pan-Canadian Pharmaceutical Alliance (pCPA): October 2018 Negotiation Status Update
The pan-Canadian Pharmaceutical Alliance Office (pCPAO) has issued the status of brand negotiations as of October 31, 2018. The key highlights since the September update are:
- 6 new drug products have initiated pCPA negotiations, for a total of 57 active negotiations;
- 2 negotiations were completed for a total of 216 completed negotiations; and
- 1 negotiation was closed since the last update, for a total of 28 closed negotiations.
Negotiation Initiation
The pCPA has initiated 6 new negotiations since the last update, for a total of 57 active negotiations
| Brand Name | Generic Name | Manufacturer | Indication | Recommendation/ Notification to Implement Date |
Time to Initiation* |
|---|---|---|---|---|---|
| Keytruda | Pembrolizumab | Merck Canada Inc. | classic Hodgkin lymphoma | January 22, 2018 | 266 days |
| Tremfya | guselkumab | Janssen Inc. | Psoriasis, moderate to severe plaque | February 21, 2018 | 236 days |
| Lapelga | Pegfilgrastim | Apobiologix | Febrile neutropenia | May 8, 2018 | 160 days |
| Opdivo | Nivolumab | Bristol-Myers Squibb | classical Hodgkin Lymphoma after failure of ASCT | May 18, 2018 | 150 days |
| Siliq | Brodalumab | Valeant Canada LP | Moderate to severe plaque psoriasis | June 20, 2018 | 117 days |
| Taltz | ixekizumab | Eli Lilly Canada | Psoriatic arthritis | August 21, 2018 | 55 days |
*Approximation: Negotiation initiation date assumed to be mid-month for the purposes of the calculation
Signals Decoded:
October provides two more examples of concurrent pCPA negotiations when more than one product with similar indications are under consideration. While the final HTA recommendations for Tremfya and Keytruda were issued 4 months before the recommendations for Siliq and Opdivo, it appears that the pCPA has chosen to initiate negotiations simultaneously and not sequentially.
Files Under pCPA Consideration
In addition to the monthly updates to the pCPA website, MORSE Consulting tracks the number of products “under pCPA Consideration” which have been reviewed by CADTH but have not yet been initiated for negotiation or closed without negotiations.
Five new drug products received a CDEC or pERC recommendation or notification to implement in October 2018, for a total of approximately 18 products under pCPA Consideration.
| Brand Name | Generic Name | Manufacturer | Indication | Final Recommendation/Notification to Implement |
|---|---|---|---|---|
| Nucynta | tapentadol hydrocholoride | Paladin Labs Inc | pain, severe |
Do not reimburse
|
| Biktarvy | bictegravir/
emtricitabine/ tenofovir alafenamide |
Gilead Sciences Canada, Inc. | HIV-1 infection | Reimburse with clinical criteria and/or conditions |
| Mavenclad | cladribine | EMD Serono, a Division of EMD Inc., Canada | Multiple Sclerosis, relapsing | Reimburse with clinical criteria and/or conditions |
| Ozanex | ozenoxacin | Ferrer Internacional, S.A. | Impetigo |
Do not reimburse
|
| Ozurdex | dexamethasone | Diabetic macular edema | Diabetic macular edema |
Do not reimburse
|
Signals Decoded:
Since peaking in mid-2018, both the number of files as well as the average time files are spending under pCPA consideration, have both steadily decreased. Despite this shift, the total number of files under pCPA Management (under consideration + active negotiation) in October is 75, which is just two fewer than the all-time high of 77, recorded in June 2018. This number has remained relatively consistent, hovering above 70, since April 2018.
Negotiations Completed/Closed
2 negotiations were completed since the last update, for a total of 216 completed negotiations.
| Brand Name | Generic Name | Manufacturer | Indication | Negotiation Initiation | Duration * |
|---|---|---|---|---|---|
| Brivlera | Brivaracetam | UCB Canada Inc. | Epilepsy, partial-onset seizures | May, 2017 | 518 Days |
| Quinsair | Levofloxacin | Raptor Pharmaceuticals Inc. | Cystic fibrosis with chronic pulmonary Pseudomonas aeruginosa infections | May, 2017 | 518 Days |
*Approximation: Negotiation initiation and completion date assumed to be mid-month for the purposes of the calculation
1 negotiation was closed since the last update, for a total of 28 closed negotiations.
| Brand Name | Generic Name | Manufacturer | Indication | Negotiation Initiation | Duration * |
|---|---|---|---|---|---|
| Vemlidy | tenofovir alafenamide | Gilead Sciences Canada, Inc. | Hepatitis B, chronic | September 2018 | 30 days |
Signals Decoded:
After completing an average of 7 files over the previous three months, October saw the completion of just two negotiations, both of which had been active for almost a year and a half.
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