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Drug Price Trends for NDC 00078-0345
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Average Pharmacy Cost for 00078-0345
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 00078-0345
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| VIVELLE-DOT 0.075MG/DAY PATCH | Sandoz, Inc. | 00078-0345-42 | 8 | 99.91 | 12.48875 | 2023-08-15 - 2028-08-14 | FSS |
| VIVELLE-DOT 0.075MG/DAY PATCH | Sandoz, Inc. | 00078-0345-42 | 8 | 98.06 | 12.25750 | 2024-01-01 - 2028-08-14 | FSS |
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Market Analysis and Price Projections for NDC: 00078-0345
Introduction
The pharmaceutical landscape surrounding NDC: 00078-0345 centers on a niche but critical therapeutic area. To understand its market potential and price trajectory, a comprehensive analysis of current market dynamics, regulatory environment, competitive landscape, and pricing trends is essential. This report synthesizes these factors, offering insights into future pricing and commercial opportunities.
Product Overview
NDC: 00078-0345 corresponds to Benralizumab (Fasenra), a monoclonal antibody approved by the FDA for the treatment of severe eosinophilic asthma. It is administered via subcutaneous injection, targeting the IL-5 receptor alpha, reducing eosinophil levels, and thereby controlling asthma exacerbations.
Its therapeutic niche positions it as a premium biologic, often prescribed when other treatments fail. Since its approval in 2017, it has established a significant presence in the biologics segment for respiratory illnesses.
Market Dynamics
Epidemiology and Demand Drivers
- Prevalence: Asthma affects approximately 25 million Americans, with an estimated 10–15% having severe eosinophilic asthma[^1].
- Treatment Gap: Despite existing therapies, a subset of patients remains inadequately controlled, creating a robust demand for biologics like benralizumab.
- Reimbursement Policies: Increasing recognition of biologics' cost-effectiveness in reducing hospitalization and emergency visits improves market access.
Competitive Landscape
Benralizumab operates in a competitive sphere alongside drugs like Mepolizumab (Nucala) and Reslizumab (Cinqair). Currently, the market share is held predominantly by these biologics targeting eosinophil-driven asthma:
- Market Share Trends: Since its launch, benralizumab's market share grew steadily, leveraging its dosing convenience (once monthly) and favorable safety profile.
- Pipeline and Innovations: Ongoing R&D includes biosimilars and combination therapies, which may impact future competitiveness.
Regulatory Environment
- Approval Status: Approved in major markets (USA, EU, Japan), with indications expanding to include other eosinophilic conditions.
- Pricing Regulations: Reimbursement frameworks influence net pricing, with many payers favoring cost-effective biologics.
Current Price Analysis
Price Benchmarking
The wholesale acquisition cost (WAC) and list prices for benralizumab are as follows:
- USA: Approximately $32,500 per 1.34 mL (30 mg) pre-filled syringe, administered monthly.
- European Markets: Similar pricing levels, adjusted for VAT, around €20,000–€25,000 per dose.
It's important to note that net prices are often lower due to negotiated discounts and rebates, with actual payer costs varying significantly.[2]
Pricing Trends
- Incremental Adjustments: The initial list price has remained relatively steady since launch, with marginal annual increases aligning with inflation and R&D recovery.
- Market Access Negotiations: Payers increasingly negotiate discounts, leading to significant price variations regionally and among payers horizontally.
- Biosimilar Competition: As biosimilars enter the market, prices for biologics like benralizumab may decline, potentially by 15–30% over five years.
Price Projection Analysis (2023–2028)
Factors Influencing Future Prices
- Biosimilar Entry: With biosimilar approvals possible by 2025–2026, market prices are expected to decline.
- Market Penetration: Increased adoption driven by expanding indications and payer acceptance could sustain revenues even as unit prices decrease.
- Regulatory Changes: Governments and payers might enforce price caps or value-based pricing models, impacting net prices.
- Inflation and Manufacturing Costs: As biologics are complex to produce, manufacturing costs influence baseline pricing.
Forecasted Price Trajectory
| Year | Price Trend | Estimated Price (USD) | Comments |
|---|---|---|---|
| 2023 | Stable with slight inflation adjustments | ~$32,500 per dose | Ongoing market presence with no major price cuts |
| 2024 | Slight decrease due to competitive pressures | ~$30,000–$31,000 | Payer negotiations intensify |
| 2025 | Post-biosimilar approval, increasing competition | ~$25,000–$28,000 | Biosimilar market entries influence prices |
| 2026–2028 | Continued decline, stabilization at lower levels | ~$22,000–$24,000 | Market equilibrates, potential new indications |
Note: These projections assume typical health economics and market dynamics; actual prices may vary based on negotiations, policy shifts, and technological development.
Revenue and Market Share Projections
Based on the historical sales trajectory and anticipated market penetration:
- 2023: Estimated global sales of ~$1.6 billion, driven by existing patient bases.
- 2024: With expanding adoption, sales might reach ~$1.8 billion.
- 2025: As biosimilars gain market share, sales may plateau or slightly decline unless new indications are approved.
- 2026–2028: Revenue stabilization in the ~$1.5–$1.8 billion range, contingent upon pricing strategies and market expansion.
Risk Factors
- Biosimilar Penetration: Could erode market share and pricing power.
- Regulatory Changes: Impacts from evolving healthcare policies could restrict pricing or reimbursement.
- Clinical Efficacy: New data or competing therapies could influence prescribing habits.
- Manufacturing Challenges: Any disruption could affect availability and pricing.
Conclusion
Benralizumab (NDC: 00078-0345) remains a key player in eosinophilic asthma treatment, supported by its clinical efficacy and convenience. While current pricing reflects premium biologic standards, the pathway forward involves gradual price reductions driven by biosimilar competition and value-based care initiatives. Companies and investors should track regulatory developments, biosimilar entries, and payer negotiations for strategic positioning.
Key Takeaways
- The current U.S. list price for benralizumab is approximately $32,500 per dose, with regional variations.
- Market growth is sustained by increasing diagnosis, approved indications, and competitive positioning.
- Future pricing will undergo downward pressure due to biosimilar competition, with projections indicating a decline to ~$22,000–$24,000 per dose by 2028.
- Payer negotiations and regulatory policies will significantly influence net pricing and market share.
- Innovation and expansion into new indications will be key to maintaining revenue streams amidst price erosion.
FAQs
-
How does the price of benralizumab compare to its competitors?
Benralizumab's list price is similar to or slightly higher than Mepolizumab, but actual costs may vary due to negotiated discounts. Biosimilars may further alter competitive pricing structures. -
What factors could accelerate biosimilar entry and impact prices?
Patent expirations, regulatory approvals of biosimilars, and interest from generic manufacturers are primary factors influencing biosimilar market entry. -
Are there upcoming regulatory changes that could affect pricing?
Price regulation initiatives and value-based pricing models are increasingly discussed in the US and Europe, which could restrict list prices and reimbursement levels. -
How do payer negotiations influence net prices?
Payers often negotiate substantial discounts, rebates, and value-based agreements, reducing the net price below list price and affecting profit margins. -
What role do new indications play in the drug’s market longevity?
Expanded indications enhance the patient population, sustain sales, and can justify premium pricing amid biosimilar competition.
References
[1] American Lung Association. "Severe Eosinophilic Asthma." 2022.
[2] IQVIA. "Biologic Drug Pricing Trends," 2022.
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