pan-Canadian Pharmaceutical Alliance (pCPA): May 2019 Trends and Insights
The pan-Canadian Pharmaceutical Alliance (pCPA) has issued the status of brand negotiations as of May 31, 2019. Highlights since the last update include:
- 2 negotiations completed for a total of 253 completed negotiations;
- 2 negotiations closed, for a total of 37 closed negotiations;
- 1 file closed without negotiations, for a total of 65 declined negotiations;
- 10 products completed CADTH review, for a total of 19 files under consideration; and
- 6 products initiated pCPA negotiations, for a total of 47 active negotiations.
Negotiation Initiation
The pCPA initiated 6 new negotiations since the last update, for a total of 47 active negotiations.
| Brand Name | Generic Name | Manufacturer | Indication | CADTH Date | Initiation Time* |
|---|---|---|---|---|---|
| Brilinta | Ticagrelor | AstraZeneca Canada Inc. | Secondary prevention of atherothrombotic events | N/A | N/A |
| Herzuma | Trastuzumab | Teva Pharmaceutical Industries | Early breast cancer, metastatic breast cancer, and gastric cancer | N/A | N/A |
| Lonsurf | Trifluridine and Tipiracil | Taiho Pharma Canada, Inc. | Metastatic Colorectal Cancer | July 23, 2018 | 296 days |
| Ogivri | Trastuzumab | BGP Pharma ULC | Early breast cancer, metastatic breast cancer, and gastric cancer | N/A | N/A |
| Trazimera | Trastuzumab | Pfizer Canada Inc | Early breast cancer, metastatic breast cancer, and gastric cancer | N/A | N/A |
| Unituxin | Dinutuximab | United Therapeutics Corp. | Treatment of pediatric patients with high-risk neuroblastoma | April 10, 2019 | 35 days |
*Negotiation initiation and completion/closed date assumed to be mid-month; approximate calendar days calculated.
Signals Decoded:
May 2019 saw the initiation of the latest “group” of oncology biosimilars, as three biosimilar versions of trastuzumab have entered negotiations. Brilinta has been re-initiated after being closed without an agreement in November 2017. Although Lonsurf received a “Do Not Reimburse” recommendation from pCODR in July 2018, it had remained under pCPA consideration for almost a year, before being initiated in May 2019. Of note, Lonsurf had received a “conditional” recommendation from INESSS around the same time as the pCODR review and was resubmitted to pCODR in January 2019.
Files Under pCPA Consideration
The products “under pCPA Consideration” have been reviewed by CADTH but have not yet been initiated for negotiation or closed without negotiations.
10 new drug products received a CDEC recommendation or pERC notification to implement in May 2019, for a total of approximately 19 products under pCPA Consideration as Brineura (cerliponase alfa) commenced negotiations prior to the completion of the CADTH review.
| Brand Name | Generic Name | Manufacturer | Indication | Recommendation |
|---|---|---|---|---|
| Ibrance/Faslodex | Palbociclib (with fulvestrant) | Pfizer | Advanced or metastatic breast cancer | Conditional |
| Imfinzi | Durvalumab | AstraZeneca | Non-Small Cell Lung Cancer | Conditional |
| Tafinlar/Mekinist | Dabrafenib and trametinib | Novartis | Melanoma adjuvant therapy | Conditional |
| Skyrizi | Risankizumab | AbbVie | Psoriasis, moderate to severe plaque | Conditional |
| Brineura | Cerliponase alfa | Biomarin | Neuronal Ceroid Lipofuscinosis Type 2 | Conditional |
| Jublia | Efinaconazole | Bausch Health | Onychomycosis | Do Not Reimburse |
| Cresemba | isavuconazole | AVIR Pharma | Invasive aspergillosis and mucormycosis | Conditional |
| Ozempic | semaglutide | Novo Nordisk | Diabetes mellitus, type 2 | Conditional |
| Delstrigo | doravirine lamuvidine tenofovir disoproxil fumarate | Merck | HIV-1 | Conditional |
| Pifeltro | doravirine | Merck | HIV-1 | Conditional |
Completed
| Brand Name | Generic Name | Manufacturer | Indication | Initiation | Duration* |
|---|---|---|---|---|---|
| Fasenra | Benralizumab | AstraZeneca Canada Inc. | Eosinophilic asthma | Nov 2018 | 181 days |
| Probuphine | Buprenorphine | Knight Therapeutics | Opioid Use Disorder | Nov 2018 | 181 days |
*Negotiation initiation and completion/closed date assumed to be mid-month; approximate calendar days calculated.
Closed
| Brand Name | Generic Name | Manufacturer | Indication | Initiation | Duration* |
|---|---|---|---|---|---|
| Symtuza | darunavir/cobicistat/emtricitabine/tenofovir alafenamide | Janssen Inc. | HIV | February, 2019 | 89 days |
| Viacoram | perindopril arginine/amlodipine | Servier Canada Inc. | Essential hypertension | April, 2018 | 395 days |
Signals Decoded:
Prior to the May pCPA update, Fasenra was under active pCPA negotiations based on the August 2018 CDR recommendation, and was also under pCPA consideration based on the drug plan-initiated “Request for Advice” reviews for the monoclonal antibody eosinophilic asthma treatments. Although Viacoram was re-activated after being declined by pCPA in July 2017, it has been closed without an agreement after approximately 13 months of negotiations.
Not Negotiated
| Brand Name | Generic Name | Manufacturer | Indication | CADTH Date | Time to Decision* |
|---|---|---|---|---|---|
| Adcetris | Brentuximab vedotin | Seattle Genetics Inc. | Hodgkin Lymphoma | March 22, 2019 | 54 days |
*Negotiation initiation and completion/closed date assumed to be mid-month; approximate calendar days calculated.
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