Expanded Access, sometimes referred to as compassionate use, may be an option for certain individuals with serious or life-threatening conditions or diseases who have no satisfactory or comparable alternative therapy to treat the disease or condition involved. Patients who qualify for a clinical trial on the Investigational Product requested are not eligible for Expanded Access.
Criteria For Access
Chiesi USA’s stated goals include the development of pharmaceutical solutions to improve the quality of human life and to combine commitment to result with integrity, operating in a socially responsible manner. In line with the Chiesi Mission and our core values, Chiesi USA will consider granting access to patients whenever possible who meet the following criteria:
- The patient has a serious or life-threatening illness with no comparable or satisfactory alternative therapies.
- The patient is ineligible for, or otherwise unable to, participate in a clinical trial related to the Investigational Product requested. Geographical limitations related to investigational product access will not necessarily render expanded access subjects ineligible.
- In the treating physician’s judgement, the potential patient benefit justifies the potential risks of the treatment use and those potential risks are not unreasonable in the context of the disease or condition to be treated.
- The Investigational Product is currently being studied in humans.
- Adequate supply exists or can be produced to support both the ongoing clinical investigations and compassionate use.
- Providing the Investigational Product for the requested use will not interfere with the initiation, conduct, or completion of clinical investigations that could support FDA approval of the expanded access use or otherwise compromise the potential development of the expanded access use.
Requests for Expanded Access must be made by the patient’s treating physician. The treating physician must be actively licensed; fully qualified to administer the Investigational Product; willing to comply in writing to abide by any Chiesi requirements related to medical criteria, safety reporting, drug use and protection of intellectual property; committed and supportive of the requested treatment, and to have determined in his/her own judgement that the potential benefits outweigh the risks of treatment.
The treating physician may make the request for Expanded Access at firstname.lastname@example.org. The email must contain the following information: the treating physician’s name; full address; email address; phone number; and the Investigational Product to which they are inquiring. Treating physicians are asked to avoid submission of any personal information (e.g. subject names) covered as protected health information in the initial Request for Expanded Access. Chiesi USA Medical Affairs, or someone acting on their behalf, will contact the treating physician in no more than five (5) business days of the request.
Evaluation of Requests
Each request will be reviewed on a case-by-case basis. Chiesi USA strives to make each decision comprehensively, reviewing all patient information submitted as well as the medical and scientific information available on the Investigational Product requested.
*Chiesi USA reserves the right to revise this Policy at any time. Expanded Access is not available in areas where forbidden by law or regulation including ruling by country or region specific regulatory bodies, importation requirements, and/or Ethics Committee or Institutional Review Board.