WHAT IS A MANAGED ACCESS PROGRAMME?

THE PROMISE OF MANAGED ACCESS

What is a Managed Access Programme?

A patient with a serious or life-threatening condition or illness may sometimes be helped by a drug or treatment which isn’t yet approved or available in their own country.

Managed Access Programmes (MAPs) are regulatory approved schemes which make these investigational or as-yet unlicensed products available to groups of patients.

Managed Access Programme is an umbrella term covering a variety of programs such as Compassionate Use, Extended Access and Named Patient Programs—among others, its main difference being that it is more structured and managed than other programs.

How can a patient participate?

To maintain patient safety and clinical trial integrity, strict ethical guidelines exist. The unsolicited process must be conducted through healthcare providers and fulfill conditions including:

• The condition being treated must be life-threatening, long-term or seriously debilitating.
• No currently authorized treatments must be immediately accessible to the patient.
• The patient cannot be part of an ongoing clinical trial.
• The medicine must be still undergoing clinical development or be at the stage of application for marketing authorisation.

Who Benefits?

The advantages to patients of MAPs are huge, giving them a chance of a potentially life-saving or changing treatment. CRO’s reap the benefit of exposure in additional countries and also have access to a wider, more diverse pool of trial subjects meaning more comprehensive trial results.

What role does COREX play?

In all of this, the logistics provider is crucial, helping to

• Procure the medicines.
• Navigate regulatory permissions and customs.
• Deliver promptly and safely direct to the patient or physician.

At COREX, patients are always our priority and we provide additional support such as:

• Patient transfers.
• Practical support like meals, financial assistance, psychological help, programme management diaries and more.
• Transport of samples for lab testing.
• Returns

The Future

Awareness of Managed Access is growing, and they are now increasingly considered as a flexible, ethical and cost-effective way to grant access to medicines outside of clinical trials where the medicine has been seen to be effective.

They serve to bridge the gap between clinical research and regulatory approval, enabling patients with specific needs to benefit along the way. Hope is that in the future, increased harmonisation between all of the different types of MAPs will become possible, extending opportunity and hope to seriously ill patients worldwide.