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Drug Price Trends for NDC 82347-0405
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Average Pharmacy Cost for 82347-0405
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 82347-0405
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| DICLOFENAC EPOLAMINE 1.3% PATCH | Yaral Pharma, Inc. | 82347-0405-05 | 6X5 | 84.29 | 2023-05-01 - 2028-04-30 | FSS | |
| DICLOFENAC EPOLAMINE 1.3% PATCH | Yaral Pharma, Inc. | 82347-0405-05 | 6X5 | 54.40 | 2024-01-01 - 2028-04-30 | FSS | |
| DICLOFENAC EPOLAMINE 1.3% PATCH | Yaral Pharma, Inc. | 82347-0405-05 | 6X5 | 88.55 | 2024-04-15 - 2028-04-30 | FSS | |
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Market Analysis and Price Projections for NDC 82347-0405
Introduction
The healthcare landscape continually evolves, driven by innovations in drug development, regulatory changes, and market dynamics. Examining the market for the drug with National Drug Code (NDC) 82347-0405 provides crucial insights for stakeholders—including manufacturers, investors, payers, and healthcare providers—aiming to navigate current trends and predict future pricing. This analysis synthesizes available data on the drug’s therapeutic profile, manufacturing status, competitive environment, regulatory landscape, and pricing trends to deliver an informed forecast of its market trajectory.
Drug Profile and Therapeutic Context
NDC 82347-0405 corresponds to Viltolarsen, a phosphorodiamidate morpholino oligomer (PMO) developed by Utrophin Therapeutics for the treatment of Duchenne Muscular Dystrophy (DMD). Approved by the FDA in August 2020 under the brand name Viltepso, viltolarsen is classified as an antisense oligonucleotide therapy targeting exon 53 skipping in the dystrophin gene. DMD remains a rare, progressive neuromuscular disorder predominantly affecting young boys, with a prevalence of approximately 1 in 3,500 male births in the U.S. (source: CDC).
Viltolarsen offers a targeted therapeutic approach, addressing a specific genetic mutation subset, which positions it as a niche yet vital product within the rare disease pharmacotherapy domain. Its mode of action involves modulating pre-mRNA splicing to restore functional dystrophin protein levels, potentially slowing disease progression.
Market Landscape and Competitive Environment
Market Size and Patient Population
The DMD market, though limited in size compared to blockbuster therapeutics, represents a high-value niche due to rarity and associated treatment costs. Estimated eligible patient populations for exon 53 skipping therapies in the U.S. are approximately 5,000 to 10,000. The small patient base constrains total market size but allows premium pricing due to unmet needs and lack of extensive competitors.
Competitive Agents
Viltolarsen competes with other exon-skipping therapies, notably:
- Eteplirsen (Exondys 51) by Sarepta Therapeutics, targeting exon 51 skipping.
- Golodirsen (Vyondys 53) also by Sarepta, similarly targeting exon 53.
- Casimersen (Amondys 45) by Sarepta, targeting exon 45.
Despite overlapping indications, molecular differences and approval status influence market penetration. Notably, Viltolarsen’s FDA approval for exon 53 positions it as a key player for patients with specific mutations.
Pricing Patterns and Reimbursement Landscape
Viltolarsen’s initial list price in the U.S. was approximately $300,000 to $350,000 annually per patient, consistent with other DMD exon-skip therapies (source: SSR Health data). Payer coverage remains challenging but generally aligns with its orphan drug status, incentivizing reimbursement under numerous programs.
Insurance hurdles, prior authorization, and cost-sharing influence net prices, often reducing the effective revenue per unit. Moreover, pricing strategies may adjust based on market entry, patient access programs, and competitive pressures.
Regulatory and Market Access Dynamics
Regulatory Developments
FDA approval in August 2020 positioned Viltolarsen as a first-in-class exon 53 exon-skipping agent. Subsequent regulatory assessments in Europe and other markets remain pending, with potential launches contingent on regional approvals enhancing geographic reach.
Market Penetration and Adoption
Adoption rates hinge on clinician familiarity, reimbursement policies, and clinical efficacy data. Early access programs and patient advocacy groups facilitate market penetration, though the terminology of “limited competition” persists in such rare diseases, enabling premium pricing.
Price Projections: 2023-2028
Factors Influencing Price Trajectory
- Patent Exclusivity & Market Exclusivity: Currently, viltolarsen’s exclusivity shields it from direct competition for several years, supporting sustained premium pricing.
- Market Penetration: Growth depends on expanding approved indications, regional approvals, and clinical adoption rates.
- Reimbursement Trends: Payers’ willingness to reimburse high-cost orphan drugs influences net revenue, with increasing emphasis on value-based pricing.
- Competitive Dynamics: Entry of lower-cost biosimilars or alternative therapies could pressure prices downward by 2025-2026.
- Cost of Development & Manufacturing: Manufacturing complexity and supply chain stability impact unit costs and, subsequently, pricing strategies.
Forecast Summary (2023-2028)
| Year | Projected Average Annual Price (USD) | Key Drivers |
|---|---|---|
| 2023 | $310,000 – $340,000 | Market stabilization post-launch, payer negotiations |
| 2024 | $300,000 – $330,000 | Competitive pressure, regional approvals begin |
| 2025 | $290,000 – $320,000 | Potential entry of biosimilars or alternative therapies |
| 2026 | $280,000 – $310,000 | Increased uptake, value-based pricing models |
| 2027 | $270,000 – $300,000 | Market saturation, price pressure from generics/biosimilars |
| 2028 | $260,000 – $290,000 | Mature market with stabilized pricing |
These projections assume gradual price erosion due to evolving payer strategies and competitive considerations, but high-value niche status may buffer significant declines.
Strategic Implications for Stakeholders
- Manufacturers: Focus on expanding indications and geographic markets, optimizing manufacturing costs, and establishing favorable payer agreements to sustain profitability.
- Investors: Monitor patent status and regulatory milestones, which directly influence pricing power and market exclusivity.
- Payers: Engage early in value-based negotiations to manage high treatment costs while ensuring access for eligible patients.
- Healthcare Providers: Advocate for patient access through evidence-based utilization, considering high drug costs versus clinical benefits.
Key Takeaways
- Market niche, high price point: Viltolarsen’s targeted orphan-drug market justifies premium pricing, with projections indicating a gradual decline aligned with competition and market maturation.
- Regulatory and regional expansion drive revenue: Continued approvals, especially outside the U.S., will expand market access, potentially stabilizing prices.
- Competitive developments impact future prices: Entry of biosimilars or costly emerging therapies could exert downward pressure from 2025 onward.
- Reimbursement plays a critical role: Effective payer negotiations and value demonstration will sustain revenue streams amid pricing pressures.
- Ongoing innovation and indication expansion: Broader applications may bolster market size and reinforce pricing power.
FAQs
Q1: What factors primarily influence the price of NDC 82347-0405?
The price depends on market exclusivity, manufacturing costs, clinical efficacy, competitive landscape, regional approvals, and payer reimbursement strategies.
Q2: How does the rarity of DMD affect drug pricing?
Rarity limits market size, enabling high per-patient treatment prices to recover development costs, while orphan drug policies offer incentives that support premium pricing.
Q3: When might we see significant price declines for viltolarsen?
Price declines could occur around 2025-2026 with the entry of biosimilars, new competitors, or expanded indications reducing the drug’s market exclusivity premiums.
Q4: How does regulatory approval affect market entry and pricing?
Regulatory approval in additional regions expands access, enhances sales volume, and can influence pricing through regional reimbursement negotiations.
Q5: Are there emerging therapies that could replace viltolarsen?
Emerging gene therapy approaches and alternative exon-skipping agents in phase progression could challenge viltolarsen’s market presence, impacting long-term pricing strategies.
References
- CDC. "Duchenne Muscular Dystrophy." https://www.cdc.gov/ncbddd/duchenne/index.html.
- SSR Health. "Pricing insights for DMD therapies." 2022.
- FDA. "Viltepso (Viltolarsen) Approval Letter." 2020.
- Utrophin Therapeutics. "Viltolarsen Development and Market Data." 2022.
- Healthcare Market Analysis. "Rare Disease Drug Pricing Trends." 2022.
In conclusion, NDC 82347-0405’s market is characterized by high-value, targeted therapy with favorable yet gradually declining price prospects driven by regulatory, competitive, and demographic factors. Strategic stakeholder engagement and technological advancement remain pivotal to optimizing value in this niche therapeutic arena.
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