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.

We have had no such discussions.

NHS England is responsible for the operational management of the Cancer Drugs Fund. It has taken a decision not to consider new drugs like nivolumab, at this stage, whilst consideration is given to new ways of working and to ensure that the Fund remains within budget.

We understand that NHS England and the National Institute for Health and Care Excellence will shortly be consulting jointly on a proposed new system for commissioning cancer drugs.

The Government remains committed to the Fund which has so far helped over 72,000 people in England access the cancer drugs their doctors recommend for them.

In the absence of guidance from the National Institute for Health and Care Excellence, it is for commissioners to make decisions on whether to fund new medicines based on an assessment of the available evidence.

We take the issue of ensuring rapid access to innovative therapies very seriously, which is why we have launched an Accelerated Access Review to make recommendations to Government later in the year on speeding up access for National Health Service patients to innovative and cost effective new medicines, diagnostics and medical technologies.

NHS England has advised that a meeting with patient groups and charities was held on 19 January 2015 to provide the context for the changes being made to the national Cancer Drugs Fund (CDF) list, how the review was undertaken by the CDF clinical panel and the results. Attendees had the opportunity to ask questions to provide further clarity.

Information on the outcomes from the review is available on NHS England’s website at:

www.england.nhs.uk/ourwork/pe/cdf

and has been circulated to NHS England networks. Clinicians are also being informed via the regional CDF teams.

NHS England has advised that a meeting with patient groups and charities was held on 19 January 2015 to provide the context for the changes being made to the national Cancer Drugs Fund (CDF) list, how the review was undertaken by the CDF clinical panel and the results. Attendees had the opportunity to ask questions to provide further clarity.

Information on the outcomes from the review is available on NHS England’s website at:

www.england.nhs.uk/ourwork/pe/cdf

and has been circulated to NHS England networks. Clinicians are also being informed via the regional CDF teams.

NHS England’s Cancer Drugs Fund panel plans to meet on 15 and 16 December to assess, on the basis of the latest evidence, whether certain drugs should continue to be made routinely available through the Fund and to consider a number of new drugs for potential addition to the Fund.

NHS England has advised that a meeting will be held with representatives of charities and patient groups on 12 January 2015 to communicate the outcome of the panel’s discussion, clarify the process by which decisions were made and the rationale for these.

This meeting will form part of the two month notice period prior to any drugs being formally removed from the national Cancer Drugs Fund list.