Last updated: February 24, 2026
What Is NDC 27241-0115 and Its Therapeutic Indication?
NDC 27241-0115 corresponds to Moxetumomab Pasudotox-tdfk. Approved by the FDA in September 2018 for the treatment of relapsed or refractory hairy cell leukemia (HCL) in adult patients. It is marketed under the brand name Lumoxiti.
Market Overview
Market Size and Patient Population
- Target Population: Approximately 350-500 patients annually in the US with relapsed/refractory HCL[1].
- Market Penetration: Limited; Lumoxiti is indicated after at least two prior therapies. About 20-30% of eligible patients receive it, constrained by prescribing patterns and access issues.
Competitive Landscape
Market Drivers
- Growing recognition of immunotherapy options in hematologic malignancies.
- Increasing treatment lines for relapsed HCL.
- Potential off-label uses in other B-cell malignancies pending further research.
Pricing Structure
Current Wholesale Acquisition Cost (WAC)
- List Price: Approximately $133,100 per 4-week treatment cycle[2].
- Cost per Dose: Approximate dose of 0.04 mg/kg, administered intravenously, typically once every 3 weeks.
Insurance and Reimbursement landscape
- Commercial insurers and government programs like Medicare generally cover Lumoxiti with prior authorization.
- Net prices tend to be 10-20% lower than WAC due to discounts, rebates, and negotiated agreements.
Cost Components
- Drug acquisition.
- Administration (hospital or outpatient infusion centers).
- Support services and monitoring.
Price Projections (Next 5 Years)
Assumptions
- Stable market share: 25-35% of relapsed/refractory HCL patients.
- No significant price discounts or new entrants affecting the market price.
- Introduction of approved or experimental competing therapies remains limited.
Forecast Summary
| Year |
Estimated Patients |
Approximate Revenue (USD millions) |
Notes |
| 2023 |
100 |
13.3 |
Beginning of stable market penetration |
| 2024 |
125 |
16.7 |
Slight increase in adoption |
| 2025 |
150 |
20.0 |
Expansion, possible label extensions |
| 2026 |
180 |
24.0 |
Growth driven by increased awareness |
| 2027 |
200 |
26.7 |
Market saturation nearing peak |
Price per cycle remains around $133,000, with incremental growth driven by inflation and negotiated rebates.
Regulatory and Policy Impact
- No expected price-mandated reductions from recent policy measures; however, Medicare Part D negotiations could influence net prices[3].
- Pursuit of additional indications may expand market size and influence pricing strategies.
Risks and Opportunities
Risks:
- Entry of biosimilars or alternative therapies.
- Reimbursement challenges.
- Flat or declining market size due to improved therapies or early diagnosis.
Opportunities:
- Expansion into first-line settings upon future approvals.
- Off-label uses in other hematologic diseases.
- Price adjustments reflecting increased market acceptance and competition.
Key Takeaways
- NDC 27241-0115 (Lumoxiti) has a niche market within relapsed/refractory HCL.
- Current list price: approximately $133,000 per cycle.
- Market size: 350-500 patients annually in the US.
- Revenue projections reach ~$26.7 million by 2027 under stable conditions.
- Pricing will be influenced by reimbursement policies, market expansion, and competitive dynamics.
FAQs
Q1: What factors could significantly alter Lumoxiti’s pricing in the near future?
Reimbursement negotiations and the approval of biosimilars or competing therapies could depress prices.
Q2: Is there potential for Lumoxiti to be used in other indications?
Yes, ongoing research in other hematologic malignancies could lead to expanded indications, boosting sales.
Q3: How does Lumoxiti compare price-wise to similar therapies?
At roughly $133,000 per cycle, it is priced higher than traditional chemotherapies but comparable to other targeted biologics in hematology.
Q4: How sensitive are market revenues to patient uptake?
Highly sensitive; a 10% decrease in uptake can reduce revenues by $1-2 million annually.
Q5: What policy changes could impact Lumoxiti's market?
Medicare negotiations and price controls or the introduction of biosimilar competitors could lead to pressures on pricing and profitability.
References
[1] U.S. Food and Drug Administration (FDA). (2018). FDA approves first targeted therapy for hairy cell leukemia.
[2] Red Book Online. (2023). Lumoxiti pricing details.
[3] Centers for Medicare & Medicaid Services (CMS). (2022). Price negotiation and drug reimbursement policies.
[4] Evaluate Pharma. (2022). Hematology drug market outlook.
