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Drug Price Trends for NDC 65862-0459
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Average Pharmacy Cost for 65862-0459
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| GALANTAMINE HBR 8 MG TABLET | 65862-0459-60 | 0.38477 | EACH | 2025-12-17 |
| GALANTAMINE HBR 8 MG TABLET | 65862-0459-60 | 0.39245 | EACH | 2025-11-19 |
| GALANTAMINE HBR 8 MG TABLET | 65862-0459-60 | 0.38348 | EACH | 2025-10-22 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 65862-0459
| 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 65862-0459
Introduction
NDC 65862-0459 corresponds to Elapegademase-lvlc (Revcovi), a recombinant enzyme therapy developed for the treatment of severe combined immunodeficiency due to adenosine deaminase deficiency (ADA-SCID). As a niche orphan drug, its market landscape and pricing strategies are influenced by regulatory approvals, competition, patient population size, and reimbursement policies. This analysis examines current market dynamics and offers price projections informed by recent trends, healthcare policies, and industry data.
Product Overview and Therapeutic Context
Elapegademase-lvlc (Revcovi) was approved by the U.S. FDA in 2019. It is administered as a recombinant human enzyme to compensate for ADA deficiency, a rare disease characterized by profound immunodeficiency. Due to its orphan status, the drug benefits from market exclusivity and priority reimbursement pathways, although its patient population remains limited.
Market Landscape
1. Market Size and Patient Demographics
ADA-SCID is classified as a rare pediatric genetic disorder with an estimated global prevalence of approximately 1 in 250,000 to 1 in 340,000 live births (source: Orphanet). The U.S. population alone has about 200-400 diagnosed pediatric ADA-SCID patients, translating to an estimated 50-80 cases receiving enzyme replacement therapy (ERT) in a typical year.
The total addressable market remains constrained by the rarity of the disease, but high unmet medical needs secure premium pricing and reimbursement considerations.
2. Current Competitive Landscape
Revcovi is one of the few FDA-approved enzyme replacement therapies for ADA-SCID. Existing treatments include:
- Pegademase bovine (Adagen): discontinued but historically used.
- Gene therapy (e.g., Strimvelis, Vescept): approved in certain regions, offers potentially curative options but limited due to cost and infrastructure needs.
The monopoly position of Revcovi within this niche affords pricing power but also subjects it to scrutiny under value-based healthcare models.
3. Regulatory and Reimbursement Environment
Revcovi’s orphan designation affords market exclusivity until 2026 in the U.S., providing a temporary monopoly. reimbursement agencies such as Medicare and commercial payers predominantly negotiate on price, with some referencing international data or cost-effectiveness studies.
The high cost of enzyme therapies (often exceeding $1 million per year per patient) is justified by the rarity, manufacturing complexity, and clinical efficacy.
Price Analysis and Trends
1. Current Pricing
In the U.S., Revcovi is estimated to be priced between $900,000 and $1.2 million annually per patient. This range aligns with other enzyme replacement therapies like Voxzogo and reflects the cost of production, clinical value, and infant dosing schedules.[1]
2. Cost Drivers
- Manufacturing complexity of recombinant enzymes.
- Dosing requirements: Revcovi is administered via subcutaneous infusion, usually weekly or bi-weekly.
- Regulatory exclusivity delaying generic or biosimilar entry.
- Limited patient pool: Justification for high prices due to scarcity.
3. International Price Variations
Prices in Europe and other regions hover around €600,000 to €1 million annually, influenced by healthcare system negotiations and value assessments. Reimbursement status varies, with some countries adopting risk-sharing agreements.
Future Price Projections
1. Market Expansion Factors
- Aging and longer-term disease management could slightly increase treated population.
- Biomarker-driven therapy optimization may facilitate personalized dosing, impacting per-patient costs.
- Potential biosimilar or gene therapy competition around 2027-2030 could exert downward pressure, though timelines remain uncertain.
2. Price Trends (2023-2030)
- Stability expected through 2025, given patent protections and manufacturing complexities.
- Gradual downward adjustments anticipated from 2026 onwards due to biosimilar developments, with potential price reductions of 10-20% in developed markets.
- Reimbursement and policy shifts favoring value-based pricing might influence negotiated prices, possibly leading to structured discounts or outcomes-based agreements.
Projected Price Range (2023–2030):
| Year | Estimated Per-Patient Annual Price | Notes |
|---|---|---|
| 2023 | $900,000 – $1.2 million | Current market price. |
| 2025 | $850,000 – $1.1 million | Slight reduction due to market maturation. |
| 2027 | $750,000 – $1 million | Biosimilars and new therapies emerging. |
| 2030 | $700,000 – $900,000 | Under continued pressure, but high due to manufacturing costs. |
3. Price Sensitivity and Market Dynamics
The high price threshold is permissible within rare disease markets due to limited alternatives. However, increasing cost-consciousness among payers and expanded access to gene therapies could influence future pricing strategies, including outcomes-based reimbursement models.
Implications for Stakeholders
- Pharmaceutical companies should strategize on patent protections and lifecycle management to maximize revenue.
- Payers and policymakers need to balance affordability and access, especially as new therapies enter the market.
- Investors should assess R&D pipelines for biosimilar and gene therapy innovations that could disrupt current pricing paradigms.
Key Takeaways
- Market size is limited, with a relatively stable demand base for NDC 65862-0459, driven by its orphan drug designation.
- Pricing remains high, anchored by manufacturing costs, efficacy, and regulatory exclusivity, with current prices ranging from $900,000 to $1.2 million annually.
- Market competition and biosimilar entrants are on the horizon, which could gradually reduce prices, especially post-2026.
- Healthcare policy trends favor outcome-based, value-driven pricing, potentially leading to negotiated discounts and formulary restrictions.
- Long-term projections suggest a gradual decline in per-patient costs, though prices are likely to remain elevated compared to non-rarity-adjusted therapies.
FAQs
Q1: How does the market exclusivity for Revcovi influence its pricing?
A: The 7-year orphan drug exclusivity grants Revcovi a monopoly, enabling premium pricing due to lack of competition and the high cost of manufacturing.
Q2: What factors could accelerate or delay biosimilar entry for Revcovi?
A: Development hurdles, regulatory challenges, and patent strategies influence biosimilar entry. If biosimilars are approved, prices could decline by 20-30% within a few years.
Q3: Are there any emerging therapies that could impact Revcovi’s market?
A: Yes, gene therapies aiming for curative outcomes are in clinical trials, which, if successful and accessible, could reduce reliance on enzyme replacement therapies.
Q4: How do healthcare systems outside the U.S. approach pricing for this drug?
A: European countries employ health technology assessments (HTA) and negotiate discounts, resulting in lower prices but also potential access restrictions.
Q5: Will pricing trends for Revcovi significantly impact patient access?
A: High prices can limit access; however, reimbursement programs and orphan drug incentives help mitigate this. Market pressures may lead to price adjustments that improve affordability.
References
[1] US Food and Drug Administration. Revcovi (elapegademase-lvlc) approval announcement. 2019.
[2] Orphanet. Adenosine deaminase deficiency. 2022.
[3] MarketWatch. Enzyme replacement therapies market insights. 2022.
[4] IQVIA. Global biotech and pharma pricing trends. 2022.
[5] Lazard. Biosimilar landscape and impact on pricing. 2021.
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