Last updated: March 29, 2026
What is NDC 62332-0784?
The National Drug Code (NDC) 62332-0784 is assigned to a specific drug product registered with the FDA. Based on available data, this NDC corresponds to Voretigene Neparvovec (Luxturna), a gene therapy indicated for inherited retinal disease caused by deficiency of RPE65.
Market Overview
Product Details
| Attribute |
Description |
| Drug Name |
Voretigene Neparvovec (Luxturna) |
| Manufacturer |
Spark Therapeutics (a Roche subsidiary) |
| Approval Date |
December 19, 2017 |
| Indication |
Hereditary retinal dystrophy caused by RPE65 mutations |
| Delivery System |
Single-dose, intravitreal gene therapy |
Market Size and Growth Drivers
- Estimated prevalence of RPE65-related retinal dystrophy: 1 in 300,000 to 1 in 400,000 retinal dystrophies.
- Estimated US patient population: approximately 1,000-1,200 individuals.
- Global market potential exceeds USD 300 million annually, primarily driven by the US, EU, and Japan.
- Growth driven by increased diagnosis, approval expansion, and payer willingness to cover high-cost therapies.
Competitive Landscape
- No direct gene therapy competitors approved for RPE65 deficiency.
- Potential competition from emerging gene-based interventions and traditional treatments.
- Existing supportive care options include low vision aids and surgical interventions, but no curative therapies.
Price Structure and Historical Pricing
Luxturna Pricing
- List Price (US): USD 850,000 for a one-time treatment (per patient) [1].
- Price variation exists with discounts and rebates influenced by payer negotiations.
- Cost includes administration and follow-up care, often managed under a case-by-case basis.
Pricing Trends
| Year |
Price (USD) |
Notes |
| 2017 |
USD 850,000 |
Approved for rare retinal dystrophy |
| 2018-2022 |
Stable around USD 850,000 |
No significant price change reported |
| 2023 |
Slight discounts reported |
Rebates and value-based agreements in place |
Price Comparison with Similar Therapies
| Therapy |
Indication |
Price (USD) |
Delivery Type |
Notes |
| Zolgensma (onasemnogene abeparvovec-Xioi) |
SMA Type 1 |
USD 2.1 million |
Single-dose gene therapy |
Largest gene therapy price |
| Kymriah (tisagenlecleucel) |
Leukemia |
USD 475,000 |
CAR T-cell therapy |
High-cost cell therapy |
| Strimva (mecapegfilgrastim) |
Neutropenia |
USD 300 per dose |
Pegfilgrastim biosimilar |
Lower-cost, routine therapy |
Market Dynamics and Price Projections
Short-term Outlook (Next 1-2 Years)
- Stable pricing at USD 850,000 with possible rebates.
- Payers and insurers are under pressure to reduce drug spending, leading to increased negotiations.
- Expansion into international markets may drive volume but could pressure up-front pricing.
Medium-term Outlook (3-5 Years)
- Potential price adjustments after biosimilar or alternative gene therapies are introduced.
- Increased competition and reimbursement reforms could lead to US prices declining by 10-15%.
- Manufacturing costs remain high, limiting significant price drops unless technological improvements occur.
Long-term Outlook (5+ Years)
- Market expansion beyond the initial indication could influence price adjustments.
- Price reductions of 20-30% are expected if biosimilars or generic gene therapy options emerge.
- Potential value-based pricing models may base payments on patient outcomes, possibly reducing the initial list price.
Regulatory and Reimbursement Factors
- FDA approval provides patent protections and marketing exclusivity.
- CMS and private payers often negotiate discounts, rebates, or value-based agreements.
- International pricing varies considerably, reflecting healthcare system differences.
- Reimbursement success hinges on demonstrated clinical benefit and cost-effectiveness.
Risks and Opportunities
Risks
- Entry of biosimilars or innovative therapies could erode market share.
- Reimbursement pressures may reduce net revenues.
- Manufacturing complexities may influence supply stability and costs.
Opportunities
- Expanding indication approvals could increase patient access.
- Demonstrated long-term efficacy could justify premium pricing.
- International expansion offers revenue growth potential.
Key Takeaways
- NDC 62332-0784 corresponds to Luxturna, a high-cost gene therapy with stable pricing around USD 850,000 in the US.
- The total market remains limited by the rarity of the indication but has growth potential with increased diagnosis.
- Price projections suggest stable or slightly declining prices due to payer negotiations and market competition.
- Regulatory exclusivities and international market dynamics heavily influence pricing.
- Advancements in gene therapy technology could reshape the pricing landscape in the coming years.
FAQs
Q1: What factors influence the price of Luxturna?
Coverage negotiations, manufacturing costs, market competition, and regulatory exclusivity all impact pricing.
Q2: How might biosimilars affect Luxturna’s price?
Entry of biosimilars or alternative gene therapies could lead to significant price reductions over 5 years.
Q3: Is the current pricing justified?
Pricing reflects R&D costs, rarity of the condition, and the therapy's curative potential, though payer pressure could adjust net prices.
Q4: What is the global market for Luxturna?
Primarily in the US, Europe, and Japan, with market access influenced by local reimbursement policies.
Q5: Will pricing change with new indications?
Expanding indications can increase volume and justify price adjustments, but reimbursement negotiations will still influence the final price.
References
[1] Spark Therapeutics. (2017). Luxturna (voretigene neparvovec-rzyl) Prescribing Information.
[2] IQVIA. (2022). Gene Therapy Market Data.
[3] U.S. Food and Drug Administration. (2017). FDA approves novel gene therapy to treat inherited blindness.
