Category C3
Self-monitoring, self-treatment
Which solutions fall into category C3?
These are those that contribute toimproving the autonomous management of treatments by people suffering from a disease thanks to the self-monitoring of physiological parameters in particular.
Systems that enable diagnosis, autonomous initiation of treatment, automatic transmission of data via a remote monitoring solution are not included in this category.
Target users
This category includes digital solutions used bypatients only.
Existing funding
In order to assess the value of these devices falling into this category they must be compared with comparable non-connected devices.The assumption of responsibility that results from the HAS's scientific assessment therefore depends on the assumption of responsibility of the comparator, for example, a medical device with no digital function.
Thus, if the comparator is covered by the LPP, this type of device may be covered via the LPP. The value of the digital function may be enhanced if the HAS assessment demonstrates its added value.
The digital solution could also be financed bythe patient or via the intermediary of complementary organizations.
Example
A device that pairs a blood glucose meter with an external insulin pump
This solution enables both self-monitoring and self-treatment. It communicates by radio frequency with the pump designed to store and administer insulin subcutaneously, and therefore has a therapeutic function. The wireless programmer integrating the blood glucose meter controls the pump and suggests insulin bolus doses to be delivered according to the blood glucose level determined by the bolus calculator. This device includes alert functions for the patient in the event of pump expiry, when the insulin reservoir is empty.
This device has had a favorable opinion for reimbursement via the LPP by the HAS which concluded that there was no improvement in the expected service compared with insulin pumps with external tubing.