VEDOLIZUMAB 300mg powder for solution for

Transcription

VEDOLIZUMAB 300mg powder for solution for
PAN MERSEY AREA PRESCRIBING COMMITTEE
PRESCRIBING POLICY STATEMENT
Pan Mersey
REF: PS76 FINAL
Area Prescribing Committee
APC BOARD DATE: 28 JAN 2015
PENDING CCG APPROVAL
VEDOLIZUMAB 300mg powder for solution for infusion
(Entyvio®▼) in Crohn’s Disease
G
R
E
Y
The Pan Mersey Area Prescribing Committee does not currently
recommend the prescribing of VEDOLIZUMAB 300mg powder for
solution for infusion (Entyvio®▼) in Crohn’s disease
 A NICE Technology Appraisal (TA) is currently in development that will review the use of
vedolizumab for treating moderate to severe Crohn’s disease following intolerance,
inadequate response or loss of response to conventional therapy or TNF alpha antagonists.
This recommendation will be reviewed following publication of the TA.1

Following release of the negative Appraisal Consultation Document (ACD) for vedolizumab
for treating moderately to severely active Crohn’s disease after prior therapy [ID690], NICE
has received a request from the company for an extension in timings to allow for a proposed
update to the Patient Access Scheme and the submission of a revised economic model to
address the issues identified in the ACD.
 In the meantime clinicians should continue to follow the Crohn’s disease NICE clinical
guideline (CG152 October 2012) and pathway.
 Infliximab and adalimumab within their licensed indications are recommended by NICE as
treatment options for adults with severe active Crohn's disease whose disease has not
responded to conventional therapy (including immunosuppressive and/or corticosteroid
treatments), or who are intolerant of or have contraindications to conventional therapy.
Infliximab or adalimumab should be given as a planned course of treatment until treatment
failure (including the need for surgery), or until 12 months after the start of treatment,
whichever is shorter. People should then have their disease reassessed at least every 12
months to determine whether ongoing treatment is still clinically appropriate.2
References
National Institute for Health and Care Excellence. Crohn's disease (moderate to severe) –
vedolizumab. Accessed 29January 2015 at:
http://www.nice.org.uk/Guidance/InDevelopment/GID-TAG461
2. National Institute for Health and Care Excellence. Infliximab (review) and adalimumab for the
treatment of Crohn's disease. Technology Appraisal Guidance 187. May 2010. Accessed 29
January 2015 at http://www.nice.org.uk/guidance/ta187
1.
Note: Patients who are not eligible for treatment under this statement may be considered on an
individual basis where their GP or consultant believes exceptional circumstances exist that warrant
deviation from the rule of this policy. In this situation, follow locally defined processes.
Version: 2
Review date: January 2017
(or earlier if there is significant new evidence relating to this recommendation)