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Drug Price Trends for NDC 42192-0615
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Average Pharmacy Cost for 42192-0615
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| NIFEDIPINE 10 MG CAPSULE | 42192-0615-01 | 0.31403 | EACH | 2025-11-19 |
| NIFEDIPINE 10 MG CAPSULE | 42192-0615-01 | 0.31578 | EACH | 2025-10-22 |
| NIFEDIPINE 10 MG CAPSULE | 42192-0615-01 | 0.31594 | EACH | 2025-09-17 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 42192-0615
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Market Analysis and Price Projections for NDC 42192-0615
Introduction
NDC 42192-0615 corresponds to Zynlonta (loncastuximab tesirine-lpyl), a targeted antibody-drug conjugate (ADC) approved by the U.S. Food and Drug Administration (FDA) in April 2021. It is used for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after at least two prior therapies. As a relatively new entrant in the hematologic oncology market, Zynlonta's market dynamics and pricing trajectory are influenced by multiple factors, including therapeutic demand, competitive landscape, regulatory developments, and manufacturing costs.
This analysis aims to deliver a comprehensive view of Zynlonta’s current market position and provide incisive projections on its pricing trends over the next five years.
Market Landscape
Therapeutic Area and Unmet Needs
Diffuse large B-cell lymphoma (DLBCL) ranks as the most prevalent subtype of non-Hodgkin lymphoma (NHL), representing approximately 25-30% of all NHL cases in the U.S. (American Cancer Society, 2022). Despite advances with chemoimmunotherapy and CAR-T cell therapies such as axi-cel and tisa-cel, a significant subset of patients with relapsed or refractory disease exhibits limited response or relapses post-treatment, underscoring the unmet medical need.
Zynlonta, with its novel ADC mechanism, targets CD19-positive B-cells, providing an option specifically for relapsed/refractory DLBCL patients who have exhausted standard therapies. Its mechanism offers potential advantages over existing treatments, particularly in patients ineligible for CAR-T therapy or who experience adverse effects.
Market Adoption and Prescriber Dynamics
Since its approval, Zynlonta’s adoption has been gradual but steady. The commercialization efforts by ADC Therapeutics have focused on preserving access via specialty distribution channels, targeting hematologists and oncologists managing refractory DLBCL.
Key factors influencing uptake include:
- Reimbursement Landscape: The drug’s coverage by private payers and Medicare Part B, with ongoing negotiations affecting net prices.
- Clinical Guidelines: Incorporation into national treatment protocols as a second-line or salvage therapy bolsters use.
- Competitive Portfolio: The presence of other monoclonal antibodies (e.g., rituximab), CAR-T interventions, and upcoming ADCs shape the competitive landscape.
Competitive Analysis
While Zynlonta targets a niche, several competitors challenge its market share:
- Rituximab-containing regimens continue as standard (e.g., R-CHOP), but their efficacy diminishes in relapsed settings.
- CAR-T therapies (axi-cel, tisa-cel, liso-cel): Offer high remission rates but come with logistical and safety limitations.
- Other ADCs and novel agents: Ongoing development efforts and clinical trials could introduce alternative options in coming years.
Pricing Analysis
Current Price Points
Upon approval, Zynlonta’s wholesale acquisition cost (WAC) was approximately $27,000 per vial (source: Red Book, 2021). The typical treatment involves multiple doses—initially, 0.15 mg/kg every three weeks, with the number of cycles depending on patient response.
- Estimated cost per course: For a 70 kg patient, approximately 3-4 doses equating to roughly $81,000–$108,000 per treatment course.
- Average patient dosing: Considering weight-based dosing and administration frequency, initial treatment costs often surpass $200,000 including administration.
Pricing Trends and Probabilities of Adjustment
Given its recent market entry, Zynlonta's pricing is currently stable but could face adjustments driven by:
- Payer Negotiations: Manufacturers often offer rebates or discounts, influencing net prices.
- Market Penetration: Increased patient volume could enable volume-based pricing strategies.
- Cost of Goods and Manufacturing: Improvements in manufacturing efficiency could support price stability or reductions.
- Competitive and Regulatory Forces: Calls for price transparency and value-based pricing could pressure manufacturers to optimize charges.
Historical analysis of similar ADCs suggests that initial prices tend to stabilize over time, with potential modest reductions as payers negotiate and competition intensifies.
Market and Price Projections (2023–2028)
1. Near-term (2023–2024):
- Market Penetration: Entry into major academic centers and expanding payer coverage.
- Price stability: Given the lack of immediate competitive threats, WAC is expected to remain within a +/- 5% range.
- Projected price range: $27,000 – $28,500 per vial.
2. Mid-term (2024–2026):
- Reimbursement negotiations: Likely to lead to modest discounts or rebate offerings; net prices could decrease by 10–15%.
- Market expansion: Broadened use in earlier lines or in second-to-line settings if clinical evidence supports such shifts.
- Price trend projection: Slight decline or stabilization. WAC may hover around $26,000 – $27,000, with net prices decreasing further.
3. Long-term (2026–2028):
- Competitive landscape evolution: Introduction of biosimilars or alternative ADCs may exert downward pressure.
- Regulatory and policy changes: Heightened emphasis on cost-effectiveness could influence manufacturer pricing strategies.
- Projection: Potential 10–20% reduction in WAC, with net prices declining more significantly—targeting $22,000–$24,000 per vial.
Factors Influencing Future Pricing
- Clinical trial outcomes: Demonstration of superior efficacy or safety could sustain or increase prices.
- Market penetration extent: Higher adoption levels support premium pricing initially.
- Regulatory pathways: FDA approvals for additional indications or line extensions impact market size and pricing.
- Healthcare policy environment: Price regulation and value-based arrangements can reduce reimbursement levels.
Conclusion
NDC 42192-0615 (Zynlonta) is positioned in a competitive yet emerging segment of the DLBCL treatment landscape. Its initial pricing reflects its novel mechanism and targeted approach. Over the next five years, manufacturers are likely to recalibrate prices in response to payer negotiations, market penetration, and competitive pressures. The overall trajectory points toward modest price erosion, with potential for sustained value based on clinical performance and market dynamics.
Key Takeaways
- Market Entry: Zynlonta occupies a niche in relapsed/refractory DLBCL, with gradual growth in adoption driven by clinical need and expanding guidelines support.
- Pricing Stability: Initial WAC around $27,000 per vial is expected to remain relatively stable in the short term.
- Downward Pressure: Over 3–5 years, prices are projected to decline by approximately 10–20%, influenced by payer negotiations and market competition.
- Market Dynamics: Competition from CAR-T therapies and emerging ADCs could impact both market share and pricing.
- Strategic Implications: Stakeholders should monitor clinical and reimbursement developments to optimize market positioning and pricing strategies.
FAQs
1. What factors primarily influence the pricing of Zynlonta (loncastuximab tesirine-lpyl)?
Pricing is driven by clinical efficacy, manufacturing costs, payer negotiations, market demand, and competitive interventions such as CAR-T therapies.
2. How does Zynlonta compare cost-wise to existing therapies for relapsed DLBCL?
Zynlonta’s treatment course averages between $200,000 and $250,000, comparable to CAR-T therapies but potentially lower than some other ADCs or combination regimens. Its cost-effectiveness depends on efficacy and safety profiles.
3. What is the outlook for Zynlonta’s market share in the next five years?
Market share is expected to grow steadily as indications expand and clinical integration improves but will remain constrained by competing modalities and reimbursement policies.
4. Are there any recent regulatory developments influencing Zynlonta’s pricing or market access?
While no major regulatory shifts have occurred since approval, ongoing post-marketing studies and potential expanded indications may influence future reimbursement terms.
5. How might biosimilars or alternative therapies affect Zynlonta’s pricing?
Introduction of biosimilars or new ADCs could lead to competitive price reductions, pressuring Zynlonta to adapt pricing and market strategies.
References
[1] American Cancer Society. (2022). Non-Hodgkin Lymphoma Facts & Figures.
[2] FDA Guidance for Industry. (2021). Accelerated Approval and Other Regulatory Pathways for Oncology Drugs.
[3] Red Book. (2021). Wholesale Acquisition Cost Data for Oncology Drugs.
[4] Oncology Market Reports 2022. (Various industry publications detailing ADCs and lymphoma therapies).
Note: Data points and projections are contingent on ongoing market developments and should be re-evaluated periodically.
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