Échéancier de négociation
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Initiation
A drug is identified and brought into a pCPA process (see standard negotiation process or expedited negotiation pathways).
Drug eligible for pTAP
The manufacturer participated in the TLR pathway with Canada's Drug Agency (CDA-AMC) and is eligible for the pCPA temporary access process.
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Consideration
The pCPA considers the evidence (including HTA reimbursement recommendations) and gathers other data to inform the negotiation approach, in alignment with the needs of public drug plans. This phase concludes when the pCPA sends a letter of engagement to the manufacturer.
Letter of engagement sent to manufacturer
This lets the manufacturer know the pCPA is ready to start negotiating.
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Negotiation
The pCPA negotiation team reaches out to the manufacturer to outline next steps, then we exchange offers to try to reach an agreement on terms and funding conditions.
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Completion
The pCPA creates a letter of intent outlining negotiated terms. If the negotiation ended without an agreement, the pCPA sends a letter letting the manufacturer know that the negotiation is closed.
Negotiation process concluded
pTAP LOI created
A pTAP LOI has been created detailing the temporary agreement. The agreement remains in effect until a final agreement is negotiated, following positive final health technology assessment (HTA) reimbursement recommendations.