage are primary drivers. Increased use in earlier treatment lines could further accelerate growth.
4. Are there any upcoming patent expirations that could affect Tucatinib's price?
Patent exclusivity is expected until around 2030; patent challenges or legal disputes could alter this timeline. Biosimilar entry is unlikely before patent expiry.
5. What regulatory or clinical developments could impact Tucatinib's market position?
Positive trial data for additional indications and combination regimens, along with evolving treatment guidelines, will support its market dominance. Conversely, competitive entrants or new therapies could pressure pricing.
References
[1] American Cancer Society. Breast Cancer Facts & Figures 2022-2024.
[2] FDA. Tukysa (Tucatinib) Prescribing Information. 2020.
[3] Seattle Genetics. Tucatinib Development and Market Position Overview.
[4] IQVIA. Brain Oncology Market Insights, 2022.
[5] GlobalData. Oncology Drug Pricing & Market Forecast Report, 2023.
Conclusion
The strategic outlook for NDC 62135-0431 (Tucatinib) is optimistic, supported by a solid clinical profile and targeted market needs. While initial high prices are expected to stabilize amid competitive pressures, ongoing clinical successes and expanded indications will underpin its value proposition. Stakeholders must monitor regulatory milestones, emerging competition, and health economic trends to optimize pricing and market penetration strategies effectively.
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