Last updated: February 24, 2026
What is the drug designated by NDC 68308-0781?
NDC 68308-0781 refers to Gleolan (aminolevulinic acid hydrochloride). It is a prescription drug used in oriented surgical procedures for glioma resection, specifically to assist in identifying malignant tissue during surgery.
Market Overview
Indication and Usage
Gleolan is indicated for visualizing malignant glioma tissue during surgical resection. Its primary use is in brain tumor surgeries, with a focus on enhancing the detection of malignant tissue under fluorescent light.
Market Size and Potential
In the US, approximately 25,000 to 30,000 glioma surgeries are performed annually, with glioblastoma multiforme (GBM) accounting for roughly 60-70% of cases.[1] The drug's market penetration is driven by neurosurgical adoption, insurance coverage, and clinical guidelines.
Competition and Market Share
Key competitors include 5-ALA (used outside the US), commercially available under different brand names. Gleolan holds a significant share in the US due to FDA approval, with sales concentrated among leading neuro-oncology centers.
Pricing Data
Current Price Points
- Per-Use Cost: Sellers list Gleolan’s price per dose between $2,500 and $3,100.
- Average Wholesale Price (AWP): Approximately $2,950 per vial (Dose: 20 mL/5 mg/mL).
- Reimbursement: Payers reimburse between $3,000 and $3,500 per procedure, including drug costs.
Cost Dynamics
The high price derives from manufacturing complexity, specialized use, and limited competition. The drug is administered as an intravenous infusion, with the cost being predominantly drug pricing and associated procedural costs.
Price Projections
Short-Term (Next 1-2 Years)
- No immediate price reductions anticipated unless generic competition emerges.
- Price pressure from hospital procurement negotiations could reduce effective prices 5-10%.
- Reimbursement rates are stable, driven by Medicare and private insurers.
Medium to Long-Term (3-5 Years)
- Entry of biosimilars, if approved, could lower prices by 15-20%.
- Volume growth depends on clinical guideline adoption and neurosurgeon preferences.
- Potential for value-based pricing models if outcomes data demonstrate clear benefits over alternatives.
Factors Influencing Future Prices
- Regulatory changes expanding or restricting use.
- Competitive pressures from alternative fluorescence agents.
- Reimbursement policy shifts favoring reduced drug prices.
- Market expansion outside the US, where pricing and coverage are less established.
Policy and Reimbursement Landscape
- FDA approval confirms the drug's value in surgical guidance.
- Centers for Medicare & Medicaid Services (CMS) reimbursement is aligned with current prices.
- Payer negotiations, especially via hospital formulary committees, may result in discounts or restricted access.
Financial and Strategic Implications
- Manufacturers could consider tiered pricing for different markets.
- Partnerships with hospitals to secure bulk purchasing agreements may reduce costs.
- Monitoring clinical trial results and regulatory developments can influence future pricing strategies.
Key Takeaways
- Gleolan's current price per procedure ranges between $2,500 and $3,100, with stable reimbursement levels.
- Market size is primarily driven by surgical cases of glioma and glioblastoma.
- Competition is limited; biosimilars or new fluorescence agents could induce price declines.
- In the next 2 years, prices are unlikely to fall significantly unless biosimilar competition materializes.
- Long-term price trends depend on competitive dynamics, clinical adoption, and regulatory factors.
Frequently Asked Questions
1. What factors could reduce the price of Gleolan in the short term?
Reimbursement negotiations, hospital procurement strategies, and the emergence of alternative agents may exert downward pressure.
2. How does Gleolan compare in price to similar agents outside the US?
In Europe, 5-ALA is used, typically at lower per-dose prices due to different healthcare pricing systems.
3. What is the potential impact of biosimilar entry?
Biosimilar or generic entrants could reduce prices by 15-20%, contingent on regulatory approval and market acceptance.
4. How does clinical practice influence market dynamics?
Widespread adoption by neurosurgeons and inclusion in surgical guidelines bolster demand and support stable or increasing prices.
5. Are there policy initiatives that could influence future drug pricing?
Healthcare reforms emphasizing value-based care and cost containment could lead to price adjustments or reimbursement modifications.
References
[1] American Brain Tumor Association. (2021). Brain Tumor Statistics. Retrieved from https://www.abta.org/tumor_resources/statistics/
