When patients have exhausted every other treatment option, their physicians sometimes find that the best way to meet their needs is to prescribe medicines that are not yet approved or licensed. This is a form of managed access program called ‘early access’.
In June 2012, we initiated a managed access program supplying an investigational medicine to prostate cancer patients. At the time, the product was not approved in any country, but during our program patients in the EU and Canada had access to it.
When European Marketing authorization was granted in June 2013, the product became commercially available in EU Member states. We managed the transition of patients from the access program to commercial supply, with some local health authorities allowing patients already in the program to continue until the end of their treatment rather than being converted to the commercial supply, while in other countries, we were required to end the managed access program as soon as commercialization was complete.
By June 2014, Idis MA had provided 2,941 patients in 21 countries with access to the drug. Throughout the program, we have been contacted by physicians thanking us for our assistance and ‘real engagement’ and letting us know that their patients have benefited from inclusion in the program. Both Idis MA and the sponsor have also received thanks direct from patients.