A Managed Access Program (MAP) offers patients access to unapproved or investigational drugs outside of clinical trials, primarily aimed at those with severe conditions who have no other treatment options. While MAPs address unmet medical needs and provide ethical access to therapies, they face challenges such as limited drug supply and safety uncertainties. Requests for these programs must be submitted by a treating doctor and are evaluated based on local regulations.

1. Managed Access Program (Indian pharma Network )
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 Program (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.
Apatt from this, there are also certain challenges and limitations linked with Managed Access
Programs (MAPs):
Limited Drug Supply: The existence of the 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.

2. 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 do 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.
Source - https://helpforheallth.blogspot.com/2023/05/managed-access-program-map.html