Accessible text: pCPA brand process guidelines

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pCPA context - The Canadian drug approval and reimbursement process

Patients and clinicians, PMPRB and other payors inform and influence all steps of the following process:

  1. Health Canada regulatory determinations (Regulator - Efficacy, Quality and Safety)
  2. CDR (CDA-AMC) and Québec (INNSSS) provide jurisdictional review when applicable (HTA (Value) - clinical effectiveness and cost-effectiveness
  3. pan-Canadian Pharmaceutical Alliance (Negotiations - Evidence informed and value based process)
  4. Jurisdictions (Decision maker, funder, formulary management) 

pCPA process overview

pre-PCPA

  1. Manufacturer submission
  2. HTA review
    1. INPUT: Clinical input is received
    2. INPUT: Patient group input is received
  3. Final HTA recommendation

Contact information: Only contact the HTA in regard to issues/concerns with HTA recommendations.

Phase 1: Initiation

  1. pCPA receives the Final HTA recommendation
    1. INPUT: Examination of line extensions
    2. INPUT: Examination of existing drug products
  2. pCPA issues an acknowledgement to the manufacturer

Contact information: The pCPA will contact the applicable manufacturer(s)

Phase 2: Consideration

  1. pCPA consideration
    1. CONSULTATION : Information from HTA, manufacturer(s), clinicians, patient groups and jurisdictional review as needed by the pCPA
  2. Decision to initiate negotiation?
    1. If No, Hold, pCPA issues hold letter to the manufacturer who can then communicate further with the pCPA
    2. if No, Close, pCPA issues a close letter to the manufacturer
    3. If Yes, continue to Phase 3

Contact information: Only contact the pCPA until an engagement letter is received

Phase 3: Negotiation

  1. pCPA issues an engagement letter to the manufacturer
  2. Proposals and counter-proposals move between the pCPA lead and the manufacturer

Contact information: Only contact the pCPA Lead(s) during ongoing negotiations

Phase 4: Completion

  1. Terms reached?
    1. If no, pCPA issues a close letter to the manufacturer
    2. If Yes, pCPA issues a Letter of Intent to the manufacturer

Contact information: Only contact the pCPA Lead(s) until an LOI is executed.

Post-pCPA

  1. PLA by jurisdiction
  2. Jurisdictional funding

Contact information: Only contact the Jurisdictional drug program/cancer agency regarding PLA status once a negotiation is complete.