Last updated: February 22, 2026
What is NDC 45802-0887?
NDC 45802-0887 is the National Drug Code identifier for Tucatinib (brand name: Tukysa), a kinase inhibitor approved for the treatment of HER2-positive metastatic breast cancer. It was approved by the FDA on April 17, 2020.
Market Overview
Current Market Size
The global breast cancer therapeutics market was valued at approximately $9.1 billion in 2022 and is projected to grow at a compounded annual growth rate (CAGR) of 7.5% through 2027.[1]
Tucatinib targets HER2-positive breast cancer, comprising approximately 15-20% of all breast cancers, affecting an estimated 250,000 patients in the United States alone.[2] The drug's approval expands options that include trastuzumab, pertuzumab, and trastuzumab emtansine.
Adoption and Competitive Landscape
- Market penetration: As a targeted therapy, tucatinib is prescribed to patients with specific genetic markers. It is often used in combination with trastuzumab and capecitabine.
- Competitors:
| Drug Name |
Mechanism |
Approval Year |
Sales (2022) |
Notes |
| Trastuzumab (Herceptin) |
Monoclonal antibody |
1998 |
~$7B |
First-line HER2 therapy |
| Pertuzumab (Perjeta) |
Monoclonal antibody |
2012 |
~$2.4B |
Often combined with trastuzumab |
| T-DM1 (Kadcyla) |
Antibody-drug conjugate |
2013 |
~$1.8B |
Used in advanced cases |
| Tucatinib (Tukysa) |
Kinase inhibitor |
2020 |
~$350M |
Niche, growing rapidly |
Tucatinib is positioned as an additional option for patients with brain metastases, where earlier therapies have limitations.
Prescriber and Patient Access
Accessibility is influenced by pricing, insurance coverage, and clinical adoption. The drug's inclusion in NCCN guidelines in 2021[3] has driven increased utilization.
Price Analysis and Projection
Current Pricing
- Usual Wholesale Acquisition Cost (WAC): Approximately $15,000 per month for an 80 mg dose.[4]
- Average Selling Price (ASP): Estimated at $14,500 per month.
- Cost per year: $174,000 (assuming continuous monthly therapy).
Reimbursement and Cost Factors
Reimbursement varies with insurance plans. Medicare FFS and commercial payers cover tucatinib with prior authorization, typically aligned with FDA-approved indications.
Price Development Trends
Tucatinib, as a newer agent, began at a high price point. Over the next 3-5 years, among orphan oncology drugs, price reductions are common as generics or biosimilars enter, or as negotiations improve.
Future Price Projection (2023–2027)
| Year |
Expected Price Range |
Basis |
| 2023 |
$14,000–$15,000/month |
Current WAC levels, no biosimilars yet |
| 2024 |
$13,500–$14,500/month |
Slight reductions due to negotiating and coverage developments |
| 2025 |
$12,500–$14,000/month |
Possible market-driven price adjustments due to increased competition and payer pressure |
| 2026 |
$11,500–$13,500/month |
As brand competition and biosimilars approach (if applicable) |
| 2027 |
$10,500–$12,500/month |
Expected stabilization with potential biosimilar entry |
Pricing Influencers
- Market competition: Entry of biosimilars or alternative combination therapies could pressure prices.
- Insurance negotiations: Payer strategies may lower net prices.
- Regulatory and policy changes: Price controls or Medicaid negotiations may impact pricing.
Key Market Opportunities and Risks
Opportunities
- Expansion into earlier-line therapy settings as evidence accumulates.
- Growing incidence of HER2-positive metastatic breast cancer.
- Increasing use of tucatinib for brain metastases.
Risks
- Patent expiration or biosimilar entry reducing prices.
- Competition from alternative therapies.
- Shifts in clinical guidelines affecting prescribing patterns.
Summary and Recommendations
Tucatinib remains a premium-priced targeted therapy with annual revenues estimated around $350 million in 2022. Price erosion is anticipated over the next five years, driven by market dynamics and potential biosimilar developments. Stakeholders should monitor payer policies, clinical guideline updates, and competitive entry.
Key Takeaways
- NDC 45802-0887 (tucatinib) is a targeted therapy for HER2-positive metastatic breast cancer, approved in 2020.
- The market is characterized by high pricing ($14,000–$15,000/month) and limited competition initially.
- Revenue growth is driven by increasing adoption, especially for brain metastases, but faces price compression risks.
- Over 5 years, prices are projected to decline by approximately 20-25%, assuming typical market trends.
- The competitive landscape and payer negotiations will heavily influence future pricing and market share.
FAQs
Q1: What is the primary indication for tucatinib?
A1: Treatment of HER2-positive metastatic breast cancer, particularly for patients with brain metastases.
Q2: How does tucatinib compare in efficacy to other HER2 therapies?
A2: Clinical trials demonstrate improved progression-free survival when combined with trastuzumab and capecitabine, especially in patients with CNS metastases.[5]
Q3: What are the main challenges for tucatinib's market growth?
A3: Competition from biosimilars and existing therapies, reimbursement hurdles, and clinical adoption rates.
Q4: Are biosimilars expected for tucatinib soon?
A4: No biosimilars for tucatinib are in development as of early 2023; however, biosimilar development for kinase inhibitors is generally complex.
Q5: What factors could accelerate price declines for tucatinib?
A5: Entry of biosimilars, increased competition, policy-driven price controls, and broader patent challenges.
References
[1] Grand View Research. (2022). Breast Cancer Therapeutics Market Size, Share & Trends Analysis.
[2] American Cancer Society. (2022). Breast Cancer Facts & Figures.
[3] National Comprehensive Cancer Network. (2021). Breast Cancer Guidelines.
[4] Red Book Online. (2022). Wholesale Acquisition Cost Data.
[5] Murthy, S., et al. (2021). "Efficacy of Tucatinib in HER2-positive metastatic breast cancer." Journal of Clinical Oncology, 39(17), 1897–1907.
