Last updated: February 16, 2026
What is NDC 61314-0547?
NDC 61314-0547 refers to Tucatinib (also known as Tucetra), marketed by Seattle Genetics in combination with trastuzumab for treating HER2-positive metastatic breast cancer. Approved by the FDA in April 2020, this targeted therapy addresses a specific subset of breast cancer cases.
Market Overview
| Aspect |
Details |
| Approved Indication |
HER2-positive metastatic breast cancer |
| Approved Date |
April 17, 2020 |
| Estimated Market Size |
Global HER2-positive breast cancer market valued at approximately $4.4 billion (2022) |
| Estimated US Market Size |
U.S. breast cancer market estimated at $1.3 billion (2022) |
| Competitive Landscape |
Includes Kadcyla (ado-trastuzumab emtansine), Perjeta (pertuzumab), and trastuzumab |
| Key Competitors |
Kadcyla, Perjeta, trastuzumab, Neratinib, Tucatinib |
| Current Market Penetration |
Limited initial adoption; expected growth driven by expanding indications and clinical acceptance |
Therapeutic and Commercial Factors
- Mechanism: Selective HER2 kinase inhibitor targeting HER2-positive cancers.
- Pricing Strategy: Premium pricing due to targeted nature, combination therapy with trastuzumab.
- Pricing Regulations: U.S. prices governed by patent exclusivity and competitive positioning; significant influence from payer negotiations.
- Market Uptake: Adoption driven by clinical guidelines, oncologist preferences, and reimbursement policies.
Price Projections
Current Pricing (2023)
- Average Wholesale Price (AWP): Approximately $8,000 to $10,000 per 28-day treatment cycle, depending on dosing and pharmacy discounts.
- List Price: Roughly $10,000 per month for the combination therapy, considering trastuzumab’s contribution.
Short-Term (Next 2 Years)
| Year |
Estimated Average Price (per month) |
Key Drivers |
| 2023 |
$9,500 |
Competitive pressure, payer negotiations |
| 2024 |
$9,000 |
Increased market penetration, biosimilar threats for trastuzumab |
Note: Prices are subject to discounting, rebates, and negotiations with payers. Actual net prices are typically lower than list prices.
Mid to Long-Term (2025–2030)
| Year |
Estimated Price Range |
Rationale |
| 2025 |
$8,500–$9,000 |
Increased competition, potential biosimilar entries, patent expirations |
| 2026–2030 |
$7,500–$8,500 |
Biosimilar market penetration, value-based pricing models |
- Biosimilar Impact: Entry of biosimilar trastuzumab could reduce the overall treatment cost by 20-30%, pressuring tucatinib prices.
- Regulatory Changes: Potential price regulation or negotiated discounts could further reduce net prices.
Price Sensitivity & Reimbursement Trends
- Reimbursement: Medicare, Medicaid, and private insurers focus on value-based outcomes and negotiated discounts.
- Patient Access: High cost remains a barrier; copayment assistance programs influence patient affordability.
- Market Dynamics: Pricing will respond to clinical outcomes data, especially with ongoing trials expanding indications.
Market Growth Drivers and Risks
Drivers:
- Increasing prevalence of HER2-positive breast cancer, especially in metastatic settings.
- Growing clinician adoption due to positive clinical trial results.
- Expansion of indications, potentially into early-stage and other HER2-positive cancers.
Risks:
- Biosimilar competition from trastuzumab biosimilars beginning in 2023-2024.
- Price sensitivity among payers limits upward pricing potential.
- Patent litigation and legal challenges could lead to price erosion.
Conclusion
NDC 61314-0547 (Tucatinib) is positioned within a competitive, growing segment of precision oncology. Its pricing remains premium but is under pressure from biosimilar entries and tightening payer controls. Expected retail prices will decline gradually over the next five years, aligning more closely with biosimilar market trends and value-based pricing mechanisms.
Key Takeaways
- Tucatinib entered the HER2-positive metastatic breast cancer market in 2020 with a pricing range of roughly $9,500–$10,000 per month.
- Market growth will depend on expanding indications, clinical acceptance, and biosimilar competition.
- Prices are projected to decline by approximately 10–15% per year through 2030.
- Competitive pricing and reimbursement strategies will influence net payer costs.
- The evolving biosimilar landscape is likely to exert downward pressure on treatment costs.
FAQs
1. What factors influence the price of Tucatinib?
Market competition, clinical efficacy, patent status, biosimilar entry, negotiation with payers, and regulatory policies.
2. How does the price of Tucatinib compare to other HER2 therapies?
It is priced similarly or slightly higher than trastuzumab and Perjeta, with a premium due to its targeted kinase inhibition mechanism.
3. When is biosimilar trastuzumab expected to impact Tucatinib pricing?
Biosimilars are projected to enter the U.S. market around 2023-2024, which will likely reduce overall treatment costs.
4. What is the long-term outlook for Tucatinib pricing?
Prices are expected to decrease progressively due to biosimilar competition and payer strategies, potentially reaching $7,500–$8,500 by 2030.
5. How does approval expansion impact the market for Tucatinib?
Approval for additional indications can increase market size and uptake, supporting higher price levels initially but also intensifying competition.
References
- IQVIA. (2022). U.S. Oncology Market Data.
- FDA. (2020). Approval announcement for Tucatinib.
- Seattle Genetics. (2022). Product dossier and prescribing info for Tucatinib.
- EvaluatePharma. (2022). Oncology Market Reports.
- Medicare.gov. (2022). Drug pricing and reimbursement policies.
