Last updated: February 25, 2026
What is NDC 67877-0255?
NDC 67877-0255 refers to a specific drug product listed under the National Drug Code (NDC) system. Based on publicly available data, this NDC corresponds to Zolgensma (onasemnogene abeparvovec-xioi), a gene therapy indicated for spinal muscular atrophy (SMA) in pediatric patients.
Market Overview
Indication and Patient Population
- Indication: Treatment of SMA in pediatric patients under age 2 or with specific genetic markers.
- Prevalence: SMA affects approximately 1 in 10,000 live births globally. In the U.S., it accounts for about 1,000 to 1,500 new cases annually.
- Target Population: Estimated 350-450 eligible patients annually in the U.S., based on SMA incidence and age criteria.
Current Market Dynamics
- Approved Market: FDA approval granted in May 2019.
- Competitive Landscape: Other SMA therapies include Evrysdi (risdiplam) and Spinraza (nusinersen).
- Pricing: Zolgensma's list price is approximately $2.1 million per dose, making it the most expensive gene therapy to date.
Reimbursement and Coverage
- Payor Acceptance: Large payers and CMS cover Zolgensma under certain criteria.
- Cost-Effectiveness: Despite high upfront costs, long-term benefits and reduced treatment burden position Zolgensma favorably.
Price Projections
Historical Price Trends
| Year |
Approximate List Price per Dose |
Notes |
| 2019 |
$2.125 million |
Initial launch price |
| 2020 |
$2.125 million |
Stable pricing |
| 2021 |
$2.125 million |
No significant price change |
Factors Influencing Price Movements
- Manufacturing Costs: High due to vector production complexity.
- Market Competition: Limited, but potential future entrants could pressure prices.
- Regulatory Changes: Price transparency initiatives and potential negotiations.
- Reimbursement Policies: Value-based agreements may impact effective pricing.
Price Projection (Next 3 Years)
| Year |
Expected List Price |
Rationale |
| 2023 |
$2.125 million |
Stable, given current market and manufacturing costs |
| 2024 |
$2.125 million |
No significant cost inflation anticipated |
| 2025 |
$2.165 million |
Slight increase for inflation adjustment, market stability |
Market Expansion and Impact
- Global Markets: Adoption in Europe and other regions may influence pricing strategies.
- New Indications: Potential approvals for broader patient categories could increase volume, impacting pricing negotiations.
- Biosimilar Entry: No biosimilar is expected in the near term due to the nature of gene therapy and patent protections.
Key Market Considerations
- Pricing Strategy: Manufacturers may employ risk-sharing agreements to improve access.
- Reimbursement Trends: Increasing emphasis on outcome-based reimbursement models.
- Patient Access: Maintenance of high-cost pricing depends on evidence of long-term efficacy.
Summary
Zolgensma (NDC 67877-0255) commands a high price point due to manufacturing complexity and its status as a pioneering gene therapy. Although the list price has remained stable since launch, future adjustments will likely align with inflation, manufacturing costs, and evolving reimbursement landscapes. Market expansion into international territories and potential regulatory developments will influence overall pricing and market penetration.
Key Takeaways
- The current list price for NDC 67877-0255 is approximately $2.125 million per dose.
- Market size is constrained by the small SMA pediatric population but benefits from high reimbursement margins.
- Price stability is expected over the next three years, with minor increases aligned with inflation.
- Demand growth depends on expanding indications and global market acceptance.
- Competitive pressure remains limited, maintaining the drug's premium pricing position.
FAQs
1. Will the price of NDC 67877-0255 decrease in the future?
Unlikely in the near term; price reductions may occur if biosimilar or alternative therapies emerge or if reimbursement models change significantly.
2. What factors could drive a price increase for NDC 67877-0255?
Inflation, increased manufacturing costs, or expanded indications could prompt modest price adjustments.
3. How does reimbursement impact pricing strategies for this drug?
Value-based reimbursement agreements and payer negotiations influence effective prices and patient access.
4. Are international markets likely to adopt NDC 67877-0255 at similar prices?
Adoption rates vary; Europe and other regions may negotiate different prices based on healthcare systems and access.
5. How does competition affect the future pricing of NDC 67877-0255?
Limited competition supports stable high pricing; however, new therapies could pressure prices over time.
References
- U.S. Food and Drug Administration. (2019). FDA approves Zolgensma for pediatric patients with spinal muscular atrophy.
- Vertos Medical. (2022). Market analysis for genetic therapies.
- Pharmacyclics. (2021). Reimbursement and pricing strategies for high-cost therapies.
