Last updated: February 21, 2026
What is NDC 10631-0115?
NDC 10631-0115 corresponds to Tivdak (tivdak), a drug approved by the U.S. Food and Drug Administration (FDA) for the treatment of metastatic cervical cancer that has progressed on chemotherapy. Tivdak is a tisotumab vedotin-based antibody-drug conjugate, introduced by Genmab and Seagen.
Market Overview
Indication and Patient Demographics
- Indication: Recurrent or metastatic cervical cancer after chemotherapy.
- Prevalence: Approximately 13,800 new cervical cancer cases annually in the U.S., with an estimated 40% progressing to metastatic disease.
- Target Population: Patients with advanced disease who have received prior chemotherapy, representing an underserved segment due to limited treatment options.
Competitive Landscape
- Primary Competitors: Bevacizumab (Avastin), pembrolizumab (Keytruda), and other immune-checkpoint inhibitors.
- Market Entry: Tivdak is the first antibody-drug conjugate approved specifically for this indication, with a unique mechanism of action targeting tissue factor.
Pricing History and Regulation
- Initial Price: The wholesale acquisition cost (WAC) was set at approximately $5,200 per 20 mg vial upon approval in September 2021.
- Dosing Schedule: 2 mg/kg intravenously every three weeks, with an average treatment course estimated at six doses.
Market Penetration and Adoption
Tivdak's uptake depends on:
- Physician familiarity with ADCs.
- Reimbursement frameworks, including Medicare and private insurance.
- Treatment guidelines updates, which may incorporate Tivdak in later iterations.
Initial sales were modest, with projections estimating roughly 2,000 to 3,000 annual treatment courses in the U.S. by 2023, based on the prevalence of eligible patients and typical treatment adoption rates.
Price Projection Models
Short-term (2023-2024)
- Price Stability: Initial prices are likely to remain steady due to limited competition.
- Reimbursement negotiations may influence net prices; discounts of 10-20% are typical for negotiated payers.
Medium-term (2025-2027)
- Potential for price adjustments: Prices could decrease as competition emerges or biosimilars enter the pipeline.
- Market expansion: Off-label use or expanded indications could influence pricing dynamics and volume.
Long-term (2028 and beyond)
- Biosimilar impact: Introduction of biosimilar ADCs could reduce prices by 30-50%.
- Evolving treatment standards: New therapies improving efficacy or tolerability may decrease demand for Tivdak, impacting price and volume.
Price Sensitivity Analysis
| Scenario |
Assumed Price per Course |
Estimated Annual Revenue |
Notes |
| Base case |
$31,200 (6 doses at $5,200 each) |
$62.4M |
No discounts, full uptake |
| Discounted |
$25,000 |
$50M |
Payer negotiations |
| Biosimilar entry |
$20,000 |
$40M |
Competition causes price decline |
Key Factors Affecting Future Prices
- Regulatory changes: Price controls or reimbursement reforms.
- Competitive dynamics: Entry of biosimilars or new therapies.
- Clinical evidence: Demonstration of superior efficacy or safety.
- Healthcare policies: Changes in coverage and access.
Conclusion
Tivdak’s initial pricing aligns with other ADC therapeutics, with limited immediate competition. Its market growth remains constrained by the small eligible population but is expected to grow as treatment guidelines evolve. Price projections suggest stability for the next two years, with potential declines driven by biosimilar competition and shifts in treatment paradigms thereafter.
Key Takeaways
- Tivdak (NDC 10631-0115) is a targeted therapy for metastatic cervical cancer with an initial wholesale price of approximately $5,200 per 20 mg vial.
- Market penetration remains low but is expected to increase with clinician familiarity and expanded indications.
- Short-term prices are expected to stay stable; long-term prices may decline due to biosimilar competition.
- Revenue estimates range from $50M to $62M annually in the U.S., depending on uptake and discounting.
- Price shifts will be influenced by regulatory policies, clinical advances, and competitive landscape developments.
FAQs
1. How does Tivdak compare to other treatments for metastatic cervical cancer?
Tivdak offers a novel mechanism via antibody-drug conjugation, targeting tissue factor, with demonstrated efficacy in patients previously treated with chemotherapy. It fills an unmet need where immune-checkpoint inhibitors and anti-angiogenic agents are typically used first-line.
2. What is the potential market size for Tivdak?
Approximately 13,800 new cases annually in the U.S., with about 5,520 patients (40%) developing metastatic disease, most of whom would be candidates for Tivdak. Actual treatment rates could be lower due to access and physician preference.
3. What factors might influence Tivdak’s price in the future?
Introduction of biosimilars, regulatory price controls, reimbursement negotiations, and new clinical data supporting or challenging its efficacy.
4. Are there significant reimbursement challenges for Tivdak?
Current reimbursement is aligned with standard oncology drug reimbursement pathways, but future changes could impact net pricing.
5. What are the biggest risks to Tivdak’s market growth?
Emergence of competitive therapies, reduced treatment indications, or unfavorable reimbursement policies that limit patient access.
References
[1] U.S. Food and Drug Administration (2021). FDA approves Tivdak for advanced cervical cancer.
[2] IQVIA360, 2023 Market Data.
[3] Department of Health and Human Services, 2022. Pricing and reimbursement policies.
[4] Genmab and Seagen press releases, 2021-2023.
