pan-Canadian Pharmaceutical Alliance (pCPA): March 2021 Trends and Insights
March 2021 Highlights:
- 5 products completed CADTH review
- 3 products initiated pCPA negotiations
- 2 negotiations were completed with an LOI
- 3 negotiations were closed without an LOI
- 0 files were closed without negotiation
Key Take-Aways:
- The average duration that files are under consideration reaches an annual peak of ~160 days. In addition, the number of files under consideration matches its highest for the past year at 30. Even with the introduction of the Targeted Negotiation Process (TNP), these metrics appear to signal that pCPA continues to have capacity challenges.
- The ratio of active to under consideration files remains relatively constant at around 1:1. The number of active negotiations has hovered around the 30 mark since June 2020 which signals this may be around the maximum capacity for active negotiations with the pCPA’s reduced capacity.
- March saw the first enoxaparin biosimilar reach a LOI and 3 negotiations closed quickly (within 63-65 days). Otezla negotiations were not driven by a new HTA recommendation. Taltz was under consideration for just under 300 days prior to pCPA initiation in January. As such, although speculative, Taltz and Otezla may be the first window into outcome of files going through the TNP.
- There has been an increase in the number of files under negotiation for over a year which sits at 5, relative to 1 at this time last year. The number of total files adjudicated per month remains low and continues to signal reduced capacity within the pCPA.
Files Under pCPA Consideration*:
CADTH issued 5 new recommendations in March (30 files under pCPA consideration as of March 31st) – up from 28 in February. One of the 5 new recommendations was for Vonvendi (von Willebrand Factor) which went through the Interim Plasma-Protein Products Review Process and will go to Canadian Blood Services (CBS) and not pCPA for next steps (see CADTH CBS PPP Process)
| PRODUCT | INDICATION | SPONSOR | Type | REC’N* DATE |
|---|---|---|---|---|
| Ajovy (fremanezumab) | migraine | Teva Canada Innovation | Non-oncology | 2021-03-24 |
| Zolgensma (onesemnogene abeparvovec) | Spinal muscular atrophy (SMA), pediatrics | Novartis Pharmaceuticals Canada Inc. | Non-oncology | 2021-03-24 |
| Entresto (Sacubitril/valsartan) | Heart failure, NYHA Class II or III | Novartis Pharmaceuticals Canada Inc. | Non-oncology | 2021-03-24 |
| Opdivo & Yervoy (Nivolumab & Ipilimumab in combo) | Non-Small Cell Lung Cancer (NSCLC) | BMS | Oncology | 2021-03-19 |
Signals Decoded:
The average duration that files are under consideration reaches an annual peak of ~160 days. In addition, the number of files under consideration matches its highest for the past year at 30. Even with the introduction of the Targeted Negotiation Process (TNP), these metrics appear to signal that pCPA continues to have capacity challenges.
*Note: Since MORSE began issuing pCPA updates, we have defined “under pCPA consideration” as the time between receipt of a final recommendation or notification to implement from CADTH. This does not match the date that the pCPA website has recently started to publish (which starts after issuance of the acknowledgement letter which is not publicly available). This is to ensure consistency of data analysis historically.
Negotiation Initiation:
The pCPA initiated 3 new negotiations in March (31 active negotiations as of March 31st) – down from 33 in February.
| PRODUCT | INDICATION | SPONSOR | CATEGORY | INITIATE DATE | TTI* |
|---|---|---|---|---|---|
| Tecentriq & Avastin (Atezolizumab & Bevacizumab) | Hepatocellular Carcinoma (HCC) | Hoffmann-LA Roche Limited | Oncology | 2021-03-26 | 114 |
| Soliris (Eculizumab) | Neuromyelitis optica spectrum disorder | Alexion Pharma GMBH | Non-oncology | 2021-03-02 | 195 |
| Suboxone (film) (Buprenorphine/naloxone) | Opioid drug dependence (substitution treatment) | Indivior UK Limited | Other | 2021-03-02 | N/A |
Signals Decoded:
The ratio of active to under consideration files remains relatively constant at around 1:1. The number of active negotiations has hovered around the 30 mark since June 2020 which signals this may be around the maximum capacity for active negotiations with the pCPA’s reduced capacity.
Completed/Closed Negotiations:
The pCPA completed 2 negotiations with a Letter of Intent (LOI) and closed 3 negotiations without an LOI in March 2021.
Completed Negotiations
| PRODUCT | INDICATION | Sponsor | Type | Status | LOI DATE | TTN* |
|---|---|---|---|---|---|---|
| Xospata (Gilteritinib) | Acute Myeloid Leukemia (AML) | Astellas Pharma Inc. | Oncology | Completed | 2021-03-15 | 210 |
| Redesca (enoxaparin) | Deep Vein Thrombosis (treatment), without Symptomatic Pulmonary Embolism | Valeo Pharma Inc. | Biosimilar | Completed | 2021-03-24 | 142 |
* TTN = Time to Negotiate in calendar days
Closed Negotiations
| PRODUCT | INDICATION | Sponsor | Type | Status | LOI DATE | TTN* |
|---|---|---|---|---|---|---|
| Taltz (Ixekizumab) | Ankylosing spondylitis | Eli Lilly Canada Inc. | Non-oncology | Closed | 2021-03-19 | 65 |
| Otezla (Apremilast) | Psoriasis, moderate to severe plaque | Amgen Canada Inc. | Other | Closed | 2021-03-17 | 63 |
| Otezla (Apremilast) | Psoriatic Arthritis | Amgen Canada Inc. | Other | Closed | 2021-03-17 | 63 |
* TTN = Time to Negotiate in calendar days
Signals Decoded:
March saw the first enoxaparin biosimilar reach a LOI and 3 negotiations closed quickly (within 63-65 days). Otezla negotiations were not driven by a new HTA recommendation. Taltz was under consideration for just under 300 days prior to pCPA initiation in January. As such, although speculative, Taltz and Otezla may be the first window into outcome of files going through the TNP.
Signals Decoded:
There has been an increase in the number of files under negotiation for over a year which sits at 5, relative to 1 at this time last year. The number of total files adjudicated per month remains low and continues to signal reduced capacity within the pCPA.
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