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.