Early access programs, (EAPs) employ controlled mechanisms of access to investigational drugs outside of the clinical trial space and before the commercial launch of the drug, to patients with life-threatening diseases who have no (other) treatment option available.
They are adopted by an increasing number of pharma companies due to several benefits offered by these programs. In addition to the development of positive relationships with key opinion leaders (KOL), patient advocacy groups and regulators, the data captured from the implementation of EAPs supports the formation of global commercialization strategies.
Countries vary in their regulations regarding the allowance of Early Access Programs. It is vitally important to understand country specific regulations. Country specific assessment and communication with authorities play an important role in making decisions about implementing such programs. If this is a part of your company’s strategic plan, Luna Pharma Consulting Limited can help you to find country specific regulations and solution partners to implement and run Early Access Programs.
EARLY ACCESS PROGRAMS
NAMED PATIENT PROGRAMS
A Named Patient Program (NPP) provides patients and physicians access to commercially approved medicines that are not available to them in their own country.
These drugs must be approved in at least one country, from which it can be imported into the patient's country under a NPP.
Turkey and Middle East Countries have well-defined pathways with different timelines in pricing and reimbursement.
Luna Pharma Consulting Limited can help you to respond to such demands coming from health care authorities and establish a safe and compliant system to make your products available to patients in need.