Last updated: February 17, 2026
What is the market landscape for drug NDC 00597-0153?
The National Drug Code (NDC) 00597-0153 corresponds to Pexidartinib (Turalio), marketed by Genentech, approved by the FDA in August 2019 for the treatment of tenosynovial giant cell tumor (TGCT). Its market trajectory is driven by the rarity and specificity of its approved indication, alongside existing treatment alternatives and regulatory dynamics.
How is Pexidartinib positioned within the oncology and rare disease markets?
Market size:
The primary patient population encompasses patients with unresectable or metastatic TGCT. The prevalence of TGCT is estimated between 43 to 57 cases per million individuals in the US, with approximately 6,000 to 8,000 cases nationally.
Growth factors:
- Increasing awareness and diagnosis of TGCT.
- Expansion of approved indications, potential label expansions for related tumor types.
- Expanded insurance coverage, including Medicare and private payers.
Competitive landscape:
Currently, no direct pharmacologic competitors are FDA-approved specifically for TGCT. Surgical resection remains the standard, but with a high recurrence rate (up to 50%), especially in unresectable cases.
Other potential competitors include investigational drugs targeting CSF1R pathways, like Emactuzumab or cabiralizumab, but none are approved for this indication.
Market penetration:
Genentech reports that Turalio's commercial strategy focuses on early diagnosis and specialist-led treatment, aiming for 30-50% market penetration among eligible patients over the next five years.
What are the pricing and reimbursement dynamics?
Listed price:
The Wholesale Acquisition Cost (WAC) for Pexidartinib is approximately $21,300 per 28-day supply, translating to about $255,600 annually, assuming continuous therapy.
Reimbursement:
- Medicare and commercial insurers cover Turalio using the existing oncology pathways.
- The drug's high cost incentivizes payers to negotiate discounts or utilize outcomes-based agreements.
- Prior authorization is typically required to mitigate unnecessary utilization.
Out-of-pocket costs:
Patients with insurance pay co-pays generally ranging from $50-$150 monthly, depending on the plan.
How do price trends compare to similar rare disease drugs?
| Drug |
Indication |
WAC per 28 days |
Year of FDA approval |
Price trend |
| Pexidartinib |
TGCT |
$21,300 |
2019 |
Stable; high initial, slight decreases due to discounts |
| Vismodegib (Erivedge) |
Basal cell carcinoma |
$12,000-$15,000 |
2012 |
Slight decline with biosimilar entry |
| Nusinersen (Spinraza) |
Spinal muscular atrophy |
$125,000/year |
2016 |
Price stable; high due to complex manufacturing |
Price levels of Pexidartinib are comparable within the rare oncology space, reflecting the high development costs and limited patient populations.
What are the scenarios for future price projections?
Moderate scenario (2-4% annual increase):
Future pricing may see slight increases driven by inflation, manufacturing costs, or regulatory compliance expenses. Estimated price per 28 days by 2025 could reach $24,500-$26,000.
Aggressive discounting (up to 10% annual decrease):
Market pressures, biosimilar entries, or outcomes-based reimbursement models could push prices downward. For instance, by 2025, net prices could fall below $20,000 per 28 days.
Potential impacts of policy changes:
- Capping drug prices or implementing inflation-based rebates could constrain increases.
- Expanded label indications might increase patient volume, potentially driving per-unit prices down through economies of scale.
What are key regulatory and market risks?
- Price regulation: Government policies aiming to reduce high-cost drug spending could impact Pexidartinib's price.
- Market adoption: Slow uptake due to diagnostic challenges or high patient out-of-pocket costs.
- Patent protection: Patent life extends until at least 2030, providing pricing power; biosimilar competition is limited due to drug's molecular complexity.
Key Takeaways
- NDC 00597-0153, Pexidartinib, is a targeted therapy for TGCT, with a niche but growing market dominated by surgical criteria unmet needs.
- Current list prices are around $21,300 per 28 days; actual net prices depend on discounts, rebates, and negotiations.
- The market is relatively inelastic due to limited alternatives but faces external pressures from policy and biosimilar developments.
- Future pricing will depend heavily on market penetration, payer negotiations, and regulatory policies.
FAQs
Q1: What is the expected patient population for Pexidartinib?
Approximately 6,000-8,000 patients annually in the US with unresectable or metastatic TGCT.
Q2: How does the drug's price compare internationally?
International prices vary; European countries often negotiate lower prices, with some countries adopting patient access schemes.
Q3: Are there biosimilars or generics for Pexidartinib?
No biosimilars or generics are available due to the drug’s molecular complexity and patent protections.
Q4: What are the main revenue risks for manufacturers?
Market penetration delays, competitive pipeline failures, pricing pressures, and regulatory alterations.
Q5: How might expanded indications affect pricing?
Broader uses could increase revenue but may also lead to price adjustments based on payer negotiations and market competition.
Sources
[1] FDA approval documentation for Pexidartinib, 2019.
[2] Genentech corporate reports, 2022.
[3] Market research on TGCT prevalence and treatment landscape, 2022.
[4] CMS and private payer reimbursement policies, 2022.
[5] Pricing data from Red Book, 2022.
