Brand Name Drug Negotiations Status
The pCPA is a part of the overall Canadian drug approval and reimbursement process. It starts with regulatory approval through Health Canada where drugs are evaluated for efficacy, quality and safety. Following a positive approval from Health Canada, all drugs then go through a health technology assessment for clinical and cost-effectiveness. In Canada there are two review boards:
- Canada’s Drug Agency (formerly CADTH)
- The Institut national d’excellence en santé et en services sociaux (INESSS) in Québec
For the majority of new drugs, the pCPA negotiation process begins once a recommendation is published by Canada’s Drug Agency and/or INESSS.
Together with our partners, we have designed the pCPA Temporary Access Process (pTAP) that will allow patients to have temporary access to some drugs earlier. More information is available on our pTAP webpage.
| Product | Manufacturer | Status | Indication |
|---|---|---|---|
| Fabhalta (iptacopan) | Novartis Pharmaceuticals Canada Inc. | Under consideration for negotiation | Paroxysmal nocturnal hemoglobinuria (PNH) |
| Imdelltra (tarlatamab) | Amgen Canada Inc. | Under consideration for negotiation | For the treatment of adult patients with extensive stage small cell lung cancer (ES-SCLC) with disease progression on or after at least two prior lines of therapy including platinum-based chemotherapy |
| Ryaltris (olopatadine hydrochloride and mometasone) | Bausch Health, Canada Inc. | Under consideration for negotiation | Seasonal allergic rhinitis |
| Rybrevant (amivantamab) | Janssen Inc. | Under consideration for negotiation | In combination with carboplatin and pemetrexed for the first-line treatment of adult patients with locally advanced (not amenable to curative therapy) or metastatic non-small cell lung cancer (NSCLC) with activating epidermal-growth factor receptor (EGFR) exon 20 insertion mutations. |
| Casgevy (exagamglogene autotemcel) | Vertex Pharmaceuticals (Canada) Incorporated | Under consideration for negotiation | Sickle cell disease |
| Casgevy (exagamglogene autotemcel) | Vertex Pharmaceuticals (Canada) Incorporated | Under consideration for negotiation | Transfusion-dependent β-thalassemia |
| Spevigo (spesolimab) | Boehringer Ingelheim (Canada) Ltd. | Under consideration for negotiation | generalized pustular psoriasis (GPP) |
| Ferinject (ferric carboxymaltose) | CSL Vifor | Under consideration for negotiation | Iron Deficiency Anemia |
| Talvey (talquetamab) | Janssen Inc. | Under consideration for negotiation | For the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least three prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody, and have demonstrated disease progression on or after the last therapy. |
| Winlevi (clascoterone) | Sun Pharma Canada Inc. | Under consideration for negotiation | Acne Vulgaris |
| Voydeya (danicopan) | Alexion Pharma GmbH | Under consideration for negotiation | Paroxysmal nocturnal hemoglobinuria (PNH) |
| Olumiant (baricitinib) | Eli Lilly Canada Inc. | Under consideration for negotiation | Alopecia areata, severe |
| Lumakras (sotorasib) | Amgen Canada Inc. | Under consideration for negotiation | Advanced non-small cell lung cancer, KRAS G12C-mutated |