pan-Canadian Pharmaceutical Alliance (pCPA): May 2020 Trends and Insights
May Highlights:
- 8 products completed CADTH review
- 5 products initiated pCPA negotiations
- 0 negotiations were completed with an LOI
- 0 negotiations were closed without an LOI
- 1 file was closed without negotiation
There was an evident slow down in May as the pCPA continues to adjust to the evolving COVID-19 situation. No negotiations were completed or closed for the first time in over three years and there are a growing number of files with CADTH recommendations that remain under pCPA consideration.
Files Under pCPA Consideration:
CADTH issued 8 new recommendations in May (24 files as of May 31).
| PRODUCT | INDICATION | SPONSOR | HTA | REC’N* DATE | TUC** |
|---|---|---|---|---|---|
| Crysvita (burosumab) |
X-Linked Hypophosphatemia | Kyowa Kirin | CDR | May 27 | 4 |
| Contrave (naltrexone hydrochloride and bupropion hydrochloride) |
Chronic weight management in adults | Bausch Health | CDR | May 27 | 4 |
| Kisqali (ribociclib with fulvestrant) |
Advanced or Metastatic Breast Cancer | Novartis | pCODR | May 11 | 4 |
| Beovu (brolucizumab) |
Age Related Macular Degeneration | Novartis | CDR | May 21 | 10 |
| Entyvio (vedolizumab) |
Ulcerative Colitis | Takeda | CDR | May 19 | 12 |
| Cabometyx (cabozantinib) |
Hepatocellular Carcinoma | Ipsen | pCODR | May 7 | 24 |
| Erleada (apalutamide) |
Metastatic Castration-Sensitive Prostate Cancer | Janssen | pCODR | May 7 | 24 |
| Nubeqa (darolutamide) |
Non-Metastatic Castration Resistant Prostate Cancer | Bayer | pCODR | May 7 | 24 |
* REC’N DATE = Date of CDEC Final Recommendation (CDR), Date Notification to Implement Issued (pCODR)
** TUC = Time Under Consideration in calendar days to end of month or initiation date.
Signals Decoded:
The total number of files under consideration rose to 24 in May, which is the highest count in over a year. In addition, these files have been under consideration for an average of 2 months (range: 0-7 months), the first time since December 2018 that the month-end average time under consideration was ≥ 2 months. While both the volume of files and average time under consideration metrics are increasing, on average, the pCPA is still initiating negotiations within its target timeline of 40 business days.
Negotiation Initiation:
The pCPA initiated 5 new negotiations in May (25 active negotiations as of May 31)
| PRODUCT | INDICATION | SPONSOR | CATEGORY | INITIATE DATE | TTI* |
|---|---|---|---|---|---|
| Allerject (epinephrine) |
Emergency treatment of severe acute allergic reactions (anaphylaxis) | Kaleo | Other | May 22 | N/A |
| Avsola (infliximab) |
Ankylosing spondylitis, plaque psoriasis, psoriatic arthritis, rheumatoid arthritis, Crohn’s Disease & Ulcerative Colitis | Amgen | Biosimilar | May 15 | N/A |
| Kisqali (ribociclib with fulvestrant) |
Advanced or Metastatic Breast Cancer | Novartis | pCODR | May 11 | 4 |
| Keytruda (pembrolizumab) |
Renal Cell Carcinoma | Merck | pCODR | May 11 | 21 |
| Kadcyla (trastuzumab emtansine) |
Early Breast Cancer | Hoffmann-La Roche | pCODR | May 21 | 105 |
* TTI = Time to Initiate in calendar days
Signals Decoded:
Joining the 4 biosimilar negotiations initiated in April, the latest biosimilar version of infliximab was added to the Active Negotiation list in May. The initiation of 3 oncology negotiations is perhaps an early indicator that some negotiating capacity has returned to the oncology table, although it is worth noting that all 3 are new indications for products which have an existing LOI.
Completed/Closed Negotiations:
The pCPA neither completed a negotiation with a Letter of Intent (LOI), nor closed a negotiation without an agreement in May 2020.
Signals Decoded:
April’s significant activity (11 completions + 2 closures) resulted in somewhat of a “re-set” of the active negotiation volume and average duration metrics. Although the total number of files under pCPA management (49) is at its highest level in 7 months, new negotiations are still being initiated and the volume of active files is well below historical levels. As several of the files concluded in April had been active for extended periods, as of May 31st, the 25 active files have been in this process phase (range 0-18 months) for an average of 3.96 months – the shortest month-end average negotiation duration measure on record.
Signals Decoded:
The files under consideration (Pomalyst and Idhifa) and in active negotiation (Kanuma) for an extended duration remain relatively low.
Not Negotiated:
The pCPA declined negotiations on 1 file in May 2020.
| PRODUCT | INDICATION | SPONSOR | DECLINE DATE | TTD* |
|---|---|---|---|---|
| Rydapt (midostaurin) |
Systemic Mastocytosis | Novartis | May 25 | 35 |
* TTD = Time to Decline in calendar days
Signals Decoded:
Rydapt received a “do not reimburse” recommendation from CADTH and was declined without negotiations in May.
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