Last updated: March 11, 2026
What is NDC 23155-0794?
NDC (National Drug Code) 23155-0794 refers to Tafasitamab-cxix (Monjuvi), a monoclonal antibody indicated for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL) in combination with lenalidomide in adult patients who are not candidates for transplant.
Market Overview
Therapeutic Area and Indication
- Primary use: Treatment of adult DLBCL patients.
- Market size: Estimated 7,500 new cases in the U.S. annually.
- Treatment landscape: With the approval of Monjuvi in 2020 by the FDA, it entered a competitive lymphoma market including rituximab, CAR-T therapies (e.g., axi-cel, tisa-cel), and other immunochemotherapies.
Competitive Position
- Monjuvi is positioned as a secondary-line therapy, primarily for patients ineligible for CAR-T.
- Clinical trials demonstrate response rates of approximately 37% in relapsed or refractory DLBCL.
- It is used as part of combination therapy with lenalidomide.
Market Penetration
- Initial adoption was slow due to:
- Limited awareness among oncologists.
- Competition from established therapies.
- As of 2022, Monjuvi accounted for estimated U.S. sales of $150 million.
- Growth drivers include:
- Expanding indications.
- Increasing adoption in off-label uses.
- Continued clinical efficacy data.
Regulatory and Pricing Policies
Pricing Overview
- The wholesale acquisition cost (WAC) for Monjuvi in 2023 is approximately $12,000 per infusion.
- Typical dosing involves four infusions over a 21-day cycle, equating to approximately $48,000 per treatment.
- Cost per patient annually varies based on treatment duration.
Reimbursement Factors
- Reimbursement primarily from commercial insurance and Medicare Part B.
- No significant price discounts or rebates disclosed publicly.
- Pricing remains aligned with similar monoclonal antibody therapies in hematologic oncology.
Price Projections (Next 5 Years)
| Year |
Estimated Price per Infusion |
Projected Annual Revenue |
Growth Factors |
| 2023 |
$12,000 |
$150 million |
Moderate adoption, competitive landscape |
| 2024 |
$12,000 |
$180 million |
Expanded indications, increased clinician familiarity |
| 2025 |
$12,000 – $12,500 |
$210 million |
Potential label expansion, new combination regimes |
| 2026 |
$12,500 |
$250 million |
Broader adoption, increased off-label use |
| 2027 |
$13,000 |
$290 million |
Presumed stable market share, possible price increases |
Key Drivers
- Increased clinical adoption.
- Expansion into earlier lines of therapy.
- Competitive pressures may limit significant price increases unless new indications are approved.
Price Sensitivity
- Price elasticity appears low due to the niche patient population.
- Cost-effectiveness depends on response rates and durability of remission.
Risks to Market and Price
- Development of biosimilars or generic monoclonal antibodies.
- Changes in reimbursement policies reducing pricing.
- Emergence of new therapies with superior efficacy or safety profiles.
Summary
- Monjuvi (NDC 23155-0794) has a niche but growing market within the hematologic oncology space.
- Its pricing remains steady at around $12,000 per infusion, with modest growth projected in the absence of major label changes or disruptive technology.
- Sales are driven by clinical adoption, competition, and regulatory developments.
Key Takeaways
- The drug's current market value is approximately $150 million annually in the U.S.
- Pricing is stable with a slight upward trend expected over five years.
- Market growth hinges on expanding use cases and clinician familiarity.
- Entry of biosimilars or new therapies could impact pricing and sales.
- Policies favoring cost containment and reimbursement adjustments may moderate future price increases.
FAQs
Q1: What is the primary indication for Monjuvi?
Relapsed or refractory diffuse large B-cell lymphoma in adult patients ineligible for transplant.
Q2: How is the drug priced?
At approximately $12,000 per infusion, averaging $48,000 per treatment cycle.
Q3: What are the key growth drivers?
Expanded indications, increased clinician adoption, and label expansions.
Q4: Could biosimilars impact the market?
Yes. Biosimilars could reduce prices and market share, affecting profitability.
Q5: What reimbursement policies influence prices?
Reimbursement through Medicare Part B and commercial payers, with limited price discounts publicly disclosed.
References
[1] U.S. Food and Drug Administration. (2020). FDA approves Monjuvi for certain lymphoma.
[2] IQVIA. (2022). US Oncology Market Data.
[3] Drug pricing data. (2023). Monjuvi WAC pricing and reimbursement policies.
