In today’s world, pharmaceutical and biotechnology companies must expect that patient demand throughout the lifecycle of the product cannot be met via the traditional mechanisms of access. As a result, companies must be prepared to identify and implement solutions to address this demand gap. Companies can bridge the demand gap through use of a Managed Access Program, or MAP.

“Managed Access” is a term that encompasses a variety of regulatory approaches used to provide access to medicines outside the clinical trial or commercial setting for a variety of reasons including those drugs that:

• Are still in clinical development and have yet to be approved
• May never be approved, but still have medicinal value for a very small population (for example, some orphan drugs)
• Are approved in one country, but not another
• Have been discontinued in a particular market
• Are an alternative to a drug discontinued globally
• Are used off-label in some countries

Managed Access Programs are structured programs developed and managed in partnership with pharmaceutical and biotechnology companies as a way to allow ethical access to medicines for unmet medical needs in a fully compliant manner.

The important point to remember is that Managed Access Programs are not clinical trials. The primary intent of the mechanisms of managed access globally is to make medicines available for patients who have run out of treatment options in their country.

Managed Access programs can be put in place on a patient-by-patient basis, or for a group or cohort of patients, and are effective at helping companies address patient demand for medicines around the world. A variety of terms are used around the world to describe these programs including “expanded access”, “named patient”, “temporary authorization for use”, “compassionate use”, and “early access”.