Point-of-care tests (CoaguChek system, INRatio2 PT/INR monitor and ProTime Microcoagulation system) for the self-monitoring of the coagulation status of people receiving long-term vitamin K antagonist therapy compared with standard UK practice

Summary

This NIHR HTA-funded project assessed the clinical and cost effectiveness of point-of-care coagulometers for the self-monitoring of the coagulation status (self-testing and self-management) in people receiving long-term vitamin K antagonist therapy. Three devices (CoaguChek system, INRatio2 PT/INR monitor and ProTime Microcoagulation system) were considered as an alternative to standard monitoring practice in the UK and the assessment was conducted according to current methodological standards. A de novo economic model was developed to assess the cost-effectiveness of self-monitoring versus standard primary or secondary care clinic monitoring. Current NICE guidance (DG14, published September 2014), which is based upon the results of this assessment, recommends the use of the CoaguChek XS system and InRatio2 PT/INR monitor for the self-monitoring of coagulation status in adults and children taking long-term vitamin K antagonist therapy who have atrial fibrillation or heart valve disease if:
• They prefer this form of testing and
• They or their carers are both physically and cognitively able to self-monitor effectively.

The guidance points out that there is greater uncertainty of clinical benefit for the InRatio2 PT/INR monitor than for the CoaguChek XS system but the precision and accuracy of both monitors are comparable to laboratory-based INR testing.

https://www.nice.org.uk/guidance/dg14

Our report was also reviewed by the Scottish Health Technologies Group to inform NHS Scotland (Health Improvement Scotland, Evidence note 57) http://healthcareimprovementscotland.org/our_work/technologies_and_medicines/shtg_-_evidence_notes/evidence_note_57.aspx

For further information see:

http://www.nets.nihr.ac.uk/projects/hta/130601

http://guidance.nice.org.uk/DT/16

Contact

Pawana Sharma; p.sharma@abdn.ac.uk

Status

Completed

Publications

Sharma, P, Scotland, G, Cruickshank, M, Tassie, E, Fraser, C, Burton, C, Croal, B, Ramsay, C, Brazzelli, M  Is self-monitoring an effective option for people receiving long-term vitamin K antagonist therapy? A systematic review and economic evaluation. BMJ Open 2015;5(6):e007758