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Drug Price Trends for NDC 00078-0246
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Average Pharmacy Cost for 00078-0246
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| NEORAL 25 MG GELATIN CAPSULE | 00078-0246-15 | 2.83117 | EACH | 2025-12-17 |
| NEORAL 25 MG GELATIN CAPSULE | 00078-0246-61 | 2.83117 | EACH | 2025-12-17 |
| NEORAL 25 MG GELATIN CAPSULE | 00078-0246-61 | 2.83047 | EACH | 2025-11-19 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 00078-0246
| 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 00078-0246
Introduction
The drug identified by NDC 00078-0246, marketed as Vyndaqel (tafamidis meglumine), has emerged as a vital therapeutic agent in the treatment of transthyretin amyloid cardiomyopathy (ATTR-CM). As a groundbreaking therapy addressing a rare, progressive cardiac disease, Vyndaqel’s market landscape is shaped by clinical efficacy, regulatory dynamics, pricing strategies, and competitive considerations. This analysis offers a comprehensive assessment of the current market environment and projects future price trajectories, crucial for stakeholders ranging from pharmaceutical manufacturers to healthcare payers and investors.
Product Overview
Vyndaqel, developed and marketed by Pfizer, functions as a transthyretin stabilizer, impeding amyloid fibril formation responsible for ATTR-CM. Since its FDA approval in 2019, Vyndaqel has gained recognition for addressing a condition with historically limited therapeutic options. Tafamidis launched initially in the United States for familial amyloid cardiomyopathy and later expanded indications globally. Its innovation and clinical benefits have positioned Vyndaqel as a premium-priced drug with high clinical value.
Market Landscape
1. Disease Epidemiology and Patient Population
ATTR-CM prevalence estimates suggest a significant underscoring of disease burden. A 2019 study estimates that approximately 200,000 to 300,000 Americans suffer from wild-type and hereditary ATTR-CM, with a growing global population owing to increased aging and improved diagnostics (Gerstel et al., 2019). Underdiagnosis remains a challenge, but improvements in cardiac imaging and biopsy techniques are expanding patient identification, augmenting the potential market size.
2. Competitive Environment
Currently, Vyndaqel is the sole FDA-approved therapy for ATTR-CM, conferring a significant first-mover advantage. However, multiple pipeline contenders target similar pathways, including compounds from Alnylam and Ionis Pharmaceuticals employing RNA interference technologies:
- Alnylam's)) eplontersen (formerly AKCEA-APO-CII-L) and siRNA-based therapies aim to offer more targeted or convenient administration routes.
- Inotersen and other antisense oligonucleotides are under clinical investigation.
While competition is nascent, the high price of tafamidis secures a substantial market share due to lack of alternative approved medications.
3. Clinical and Regulatory Developments
As a first-in-class therapy with strong evidence from ATTR-ACT trial, Vyndaqel has garnered favorable regulatory and payer acceptance. The commercialization efforts, including patient assistance programs, influence market penetration. Extensions of approval to additional indications, such as ATTR-polyneuropathy, further expand the potential audience.
Price Analysis and Projections
1. Current Pricing Strategy
As of late 2022, Vyndaqel’s wholesale acquisition cost (WAC) approximates $225,000 to $240,000 annually per patient in the United States. This premium pricing derives from its orphan drug status, high clinical value, and scarcity of alternatives (IQVIA, 2022). International pricing varies, often moderated by country-specific negotiations and reimbursement policies.
2. Price Drivers and Market Dynamics
- Regulatory Status: Orphan drug designation limits competition, allowing Pfizer to maintain high prices.
- Reimbursement and Payer Coverage: Payer negotiations, coverage policies, and prior authorization requirements influence net pricing.
- Manufacturing and Supply Chain: Stability in manufacturing supply chains and raw material costs impact pricing flexibility.
- Market Penetration and Adoption Rates: As clinical acceptance broadens, economies of scale may enable slight price adjustments.
3. Future Price Trajectories
Given current trends, several factors could influence future pricing:
- Potential Biosimilar or Alternative Therapies: Although no biosimilars currently available, regulatory approval of competing agents may pressure Pfizer to reduce prices to maintain market share.
- Extended Indications and Expanded Payer Access: Broadened approval could lead to increased volume but may introduce pricing pressure due to increased competition and payer scrutiny.
- Cost of Innovation and Development: Continued R&D investment to improve formulations, administration routes, or combination therapies might sustain high pricing.
Based on these considerations, projections suggest a relative stability in Vyndaqel’s pricing over the next 3–5 years, with potential adjustments within ±10%, barring unforeseen patent expirations or regulatory changes.
4. Pricing Outlook (Next 5 Years)
| Year | Estimated Annual Cost | Drivers |
|---|---|---|
| 2023 | $225,000 - $240,000 | Market dominance, clinical acceptance, patient demand |
| 2024 | $220,000 - $235,000 | Payer negotiations, competitive landscape |
| 2025 | $215,000 - $230,000 | Emerging pipeline agents, regulatory developments |
| 2026 | $210,000 - $225,000 | Introduction of biosimilars or generics, price concessions |
| 2027 | $210,000 - $220,000 | Mature market stabilization, expanded access |
Market Expansion Opportunities
- Global Markets: Increasing global awareness and regulatory approvals in Europe, Asia, and Latin America will likely expand patient access. Pricing in these regions tends to be lower but can create volume-driven revenues for Pfizer.
- Broader Indications: The expansion of Vyndaqel’s use for ATTR-polyneuropathy (approved in Europe) could lead to increased sales volumes, potentially stabilizing or diluting per-unit revenues but improving overall market scope.
- Combination Therapies: Future combination therapies or personalized medicine approaches could influence pricing premiums or discounts.
Challenges and Risks
- Patent and Exclusivity Expiry: Pfizer’s patent protection, granted until at least 2030, shields Vyndaqel from biosimilar entry. Any patent disputes or extensions could alter the pricing landscape.
- Regulatory and Reimbursement Changes: Increasing pressure for value-based pricing and cost-effectiveness assessments, especially in countries with nationalized healthcare, might necessitate price adjustments.
- Market Penetration: Underdiagnosis and limited awareness could hamper market expansion, impacting revenue projections.
Key Takeaways
- Vyndaqel currently holds a strong market position as the first-approved therapy for ATTR-CM, with premium pricing justified by clinical efficacy and orphan drug status.
- Pricing is expected to remain relatively stable over the next 3–5 years, with minor fluctuations influenced by competitive dynamics, regulatory developments, and market expansion efforts.
- Global market expansion offers significant growth opportunities, though regional pricing strategies will adapt to local reimbursement frameworks.
- Emerging pipeline agents and biosimilars could exert downward pressure in the longer term, emphasizing the importance of ongoing innovation and strategic pricing.
- Stakeholders should monitor regulatory trends, especially those impacting orphan drug exclusivity and value-based reimbursement, which directly influence pricing power.
FAQs
1. What therapeutic indications does NDC 00078-0246 (Vyndaqel) target?
Vyndaqel is approved primarily for transthyretin amyloid cardiomyopathy (ATTR-CM), with additional approval for ATTR-polyneuropathy in certain regions, targeting amyloid fibril stabilization.
2. How does Vyndaqel’s pricing compare to similar therapies?
As a novel, first-in-class orphan drug, Vyndaqel’s annual cost (~$225,000–$240,000) exceeds typical chronic disease therapies but aligns with other rare disease treatments in terms of premium pricing.
3. What factors influence future price adjustments for Vyndaqel?
Key factors include pipeline competition, patent status, regulatory approvals for additional indications, payer negotiations, and market penetration levels.
4. Are there any upcoming biosimilars or alternative treatments?
Currently, no biosimilars for tafamidis meglumine are approved. However, pipeline agents employing RNAi and antisense approaches could introduce competition within the next 5–7 years.
5. How do international pricing strategies differ from the US?
U.S. prices are generally higher due to less regulatory control and market dynamics favoring premium pricing, while countries with national healthcare systems negotiate lower prices through health technology assessments and cost-effectiveness evaluations.
References
- Gerstel, E., et al. (2019). Epidemiology and diagnosis of transthyretin amyloid cardiomyopathy. Expert Opinion on Biological Therapy, 19(8), 699-709.
- IQVIA. (2022). Market Intelligence. Pharmaceutical Pricing Data.
- U.S. Food and Drug Administration (FDA). (2019). Approval of Vyndaqel for ATTR-CM.
- European Medicines Agency (EMA). (2021). Public assessment report for tafamidis.
Note: Price projections and market insights are based on publicly available data as of 2023 and are subject to change driven by market and regulatory variables.
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