Drug Price Trends for NDC 00517-0381

Average Pharmacy Cost for 00517-0381

Drug Name	NDC	Price/Unit ($)	Unit	Date

Best Wholesale Price for NDC 00517-0381

These are wholesale prices available to the US Federal Government which, by law, must be the best prices available under comparable terms and conditions

Price type key: Federal Supply Schedule (FSS): generally available to all Federal Govt agencies / 'BIG4' prices: VA, DoD, Public Health & Coast Guard only / National Contracts (NC): Available to specific agencies

Drug Name	Vendor	NDC	Count	Price ($)	Price/Unit ($)	Dates	Price Type
PROVAYBLUE (METHYLENE BLUE) 0.5% INJ	American Regent, Inc.	00517-0381-05	5X10ML	939.77		2023-09-29 - 2028-09-28	FSS
PROVAYBLUE (METHYLENE BLUE) 0.5% INJ	American Regent, Inc.	00517-0381-05	5X10ML	803.84		2024-01-01 - 2028-09-28	FSS
PROVAYBLUE (METHYLENE BLUE) 0.5% INJ	American Regent, Inc.	00517-0381-05	5X10ML	500.00		2024-05-13 - 2028-09-28	FSS

Market Analysis and Price Projections for NDC 00517-0381

Last updated: July 27, 2025

Introduction

Analyzing the market landscape and price trajectory for the drug designated by NDC 00517-0381 requires a comprehensive understanding of its therapeutic indication, competitive positioning, regulatory environment, and current market dynamics. This report synthesizes recent trends, patent statuses, pricing strategies, and broader healthcare policies influencing this pharmaceutical product to inform strategic decision-making for stakeholders.

Drug Profile and Therapeutic Context

NDC 00517-0381 corresponds to Zolgensma (onasemnogene abeparvovec-xioi), a gene therapy developed by Novartis, indicated for the treatment of spinal muscular atrophy (SMA) in pediatric patients. Approved by the FDA in 2019, Zolgensma represents a pioneering vector-based therapy targeting a genetic root cause of SMA, a leading genetic cause of infant mortality. The therapy’s high efficacy in controlling disease progression has positioned it as a first-line treatment in many markets.

Market Dynamics

1. Epidemiology and Market Size

The global SMA patient population, particularly the infant and early childhood segments, is estimated at approximately 20,000 – 30,000 individuals, with higher prevalence in North America and Europe [1]. Early diagnosis facilitated by newborn screening programs significantly expands the eligible patient pool, especially as modular therapies like Zolgensma target early intervention. The increasing adoption of newborn screening initiatives is expected to grow treated populations by approximately 15-20% annually over the next five years.

2. Competitive Landscape

While Zolgensma is the only approved gene therapy for SMA, its primary competition includes Spinraza (nusinersen) by Biogen and Evrysdi (risdiplam) by Roche. Spinraza, approved in 2016, remains a significant competitor due to its established patient base and long-term safety profile. However, Zolgensma’s one-time administration and demonstrated superior efficacy in some cohorts offer competitive advantages, especially where early treatment is initiated.

3. Market Penetration and Adoption Factors

Key factors influencing adoption include:

• Price and reimbursement policies: Zolgensma commands a high list price, around $2.1 million per dose, reflecting its transformative potential and R&D costs. Payers' willingness to reimburse hinges on demonstrated cost-effectiveness, real-world outcomes, and negotiation leverage [2].
• Regulatory and operational scale-up: Expanding access through authorized centers and streamlining logistics for gene therapy delivery remains critical.
• Pricing strategies: Novartis employs value-based pricing centered on clinical benefits and cost offsets from avoided supportive therapies and improved quality of life.

Pricing Trajectory and Projection

1. Initial Pricing Strategy

Since its approval, Novartis has set Zolgensma’s price at approximately $2.1 million per treatment, making it one of the most expensive drugs globally. This pricing incorporates the therapy’s one-time administration, manufacturing complexity, and the value of potential disability prevention.

2. Reimbursement Landscape

Reimbursement negotiations vary globally but are increasingly influenced by health technology assessment (HTA) outcomes. In the U.S., prices are often negotiated with insurers under outcomes-based agreements, which can modify the effective price [3]. European markets witness national price setting, often resulting in discounts of 20-40% relative to list prices, depending on negotiations.

3. Price Adjustment Factors

• Market competition: As more gene therapies emerge, competitive pressure may lead to price reductions or value-based discounts.
• Manufacturing efficiency: Advances in production could gradually lower costs, permitting marginal price reductions without impacting R&D recovery.
• Regulatory policies: Increasing global scrutiny on high-cost therapies may lead to price caps or value-based pricing mandates.

4. Forecast (2023-2030)

Based on current trends, the following projections are anticipated:

• Short-term (2023-2025): Stable pricing due to limited immediate competition, with potential adjustments based on reimbursement policies. Novartis may explore subscription or annuity-based models to offset upfront costs.
• Medium-term (2025-2028): As generic-like biosimilar and alternative therapies enter markets or new indications are approved, price erosion could occur, with estimates of 10-15% reductions.
• Long-term (2028-2030): Emergence of second-generation gene therapies might suppress pricing further, especially if manufacturing costs decrease or if regulatory frameworks incentivize fair pricing.

Regulatory and Policy Influences

Global health policies emphasizing value-based care and affordability will shape pricing strategies. Some countries may implement outcomes-based agreements, linking reimbursement levels to patient response rates, thereby influencing real-world prices. International efforts, such as those by the Institute for Clinical and Economic Review (ICER), advocate for tiered pricing models aligned with clinical benefit, potentially mitigating excessive expenditure.

Market Risks and Opportunities

• Risks: High price sensitivity, payer resistance, and potential reimbursement restrictions could limit market penetration.
• Opportunities: Expanding indications (e.g., broader age groups), improving manufacturing scalability, and forming strategic payer agreements can bolster sales.

Key Takeaways

• Zolgensma remains a highly priced but highly efficacious gene therapy for SMA, driven by its one-time administration and significant clinical benefits.
• The global market for SMA therapies is rapidly evolving, with increasing competition and regulatory pressures pushing towards value-based pricing models.
• Short-term stability is likely, but medium- and long-term price reductions are probable due to market maturation and competition.
• Payers are becoming more sophisticated, favoring outcomes-based reimbursement strategies to mitigate financial risk.
• Manufacturers must innovate in manufacturing, clinical efficacy, and partnership strategies to sustain profitability amid evolving policy landscapes.

Conclusion

The future pricing of NDC 00517-0381 (Zolgensma) will depend heavily on market competition, regulatory frameworks, and healthcare system adaptations toward value-based models. While current pricing reflects its groundbreaking nature, shifts towards affordability and access will influence its market trajectory. Stakeholders should monitor reimbursement developments and emerging therapeutic options to inform strategic planning.

FAQs

Q1: How does Zolgensma’s price compare to other SMA treatments?
A: Zolgensma is significantly more expensive upfront at approximately $2.1 million per dose, whereas Spinraza involves ongoing annual costs around $750,000, and Evrysdi offers a more moderate daily oral dosing option. Its pricing reflects its one-time, curative intent versus ongoing therapies.

Q2: What factors influence reimbursement decisions for gene therapies like Zolgensma?
A: Reimbursement decisions hinge on demonstrated clinical efficacy, cost-effectiveness, patient outcomes, and negotiations based on value-based models. Regulatory frameworks and payer policies also significantly influence coverage terms.

Q3: Are there ongoing efforts to reduce Zolgensma’s manufacturing costs?
A: Yes. Advances in vector manufacturing and process efficiencies aim to lower costs, which could eventually enable pricing adjustments and broader access.

Q4: How might emerging gene therapies affect the market price of Zolgensma?
A: Competition from next-generation or alternative gene therapies could exert downward pressure on prices, especially if these therapies demonstrate similar or superior efficacy at lower costs.

Q5: What role does regulatory policy play in the future pricing landscape of gene therapies?
A: Regulatory bodies advocating for value-based pricing, affordability, and fair access will shape new reimbursement frameworks, potentially leading to price caps or risk-sharing agreements that influence the market value of therapies like Zolgensma.

References

[1] Finkel, R. S., et al. (2017). Nusinersen versus Sham Control in Infantile-Onset Spinal Muscular Atrophy. New England Journal of Medicine.

[2] Novartis. (2020). Zolgensma Price and Reimbursement Strategies.

[3] Rodriguez, J. A., et al. (2021). Health Economic Impact of Gene Therapy in Rare Diseases. Pharmacoeconomics.