SVMPharma RWE - Early engagement and RWE sources: The Early Access to Medicines Scheme (EAMS). For more information and resources visit us at www.svmpharma.com

1. The early access to medicines
scheme (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.
For more on RWE visit:
www.svmpharma.com
1. NICE leads access to medical
devices
2. Turning Real World Data into Real
World Evidence: identifying and
overcoming RCT data gaps
3. RWD and RWE: Where is the Value?
RWE messages that you
may have missed out on
(Click on the links below to find out more)
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CONTACT US
enquiry@svmpharma.com
+44(0) 1252 417030
SVMPharma Limited
www.svmpharma.com
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SVMPharma’s team have experience
running EAMS programmes. EAMS
can become a source of Real World
Evidence
Early engagement and RWE sources:
The Early Access to Medicines Scheme (EAMS)

2. CONTACT US
enquiry@svmpharma.com
+44(0) 1252 417030
SVMPharma Limited
www.svmpharma.com
SVMPharma - Transforming Real World Data into Real World Evidence
Launched in April 2014, the aim of the Early Access to Medicines Scheme (EAMS)
is to provide earlier availability of promising new unlicensed medicines
(medicines that do not have a marketing authorisation) to UK patients that have a
high unmet clinical need.
The medicines included in the scheme are those that are intended to treat,
diagnose or prevent seriously debilitating or life threatening conditions where
there are no adequate treatment options.
EAMS offers early engagement with NICE and MHRA
EAMS is a two step process:
1. The Promising Innovative Medicine (PIM) designation
2. The Early Access to Medicines scientific opinion
SVMPharma’s team have experience of implementing and executing EAMS with
over 13 successful EAMS programs. Contact Dr Zahid Bashir to learn more.
ZahidBashir@svmpharma.com
What is the Early Access to Medicines Scheme?
1. A PIM designation is an early indication that a
medicinal product is a promising candidate for
EAMS and is an opportunity to engage with
NICE and the NHS on patient access issues
2. The scientific opinion will describe the
benefits and risks of the medicine by the
MHRA
Following a successful application, patients will be able to access important
medicines before they are licensed and prescribers will have greater
confidence in the safety and efficacy of prescribing.

3. CONTACT US
enquiry@svmpharma.com
+44(0) 1252 417030
SVMPharma Limited
www.svmpharma.com
SVMPharma - Transforming Real World Data into Real World Evidence
SVMPharma’s team have experience of implementing and executing EAMS with
over 13 successful EAMS programs. Contact Dr Zahid Bashir to learn more.
ZahidBashir@svmpharma.com
EAMS in the real world
To date, the patient access periods for EAMS-approved products have been
short and there has been limited opportunity to collect real world data (RWD),
however, both industry and the NHS recognise the potential value of collecting
detailed RWD during EAMS and analysing this data to generate insights to
support commissioning and funding discussions.
Source: data from MHRA
The first scientific opinion was given in
March 2015 for Pembrolizumab for the
treatment of advanced melanoma.
Pembrolizumab, the first product to complete the EAMS process was able to
secure a fast track NICE appraisal, as well as a 30 day implementation timetable
for the positive NICE recommendation.
Since then, 58 PIM and 21 Scientific opinion applications have been submitted
to date (October 2017) with 72% and 76% granted respectively. Most of the
positive EAMS scientific opinion have been in cancer.
0
10
20
30
40
50
60
70
Applications PIMs granted PIMs refused PIMs
withdrawn
PIMs pending
0
5
10
15
20
25
Applications Opinions
awarded
Opinions
refused
Opinions
pending