Roche 4625358019 CoaguChek XS PT Test Strip, Pack of 24

Product Information

The 2 UK-based economic evaluations were based on data from the same trial. One evaluation adopted an NHS and wider societal perspective, and the other adopted an NHS and personal social services perspective. Self-monitoring strategies appeared to increase the costs of INR monitoring in the short term and because these 2 evaluations applied small effect estimates, consistent with those seen in the largest UK-based trial of patient self-management, self-monitoring of INR appeared unlikely to be cost effective. However, no UK-based trials have been sufficiently powered to detect a statistically significant difference between standard INR monitoring and patient self-monitoring in terms of major thromboembolic or haemorrhagic events. Therefore, the External Assessment Group carried out a meta-analysis of relevant trials including evidence from a number of European trials in which standard care is similar to that provided in the UK in terms of approach, frequency and the level of INR control achieved. Economic analysis Dabigatran etexilate for the prevention of stroke and systemic embolism in atrial fibrillation. NICE technology appraisal guidance 249 (2012). Target range aware: Once you set up targets in your CoaguChek INRange, it will clearly let the patient know about results out of that range. Permits systems communications with hospital and laboratory information systems via Roche cobas IT 1000 or other standards-compliant data management solutions New oral anticoagulants are an alternative to vitamin K antagonists and can be administered to reduce the risk of thrombosis or stroke. The new oral anticoagulants have fewer food and drug interactions than vitamin K antagonists and they do not involve therapeutic monitoring. However, they may be unsuitable for some people such as people with mechanical heart valves, people with renal or liver dysfunction and those taking concurrent drugs that cannot be taken with the new oral anticoagulants. NICE technology appraisal guidance recommends the use of 3 new oral anticoagulants: apixaban, rivaroxaban and dabigatran etexilate, for preventing stroke and systemic embolism in people with non-valvular atrial fibrillation.

Value": "The CoaguChek XS System is intended for use by professional healthcare providers for quantitative prothrombin time testing for the monitoring of warfarin therapy. The CoaguChek XS System uses fresh capillary or nonanticoagulated venous whole blood.",The INRatio2 PT/INR monitor is only recommended for use in research for self-monitoring coagulation status in people on long-term vitamin K antagonist therapy who have atrial fibrillation or heart valve disease. Research is recommended into the clinical benefit and cost effectiveness of using this point-of-care coagulometer (see section7.1). 2 The technologies

April 2022, Roche Diagnostics will partner with Williams Medical We’re pleased to announce that from 4th April 2022, Williams Medical and Roche Diagnostics will be joining forces code chip, which contains calibration data and the expiry date of the test strips, is inserted into the meter before it is switched on. Once the device is switched on, a test strip is inserted and the blood sample is applied. The test result is displayed approximately 1 minute after applying the sample and the monitor automatically stores the result in its memory. The user is guided through the process by on-screen graphical instructions. The structure of the Markov model was based on the review of published models of INR self-monitoring and previous models evaluating the cost effectiveness of new anticoagulant drugs compared with warfarin therapy in people with atrial fibrillation. A further unpublished economic model of INR self-monitoring was provided by the manufacturer of CoaguChek XS, and this model was also used to inform the structure of the new economic model. Heneghan, C., Alonso-Coello, P., Garcia-Alamino, J.M., Perera, R., Meats, E., Glasziou, P. (2006). Self-monitoring of oral anticoagulation: a systematic review and meta-analysis. Lancet 367, 404–411

4  The diagnostic tests

could have a different impact on people protected by the equality legislation than on the wider population, for example by making it more difficult in practice for a specific group to access the technology

One trial reported the time for each INR monitoring (that is, time from INR measurement to test results) and the total time spent for anticoagulant management during the 4-month follow-up period. The time spent for each INR measurement by self-managed participants was statistically significantly lower (mean 5.3 minutes, standard deviation [SD] 2.6 minutes) compared with the time spent by participants receiving standard care (mean 158 minutes, SD 67.8 minutes, p<0.001). During the 4-month follow-up, the total time spent for anticoagulation monitoring by participants in standard care was statistically significantly higher (mean 614.9 minutes, SD 308.8 minutes) than the total time spent by participants who self-managed their therapy (mean 99.6 minutes, SD 46.1 minutes, p<0.0001). Patient compliance with testing This document has been prepared for public consultation. It summarises the evidence and views that have been considered, and sets out the draft recommendations made by the Committee. NICE invites comments from registered stakeholders, healthcare professionals and the public. This document should be read along with the evidence base (the diagnostics assessment report).

1 Provisional recommendations

As one of the UK’s largest suppliers of medical disposables, equipment, pharmaceuticals and medical services, we are constantly The CoaguChek XS system is recommended for self-monitoring coagulation status in people on long-term vitamin K antagonist therapy who have atrial fibrillation or heart valve disease if:

Patients who self-test are more engaged in their own care, test more often and spend more time in therapeutic range. 4,5 The INRatio2 PT/INR monitor analyses fresh capillary blood and when the blood sample is applied to the sample well, it is drawn through the narrow channels by capillary action to the clot cells, where the impedance of the sample is measured by the monitor through the electrodes. Clot cells have reagents applied and the reagents are different for each channel. One channel contains the thromboplastin reagent for the prothrombin time test. The other 2 channels contain reagents that produce a low and high control time, regardless of the clotting time of the sample. the patient or their carer is both physically and cognitively able to do the self-monitoring effectively. Senior Clinical Advisor, NIHR Evaluation Trials and Studies Coordinating Centre, University of Southampton There are a number of conditions that can result in people having an increased risk of thrombosis and consequently, receiving long- term vitamin K antagonist therapy. These conditions include atrial fibrillation and heart valve disease. Guidance on self-monitoring the coagulation status of people who have had a venous thromboembolism and are receiving long-term vitamin K antagonist therapy is included in Venous thromboembolic diseases (NICE clinical guideline 144) and so this population is not included in the scope of this diagnostics assessment of self-monitoring coagulometers. Atrial fibrillationData on the resource use and costs associated with the alternative monitoring strategies were informed by published literature, existing guidance, expert opinion, manufacturers’ and suppliers’ prices, and other routine sources of unit cost data. Some costs were informed by expert opinion if suitable data from other sources were not available. Health-related quality of life One trial compared self-management with self-testing in children and provided quality-of-life data using the KIDCLOT PAC QL parent-proxy (parents’ quality of life and their assessment of child's quality of life) and the child teen KIDCLOT PAC QL. The 5 common themes identified were: awareness, communication, relationship between parent and child, flexibility and anxiety. Costs and cost effectiveness Professor of Public Health and Clinical Epidemiology, Peninsula Technology Assessment Group (PenTAG)