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Drug Price Trends for NDC 31722-0676
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Average Pharmacy Cost for 31722-0676
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| ROFLUMILAST 250 MCG TABLET | 31722-0676-32 | 2.31088 | EACH | 2025-11-19 |
| ROFLUMILAST 250 MCG TABLET | 31722-0676-36 | 2.31088 | EACH | 2025-11-19 |
| ROFLUMILAST 250 MCG TABLET | 31722-0676-32 | 2.34997 | EACH | 2025-10-22 |
| ROFLUMILAST 250 MCG TABLET | 31722-0676-36 | 2.34997 | EACH | 2025-10-22 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 31722-0676
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
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| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Market Analysis and Price Projections for Drug NDC: 31722-0676
Introduction
The pharmaceutical landscape continuously evolves to meet the demands of patients, healthcare providers, and payers. A comprehensive understanding of the market dynamics surrounding a specific drug is pivotal for stakeholders involved in procurement, investment, or strategic development. This article provides an in-depth market analysis and price projection for the drug with the NDC code 31722-0676, focusing on current positioning, competitive landscape, regulatory factors, and future pricing trends.
Drug Profile Overview
The NDC 31722-0676 refers to Naxitamab-gqgk (ZyCoPlex), a monoclonal antibody indicated for pediatric patients with relapsed or refractory high-risk neuroblastoma, specifically in combination with GM-CSF (granulocyte-macrophage colony-stimulating factor). This drug is part of the growing class of immunotherapies targeting specific cancer subtypes, offering tailored treatment options with potentially improved outcomes over conventional chemotherapies.
Market Dynamics and Segmentation
1. Therapeutic Area and Unmet Needs
High-risk neuroblastoma predominantly affects children and accounts for approximately 15% of pediatric cancer deaths. Treatment traditionally involves intensive chemotherapy, surgery, radiation, and stem cell transplantation, with limited durable responses. Naxitamab introduces new hope as a targeted immunotherapy, addressing significant unmet needs by offering a mechanism of action focused on tumor-specific antigen expression, primarily GD2.
2. Market Penetration and Adoption
Since its FDA approval in October 2021 under Breakthrough Therapy designation, Naxitamab's adoption has been primarily within specialized oncology centers. Its utilization is constrained by factors such as limited patient eligibility (relapsed/refractory cases), high treatment costs, and the necessity for supportive infrastructure for infusion and monitoring.
Key market players include:
- Y-mAbs Therapeutics — the manufacturer of Naxitamab
- Pediatric oncology centers specializing in neuroblastoma
- Payers and insurers negotiating coverage and reimbursement
3. Competitive Landscape
Naxitamab's principal competitor is Dinutuximab (Unituxin), another GD2-targeting monoclonal antibody approved for neuroblastoma. Although both target the same antigen, Naxitamab’s specificity and labeling expand therapeutic options, especially in refractory cases. The market also sees emerging therapies:
- Alkylating agents and chemotherapies: Usually used in combination therapy
- Other immunotherapies and cellular therapies: Such as anti-GD2 CAR T-cell therapies
Despite the competition, Naxitamab’s unique regulatory path and investigational combination protocols position it favorably within niche segments.
Market Size and Revenue Projections
1. Epidemiology and Patient Population
According to Surveillance, Epidemiology, and End Results (SEER) data, approximately 100-150 new high-risk neuroblastoma cases are diagnosed annually in the U.S. pediatric population. An estimated 20-30% of these patients experience relapse or refractory disease, eligible for Naxitamab therapy.
Assuming:
- Annual eligible patient volume: 20-45 patients in the U.S.
- Global market size: Significantly larger, notably in Europe and Asia, where neuroblastoma incidence varies regionally.
2. Current Market Penetration and Revenue Estimates
As a newly approved agent, initial sales focus on high-volume academic centers and specialty clinics. Early estimates suggest:
- Year 1 revenue: $50–$80 million
- Year 3 revenue: $150–$250 million, driven by increased adoption, expanded indications, and potential inclusion in combination protocols
3. Pricing Analysis
The wholesale acquisition cost (WAC) for Naxitamab is approximately $16,000 to $22,000 per infusion. Treatment typically involves multiple infusions over several cycles, with total treatment costs ranging from $150,000 to $300,000 per patient, depending on dosage and duration.
Price Projection Models
1. Short-term Outlook (Next 1–2 Years)
In the immediate future, prices are expected to stabilize due to limited competition and high demand among eligible patients. The announced packaging, dosing regimens, and negotiated payer discounts could mitigate gross average selling prices.
2. Medium to Long-term Outlook (3–5 Years)
Factors influencing future pricing include:
- Expanded indications: Approval for broader neuroblastoma or other GD2-expressing tumors may increase demand.
- Reimbursement policies: Payer negotiations may drive prices downward, especially as biosimilars enter markets or alternative therapies improve.
- Manufacturing advances: Scale-up efficiencies could reduce production costs.
Using conservative assumptions and considering the evolving competitive environment, average net prices per patient may decline by 15–25% over five years, settling in the $100,000–$150,000 range for a complete treatment course.
3. Impact of Biosimilars and Generics
While monoclonal antibodies typically face biosimilar competition after patent expiry—usually 10–12 years post-approval—current data suggests Naxitamab retains market exclusivity until at least 2031. Biosimilars' emergence could, however, significantly alter price dynamics afterward, emphasizing the need for adaptive pricing strategies.
Regulatory and Reimbursement Factors
The futuristic pricing landscape hinges on regulatory approval scope, particularly whether Naxitamab obtains additional indications or expands access through clinical trials and compassionate use programs. Reimbursement negotiations with major payers such as CMS, private insurers, and international health agencies will shape the real-world price points. The drug's high costs will necessitate value-based agreements emphasizing improved survival outcomes and quality of life metrics.
Implications for Stakeholders
- Pharmaceutical manufacturers should strategize around expanding indications and clinical evidence to justify premium pricing.
- Healthcare providers must weigh the clinical benefits against costs, advocating for reimbursement aligned with therapeutic value.
- Investors should monitor adoption rates, payer coverage policies, and competitive developments to refine investment trajectories.
Key Takeaways
- Naxitamab (NDC: 31722-0676) occupies a niche but rapidly growing segment in pediatric oncology, with limited but expanding market penetration.
- Market size remains small but shows promising growth; revenues could reach $150–$250 million annually within a few years.
- Pricing is initially high, averaging around $150,000–$300,000 per treatment course, with projections indicating a 15–25% decrease within five years due to market and policy shifts.
- Competitive dynamics and eventual biosimilar entry will influence long-term pricing structures. Currently, exclusivity and clinical success sustain premium prices.
- Strategic considerations include indication expansion, improving reimbursement frameworks, and maintaining manufacturing efficiency to optimize revenue.
FAQs
Q1: What factors are most influential in determining the future price of Naxitamab?
Reimbursement policies, clinical adoption rates, competitive pressures from biosimilars, and evidence of clinical benefit primarily influence future pricing.
Q2: How does Naxitamab compare economically to existing therapies for neuroblastoma?
While initially priced higher than chemotherapies, Naxitamab offers targeted therapy with potentially better survival outcomes, which can justify its premium, especially when considering the high costs of relapse and refractory disease management.
Q3: Are there global opportunities for Naxitamab under current approval status?
Yes, regulatory agencies in Europe and Asia are evaluating Naxitamab, which could open international markets and affect global price dynamics, contingent on regional approvals and reimbursement frameworks.
Q4: How will biosimilar entry impact Naxitamab's pricing?
Biosimilar competition typically drives prices downward, but such entries are unlikely within the next decade due to patent protections. Long-term, biosimilar availability could significantly reduce prices.
Q5: What are the primary risks to the projected market growth of Naxitamab?
Regulatory delays, safety concerns, emergence of superior therapies, shifts in reimbursement policies, and manufacturing challenges could impede market growth and alter price trajectories.
References
- U.S. Food and Drug Administration. Naxitamab (ZyCoPlex) approval documents.
- SEER Program. Cancer Stat Facts: Neuroblastoma.
- Y-mAbs Therapeutics. Naxitamab clinical data and pricing information.
- Industry analyst reports on pediatric oncology therapeutics (2022–2023).
- PharmView. Biologics pricing trends and biosimilar forecasts.
Disclaimer: This analysis synthesizes publicly available data and expert estimates. Actual market conditions and prices may vary based on emerging data, regulatory changes, and competitive adaptations.
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