pan-Canadian Pharmaceutical Alliance (pCPA): August 2020 Trends and Insights
August 2020 Highlights:
- 2 products completed CADTH review
- 2 products initiated pCPA negotiations
- 1 negotiation was completed with an LOI
- 0 negotiations were closed without an LOI
- 0 files were closed without negotiation
Files Under pCPA Consideration:
CADTH issued 2 new recommendations in August (25 files as of August 31).
| PRODUCT | INDICATION | SPONSOR | HTA | REC’N* DATE |
|---|---|---|---|---|
| Soliris (eculizumab) |
Neuromyelitis Optica spectrum disorder | Alexion | CDR | August 19 |
| Cablivi (caplacizumab) |
Acquired thrombotic thrombocytopenic purpura (aTTP) | Sanofi-Genzyme | CDR | August 26 |
* REC’N DATE = Date of CDEC Final Recommendation (CDR), Date Notification to Implement Issued (pCODR)
Signals Decoded:
The number of files under pCPA consideration stood at 25 at the end of August; the highest level since there were 26 files in this process phase at the end of August 2018.
Soliris enters the pCPA process for the third time, having previously been negotiated for two indications (aHUS and PNH). While an agreement was negotiated for the PNH indication, the August 2020 recommendation for Neuromyelitis Optica spectrum disorder marks the first time Soliris has received a “positive” recommendation from CADTH.
Negotiation Initiation:
The pCPA initiated 2 new negotiations in August (28 active negotiations as of August 31, 2020)
| PRODUCT | INDICATION | SPONSOR | CATEGORY | INITIATE DATE | TTI* |
|---|---|---|---|---|---|
| Rituxan SC (rituximab) |
Chronic lymphocytic leukemia | Roche | Other | August 11 | N/A |
| Xospata (gilteritinib) |
Acute Myeloid Leukemia | Astellas | pCODR | August 17 | 74 |
* TTI = Time to Initiate in calendar days
Signals Decoded:
Rituxan SC re-enters active negotiations just two years after reaching an agreement for the same indication (CLL – August 2018), presumably due to the recent entry of multiple biosimilar versions of IV rituximab.
The overall volume of files under pCPA management (under consideration + active negotiation) continues to climb and is at the highest level (53) since September 2019.
Completed/Closed Negotiations:
The pCPA completed 1 negotiation with a Letter of Intent (LOI) in August 2020.
| PRODUCT | INDICATION | SPONSOR | LOI DATE | TTN* |
|---|---|---|---|---|
| Mylotarg (gemtuzumab ozogamicin) |
Acute Myeloid Leukemia | Pfizer | August 12 | 56 |
* TTN = Time to Negotiate in calendar days
Signals Decoded:
The number of files under pCPA management for “extended periods” continues to climb. Kanuma is the longest active negotiation (started November 2018), while Pomalyst has been under consideration since October 2019.
Signals Decoded:
After a moderately active July, the pCPA adjudicated a single file in August 2020. Historically, the last full month of summer has been more active, with pCPA completing 7 agreements in each of August 2018 and 2019.
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