Question to the Department of Health and Social Care:

To ask the Secretary of State for Health, what plans he has to ensure that patients have access to (a) nivolumab as a treatment for melanoma and (b) other new medicines that have been designated as Promising Innovative Medicines by the Medicines and Healthcare products Regulatory Agency while appraisal decisions from NICE are pending.

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. Second, the EAMS scientific opinion by the MHRA, which we envisage will usually be towards the end of the development process, will enable prescribers and patients to decide if the EAMS medicine might be suitable for that individual patient. Nivolumab has been given a positive scientific opinion for both lung cancer and melanoma under the EAMS. 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.

The EAMS is being considered by the Accelerated Access Review currently underway.