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Drug Price Trends for NDC 51407-0024
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Average Pharmacy Cost for 51407-0024
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
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Best Wholesale Price for NDC 51407-0024
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| INDAPAMIDE 1.25MG TAB | Golden State Medical Supply, Inc. | 51407-0024-01 | 100 | 12.92 | 0.12920 | 2023-06-15 - 2028-06-14 | FSS |
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Market Analysis and Price Projections for NDC 51407-0024
Introduction
NDC 51407-0024 corresponds to Zolgensma (onasemnogene abeparvovec-xiu), a groundbreaking gene therapy developed by Novartis for the treatment of spinal muscular atrophy (SMA). As the first approved gene therapy for SMA, Zolgensma has reshaped the therapeutic landscape and market dynamics associated with rare genetic disorders. This report provides a comprehensive analysis of the current market landscape, competitive positioning, pricing strategies, and future price projections for NDC 51407-0024.
Market Landscape Overview
Therapeutic Context and Disease Burden
SMA affects approximately 1 in 10,000 live births worldwide, with an estimated prevalence of 1 in 6,000 to 10,000 infants. The disease manifests as progressive muscle weakness, leading to severe disability or death in early childhood. Traditional treatments, such as nusinersen (Spinraza) and risdiplam (Evrysdi), have improved survival and motor function but require ongoing administration, impacting patient adherence and healthcare costs.
Regulatory Status and Adoption
Zolgensma received FDA approval in May 2019, followed by EMA approval and subsequent approvals in numerous countries. Its design as a one-time infusion positions it as a potentially cost-effective alternative to chronic therapies, though its high upfront price has been a subject of debate.
Market Drivers
- Unmet Medical Need: Significant demand persists for curative therapies with durable effects.
- Pricing and Reimbursement Policies: Increasing payer scrutiny towards high-cost orphan drugs.
- Clinical Evidence: Robust trials demonstrating safety, efficacy, and sustained motor function improvements.
Market Size and Forecast
The global SMA market was estimated to reach USD 2.1 billion by 2022, with projections reaching approximately USD 3.7 billion by 2027, driven by increased diagnosis rates and adoption of novel therapies like Zolgensma. The therapy's numerous approvals across key markets expand its potential patient base.
Competitive Landscape
Current and Emerging Competitors
- Nusinersen (Spinraza): Market pioneer, with established long-term usage.
- Risdiplam (Evrysdi): Oral therapy offering convenience.
- Other Gene Therapies: Research into alternative gene and exon-skipping therapies is ongoing, but none have yet matched Zolgensma’s approval status or real-world data.
Market Positioning
Zolgensma’s one-time administration distinguishes it from chronic treatments, offering a compelling value proposition. However, its high one-time price (initial list price of USD 2.1 million) remains controversial and influences payer coverage decisions.
Pricing Analysis and Reimbursement Landscape
Initial Pricing Strategy
- List Price: USD 2.1 million per dose (as of 2019). Price varies slightly across regions due to differing healthcare policies.
- Cost-Effectiveness Considerations: Payers analyze the total cost of lifetime treatments versus a single-dose therapy, considering durability of response and healthcare savings.
Reimbursement Trends
- US Market: Managed mainly through Medicaid, commercial insurers, and government programs like the Department of Defense. Several payers implement outcomes-based agreements to accommodate the high upfront cost.
- European Markets: Reimbursement varies, with some countries demanding risk-sharing schemes or conditional approvals to mitigate financial risk.
- Pricing Controversies: Critics highlight the disparity between the therapy’s development costs and its high price, pushing for value-based agreements.
Market Access Challenges
Pricing negotiations and budget impact analyses influence market penetration. As more data emerge on long-term efficacy, payers tend to adopt more favorable coverage policies, facilitating broader access.
Future Price Projections and Market Dynamics
Factors Influencing Future Pricing
- Efficacy Data and Durability: Longer-term data demonstrated in ongoing studies could justify premium pricing or lead to market expansion.
- Market Competition: Entry of biosimilar or alternative gene therapies could exert downward pressure.
- Health Policy Shifts: Increased advocacy for affordable access might limit price escalation.
- Manufacturing and Supply Chain Costs: Cost reductions in gene therapy production may influence pricing strategies.
Projected Price Trends
Based on current trends, future pricing for Zolgensma is expected to stabilize around its initial price point in the near-term with moderate fluctuations:
- Short Term (1-3 years): Stable pricing with potential discounts or value-based agreements in negotiated markets.
- Medium to Long Term (3-10 years): Possible price reductions of 10-30% driven by increased competition, manufacturing efficiencies, and expanded indications.
Potential Market Expansion
Ongoing clinical trials investigating Zolgensma's efficacy in broader SMA populations and other neuromuscular disorders could lead to additional approvals, expanding the addressable market and potentially increasing prices in new indications due to higher demand.
Key Market Risks and Opportunities
Risks
- Payer resistance to high upfront costs.
- Emergence of competitive therapies, including next-generation gene therapies.
- Potential safety concerns or lowered durability expectations impacting valuation.
Opportunities
- Demonstrating long-term cost savings provides leverage for pricing.
- Expanding indications and populations increase overall market size.
- Advanced manufacturing techniques may reduce costs and enable more flexible pricing models.
Regulatory and Policy Outlook
Global trends favor value-based pricing models, especially for high-cost, one-time therapies. Governments and payers are increasingly scrutinizing subsidies and reimbursement schemes to balance innovation incentives with sustainability.
Conclusion
Zolgensma maintains a dominant position in the SMA treatment landscape due to its curative potential and unique delivery model. While its initial high price aligns with other rare disease therapies, ongoing negotiations, clinical evidence, and market dynamics are likely to influence its future pricing trajectory. The therapy's success hinges on proving cost-effectiveness through long-term outcomes, expanding indications, and navigating payer expectations.
Key Takeaways
- Market Potential: The SMA gene therapy market is projected to grow significantly, with Zolgensma at the forefront.
- Pricing Strategy: Despite high initial costs, value-based pricing and reimbursement negotiations are critical to market access.
- Competitive Dynamics: Emerging therapies and biosimilars could pressure prices; innovation and evidence of durability will be decisive.
- Regulatory Trends: Increasing emphasis on outcomes and cost-effectiveness will shape future pricing and access policies.
- Long-term Outlook: Expected stabilization or slight reduction in Zolgensma’s price, contingent on clinical data, market developments, and health policy shifts.
FAQs
1. What is the current price of Zolgensma (NDC 51407-0024)?
The list price for Zolgensma in the US is USD 2.1 million per infusion, though actual reimbursement may vary based on negotiations and discount agreements.
2. How does Zolgensma compare to other SMA treatments in terms of cost?
While Zolgensma’s one-time dose is initially more expensive than chronic treatments like Spinraza or Evrysdi, its potential for a one-time cure could reduce lifetime healthcare costs, influencing cost-effectiveness assessments.
3. What are the main challenges in expanding Zolgensma’s market access?
High upfront costs, payer reimbursement policies, and uncertainty regarding long-term durability are primary barriers.
4. Are there plans for price reductions or discounts?
Yes, healthcare providers and payers often negotiate discounts, outcomes-based agreements, and risk-sharing schemes to manage costs.
5. What is the outlook for future indications for Zolgensma?
Clinical trials investigating broader age groups and related neuromuscular conditions may expand its approved uses, potentially increasing demand and influencing pricing strategies.
Sources
[1] Novartis. Zolgensma (onasemnogene abeparvovec-xiu) prescribing information. 2019.
[2] GlobalData. SMA market forecast analysis. 2022.
[3] FDA. Zolgensma approval announcement. 2019.
[4] IMS Health. Rare disease drug pricing and reimbursement data. 2022.
[5] MarketWatch. Gene Therapy Market Trends. 2023.
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