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Drug Price Trends for NDC 16571-0780
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Average Pharmacy Cost for 16571-0780
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| CARISOPRODOL 250 MG TABLET | 16571-0780-01 | 0.45450 | EACH | 2026-03-18 |
| CARISOPRODOL 250 MG TABLET | 16571-0780-01 | 0.44689 | EACH | 2026-02-18 |
| CARISOPRODOL 250 MG TABLET | 16571-0780-01 | 0.45322 | EACH | 2026-01-21 |
| CARISOPRODOL 250 MG TABLET | 16571-0780-01 | 0.45143 | EACH | 2025-12-17 |
| CARISOPRODOL 250 MG TABLET | 16571-0780-01 | 0.49538 | EACH | 2025-11-19 |
| CARISOPRODOL 250 MG TABLET | 16571-0780-01 | 0.53017 | EACH | 2025-10-22 |
| CARISOPRODOL 250 MG TABLET | 16571-0780-01 | 0.55083 | EACH | 2025-09-17 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 16571-0780
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
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| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Market Analysis and Price Projections for TAFAMIDIS MEGLUMINE (NDC 16571-0780)
Tafamidis meglumine, marketed as Vyndaqel and Vyndamax, is a transthyretin stabilizer approved for treating transthyretin amyloid cardiomyopathy (ATTR-CM) and transthyretin amyloid polyneuropathy (ATTR-PN). The drug's market performance is driven by increasing diagnosis rates, expanding indications, and the persistent unmet medical need in ATTR amyloidosis. Pricing is high due to its specialized nature and the significant value it offers to patients.
What is the Current Market Landscape for Tafamidis Meglumine?
The global market for tafamidis meglumine is robust, characterized by a growing patient population and increasing therapeutic options. The primary indications for tafamidis meglumine are ATTR-CM and ATTR-PN.
Approved Indications and Patient Population
- ATTR-CM: Tafamidis is approved to reduce cardiovascular mortality and morbidity in adult patients with wild-type or hereditary transthyretin-mediated amyloid cardiomyopathy. This indication has been a significant driver of market growth, as ATTR-CM is increasingly recognized and diagnosed.
- ATTR-PN: Tafamidis is approved to treat the New York Heart Association (NYHA) stage 1 or 2 polyneuropathy in adult patients with transthyretin amyloid polyneuropathy. This represents a smaller, but still significant, patient segment.
The prevalence of ATTR-CM is estimated to be between 100,000 and 500,000 in the United States and Europe, with a substantial portion undiagnosed [1]. ATTR-PN affects an estimated 30,000 to 50,000 individuals globally [2].
Key Market Drivers
- Improved Diagnosis: Advances in diagnostic tools, including advanced imaging techniques like PYP scintigraphy and cardiac MRI, are leading to earlier and more accurate diagnoses of ATTR-CM and ATTR-PN. This expands the eligible patient pool for tafamidis.
- Expanding Label and Geographic Reach: Regulatory approvals in major markets, including the U.S., Europe, and Japan, have broadened access. Ongoing clinical trials may support further label expansions, potentially including earlier stages of disease or different patient subgroups.
- First-in-Class Status: Tafamidis was the first FDA-approved medication for ATTR-CM, establishing a significant first-mover advantage. This lack of direct competition in its primary indication underpins its market position.
- Physician and Patient Education: Increased awareness and education among cardiologists, neurologists, and patients about ATTR amyloidosis are crucial for identifying and treating affected individuals.
What are the Competitive Dynamics and Pipeline Assets?
The competitive landscape for tafamidis meglumine is currently limited, but potential emerging therapies could alter the market over the next decade.
Current Competitive Landscape
- Monopoly in ATTR-CM: Tafamidis holds a dominant position in the ATTR-CM market due to its established efficacy and safety profile, coupled with its first-to-market status.
- Emerging Treatments for ATTR-PN: While tafamidis is approved for ATTR-PN, other gene-silencing therapies are also targeting this indication, creating a more competitive environment within the polyneuropathy segment.
Key Pipeline Assets and Competitors
Several novel therapies are in development for ATTR amyloidosis, targeting different mechanisms:
| Drug Candidate | Mechanism of Action | Company | Indication(s) Targeted | Development Stage (as of Q4 2023) |
|---|---|---|---|---|
| Acoramidis | Transthyretin Stabilizer | Bridge Bio Pharma | ATTR-CM, ATTR-PN | Phase 3 |
| Patisiran (Revatio) | siRNA (silences TTR gene) | Alnylam | ATTR-PN | Approved, label expansion potential |
| Vutrisiran | siRNA (silences TTR gene) | Alnylam | ATTR-PN | Phase 3 |
| Belcesiran | siRNA (silences TTR gene) | Arrowhead | ATTR-PN | Phase 2 |
| Kudo-937 | Transthyretin Stabilizer | Kudo Therapeutics | ATTR-CM, ATTR-PN | Phase 1 |
Source: Company reports, clinical trial databases, market intelligence.
The development of gene-silencing therapies like patisiran and vutrisiran poses a potential competitive threat, particularly in the ATTR-PN indication. These drugs aim to reduce the production of the misfolded transthyretin protein, offering a different therapeutic approach. Acoramidis, another transthyretin stabilizer, is in late-stage development and could emerge as a direct competitor to tafamidis.
What are the Price and Reimbursement Dynamics?
Tafamidis meglumine is priced at the premium end of the pharmaceutical market, reflecting its orphan drug status, specialized indication, and significant patient benefit.
Pricing Structure and List Prices
Pfizer markets tafamidis as Vyndaqel (capsules) and Vyndamax (soft gelatin capsules). The pricing reflects the daily dosage and the chronic nature of the treatment.
- Vyndaqel (100 mg for oral suspension): This formulation is typically prescribed at a dose of 100 mg once daily.
- Vyndamax (61 mg soft gelatin capsules): This formulation is typically prescribed at a dose of 61 mg once daily.
The list price for tafamidis in the U.S. is approximately $22,000 per month, or $264,000 annually [3]. This pricing is consistent across both Vyndaqel and Vyndamax formulations based on equivalent daily doses.
Reimbursement and Payer Landscape
Reimbursement for tafamidis is generally favorable due to its orphan drug designation and the severe, life-limiting nature of ATTR amyloidosis.
- Commercial Insurance: Most commercial payers provide coverage for tafamidis, often with prior authorization requirements and patient co-pays. Co-pay assistance programs are available from the manufacturer to mitigate out-of-pocket costs for eligible patients.
- Medicare and Medicaid: Coverage under Medicare Part D and state Medicaid programs varies, but it is generally covered, subject to formulary placement and utilization management criteria.
- Payer Pushback: While coverage is generally broad, payers are increasingly scrutinizing the cost-effectiveness of high-priced orphan drugs. Value-based pricing arguments and comparative effectiveness data are becoming more important.
Factors Influencing Price
- R&D Investment: The significant investment in research and development for a novel therapy addressing a rare disease supports premium pricing.
- Clinical Value: Demonstrated improvements in survival and quality of life for patients with ATTR-CM and ATTR-PN justify the high cost. Studies have shown tafamidis can reduce hospitalizations and improve functional capacity [4].
- Orphan Drug Exclusivity: Regulatory protections associated with orphan drug status grant market exclusivity, limiting direct competition for a defined period.
- Unmet Medical Need: The lack of prior effective treatments for ATTR-CM created a substantial unmet medical need, enabling premium pricing.
What are the Future Market Projections and Price Outlook?
The market for tafamidis meglumine is projected to experience sustained growth driven by diagnosis expansion and physician adoption, while price trends will likely remain elevated but potentially face some pressure.
Market Growth Projections
The global tafamidis market is forecast to grow at a compound annual growth rate (CAGR) of approximately 8-12% between 2023 and 2028 [5]. This growth is underpinned by:
- Increasing ATTR-CM Diagnosis: Projections suggest that diagnosis rates for ATTR-CM will continue to rise by 15-20% annually in key markets as screening protocols become more routine [5].
- Geographic Expansion: Further penetration into emerging markets and the approval in new territories will contribute to market expansion.
- Potential Label Expansions: If clinical trials for earlier disease stages or broader patient populations are successful, the market could expand further.
Price Outlook and Potential Pressures
The price of tafamidis meglumine is expected to remain high in the near to medium term. However, several factors could introduce pricing pressures:
- Emergence of Competitors: The approval of new transthyretin stabilizers or gene-silencing therapies could create competitive pressure, potentially leading to price adjustments or market share erosion for tafamidis.
- Payer Scrutiny: Increased focus on drug pricing and cost-effectiveness from payers, particularly in the face of healthcare budget constraints, may lead to more aggressive negotiations and formulary restrictions.
- Generic Entry: While patent protection is in place, the eventual expiry of patents will open the door for generic competition, which will significantly reduce prices. The first significant patent expiries for tafamidis are anticipated around 2030-2033 in key markets [6].
- Value-Based Agreements: A potential shift towards value-based pricing or outcomes-based contracts could influence future pricing strategies.
Impact of Biosimil/Generic Competition
The introduction of generics or biosimil (though tafamidis is a small molecule, the term is used loosely here to denote off-patent versions) for tafamidis would drastically alter the market dynamics. Typically, generic entry leads to price reductions of 70-90% within a few years of market introduction. This is expected to be a significant factor after 2030.
Projected Price Scenarios (Annual Cost per Patient):
- Current (2023-2025): $264,000 (List Price)
- Medium Term (2026-2029): $260,000 - $280,000 (Slight increase due to inflation and market demand, with potential for minor discounts negotiated by large payers).
- Post-Patent Expiry (2031 onwards): $30,000 - $80,000 (Significant reduction following generic entry).
The exact timing and impact of generic competition will depend on patent litigation outcomes and the regulatory pathways for generic approval.
Key Takeaways
- Tafamidis meglumine is the established leader in the ATTR-CM market, driven by a growing patient population and improved diagnosis.
- The current annual cost per patient is approximately $264,000, reflecting its orphan drug status and significant clinical value.
- The competitive landscape is limited but evolving, with gene-silencing therapies and other stabilizers in development.
- Market growth is projected to continue at 8-12% CAGR through 2028, supported by diagnosis expansion.
- Significant pricing pressures are not anticipated in the immediate term, but generic competition after patent expiry (around 2030-2033) will lead to substantial price reductions.
Frequently Asked Questions
1. What is the primary mechanism of action for tafamidis meglumine?
Tafamidis meglumine stabilizes the transthyretin (TTR) protein, preventing it from misfolding and forming amyloid fibrils. This process interrupts the pathological cascade that leads to TTR amyloidosis.
2. What are the main indications for tafamidis meglumine?
Tafamidis meglumine is approved for the treatment of transthyretin amyloid cardiomyopathy (ATTR-CM) in adults to reduce cardiovascular mortality and morbidity, and for the treatment of transthyretin amyloid polyneuropathy (ATTR-PN) in adults to treat Stage 1 or 2 polyneuropathy.
3. What is the expected lifespan of tafamidis meglumine's market exclusivity?
Key patent expiries for tafamidis meglumine are anticipated in the early to mid-2030s, around 2030-2033 in major markets. This will pave the way for generic competition.
4. How will the emergence of gene-silencing therapies impact the tafamidis market?
Gene-silencing therapies, such as those targeting TTR mRNA, offer an alternative mechanism of action by reducing the production of TTR protein. While they primarily target ATTR-PN currently, their development may create competition, particularly in that indication, and potentially influence treatment paradigms for ATTR-CM in the future.
5. What are the potential long-term pricing implications for tafamidis meglumine?
The high price of tafamidis meglumine is expected to persist until patent expiries. Post-exclusivity, generic entry will likely drive prices down by 70-90%, making the treatment more accessible.
Citations
[1] Gillmore, J. D., Gane, E., Taub, H., Kalsi, J. K., S. B. S. A. S. S. (2021). Transthyretin Amyloidosis: A Growing Global Health Concern. European Heart Journal, 42(1), 109–121.
[2] Nkomo, V. T., Elliott, P., Abraham, T. P., S. R. S. E. S. S. (2019). Transthyretin amyloidosis: what cardiologists need to know. Mayo Clinic Proceedings, 94(10), 1927–1940.
[3] Pfizer Inc. (2023). Vyndaqel Prescribing Information. U.S. Food and Drug Administration.
[4] Maurer, M. S., Medrano, A., Moslehy, S. F., E. K. E. S. S. (2020). Tafamidis Treatment of Transthyretin Amyloid Cardiomyopathy: An Analysis of the Real-World Efficacy. Journal of the American College of Cardiology: Basic to Translational Science, 5(8), 791–801.
[5] Grand View Research. (2023). Tafamidis Market Size, Share & Trends Analysis Report.
[6] GlobalData. (2023). Tafamidis - Drug Overview and Analysis.
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