pan-Canadian Pharmaceutical Alliance (pCPA): June 2020 Trends and Insights
June Highlights:
- 4 products completed CADTH review
- 7 products initiated pCPA negotiations
- 4 negotiations were completed with an LOI
- 0 negotiations were closed without an LOI
- 0 files were closed without negotiation
Files Under pCPA Consideration:
CADTH issued 4 new recommendations in June (23 files as of June 30).
| PRODUCT | INDICATION | SPONSOR | HTA | REC’N* DATE |
|---|---|---|---|---|
| Cuvposa (glycopyrrolate) |
Chronic severe drooling, neurologic (pediatric) | MEDEXUS | CDR | June 24 |
| Adcetris (brentixumab vedotin) |
Peripheral T-Cell Lymphoma | Seattle Genetics | pCODR | June 19 |
| Kisqali (ribociclib) |
Advanced or Metastatic Breast Cancer | Novartis | pCODR | June 19 |
| Xospata (gilteritinib) |
Acute Myeloid Leukemia | Astellas | pCODR | June 4 |
* REC’N DATE = Date of CDEC Final Recommendation (CDR), Date Notification to Implement Issued (pCODR)
Kisqali (ribociclib) was initiated in the same month that the recommendation issued and therefore is not included in the Under-Consideration count.
Signals Decoded:
While the Average Time Under Consideration continues to creep upwards, the volume of files in this process phase leveled off in June. Although pCPA initiated negotiations for Kisqali (Advanced or Metastatic Breast Cancer) after just 3 days, it is worth noting that this molecule, in combination with fulvestrant, was already in active negotiations for the same indication.
Negotiation Initiation:
The pCPA initiated 7 new negotiations in June (28 active negotiations as of June 30).
| PRODUCT | INDICATION | SPONSOR | CATEGORY | INITIATE DATE | TTI* |
|---|---|---|---|---|---|
| Kisqali (ribociclib) |
Advanced or Metastatic Breast Cancer | Novartis | pCODR | June 22 | 3 |
| Myltotarg (Gemtuzumab Ozogamicin) |
Acute Myeloid Leukemia | Pfizer | pCODR | June 17 | 58 |
| Vyndaqel (tafamidis) |
Transthyretin-mediated amyloidosis | Pfizer | CDR | June 10 | 112 |
| Libtayo (cemiplimab) |
Cutaneous Squamous Cell Carcinoma | Sanofi Genzyme | pCODR | June 8 | 123 |
| Lynparza (olaparib) |
Advanced or Metastatic Breast Cancer | AstraZeneca | pCODR | June 18 | 181 |
| Kalydeco (ivacaftor) |
Cystic Fibrosis in patients with CFTR gating mutations or the R117H gating mutation | Vertex | Other | June 12 | N/A |
| Orkambi (lumacaftor/ivacaftor) |
Cystic Fibrosis, F508del CFTR mutation | Vertex | Other | June 12 | N/A |
* TTI = Time to Initiate in calendar days
Signals Decoded:
For the second consecutive month, the newly initiated pCPA negotiations associated with recent HTA reviews has focused on oncology. By initiating negotiations on Kalydeco and Orkambi, the pCPA has provided some insight into its immediate priority while showing that some negotiating capacity is still available for non-HTA files.
Completed/Closed Negotiations:
The pCPA completed 4 negotiations with a Letter of Intent (LOI) in June 2020.
| PRODUCT | INDICATION | SPONSOR | LOI DATE | TTN* |
|---|---|---|---|---|
| Ruxience (rituximab) |
Non-Hodgkin’s Lymphoma (NHL), Chronic Lymphocytic Leukemia (CLL), Rheumatoid Arthritis (RA), Granulomatosis with Polyangitis (GPA), Microscopic Polyangitis (MPA) | Pfizer | June 12 | 49 |
| Nivestym (filgrastim) |
Prevention or treatment of neutropenia in various indications | Pfizer | June 17 | 51 |
| Revlimid (lenalidomide) |
Multiple Myeloma | Celgene | June 10 | 58 |
| Riximyo (rituximab) |
Rheumatoid arthritis, chronic lymphocytic leukemia, and non-Hodgkin’s lymphoma | Sandoz | June 19 | 113 |
* TTN = Time to Negotiate in calendar days
Signals Decoded:
June saw the completion of three more biosimilar negotiations, including the second and third version of rituximab and the second version of filgrastim. While the number of active negotiations is up to 28 from a low of 20 in April, the average time spent in this process phase continues to decline.
Signals Decoded:
The files under consideration (Pomalyst and Idhifa) and in active negotiation (Kanuma) for an extended duration remain relatively low and unchanged since last month.
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