Managed Access Program

The term “Managed Access Program” refers to the authorized programs which allow patients access to hard-to-access medicines which are not available in their native country. At times patients cannot wait for investigational drugs to reach the market in such conditions such programs become savior. The other terms for Managed Access Program are “Compassionate Use”, “Expanded Access”, “Named Patient Supply”, “Special Access Schemes/Programs”, “Autorisations temporaires d’utilisation (ATU)” and others. We work on individual patients, on a Managed Access Program basis, in accordance with their treating healthcare professional. We favor them in accessing life-saving medicines when certain needs are fulfilled:

  • The life-saving medication has market approval in another nation and is unapproved or unavailable in their own nation.
  • There is no alternative on the market.
  • The medication is for personal use.
  • The respective patient has a valid prescription-letter from their doctor in their home country.

How to make a request?

  • Requests for such medicines/drugs which are not authorized in your country yet, can only be made by the treating physician of the specific patient.
  • To make the request the treating physicians can click on the link; Ikris’s receipt of the request will be acknowledged by email within 1 business day.
  • IPI 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 Ikris Pharma International via toll-free no. +91 9310090915.

What We Provide

  • Managed Access Program We develop ethical and regulatory compliant strategic solutions for pharmaceutical and biotechnology companies enabling a fast and efficient response...
  • RLD Sourcing Specialized in sourcing branded Innovator Samples/Reference Listed Drugs (RLD) from single/multiple batches...
  • Clinical Trial Materials Supply Sourcing and supply of commercial medicines/comparators for clinical trials study across all therapeutic areas...
  • Good Distribution Practices Good Distribution Practices of medicines are designed to allow that a high level of quality is maintained throughout the drug distribution network....

What does the term Managed access program mean?

Managed access program helps patients and physicians access much-required medicines when other alternative options are exhausted, or the particular is not available in a specific country. Managed Access Program is also known as an Expanded Access Program (EAP), Early Access Program, Compassionate Use Program, and Named Patient Program (NPP). These programs help especially needy patients improve their quality of life or save patients’ lives. Such programs also facilitate accessing unlicensed medication from another country when patients have no alternative at the local level.

In almost every country in the World, any patient with a chronic disease, life-threatening, has the right to buy, import, or access medication that can improve or save their life. Every country has its own rules and regulations set up for importing such medicines. Ikris Pharma International (IPI) is the fastest-growing pharmaceutical consultancy and service organization globally, facilitating access to advanced medicines for needy patients in India or any part of the World via the Named Patient Program. They have already successfully assisted more than 600 patients through this program across different geographies in the World.

Importance of Managed Access Program: Pharmaceutical industry

The other terms for "Managed Access Program" are: "Compassionate Use," "Expanded Access," "Named Patient Supply," "Special Access Schemes/Programs," "Autorisations temporary d'utilisation (ATU)," and others. Such programs help needy patients to access hard-to-access medicines in their native place, which are not authorized at that particular place yet. Making such medicines available to eligible patients allows companies to do the right thing and handle unsolicited patient drug requests in an ethical and regulated manner.

"Named-patient basis" is another way of obtaining medicine before authorization. A doctor requests a supply of an unauthorized medicine directly from the manufacturer to treat an individual patient under the doctor's direct responsibility. In all situations, the request must be unsolicited, and the following conditions must be fulfilled:

  • The patient/s suffers from a life-threatening, long-lasting, or seriously debilitating illness.
  • No currently authorized treatments are available to treat the disease or condition satisfactorily.
  • The patient cannot enroll in an ongoing clinical trial.
  • The medicine/ therapy must undergo clinical trials or have entered the marketing authorization application process.
  • Any Managed Access Program requires that the product's benefit-risk profile is evaluated as favorable for the relevant patients based on the most recent available data, and the intended use must fall within the scope of the targeted indication for the product. Where Ikris Pharma International decides to positively respond to any individual request under a Managed Access Program/ Named patient program, the product will be only provided through such programs.