Basis of a recommendation
Given the available data, the CNEDiMTS assesses the following for medical devices :
actual clinical benefit,
clinical added value,
intended role in the therapeutic strategy for a given disease,
indications and usage (treatment duration, frequency, proper use)
target population (estimated number of patients affected by the therapeutic indications).
Actual Clinical Benefit (ACB)
Does the medical device provide sufficient benefit for coverage by the National Health Insurance Fund ?
To respond to this question, the ACB must take into consideration :
severity of the disease,
intended role in the therapeutic strategy in comparison to other available therapies,
public health benefits.
The ACB levels used for medical devices are :
- "Sufficient" : a favourable opinion for registration on the list of products and services qualifying for reimbursement (established in Article L.165-1 of the French Social Security Code).
- "Insufficient" : an unfavourable opinion for registration on the list of products and services qualifying for reimbursement (established in Article L.165-1 of the French Social Security Code).
Clinical Added Value (CAV)
Does the medical device provide clinical added value when compared with available therapies ? If yes, to what extent ?
To respond to this question, the CAV must take comparative efficacy and safety data into consideration with regards to available therapies (reference medical device or better therapy).
The 5 CAV levels used for medical devices, when compared with existing therapeutic strategies, are :
- I : major
- II : important
- III : moderate
- IV : minor
- V : no improvement
The registration can only be renewed if the medical device provides a sufficient actual clinical benefit to justify its reimbursement. The actual clinical benefit is determined by reassessing the criteria led to the ACB, taking new available data into consideration. The ACB is assessed in each indication initially accepted for reimbursement.
When the ACB is sufficient to justify registration renewal, the clinical added value (CAV) is assessed versus the comparator considered as the standard according to the current data.