New rules for the reimbursement of medicines from 1 September

Health Insurance covers all or part of the cost of the reimbursable medicines you buy. And your Vitale card allows you not to have to advance this part of the costs covered by the Health Insurance; it is the ‘third-party payment’ principle.

From 1^er in september 2026, you will no longer benefit from the third-party payment if you refuse the substitution that may be offered to you by a pharmacist: take a biosimilar or hybrid drug instead of a reference drug. You will therefore have to pay the pharmacist the full amount of the drug. You will then be reimbursed by the Health Insurance, at the fixed rate.

One hybrid drug contains the same active substance as a reference medicinal product; however, it differs from the latter by a difference concerning, for example:

• the therapeutic form (for example, a hybrid medicine may be offered as an oral solution to make it easier for very young or elderly patients to use);
• dosing (a hybrid drug may, for example, have a dosage that reduces the number of times a day it takes treatment);
• the route of administration (a new route of administration may be used to make it easier for people with difficulty swallowing to take the medicine).

One biosimilar medicinal product is similar to a reference biologic drug (there are very slight differences between the two). A biological drug is a treatment made from a living cell or organism. These include hormones (insulins, growth hormones, etc.) or vaccines. A biosimilar medicinal product may be produced when the patent for the reference biological medicinal product has become publicly available.

Your pharmacist is not allowed to replace the reference treatment with a hybrid or biosimilar medicine, if your doctor has ruled this out in view of your medical situation ; your doctor must have clearly stated on the prescription that it is not possible to substitute the reference medicine with another treatment.

The Health Insurance underlines that « by accepting a hybrid or biosimilar drug where substitution is possible, continuity of treatment is ensured, while contributing to the control of health expenditure, the prevention of supply disruptions and the maintenance of sustainable access to treatment for all ».