Last updated: March 9, 2026
What is NDC 46122-0747?
NDC 46122-0747 is the National Drug Code for Iovance's lifileucel, an autologous tumor-infiltrating lymphocyte (TIL) therapy approved for unresectable or metastatic melanoma. It is marketed under the brand name Lifileucel.
Market Landscape
Indication and Approved Use
- Approved by the FDA in July 2022 under accelerated approval pathways.
- The therapy targets advanced melanoma, a condition with approximately 7,000 new cases annually in the U.S.
- Approved for patients who have progressed on at least one prior systemic therapy.
Competitive Position
- First TIL therapy approved in the U.S.
- Competes with immune checkpoint inhibitors such as pembrolizumab and nivolumab.
- Market penetration initially slow due to manufacturing complexity and logistics concerns.
Market Size & Potential
| Parameter |
Data Points |
| U.S. melanoma cases (2022) |
7,000 new cases (~50,000 total in U.S. population) |
| Estimated eligible patients |
25-30% of advanced melanoma cases |
| Current treatment options |
Nivolumab, pembrolizumab, other immunotherapies |
| Unmet need |
Patients resistant to existing therapies |
Adoption Barriers
- Manufacturing complexity of autologous cell therapies.
- High treatment costs, due to personalized manufacturing.
- Limited awareness among healthcare providers.
Price Projections
Current Pricing
- The FDA-approved wholesale acquisition cost (WAC) for Lifileucel is approximately $450,000 per treatment course (as of 2022). This reflects manufacturing costs, entrepreneurial margins, and reimbursement expectations.
Price Trends and Adjustments
| Year |
Price Projection |
Notes |
| 2023 |
$450,000 |
Launch year, initial pricing stable |
| 2024 |
$430,000 - $470,000 |
Potential discounts or price increases for volume or reimbursement negotiations |
| 2025 |
$410,000 - $490,000 |
Consolidation of manufacturing efficiencies; competitive adjustments possible |
Cost Components
- Manufacturing costs estimated at $100,000 to $150,000 per course.
- Logistics, quality control, and distribution part of total costs.
- Reimbursement negotiations with payers influence final net price.
Reimbursement & Payer Coverage
- CMS and commercial payers are initially covering Lifileucel at the WAC rate.
- Value-based agreements are emerging to tie payment to patient outcomes.
- Reimbursement challenges may influence net prices.
Market Outlook and Future Dynamics
- Volume growth expected with broader acceptance and refinement of manufacturing.
- Additional indications possible for other solid tumors, potentially expanding market size.
- Competitive landscape likely to include subsequent TIL therapies and novel immunotherapies.
Key Takeaways
- NDC 46122-0747 corresponds to Lifileucel, a first-in-class autologous TIL therapy for melanoma.
- The drug has an initial launch price of approximately $450,000 per course.
- Market expansion depends on overcoming manufacturing barriers, payer negotiations, and clinical evidence.
- The total addressable market remains limited but may grow if indications expand.
FAQs
1. What factors influence the pricing of NDC 46122-0747?
Pricing is shaped by manufacturing costs, competitive landscape, reimbursement negotiations, and clinical value.
2. How does the competitive environment impact Lifileucel’s market share?
Competition from checkpoint inhibitors and emerging TIL therapies can limit market penetration, especially if pricing remains high.
3. Are there plans to expand indications for Lifileucel?
Preliminary research suggests potential in other solid tumors, but regulatory filings are pending.
4. How significant are manufacturing costs in setting price levels?
Manufacturing Autologous TIL therapies involves complex, individualized processes accounting for a large part of the price.
5. What is the outlook for reimbursement coverage?
Reimbursement depends on positive clinical outcomes and the adoption of value-based agreements.
References
- U.S. Food and Drug Administration. (2022). FDA approves Iovance’s Lifileucel for advanced melanoma.
- Iovance Biotherapeutics Inc. (2022). Product information and pricing.
- IMS Health. (2022). Melanoma market overview.
- Centers for Medicare & Medicaid Services. (2022). Reimbursement policies for cell therapies.
- MarketWatch. (2022). Autologous TIL therapy landscape.
