Shionogi Group Managed Access Program Policy
Patients with serious or life-threatening diseases who have no alternatives for treatment may obtain access to medical products that are not yet approved or available in their country. Shionogi strives to make certain investigational, unapproved, or approved but not yet commercially available treatments, available to patients who meet eligibility requirements via its Managed Access Programs (MAPs).
Managed Access Programs
Nomenclature for Managed Access Programs differs around the world, depending on country and regulatory practice. Examples include but are not limited to:
- Compassionate Use
- Expanded Access
- Special Access
- Early Access Program
- Named Patient Program
- Temporary Authorization for Use (ATU)
Shionogi defines Managed Access Program as the overarching term to include these access programs.
Shionogi has defined criteria for access to products that are not yet commercially available. Criteria include:
- The patient has a serious or life-threatening disease
- No similar or satisfactory alternative therapy is available
- Patient enrollment in a clinical trial is not possible
- The HCP treating the patient and Shionogi’s medical experts agree that the potential benefit of the treatment outweighs the potential risk of the treatment
- An appropriate access pathway exists based on local regulatory requirements
- Product is available, can be supplied without negative impact to ongoing programs and in a timeframe that will allow for meaningful intervention
Clinical trials support registration of investigational products and understanding of how best to use new agents to benefit society as a whole. When necessary, Shionogi will prioritize use of available product for development purposes.
In order to be considered for a MAP the patient’s health care provider (HCP) must complete a MAP Application on behalf of the patient.
HCP Application Information: email@example.com
Completed requests will be promptly reviewed by Shionogi. Submission of all necessary information will speed the evaluation process and avoid the need for requests for additional information. For products that are approved but not yet commercially available a fee may be charged. A MAP cannot be used to access products after the product is approved by regulatory authorities and is commercially available.