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Drug Price Trends for NDC 00338-5002
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Average Pharmacy Cost for 00338-5002
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Best Wholesale Price for NDC 00338-5002
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Market Analysis and Price Projections for NDC 00338-5002
Introduction
The drug identified by NDC 00338-5002 is Entyvio (vedolizumab), an FDA-approved biological agent used for treating moderate to severe ulcerative colitis and Crohn’s disease. Its targeted mechanism, safety profile, and clinical efficacy position it prominently within inflammatory bowel disease (IBD) therapeutics. Understanding the market dynamics and pricing trajectories for Entyvio offers vital insights for pharmaceutical stakeholders, healthcare payers, and investors.
Market Overview
Therapeutic Landscape and Competition
Entyvio functions as an integrin receptor antagonist, specifically targeting α4β7 integrin to inhibit gut-specific lymphocyte trafficking. Since its approval in 2014, it has become a core therapy within IBD treatment regimens, competing primarily with biologics such as Humira (adalimumab), Remicade (infliximab), Cimzia (certolizumab pegol), and newer agents like Stelara (ustekinumab).
The IBD market demonstrates sustained growth driven by increased diagnosis rates, unmet needs in refractory patients, and expanding indications [1]. The global IBD therapeutics market was valued at approximately $7 billion in 2021, with projections exceeding $10 billion by 2028, expanding at a CAGR of over 6% [2].
Patient Population Dynamics
An estimated 3 million Americans suffer from IBD, with prevalence rates continuing to ascend globally [3]. Aging populations, improved diagnostics, and a broader acceptance of biologics bolster demand for drugs like Entyvio. Furthermore, the subset of patients refractory to conventional therapies continues to grow, bolstering the drug’s utilization.
Market Penetration and Competitive Differentiation
Entyvio's gut specificity confers a favorable safety profile compared to systemic immunosuppressants, fostering its uptake, especially among patients with contraindications [4]. Nevertheless, the commercialization faces challenges from biosimilars, emerging novel agents (e.g., Janus kinase inhibitors like tofacitinib), and evolving treatment algorithms favoring combination approaches.
Regulatory and Reimbursement Considerations
Current Approvals
Entyvio holds approvals in the US, EU, and several other markets for ulcerative colitis and Crohn’s disease. Its designation as a first-in-class anti-integrin biologic positions it uniquely, although other agents seek similar indications with innovative mechanisms.
Pricing and Reimbursement Landscape
Pricing strategies generally align with other biologics, often reflecting the cost of manufacturing, clinical value, and competitive positioning. The average wholesale price (AWP) for Entyvio has been historically around $3,200–$3,600 per infusion (~300 mg dose), but actual net prices vary due to discounts and rebates [5].
Reimbursement hinges on insurance formulary placement, cost-effectiveness analyses, and regional healthcare policies. Payors increasingly favor biosimilars and value-based agreements, potentially pressuring prices downward over time.
Price Projections and Future Trends
Historical Price Trends
From launch to present, Entyvio’s prices have remained relatively stable, with modest annual increases (~3-5%), aligning with inflation and manufacturing cost trajectories. Price erosion has been mitigated by its clinical differentiation and branded status.
Projected Price Trajectory (2023–2028)
Given the current market momentum, the following projections are plausible:
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Short-term (1–2 years): Slight price stabilization or minor reductions (~1-2%) due to negotiations with payers and increased availability of biosimilars. Despite biosimilar entry—particularly in Europe—brand-name Entyvio may retain a pricing premium to maintain revenue streams.
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Medium-term (3–5 years): Potential marginal price decreases (~5–8%) driven by biosimilar market entries, competitive pressure from emerging therapeutics, and cost-containment policies. However, if clinical outcomes or patient preferences favor Entyvio, its prices may stay relatively resilient.
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Long-term (5+ years): Considerable price reductions could occur if biosimilars achieve widespread adoption or if new therapies demonstrate superior efficacy or safety profiles, prompting formulary shifts.
Influencing Factors
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Biosimilar market entry: European markets have seen biosimilar infliximab and adalimumab adoption, pressuring brand prices. U.S. biosimilar approval remains cautious due to patent litigations, but anticipated approvals could influence pricing strategies [6].
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Innovative therapeutics: New oral agents and precision medicine approaches will shape demand; a shift toward less invasive and more flexible therapeutics could impact Entyvio’s market share and pricing.
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Healthcare policies: Cost containment measures, value-based pricing, and outcomes-based contracts will likely establish downward pressure on biologic prices.
Strategic Implications
Manufacturers may adopt tiered pricing, discounts, or patient assistance programs to sustain market share amid price pressures. Further, real-world evidence demonstrating long-term cost-effectiveness could support favorable reimbursement terms.
Regulatory and Market Opportunities
Recent developments, such as the FDA’s breakthrough therapy designations for novel IBD agents and evolving guidelines, suggest a dynamic landscape. For Entyvio, opportunities exist in expanding indications and optimizing delivery protocols, which could stabilize or enhance pricing in the longer term.
Conclusion
Entyvio (vedolizumab) maintains a robust position within the IBD treatment landscape, characterized by moderate but steady pricing leverage. Although competitive pressures, biosimilar entry, and evolving therapeutic options pose potential price erosion risks, its differentiated safety profile and clinical efficacy sustain value. Strategic adaptations—like demonstrating long-term cost-effectiveness and expanding indications—are pivotal to preserving its market valuation.
Key Takeaways
- The global IBD market’s growth supports continued demand for Entyvio, especially among refractory patients.
- Current pricing averages around $3,200–$3,600 per infusion, with stability expected in short-term projections.
- Biosimilar market entry and new therapeutics are likely to induce modest price reductions over the next 3–5 years.
- Value-based reimbursement models and insurance negotiations will influence net prices, requiring ongoing strategic engagement.
- Expanding indications and demonstrating long-term economic benefits could help sustain premium pricing and market share.
FAQs
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What factors influence the pricing of Entyvio?
Pricing is affected by manufacturing costs, clinical efficacy, safety profile, competitive biosimilars, payer negotiations, healthcare policies, and market demand dynamics. -
How does biosimilar competition impact Entyvio's pricing?
Biosimilars in the European Union have demonstrated a significant price reduction, often 15–30% below the brand. In the U.S., biosimilar entry may exert similar pressure, leading brand manufacturers to adjust pricing or offer discounts. -
Are there opportunities for price increases with Entyvio?
Price hikes are limited by regulatory and payer constraints, but clinical advancements, new formulations, or expanded indications could justify modest increases rooted in added value. -
What is the outlook for Entyvio’s market share amid emerging therapies?
While newer agents and oral therapies pose competition, Entyvio's unique gut-selective mechanism and safety profile support its continued use, particularly in treatment-refractory cases. -
How do healthcare policies influence Entyvio's future pricing?
Policy shifts favoring biosimilars and value-based care are likely to promote price reductions, emphasizing outcomes and cost-effectiveness over list price enhancements.
References
[1] Morais, T., et al. (2021). Epidemiology of inflammatory bowel disease: a global challenge. Gastroenterology Review, 16(3), 228-238.
[2] MarketsandMarkets. (2022). Inflammatory Bowel Disease (IBD) Therapeutics Market.
[3] Loftus, E. V. (2014). Clinical epidemiology of inflammatory bowel disease: Incidence, prevalence, and environmental influences. Gastroenterology, 147(4), 657-674.
[4] Feagan, B. G., et al. (2013). Vedolizumab as induction and maintenance therapy for ulcerative colitis. New England Journal of Medicine, 369(8), 699-710.
[5] IQVIA. (2022). Biologic Pricing Trends.
[6] U.S. Food and Drug Administration. (2022). Biosimilar and interchangeable products.
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