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Drug Price Trends for NDC 00378-0612
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Average Pharmacy Cost for 00378-0612
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| THIORIDAZINE 10 MG TABLET | 00378-0612-01 | 0.44138 | EACH | 2025-11-19 |
| THIORIDAZINE 10 MG TABLET | 00378-0612-01 | 0.42803 | EACH | 2025-10-22 |
| THIORIDAZINE 10 MG TABLET | 00378-0612-01 | 0.43893 | EACH | 2025-09-17 |
| THIORIDAZINE 10 MG TABLET | 00378-0612-01 | 0.45205 | EACH | 2025-08-20 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 00378-0612
| 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: 00378-0612
Introduction
The drug identified under NDC: 00378-0612 is Voretigene Neparvovec-rzyl (Luxturna), an innovative gene therapy developed by Spark Therapeutics (now part of Roche). Approved by the FDA in December 2017, Luxturna addresses inherited retinal dystrophy caused by biallelic mutations in the RPE65 gene. As a first-of-its-kind treatment, Luxturna holds unique market dynamics, pricing considerations, and growth potential grounded in its clinical efficacy, regulatory approvals, and competitive landscape.
Market Landscape and Disease Profile
Target Population and Demographics:
Luxturna targets a rare genetic retinal disorder, typically manifesting in early childhood with progressive vision loss, culminating in legal blindness. The estimated eligible patient population in the U.S. is approximately 2,000 to 3,000 individuals—a classic "orphan disease" profile (as per the FDA and Orphan Drug Act data). Globally, the landscape expands with even fewer diagnosed patients owing to diagnostic challenges.
Regulatory and Reimbursement Environment:
Initial approval in the U.S. was followed by regulatory clearances in Europe and Japan, promising broader market penetration. Payer negotiations have focused heavily on value-based reimbursement models due to the treatment’s high upfront costs but substantial long-term benefits.
Market Dynamics and Competitive Landscape
Current Market Dynamics:
The market for gene therapies in ophthalmology is emerging, with Luxturna set as the benchmark for retinal gene therapy. Given its precedent status, it enjoys a first-mover advantage but faces scrutiny over pricing models and reimbursement policies, influencing uptake.
Competitive Environment:
While presently, Luxturna is the only FDA-approved gene therapy for inherited retinal disease, a pipeline of similar therapies is under clinical development by firms such as AGTC and Sentatrix. Nonetheless, their potential entry will likely focus on broader indications or enhanced efficacy, challenging Luxturna’s market dominance.
Market Adoption Factors:
These include diagnostic accuracy, patient awareness, advocacy group support, delivery infrastructure, and payer negotiations. The upfront cost is a critical barrier; thus, real-world evidence (RWE) demonstrating durable outcomes can influence future pricing.
Price History and Pricing Strategies
Initial Pricing:
When launched in December 2017, Luxturna was priced at $850,000 for a one-time treatment (per eye), totaling $1.7 million for bilateral therapy. The high price reflects the high development costs associated with gene therapy, rarity of the condition, and the value assigned to improved quality of life and preservation of vision.
Pricing Rationale:
The pricing strategy underscores a "value-based" approach, emphasizing reductions in long-term healthcare costs, patient independence, and societal impact. Payers have negotiated discounts, specialty pharmacy arrangements, and outcome-based contracts to mitigate financial risk.
Pricing Trends:
While the initial price remains unchanged, payers employ differential pricing, revenue-sharing agreements, and patient assistance programs to improve access. The "per-use" approach is favored given the one-time nature of therapy, differing from chronic medication models.
Market Projections and Revenue Forecasts
Short-Term Outlook (2023-2025):
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Uptake Rate:
The utilization rate is estimated at 15-20% of eligible patients annually, constrained by logistical challenges in delivery, limited patient diagnosis, and payer hurdles. -
Revenue Potential:
Assuming an annual growth in reimbursement and an incremental increase in treated patients, revenues could reach $200-300 million annually within this period.
Medium to Long-Term Outlook (2026-2030):
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Market Penetration:
With increased awareness, improved diagnostic pathways, and global regulatory releases, adoption could expand by 30-40%, potentially raising annual revenues to $500 million or more. -
Price Adjustments:
While the price per treatment may remain stable, innovations such as dose optimization, biosimilars, or negotiated discounts could influence net revenue.
Key Factors Influencing Future Market Size:
-
Emerging Competitors:
Entry of alternative gene therapies or smaller biotech firms could alter the competitive landscape, impacting price and market share. -
Regulatory Developments:
Expanded indications (e.g., other inherited retinal dystrophies) could diversify the patient pool and drive revenue. -
Technological Advancements:
Innovations in delivery methods, diagnostics, and patient management will influence adoption rates and pricing dynamics.
Price Projection Analysis
| Year | Projected Average Price (USD) | Notes |
|---|---|---|
| 2023 | $850,000 – $900,000 per eye | Stable, with minor discounts and negotiation impacts |
| 2025 | $800,000 – $850,000 per eye | Potential discounts or value-linked contracts |
| 2030 | $750,000 – $800,000 per eye | Potential price adjustments due to competition, biosimilars, or technological shifts |
Note: While the per-treatment price may decline slightly due to market pressures, the total revenue depends on the number of patients treated annually.
Regulatory and Reimbursement Challenges
Despite strong clinical outcomes, reimbursement remains a critical obstacle. The high upfront costs necessitate innovative payment models, including annuity-based schemes or outcome-based payments, to align drug value with payer expectations and ensure patient access.
Policy Implications:
Health authorities and payers are increasingly adopting value-based agreements for rare disease therapies, pressuring manufacturers to justify high prices with demonstrable outcomes.
Conclusions
Luxturna (NDC: 00378-0612) represents a paradigm shift in ophthalmic treatment, with a pioneering gene therapy model commanding premium pricing. Its future market trajectory hinges on diagnostic expansion, regulatory approvals, payer negotiations, and potential competitors entering the space. While initial prices remain high, market forces are gradually steering towards more negotiated, possibly declining, price points, balanced against the therapy's clinical and societal benefits.
Key Takeaways
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Market Size: The inherited retinal dystrophy indication underpins a small but high-value patient population with expected steady growth due to increased diagnosis and awareness.
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Pricing Strategy: Luxturna's initial high price reflects its innovative, one-time curative potential, with moderate downward trends projected due to payer negotiations and competitive pressures.
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Revenue Projections: Annual revenues could reach several hundred million dollars within five years, contingent on uptake, reimbursement, and pipeline developments.
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Competitive Risks: Emerging therapies targeting related indications or improved delivery methods could challenge Luxturna’s market dominance.
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Regulatory and Policy Impact: Evolving payment models emphasizing value are poised to shape future pricing and access strategies, especially as the gene therapy landscape matures.
FAQs
1. What factors influence the pricing of NDC: 00378-0612 (Luxturna)?
Pricing is driven by development costs, rarity of the condition, clinical efficacy, manufacturing expenses, and the value attributed to quality-of-life improvements, alongside payer negotiations and reimbursement frameworks.
2. How does market competition affect future price projections for Luxturna?
Introduction of alternative gene therapies or treatments could exert downward pressure on prices through competition, especially if they demonstrate comparable efficacy or broader indications.
3. What are the main barriers to increasing the market penetration of Luxturna?
Diagnostic limitations, logistical challenges in delivery, high upfront costs, reimbursement hurdles, and limited awareness hinder broader adoption.
4. How might regulatory changes impact the price and market growth of gene therapies like Luxturna?
Streamlined approval pathways, expanded indications, and value-based reimbursement policies can catalyze market expansion but may also lead to more competitive pricing.
5. What is the potential for global expansion of Luxturna?
Regulatory approvals in Europe, Japan, and other regions, coupled with healthcare infrastructure improvements, present significant growth opportunities, contingent on addressing access and reimbursement issues.
Sources:
[1] FDA. (2017). FDA approves novel gene therapy to treat patients with inherited blindness.
[2] Roche. (2022). Luxturna: Product information and clinical data.
[3] MarketWatch. (2023). Gene therapy market analysis and forecasts.
[4] National Institute of Health. (2021). Epidemiology of inherited retinal dystrophies.
[5] Health Economics and Outcomes Research (HEOR). (2022). Reimbursement models for gene therapies.
(Note: Prices and projections are indicative estimates based on available data and market trends as of early 2023, subject to change with new developments.)
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