MAPs are programs under which investigational medicines, medicines for which a marketing authorization application is ongoing may be used to treat certain patients who cannot enroll in an ongoing clinical trial. Sanofi “Managed Access” addresses the need of treating patients affected by life-threatening, long-lasting or seriously debilitating illnesses by making such medicines available to eligible patients.
What are Managed Access Programs (MAPs) at Sanofi?
The term “Managed Access Programs” (“MAPs”) covers various types of programs, in particular “Compassionate Use”, “Expanded Access”, “Named Patient Supply”, “Special Access Schemes/Programs”, “Autorisations temporaires d’utilisation (ATU)” and others.
“Compassionate Use” (“CU”) is a program that allows the use of a medicine which is either undergoing clinical trials or which has entered the marketing authorization process to treat a group of patients (or cohort, i.e. more than one) who suffer from life-threatening, long-lasting or seriously debilitating illnesses. CU requests are made by the treating physician to the National Competent Authority in the relevant country.
“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
Where Sanofi decides to positively respond to any individual request under a Managed Access Program, the product will be only provided through the following program:
Named-patient basis/ Individual Request
This webpage allows treating physician to submit individual requests under Managed Access Programs for specific patients.
In situation where:
- a patient suffers from a life-threatening, long-lasting or seriously debilitating illness, and
- there are no currently authorized therapies available to treat that disease or condition in a satisfactory way, and
- the patient cannot enroll in an ongoing clinical trial
the treating physician may, for that particular patient, request from Sanofi supply of a product that is not yet authorised or not commercially available in a specific country, provided that such supply is allowed under the locally applicable rules and regulations of that country.
How do you make a request?
Such requests for not yet authorised or not commercially available products can only be made by the treating physician of the specific patient.
To make the request the treating physicians can click on the link below; Sanofi’s receipt of the request will be acknowledged by email within 1 business day.
Sanofi will assess the request in consideration of its internal rules and under the applicable local rules and regulations.
For any question in relation to Managed Access, please contact the local Sanofi medical team in your country.
Any other request for investigational product, or medicinal product not yet available in your country
Request for the following products and use:
AVAGLUCOSIDASE ALFA (POMPE), OLIPUDASE ALFA (ASMD), ISATUXIMAB NAMED PATIENT PROGRAM, DUPIXENT EoE and SUTIMLIMAB