When to plan an Early Access Program?

When to plan an EAP ?

Planning for your managed access program should be considered as early as possible from Phase II trials onwards. This allows time for preparation of standard operating procedures, consultation with regulatory authorities for approval, agreeing the label and development of information for physicians and pharmacists regarding dosing, administration and restrictions. Your targeted price has to be set, as it has to be close to price at launch.

An important factor when implementing a program is clear delineation of which patients will be included. While all programs must specify access/inclusion criteria, your company may receive requests for access from patients suffering from a type of disease not currently being evaluated in trials. For this reason, your company must proactively establish criteria to ensure proper selection of patients for inclusion in the program.

Your company must ensure that there is adequate supply of the drug to complete registration studies and support the access program in parallel. Another consideration is the resource needed to establish and run the program, including processes for handling and vetting requests, mechanisms to review physicians requests and procedures to handle adverse event reporting.

For any question, please contact us at: eap@carthagenetics.com

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