Early Access Programs
At Helsinn, we’ve made it our mission to improve the everyday lives of patients. We do this by developing and bringing to market a range of cancer therapeutics and cancer supportive care products.
Helsinn is aware that patients with serious or life-threatening disease or condition may seek urgently access to therapeutic options which are not available yet in their country or which may not have marketing approval yet. For this reason, under specific circumstances and in agreement with local health regulations, Helsinn may grant access to those medicinal products before marketing approval, these situations are referred to as Early Access Programs (EAPs) at Helsinn.
What are EAPs ?
EAPs allow pre-approval, ethical, compliant and controlled access to investigational drugs outside clinical trials and prior to product launch to patients with life-threatening and serious debilitating diseases having no other treatment options available. Helsinn takes EAP requests into great consideration and is open to allow access to its drugs in selected countries, on condition that:
- the EAP request concerns a drug which applies to EAP criteria outlined by local regulations;
- the concerned drug is not marketed in the country of origin of the EAP request;
- provision of the investigational product will not interfere with ongoing clinical trial(s) or overall development program
Different types of EAPs exist:
- Groups of Patients, also known as Cohort Programs, Compassionate Use Programs (CUP), or Treatment Protocols (in USA), may be initiated by the pharmaceutical company to make a medicinal product available to a group of patients in a selected clinic, hospital or in a selected country for patients with a serious debilitating disease, or patients whose disease is considered to be life-threatening and who cannot be treated satisfactorily by an authorized medicinal product.
- Individual Patients, also known as Named Patient Program (NPP) or Single Patient Expanded Access, can be granted by local regulatory bodies in response to requests by physicians for a specific patient with an unmet medical need that cannot be treated satisfactorily by an authorized medicinal product.
How to make the request?
The EAP request form shall be completed by a physician. Please, note that only requests from verified physicians may be taken into consideration, therefore, if you are a patient, please contact your treating physician who will be responsible for completing the EAP request form. Subsequently, we will acknowledge receipt of the request within 7 business days and once all required information is collected, we will carefully review the request through a dedicated internal review committee, and we will aim to providing a response promptly.
Who is Eligible?
EAPs are intended for patients with a life-threatening or serious debilitating disease, who have exhausted all alternative treatment options and who cannot participate in clinical trials due to not meeting entry criteria or their geographic location. The potential patient benefit shall justify the potential risks of the new medicine and there shall be clear biological rationale set forth to believe that the patient will benefit from treatment.