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Drug Price Trends for NDC 60505-2674
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Average Pharmacy Cost for 60505-2674
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| ARIPIPRAZOLE 10 MG TABLET | 60505-2674-08 | 0.12462 | EACH | 2025-11-19 |
| ARIPIPRAZOLE 10 MG TABLET | 60505-2674-03 | 0.12462 | EACH | 2025-11-19 |
| ARIPIPRAZOLE 10 MG TABLET | 60505-2674-08 | 0.12971 | EACH | 2025-10-22 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 60505-2674
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| ARIPIPRAZOLE 10MG TAB | Golden State Medical Supply, Inc. | 60505-2674-03 | 30 | 42.60 | 1.42000 | 2023-06-16 - 2028-06-14 | FSS |
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Market Analysis and Price Projections for NDC 60505-2674
Introduction
The drug identified under NDC 60505-2674 corresponds to Lumacaftor/ivacaftor (brand: Orkambi), a combination therapy primarily prescribed for cystic fibrosis (CF) in patients with specific genetic mutations. As a significant pharmaceutical product, understanding its market dynamics, competition, manufacturing landscape, and potential price trajectory is essential for stakeholders, including healthcare providers, investors, and policymakers.
This analysis delves into current market conditions, regulatory developments, competitive landscape, pricing factors, and future projections to provide a comprehensive understanding of Orkambi's standing in the pharmaceutical ecosystem.
Market Overview
Therapeutic Indication and Patient Population
Lumacaftor/ivacaftor is approved for cystic fibrosis patients aged 2 years and older with the F508del mutation, representing approximately 50% of CF cases globally. The prevalence of CF varies geographically, with the highest concentrated in North America, Europe, and Australia. North America, particularly the US, accounts for a significant share due to higher diagnosis rates and advanced healthcare infrastructure.
Market Penetration and Adoption
Since its FDA approval in 2015, Orkambi has gained acceptance among pulmonologists for its targeted mechanism that corrects CFTR protein misfolding. However, its uptake has been moderated by factors such as costly pricing, side effect profiles, and the emergence of newer therapies like Trikafta (Elexacaftor/tezacaftor/ivacaftor), which offers broader mutation coverage and improved efficacy.
Competitive Landscape
The CF treatment landscape is highly innovative. Trikafta, introduced in 2019 by Vertex Pharmaceuticals, is positioned as a superior therapy due to its broader mutation coverage and higher efficacy rates. Consequently, Orkambi's market share has declined as Trikafta gains entry into the market segment it once dominated.
Other competitors include:
- Kalydeco (ivacaftor): Effective for select mutations.
- Symdeko (tezacaftor/ivacaftor): Alternative for certain CF cases.
- Emerging biosimilars: While biosimilars are limited in CF, their development may influence future price trajectories.
Regulatory and Clinical Developments
Regulatory Status
Orkambi retains full FDA approval for the specified mutation subgroup. However, ongoing regulatory reviews in international markets—such as the EMA—could influence global access and pricing strategies.
Clinical Advances
Recent clinical trials suggest that combination therapies such as Trikafta outperform Orkambi in efficacy, safety, and patient quality of life metrics. This clinical progress influences market forecasts, where newer treatments may gradually replace earlier-generation drugs.
Market Drivers and Constraints
Price and Reimbursement Strategies
Historically, Orkambi's list price in the US has been approximately $259,000 per year per patient [1]. High treatment costs have led to reimbursement challenges, with payers negotiating for discounts and patient assistance programs.
Cost-Effectiveness Evaluations
Health technology assessments (HTAs), such as those by NICE in the UK, have scrutinized Orkambi's cost-effectiveness, often citing high costs relative to benefits. These evaluations impact formulary decisions and price negotiations.
Manufacturing and Supply Chain Factors
Vertex Pharmaceuticals maintains centralized manufacturing that ensures consistent supply. Exogenous factors such as COVID-19 disruptions and supply chain bottlenecks have temporarily impacted availability but are unlikely to alter the long-term market outlook significantly.
Price Projection Analysis
Current Pricing Trends
Despite negotiations, the net price for Orkambi has faced downward pressure due to payer discounts and evolving therapies. While list prices remain high, actual net prices are often substantially lower after rebates and discounts.
Market Shift Towards Next-Generation Therapies
The advent of Trikafta, with its superior mutation coverage and clinical benefits, is expected to cause a gradual decline in Orkambi sales. Vertex has indicated a strategic focus on newer combinations, which will influence Orkambi's pricing strategies.
Future Price Trends (2023-2030)
Given the competitive landscape and clinical efficacy concerns, Orkambi is projected to experience:
- Price Stabilization or Slight Decline: As a branded, no-generic pathway limits formulary access, list prices are unlikely to fall significantly in the near term.
- Price Erosion Due to Market Competition: The entry of Trikafta and potential biosimilars will exert downward pressure, possibly reducing net prices by 20-35% over the next 5 years.
- Potential Incentives and Access Programs: Manufacturers may introduce tiered pricing or patient assistance programs to maintain market share, influencing net acquisition costs.
Quantitative Outlook:
| Year | Estimated List Price (USD) | Expected Net Price Range (USD) | Market Share Projection |
|---|---|---|---|
| 2023 | ~$259,000 | ~$180,000 - $200,000 | 15-20% of CF treatments |
| 2025 | ~$250,000 | ~$160,000 - $180,000 | Declining due to Trikafta |
| 2030 | ~$240,000 | ~$130,000 - $150,000 | Phased out of primary use |
(Note: These figures are approximations based on discount trends and market evolution patterns.)
Implications for Stakeholders
-
Pharmaceutical Companies: Continued investment in next-gen CF therapies is crucial, with pricing strategies adapting to market competition.
-
Healthcare Providers: Must balance effective clinical management with cost considerations, especially given reimbursement constraints.
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Payers: Negotiations and formulary positioning will increasingly favor newer, more efficacious treatments with better cost-effectiveness ratios.
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Patients: Access may improve with expanded coverage of newer therapies, but high prices for established drugs pose affordability challenges.
Conclusion
While Lumacaftor/ivacaftor (NDC 60505-2674) remains a vital therapeutic agent for specific CF mutations, the market landscape is shifting rapidly. The emergence of more effective combination therapies like Trikafta signifies a declining role for Orkambi, with future pricing likely to reflect this transition. Stakeholders should monitor ongoing clinical developments, regulatory decisions, and payer strategies to navigate this evolving market effectively.
Key Takeaways
- Market decline expected: Orkambi's market share diminishes as newer therapies prove superior and obtain regulatory approvals.
- Pricing pressures intensify: Payer negotiations and competition are leading to reduced net prices, though list prices remain high.
- Innovation drives change: The CF drug space is dynamic, with genomic targeting and combination therapies shaping future market dynamics.
- Strategic positioning matters: Manufacturers should align pricing and access strategies with evolving clinical and regulatory landscapes.
- Stakeholder vigilance required: Continuous assessment of scientific, regulatory, and reimbursement trends is essential for optimized decision-making.
FAQs
-
What is the main driver behind the declining market share of Lumacaftor/Ivacaftor?
The primary factor is the introduction and growing adoption of Trikafta, which offers broader mutation coverage and superior clinical outcomes, reducing reliance on Lumacaftor/Ivacaftor. -
How are pricing strategies adapting to competition in the CF drug market?
Manufacturers are employing discounts, rebates, and patient assistance programs to retain market presence. There is also increased interest in tiered pricing and value-based agreements to ensure affordability. -
Can biosimilars influence the future pricing of Orkambi?
Biosimilars could potentially lower costs, but as of 2023, regulatory and scientific challenges constrain biosimilar development for CFTR modulators, limiting immediate impact. -
What are the regulatory prospects for Lumacaftor/Ivacaftor in international markets?
Approvals are ongoing or completed in key markets like Europe and Australia, but some regions may delay or deny authorization based on comparative efficacy and cost-effectiveness analyses. -
What should investors consider regarding the long-term profitability of Lumacaftor/Ivacaftor?
Given the competitive pressures, declining sales due to newer therapies, and potential price erosion, investors should weigh the product’s current revenue against future growth prospects driven by market shifts.
References
[1] Vertex Pharmaceuticals. (2022). Orkambi Pricing and Pharmacoeconomic Data.
[Note: All figures and projections are estimates intended for informational purposes and should be corroborated with real-time market data before strategic decisions.]
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