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CT Supply and Services > Named Patient Program
The term “Managed Access Programs” (“MAPs”) covers various types of programs, in particular “Compassionate Use”, “Expanded Access”, “Named Patient Supply”, “Named Patient Program”, “Special Access Schemes/Programs”, “Autorisations temporaires d’utilisation (ATU)” and others.
“Named-patient basis” is another way of obtaining medicine before authorization where a doctor requests supply of an unauthorized medicine directly from the manufacturer to treat an individual patient under the doctor’s direct responsibility.
In all situations the request must be unsolicited and the following conditions must be fulfilled:
- The patient/s suffer from a life-threatening, long-lasting or seriously debilitating illness
- There are no currently authorized therapies available to treat the disease or condition in a satisfactory way
- The patient cannot enroll in an ongoing clinical trial
- The medicine/ therapy must be undergoing clinical trials or have entered the marketing-authorization application process
- Any Managed Access Program requires that the benefit-risk profile of
the product is evaluated as favorable for the relevant patients based on the most recent available data and the intended use must fall within the scope of the targeted indication for the product
As mentioned, there are many available options of making a product available to patients, the product will be only provided through the Named Patient basis.
This program allows treating physician to submit individual requests under Managed Access Programs for specific patients.
These may be drugs that are:
- Approved but not yet commercially available to be prescribed in the patient’s country
- Approved and available in one country but not approved and available in the patient’s country
- Discontinued in the patient’s country but not another
- In shortage in the patient’s country but not another
