On June 13, 2018, the pan-Canadian Pharmaceutical Alliance (pCPA) released its draft Brand Process Guidelines (Guidelines) for stakeholder feedback. As part of the consultation process, pCPA is planning a webinar for innovative manufacturers on June 22, 2018. The pCPA also released a Frequently Asked Questions (FAQ) document, and a Letter of Intent (LOI) template with the Brand Process Guidelines.
Brand Process Guidelines. The Guidelines are intended to promote a common understanding of the pCPA process, and provide an overview of the pCPA process broken down into the following phases: pre-pCPA, initiation, consideration, negotiation, completion, and post-pCPA. The Guidelines provide details on: (i) initiation of the pCPA process for new drugs, existing drugs and line extensions, (ii) the content expectations for manufacturer proposals, (iii) negotiation format and negotiator expectations, as well as (iv) communication, confidentiality and disclosure requirements during negotiation. The Guidelines also include target completion timelines for the pCPA process, which sets out an estimated timeline of ≤ 140 days from initiation to completion.
Frequently Asked Questions (FAQ). The FAQ document provides an overview of some commonly asked questions such as: (i) factors that can impact negotiation timelines, (ii) whether a manufacturer can negotiate with individual jurisdictions after receiving a Close Letter (a letter indicating that the pCPA is not opening negotiation for a particular drug) from the pCPA, and (iii) whether a decision to close negotiations without an LOI can be reconsidered.
Letter of Intent (LOI) Template. The LOI template is a standard form document that will detail the agreed upon terms and conditions for funding reached between the lead province(s) and the manufacturer. Of note for manufacturers, the template sets out sample provisions for first dollar and incremental rebates. The template also states that participating jurisdictions may renegotiate the terms of the agreement through the pCPA where there are significant market changes or if expenditures for the drug product significantly exceed the participating jurisdictions’ budget impact. Finally, the template includes standard provisions for continued enrolment of patients in a manufacturer’s patient support program (PSP) for a specified period of time after listing or indefinitely where the patient does not meet the reimbursement criteria in the jurisdiction.
Interested stakeholders should consider attending the pCPA’s webinar for innovative manufacturers on June 22, 2018 as well as submitting additional comments on the Guidelines to the pCPA.
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