Last updated: March 6, 2026
What is NDC 75907-0059?
NDC 75907-0059 corresponds to Tucatinib (TUKYSA), a targeted therapy approved by the FDA in April 2020. It is used for the treatment of unresectable or metastatic HER2-positive breast cancer, typically in combination with trastuzumab and capecitabine.
Market Landscape
Product Positioning
Tucatinib is a selective tyrosine kinase inhibitor targeting HER2. It offers an alternative for patients with HER2-positive breast cancer, especially those who have progressed on prior therapies. The drug competes with existing therapies like trastuzumab, pertuzumab, and ado-trastuzumab emtansine.
Market Size and Growth
| Metric |
Data |
Source |
| HER2-positive breast cancer global prevalence (2022) |
2.2 million cases |
[1] |
| US HER2-positive breast cancer market (2022) |
Approx. 150,000 new cases/year |
[2] |
| Estimated Tucatinib market share (2022) |
10-15% of HER2-positive breast cancer market |
Calculated based on current therapy shares |
Sales Performance
Initial US sales (2022) estimated at $150 million, with projections reaching $300-350 million by 2025. Growth driven by expanded Medicare coverage, increased adoption post-approval, and clinical integration.
Competitive Landscape
| Competitors |
Drugs |
Market Share (2022) |
Notes |
| Trastuzumab |
Herceptin |
50% |
Established first-line therapy |
| Pertuzumab |
Perjeta |
25% |
Often combined with trastuzumab |
| Ado-trastuzumab emtansine |
Kadcyla |
15% |
Used in later-line settings |
| Tucatinib |
TUKYSA |
5-10% |
Gaining adoption in resistant cases |
Emerging therapies include neratinib, margetuximab, and combination regimens with immunotherapies.
Pricing and Reimbursement
Current Pricing
| Parameter |
Data |
Notes |
| Wholesale Acquisition Cost (WAC) |
$11,350 per month |
As per wholesale price reports (2023) |
| Average Selling Price (ASP) |
Slightly below WAC |
Reflects negotiated rebates/discounts |
| Cost per treatment cycle |
$34,050 (monthly dose) |
Based on typical 3-month cycles |
Reimbursement Landscape
Medicare and private payers reimburse for Tucatinib at rates aligned with other targeted therapies. FDA approval for expanded indications (e.g., earlier lines) expected in the near future. Commercial coverage varies depending on prior therapies and set clinical guidelines.
Price Trends and Adjustments
Clinics and payers are increasingly negotiating discounts based on volume and formularies. The introduction of biosimilars or generics is unlikely due to Tucatinib's patent protection expiring no sooner than 2030.
Pricing Projections (2023-2027)
| Year |
Estimated WAC |
Estimated ASP |
Market Penetration |
Notes |
| 2023 |
$11,350/month |
$10,950/month |
10% of target market |
Initial uptake |
| 2024 |
$11,150/month |
$10,750/month |
25% |
Clinical guidelines favoring early integration |
| 2025 |
$10,950/month |
$10,550/month |
40% |
Reimbursement gains and physician familiarity |
| 2026 |
$10,850/month |
$10,350/month |
55% |
Further market expansion |
| 2027 |
$10,750/month |
$10,200/month |
65% |
Price stabilization with increased usage |
Pricing declines are moderate, reflecting limited competition and patent life.
Risks and Opportunities
- Risks: Patent expiration, competition from biosimilars, regulatory delays in label expansion, payer restrictions.
- Opportunities: Line extension for earlier-stage HER2-positive cancers, combination with immunotherapies, global market expansion.
Regulatory and Policy Impact
Recent policies favor value-based pricing models for oncology drugs. The FDA’s push for accelerated approvals can influence market entry and pricing strategies. US and European health agencies continue to evaluate real-world effectiveness to guide reimbursement decisions.
Key Takeaways
- Tucatinib (NDC 75907-0059) targets HER2-positive breast cancer with a current US market value estimated at $150 million in 2022.
- The drug faces competition mainly from trastuzumab and pertuzumab; however, it commands a niche in resistant cases.
- Pricing remains around $11,350 WAC per month, with gradual declines projected over five years to approximately $10,750.
- Market growth depends on expanded indications, clinical adoption, and reimbursement policies.
- Competitive threats include patent expiry and biosimilar developments; opportunities lie in early-line combination therapies.
FAQs
1. What factors could influence the price of Tucatinib after 2027?
Patent expiration, biosimilar entry, changes in regulatory policies, and market competition can decrease prices.
2. How does Tucatinib’s efficacy compare with other HER2-targeted therapies?
Clinical trials demonstrate comparable efficacy in resistant HER2-positive breast cancer, with a favorable safety profile.
3. What are the key drivers for market growth for Tucatinib?
Expanded indications, increased line adoption, payer coverage, and international approval.
4. What are the limitations of current pricing projections?
Assumptions about market adoption, payer negotiations, and future regulatory changes introduce uncertainty.
5. How does reimbursement for Tucatinib vary across regions?
US coverage is primarily based on private and public payer negotiations; European markets depend on country-specific health policies.
References
[1] Global Cancer Observatory. (2022). Breast cancer statistics. International Agency for Research on Cancer.
[2] American Cancer Society. (2022). Breast cancer facts & figures. ACS.
[3] IQVIA. (2023). Oncology drug sales report.
[4] FDA. (2020). Tucatinib (TUKYSA) approval announcement.
[5] Centers for Medicare & Medicaid Services. (2023). Coverage policies for oncology drugs.
