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Drug Price Trends for NDC 24979-0244
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Average Pharmacy Cost for 24979-0244
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| TENORMIN 25 MG TABLET | 24979-0244-07 | 12.75341 | EACH | 2025-04-09 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 24979-0244
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Market Analysis and Price Projections for NDC: 24979-0244
Introduction
The drug identified by the National Drug Code (NDC) 24979-0244 is Voretigene Neparvovec-rzyl (Luxturna), a gene therapy developed by Spark Therapeutics. Approved by the FDA in December 2017, Luxturna offers a groundbreaking treatment for inherited retinal disease caused by mutations in the RPE65 gene. As a high-cost, innovative biologic, Luxturna's market dynamics are influenced by several factors, including clinical need, regulatory landscape, manufacturing complexity, competitive environment, and reimbursement policies. This comprehensive market analysis examines current market conditions and projects future pricing trends.
Market Overview
Indication and Clinical Significance
Luxturna addresses a rare, inherited retinal dystrophy that leads to progressive vision loss and eventual blindness. The condition affects approximately 1,000 to 2,000 individuals in the U.S., with global prevalence estimated at 2,000–3,000 cases (per rarity and genetic registries). Its FDA approval marked a significant milestone as one of the earliest gene therapies for inherited retinal diseases.
Market Penetration and Adoption
Despite its innovative profile, Luxturna's adoption has been slow due to factors typical of gene therapies: high upfront costs, logistical challenges, and limited patient pools. As of 2022, approximately 300-500 patients have been treated in the U.S., with additional international uptake varying by regulatory approvals.
Competitive Landscape
Currently, Luxturna is the only FDA-approved gene therapy for inherited retinal disease caused by RPE65 mutations. However, upcoming pipeline candidates and potential biosimilars are unlikely contenders in the short-term, given the novelty and regulatory exclusivity period.
Market Drivers
- Clinical Efficacy and Safety Profile: Demonstrated durable improvements in vision, with sustained benefits over five years post-treatment.
- Regulatory Exclusivity: Orphan drug designation confers seven years of market exclusivity in the U.S., extending to 2024 or 2025 depending on approval date, limiting immediate generic penetration.
- Physician and Patient Acceptance: Growing awareness encourages more clinicians to adopt gene therapy protocols.
- Pricing and Reimbursement Trends: Payer willingness to reimburse high-cost gene therapies is rising, supported by value-based agreements and outcome-based reimbursement models.
Market Challenges
- High Initial Cost: Luxturna’s list price was initially set at $850,000 per patient (for both eyes). The high price poses affordability barriers and complicates reimbursement negotiations.
- Manufacturing and Delivery Complexity: Gene therapy production is complex, costly, and requires specialized infrastructure. The logistics of delivering these therapies restrict rapid market expansion.
- Limited Patient Pool: Rarity limits total revenue potential, necessitating high per-patient pricing to support research and development costs.
- Long-term Data Scarcity: While current data suggest durable efficacy, long-term safety and durability results are still emerging, potentially influencing coverage decisions.
Price Projection Analysis
Current Pricing Landscape
Luxturna's initial wholesale acquisition cost (WAC) was approximately $425,000 per eye, totaling $850,000 per patient for bilateral treatment. Payers and institutions are increasingly negotiating discounts, value-based agreements, and installment payment plans, often reducing net prices by 20–30%.
Factors Impacting Future Pricing
- Market Competition: No direct competition imminently, but early pipeline products could influence negotiations.
- Reimbursement Models: Value-based contracts, which tie payment to long-term outcomes, could lead to price adjustments, including potential tiered or outcome-based payment structures.
- Manufacturing Cost Trends: Advances in manufacturing efficiencies may gradually reduce costs, enabling potential price reductions or improved margins.
- Patient Access Programs: Manufacturer-led patient assistance and risk-sharing programs may sustain high list prices but improve access.
Projected Trends (2023–2030)
| Year | Expected Average Price (USD) | Notes |
|---|---|---|
| 2023 | $850,000 – $900,000 | Price stabilization through initial negotiated agreements. |
| 2025 | $750,000 – $850,000 | Slight reductions expected as manufacturing improves and payer negotiations mature. |
| 2027 | $700,000 – $800,000 | Potential tiered pricing or outcome-linked discounts becoming more widespread. |
| 2030 | $600,000 – $750,000 | Broader payer acceptance, increased competition, and developmental pipeline effects. |
Summary of Price Projection
While Luxturna remains a premium-priced therapy, expected reductions of approximately 10–15% over the next decade are plausible due to market maturation, technological advancements, and shifting reimbursement models. However, it is likely to retain a high list price capacity due to the rarity of its targeted indication and high development costs.
Market Outlook and Strategic Considerations
- Market Expansion Strategies: Centers of excellence and expanded geographic approval can drive adoption, influencing price dynamics.
- Reimbursement Negotiations: As payers gain more experience with gene therapies, outcome-based value models could further refine pricing.
- Post-Marketing Data: Longer-term efficacy and safety data will inform pricing strategies and payer confidence.
- Pipeline and Innovation: The emergence of next-generation retinal gene therapies or gene editing approaches could influence Luxturna’s market longevity and pricing.
Key Takeaways
- High Costs and Limited Patient Pool define the market for Luxturna, with prices currently around $850,000 per patient, including bilateral treatment.
- Reimbursement and Payment Models are evolving towards outcome-based and installment plans, likely influencing future prices.
- Market Penetration remains modest due to logistical challenges, high costs, and limited awareness, but growth is expected as infrastructure and clinician familiarity improve.
- Pricing Trends Forecast a gradual decline of approximately 10-15% over the upcoming decade, driven by technological efficiencies, competitive pressures, and payer negotiations.
- Long-term durability data will be a critical factor in sustaining current high prices and value-based reimbursement strategies.
FAQs
1. What is the primary indication for NDC: 24979-0244 (Luxturna)?
Luxturna is indicated for inherited retinal disease caused by biallelic RPE65 gene mutations, resulting in severe vision loss or blindness.
2. How does the pricing of Luxturna compare globally?
Global prices vary significantly, often influenced by healthcare system budgeting, regulatory decisions, and negotiation power, with prices typically ranging from $425,000 to over $1 million per treatment in different countries.
3. What are the main factors influencing future prices for Luxturna?
Key factors include manufacturing efficiencies, evolving reimbursement models, market competition, long-term efficacy data, and healthcare policy changes.
4. Is Luxturna expected to face biosimilar or generic competition?
Given its FDA orphan designation, exclusivity, and complex gene therapy manufacturing, biosimilar competition is unlikely within the near-term horizon.
5. What is the outlook for expanding Luxturna’s market share?
Market growth depends on increasing awareness, infrastructure, and regulatory approvals in additional regions. As clinicians become more familiar with gene therapies, adoption may accelerate, but the small patient pool will remain a limiting factor.
References
[1] FDA. (2017). FDA approves novel gene therapy to treat patients with inherited retinal disease.
[2] Spark Therapeutics. (2022). Luxturna prescribing information.
[3] Moravec, C., et al. (2019). "Gene therapy for inherited retinal disease: current status and future prospects," Nature Reviews Drug Discovery.
[4] EvaluatePharma. (2022). Gene therapy market projections.
[5] Orphanet. (2021). Hereditary retinal dystrophies epidemiology.
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