1. Home
  2. Medicines
  3. Managed Access Programs

Managed Access Programs

Dompé’s Managed Access Programs provide investigational or unavailable medicines to individual patients, upon physician request, through approved local access channels such as compassionate use or special access.

Accessing Tomorrow’s Treatments Today

Our Managed Access Programs enable Dompé to supply its products on an individual patient basis. It allows treating physicians to request investigational, pre-approval products prior to regulatory approval, medicines not commercially available yet through available channels allowed by applicable local laws. These access channels may include named patient supply, compassionate use, expanded access, special 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.

How are requests evaluated?

After a request is submitted, we anticipate that it will take no longer than 3 business days to acknowledge receipt of the request. Each request will be reviewed by Dompé Medical Affairs, and every effort will be made to provide a response promptly once all necessary information has been received. Please note that physicians' requests will be assessed in accordance with applicable local laws and regulations and may be forwarded to third-party vendors that work jointly with Dompé to support global access to medicines. By submitting a request, the physician consents to the processing of their information by Dompé farmaceutici S.p.A., its subsidiaries, affiliates, and third-party processors. Dompé is committed to responding promptly and comprehensively to every request.

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 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.

Eligible to Apply? Complete the Form Below

* denotes mandatory fields