Last updated: February 15, 2026
What Is NDC 61958-0401?
NDC 61958-0401 refers to Sotorasib (LUMAKRAS), a KRAS G12C inhibitor approved by the FDA in May 2021. It is indicated for the treatment of metastatic non-small cell lung cancer (NSCLC) with KRAS G12C mutation in patients who have received at least one prior systemic therapy.
Market Landscape
Current Demand and Adoption
- Target Population: Estimated 30,000-35,000 US patients annually with KRAS G12C-mutant NSCLC, based on epidemiological data.[1]
- Market Penetration: As of 2023, approximately 15-20% of NSCLC cases have KRAS G12C mutations. Sotorasib's adoption varies, influenced by treatment guidelines, payer policies, and physician familiarity.
- Clinical Competition: The primary competitor is adagrasib (MRTX849), also targeting KRAS G12C. Several pipeline drugs targeting KRAS pathways are in development, but Sotorasib maintains the earliest market entry.[2]
Regulatory and Reimbursement Status
- FDA Approval: Received accelerated approval with full approval anticipated after confirmatory trials.
- Pricing and Reimbursement: As of 2023, initial wholesale acquisition cost (WAC) set at approximately $17,900 per month (~$214,800 annually).[3] Payer coverage is generally broad but subject to formulary restrictions.
Market Drivers and Challenges
- Drivers: High unmet need in targeted NSCLC, durable response rates in early trials, label expansion possibilities for other KRAS mutations.
- Challenges: Pricing pressures, competition from adagrasib, and the eventual emergence of combination therapies to improve efficacy.
Price Projections
Short-Term (Next 1-2 Years)
- Price Stability: Maintaining current high-price levels due to novelty and limited competition within the knowledge domain.
- Influencing Factors: Payer negotiations, potential discounts, and bundled payment models could lower net price by 10-15%.
Medium-Term (3-5 Years)
- Market Penetration: Assuming increased adoption, with roughly 30-40% of eligible patients receiving Sotorasib.
- Pricing Trends: Slight declines of 5-10% expected as biosimilar or alternative KRAS G12C inhibitors acquire approval or as negotiated discounts increase.
- Budget Impact: With annual costs around $214,800 per patient, total market expenditure could reach $350-450 million annually in the U.S., assuming 2,000-2,500 treated patients.
Long-Term (5+ Years)
- Market Saturation and Biosimilars: Patent exclusivity expires around 2030, potentially introducing biosimilars that reduce prices by 25-50%.[4]
- Label Expansion: Use in additional tumor types or earlier lines could increase demand, offsetting price reductions.
Strategic Considerations
- Pricing Strategy: Maintaining premium pricing in early years supports revenue but may hinder access; phased discounts aligned with market penetration could optimize long-term revenue.
- Market Expansion: Accelerating label extensions or combination therapies enhances market size and justifies higher price points.
- Competition Management: Monitoring adagrasib’s pricing and market move influences price positioning.
Key Takeaways
- NDC 61958-0401, Sotorasib, is a targeted therapy for KRAS G12C-mutant NSCLC.
- Its current price is approximately $17,900/month in the U.S.
- Market projections indicate steady demand growth, with potential for slight pricing declines over the next five years.
- Long-term outlook involves biosimilar entry and possible label extensions impacting price dynamics.
- Competitive pressures and evolving reimbursement policies will influence pricing and market share.
FAQs
Q1: What factors most influence Sotorasib's pricing in the U.S.?
A1: Market demand, competition, payer negotiations, and patent status are primary. High unmet clinical need supports premium pricing.
Q2: How does Sotorasib’s price compare to other targeted cancer therapies?
A2: It is consistent with other targeted oncology drugs, which often range from $10,000 to $30,000 per month.
Q3: What is the outlook for biosimilar entry?
A3: Biosimilars for Sotorasib could enter after patent expiry, potentially reducing prices by up to 50%.
Q4: Will label expansion affect the market value?
A4: Yes, expanding indications can increase demand and justify sustained or increased pricing.
Q5: How might healthcare policy changes impact Sotorasib's market?
A5: Policy shifts toward value-based pricing and negotiated discounts may lower net prices and influence access.
References
[1] American Cancer Society. "Cancer Statistics, 2022."
[2] R. W. Coopey et al., "KRAS Inhibitors," Nat Rev Drug Discov, 2022.
[3] GoodRx. "Sotorasib (LUMAKRAS) Cost," 2023.
[4] IQVIA Institute. "Future of Biosimilars," 2022.
