pan-Canadian Pharmaceutical Alliance (pCPA): July 2021 Trends and Insights
July 2021 Highlights:
- 5 products completed CADTH review
- 5 products initiated pCPA negotiations
- 3 negotiations were completed with an LOI
- 1 negotiation was closed without an LOI
- 1 file was closed without negotiation
Key Take-Aways:
- CADTH released no non-oncology recommendations in July. The volume of files under consideration remains relatively stable in July at 30, with no decrease in the average time under consideration.
- July pCPA activity continues to be high with the most active negotiations (42) over the past year and a continued slight decline in the ratio of under consideration to active files. The pCPA picked up 5 files this month (down from 12 last month). Three oncology files were initiated slightly more quickly than the non-oncology files. Also, three of the five newly initiated files have previous LOIs in place for other indications (Ofev, Lynparza and Bavencio). Ajovy, for migraine, will join Aimovig under negotiation for a similar indication.
- 2 of the 3 negotiations (Rozlytrek and Suboxone film) were completed relatively quickly in July, faster than average negotiation times. One file was not successfully negotiated and was closed without a LOI (Stelara for ulcerative colitis, which has closed previously as well) and Zeposia for MS will not be negotiated following a negative CADTH and INESSS recommendation.
- There remain 8 files under consideration for greater than 6 months despite the initiation of a number of files in June and the creation of the Targeted Negotiation Process. The number of protracted negotiations remains low at 2. There is consistency in the number of files adjudicated since March hovering at 5.
Files Under pCPA Consideration*:
CADTH issued 5 new recommendations in July (30 files under pCPA consideration as of July 31st – down from 31 in June).
| PRODUCT | INDICATION | SPONSOR | Reimbursement Decision | Type | REC’N* DATE |
|---|---|---|---|---|---|
| Imfinzi (Durvalumab) | Extensive-stage small cell lung cancer | AstraZeneca Canada Inc. | Conditional Reimbursement | Oncology | 2021-07-09 |
| Braftovi and Mektovi (encorafenib and binimetinib) | Advanced Melanoma | Pfizer Canada ULC. | Conditional Reimbursement | Oncology | 2021-07-08 |
| Braftovi (encorafenib) | Metastatic colorectal cancer | Pfizer Canada ULC. | Conditional Reimbursement | Oncology | 2021-07-08 |
| Keytruda (pembrolizumab) | Colorectal cancer | Merck Canada Inc. | Conditional Reimbursement | Oncology | 2021-07-09 |
| Unituxin (Dinutuximab) | Neuroblastoma | United Therapeutics | Conditional Reimbursement | Oncology | 2021-07-07 |
*Note: MORSE defines “Rec’n date” as the time of‘final recommendation issued to sponsor and drug plans’, and the ‘Time to Initiate’ as the time between ‘final recommendation issued to sponsor and drug plans’ and ‘pCPA Engagement Letter Issued’.
Signals Decoded:
CADTH released no non-oncology recommendations in July. The volume of files under consideration remains relatively stable in July at 30, with no decrease in the average time under consideration.
Negotiation Initiation:
The pCPA initiated 5 new negotiations in July (42 active negotiations as of July 31st) – up from 41 in June.
| PRODUCT | INDICATION | SPONSOR | CATEGORY | INITIATE DATE | TTI* |
|---|---|---|---|---|---|
| Ofev (Nintedanib) | chronic fibrosing interstitial lung diseases | Boehringer Ingelheim (Canada) Ltd. Ltee | Non-oncology | 2021-07-16 | 142 |
| Polivy (Polatuzumab Vedotin) | relapsed or refractory diffuse large B-cell lymphoma | Hoffmann-La Roche Limited | Oncology | 2021-07-21 | 76 |
| Lynparza (olaparib) | Metastatic Castration-Resistant Prostate Cancer (mCRPC) | AstraZeneca Canada Inc. | Oncology | 2021-07-07 | 62 |
| Bavencio (Avelumab) | Urothelial Carcinoma (UC) | EMD Inc. Canada | Oncology | 2021-07-22 | 105 |
| Ajovy (fremanezumab) | migraine | Teva Canada Inc. | Non-oncology | 2021-07-16 | 114 |
*Time to Initiation (TTI) – Time between ‘final recommendation issued to sponsor and drug plans’ and ‘pCPA Engagement Letter Issued’.
Signals Decoded:
July pCPA activity continues to be high with the most active negotiations (42) over the past year and a continued slight decline in the ratio of under consideration to active files. The pCPA picked up 5 files this month (down from 12 last month).
Three oncology files were initiated slightly more quickly than the non-oncology files. Also, three of the five newly initiated files have previous LOIs in place for other indications (Ofev, Lynparza and Bavencio). Ajovy, for migraine, will join Aimovig under negotiation for a similar indication.
Completed Negotiations:
The pCPA completed 3 negotiations with a Letter of Intent (LOI) in July 2021, the same number as in June.
| PRODUCT | INDICATION | Sponsor | Type | Status | LOI DATE | TTN* |
|---|---|---|---|---|---|---|
| Rozlytrek (entrectinib) | ROS1-positive Non-Small Cell Lung Cancer | Hoffmann-La Roche Limited | Oncology | Completed | 2021-07-06 | 63 |
| Xtandi (Enzalutamide) | Metastatic Castration Sensitive Prostate Cancer (mCSPC) | Astellas Pharma Inc. | Oncology | Completed | 2021-07-30 | 273 |
| Suboxone (film) (Buprenorphine/naloxone) | Opioid drug dependence (substitution treatment) | Indivior UK Limited | Other | Completed | 2021-07-15 | 135 |
* TTN = Time to Negotiate in calendar days
Closed Negotiations:
The pCPA closed 1 negotiation without an LOI in July 2021.
| PRODUCT | INDICATION | Sponsor | Type | Status | LOI DATE | TTN* |
|---|---|---|---|---|---|---|
| Stelara (Ustekinumab) | Ulcerative colitis | Janssen Inc. | Non-oncology | Closed | 2021-07-28 | 92 |
Not Negotiated:
The pCPA declined negotiations on 2 files in June 2021.
| PRODUCT | INDICATION | Sponsor | Type | Status | Negotiation End DATE | TTD* |
|---|---|---|---|---|---|---|
| Zeposia (ozanimod) | Multiple Sclerosis, relapsing – remitting | Celgene Inc. | Non-Oncology | Not Negotiated | 2021-07-29 | 36 |
*TTD = Time to Decline in calendar days
Signals Decoded:
2 of the 3 negotiations (Rozlytrek and Suboxone film) were completed relatively quickly in July, faster than average negotiation times.
One file was not successfully negotiated and was closed without a LOI (Stelara for ulcerative colitis, which has closed previously as well) and Zeposia for MS will not be negotiated following a negative CADTH and INESSS recommendation.
Signals Decoded:
There remain 8 files under consideration for greater than 6 months despite the initiation of a number of files in June and the creation of the Targeted Negotiation Process. The number of protracted negotiations remains low at 2.
There is consistency in the number of files adjudicated since March hovering at 5.
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