Last updated: March 3, 2026
What is NDC 75907-0074?
NDC 75907-0074 corresponds to Givlaari (givosiran) injection, developed by Alnylam Pharmaceuticals. It is approved for treating acute hepatic porphyria (AHP) in adult patients. Givlaari was first approved by the FDA in November 2019.
Market Overview
Indication and Patient Population
- Indication: Treatment of adults with AHP to reduce the frequency of painful attacks.
- Prevalence: Estimated at approximately 5,000 to 10,000 patients in the U.S.
- Treatment Landscape: Limited options, with Givlaari as a first FDA-approved therapy.
Competitive Position
- Main Competitor: Hep branch of RNA interference (RNAi) therapeutics, mainly Givlaari's direct competitor, Oxlumo (lumasiran), approved by the FDA for primary hyperoxaluria type 1.
- Market Share: Limited, but growing as awareness of RNAi therapies increases.
- Pricing Strategy: Givlaari is priced at approximately $485,000 annually, reflecting its specialty status.
Pricing Analysis
Current Price Point
| Parameter |
Details |
| List Price |
~$485,000 per year |
| Cost per Dose |
Approx. $4,000 (assuming bi-weekly dosing) |
| Pricing Justification |
High manufacturing costs, rarity, and clinical efficacy |
Insurance and Reimbursement
- Reimbursement is typically through Medicare, Medicaid, and private insurers.
- Despite high list prices, net prices can vary due to negotiations, discounts, and rebates.
Price Trends and Projections
- Recent Trends: No significant decrease in list price since launch in 2019.
- Projection for 2023-2028:
| Year |
Expected Price Range |
Supporting Factors |
| 2023 |
$480,000 - $495,000 |
Steady demand, no competitive price erosion |
| 2024 |
$475,000 - $490,000 |
Potential negotiations and market penetration effects |
| 2025 |
$470,000 - $485,000 |
Increased competition, as RNAi therapies expand |
| 2026 |
$460,000 - $470,000 |
Possible biosimilar entry or price negotiations |
Key Variables Impacting Price Projections
- Market penetration: Increasing awareness could sustain or elevate prices.
- Competition: Emergence of biosimilars or new therapies may pressure prices downward.
- Reimbursement policies: Moves toward value-based pricing could impact net revenue.
- Manufacturing costs: Advances in RNAi technology may reduce costs.
Market Dynamics and Growth Drivers
- Rising diagnosis awareness increases eligible patient pool.
- Limited treatment options favor Givlaari's market dominance.
- Advances in RNA interference technology potentially lead to broader indications.
- Pricing pressures from health authorities and insurers could moderate list-price growth.
Challenges and Risks
- Market penetration: Slow adoption due to high cost.
- Reimbursement hurdles: Challenging negotiations may limit accessible patient base.
- Competition: Price competition or new therapies could erode market share.
- Regulatory shifts: Changes in drug approval or reimbursement policies can impact market viability.
Summary of Key Takeaways
- Givlaari (NDC 75907-0074) has a high list price of approximately $485,000 per year.
- The market for AHP treatment is limited in size but prioritized by unmet medical needs.
- Price projections remain stable in the short term, with potential slight declines due to increased competition and policy pressures.
- Market growth depends on diagnosis rates, reimbursement policies, and the introduction of competing therapies.
FAQs
Q1: What factors contribute to the high price of Givlaari?
Limited patient population, R&D costs for RNAi therapies, and the lack of alternative treatments contribute to the high price.
Q2: How vulnerable is Givlaari to biosimilar competition?
As a biological product, biosimilar entry could occur after patent expiration, risking price erosion.
Q3: Are there regional price variations for Givlaari?
Yes, list prices vary internationally due to healthcare system differences, rebates, and negotiated discounts.
Q4: What is the potential impact of policy reforms on Givlaari pricing?
Value-based pricing initiatives and regulatory changes could result in discounts or reimbursement constraints.
Q5: How does Givlaari compare to alternative therapies in efficacy?
It effectively reduces attack frequency but lacks significantly comparable alternatives, maintaining its market position.
References
[1] U.S. Food and Drug Administration. (2019). FDA approves Givlaari to treat acute hepatic porphyria. Retrieved from https://www.fda.gov
[2] Alnylam Pharmaceuticals. (2022). Givlaari prescribing information.
[3] IQVIA. (2022). Specialty drug market data.
