Managed Access Programs
Dompé farmaceutici S.p.A. is committed to discovering, developing and producing innovative therapeutic solutions. Treating physicians of patients with serious or life-threatening conditions may seek medical products that are not yet approved or available in their country. Dompé is dedicated to being an active player in the global healthcare industry and providing access to certain investigational or unapproved products to patients.
Our Managed Access Programs is a program that enables Dompé’s to supply its products on an individual patient basis. It allows treating physicians to request investigational or pre-approval products prior to regulatory approval through available channels allowed by applicable local laws. These access channels may include named patient supply, compassionate use, special access, expanded access, and others.
Criteria for Consideration
All Managed Access Programs requests for investigational products received from a treating physician will be assessed on a case-by-case basis. Dompé cannot guarantee that requests for access will be granted. Each request will be considered based on whether certain conditions are met. These conditions include, but are not limited to:
- The patient must have a serious or life-threatening disease or condition.
- There must be an unmet medical need where all currently available treatment options have been exhausted and alternative therapies are not available.
- The patient is not eligible or cannot participate in a clinical trial. In assessing the eligibility of a patient for potential pre-approval access, preference will be given to clinical trials,then Managed Access Programs.
- Sufficient scientific evidence to demonstrate that the benefits of the investigational medicine outweigh the risks.
- Providing pre-approval access will not jeopardize the initiation, conduct, or completion of clinical investigations and the overall development program to support registration of the product.
- Utilization of Managed Access Programs must be permitted by, and run-in accordance with, applicable laws.
- The treating physician making the request must be licensed, in good standing, and qualified to administer the investigational medicine within the local jurisdiction where such physician practices, and must agree to comply with Dompé’s requirements and local regulations governing Managed Access Programs and adhere to applicable laws and regulations.
Who can make a request?
Only the treating physician on behalf of the patient can request a Dompé product, provided it is allowed by the applicable local laws.
How are requests evaluated?
Each request will be acknowledged and reviewed by the relevant Dompé’s Medical Affairs department with every effort made to provide a response promptly once we have all the necessary information.
Please note that physician’s request will be assessed subject to any applicable local laws and regulations and may be forwarded to third party vendors that work jointly with Dompé to allow global access to medicines. By making the request, the physician is consenting to have his/her information processed by Dompé farmaceutici S.p.A., its subsidiaries, affiliates and third party processors. Dompé is committed to respond promptly and comprehensively to every request.
How can I make a request?
Only the treating physician can request a Dompé product, provided it is allowed by applicable local laws.
The physician who wants to send the request, must fill this form.