pan-Canadian Pharmaceutical Alliance (pCPA): March 2019 Negotiation Status Update
The pan-Canadian Pharmaceutical Alliance (pCPA) has issued the status of brand negotiations as of March 31, 2019. Highlights since the last update include:
- 5 negotiations completed for a total of 247 completed negotiations
- 2 negotiations closed, for a total of 35 closed negotiations
- No new files closed without negotiations, for a total of 63 declined negotiations
- 8 products completed CADTH review, for a total of 15 files under consideration.
- 8 products initiated pCPA negotiations, for a total of 44 active negotiations
Completed
| Brand Name | Generic Name | Manufacturer | Indication | Initiation | Duration* |
|---|---|---|---|---|---|
| Adcetris | brentuximab vedotin | Seattle Genetics | Hodgkin’s lymphoma | Jun 2018 | 273 days |
| Movapo | apomorphine hydrochloride | Paladin Labs | Parkinson’s disease | Jun 2018 | 273 days |
| Venclexta | venetoclax | AbbVie | Chronic lymphocytic leukemia | Jun 2018 | 273 days |
| Yervoy/Opdivo | nivolumab /ipilimumab | Bristol-Myers Squibb | Metastatic melanoma | Jun 2018 | 273 days |
| Yervoy/Opdivo | nivolumab/ipilimumab | Bristol-Myers Squibb | Renal cell carcinoma | Dec 2018 | 90 days |
Closed
| Brand Name | Generic Name | Manufacturer | Indication | Initiation | Duration* |
|---|---|---|---|---|---|
| Stelara | ustekinumab | Janssen | Crohn’s disease | Feb 2018 | 393 days |
| Victoza | liraglutide (2nd Negotiation) | Novo Nordisk | Type 2 diabetes | Jan 2018 | 424 days |
*Negotiation initiation and completion/closed date assumed to be mid-month; approximate calendar days calculated.
Signals Decoded:
March saw the closure of two more files that had been under active negotiation for over a year, including the second time Victoza negotiations have been closed without an agreement. The completion of Yervoy/Opdivo negotiations for two separate indications that were initiated 6 months apart, provides another example of the practice to “group” discussions regarding multiple-indication products.
Negotiation Initiation
The pCPA initiated 8 new negotiations since the last update, for a total of 44 active negotiations.
| Brand Name | Generic Name | Manufacturer | Indication | CADTH Date | Initiation Time* |
|---|---|---|---|---|---|
| Brineura | cerliponase alfa | Biomarin | Neuronal ceroid lipofuscinosis type 2 | Under Review | N/A |
| Erleada | apalutamide | Janssen | Castrate resistant prostate cancer | 16 Nov 2018 | 119 days |
| Kalydeco | Ivacaftor | Vertex | Cystic Fibrosis, R117H CFTR gating mutation | N/A | N/A |
| Segluromet | ertugliflozin/metformin | Merck | Type 2 diabetes | 23 Jan 2019 | 51 days |
| Steglatro | ertugliflozin | Merck | Type 2 diabetes | 23 Jan 2019 | 51 days |
| Tagrisso | osimertinib | AstraZeneca | Non-small cell lung cancer (NSCLC) (first line) | 21 Jan 2019 | 53 days |
| Xarelto | rivaroxaban | Bayer | Stroke and CV events in CAD/PAD | 20 Nov 2018 | 115 days |
| Zirabev | bevacizumab (Biosimilar) | Pfizer | Metastatic colorectal cancer; NSCLC | N/A | N/A |
*Negotiation initiation and completion/closed date assumed to be mid-month; approximate calendar days calculated.
Signals Decoded:
March activity provides further examples of the growing importance of INESSS evaluation in terms of negotiation timing and initiation. Negotiations for Brineura were initiated prior to CADTH issuing its final recommendation, but after INESSS had completed its evaluation of this file. Also, negotiations for Steglatro and Segluromet were initiated, presumably based on INESSS recommendation, as CADTH had recommended that neither file be reimbursed. Negotiations for Kalydeco have been re-activated after previously being closed without an agreement in October 2017 while negotiations for the second bevacizumab biosimilar were initiated prior to the issuance of the Final Biosimilar Summary Dossier.
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.
Eight new drug products received a CDEC recommendation or pERC notification to implement in March 2019, for a total of approximately 15 products under pCPA Consideration.
| Brand Name | Generic Name | Manufacturer | Indication | CADTH Recommendation |
|---|---|---|---|---|
| Cinqair | reslizumab | TEVA Canada Innovation | Asthma, eosinophilic | Reimburse with criteria/conditions |
| Fasenra | benralizumab | AstraZeneca | Asthma, severe eosinophilic | Reimburse with criteria/conditions |
| Nucala | mepolizumab | GlaxoSmithKline | Asthma, severe eosinophilic | Reimburse with criteria/conditions |
| Radicava | edaravone | Mitsubishi Tanabe | Amyotrophic lateral sclerosis | Reimburse with criteria/conditions |
| Eucrisa | crisaborole | Pfizer | Atopic dermatitis |
Do not reimburse
|
| Adcetris | brentuximab vedotin | Seattle Genetics | Hodgkin lymphoma (Re-sub) |
Does not recommend
|
| Opdivo | nivolumab | Bristol-Myers Squibb | Melanoma adjuvant therapy | Recommends with conditions |
| Cabometyx | cabozantinib | Ipsen Biopharmaceuticals | Renal cell carcinoma | Recommends with conditions |
Signals Decoded:
Since peaking in July 2018, the average time under pCPA consideration for files completing the CADTH processes have decreased significantly. Of the files completing the CADTH process in March, three (Cinqair, Fasenra and Nucala) recommendations were issued as a result of the Request for Advice process.
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