Last updated: February 21, 2026
What is the drug associated with NDC 68180-0401?
NDC 68180-0401 refers to Lumoxiti (moxetumomab pasudotox-tdfk), a targeted therapy approved by the FDA in September 2018 for treatment of relapsed or refractory hairy cell leukemia (HCL).
Market Size and Demand
Indication and Patient Population
- Primary indication: Hairy cell leukemia, a rare B-cell malignancy.
- US prevalence: Approximately 650 new cases annually; total patient population estimated at 2,600 individuals predominantly in the US.
- Treatment landscape: Prior to Lumoxiti, treatment options included cladribine and pentostatin. Lumoxiti is used following at least two prior therapies.
Market Drivers
- Increasing awareness of HCL treatment options.
- FDA approval for refractory cases expands potential patient cohort.
- Growing recognition among oncologists for targeted therapies.
Market Trends
- High unmet medical need due to limited first-line options.
- Shift from chemotherapies toward targeted biologics.
- Reimbursement coverage by major payers facilitates market penetration.
Competitive Landscape
| Drug Name |
Approval Year |
Indication |
Price (USD) |
Market Share (Est.) |
| Lumoxiti (moxetumomab pasudotox-tdfk) |
2018 |
Refractory HCL |
approx. $205,000 per treatment course |
100% of niche in refractory HCL |
Note: Prices are based on wholesale acquisition costs (WAC) and list prices, subject to discounts and insurance negotiations.
Pricing and Reimbursement
Price Structure
- List price: About $205,000 per treatment course.
- Dosing specifics: Typically administered over a 28-day cycle for 2 cycles (adjusted based on patient response).
- Cost components:
- Drug acquisition: Premium due to specialty biologic status.
- Administration: Infusion costs, hospital or outpatient clinic fees.
- Monitoring: Laboratory tests and follow-up imaging.
Reimbursement Considerations
- Falls under oncology and biologic drug policies.
- Reimbursement largely determined by Medicare, commercial insurers, and Medicaid.
- Prior authorization required, with coverage often tied to specific HCPCS and ICD-10 codes.
Price Projection
Short-term (Next 2 Years)
- Stable due to rarity of condition and high treatment costs.
- Slight variation (+/- 5%) possible influenced by insurance negotiations and institutional discounts.
Mid to Long-term (3-5 Years)
- Potential for price adjustment driven by:
- Introduction of biosimilars or generics (unlikely in biologics with complex manufacturing).
- New indications or expanded approval.
- Competitive products emerging (none currently in late-stage development for refractory HCL).
Volume Projections
- Estimated annual treatments: 150–200 courses based on prevalence and clinical adoption.
- Revenue projection:
| Year |
Treated Patients |
Revenue (USD, millions) |
| 2023 |
150 |
30.75 |
| 2024 |
180 |
36.9 |
| 2025 |
200 |
41.0 |
Assumes consistent pricing with slight growth.
Regulatory and Market Access Trends
- Since FDA approval, expanded payer coverage has increased.
- Incentives for hospitals and clinics to adopt due to unmet need.
- Future policy changes around drug pricing could influence margins.
Key Takeaways
- NDC 68180-0401 refers to Lumoxiti, a targeted biologic for refractory hairy cell leukemia.
- Market size remains small due to disease rarity; treatment cost is approximately $205,000 per course.
- Total sales in the US are estimated to reach $31 million in 2023, growing modestly in subsequent years.
- Price stability is expected over the near term; significant changes depend on market entry of biosimilars or new indications.
- Budget impact remains limited given patient prevalence but may be substantial on a per-treatment basis.
FAQs
What is the main driver for Lumoxiti’s pricing?
Market exclusivity and manufacturing complexity of the targeted biologic sustain high prices.
Could biosimilars influence future prices?
Biosimilars are unlikely due to regulatory complexity, though patent challenges could alter the competitive landscape.
What are the key factors affecting reimbursement?
Specialty drug policies, prior authorization processes, and reimbursement levels determined by payers.
Is Lumoxiti used as first-line therapy?
No; approved specifically for relapsed or refractory cases after at least two prior therapies.
How does market demand impact long-term pricing?
Limited demand constrains pricing flexibility but sustains revenues due to the small patient population.
References:
- U.S. Food and Drug Administration (FDA). (2018). Lumoxiti approval press release.
- IQVIA. (2022). Oncology drug utilization data.
- Centers for Disease Control and Prevention (CDC). (2020). Hairy cell leukemia statistics.
[1] FDA. (2018). FDA approves Lumoxiti for hairy cell leukemia.
[2] IQVIA. (2022). Oncology Market Trends Report.
[3] CDC. (2020). Hematologic malignancies statistics.
