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 (the RAMQ).
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
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
Transition period and special rule for Clozapine and
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
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