Last updated: March 4, 2026
What is the drug corresponding to NDC 16571-0735?
The National Drug Code (NDC) 16571-0735 corresponds to Ravulizumab-cwvz (Ultomiris), a monoclonal antibody used to treat paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS). Manufactured by Alexion Pharmaceuticals, Ultomiris is a complement inhibitor approved by the FDA in 2018 for these indications.
What is the current market size for Ravulizumab-cwvz?
Market Launch and Adoption
- Launch Date: 2018
- Indications: PNH, aHUS
- US Sales (2022): Approximately $1.8 billion (IQVIA)
- Market Penetration: High among specialty therapies for complement-mediated disorders
Estimated Global Market
- 2022 Global Sales: $2.2 billion
- Projection for 2027: $4.2 billion (CAGR 15%)
Key Competitors and Market Share
| Drug |
Indication |
Estimated 2022 US Sales |
Market Share (US) |
Notes |
| Ravulizumab-cwvz (Ultomiris) |
PNH, aHUS |
$1.8 billion |
58% |
Preferred for less frequent dosing |
| Eculizumab (Soliris) |
PNH, aHUS |
$1.4 billion |
42% |
Market leader, longer dosing interval |
Ravulizumab's twice-monthly dosing appeals as a convenience over eculizumab's weekly or biweekly schedule.
What are the price trends and projections?
Current Pricing
- USA Retail Price: Approximately $525,000 annually per patient (per NICE, 2022)
- Dose Considerations: Dose varies based on patient weight; average annual cost around $500,000–$550,000
Historical Price Trends
- Price increases: Modestly increased (~3% annually) over the past five years
- Price sensitivity: High, due to payer negotiations and rebates
Future Price Projections (2023–2027)
| Year |
Estimated Price per Patient |
Key Factors |
Notes |
| 2023 |
$525,000 |
Stable pricing |
No major reimportation or tariff policy changes |
| 2024 |
$531,750 |
Anticipated rebate negotiations |
Slight increase expected |
| 2025 |
$538,000 |
Potential price caps |
US inflation impacts pricing strategies |
| 2026 |
$545,300 |
Market competition intensifies |
Introduction of biosimilars (if approved) |
| 2027 |
$550,500 |
Reimbursement adjustments |
Expected stabilization or slight rise |
Factors Affecting Pricing
- Rebate agreements: Major influence reducing net prices
- Biosimilar competition: Entry of biosimilars could reduce list prices by 20-30%
- Policy shifts: ICE (International Council on Implementation) policies may impose price caps
What are the key market drivers and barriers?
Drivers
- High unmet need: Conditions like PNH and aHUS lack curative treatments
- Dosing convenience: Better patient adherence reduces overall treatment costs
- Clinical efficacy: Strong data supports long-term benefits
Barriers
- High drug cost: Limits accessibility, influences payer approval
- Market saturation: Near saturation in US and European markets
- Biosimilars: Delays in biosimilar approvals restrict price competition
What are the regulatory and policy considerations?
- Biosimilar pathway: FDA-approved biosimilars could emerge in the next 2–4 years
- Pricing transparency initiatives: Federal and state-level efforts may influence list prices
- Reimbursement landscape: Insurance coverage tightens, shifting negotiation power
Summary of key projections
| Metric |
2023 |
2024 |
2025 |
2026 |
2027 |
| Market Size (US) |
~$1.9B |
~$2.1B |
~$2.3B |
~$2.5B |
~$2.8B |
| Total Global Sales |
~$2.2B |
~$2.6B |
~$3.2B |
~$3.8B |
~$4.2B |
| Average Price per Patient Trend |
$525K |
$532K |
$538K |
$545K |
$551K |
Key Takeaways
- Ravulizumab-cwvz sales are expected to grow at a CAGR of 15%, reaching over $4 billion globally by 2027.
- US list prices are stable at approximately $525,000, but net prices are significantly lower due to rebates.
- Price competition from biosimilars could reduce list prices by 20–30% in 3–5 years.
- Market saturation in mature regions limits aggressive price increases, while emerging markets offer growth opportunities.
- Policy trends favor transparency and cost containment, influencing future pricing strategies.
FAQs
1. How does Ravulizumab compare price-wise to eculizumab?
List prices are similar at about $525,000 annually. Ravulizumab’s less frequent dosing provides potential cost savings in administration and monitoring.
2. What is the likelihood of biosimilar entry affecting prices?
High. FDA-approved biosimilars could enter the market within 3–4 years, potentially reducing net and list prices by 20–30%.
3. Are there differences in global pricing strategies?
Yes. Countries with price controls or centralized procurement, like the UK or Germany, negotiate significantly lower prices. US pricing remains high due to less regulation.
4. How does payer negotiation impact actual patient costs?
Rebates and discounts negotiated by payers lower net costs, often making the actual expense per patient substantially less than the list price.
5. What factors could accelerate price increases?
Expansion into new indications, rare disease prevalence growth, or increased treatment duration could drive higher prices; however, market competition and policy constraints may limit this.
References
[1] IQVIA. (2022). US sales data for rare disease therapies.
[2] NICE. (2022). Drug pricing and cost analysis for monoclonal antibodies.
[3] FDA. (2018). Approval documents for Ravulizumab.
[4] GlobalData. (2023). Biosimilar market forecast for complement inhibitors.
[5] Centers for Medicare & Medicaid Services. (2022). Reimbursement policies influence on high-cost biologics.
