Announcement Of EMEA Authorisation Of Celgene’s VIDAZA (Azacitidine) For Treatment Of MDS And AML
The granting by EMEA of full marketing authorisation for Celgene’s VIDAZA
will bring new hope to MDS patients, particularly those with high risk forms
of these diseases that historically have been associated with a bleak
outlook.
Patients who are ineligible for stem cell transplant therapy are often
subjected to the discomfort, inconvenience and complications that can be
associated with essential, regular blood transfusions, a life saving
procedure which remains the mainstay of MDS treatment.
Recent published studies indicate that Celgene’s VIDAZA presently has the
unique potential to increase, significantly, survival of many, although not
all, patients with high risk MDS, at the same time reducing suffering and
improving quality of life.
However, in UK, EMEA approval is no guarantee of patient access to such a
new and potentially highly effective therapy. Until the National Institute of
Clinical Excellence (NICE) has, in turn, exercised its lengthy approval
procedure, prescription of demonstrably efficacious drugs may only be at the
discretion of local Primary Care Trusts (PCT’s). The experience of our Group
is that a combination of procedural inertia, ignorance of the degree of
patient suffering and misplaced costing assumptions, make it extremely
unlikely, in the majority of the UK regions, that the required levels of
funding will be authorised. This, coupled with the long approval cycle from
NICE, represent a frustrating, unnecessarily long and painful wait for
medication, after EMEA’s imprimatur.
Let’s hope that the introduction of this new, powerful medication from
Celgene, with significant, demonstrable benefits to many of the more severe
aspects of MDS, will attract an appropriately urgent and sympathetic response
from those charged with its availability and distribution to the patient
base.
David R Hall
Chairman – MDS UK Patient Support Group
http://www.mds-foundation.org
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