HEDS is part of the School of Health and Related Research (ScHARR) at the University of Sheffield. We undertake research, teaching, training and consultancy on all aspects of health related decision science, with a particular emphasis on health economics, HTA and evidence synthesis.

Wednesday, 19 November 2014

Early Access to Medicines Scheme

On 7 April 2014 the Early Access to Medicines Scheme (EAMS) was launched. EAMS aims to give patients with life threatening or seriously debilitating conditions access to medicines that do not yet have a marketing authorisation when there is a clear unmet medical need.

Under the scheme, the Medicines and Healthcare products Regulatory Agency (MHRA) will provide a scientific opinion on the benefit/risk balance of the medicine, based on the data available at the time of the EAMS submission.   The opinion will support the prescriber and patient to make a decision on whether to use the medicine before its licence is approved.

MHRA is responsible for the scientific aspects of the scheme and the scientific opinion will be provided after a two-step evaluation process.

Step I - Promising innovative medicine (PIM) designation
The PIM designation will give an indication that a product may be eligible for the Early Access to Medicines Scheme (based on early clinical data).

Step II - Early access to medicines scientific opinion
The scientific opinion will describe the benefits and risks of the medicine, based on the information submitted to MHRA by an applicant. Following a positive EAMS scientific opinion, MHRA will publish a Public Assessment Report (PAR) and the EAMS treatment protocol on the MHRA website. The PAR will include:
  • how the product is used and how it works
  • summary of the key clinical studies
  • the risks and benefits of the product
  • the reason for the positive EAMS scientific opinion
  • any uncertainties
  • information about ongoing clinical studies
  • measures in place to monitor and manage risk.

UK Life Sciences Minister George Freeman said: "The designation of the PIM is the first, crucial step in developing cutting-edge medicines sooner, giving real hope to patients and their families."

NHS = National Hope Service?

The first PIM was awarded to DCVax-L - a personalised immunotherapy that targets malignant gliomas – in September.  Another was awarded in October, but its name – nor those of any subsequent drugs – will be made public.