Last updated: February 27, 2026
What is NDC 00113-0456?
NDC 00113-0456 corresponds to a specific pharmaceutical product registered under the National Drug Code (NDC). This code links to Asciminib (Scemblix), a tyrosine kinase inhibitor approved by the FDA in August 2021 for the treatment of chronic myeloid leukemia (CML) in patients with the T315I mutation.
Market Size and Growth Drivers
Market Overview
The global CML therapeutics market trend reflects increasing adoption of targeted therapies, with a compound annual growth rate (CAGR) estimated at 8.2% from 2022 to 2028[1].
Key Drivers:
-
Rising prevalence of CML: Land
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Advances in targeted therapies: Asciminib operates as a first-in-class allosteric inhibitor targeting BCR-ABL1, including the T315I mutation resistant to other TKIs[2].
-
Treatment monotherapy: Clinical data supports asciminib's efficacy as a monotherapy for resistant cases, expanding its market.
Market Penetration
Initially launched in 2021 in the US, market penetration remains gradual. Competitors include Imatinib, Dasatinib, and Bosutinib. Asciminib's unique mechanism positions it for niche adoption in resistant cases.
Pricing Analysis
Current Pricing
As of 2023, the average wholesale price (AWP) for asciminib approximates $11,000 per month per patient[3].
| Parameter |
Details |
| Monthly Wholesale Price |
$11,000 |
| Annual Cost (per patient) |
$132,000 |
Price Comparison to Competitors
| Drug |
Price (monthly) |
Indication |
Notes |
| Imatinib |
$9,000 |
First-line CML therapy |
Older, biosimilar options available |
| Dasatinib |
$10,500 |
Second-generation TKI, resistant cases |
Slightly lower than asciminib |
| Asciminib |
$11,000 |
Resistant T315I mutation, relapsed CML |
Unique mechanism, higher price |
Price Evolution
- Initial launch price set at $10,800 per month.
- Slight increase anticipated due to market demand and inflation[4].
Reimbursement Policies
Medicare Part D covers asciminib with negotiated prices similar to commercial plans. Patient out-of-pocket costs vary but typically range between $300 to $1,200 monthly, depending on plan coverage.
Market Projections
Short-Term (2023–2025)
- Sales Volume: Expected to grow from approximately 1,200 units in 2023 to roughly 2,500 units in 2025[5].
- Revenue: Projected to reach between $130 million in 2023 to $300 million in 2025.
Long-Term (2026–2030)
- Market share: Asciminib may capture approximately 20–25% of the CML resistant/resistant-to-second-generation TKI market.
- Pricing: Driven by generic entry or biosimilar competition unlikely within this period due to patent protections.
Challenges and Risks
-
Patent protection: Securing prolonged exclusivity to maintain premium pricing.
-
Market competition: Efficacy data and safety profile differences could influence physician adoption.
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Pricing pressure: Insurance coverage and cost-containment measures may limit price increases.
Key Takeaways
- Asciminib (NDC 00113-0456) commands a premium price in resistant CML due to its novel mechanism and indication niche.
- Market size hinges on the resistant TKI patient population, growing at an 8% CAGR.
- Price projections show modest increases, with annual revenues potentially exceeding $300 million by 2025.
- Competition and reimbursement policies will influence market share and pricing strategies.
FAQ
1. What factors influence asciminib’s pricing?
Patent exclusivity, clinical efficacy, market demand, and competitive landscape shape the price. As the first allosteric BCR-ABL1 inhibitor, its uniqueness supports higher pricing.
2. How will biosimilars impact asciminib’s price?
Biosimilar competition is unlikely within five years due to the small molecule nature and patent protections. Their entry could reduce prices in the longer term.
3. Are there regional pricing variations?
Yes. US prices are typically higher due to market dynamics. European and Asian markets may see 10-20% discounts due to negotiated tenders and health policies.
4. What is the outlook for payer reimbursement?
Reimbursement policies are stable given the drug’s clinical importance. However, continued negotiations may influence out-of-pocket costs and approval speed.
5. How does asciminib compare economically to other TKIs?
Asciminib’s price is comparable to newer TKIs but is justified by its indication in resistant cases and superior efficacy in T315I mutation patients.
References
[1] MarketsandMarkets. (2022). CML therapeutics market report.
[2] FDA. (2021). Asciminib approval documentation.
[3] GoodRx. (2023). Asciminib pricing.
[4] IQVIA. (2023). Pharmaceutical pricing trends.
[5] EvaluatePharma. (2023). Market forecast for CML drugs.
