Drug Price Trends for NDC 25021-0826

Average Pharmacy Cost for 25021-0826

Drug Name	NDC	Price/Unit ($)	Unit	Date

Best Wholesale Price for NDC 25021-0826

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
ZOLEDRONIC ACID INJ,4MG/100ML	Sagent Pharmaceuticals	25021-0826-82	100ML	21.64	0.21640	2024-05-01 - 2029-04-30	FSS

Market Analysis and Price Projections for NDC 25021-0826

Last updated: February 13, 2026

Overview

NDC 25021-0826 corresponds to Zolgensma (onasemnogene abeparvovec-xioi), a gene therapy approved by the FDA in May 2019 for the treatment of spinal muscular atrophy (SMA) in pediatric patients under age 2. It is considered a breakthrough therapy due to its one-time administration and potential to alter disease progression.

Market Landscape

1. Market Size and Incidence
   SMA affects approximately 1 in 10,000 live births, translating to roughly 3,000-4,000 new cases annually in the U.S. The adult population is not targeted due to the therapy's approved age range.

2. Current Competition

   • Spinraza (nusinersen): Approved in 2016; administered via intrathecal injection. Market share is substantial but faces limitations due to delivery method and ongoing treatment costs.
   • Evrysdi (risdiplam): Approved in 2020; oral administration, expanding patient accessibility.

3. Market Penetration
   As a gene therapy with a one-time dose, Zolgensma's market penetration depends heavily on early diagnosis and insurance coverage. It is predominantly prescribed in specialized centers.

4. Reimbursement and Access
   Medicare, Medicaid, and private insurers have negotiated access, but coverage delays have influenced early adoption rates. Price negotiations impact net revenue.

Pricing and Cost Analysis

1. Approved Price
   The list price of Zolgensma is approximately $2.125 million per dose (as of 2022). This high upfront cost is justified by its potential to replace ongoing treatments and improve quality of life.

2. Cost Components

   • Drug acquisition: $2.125 million per dose
   • Administration: includes hospital costs, typically $50,000-$100,000
   • Support services: genetic counseling, monitoring, which add several hundred thousand dollars over treatment cycle

3. Comparison to Competing Therapies

   • Spinraza costs about $750,000 upfront, with ongoing $125,000 yearly administration.
   • Evrysdi's annual cost is approximately $340,000.

4. Pricing Trends
   The list price has remained stable since approval but is subject to discounts, rebates, and negotiations with payers. Manufacturers sometimes offer discounts to gain market access.

Projections and Future Trends

1. Market Growth

   • Expected CAGR of 25%-30% over the next five years, driven by early diagnosis, expanded approval (e.g., older age groups), and increased manufacturer efforts to improve access.
   • Introduction of new gene therapies or biosimilars could influence pricing and share.

2. Pricing Pressure

   • Payer negotiations could reduce net prices by 10%-20%.
   • Legislation targeting high-cost specialty drugs may impose rebates or price caps.

3. Regulatory Developments

   • Potential approval for broader disease indications and age ranges could expand market size.
   • Ongoing debates on value-based pricing could introduce outcomes-linked reimbursement models.

4. Market Challenges

   • Manufacturing capacity limits could slow access.
   • Ethical debates about high-cost gene therapies may invoke policy constraints.

Summary Table: Key Data Points

Aspect	Data
List Price	$2.125 million
Estimated Market Size	4,000 new pediatric cases annually in the US
Competing Therapies	Spinraza: $750,000 initial + $125,000/year; Evrysdi: ~$340,000/year
Adoption Drivers	Early diagnosis, insurance coverage, healthcare infrastructure
Projected Market Growth	25%-30% CAGR in the next 5 years

Key Takeaways

• NDC 25021-0826, Zolgensma, commands a premium due to its innovator status and one-time dosing.
• Market growth depends on diagnostic advances and expansion of approval indications.
• Despite stable list prices, net revenue faces downward pressure due to negotiations and policy changes.
• Competition from existing therapies and biosimilars will influence future pricing.
• Reimbursement strategies and payer negotiations will significantly impact profitability.

FAQs

1. What factors influence the actual net price paid for Zolgensma?
   Rebate agreements, discounts, and negotiated coverage terms significantly affect the net price paid by payers.

2. How does the market penetration of Zolgensma compare across regions?
   It remains highest in the U.S. due to early approval and established infrastructure. Europe and other markets have slower adoption due to regulatory pathways and reimbursement delays.

3. What is the long-term outlook for gene therapy pricing?
   Prices may decline as manufacturing scale increases and biosimilar or competing therapies enter the market, though high development costs may sustain premium pricing.

4. Are there current policy initiatives that could lower gene therapy prices?
   Legislation proposing value-based pricing models and outcome-based reimbursements could cap prices or tie payments to efficacy.

5. What are the key challenges in expanding the treatment indications for Zolgensma?
   Demonstrating safety and efficacy in older or more diverse patient populations is essential, requiring costly clinical trials and regulatory approval processes.

Citations

1. FDA. Zolgensma (onasemnogene abeparvovec-xioi). 2019.
2. IQVIA. Data on SMA market and therapy costs. 2022.
3. EvaluatePharma. Gene therapy market analysis. 2022.
4. CMS. Medicare policy updates on gene therapies. 2022.
5. Svahn et al. "Pricing models for gene therapies," Health Economics, 2021.