Last updated: February 17, 2026
Overview and Context
NDC 30698-0459 is identified as a monoclonal antibody marketed under the name Satralizumab. It treats neuromyelitis optica spectrum disorder (NMOSD). It was approved by the FDA in August 2020. The product is marketed by Roche and Genentech.
Market Landscape
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Target Population: NMOSD affects about 1-2 per 100,000 people globally, with a higher prevalence in women. Estimated US patients: approximately 10,000-15,000.
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Competitors:
- Eculizumab (Soliris), approved for NMOSD since 2019.
- Inebilizumab (Uplinza), approved 2020.
- Ravulizumab (Ultomiris), off-label use; no FDA approval specific for NMOSD.
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Market Penetration:
- Initial uptake remains limited due to high drug costs and rare disease status.
- Adoption rates are expected to grow as long-term safety and efficacy data expand.
Pricing Details
- Wholesale Acquisition Cost (WAC): Approximately $88,000 for a 120 mg dose per month.
- Average Selling Price (ASP): Estimated at $92,000 to $96,000 annually per patient, considering dosing adjustments.
- Per Capsule Cost: Approximate $7,300 per 120 mg dose administered subcutaneously.
Pricing Trends and Projections
- Historical Pricing Trends:
- Since launch, price has stabilized around $88,000-$96,000 annually.
- Projection for 2023-2025:
- Slight increases anticipated, driven by inflation, manufacturing costs, and value-based pricing negotiations.
- Expected annual growth rate of 2-3%.
- For 2025, price per patient projected between $95,000 and $100,000.
Market Revenue Estimates
- Current Market Revenue (2023):
- Assuming 1,500 trea ted patients in the US, revenue is approximately $180 million annually.
- Future Revenue (2025):
- With market penetration increasing to 2,500 patients, revenue would grow to approximately $250 million annually.
Reimbursement and Access
- Coverage under private payers and Medicaid is common, but reimbursement levels vary.
- High patient out-of-pocket costs persist, limiting access for some populations.
Regulatory Factors and Policy Impact
- Price setting is influenced by negotiations with payers and formulary inclusion.
- There is increased pressure for price transparency; recent legislative proposals target high-cost therapies.
Conclusion
The market for NDC 30698-0459 is constrained by the rarity of NMOSD but benefits from premium pricing due to the unmet need and specificity. Price stability is expected around current levels, with modest incremental increases. Market growth hinges on expanded diagnosis and improved access, while pricing strategies will adapt to payer negotiations and policy shifts.
Key Takeaways
- NDC 30698-0459 (Satralizumab) targets NMOSD, a rare autoimmune condition.
- Market size in the US is approximately 10,000-15,000 patients with limited penetration.
- Current annual treatment price ranges $88,000-$96,000 per patient.
- Revenue projections near $180-250 million annually over the next two years given market adoption.
- Price stability expected with potential slight increases, influenced by payer negotiations and policy.
Frequently Asked Questions
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What influences the pricing of Satralizumab?
Pricing is primarily driven by manufacturing costs, the value provided in a rare disease context, payer negotiations, and regulatory policies.
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How does Satralizumab compare to competitors?
It offers a convenient subcutaneous administration and is positioned for earlier treatment; price points are comparable to similar biologics for NMOSD.
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What is the long-term market outlook?
Growth depends on increased diagnosis rates, expanded insurance coverage, and potential expansion into additional autoimmune indications.
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Are price reductions expected?
Price reductions are unlikely unless driven by policy mandates or significant market competition.
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How are reimbursement trends affecting the market?
Payers increasingly scrutinize high-cost therapies, which may influence net pricing, formulary access, and patient out-of-pocket costs.
Sources
[1] IQVIA National Sales Perspectives, 2023
[2] FDA Drug Approvals Database, 2020
[3] Manufacturer disclosures and market reports, 2023