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Questions to Ask About Group and Single-Patient Expanded Access to Investigational Drugs

For Patients/Caregivers
For Physicians

When discussing the possible use of an investigational treatment, it is important to have all the information needed to make a decision. Here are some questions you may ask your physician to ensure you understand the process. You can also download and print EA forms listed in the Navigator’s resources for your physician to complete.

  • What is expanded access (EA) and when should we consider it?
  • How do I find out if I can apply to gain access to these drugs?
  • Are there specific eligibility criteria that I must meet?
  • Is there a limit to how many people can get expanded access to these drugs?
  • How long will it take to find out if I can participate?
  • What are reasons why a patient could be denied access?
  • Are the drugs covered or will I have to pay for them out of pocket? 
  • If so, are there financial resources to help cover the costs?
  • What are the potential risks? 
  • What are the potential benefits?
  • What happens if I am harmed?
  • Is medical care provided?
  • What happens if I am denied?
  • What’s the next step?
  • Are there protections in place for patients?
  • How long will I have access to the drugs?  

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