Last updated: February 13, 2026
Overview
NDC 68094-0867 refers to a specific prescription drug product, which, based on current data, is identified as Amgen's Lumakras (sotorasib). Lumakras is a first-in-class targeted therapy approved in May 2021 for treating non-small cell lung cancer (NSCLC) with KRAS G12C mutation. As the landscape for KRAS inhibitors evolves, monitoring market dynamics and pricing trends is crucial.
Market Landscape
- Therapeutic Area: Oncology, specifically KRAS G12C-mutated NSCLC.
- Approval Date: May 28, 2021 (FDA).
- Manufacturers: Amgen holds rights; hopeful competition from other pipeline agents.
- Approved Indication: Locally advanced or metastatic NSCLC with KRAS G12C mutation.
- Market Penetration (2023): The drug entered a competitive scene dominated by immunotherapies, with an emerging niche.
Market Potential
| Aspect |
Data |
| Estimated U.S. NSCLC KRAS G12C patients (2023) |
~30,000-35,000 cases (per NCCN guidelines and epidemiological data [1]) |
| Market Penetration (2023) |
Estimated 15-20% of KRAS G12C patients receive Lumakras (due to clinical adoption, resistance, and awareness) |
| Annual Treatment Cost (2023) |
$17,490 per month (per labeled dosing and wholesale acquisition cost) [2] |
Key Competitive Factors
- Therapies: Immunotherapies (Keytruda, Opdivo), chemotherapy.
- Emerging Agents: Sotorasib competitors like Gilead's GDC-6036, Mirati's adagrasib.
- Diagnostic Tests: KRAS mutation testing is vital; cost influenced by testing availability and reimbursement policies.
Pricing Analysis
- List Price: Approximately $17,490 per month; annual list price ~$209,880.
- Pricing Comparison: Similar targeted therapies (e.g., Gilead's adagrasib) range from $15,000 to $20,000 per month.
- Reimbursement Landscape: Payer coverage expanded post-approval, encouraging access but with utilization constraints due to the mutation-specific indication.
Price Trends and Projections
| Year |
Estimated Average Monthly Price |
Notes |
| 2023 |
$17,490 |
List price; notable for stability due to patent protection |
| 2024 |
$17,490 |
Expected to remain stable with minimal discounts |
| 2025 |
$17,000 - $18,000 |
Slight downward pressure from payer negotiations and market competition |
| 2026 |
$16,500 - $17,500 |
As more competitors enter and biosimilar considerations arise |
Factors Affecting Price Trajectory:
- Patent and Exclusivity: Patent expiry not expected before 2035.
- Competitive Dynamics: Arrival of competitors may pressure list prices downward.
- Market Access and Reimbursement: Increased payer negotiations could result in discounts.
- Pipeline Development: New agents targeting KRAS G12C could influence price adjustments.
Distribution and Uptake
- Market Access: Early adoption by major oncology centers; partnerships with payers facilitate widespread coverage.
- Off-Label Use: Limited; driven by clinical guidelines and mutation testing.
Implications for Stakeholders
- Pharmaceutical Companies: Continued investment in clinical trials expanding indications could stabilize or increase prices.
- Investors: Stability in list price suggests predictable revenue streams with potential for growth if market penetration expands.
- Payers: Increased negotiations for discounts amid emerging competition.
Summary
Lumakras (NDC 68094-0867) remains a high-cost targeted therapy with a stable price base, supported by patent protection and initial market penetration. Price projections indicate limited declines in the near term, barring unforeseen market entrants or reimbursement policy shifts.
Key Takeaways
- Lumakras’s current annual list price exceeds $200,000.
- Market penetration is limited but growing among eligible NSCLC patients.
- Competitive landscape shaping future pricing, with potential slight discounts anticipated by 2026.
- Market factors such as diagnostic testing access and pipeline developments influence price stability and growth.
- Stakeholders should monitor payer negotiations and pipeline progress for strategic planning.
FAQs
1. How does Lumakras compare to other targeted therapies in oncology?
It is among the higher-cost therapies, comparable to drugs like Kymriah or Yescarta in maintenance costs but lower than some biologics.
2. What factors influence the price of NDC 68094-0867?
Patent status, competitive pressure, clinical demand, payer negotiations, and manufacturing costs.
3. Are there discounts available for Lumakras?
Most discounts are negotiated between manufacturers and payers; list price remains a benchmark.
4. How does diagnostic testing impact pricing and market access?
Widespread access to mutation testing increases eligible patient pool, supporting sales volume but may restrict access if testing costs are high.
5. What is the outlook for pipeline agents competing with Lumakras?
Pipeline agents could lower prices or provide alternatives, potentially impacting Lumakras's market dominance and pricing.
Citations
[1] NCCN Clinical Practice Guidelines in Oncology, Non-small Cell Lung Cancer, 2023.
[2] Amgen’s pricing disclosures, 2023.
