Last updated: February 25, 2026
What is NDC 31722-0935?
NDC 31722-0935 corresponds to emicizumab-kxwh (Hemlibra), marketed by Genentech. It is a monoclonal antibody used for prophylaxis in patients with hemophilia A with inhibitors.
Market Overview
Indication and Approved Use:
- Hemlibra is approved in both pediatric and adult patients.
- It prevents bleeding episodes by mimicking Factor VIII activity.
- Its approval by the FDA (October 2017) and EMA (June 2018) positions it as a leading therapy in hemophilia A management.
Market Size:
- Hemophilia A affects approximately 1 in 5,000 live male births globally.
- Estimated prevalence exceeds 200,000 patients worldwide.
- The inhibitor subset comprises about 25-30% of these patients, totaling roughly 50,000 globally.
Adoption and Revenue:
- Hemlibra became the best-selling hemophilia drug within 2 years of launch.
- 2022 global sales crossed $4 billion.
- Top markets include the U.S., EU, and Japan, accounting for roughly 80% of revenue.
Price and Reimbursement
List Price:
| Region |
Approximate Monthly Cost |
Notes |
| U.S. |
$27,000 - $30,000 |
Based on dosing protocols, varies by patient weight |
| EU |
€22,000 - €25,000 |
Regional price regulation influences variation |
| Japan |
¥3,000,000 |
Similar to US pricing, subject to negotiation |
Dosing and Cost Factors:
- Typically administered weekly or bi-weekly.
- Dosing depends on patient weight; the standard regimen is 1.5 mg/kg weekly, or 3 mg/kg every 2 weeks.
- Higher weight patients incur proportionally higher costs.
Reimbursement and Payer Landscape:
- Largely covered by commercial insurers, Medicaid, and national health services.
- High drug cost has driven advocacy for value-based arrangements.
Market Trends and Competitive Landscape
Key Competitors:
- Bayer's Jivi: Extended half-life factor VIII product.
- Pfizer's Rebyt: Gene therapy candidates under development.
- Eloctate (rFVIIIFc): Extended half-life factor VIII.
- Concizumab and Fitusiran: Under clinical development as non-factor therapies.
Market Dynamics:
- Adoption driven by convenience, reduced infusion frequency, and bleeding reduction.
- The emergence of gene therapies (e.g., valoctocogene roxaparvovec) may impact long-term demand.
- Payers are increasingly adopting risk-sharing and outcome-based agreements.
Price Projections
Short-term (Next 2 years):
- Prices will largely stabilize around current levels, with minor regional adjustments.
- High inflation in healthcare costs may lead to slight increases (~2-3%).
Medium-term (3-5 years):
- Entry of biosimilar products could exert downward pressure.
- Price reductions of 10-15% plausible in mature markets due to increased competition.
- Continued adoption of early initiation protocols may drive volume growth but not significantly alter unit price.
Long-term (5+ years):
- Potential impact from gene therapy approval timelines suggests a decline in demand.
- Prices may decline by 20-30% as biosimilar options and gene therapies become mainstream.
- Reimbursement models may shift toward value-based pricing, affecting nominal list prices.
Key Drivers of Price Changes:
- Regulatory approvals of biosimilars.
- Payer negotiations and formulary placements.
- Advances in competing therapies, including gene therapies.
- Patent expirations, expected in the late 2020s.
Conclusion
NDC 31722-0935 (Hemlibra) maintains a high value in the hemophilia A market driven by its efficacy, convenience, and regulatory approvals. While current pricing remains high, market dynamics, particularly biosimilar entry and gene therapies, forecast a gradual reduction in prices over the next five years.
Key Takeaways:
- Hemlibra is among the fastest-growing hemophilia treatments, with 2022 global sales surpassing $4 billion.
- Pricing varies regionally, averaging roughly $27,000-$30,000 per month in the U.S.
- Competition from biosimilars and gene therapies will pressure prices, potentially decreasing them by 20-30% within five years.
- The market is influenced heavily by regulatory developments, payer strategies, and the evolution of alternative therapies.
FAQs
Q1: How does Hemlibra's price compare to traditional factor VIII therapies?
Hemlibra's monthly costs are higher than traditional factor VIII products, which typically range from $15,000 to $20,000, but its dosing schedule offers convenience and reduces infusion frequency.
Q2: What is the impact of biosimilars on Hemlibra's price?
Biosimilars are expected to enter the market by the late 2020s and may reduce Hemlibra prices by 10-15%, depending on regional regulatory policies and market acceptance.
Q3: How will gene therapy developments influence Hemlibra's market position?
Successful gene therapy approvals could reduce demand for prophylactic treatment options like Hemlibra, potentially eroding market share over the next decade.
Q4: What are the major regional price differences for Hemlibra?
The U.S. sees prices around $27,000-$30,000 monthly, while Europe’s prices range from €22,000 to €25,000, influenced by regional regulations and negotiation power.
Q5: Are there any policy initiatives that could alter Hemlibra’s pricing?
Yes, moves toward value-based pricing and outcome-based reimbursement models could lead to more flexible, potentially lower prices, especially in markets prioritizing cost-effectiveness.
References
- FDA (2017). Hemlibra (emicizumab-kxwh) approval notice.
- EMA (2018). Hemlibra marketing authorization.
- Evaluate Pharma (2022). Hemlibra annual sales report.
- IQVIA (2022). Global pricing data for hemophilia therapies.
- Amgen (2023). Biosimilar market forecast for monoclonal antibodies.
