Question to the Department of Health and Social Care:
To ask the Secretary of State for Health, what assessment he has made of the effect of patient access to innovative drugs approved under the MHRA's Early Access to Medicines Scheme ahead of NICE assessments and in the absence of any planned Cancer Drugs Fund meetings.
The Early Access to Medicines Scheme (EAMS) was launched in April 2014. Its purpose is to support access in the United Kingdom to unlicensed or off-label medicines representing a significant advance in treatment in areas of unmet medical need.
EAMS is a 2 step process. First, the Promising Innovative Medicine designation by the Medicines and Healthcare products Regulatory Agency (MHRA) is designed to give an early signal that based on early clinical evidence the medicine may be a possible candidate for EAMS and thus have the potential to be of value in areas of unmet medical need. There have been eight EAMS Promising Innovative Medicines designations issued so far.
Second, the EAMS scientific opinion by the MHRA, which we envisage will usually be towards the end of the development process, enables prescribers and patients to decide if the EAMS medicine might be suitable for that individual patient. Four positive EAMS scientific opinions have been issued.
For medicines granted a scientific opinion and which then receive a marketing authorisation, it is for commissioners to make funding decisions in advance of any technology appraisal guidance from the National Institute for Health and Care Excellence.
There will be a review of EAMS as part of the Accelerated Access Review currently underway.