Where was this system introduced?
The system of substitutable medications is provided for within the scope of the Law from 17th December 2010 on the reform of the health care system, more specifically with the new article 22bis of the Social Security Code, which sets up a system of reimbursement basis in order to encourage delivery of substitution medications, i.e. medications containing the same active ingredient which are no longer patent-protected and therefore usually less expensive.
Which groups of medications does it apply to?
Currently, only two groups of medications are considered:
- hypocholesterolemic agents, more specifically the inhibitors of the HMG-CoA reductase (statines) ATC C10AA and
- preparations against peptic ulcers and reflux, in this case the Proton Pump Inhibitors (PPI) ATC A02BC.
How are these groups determined?
The Ministry of Health establishes a list of medications on the basis of the international scientific classification of the World Health Organisation (WHO).
Which obligations must the pharmacist assume?
It is the pharmacist's duty to inform the insured person when delivering medications that these are medications found on the list of groups of medications subject to a reimbursement basis. The pharmacist then offers a substitution with a less expensive medication belonging to the same group.
What if a medical treatment belonging to a group of substitution medications is prescribed under its INN name?
When a medication is prescribed under its International Nonproprietary Name (INN), the coverage is limited to the medication containing the same active ingredient and the least expensive from the positive list of medications.
What does INN stand for?
International Nonproprietary Names (INN; in French dénominations communes internationales DCI) identify pharmaceutical substances or active pharmaceutical ingredients. Each INN is a unique name that is globally recognized and is public property. A nonproprietary name is also known as a generic name (source : WHO - World Health Organisation).
Is the use of substitute medications mandatory?
For a prescribed medication to be substitutable, it must belong to a group of substitute medications defined by the Health Directorate (Direction de la Santé).
If this is the case, the pharmacist compares its retail price with the reimbursement basis calculated for this specific medication.
There are two possible scenarios:
- The price of the prescribed medication is lower than or equal to the calculated reimbursement basis; the pharmacist can supply the prescribed medication.
- The price of the prescribed medication is higher than the calculated reimbursement basis; the pharmacist must offer the patient the most economical substitute medication belonging to the same group.
He informs the patient that the requirement to supply substitute medications does not affect the doctor’s prescription and that the medication is therapeutically equivalent.
The insured person may decide to either take the suggested substitute medication or refuse it.
What about reimbursement?
For each medication included in the list of reimbursable medications and defined by the Health Directorate (Direction de la Santé) as having a generic equivalent, the CNS sets a reimbursement basis, i.e. a reference amount on which the calculation of the patient’s participation is based. If the insured person refuses the substitution with a therapeutically equivalent medication and instead chooses the medication stated on the prescription, they must pay the difference between the set reimbursement basis and the retail price of the medication supplied, in addition to the statutory participation.
Does substitution affect all medications for which generics exist?
Currently, substitution only concerns two specific groups of medications, which are the hypocholesterolemic agents and preparations against peptic ulcers and reflux.
Where can I find the groups of substitutable medications?
The list of substitutable medications can be found under Medicines > Substitutable medications > In practice.
Where can I find the list of excipients with notorious effects?
The list of excipients with notorious effects can be found under Medicines > Substitutable medications > In practice.