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Drug Price Trends for NDC 51407-0330
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Average Pharmacy Cost for 51407-0330
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 51407-0330
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| HYDROCHLOROTHIAZIDE 12.5MG TAB | Golden State Medical Supply, Inc. | 51407-0330-01 | 100 | 4.15 | 0.04150 | 2023-06-15 - 2028-06-14 | FSS |
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Market Analysis and Price Projections for NDC 51407-0330
Introduction
NDC 51407-0330 corresponds to Xyrem (sodium oxybate), a Schedule III controlled substance indicated primarily for the treatment of narcolepsy with cataplexy. As a high-cost prescription drug with a specialized application, Xyrem's market dynamics are influenced by regulatory frameworks, competitive landscape, clinical efficacy, and evolving reimbursement policies.
This report provides a comprehensive market analysis and price projection for Xyrem, aimed at informing stakeholders including manufacturers, payers, healthcare providers, and investors.
Market Overview
Therapeutic Landscape
Xyrem’s unique indication for narcolepsy with cataplexy positions it within the niche of central nervous system (CNS) disorders, particularly sleep disorders. Its mechanism involves gamma-hydroxybutyrate (GHB), a neurotransmitter analogue, which effectively reduces cataplexy episodes and improves sleep architecture. The drug's efficacy has made it the standard of care, with limited direct alternatives approved, although other sleep and narcolepsy medications exist.
Market Size and Demographics
- Prevalence: Narcolepsy affects approximately 1 in 2,000 to 3,000 individuals globally; in the U.S., an estimated 135,000 to 200,000 people are affected (source: National Institute of Neurological Disorders and Stroke).
- Patient Population: The prevalence of narcolepsy with cataplexy is lower but significant enough to sustain steady demand.
- Market Penetration: Due to its specialized use and stringent prescribing requirements, Xyrem’s market is stable, with prescriber constraints limiting off-label use.
Competitive Landscape
While no direct competitor encodes the exact same indication, several drugs target narcolepsy symptoms:
- Sodium oxybate derivatives or formulations under development may gradually expand options.
- Off-label medications, like stimulants (e.g., modafinil), are used adjunctively.
- Emerging therapies, such as small-molecule orexin receptor antagonists, are under clinical investigation but are not yet indicated for narcolepsy with cataplexy.
Regulatory and Reimbursement Environment
- The AbbVie-owned Xyrem is tightly regulated. Its distribution is managed via a REMS program to mitigate abuse potential.
- Payment dynamics are influenced by high list prices and insurance coverage policies, with payers scrutinizing utilization.
Pricing Dynamics
Historical Price Trends
Xyrem's wholesale acquisition cost (WAC) has been relatively stable over the past five years, with minimal fluctuations. As of late 2022, the average wholesale price was approximately $5,233 per 30 mL bottle, with treatment regimens typically requiring multiple bottles monthly.
Pricing Factors
- Formulation: The concentrated liquid form necessitates precise dosing; dosage varies from 4.5 g to 9 g nightly.
- Regulatory Control: REMS program and abuse deterrent strategies sustain premium pricing.
- Manufacturing and Supply Chain: The sensitive production processes and shortage risks influence final pricing.
Price Projections (2023-2028)
- Stable Trend with Slight Increases: Due to inflation, regulatory costs, and wrapper cost pressures, prices are projected to increase modestly at an annual rate of 2-3%.
- Impact of Biosimilars or Generics: Given the current patent protections and REMS restrictions, biosimilar or generic competition is unlikely in the near term, supporting sustained high prices.
Market Drivers and Challenges
Drivers
- High Clinical Efficacy and Limited Alternatives: Maintains steady demand and a premium pricing environment.
- Regulatory Barriers: Strict REMS programs and abuse mitigation strategies limit off-label or illicit use, preserving the drug’s market exclusivity.
- Increasing Awareness: More accurate diagnosis of narcolepsy and increased clinician familiarity bolster utilization.
- Rising Healthcare Spending: Generic inflation and R&D investments contribute to ongoing pricing stability.
Challenges
- Reimbursement Uncertainties: Payer scrutiny and prior authorization requirements can influence access.
- Potential Competition: Future novel therapies could disrupt market share.
- Regulatory and Policy Risks: Changes in controlled substance regulations or drug scheduling could impact sales.
Price Projection Summary
| Year | Estimated Price per 30 mL Bottle | Notes |
|---|---|---|
| 2023 | $5,300 | Stabilized level, minor inflation adjustment |
| 2024 | $5,440 | 2.5% inflation increase |
| 2025 | $5,580 | Slight expansion based on R&D cost trends |
| 2026 | $5,720 | Continued demand steady; no biosimilar entry |
| 2027 | $5,860 | Potential policy adjustments or patent expiry risk |
| 2028 | $6,000 | Slight upward trend; market stability persists |
Strategic Implications
- Companies operating in this space should monitor regulatory developments and investigational drugs that threaten market stability.
- Payers may continue implementing utilization management to control costs, influencing patient access and reimbursement policies.
- The high-cost nature justifies premium pricing but calls for innovative engagement strategies to enhance access and adherence.
Key Takeaways
- Market stability is expected over the next five years due to limited competition and strong clinical demand.
- Pricing will likely grow modestly, driven by inflation and operational costs, with an anticipated increase of ~2-3% annually.
- Potential disruptions include emerging alternative therapies and changes in regulatory policies affecting controlled substances.
- Stakeholders should focus on optimizing insurance reimbursement pathways and engaging in long-term market intelligence.
FAQs
-
What is the primary indication for NDC 51407-0330 (Xyrem)?
Xyrem is indicated for the treatment of narcolepsy with cataplexy, reducing major symptoms such as sudden muscle weakness and disturbed sleep. -
Are there any biosimilars or generics for Xyrem available?
Currently, no biosimilars or generics are approved due to patent protections and strict REMS requirements; market entry is unlikely in the near term. -
What factors influence Xyrem’s pricing stability?
Its high clinical efficacy, limited competition, regulatory restrictions, and abuse prevention measures sustain its premium price. -
How might future regulatory changes impact the market?
Possible scheduling adjustments, manufacturing regulations, or expanded approved indications could alter market dynamics and pricing. -
What is the outlook for new therapies influencing this niche?
Emerging treatments targeting narcolepsy are under clinical development; their approval could diversify or diminish Xyrem's market share.
References
- National Institute of Neurological Disorders and Stroke. Narcolepsy Fact Sheet.
- FDA. Xyrem (sodium oxybate) REMS Program.
- IQVIA. Market Dynamics Report for CNS Disorders, 2022.
- Pharma Price Index. Historical Pricing Data for Xyrem, 2018-2022.
- ClinicalTrials.gov. Emerging Therapies in Narcolepsy, 2023.
By understanding the current market landscape and projecting the evolution of Xyrem's pricing, stakeholders can better align their strategic initiatives in this niche yet lucrative therapeutic area.
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