Last updated: March 2, 2026
What is the Drug NDC 68462-0577?
NDC 68462-0577 corresponds to Ravulizumab-cwvz (Ultomiris), a monoclonal antibody used to treat complement-mediated rare blood disorders. It is approved for symptomatic paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS), and other complement-mediated diseases.
Market Landscape Overview
Current Market Size
The global PNH and aHUS treatment markets are valued at approximately $2.2 billion in 2022. Growth is driven by increased diagnosis rates, longer patient life expectancy, and expanding indications.
Key Competitors
- Soliris (eculizumab) by Alexion/AstraZeneca: Holds majority market share, revenue exceeding $4 billion annually.
- Ultomiris (ravulizumab-cwvz) by Alexion/AstraZeneca: Launched in 2018, with rapid uptake due to improved dosing schedule.
Regulatory Status
Ultomiris received FDA approval in December 2018 for PNH and aHUS indications. It is also approved in Europe, Japan, and other markets, with ongoing trials for additional indications like generalized myasthenia gravis and neuromyelitis optica.
Distribution Channels
Primarily administered via intravenous infusion in hospital or specialized clinics. Reimbursement depends heavily on health insurance industry policies in major markets.
Pricing and Reimbursement Landscape
Current Pricing
- In the US, the wholesale acquisition cost (WAC) for Ultomiris is approximately $549,000 per year per patient, billed per infusion with a recommended dosing schedule of every 8 weeks.
- For comparison, Soliris's annual cost is about $500,000.
Reimbursement Dynamics
Payor contracts favor drugs with less frequent dosing due to lower administration costs, giving Ultomiris a competitive advantage.
Cost Drivers
- Drug acquisition cost: roughly $549,000 annually.
- Administration costs: infusion-related expenses.
- Disease management costs: monitoring, supportive care.
Price Trends
Since launch in 2018, prices have remained stable, although negotiations may lead to discounts in certain markets.
Future Market Opportunities and Price Projections
Key Drivers for Growth
- Expanded indications: Clinical trials for additional complement-related conditions.
- Market penetration: Increased adoption in existing indications.
- Competitive pressures: Biosimilars and alternative therapies may influence pricing strategies.
Price Projections (2023-2028)
| Year |
Estimated Annual Cost (USD) |
Rationale |
| 2023 |
$549,000 |
Current price maintained; inflation adjustments and contract negotiations considered. |
| 2024 |
$560,000 |
Slight increase expected, aligned with inflation and R&D costs. |
| 2025 |
$572,000 |
Potential price stabilization, with cross-market negotiations. |
| 2026 |
$580,000 |
Market adjustments for new indications and competitive shifts. |
| 2027 |
$590,000 |
Possible premium for expanded indications or labeled uses. |
| 2028 |
$600,000 |
Inflation and potential cost-sharing reductions. |
Market Penetration and Volume Considerations
By 2028, an estimated patient population in the US, EU, and Japan could reach 10,000-15,000 patients, assuming consistent diagnosis rates and expanded indications usages.
Risks to Pricing Stability
- Introduction of biosimilars or generic versions.
- Regulatory delays or unfavorable policies.
- Changes in reimbursement landscape.
Summary of Key Data
- Current price: ~$549,000 per patient annually.
- Market size: ~$2.2 billion (2022).
- Competitors: Soliris, upcoming biosimilars.
- Future growth: Driven by expanded indications and increased uptake.
- Price trajectory: Slight upward trend, stabilizing around $600,000 by 2028.
Key Takeaways
- Ultomiris maintains a high price point, with minimal variation since launch.
- Market penetration is constrained by the rarity of indications but expected to grow steadily.
- Price projections indicate modest increases aligned with inflation and clinical expansion.
- Competitive landscape, including biosimilar entry, could pressure prices post-2028.
- Market growth depends on expanded indications, improved diagnostics, and healthcare policy developments.
FAQs
Q1: How does Ultomiris’s pricing compare to Soliris?
A: Ultomiris is priced roughly 10% higher but offers less frequent dosing, which can reduce administration costs.
Q2: What factors could lead to price declines?
A: Entry of biosimilars, increased competition, and payer negotiations.
Q3: Are there emerging indications that could impact pricing?
A: Yes, clinical trials for other complement-mediated diseases may drive growth and justify premium pricing.
Q4: How does reimbursement environment affect price projections?
A: Favorable reimbursement policies allow for higher prices; policy changes could compress margins.
Q5: What is the potential market size for new indications?
A: Estimated to add 1,000–3,000 patients globally over the next five years.
References
- IQVIA. (2022). Global Hematology Market Report.
- FDA. (2018). Ultomiris (ravulizumab-cwvz) approval documents.
- EvaluatePharma. (2022). Pharmaceutical market forecasts.
- Lazarev, J. (2020). Pricing and reimbursement strategies for biosimilars. Health Economics, 29(4), 461-470.
- European Medicines Agency. (2019). Ultomiris summary of product characteristics.
