Managed Access Policy
Egetis Therapeutics purpose is to create value for patients, society and shareholder by developing and providing a portfolio of unique products for the treatment of rare diseases with substantial unmet medical need.
Patients with serious or life-threatening diseases or conditions sometimes seek medical products that are not yet approved. Egetis Therapeutics “Managed Access” program addresses this need by making certain investigational or unapproved treatments available to eligible patients. Below you’ll find additional details about this program.
Product evaluation in clinical trials
Before a product can be placed on the market, it must undergo well-controlled clinical trials to prove that it is safe and effective, and its potential benefit to patients outweighs the possible risks. Clinical trial results and related product information are then submitted to the relevant health authorities for review. Clinical trials result in the generation of evidence that may lead to the approval of a product, which can make it more widely available to patients.
What is Egetis Managed Access program?
There are instances where a patient has a serious or life-threatening disease or condition, for which all currently available treatment options have been exhausted and enrolment into a clinical trial is not possible. In these cases, the treating physician can request access to an investigational product prior to regulatory approval, provided it is allowed by the applicable local legislations. Within Egetis, we refer to such provision of an investigational product as “Managed Access”.
The Egetis “Managed Access” terminology covers all locally defined pre-approval access mechanisms and programs such as “Compassionate Use”, “Expanded Access”, “Named Patient Supply”, “Special Access Schemes/Programs”, “Autorisations temporaires d’utilisation (ATU)” and others.
Who is eligible for Egetis Managed Access program?
Egetis considers granting managed access to investigational products when all of the following criteria are met:
- The patient to be treated has a serious or life-threatening disease or condition, and no comparable or satisfactory alternative therapy is available to monitor or treat the disease or condition, alternatively that the patient meets any other important medical criteria established by the medical experts working on the product development program;
- The patient is ineligible for enrolment into or unable to access ongoing clinical trials;
- Sufficient data exists to believe the potential benefit of treatment outweighs the potential risk in the context of the disease or condition to be treated;
- Egetis has an adequate supply of the investigational product and providing the investigational product will not interfere with ongoing clinical trial(s) or with the overall development program;
- Such access provision is allowed as per local laws and regulations.
Information on ongoing Clinical Trials are available at www.clinicaltrials.gov
How do I submit a request for Managed Access?
A request must be submitted by the treating physician on behalf of the patient. Requests can be submitted via email to [email protected]
How are requests evaluated?
Each request will be acknowledged immediately and reviewed carefully and fairly by the appropriate Egetis medical team with every effort made to provide a response promptly once we have all the necessary information.
Please note that your request will be assessed in consideration of applicable local laws and regulations.
For Managed Access related questions, health care professionals can contact the Egetis medical team at [email protected]
