pan-Canadian Pharmaceutical Alliance (pCPA): December 2020 Trends and Insights
December 2020 Highlights:
- 8 products completed CADTH review
- 2 products initiated pCPA negotiations
- 4 negotiations were completed with an LOI
- 1 negotiation was closed without an LOI
- 0 files were closed without negotiation
Beginning this month and over the next few months, the pCPA is introducing a Targeted Negotiation Process (TNP) to address selected files that have been on hold for several months. The TNP is a structured process that streamlines negotiations in order to reach resolution in a defined time period. Manufacturers will be informed by the pCPA by means of a modified Letter of Engagement and will have the opportunity to decline participation.
Files Under pCPA Consideration:
CADTH issued 8 new recommendations & notifications to implement in December (30 files under pCPA consideration as of December 31) – up from 4 in November.
| PRODUCT | INDICATION | SPONSOR | Type | REC’N* DATE |
|---|---|---|---|---|
| Venclexta (venetoclax Obinutuzumab) |
Chronic Lymphocytic Leukemia | AbbVie | Oncology | December 2 |
| Calquence (acalabrutinib) |
Chronic Lymphocytic Leukemia | AstraZeneca | Oncology | December 2 |
| Tecentriq & Avastin (atezolizumab & bevacizumab) |
Hepatocellular Carcinoma | Hoffmann-La Roche | Oncology | December 2 |
| Spravato (esketamine hydrochloride) |
Major Depressive Disorder, Adults | Janssen |
Non-Oncology
|
December 16 |
| Adcetris (brentuximab vedotin) |
Primary Cutaneous Anaplastic Large Cell Lymphoma or CD30-Expressing Mycosis Fungoides | Seattle Genetics | Oncology | December 18 |
| Adcetris (brentuximab vedotin) |
Stage IV Hodgkin lymphoma (HL) in combination with doxorubicin, vinblastine, and dacarbazine (AVD) | Seattle Genetics | Oncology | December 18 |
| Hemlibra (emicizumab) |
Hemophilia A – patients with or without factor VIII inhibitors | Hoffmann-La Roche |
Non-Oncology
|
December 21 |
| Forxiga (dapagliflozin) |
Heart Failure with reduced ejection fraction | AstraZeneca |
Non-Oncology
|
December 23 |
* REC’N DATE = Date of CDEC Final Recommendation (non-oncology), Date Notification to Implement Issued (oncology).
Signals Decoded:
The number of files under consideration has increased to 30 files in December 2020, the highest under consideration count in the past 3 years. This includes 21 non-oncology files and 9 oncology files.
Negotiation Initiation:
The pCPA initiated 2 new negotiations in December (29 active negotiations as of December 31) – down from 8 in November.
| PRODUCT | INDICATION | SPONSOR | CATEGORY | INITIATE DATE | TTI* |
|---|---|---|---|---|---|
| Baqsimi (glucagon) |
Severe hypoglycemia | Eli Lilly |
Non-Oncology
|
December 14 | 327 |
| Blincyto (blinatumomab) |
MRD Positive B-Cell Precursor Acute Lymphoblastic Leukemia | Amgen | Oncology | December 17 | 34 |
Signals Decoded:
The volume of files at pCPA is hovering at almost 60, with the Under Consideration files now representing just over 50% of the volume of files within the pCPA’s workload. For comparison, at this time last year, the Under Consideration files only represented 24% of the pCPA workload.
Completed/Closed Negotiations:
The pCPA completed 4 negotiations with a Letter of Intent (LOI) in December 2020 – down from 5 in November.
| PRODUCT | INDICATION | SPONSOR | LOI DATE | TTN* |
|---|---|---|---|---|
| Keytruda (pembrolizumab) |
Renal cell carcinoma | Merck Canada | December 1 | 204 |
| Trintellix (vortioxetine) |
Major Depressive Disorder | Lundbeck | December 3 | 150 |
| Blood Glucose Test Strips | Diabetes Mellitus, Type 1 and 2 | Multiple Manufacturers | December 9 | 168 |
| Opsumit (macitentan) |
Pulmonary Arterial Hypertension | Janssen | December 23 | 511 |
* TTN = Time to Negotiate in calendar days
The pCPA closed 1 negotiation without agreement in December 2020.
| PRODUCT | INDICATION | SPONSOR | CLOSURE | TTC* |
|---|---|---|---|---|
| Darzalex SC (daratumumab) |
Multiple Myeloma | Janssen | December 16 | 159 |
* TTC = Time to Close in calendar days
Signals Decoded:
The pCPA completed a category negotiation for blood glucose test strips and a re-activation of Opsumit for the treatment of pulmonary arterial hypertension which was previously closed without an LOI in December 2015. The number of files under consideration for six or more months has remained at 10 for the past 3 months and the number of files under active negotiation for more than 12 months remains relatively low at 2 in December.
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