NorthWest Biotherapeutics Inc (NWBO)

[monarch6500]

UK info from Sep 2014 Phase 3 dependent.
from Evaluate

Tuesday, 09/16/14 11:42:23 PM
Re: None
Post 18995 of 125128

Early Access to Medicines Scheme (EAMS)
"7 April 2014 Applications now welcome"

Starting around 0:54 ... description of Step 2 ... Scientific Opinion ... more data ... at conclusion of Phase III .... or possibly a bit sooner.

Also see
http://www.mhra.gov.uk/home/groups/comms-ic/documents/websiteresources/con392877.pdf
includes:
STAGE 2: AN “EARLY ACCESS TO MEDICINES” SCIENTIFIC OPINION
The MHRA will issue a new benefit: risk scientific opinion that will support the
prescriber to make a decision with the patient on using this medicine, when still
unlicensed or used off-label.
The Government recognises that a clear route for earlier access is required following
a PIM designation. This opinion could support access by patients to innovative
medicines (outside of clinical trials) significantly earlier than the timeframes of the
normal drug development process – for instance, where compelling evidence exists,
we envisage this opinion being potentially given on the basis of phase II studies
instead of normally on the basis of phase III.
The MHRA will issue an opinion if the quality, safety and efficacy data provided in
support of the application is sufficiently compelling for a positive benefit:risk balance
and added clinical value. Information will be published on the MHRA website and, in
addition, prescribers could be informed through stakeholder engagement with
organisations such as the royal colleges and professional groups of specialists in the
disease areas where opinions have been given. The MHRA is also considering the
use of a number of alerting systems where healthcare professionals can sign up to
receive an email alert for news items and the monthly bulletin Drug Safety Update for
doctors and pharmacists.
The medicine will be made available free of charge by the company until the
marketing authorisation is granted, after which it would be expected to be subject to
standard NICE technology appraisal.
NHS England (or CCGs if relevant) would then act on the NICE guidance.
STAGE 3: LICENSING AND RAPID COMMISSIONING
Complementing the designation and earlier access, a newly co-ordinated NICE
technology appraisal and NHS England Commissioning process will be introduced
by which:
• Once licensed, medicines which have been developed through the Early
Access Scheme will be appraised by NICE for routine use on the basis of the
evidence collected in the earlier stages of the Scheme.
• As part of the appraisal process, manufacturers would be able to make use of
PPRS provisions for Flexible Pricing (or Patient Access Schemes) to adjust
the value proposition for medicines, taking account of the value of:
o The benefits of access and approval to the Sponsor.
o The benefits of the innovative medicine to the patient and healthcare
system.
• Medicines in the Early Access Scheme, once licensed, will typically be
commissioned by NHS England through its specialised commissioning
arrangements, delivering a single national approach to commissioning. NHSE
has (like CCGs) a legal duty to fund technologies positively appraised by
NICE within three months of publication.
• Academic Health Science Networks (AHSNs) will have significant potential to
support this process.