Named Patient Supply
December 7, 2021 2022-12-17 13:24Named Patient Supply
Fedelty Health Care
Finding the Best Fit Pharma Products for You
It is possible to get drugs via a Named Patient Program (NPP) that are not accessible in the patient's home country. These pharmaceuticals must be authorized in at least one nation before they may be imported into the patient's country under the terms of a Named Patient Program.
These might be medications such as:
- Approved for use in the patient's country but not yet commercially accessible.
- Available in one nation, but not in the patient's place of origin
- Only in the patient's home country medication has been discontinued.
- the patient's nation but not the other
Another method of getting medication before an authorization is “named-patient basis,” in which a doctor asks for a supply of an unapproved drug directly from the manufacturer to treat an individual patient under the doctor’s direct responsibility.
The request must always be made in an unexpected manner, and the following must be met:
A disease that poses a major danger to the patient's life and/or is expected to endure for a long time
At this time, there are no approved treatments available to treat the illness or condition in a manner that is acceptable to patients.
The patient is unable to participate in a clinical study that is currently taking place.
The medication or treatment must be in clinical trials or in the marketing-authorization application stage before it may be considered for release.
To be eligible for a Managed Access Program, a product must have a positive benefit-risk profile for the relevant patients, as determined by the most current data, and its intended usage must correspond to the product's specific indication.
The patient is unable to participate in a clinical study that is currently taking place.
Fedelty Health Care will only deliver a product via the following program
when responding favorably to any individual request under a Managed Access Program:
- Requests for medications that haven’t been approved or aren’t currently on the market may only be made by the doctor treating the patient.
- Fedelty Health Care will confirm receipt of the request through email within one business day of the request being submitted.
- The request will be evaluated by Fedelty Health Care in accordance with its internal procedures and the relevant local laws and regulations.
Please contact your medical team in your country if you have any questions about Managed Access.
