First PT/INR home self-testing device with Bluetooth technology enabling remote care programmes for anticoagulated patients

CoaguChek INRange system enhances patient engagement with healthcare providers for optimal therapy management

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has launched the CoaguChek® INRange system in countries accepting the CE Mark*. The CoaguChek INRange system is the first Bluetooth enabled PT/INR home health device that helps patients and their healthcare providers (HCPs) have greater control over their coagulation status and the ability to monitor Vitamin K Antagonist (VKA) therapy. Patient self-testing with CoaguChek INRange sets a new standard of care by enabling HCPs to monitor patient PT/INR data, while reducing visits to the lab.

Frequent self-testing offers both clinical and patient benefit as it has been proven that patients that adhere to their monitoring therapy spend more time in their therapeutic range, which results in lower incidence of stroke¹ or bleeding.² It has been demonstrated that 50–60% of patients can be expected to remain in their target range if monitoring of INR occurs monthly, 77–85% if monitored weekly and up to 92% if monitored every three days.³ Patients who spend a high proportion of time (> 70%) in the therapeutic range achieve better clinical outcomes.^4,5

Evidence suggests that patients who have a strong link with their healthcare professional adhere better to their anticoagulant therapy plan.³ The CoaguChek INRange system helps enhance the relationship between patients and their healthcare providers. Patients build a deeper understanding of their PT/INR results through frequent self-testing and physicians are more confident that they can optimise treatment decisions effectively as they have access to patient data in near real-time.

“As healthcare systems face continued pressure to deliver improved access to care at a lower cost, increased connectivity between HCPs and patients becomes even more important,” said Roland Diggelmann, COO, Roche Diagnostics. “This innovative technology continues the CoaguChek legacy of setting the standard in coagulation monitoring by providing high quality, convenient care, while optimising outcomes for patients. This is another proof point towards our aim to position patient self-testing as the standard of care to monitor VKA therapy.”

Usual care or management of patients on VKA therapy includes frequent visits to the hospital or general practitioner for PT/INR testing with a venipuncture and waiting up to 2-3 days for the lab results. The CoaguChek INRange system engages patients in their care with a simple fingerstick and 60-second test, giving patients the independence to continue their normal daily activities and quality of life while maintaining connections with their HCPs.

"In a clinical environment, we need to establish a model of care that empowers patients, helping them to understand their health condition and allowing them to take responsibility of their own health care needs,” stated Juan Carlos Souto, renowned Physician at the Hospital de Sant Pau in Barcelona, Spain and author of over 400 scientific articles and communications. “The new technology will enable us to access the test results in the clinic’s database, to keep track of the individual patient’s status and to measure the quality of care provided by our clinic."

More about the CoaguChek INRange system

Since 1993, CoaguChek® systems from Roche have set the standard in point-of-care INR testing for patients on oral anticoagulant therapy–giving clinicians confidence in making critical treatment decisions.

The CoaguChek INRange system helps patients to spend more time in therapeutic range with minimal training, including medication and testing reminders, flagging of results in relation to the target range and the option to insert comments to the result. The hand-held home health device enables patients to conveniently monitor PT/INR results with an intuitive user-interface, while enabling flexible remote connectivity to their healthcare providers through Bluetooth technology. Trend report functionality also provides both patients and their healthcare provider with an overview on the stability of their anticoagulation levels, enabling optimised therapy management.⁶ To learn more about the CoaguChek INRange system and patient self-testing, please visit www.coaguchek.com.

More about anticoagulant therapy

Millions of people worldwide are taking Vitamin K Antagonists (VKAs) for a variety of indications or conditions, such as atrial fibrillation (AF), deep vein thrombosis (DVT), pulmonary embolism (PE), and the presence of a mechanical heart valve (MHV). To best monitor the efficacy of VKAs, the prothrombin time PT (INR) needs to be frequently measured. This test can be performed at home using a small drop of blood from a patient’s fingertip. Compared with usual care or management in an anticoagulation clinic, patient self-testing has been shown to result in more time spent in the therapeutic range,^7-9 fewer very high or very low INR values,⁹ fewer thromboembolic events,^1,10 fewer major hemorrhages,¹⁰ lower mortality,¹⁰ improved patient quality of life^10,11 and better treatment satisfaction.^11,13

More about PT/INR

Taking the correct dose is crucial for efficient anticoagulation treatment. The correct dose is established by measuring how long it takes blood to clot, and is called the International Normalised Ratio (INR). The proportion of time INR values are within the upper and lower target value is called Time in Therapeutic Range, or TTR. This is important because the more time patients are in range, the less chance of complications, such as blood clots or excessive bleeding.

About Roche

Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives.

Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.

Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. Twenty-nine medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Roche has been recognised as the Group Leader in sustainability within the Pharmaceuticals, Biotechnology & Life Sciences Industry seven years in a row by the Dow Jones Sustainability Indices.

The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2015 employed more than 91,700 people worldwide. In 2015, Roche invested CHF 9.3 billion in R&D and posted sales of CHF 48.1 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.

All trademarks used or mentioned in this release are protected by law.

*Local product availability may vary independently from CE Mark approval.

References

1. Heneghan C, Ward A, Perera R, et al. Self-monitoring of oral anticoagulation: systematic review and meta-analysis of individual patient data. Lancet. 2012;379:322-334.
2. 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.
3. Khan TI, Kamali F, Kesteven P, Avery P, Wynne H. The value of education and self-monitoring in the management of warfarin therapy in older patients with unstable control of anticoagulation. Br J Haematol. 2004;126(4):557-654.
4. Gallagher, A.M., Setakis, E., Plumb, J.M., Clemens, A., van Staa, T.-P. (2011). Risks of stroke and mortality associated with suboptimal anticoagulation in atrial fibrillation patients. Thromb Haemost 106, 968–977.
5. Wan, Y., Heneghan, C., Perera, R., Roberts, N., Hollowell, J., Glasziou, P. et al. (2008). Anticoagulation control and prediction of adverse events in patients withatrial fibrillation: a systematic review. Circ Cardiovasc Qual Outcomes 1, 84–91.
6. Ward A, Tompson A, Fitzmaurice D, Sutton S, Perera R, Heneghan C. Cohort study of Anticoagulation Self-Monitoring (CASM):a prospective study of its effectiveness in the community. Br J Gen Pract. 2015;65(636):e428-437.
7. Bereznicki, L.R.E., Jackson, S.L., Peterson, G.M. (2013). Supervised patient self-testing of warfarin therapy using an online system. J Med Internet Res 15, e138.
8. Christensen, H., Lauterlein, J.-J., Sørensen, P.D., Petersen, E.R.B., Madsen, J.S., Brandslund, I. (2011). Home management of oral anticoagulation via telemedicine versus conventional hospital-based treatment. Telemed J E-Health Off J Am Telemed Assoc 17, 169–176.
9. Bussey, H.I., Bussey M., Bussey-Smith K.L., Frei, C.R. (2013). Evaluation of warfarin management with international normalized ratio self-testing and online remote monitoring and management plus low-dose vitamin k with genomic considerations: a pilot study. Pharmacotherapy 33, 1136–1146.
10. 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.
11. Matchar, D.B., Jacobson, A., Dolor, R., Edson, R., Uyeda, L., Phibbs, C.S., et al.; THINRS Executive Committee and Site Investigators. (2010). Effect of home testing of international normalized ratio on clinical events. N Engl J Med 363, 1608–1620.
12. Salvador, C.H., Ruiz-Sanchez, A., González de Mingo, M.A., Carmona Rodríguez, M., Carrasco, M.P., Sagredo, P.G., et al. (2008). Evaluation of a telemedicinebased service for the follow-up and monitoring of patients treated with oral anticoagulant therapy. EEE Trans Inf Technol Biomed 12, 696–706.
13. Gardiner, C., Williams, K., Mackie, I.J., Machin, S.J., Cohen, H. (2005). Patient self-testing is a reliable and acceptable alternative to laboratory INR monitoring. Br J Haematol 128, 242–247.