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.
Exports from our negotiations database are available for download in .CSV and .JSON formats.
| Product | Manufacturer | Status | Indication |
|---|---|---|---|
| Tevimbra (tislelizumab) | BeOne Medicines (Canada) ULC | Under consideration for negotiation | in combination with gemcitabine and platinum chemotherapy, for the first-line treatment of adult patients with recurrent or metastatic nasopharyngeal carcinoma (NPC). |
| Kisqali (ribociclib) | Novartis Pharmaceuticals Canada Inc. | Under consideration for negotiation | in combination with an aromatase inhibitor for the adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative stage II-III early breast cancer at high risk of recurrence• In pre- or perimenopausal women, or men, the aromatase inhibitor should be combined with a luteinizing hormone-releasing hormone (LHRH) agonist. |
| Kerendia (finerenone) | Bayer Inc. | Under consideration for negotiation | As an adjunct to standard of care in adults with heart failure with left ventricular ejection fraction (LVEF) ≥40% to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visits. |
| Loqtorzi (toripalimab) | Apotex Inc. | Under consideration for negotiation | In combination with cisplatin and gemcitabine, for the first-line treatment of adults with metastatic or with recurrent, locally advanced nasopharyngeal carcinoma (NPC). |
| Loqtorzi (toripalimab) | Apotex Inc. | Under consideration for negotiation | for the treatment of adults with recurrent unresectable or metastatic nasopharyngeal carcinoma (NPC) with disease progression on or after a platinum-containing chemotherapy |
| Tzield (teplizumab) | Sanofi-Aventis Canada Inc. | Under consideration for negotiation | indicated to delay the onset of stage 3 type 1 diabetes (T1D) in adult and pediatric patients 8 years of age and older with stage 2 T1D |
| Tryngolza (Olezarsen ) | Theratechnologies Inc. | Under consideration for negotiation | As an adjunct to diet for the treatment of adults with familial chylomicronemia syndrome (FCS) to reduce triglyceride levels. |
| Imfinzi (durvalumab) | AstraZeneca Canada Inc. | Under consideration for negotiation | In combination with fluorouracil, leucovorin, oxaliplatin, and docetaxel (FLOT) chemotherapy as neoadjuvant and adjuvant treatment, followed by adjuvant durvalumab monotherapy, for the treatment of adult patients with resectable gastric or gastroesophageal junction adenocarcinoma (GC/GEJC). |
| Amvuttra (vutrisiran) | Alnylam Netherlands B.V. | Under consideration for negotiation | Cardiomyopathy due to transthyretin-mediated amyloidosis |
| Elfabrio (pegunigalsidase alfa) | Chiesi Canada Corporation | Under consideration for negotiation | Fabry Disease |
| Isturisa (osilodrostat) | Recordati Rare Diseases Canada Inc. | Under consideration for negotiation | For the treatment of adult patients with Cushing’s disease who have persistent or recurrent hypercortisolism after primary pituitary surgery and/or irradiation, or for whom pituitary surgery is not an option. |
| Tecentriq (atezolizumab) | Hoffmann-La Roche Ltd. | Under consideration for negotiation | For the first-line treatment of patients with metastatic NSCLC whose tumours have high PD-L1 expression (PD-L1 stained greater than or equal to 50% of TCs or PD-L1 stained tumour-infiltrating immune cells [ICs] covering greater than or equal to 10% of the tumour area), as determined by a validated test and who do not have EGFR or ALK genomic tumour aberrations. |
| Vyvgart (efgartigimod alfa) | Argenx Canada Inc. | Under consideration for negotiation | Chronic inflammatory demyelinating polyneuropathy |
| Dupixent (dupilumab) | Sanofi Genzyme Canada | Under consideration for negotiation | Indicated as an add-on maintenance treatment in adult patients with chronic obstructive pulmonary disease (COPD) characterized by raised blood eosinophils inadequately controlled by the combination of an inhaled corticosteroid (ICS), a long-acting beta2-agonist (LABA), and a long-acting muscarinic antagonist (LAMA), or on a combination of a LABA and a LAMA if ICS is not appropriate. |
| Dayvigo (lemborexant) | Eisai Limited | Under consideration for negotiation | Insomnia |
| Blenrep (belantamab mafodotin) (in combination with bortezomib and dexamethasone) | GlaxoSmithKline Inc. | Under consideration for negotiation | For the treatment of multiple myeloma in combination with bortezomib and dexamethasone (BVd) in adult patients who have received at least one prior therapy. |
| Blenrep (belantamab mafodotin) (in combination with pomalidomide and dexamethasone) | GlaxoSmithKline Inc. | Under consideration for negotiation | For the treatment of multiple myeloma in combination with pomalidomide and dexamethasone (Bpd) in adult patients who have received at least one prior therapy including lenalidomide. |
| Scemblix (asciminib) | Novartis Pharmaceuticals Canada Inc. | Under consideration for negotiation | For the treatment of adult patients with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP) who have previously received 1 tyrosine kinase inhibitor (second line). |
| Opzelura (ruxolitinib) | Incyte Biosciences Canada Corporation | Under consideration for negotiation | Nonsegmental vitiligo |