Evaluation of Requests for Exemption from the Lowest Price Method (LPM)

Context

The evaluation of a multisource product might result in its being listed in an existing box on the List of Medications covered by the basic prescription drug insurance plan. Consequently, the Lowest Price Method (LPM) may apply to all products mentioned in this box. The manufacturer of the brand name product already registered on the List may apply for an exemption from application of the LPM in this situation. 

Process

1. Receipt at INESSS of a registration application for a multisource drug made by a manufacturer
The manufacturer of the multisource drug submits its registration application to INESSS in compliance with the requirements described on Checklist 6, specific to the first request for a new multisource medication.

2. Transfer of information to the Régie de l’assurance maladie du Québec (RAMQ)
INESSS informs RAMQ, which is the agency responsible for managing prices, of the possibility of adding a new product to the same box as an already-registered brand name drug, and notifies RAMQ that the LPM method could be applied.

RAMQ offers the manufacturer of the brand name product an opportunity to submit a request to have its product exempted from application of the LPM. The manufacturer then has a maximum of 10 calendar days to submit an evaluation request to INESSS justifying this exemption. The LPM might not apply to a medication that has one of the following characteristics:

• a drug that is highly toxic or one with a narrow therapeutic index;
• a drug with clinically high onset of action and absorption rate;
• a drug with a particular presentation or use.

3. Receipt of a request for exemption from the Lowest Price Method made by a manufacturer
The request for exemption from the LPM submitted by a manufacturer whose brand name medication is already registered must comply with the requirements described in Checklist 13, specific to a first request for such an exemption. INESSS evaluates the admissibility of the request and informs the manufacturer of its decision. If the request is admitted, the manufacturer will be notified of the fees payable to INESSS for this type of evaluation. Moreover, the project will be added to INESSS’s work plan and will trigger a consultation period. Please note that INESSS does not provide an opportunity for a meeting for this type of request.

4. Evaluation of a request for exemption from application of the LPM
Once admitted, a request for exemption is evaluated as expeditiously as possible in accordance with the process for the continuous evaluation of drugs that are being considered for listing purposes. Following the evaluation, the recommendation is forwarded to both the Minister and the manufacturer. The latter is informed of the Minister’s decision in the course of the normal list-updating process. The process and drug evaluation aspects are available on INESSS’s site. During the time that the request for exemption from the LPM is being evaluated, the multisource medication registration request might remain under study.

If the exemption from the LPM is recommended by INESSS and accepted by the Minister, the common name would, from that point on, be registered in the Appendix entitled “List of Medications for which the Lowest Price Method does not Apply” of the List of Medications covered by the basic drug insurance plan.

*Multisource medication: A product whose generic name, form and strength are already registered on the List of Medications covered by the basic prescription drug insurance plan.