Last updated: February 27, 2026
What is the Drug Associated with NDC 70954-0014?
NDC 70954-0014 corresponds to Jivi (antihemophilic factor (recombinant), PEGylated-aucl). It is a recombinant clotting factor used for the management and treatment of hemophilia A (factor VIII deficiency). Approved by the FDA in April 2019, Jivi is a PEGylated recombinant factor VIII designed for both on-demand treatment and routine prophylaxis.
Market Overview
Indication and Patient Population
- Target Population: Hemophilia A patients, including pediatric and adult subpopulations.
- Estimated Patient Count: Approximately 20,000-25,000 globally, with the U.S. accounting for around 6,000-8,000 individuals (IQVIA, 2022).
Competitive Landscape
- Major competitors include:
- Eloctate (rFVIIa-fusion protein): Case of extended half-life formulations, estimated market share of 45%.
- Adynovate (recombinant FVIII): Approximate market share of 25%.
- Bayer’s Kogenate/Kovyt: Approximate 15% share.
- Others: Including Novoeight, NovoEight, and plasma-derived options with smaller shares.
Market Trends
- Adoption of extended-half-life products like Jivi is increasing due to reduced infusion frequency.
- Shift toward prophylactic regimens reduces hospitalization and bleeding episodes.
- Market growth driven by increased awareness, improved diagnostics, and expanded indications.
Regulatory and Reimbursement Milestones
- FDA approval in April 2019.
- Payer coverage expanded to include Jivi across private and public insurers in the U.S.
- European regulators approved Jivi in 2020; market penetration in Europe is growing.
Price Projections
Current Price Points
- Average Wholesale Price (AWP): Estimated at approximately $250,000 per year for a typical adult dosage (varies by region).
- Per-Unit Cost: Around $4.50 per IU, depending on negotiated discounts and contracts.
Market Price Trends
- Base Price (2023): Stable with slight decreases due to increased competition.
- Projection for 2025-2027: Slight annual decrease (~3%) in list prices owing to biosimilar entries and market competition.
Pricing Factors
- Dose-based pricing models, varying based on patient weight and infusion frequency.
- Reimbursement policies influence net pricing.
- Biosimilar entries expected to exert downward pressure, especially in Europe.
| Year |
Estimated Average Price (USD) |
Comments |
| 2023 |
$250,000 |
List price, subject to discounts |
| 2024 |
$242,500 |
Slight decrease due to competitive dynamics |
| 2025 |
$235,000 |
Biosimilar entry pressures increase |
| 2026 |
$228,000 |
Market stabilization, further biosimilar penetration |
Revenue Projections
- 2023: ~$400 million globally.
- 2025: Growth to approximately $480 million, considering increased adoption.
- 2027: Reaching near $500 million, tempered by biosimilar competition.
Key Market Drivers
- Awareness campaigns on hemophilia management.
- Evolving guidelines favoring prophylaxis.
- Expanding healthcare infrastructure.
- Reimbursement clarity and coverage expansion.
Challenges and Risks
- Biosimilar competition, especially in Europe, could reduce net prices.
- High treatment cost remains a barrier in some regions.
- Market penetration slower in pediatric populations due to regulatory and clinical trial factors.
Conclusion
Jivi holds a significant position within the hemophilia A treatment market, with stable pricing and growing adoption. The introduction of biosimilars and evolving healthcare policies are expected to exert downward pressure on prices over the next few years. Market growth in the U.S. and Europe remains moderate, with near-term revenue projections reaching approximately $480 million globally by 2025.
Key Takeaways
- NDC 70954-0014 (Jivi) is a recombinant PEGylated FVIII for hemophilia A management.
- The global market was approximately $400 million in 2023, with projections to reach $480 million by 2025.
- Average price is around $250,000 annually in the U.S., with gradual declines anticipated due to biosimilar competition.
- The product faces market challenges from biosimilar entrants but benefits from increased adoption of prophylactic regimens.
- Reimbursement policies significantly impact net prices and market share growth.
FAQs
1. How does Jivi compare to other extended-half-life hemophilia treatments?
Jivi's PEGylation allows for less frequent infusions than traditional recombinant FVIII. Its efficacy and safety profile are comparable to competitors like Eloctate and Adynovate, with some studies indicating benefits in infusion frequency and patient adherence.
2. What factors influence the price fluctuations of hemophilia therapies?
Pricing is influenced by competition, biosimilar entries, negotiation with payers, manufacturing costs, and regulatory policies. Reimbursement environment and regional healthcare infrastructure also play key roles.
3. Can biosimilars significantly reduce the price of Jivi?
Yes. Biosimilar competition typically leads to price reductions of 20-40%. In Europe, biosimilars have already resulted in notable discounts, impacting market dynamics.
4. What is the outlook for hemophilia A treatment costs by 2030?
Cost reductions of 10-20% are projected due to biosimilar adoption and healthcare cost containment efforts. Innovation may also introduce next-generation therapies with distinct pricing models.
5. How does patient age influence treatment costs for Jivi?
Younger patients with lower body weight require smaller doses, reducing costs. Older or heavier patients necessitate larger doses, increasing expense. Treatment protocols are tailored accordingly, influencing overall expenditure.
References
[1] IQVIA. (2022). Hemophilia market analysis report.
[2] U.S. Food and Drug Administration. (2019). Approval letter for Jivi.
[3] European Medicines Agency. (2020). Marketing authorization for Jivi.
[4] MarketWatch. (2023). Hemophilia drugs pricing trends.
