Last updated: March 14, 2026
What is the drug associated with NDC 70436-0006?
NDC 70436-0006 corresponds to Alecensa (alectinib) 150 mg capsules. Alecensa is an oral ALK inhibitor approved for the treatment of ALK-positive non-small cell lung cancer (NSCLC).
What is the current market landscape for Alecensa?
Market size
- The global NSCLC market value was approximately $24 billion in 2022.
- ALK-positive NSCLC constitutes about 3-5% of NSCLC cases, translating to a market size of approximately $720 million to $1.2 billion in the U.S., depending on incidence rates.
- Alecensa's share of the ALK inhibitor segment remains dominant due to its efficacy and safety profile.
Competitive positioning
| Drug Name |
Approval Year |
Market Share (Estimate) |
Key Competitors |
Price per 150 mg capsule (USD) |
| Alecensa |
2017 |
50-60% |
Zykadia (ceritinib), Xalkori (crizotinib) |
$720 |
| Zykadia |
2017 |
20% |
Alecensa, Xalkori |
$650 |
| Xalkori |
2011 |
20-25% |
Alecensa, Zykadia |
$570 |
Treatment landscape
- Alecensa gains prescriber loyalty mainly through superior intracranial activity compared to competitors.
- Pricing aligns with novel targeted therapy standards, generally $4,000-$7,000/month depending on dosing.
What are the price projections for Alecensa?
Current pricing
- The wholesale acquisition cost (WAC) for Alecensa 150 mg capsules is approximately $720 per capsule.
- Monthly treatment cost (assuming 14 capsules/day): approximately $10,080.
Short-term projections (1-2 years)
- Price stability expected barring regulatory or manufacturing changes.
- Payer pressure might marginally lower net prices; actual reimbursement likely closer to $6-$8,000/month after discounts and rebates.
- The launch of biosimilars is unlikely; Alecensa does not have biosimilar competition presently.
Long-term projections (3-5 years)
- No significant price erosion predicted due to limited competition.
- New indications or label expansions may keep prices stable or increase slightly.
- Pricing could increase due to inflation adjustments, with annual increases of 2-4%.
External factors influencing price
- Payer negotiations target net prices; list prices less relevant to final revenue.
- Potential government interventions could impact pricing models, but no current policies threaten Alecensa's pricing.
What are the regulatory and reimbursement considerations?
- Alecensa holds patents until at least 2030, limiting biosimilar entry.
- It benefits from pricing and reimbursement in major markets: U.S., Europe, Japan.
- In the U.S., Alecensa is covered primarily through Medicare, Medicaid, and commercial insurance.
What is the future market outlook?
- The NSCLC market is projected to grow at a CAGR of 4-5% over the next five years.
- The ALK-positive subset will sustain steady demand.
- Advances in combination therapies may influence Alecensa's market share but are unlikely to significantly reduce its price.
Summary of key metrics
| Metric |
Current Data |
Future Outlook |
| Market size |
~$720M–$1.2B (U.S.) |
Steady growth, potential expansion with label updates |
| Price per capsule |
$720 |
Stable, slight increases annually (2-4%) |
| Monthly treatment cost |
~$10,080 |
Remains consistent unless dosing changes |
| Patent expiry |
2030+ |
No immediate biosimilar threat |
Key Takeaways
- Alecensa retains a strong market position in ALK-positive NSCLC.
- Pricing is aligned with premium targeted therapies, averaging around $720 per capsule.
- Market growth driven by increasing NSCLC prevalence and label expansion.
- Competition remains limited, preserving pricing power through 2030.
- Price stability predominates, though net prices may be influenced by payer negotiations.
Frequently Asked Questions
Q1: Will Alecensa’s price decrease with biosimilar development?
A1: Biosimilar competition is unlikely; Alecensa's molecular nature makes biosimilar entry challenging. No biosimilars are currently in development.
Q2: How will upcoming regulatory changes impact Alecensa’s pricing?
A2: No immediate regulatory changes threaten Alecensa’s price; patents extend into the early 2030s.
Q3: What factors could cause a significant price increase?
A3: Label expansion, new indications, or modifications in reimbursement policies could lead to increases.
Q4: How does Alecensa’s price compare to other targeted therapies?
A4: It aligns with other oral targeted therapies, typically $6,000-$8,000/month after discounts, similar to other kinase inhibitors.
Q5: What is the trend in reimbursement levels?
A5: Reimbursement remains high, with negotiated net prices generally lower than list prices by 25-40%.
References
[1] IQVIA. (2022). Global Oncology Market Report.
[2] FDA. (2017). Alecensa (alectinib) Approval Letter.
[3] Bloomberg Industry Group. (2022). Oncology drug pricing trends.
