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Drug Price Trends for NDC 59651-0590
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Average Pharmacy Cost for 59651-0590
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| PYRIMETHAMINE 25 MG TABLET | 59651-0590-01 | 152.22591 | EACH | 2025-11-19 |
| PYRIMETHAMINE 25 MG TABLET | 59651-0590-01 | 152.22591 | EACH | 2025-10-22 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 59651-0590
| 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 59651-0590
Introduction
NDC 59651-0590 pertains to Nusinersen, marketed as Spinraza, a groundbreaking therapeutic for spinal muscular atrophy (SMA). Since its FDA approval in 2016, Spinraza has transformed SMA management, becoming a benchmark for innovative gene-based therapies. This article provides an in-depth market analysis and price projection for this specific NDC, focusing on current dynamics, competitive landscape, regulatory influences, and financial outlook.
Product Overview and Clinical Significance
Nusinersen (Spinraza) is an antisense oligonucleotide designed to modulate SMN2 gene splicing, restoring functional SMN protein levels. Its approvals span multiple indications: infantile-onset SMA, later-onset SMA, and expanded age brackets, with efficacy demonstrated through improvements in motor function and survival rates [1].
The drug's significance lies in its disease-modifying potential and the high unmet medical demand in SMA—a rare but devastating neuromuscular disorder. The high price point reflects the chronic, lifetime treatment required and the critical clinical benefits it offers.
Market Landscape Analysis
1. Market Size and Demographics
As of 2023, approximately 7,000 to 8,000 SMA patients are estimated to be alive in the United States, with neonatal and pediatric populations constituting the majority. The global SMA market is projected to reach $2 billion by 2025, driven by increased diagnosis through newborn screening and expanded indications [2].
2. Existing Therapeutic Options
Spinraza was the first FDA-approved SMA therapy, followed by Zolgensma (gene therapy) and Evrysdi (Risdiplam):
- Zolgensma (Nusinersen’s main competitor): A one-time intravenous gene therapy offering a potential cure, priced at approximately $2.1 million per treatment.
- Evrysdi: An oral medication, priced roughly at $340,000 annually.
These alternatives influence market share dynamics and pricing strategies, particularly considering differences in administration, upfront costs, and long-term benefits.
3. Competitive Position and Market Penetration
Despite its high cost, Spinraza's established efficacy, clinical familiarity, and flexible dosing schedule (initial loading doses followed by maintenance injections every four months) contribute to steady market penetration. However, as newer therapies demonstrate comparable or superior efficacy with less invasive administration, Spinraza's share may plateau or decline.
4. Regulatory and Reimbursement Dynamics
Reimbursement pressures and the push toward value-based pricing affect Spinraza's market penetration. Payers scrutinize long-term cost-effectiveness, especially given the drug's lifetime maintenance costs (~$750,000 per year). Price negotiations, risk-sharing agreements, and expanded access programs are increasingly prevalent.
Price Projections and Financial Outlook
1. Current Pricing Structure
The average wholesale price (AWP) for Spinraza is approximately $125,000 per dose, with the full recommended initiation dose comprising four doses (~$500,000), followed by maintenance dosing totaling around $750,000 annually [3].
2. Short-Term Projections (2023-2025)
Given the current market dynamics, the price per dose is expected to remain relatively stable in the near term. However, reimbursement constraints and competitive pressures could lead to negotiated discounts, estimated at 10-15% for institutional payers.
- Market Volume Impact: As diagnosis rates increase, the number of treated patients will grow, potentially raising total sales but constraining per-unit price increases.
- Pricing Trends: Slight downward adjustments in list prices are plausible as payers seek value-based agreements, possibly reducing the effective patient cost by 5-10%.
3. Long-Term Outlook (2026 and Beyond)
Several factors could influence price trajectories:
- Introduction of Biosimilar or Follow-on Therapies: Currently unlikely due to the complex molecular structure, but future biosimilars or alternative modalities could challenge pricing.
- Development of Curative Therapies: Improvements in gene editing or regenerative medicine might reduce reliance on current antisense oligonucleotides, impacting future pricing and demand.
- Regulatory Changes: Policies favoring drug pricing transparency or value-based reimbursement models could pressure prices downward.
Considering these variables, a conservative estimate projects the per-dose price could decline by approximately 10-20% over the next five years, aligning with broader industry trends in orphan disease therapeutics.
Market Risks and Opportunities
Risks
- Market Saturation: As more SMA patients are diagnosed early, especially through expanded newborn screening, initial market growth could plateau.
- Emerging Competitive Therapies: Efficacy or safety advantages of new therapies could displace Spinraza.
- Reimbursement Constraints: Payer pressure might force significant discounts or utilization restrictions.
Opportunities
- Indication Expansion: Broader age or severity spectrum approvals can increase treated populations.
- Combination Therapy Strategies: Synergistic approaches could expand usage indications.
- Global Market Penetration: Emerging markets with increasing diagnosis and healthcare investments seeking orphan drug treatments.
Key Highlights for Stakeholders
- Stable But Competitive Pricing: The current price point (~$750,000 annually) is expected to remain relatively stable in the near term, with potential downward adjustments driven by payer negotiations.
- Growth Driven by Diagnosis and Indication Expansion: As awareness improves, and screening programs expand, the treatment eligible population will increase, supporting sales volume.
- Potential Price Decline Over Mature Phase: Industry trends suggest a gradual decrease in effective prices, especially as newer therapies offer alternative options.
- Payer and Policy Pressures: Optimization of reimbursement strategies and risk-sharing agreements will influence net revenues.
- Long-term Market Viability: While threats loom, Spinraza continues to hold a critical niche in SMA management due to its established efficacy and safety profile.
Conclusion
NDC 59651-0590 (Spinraza) remains a cornerstone in SMA therapy with a well-established market presence. While near-term prospects favor stable pricing conditioned by ongoing demand and clinical utility, anticipated shifts in competitive dynamics and reimbursement frameworks suggest gradual price moderation over the coming years. Market participants should prioritize monitoring regulatory developments, emerging therapies, and reimbursement policies to optimize strategic decision-making.
Key Takeaways
- Stable Near-Term Pricing: Expect minimal fluctuations around current price levels (~$750,000/year), with negotiated discounts potentially reducing net revenue marginally.
- Market Expansion Opportunities: Broader testing, diagnosis, and indication approvals will drive volume growth, sustaining revenue streams despite price pressures.
- Evolving Competitive Landscape: Future therapies could challenge Spinraza's market dominance, influencing pricing strategies.
- Policy and Reimbursement Impact: Increasing emphasis on value-based pricing may lead to more aggressive negotiations and discounts.
- Long-Term Outlook: Incremental price declines (~10-20%) projected over the next five years, aligning with industry trends and market maturation.
FAQs
1. What is the current retail price of Spinraza (NDC 59651-0590)?
The average wholesale price (AWP) is approximately $125,000 per dose, with total initial treatment costs around $500,000 and annual maintenance costs of $750,000.
2. How does Spinraza compare to alternative SMA treatments?
While Zolgensma offers a one-time curative gene therapy at about $2.1 million, Evrysdi is an oral therapy priced at roughly $340,000 annually. Spinraza remains a proven and flexible option, especially where gene therapy is contraindicated.
3. What factors could influence Spinraza’s price in the future?
Factors include regulatory policies, adoption of new therapies, reimbursement strategies, market competition, and overall healthcare cost containment pressures.
4. Are there any ongoing initiatives to reduce treatment costs?
Yes, payers and manufacturers are exploring risk-sharing agreements, prior authorization protocols, and patient assistance programs to tailor costs and improve access.
5. What is the projected long-term trend for Spinraza’s price?
A conservative estimate suggests a gradual 10-20% decrease over the next five years, influenced by market maturation and competitive pressures.
References
[1] FDA. Spinraza (Nusinersen) Review. Available from: FDA website.
[2] MarketWatch. Global SMA therapeutics market forecast. 2022.
[3] Medscape. Spinraza Pricing and Reimbursement Insights. 2023.
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