Last updated: March 12, 2026
What is the Drug with NDC 69367-0174?
NDC 69367-0174 is identified as Tucatinib (brand: Tukysa), developed by Seattle Genetics. It is an oral kinase inhibitor targeting HER2, approved by the FDA in April 2020 for HER2-positive metastatic breast cancer.
Market Overview
Indications and Approved Uses
- Primary indication: HER2-positive metastatic breast cancer, including cases with brain metastases.
- Additional potential markets: HER2-positive gastric and gastroesophageal cancers, though not currently approved for these.
Market Size and Demand Drivers
- Global breast cancer market: Valued at approximately $18 billion in 2022 [1].
- HER2-positive subset: Estimated at 20%-25% of breast cancers, roughly 2.5 million globally [2].
- Market penetration: As of 2023, Tucatinib has secured a niche in second-line treatment options.
Competitive Landscape
- Main competitors:
- Trastuzumab deruxtecan (Enhertu)
- Pertuzumab (Perjeta)
- Ado-trastuzumab emtansine (Kadcyla)
- Unique positioning: Oral administration and efficacy in brain metastases provide differentiation.
Pricing and Reimbursement Landscape
Drug Pricing
- Average wholesale price (AWP): Estimated at $11,000 per month based on publicly available data [3].
- Annual treatment cost: Approximately $132,000 per patient.
Reimbursement and Access
- Insurance coverage: Secured via commercial plans, Medicare, and Medicaid.
- Pricing pressure: Competitive pricing expected to stabilize between $10,000 and $12,000 per month.
Price Projections (2023-2028)
| Year |
Estimated Average Monthly Price |
Key Factors |
| 2023 |
$11,000 |
Current market, high initial adoption |
| 2024 |
$10,500 |
Increased competition, price negotiations |
| 2025 |
$10,000 |
Market stabilization, expanded insurance coverage |
| 2026 |
$9,750 |
Entry into broader markets, potential biosimilars |
| 2027 |
$9,500 |
Biosimilars or updated formulations influence prices |
| 2028 |
$9,250 |
Mature market, price plateau |
Market Growth Projections
- Compound annual growth rate (CAGR): 5-8% over the next five years.
- Key factors:
- Expanded approved indications.
- Increased adoption in earlier-line treatments.
- Competitive pressures from emerging therapies.
Regulatory and Policy Influences
- Pricing and access policies: Ongoing debates on drug pricing transparency may influence future costs.
- Biosimilar development: Biosimilars for HER2 therapies are in early stages; their emergence could lower prices.
Risks and Opportunities
-
Risks:
- Fast development of alternative HER2-targeted therapies.
- Regulatory changes impacting reimbursement.
- Patent litigation or expirations.
-
Opportunities:
- Broadened FDA approvals.
- Adoption in combination therapies.
- Entry into underpenetrated markets like gastric cancer.
Key Takeaways
- Tucatinib benefits from niche efficacy in brain metastases and oral administration.
- Current average treatment costs are approximately $11,000/month, with projections trending downward to ~$9,250 by 2028.
- Market growth depends on clinical expansion, competitive dynamics, and regulatory factors.
- Status quo pricing is likely for the next 1-2 years, with moderate declines thereafter.
FAQs
1. What factors most influence Tucatinib’s price?
Reimbursement policies, competition, clinical adoption, and patent status directly impact pricing.
2. How does Tucatinib compare to other HER2 inhibitors?
It offers oral dosing and efficacy in brain metastases, not always seen with IV therapies.
3. Are biosimilars expected to reduce Tucatinib’s price significantly?
Potential biosimilars could exert downward pricing pressure starting around 2026.
4. What is the primary driver of demand for Tucatinib?
The increasing prevalence of HER2-positive metastatic breast cancer, especially with brain metastases.
5. Will expanded indications affect sales volume?
Yes, approval for additional cancers could significantly increase market size and revenue.
References
- Global Market Insights. (2022). Breast Cancer Therapeutics Market Size & Trends.
- American Cancer Society. (2021). Cancer Facts & Figures.
- Medi-Span. (2023). Drug Price Files.
