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In a world where access to life-changing medicines can sometimes be hindered by regulatory processes, Ikris Pharma International (IPI) is pioneering a solution: the Managed Access Program (MAP). MAPs are special programs that play a crucial role in addressing the urgent medical needs of patients facing serious or life-threatening conditions. By providing access to investigational medicines that are still undergoing the approval process, MAPs offer a lifeline to individuals who may not qualify for clinical trials but could benefit from innovative treatments.
IPI's "Managed Access" program is specifically designed to meet the needs of patients affected by conditions that significantly impact their quality of life. Whether it's a life-threatening illness, a chronic condition, or a debilitating disease, IPI recognizes the importance of providing timely access to potentially life-saving therapies.
Through the "Managed Access" program, IPI strives to ensure that eligible patients have access to investigational medicines that have the potential to address their unmet medical needs. By working closely with healthcare providers and regulatory authorities, IPI aims to navigate the complex landscape of drug development and regulatory approval to deliver hope and healing to those who need it most.
Managed Access Programs (MAPs) refer to different kinds of programs that help people get access to medicines before they are officially approved. These programs have various names, such as Compassionate Use, Expanded Access, Named Patient Supply, Special Access Schemes/Programs, Autorisations temporaires d’utilisation (ATU), and more. They are all designed to provide patients with a way to receive treatments that may help them, especially when they have serious or life-threatening conditions and have no other options available. So, MAPs are like a pathway that allows patients to try out new medicines that are still being tested but might be helpful for their health condition.
“Compassionate Use” (“CU”) is a program that provides a pathway for patients suffering from life-threatening, chronic, or severely debilitating illnesses to access investigational medicines that are either undergoing clinical trials or in the marketing authorization process. Under this program, treating physicians can request the use of such medicines for a group of patients (referred to as a cohort) from the National Competent Authority in their respective countries. This program serves as a lifeline for patients who have exhausted all available treatment options and urgently need access to potential therapies that may improve their condition.
“Named-patient basis” is another way of acquiring medication prior to official authorization, whereby a physician directly petitions the manufacturer for a supply of an unapproved medicine to treat a specific patient under their direct care and responsibility.
In every case, the request must be unsolicited, and it has to meet these conditions:
If IPI approves an individual request under the Managed Access Program, the product will exclusively be provided through the following designated program:
Ikris Pharma International allows treating physicians to submit individual requests for specific patients through Managed Access Programs.
In a situation where:
Physicians can request investigational products from Ikris for patients if permitted by local regulations, even if the product is not yet authorized or available commercially in that country
Requests for not yet authorized or commercially available products can only be made by the treating physician on behalf of the specific patient. Treating physicians can contact Ikris Pharma International (IPI). Requests will be acknowledged within 1 business day. IPI will assess requests based on internal and local regulations. For inquiries about Managed Access, contact IPI's team today.