NICE Single Technology Appraisal Guidance No 157- Dabigatran
etexilate for the prevention of venous thromboembolism after hip or
knee replacement surgery in adults
NICE Single Technology Appraisal Guidance No
157- Dabigatran etexilate for the prevention of
venous thromboembolism after hip or knee replacement surgery in
adults - the Scottish Medicines Consortium (SMC) published
advice on this medication for this indication in June 2008:
Dabigatran etexilate
(Pradaxa®) is accepted for use within NHS
Scotland for the primary prevention of venous thromboembolic events
(VTE) in adult patients who have undergone elective total hip
replacement surgery or total knee replacement surgery.
In two large phase lll studies, in patients undergoing either
total knee or total hip replacement surgery, dabigatran was
non-inferior to low molecular weight heparin in the incidence of
VTE and all cause mortality with patients having a similar
incidence of major bleeding events. The two drugs have similar
costs per dose but dabigatran has lower administration costs and is
an oral therapy. This may facilitate longer duration of
thromboprophylaxis, however the risks and benefits of this longer
treatment duration need to be considered on a case-by-case
basis.
Access the advice of the Scottish Medicines Consortium:
http://www.scottishmedicines.org.uk/smc/files/dabigatran%20etexilate%20Pradaxa%20FINAL%20May%202008%20for%20website.pdf
In this case, there is no material difference between the NICE
STA and the SMC recommendation.
NHSScotland should note that:
- NHS Boards should continue to adhere to the SMC advice.
- The new NICE single technology appraisal process is being
monitored by NHS Quality Improvement Scotland, Scottish Government
Health Directorates and SMC for a period of time. During this
period recommendations of NICE STAs will be only for noting by NHS
Scotland in the knowledge that SMC have already issued advice on
the medicine which NHSScotland should follow.
- Hard copies of NICE appraisals are available from NHS Quality
Improvement Scotland (contact Hana Bystronova, tel 0131 623 4287 or
email hana.bystronova@nhs.net).
Published Date: 24 September 2008
