Why expanded access instead of single patient compassionate use?
Individual compassionate use can be much more difficult for a company to deal with than a defined program with well-described qualification procedures. Expanded access makes an experimental drug available to people within a defined population. When supplies are limited, an expanded access program can operate via a completely objective allocation system, like a lottery. A single patient access approach is, by nature, not objective. At the same time, there are times, especially for patients with very rare cancers, when single patient compassionate use may be appropriate.
Related Questions
- What about caps? When the insurance coverage is maxed out and insurance company refuses to pay, does the patient become eligible for compassionate consideration at that point for Tracleer?
- When the insurance coverage is maxed out and the insurance company refuses to pay, does the patient become eligible for compassionate consideration at that point for Tracleer™?
- What are the symptoms and what should the patient do?
