pan-Canadian Pharmaceutical Alliance (pCPA): July 2019 Trends and Insights
The pan-Canadian Pharmaceutical Alliance (pCPA) has issued the status of brand negotiations as of July 31, 2019. Highlights since the last update include:
- 5 products completed CADTH review, for a total of 12 files under consideration;
- 7 products initiated pCPA negotiations, for a total of 47 active negotiations;
- 6 negotiations completed for a total of 263 completed negotiations;
- 3 negotiations closed, for a total of 43 closed negotiations; and
- 1 file closed without negotiations, for a total of 67 declined negotiations.
Completed
| Brand Name | Generic Name | Manufacturer | Indication | Initiation | Duration* |
|---|---|---|---|---|---|
| Erleada | Apalutamide | Janssen | Non-metastatic castrate resistant prostate cancer | Mar 2019 | 122 days |
| Kalydeco | Ivacaftor | Vertex | CF patients with CFTR or R117H gating mutations | Mar 2019 | 122 days |
| Mvasi | Bevacizumab | Amgen | Metastatic Colorectal Cancer/Non-Small Cell Lung Cancer | Feb 2019 | 150 days |
| Ozempic | Semaglutide | Novo Nordisk | Type 2 diabetes mellitus | Jan 2019 | 181 days |
| Xeljanz XR | Tofacitinib | Pfizer | Rheumatoid Arthritis | Jan 2019 | 181 days |
| Fycompa | Perampanel | Eisai | Epilepsy, primary generalized tonic-clonic seizures | Aug 2016 | 1064 days |
*Negotiation initiation and completion/closed date assumed to be mid-month; approximate calendar days calculated.
Signals Decoded:
The first oncology biosimilar negotiation (Mvasi) was completed in July. It will be interesting to watch the status of the second biosimilar version of bevacizumab (Zirabev) in the coming months, as it started negotiations one month after discussions on Mvasi were initiated.
July also saw the successful completion of Ozempic – the first glucagon-like peptide 1 (GLP-1) receptor agonist to reach a negotiated agreement.
July also saw the completion of agreements for two files that began the pCPA process several years ago. Negotiations for Kalydeco’s CFTR and R117H gating mutations indications were closed without an agreement in October 2017, after more than two-and-a-half years of discussion. Negotiations were re-activated in March 2019 and the parties have now reached an agreement. In addition, an agreement has been reached for Fycompa after almost 3 years of active negotiations.
Closed
| Brand Name | Generic Name | Manufacturer | Indication | Initiation | Duration* |
|---|---|---|---|---|---|
| Aermony RespiClick | Fluticasone propionate | Teva | Asthma | Apr 2019 | 91 days |
| Arbesda RespiClick | Fluticasone/salmeterol | Teva | Asthma | Apr 2019 | 91 days |
| Repatha | Evolocumab | Amgen | CV event prevention in ASCVD patients | Aug 2018 | 334 days |
Signals Decoded:
With 3 more files closed in July, the pCPA has closed more negotiations without an agreement in the first 7 months of 2019 (13) than they had in both 2017 (12) or 2018 (9).
Of the 12 files closed in 2017, 5 were subsequently re-activated and successfully negotiated, including the Kalydeco agreement reached this month. Of the 9 files closed in 2018, 1 file is currently under active negotiations and 2 more are currently under pCPA consideration after further HTA consideration through Requests for Advice. Of the 13 files closed so far in 2019, including 8 in the last 3 months, none have been re-activated, to-date.
Not Negotiated
| Brand Name | Generic Name | Manufacturer | Indication | CADTH Date | Time to Decision* |
|---|---|---|---|---|---|
| Xermelo | Telotristat | Ipsen | Carcinoid Syndrome | 26 Jun 2019 | 19 days |
*Negotiation initiation and completion/closed date assumed to be mid-month; approximate calendar days calculated.
Files Under pCPA Consideration
5 new drug products received a CDEC recommendation or pERC notification to implement in July 2019, for a total of approximately 12 products under pCPA Consideration.
| Brand Name | Generic Name | Manufacturer | Indication | Recommendation |
|---|---|---|---|---|
| Revlimid | lenalidomide | Celgene | Newly Diagnosed Multiple Myeloma | Conditional |
| Vyzulta | latanoprostene bunod | Bausch Health | Open-angle glaucoma or ocular hypertension | Conditional |
| Ninlaro | ixazomib | Takeda | Multiple Myeloma (2nd-beyond) | Does Not Recommend |
| Verzenio | abemaciclib | Eli Lilly | Advanced or metastatic breast cancer | Conditional |
| Fibristal | ulipristal acetate | Allergan | Uterine fibroids (signs and symptoms) | Conditional |
Negotiation Initiation
The pCPA initiated 7 new negotiations since the last update, for a total of 47 active negotiations.
| Brand Name | Generic Name | Manufacturer | Indication | CADTH Date | Initiation Time* |
|---|---|---|---|---|---|
| Opsumit | Macitentan | Actelion | Pulmonary arterial hypertension | N/A | N/A |
| Xeljanz | Tofacitinib | Pfizer | Ulcerative Colitis | 27 Feb 19 | 138 days |
| Xtandi | Enzalutamide | Astellas | Non-metastatic castration-resistant prostate cancer | 10 Apr 19 | 96 days |
| Blincyto | Blinatumimab | Amgen | Philadelphia chromosome positive (Ph+) B-cell precursor (BCP) acute lymphoblastic leukemia (ALL) | 22 Apr 19 | 84 days |
| Cresemba | isavuconazole | AVIR Pharma | Treatment of invasive aspergillosis and mucormycosis | 15 May 19 | 61 days |
| Imfinzi | Durvalumab | AstraZeneca | non-small cell lung cancer | 21 May 19 | 55 days |
| Sublocade | Buprenorphine | Indivior | Opioid dependence | 19 Jun 19 | 26 days |
*Negotiation initiation and completion/closed date assumed to be mid-month; approximate calendar days calculated.
Signals Decoded:
After previously being closed without an agreement in December 2015, negotiations for Opsumit have been re-activated. Interestingly, the pCPA has initiated negotiations for two files that are likely impacted by negotiations completed in the same month. Negotiations for Xeljanz (ulcerative colitis) are initiated the same month they were completed for the Xeljanz XR line extension in rheumatoid arthritis. Similarly, negotiations for Xtandi in non-metastatic Castration Resistant Prostate Cancer (nmCRPC) have been initiated the same month they were completed for Erleada in the same indication.
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