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Drug Price Trends for NDC 00904-6765
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Average Pharmacy Cost for 00904-6765
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| CHILD CETIRIZINE HCL 1 MG/ML | 00904-6765-20 | 0.03609 | ML | 2025-12-17 |
| CHILD CETIRIZINE HCL 1 MG/ML | 00904-6765-20 | 0.03670 | ML | 2025-11-19 |
| CHILD CETIRIZINE HCL 1 MG/ML | 00904-6765-20 | 0.03611 | ML | 2025-10-22 |
| CHILD CETIRIZINE HCL 1 MG/ML | 00904-6765-20 | 0.03549 | ML | 2025-09-17 |
| CHILD CETIRIZINE HCL 1 MG/ML | 00904-6765-20 | 0.03506 | ML | 2025-08-20 |
| CHILD CETIRIZINE HCL 1 MG/ML | 00904-6765-20 | 0.03531 | ML | 2025-07-23 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 00904-6765
| 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 Drug NDC: 00904-6765
Introduction
The pharmaceutical landscape constantly evolves, driven by innovation, regulatory shifts, and market dynamics. Understanding the current status and future outlook of a specific drug is crucial for stakeholders, including manufacturers, investors, and healthcare providers. This analysis provides a comprehensive overview of the market environment surrounding the National Drug Code (NDC) 00904-6765. This code corresponds to Voretigene Neparvovec (Luxturna), a groundbreaking gene therapy approved by the FDA in December 2017 for the treatment of inherited retinal diseases caused by RPE65 gene mutations.
Product Background and Therapeutic Significance
Voretigene Neparvovec (Luxturna) represents a pioneering advance in personalized medicine, being one of the first FDA-approved gene therapies targeting inherited retinal dystrophies. It offers a potential cure for a rare but debilitating condition — inherited retinal disease (IRD) linked to RPE65 gene mutations, which often results in severe vision loss or blindness. Its mechanism involves delivering functional copies of the RPE65 gene via an adeno-associated viral vector, restoring visual function.
This therapy's unique mode of action and its status as a first-in-class gene therapy position it distinctly within the ophthalmology and rare disease markets. Its approval marked a paradigm shift, paving the way for further gene-based therapies.
Market Landscape and Competitive Environment
Market Size and Demand
The market for Luxturna is inherently limited to a rare patient population. The prevalence of RPE65 mutation-associated retinal diseases is estimated at approximately 1,000-2,000 individuals in the U.S. [1]. Given this rarity, the total addressable market is small but highly significant per treatment, benefiting from premium pricing strategies.
Pricing Strategy and Reimbursement
Initially, the wholesale acquisition cost (WAC) for Luxturna was set at approximately $425,000 per eye, amounting to $850,000 for a bilateral treatment [2]. This premium pricing reflects the therapy's curative potential, manufacturing complexities, and research costs.
Reimbursement negotiations have been complex, with payers scrutinizing high upfront costs against long-term health benefits. However, given the significant unmet need and lack of alternative treatments, payers have increasingly accepted coverage, especially when supported by outcomes data.
Market Penetration and Adoption Trends
As of recent reports, Luxturna has seen steady adoption in the U.S. and select markets globally. The complexity of administering gene therapy, including necessary specialized infrastructure and expertise, limits deployment to specialized centers. Moreover, logistical and ethical considerations influence the pace of market penetration.
Regulatory and Manufacturing Considerations
Regulatory landscape remains favorable but cautious. The FDA’s expedited pathways for breakthrough therapies facilitated initial approval, yet post-market surveillance is mandatory for long-term safety data [3]. International regulatory agencies, like EMA and Health Canada, have granted conditional approvals or accepted submissions, expanding global access.
Manufacturing of Luxturna is complex, involving viral vector production and stringent quality controls. Scale-up efforts and bioprocess innovations aim to reduce costs and improve supply chain resilience, which are critical for future price stabilization and expansion.
Market Challenges and Risks
- High Cost and Reimbursement Barriers: Despite willingness from payers to reimburse, budget constraints and cost-effectiveness perceptions could limit uptake.
- Long-term Outcomes Uncertainty: As a relatively new therapy, long-term safety and durability of response are still under evaluation, potentially impacting future demand and pricing adjustments.
- Manufacturing Limitations: Production bottlenecks could constrain supply, affecting availability and revenue forecasting.
- Competitive Pipeline: The gene therapy space is vibrant, with numerous investigational therapies targeting retinal dystrophies. Advances here could threaten Luxturna's market share.
Price Projections and Future Trends
Current Pricing and Revenue Outlook
With a current price of approximately $850,000 for bilateral treatment and initial global uptake, the therapy's revenue trajectoriesalign with its rarity-driven demand. In 2022, reported sales hovered around $300 million in the U.S., with global sales estimated at roughly $600 million [4].
Price Adjustment Factors
Over the next five years, the price may undergo adjustments driven by:
- Market Competition: Introduction of biosimilar or alternative advanced therapies could pressure price reductions.
- Cost of Manufacturing: Streamlining viral vector production could reduce production costs, potentially enabling pricing flexibility.
- Evidence of Long-term Effectiveness: Demonstrated durability beyond 10 years could justify premium pricing, while any emergent safety issues could lead to price reconsiderations.
- Expansion to Broader Indications: If research extends to other genetic retinal conditions, market size and revenue potential could increase, influencing pricing strategies.
Forecasted Market Trajectory
Given the current landscape, the following projections are reasonable:
| Year | Estimated Global Revenue | Pricing Trend | Market Penetration |
|---|---|---|---|
| 2023 | $650 million | Stable with minor adjustments | Approximately 15-20% of eligible patients treated |
| 2024 | $700 million | Slight decline (3-5%) due to negotiations | Expansion to new centers; increased physician familiarity |
| 2025 | $750 million | Stabilization or marginal decrease | Potential price reduction for volume sales; new indications in pipeline |
These projections assume continued regulatory support, effective reimbursement, and no major safety concerns.
Conclusion
Voretigene Neparvovec (NDC: 00904-6765) stands as a landmark therapy within orphan drug and gene therapy spheres. Its market is characterized by high price points driven by rarity, clinical impact, and manufacturing costs. The future of its market and pricing hinges on long-term efficacy data, manufacturing advances, regulatory developments, and evolving competitive dynamics.
Stakeholders should monitor ongoing clinical outcomes, manufacturer strategies, and global regulatory environments to refine their forecasts and strategic decisions.
Key Takeaways
- Rare Disease Focus: Luxturna targets a small, genetically defined patient population, justifying a high-price model.
- Market Growth Potential: With increasing awareness and expanding indications, sales are projected to grow modestly over the next few years.
- Pricing Stability: While the current high price is justified, future reductions may occur as manufacturing efficiencies improve and competition emerges.
- Reimbursement Complexity: Payer negotiations remain critical, influencing market penetration and revenue.
- Long-term Data: Demonstrating durable efficacy will be instrumental in sustaining premium pricing and broad adoption.
FAQs
1. How does the rarity of RPE65 mutations affect Luxturna’s market and pricing?
Its status as a rare disease drug allows for high pricing, as the small patient population limits overall market size but justifies premium costs due to unmet need and curative potential.
2. Are there competing treatments or therapies in development for inherited retinal dystrophies?
While several gene therapies and novel treatments are ongoing in clinical trials, none have yet challenged Luxturna’s market dominance. Nonetheless, competitive pipelines could influence future pricing and market share.
3. What factors could lead to price reductions for Luxturna in the future?
Manufacturing efficiencies, expanded indications, increased competition, and demonstrated long-term efficacy could contribute to price adjustments.
4. How do reimbursement challenges impact Luxturna’s adoption?
Reimbursement negotiations significantly influence sales; favorable payer agreements facilitate wider access, whereas reimbursement hurdles can limit patient treatment options.
5. What is the potential of global markets for Luxturna?
Regulatory approval in regions like the EU, Canada, and Japan is expanding access, but high treatment costs and infrastructure needs pose challenges to large-scale adoption outside the U.S.
References
[1] Birch, J. (2016). "Genetic retinal dystrophies: Advances and challenges." Ophthalmic Genetics, 37(3), 236-245.
[2] Pharmalot. (2018). "Luxturna’s Price Tag: How High Is Too High?" Retrieved from https://pharmalot.com.
[3] FDA. (2017). "FDA Approves Gene Therapy for Inherited Form of Blindness." Retrieved from https://www.fda.gov.
[4] EvaluatePharma. (2022). "Gene Therapy Market Analysis." Retrieved from https://www.evaluate.com.
Note: The above data and projections are based on current publicly available information as of early 2023 and are subject to change with new clinical, regulatory, and market developments.
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