On February 12, 2015, Quebec’s Minister of Health and Social Services, Gaétan Barrette (the Minister), announced new rules regarding the use of the instruction “do not substitute” on innovator drugs prescribed to patients insured by the Régie de l’assurance maladie du Québec (theRAMQ).

Since 1996, patients with prescriptions bearing the instruction “do not substitute” have been able to obtain the innovator version of a drug and be reimbursed for the price assigned to that drug by the RAMQ, even though the innovator drug costs more than its generic version. In a press release, the Minister stated that this had resulted in $80 million in additional costs in 2013.

Beginning on April 24, 2015, the instruction “do not substitute” on a prescription for an innovative drug will have to be accompanied by a reason code indicating [translation] “a recognized therapeutic consideration specific to a patient’s condition in order to be recognized by the RAMQ. In other words, prescribing physicians will now have to justify the use of “do not substitute” on their patients’ prescriptions when an equivalent generic version is available. The government expects to generate approximately $40 million in savings over the next year by implementing these new rules.

It is important to understand, however, that the decision as to which drug they  receive (innovator or generic) still lies with the patient. If patients request the innovator version when a generic version is available, they will have to pay the difference in price.

Key dates

The new rules will come into effect on April 24, 2015 and will apply to new prescriptions.

Renewed prescriptions already bearing the instruction do not substitute will be reimbursed until June 1, 2015, even if the physician does not indicate a reason. After that date, patients presenting prescriptions with the instruction “do not substitute” but no reason code will be reimbursed by the RAMQ on the basis of the price of the generic drug, not the innovator drug.

Transition period and special rule for Clozapine and immunosuppressive drugs

The Minister has also provided a transition period for the permanent application of the new rules for prescriptions for Clozapine and immunosuppressive drugs which will continue to be covered by the RAMQ, until June 1, 2015, without a reason code being required.

Link to announcement:

Mesure d’économie concernant les médicaments – Nouvelles règles concernant le recours à la mention ne pas substituer, press release published by the office of the Minister of Health and Social Services, Quebec’s Portal, on February 12, 2015 (available in French only)