microINR for anticoagulation therapy

Level of innovation

All 3 experts agreed that the use of point-of-care tests is established practice and this device offers a minor variation on current point-of-care tests available. Two experts highlighted the variation is a minor improvement in offering Bluetooth and wireless connectivity as well as smaller blood volume needs.

Potential patient impact

All 3 experts highlighted the patient impacts are the same as those from any point-of-care tests in supporting patients in self-monitoring in their own home, not having to attend appointments and having more control over their life. One expert highlighted that the specific innovation of smaller blood samples may make collection and results more reliable. Two experts discussed those on warfarin to benefit from this technology and 1 expert highlighted that those who are needle phobic or have poor venous access may particularly benefit.

Potential system impact

All experts felt it would contribute similarly to current point-of-care tests that are available. One expert highlighted the known benefits for those using point‑of‑care tests improving the time in therapeutic range than when managed with traditional international normalised ratio (INR) testing. One expert raised that the addition of this device in the market may encourage other hospital-based warfarin clinics to move to this less-invasive approach. This is potentially relevant because another expert highlighted that standard care is disparate across NHS organisations with some adopting point-of-care tests more readily than others.

All experts raised the cost increase of replacing secondary care laboratory‑based testing. However, 1 expert highlighted the benefit of increasing the number of people seen and maximising clinic time by using a point-of-care test, removing the delay waiting for laboratory test results. Two experts felt the stated price points appeared to be comparable cost implications in the primary care setting with alternative point-of-care tests.

Introduction of this device was not reported to need any facility changes, but 2 experts discussed the resource implications in training healthcare professionals. One expert highlighted the variation in training time needed for individual users to be competent. Two experts discussed the resource need for ongoing support and calibration checks once this type of technology is adopted.

General comments

Two experts reported that the number of people this device would be suitable for is reducing because of the introduction of direct oral anticoagulants which do not need INR monitoring. Experts suggested that warfarin monitoring using point-of-care tests would be suitable for between 5% and 10% of people having anticoagulation.

One expert raised the issue that individuals can purchase the devices directly, which can cause difficulties if the healthcare professionals are not consulted and are unfamiliar with the device. One user of a competitor point-of-care test reports to have used this satisfactorily, however raised the disadvantage that having had no competitor in the market has potentially limited competition‑driven pricing. This expert highlighted that often patients buy their devices themselves, so cost stops many from using the device.

One expert highlighted the limited evidence for patients with antiphospholipid antibodies using point-of-care tests. Further research to show reliable responses for these people would be useful. One expert called upon trials comparing this device with alternative point-of-care tests as well as 2 or 3 national laboratory-based analysers to confirm compliance based upon local verification.