We have pleasure in announcing the exciting news that Roche today submitted their application for an Early Access to Medicines Scheme (EAMS), a UK specific early access program which is approved by the MHRA.
What is EAMS?
The principle behind a EAMS program is to give patients with life-threatening or seriously debilitating conditions, and where there is a clear unmet medical need, access to unlicensed medicines which do not have marketing authorisation. The scheme is voluntary and the opinion from MHRA does not replace normal licensing procedures, therefore an application will still need to be submitted to the EMA at some point in the future.
Who approves the access?
The process is managed by the Medicines and Healthcare products Regulatory Agency (MHRA). They provide scientific opinions on the risk versus benefit of providing access to the unlicensed drug based on the data submitted by the company. The scientific opinion is designed to provide the prescriber and the patient with information which supports a decision as to whether they want to receive the medicine while unlicensed.
How long will it take for a decision to be made?
The EAMS process takes approximately 90 days, although in some circumstances it can be a little less.
Who will be eligible under EAMS?
At present this isn’t something we can advise and it will depend on the scientific opinion based on the submitted data. We do know that the application at the moment is for type 1 and type 2 patients, but only does who are unable to receive Spinraza. We are working with Roche to see how we can bring type 3 patients into the equation as soon as possible.
What happens next?
We wait but we as a PAG will continue to liaise with all stakeholders in an attempt to widen access.