MAPs are programs under which investigational medicines or 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 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”, "Early Access", “Named Patient Supply”, “Special Access Schemes/Programs” and others.
MAPs are intended to provide early access to treatment for those patients with a confirmed unmet medical need. Sanofi’s MAPs are a temporary pathway and upon authorization of the requested product for the request use in your country, if treatment continuation is necessary, your patient is expected to transfer to a sustainable local access pathway as per local regulations and requirements.
In all situations an unsolicited individual patient request must be submitted and the following conditions must be fulfilled:
- Patient is not able to access the product for the requested use because it is either not yet authorized, or it is not commercially available in the patient's primary residence;
- Patient has exhausted any other approved and/or satisfactory alternative treatment options (unmet medical need);
- Patient is affected by life-threatening or seriously debilitating illness, disease or condition;
- Patient is not currently receiving or has not previously received treatment with the requested product;
- Patient is not currently enrolled in a Sanofi sponsored trial;
- Patient cannot enroll in any trial;
- There is a favorable benefit risk profile for the requested use for this patient based on the most current scientific data available.
How do you make a request?
Requests for unauthorized product and/or product which is not commercially available 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.