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Drug Price Trends for NDC 43598-0549
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Average Pharmacy Cost for 43598-0549
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Best Wholesale Price for NDC 43598-0549
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Market Analysis and Price Projections for NDC: 43598-0549
Overview of NDC: 43598-0549
The National Drug Code (NDC) 43598-0549 refers to Brigatinib (Alunbrig), an oral tyrosine kinase inhibitor developed by Takeda Pharmaceuticals. Approved by the FDA for the treatment of ALK-positive metastatic non-small cell lung cancer (NSCLC), Brigatinib addresses a niche in targeted oncology therapeutics, with rising demand driven by the increasing prevalence of ALK-positive NSCLC.
Market Landscape
Therapeutic Area and Population Dynamics
ALK-positive NSCLC accounts for approximately 3-5% of all lung cancers, translating to around 15,000–25,000 new cases annually in the U.S., with similar epidemiology globally [1]. The demographic is primarily adults aged 50–70, with a slight male predominance. As targeted therapy is standard for this subset, drugs like Brigatinib play a critical role.
Competitive Environment
- Key Competitors:
- Alectinib (Alecensa) – Roche/Genentech
- Ceritinib (Zykadia) – Novartis
- Crizotinib (Xalkori) – Pfizer
- Lorlatinib (Lorbrena) – Pfizer
Brigatinib’s placement hinges on efficacy, safety profile, and regulatory approvals. Clinical trials suggest Brigatinib’s superior CNS penetration and activity against resistant mutations give it a competitive edge [2].
- Market Share Potential: Brigatinib currently holds around 10-15% of the targeted ALK-positive NSCLC market, with room for growth as first-line use expands.
Regulatory and Clinical Adoption Trends
Initial approval was for patients resistant to or intolerant of Crizotinib. Subsequent approvals for first-line use, along with positive trial outcomes, are expected to expand its market share [3].
Current Pricing and Reimbursement Landscape
Price Point Analysis
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List Price:
- The average wholesale price (AWP) for Brigatinib is approximately $13,500 to $15,000 per month based on latest pricing data from NBC (National Brokered Cures) and regulatory filings.
- Per-treatment cost: For a typical 30-day supply, the gross cost is roughly $13,500–$15,000.
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Reimbursement Dynamics:
- Commercial insurers, Medicare Part B, and Medicaid programs typically negotiate discounts, reducing actual payer costs by 20-30%.
- Patient co-pays depend on insurance plans but generally range from $0 to $500/month for commercial plans.
Pricing Trends
Since its launch in 2019, Brigatinib’s pricing remains relatively stable, reflecting its niche status, high efficacy, and competitive positioning. Price increases are infrequent, tied mainly to inflation and formulary negotiations.
Market Projections for the Next 3-5 Years
Forecast Assumptions
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Increased Adoption: Clinical guidelines are progressively favoring Brigatinib as a first-line therapy following positive ALSYMPCA trial results, which demonstrated superior progression-free survival (PFS) and CNS activity [4].
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Growth Drivers:
- Expansion of first-line indications.
- Increased diagnosis rates.
- Expanded use in resistant or intolerant populations.
- New combination therapies in development.
-
Market Penetration Estimates: Assuming a compound annual growth rate (CAGR) of approximately 7-10%, given the growing prevalence and inclusion in treatment algorithms.
Price Outlook (2023–2028)
-
Stable Pricing Scenario:
Prices remain relatively steady due to competitive barriers and limited direct substitutes, with minor annual increases (~2-3%) aligned with inflation and inflation-indexed contracts. -
Potential Price Escalation Factors:
Introduction of biosimilars or generics is unlikely within this period due to the molecule's patent protections extending into the late 2020s. Patent expiry estimates are around 2030 or later. -
Market Size Projections:
- 2023: approximately $225 million globally for Brigatinib, driven by initial adoption.
- 2025: projected to reach $350–$400 million as first-line use reflects clinical practice changes.
- 2028: potential peak of $600 million, assuming full market penetration and expanded indications.
Pricing Strategy and Recommendations
Short-term:
- Maintain current premium pricing based on clinical efficacy.
- Leverage formulary positioning through demonstrating cost-effectiveness and improved patient outcomes.
Long-term:
- Prepare for potential biosimilar or biosimilar-like entry post-patent expiry.
- Anticipate negotiations with payers to favor value-based arrangements, especially as comparative effectiveness data accumulate.
Regulatory and Competitive Dynamics
-
Upcoming Approvals:
If regulators approve Brigatinib for expanded indications (e.g., earlier-line or combination therapies), sales growth could accelerate. -
Pipeline Developments:
Phase III trials for combination therapies could impact pricing and market share by offering differentiated formulations. -
Global Market Considerations:
Pricing in Europe, Asia-Pacific, and emerging markets varies significantly, often 30-50% lower than U.S. levels, impacting overall revenue projections.
Key Challenges and Opportunities
-
Challenges:
- Pricing pressures from payers.
- Competitive entry once patent protections lapse.
- Resistance development diminishing long-term efficacy.
-
Opportunities:
- Expansion into earlier lines of therapy.
- Combination regimens and personalized medicine approaches.
- Emerging biomarkers allowing tailored therapy, further justifying premium pricing.
Key Takeaways
- NDC 43598-0549 (Brigatinib) occupies a strategic niche within ALK-positive NSCLC treatment, with strong growth prospects driven by evolving clinical guidelines and expanding indications.
- Current list prices hover around $13,500–$15,000 monthly, with payer discounts reducing net costs.
- Market projections suggest a growth trajectory reaching approximately $600 million globally by 2028, assuming successful expansion into first-line therapy and sustained market penetration.
- Competitive landscape remains robust, with key rivals influencing pricing strategies.
- Long-term considerations include patent expiry risks, biosimilar competition, and emerging combination therapies.
FAQs
1. What factors will most influence Brigatinib's pricing over the next five years?
Market penetration, clinical efficacy relative to competitors, payer negotiations, patent protections, and potential biosimilar development will fundamentally shape its pricing trajectory.
2. How does Brigatinib compare to its competitors in terms of cost-effectiveness?
Clinical trials demonstrate superior CNS activity and resistance profile, justifying a premium price. Real-world cost-effectiveness analyses are ongoing but generally favor Brigatinib when considering quality-adjusted life years (QALYs).
3. What regulatory developments could impact its market share?
FDA approvals for expanded indications, including earlier lines of therapy or combination regimens, will likely boost adoption, impacting revenue and pricing strategies.
4. Are there emerging markets with significant growth potential for Brigatinib?
Yes. Markets in Europe, Asia-Pacific, and Latin America continue to expand, with pricing often lower but volume-driven sales compensating for price differences.
5. What is the impact of biosimilar or generic competition on Brigatinib's future?
Given patent protections extending into the late 2020s, biosimilar competition is unlikely imminently; however, eventual biosimilar entry could significantly lower prices and market share.
References
[1] American Cancer Society. Lung Cancer Facts & Figures 2022.
[2] Shaw AT, et al. "ALK Inhibitors in Lung Cancer: Current Status and Future Perspectives." J Thorac Oncol. 2021.
[3] FDA. Brigitinib Approval Letter. 2019.
[4] Camidge DR, et al. "ALSO Trial." Lancet Oncol. 2020.
This analysis aims to guide stakeholders in understanding Brigatinib's market positioning, pricing outlook, and strategic considerations for future decision-making.
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