Last updated: February 27, 2026
What Is the Drug Identified by NDC 62559-0510?
NDC 62559-0510 corresponds to Retevmo (selpercatinib), developed by Eli Lilly. It is a selective RET kinase inhibitor approved by the FDA in May 2020. Retevmo targets RET gene mutations associated with medullary thyroid carcinoma, non-small cell lung cancer, and certain metastatic thyroid cancers.
Market Overview
Global and U.S. Market Size
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The RET fusion-positive cancer segment is estimated to grow substantially from an initial base. The prevalence of RET alterations varies:
- Medullary thyroid carcinoma (MTC): Approx. 2,000 cases annually in the U.S.
- RET fusion-positive NSCLC: Approx. 1-2% of non-small cell lung cancers, representing about 14,000 cases annually in the U.S.
- Other RET-positive cancers: Less than 1,000 cases annually in the U.S.
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The overall target patient population in the U.S. is approximately 16,000 individuals yearly.
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The global market for selective RET inhibitors, including Retevmo, is projected to surpass $1 billion by 2025, driven by increasing diagnostic testing and wider adoption of precision oncology.
Competition Landscape
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Currently, Retevmo holds a dominant position with a first-in-class designation.
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Pralsetinib (G5药)， developed by Blueprint Medicines, received FDA approval in September 2020 as a competitor.
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Emerging therapies include LOXO-292 (Loxo-305) by Eli Lilly, which is in late-stage development.
Market Penetration
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Retevmo's early adoption is facilitated by rapid diagnostic test integration and expanded approvals, including tissue and liquid biopsies.
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As of 2023, approximately 15-20% of eligible patients in the U.S. receive targeted testing and treatment with Retevmo.
Price Projection Analysis
Current Pricing and Reimbursement Landscape
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The average wholesale price (AWP) for Retevmo is approximately $16,843 per 30-day supply.
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Insurance reimbursement varies by payer, with commercial insurers reimbursing near AWP, and Medicaid pricing is negotiated lower.
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Its high cost limits access in some regions, but cost-effectiveness studies justify coverage due to improved progression-free survival.
Price Trends and Forecasts (2023-2028)
| Year |
Estimated Price per 30-day Supply |
Data Source / Assumptions |
| 2023 |
$16,843 |
Current market price |
| 2024 |
$16,843 |
No significant price change expected without new competition or formulation changes |
| 2025 |
$16,843 |
Forecast based on inflation, no new competitors |
| 2026 |
$18,000 |
Slight increase driven by supply chain inflation and expanded indications |
| 2027 |
$19,000 |
Potential price hikes linked to expanded use and market demand |
| 2028 |
$20,000 |
Possible price increase with increased competition and value-based pricing |
Key Factors Influencing Price Dynamics
- Market penetration: Greater adoption in clinical settings could stabilize prices.
- Generic or biosimilar entry: Unlikely within the forecast period, given patent protections.
- Healthcare policy changes: Shifts in drug pricing regulations could influence pricing.
- Expanded indications: Approval for additional tumor types could increase demand.
Regulatory and Policy Landscape
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Retevmo received Orphan Drug Designation, with extensions via breakthrough therapy and priority review.
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The HIPAA and the 21st Century Cures Act favor expanded diagnostic access, potentially increasing eligible patient pools.
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International markets face pricing challenges due to patent protections and healthcare cost-control initiatives.
Investment and R&D Outlook
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Eli Lilly continues R&D efforts exploring combination therapies involving Retevmo.
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Pipeline expansion efforts include novel indications like RET-positive gliomas, which could influence future pricing and market size.
Risk Factors
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Competition from other RET inhibitors could pressure pricing.
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Reimbursement policies evolving toward value-based models may impact profitability.
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Diagnostic costs and testing adoption rates directly affect eligible patient numbers and revenue.
Summary
Retevmo is a high-cost, targeted therapy for RET fusion-positive cancers, with a current price of approximately $16,843 per month. The market is expected to grow steadily, reaching around $20,000 per month in the next five years, driven by expanding indications and increased diagnostic testing. Competition remains limited but is emerging, which could alter pricing dynamics. Price increases will likely be moderate unless significant new competitors or policy changes occur.
Key Takeaways
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The U.S. market for Retevmo is approximately 16,000 eligible patients annually.
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Current pricing is around $16,843 per month, with modest increases forecasted through 2028.
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Market growth depends on diagnostic adoption, competing therapies, and regulatory policies.
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International pricing varies with regional healthcare policies and market access strategies.
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Long-term profitability hinges on maintaining a first-in-class position amid emerging competitors.
FAQs
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What is the primary indication for Retevmo?
It treats RET fusion-positive medullary thyroid carcinoma, non-small cell lung cancer, and thyroid cancers.
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How does Retevmo's price compare with similar targeted therapies?
Its monthly cost exceeds many targeted cancer drugs, reflecting its precision and efficacy.
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Are there generic options for Retevmo?
No; patent protection and exclusivity rights currently prevent generic entry.
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What factors could affect future pricing?
Market competition, healthcare policies, and demand expansion.
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Is Retevmo reimbursed widely in the U.S.?
Yes; insurance coverage is generally comprehensive due to its FDA approval and clinical relevance.
References
[1] U.S. Food and Drug Administration. (2020). FDA approves first targeted therapy for RET fusion-positive non-small cell lung cancer. https://www.fda.gov/news-events/press-announcements/fda-approves-first-targeted-therapy-ret-fusion-positive-non-small-cell-lung-cancer
[2] MarketWatch. (2022). RET inhibitors market size and forecasts. https://www.marketwatch.com
[3] IQVIA. (2022). U.S. pharmaceutical pricing and reimbursement data.
[4] Eli Lilly. (2023). Retevmo prescribing information.
[5] GlobalData. (2022). Oncology market analysis: RET inhibitors.
