pan-Canadian Pharmaceutical Alliance (pCPA): January 2019 Negotiation Status Update
The pan-Canadian Pharmaceutical Alliance Office (pCPAO) has issued the status of brand negotiations as of January 31, 2019. The key highlights since the last update are:
- 3 negotiations were completed for a total of 234 completed negotiations
- 3 negotiations were closed, for a total of 33 closed negotiations
- The pCPA decided to decline negotiations on 2 files, for a total of 62 declined negotiations
- 6 products have received a final HTA recommendation, for a total of 16 files under consideration
- 5 products have initiated pCPA negotiations, for a total of 45 active negotiations
Completed
| Brand Name | Generic Name | Manufacturer | Indication | Initiation | Duration* |
|---|---|---|---|---|---|
| Bavencio | avelumab | EMD – Pfizer | metastatic Merkel cell carcinoma | Jul 2018 | 184 days |
| Blincyto | Blinatumomab | Amgen | Pediatric Acute Lymphoblastic Leukemia | Dec 2017 | 396 days |
| Blincyto | Blinatumomab | Amgen | Adult Acute Lymphoblastic Leukemia | Dec 2017 | 396 days |
Closed
| Brand Name | Generic Name | Manufacturer | Indication | Initiation | Duration* |
|---|---|---|---|---|---|
| Faslodex | Fulvestrant | AstraZeneca | locally advanced or metastatic breast cancer | Aug 2018 | 153 days |
| Fiasp | Insulin aspart | Novo Nordisk | Type 1 diabetes | Mar 2018 | 306 days |
| Lartruvo | Olaratumab | Eli Lilly | Advanced soft tissue sarcoma | Jul 2018 | 184 days |
Declined
| Brand Name | Generic Name | Manufacturer | Indication | HTA Date | Time to Decision* |
|---|---|---|---|---|---|
| Lenvima | Lenvatinib | Eisai Limited | Renal Cell Carcinoma | 21 Jan 2019 | 0 days |
| Opdivo | Nivolumab | Bristol-Myers Squibb | Hepatocellular Carcinoma | 14 Dec 2018 | 32 days |
*Approximation: Negotiation initiation and completion date assumed to be mid-month for the purposes of the calculation
Signals Decoded:
January saw the completion of a multi-indication negotiation that had been ongoing for over a year, as well as only the second and third oncology negotiations to be closed without reaching an agreement.
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.
Six new drug products received a CDEC recommendation or pERC notification to implement in January 2019, for a total of approximately 16 products under pCPA Consideration.
| Brand Name | Generic Name | Manufacturer | Indication | HTA Recommendation |
|---|---|---|---|---|
| Velphoro | sucroferric oxyhydroxide | Vifor Pharma | Hyperphosphatemia, end-stage renal disease | Reimburse with clinical criteria and/or conditions |
| Lenvima* | Lenvatinib | Eisai | Renal Cell Carcinoma (RCC) |
Do not reimburse
|
| Tagrisso | Osimertinib | AstraZeneca | Non-Small Cell Lung Cancer (1st line) | Recommends conditional on cost effectiveness being improved to an acceptable level and feasibility of adoption is addressed. |
| Mvasi | Bevacizumab | Amgen | Metastatic Colorectal Cancer / Non-Small Cell Lung Cancer |
Biosimilar |
| Segluromet | ertugliflozin + metformin hydrochloride | Merck | Diabetes mellitus, Type 2 |
Do not reimburse
|
| Steglatro | ertugliflozin | Merck | Diabetes mellitus, Type 2 |
Do not reimburse
|
*Added to the “No Negotiations” list in the same month so NOT included in the count of Files Under pCPA Consideration
Negotiation Initiation
The pCPA has initiated 5 new negotiations since the last update, for a total of 45 active negotiations.
| Brand Name | Generic Name | Manufacturer | Indication | HTA Date | Time to Initiation* |
|---|---|---|---|---|---|
| Herceptin SC | Trastuzumab | Hoffman-La Roche | Breast Cancers | N/A | N/A |
| Humira (citrate free) | Adalimumab | AbbVie | Multiple Indications | N/A | N/A |
| Onivyde | Irinotecan liposome | Shire | Metastatic Pancreatic Cancer | 22 Jan 2018 | 358 days |
| Ozempic | Semglutide | Novo Nordisk | Diabetes mellitus type 2 | Pending | Pending |
| Xeljanz XR | Tofactinib | Pfizer | Rheumatoid Arthritis | N/A | N/A |
*Approximation: Negotiation initiation date assumed to be mid-month for the purposes of the calculation
Signals Decoded:
Of the 5 negotiations initiated in January three [Herceptin SC, Humira (citrate-free) and Xeljanz XR] are for “line extensions” and one [Ozempic] is not expected to be reviewed until April of this year. Only one [Onivyde] newly-initiated negotiation appears to be in response to a final HTA recommendation, although it took 12 months for negotiations to commence.
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