Managed Access Program (MAP)

A Managed Access Program (MAP) is a framework that provides patients with access to investigational or unapproved or unlicensed drugs outside of any clinical trials. These programs, sometimes referred to as Named Patient Programs (NPP), Expanded Access Programs (EAP), Compassionate Use Programs, or Early Access Programs, are designed to help those who have exhausted all existing treatment options and are unable to participate in any clinical trials. The primary goal of MAPs is to offer potentially life-saving or life-improving therapies to those with serious or life-threatening conditions.

There are several reasons for implementing a Managed Access Program (MAP) or Named Patient Program (NPP), including:

Addressing Unmet Medical Needs: MAPs help those with severe or life-threatening conditions who have no other existing treatment options or have failed to respond to existing therapies.

Limited Availability of Clinical Trials: Some patients may not be eligible for clinical trials because of strict inclusion and exclusion criteria or lack of trial availability in their region.

Gathering Additional Data: In some cases, data collected from patients in a MAP can supplement clinical trial data and provide valuable information on the safety and efficacy of a drug in a broader population.

Regulatory Compliance: MAPs are often conducted as per regulatory guidelines and can be an important step toward obtaining regulatory approval for a new medicine.

Ethical Considerations: Providing access to investigational medicines for those with no other options can be seen as an ethical obligation for pharma companies, especially when there is preliminary evidence of potential benefit.

Apart from this, there are also certain challenges and limitations linked with Managed Access Programs (MAPs):

Limited Drug Supply: The existence of investigational medicine may be limited, making it difficult to provide access to all eligible patients.

Financial Considerations: The cost of manufacturing and distributing investigational medicines can be high, and reimbursement for these costs may not always be available.

Uncertainty About Safety and Efficacy: Since the medicine has not yet been completely tested and approved, there is inherent uncertainty about its safety and efficacy.

Impact on Clinical Trial Enrolment: Offering access to an investigational medicine outside of clinical trials could potentially scale down the number of patients enrolling in the trials, which could be responsible for delaying the medicine approval process.

Despite all these challenges, Managed Access Programs remain an important mechanism for providing access to potentially beneficial therapies for those with serious or life-threatening conditions who have exhausted all other treatment options.

The “Indian Pharma Network (IPN) Managed Access” terminology covers all locally defined pre-approval access mechanisms and programs such as “Named Patient Supply”, “Compassionate Use”, “Expanded Access”, “Special Access /Programs”, and others.

How One Can Submit a Request for These Programs: A request for these programs (NPP/MAP) must be submitted by the treating doctor on behalf of the respective patient. All requests can be submitted either via our TOLL-FREE Number: 1800-889-1064 or Call/WhatsApp: +91 9310090915. Each request will be acknowledged promptly, and reviewed precisely by the appropriate IPN member with each and every effort made to provide a response quickly once we have all the required information. Please note that your request for this program will be evaluated in consideration of applicable local laws and regulations.