UK Early Access To Medicines Scheme - A New Era For Patient Access

In one of our previous blogs we discussed the US Food and Drug Administration's (FDA's) introduction of the 'breakthrough' designation concept as a way of improving earlier access to medicines for patients with high unmet medical need. In this blog we're focussing on the Early Access to Medicines Scheme (EAMS), a similar scheme launched by the UK's Medicines and Healthcare products Regulatory Agency (MHRA) in April 2014. EAMS is a voluntary scheme that provides an accelerated route to market for drugs in the UK and aims to "give patients with life threatening or seriously debilitating conditions access to medicines that do not yet have marketing authorisation".1

Drugs under EAMS will be in phase III or, in exceptional circumstances (if data is compelling and there is a significant unmet need), late stage phase II trials. To gain marketing authorisation (MA) they will still need to go through the full clinical trials and drug licencing process, the MHRA highlight EAMS is not a replacement to the MA process and will only impact 5-10 drugs a year.

Three conditions must be met in sequential order for a drug to be accepted onto EAMS:

a drug must first be awarded the status of 'promising innovative medicine' (PIM) by the MHRA, a step that mirrors the FDA's 'breakthrough' status. PIM is reserved for drugs that are "likely to demonstrate significant benefit for patients in life-threatening or seriously debilitating conditions."2 the drug manufacturer must then apply for 'EAMS scientific opinion' - the final MHRA evaluation process. The primary aim is to ensure an acceptable risk/ reward trade-off using available clinical trial data. The secondary aim is to develop guidelines and information to allow prescribers and patients to make informed decisions on drug use if accepted the manufacturer must make the drug available to the NHS free of charge for as long as it's included in EAMS. Inclusion is guaranteed for a maximum of a year on the condition that subsequent clinical trial data is shared periodically and does not compromise the risk/ reward trade-off. Once an EAMS drug receives approval through traditional approval channels it is automatically removed from EAMS There are a number of potential benefits of this scheme which impact a wide range of stakeholders:

patients benefit from earlier access to treatments that could significantly improve survival and quality of life. It's thought the scheme will allow patients and doctors access to new...