The Controversial Pricing History of Lomustine (Gleostine)
Lomustine, first approved by the FDA in 1976 under the brand name CeeNU, was a relatively affordable cancer medication for decades. The Wall Street Journal reported that before 2013, the highest dose of the drug cost around $50 per capsule. This changed dramatically when Bristol-Myers Squibb sold the rights to the drug to NextSource Pharmaceuticals in 2013. The new owner rebranded the medication as Gleostine and began a series of significant price increases. Some reports indicate that the price has been inflated by over 1,500%.
Gleostine and the Medicare Part D Issue
In 2021, NextSource added to the controversy by making the unprecedented decision to pull Gleostine from Medicare Part D coverage. This action left many elderly brain cancer patients, who are most likely to be covered by Medicare, with the full burden of the drug's cost. Reports indicated that patients who relied on Medicare were suddenly facing bills between $1,500 and $3,000 for a single six-week course of treatment. This decision was heavily criticized by patient advocacy groups and experts.
Factors Influencing the High Cost of Gleostine
The exorbitant price of Gleostine is not a simple issue and involves several contributing factors. The manufacturer, NextSource, has cited various reasons for its pricing strategy.
- Acquisition Costs: When NextSource acquired the drug from Bristol-Myers Squibb, the purchase price needed to be recouped, which is a common practice in the pharmaceutical industry. However, the extent of the price hikes has been deemed excessive by many critics.
- Lack of Generic Competition: The patent for Gleostine (lomustine) has expired, but for years, no generic competitor entered the U.S. market. This left NextSource with a monopoly, allowing them to control pricing without market pressure.
- Manufacturing and Regulatory Costs: NextSource claims that the cost of raw materials, FDA and other regulatory licensing fees, and the cost of maintaining a safety stock have contributed to the price.
- Providing for Uninsured Patients: The company also states that its pricing reflects the cost of supplying the drug at low to no cost for uninsured patients or those in government discount programs.
A Comparison of Lomustine Pricing Options
Patients prescribed lomustine often have to navigate a complex and fragmented market to find affordable access. The following table compares potential pricing scenarios, illustrating the vast differences in cost.
| Pricing Option | Source | Potential Cost per Capsule (Example) | Key Considerations |
|---|---|---|---|
| Brand-Name Gleostine (U.S. Retail) | U.S. pharmacies (via GoodRx, etc.) | $1,000+ for high-dose capsule | Highest cost, may be covered by some private insurance. Patient may be responsible for large co-pays. |
| International Pharmacy (Generic Lomustine) | Accredited online pharmacies (e.g., PharmacyChecker) | ~$10 to $12 per capsule (low-dose) | Significant savings. Involves ordering from international sources. Must verify legitimacy of pharmacy. |
| Patient Assistance Program (PAP) | NextSource CARES | Little to no cost for eligible patients | Eligibility requirements often based on income and insurance status. Requires a formal application process. |
| Charitable Foundations | Glioblastoma Foundation | Can help subsidize costs or find alternatives | Connects patients to resources for more affordable versions or financial aid. |
| In-Hospital Pharmacy | Some medical centers | Varies | May offer better pricing or access to different programs than retail pharmacies. |
How Patients Can Address the High Cost
Given the high price, especially for uninsured or Medicare patients, exploring alternatives is crucial.
Financial Assistance and Support Programs
Patients and their families can and should explore the following avenues to mitigate the cost:
- NextSource CARES Patient Assistance Program: The manufacturer provides a program for eligible, uninsured, or underinsured patients to receive Gleostine at little to no cost. Eligibility is based on household income relative to the Federal Poverty Level.
- Non-Profit Organizations: The Glioblastoma Foundation, among others, has actively sought solutions to the high cost of lomustine, including partnering with other pharmaceutical companies to increase access to affordable versions. They offer guidance and connections to more affordable options.
- Co-Pay Assistance: For patients with commercial insurance, co-pay assistance programs from third-party charities can help cover out-of-pocket expenses.
Exploring International and Generic Options
Some patients, unable to afford the domestic cost, have found success obtaining generic lomustine through accredited international online pharmacies. For example, one patient highlighted in a Wall Street Journal article obtained a version from a Canadian pharmacy for a fraction of the U.S. price. While this can be a viable option, patients must exercise caution and use reputable, accredited services to ensure drug safety and legality.
Conclusion
The price of brand-name Gleostine remains a significant barrier to access for many patients with brain tumors, largely due to a controversial pricing strategy and market factors. While the sticker price can be thousands of dollars, there are viable and legal pathways to obtain lomustine at a much more affordable rate. Patients must be proactive in exploring all options, including the manufacturer's assistance program, support from non-profit organizations like the Glioblastoma Foundation, and reputable international pharmacies offering generic versions.
For a deeper dive into the challenges and potential solutions for accessing lomustine, resources from patient advocacy groups are invaluable. For example, the Glioblastoma Foundation has been vocal about the issue and provides information on alternatives and partnerships to increase accessibility.
