pan-Canadian Pharmaceutical Alliance (pCPA): April 2021 Trends and Insights
April 2021 Highlights:
- 5 products completed CADTH review
- 6 products initiated pCPA negotiations
- 4 negotiations were completed with an LOI
- 1 negotiation was closed without an LOI
- 0 file was closed without negotiation
Key Take-Aways:
- The volume of files under consideration has remained relatively high and stable for the last 5 months (27-30), although the ratio of oncology to non-oncology files shifted slightly. The average time under consideration dropped slightly in April but remains high compared to the same time last year.
- The pCPA initiated negotiations for 6 files, more than we have seen in the last few months. Of those files, 3 had been under consideration for more than 6 months (Beovu, Stelara and Mayzent), perhaps signalling uptake through the Targeted Negotiation Process (TNP) (although that is speculative). Two of the files picked up in less than 6 months, Soliris and Stelara, are already under negotiation for other indications. The workload of the pCPA remains high with 62 files under their purview.
- The 4 successfully completed files in April were all negotiated quite quickly. Adcetris, with previous LOIs, had 2 indications negotiated in 82 days. Two biosimilars, the second enoxaparin and the 4th pegfilgrastim, negotiated in 77 and 82 days, respectively. April also saw the close of Xultophy, which had been under negotiation for well over a year.
- April saw the highest number of non-oncology files under negotiation this past year. This finding, coupled with the significant drop in files under consideration over the last few months, may signal utilization of the TNP.
Files Under pCPA Consideration*:
CADTH issued 5 new recommendations in April (29 files under pCPA consideration as of April 30th) – same as 29 in March.
Note: In our previous issue of the pCPA update, one of the 5 recommendations issued in March 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 |
|---|---|---|---|---|
| Enspryng (satralizumab) | Neuromyelitis optica spectrum disorder | Hoffmann-La Roche | Non-oncology | 2021-04-21 |
| Ruzurgi (amifampridine) | Lambert-Eaton myasthenic syndrome | Médunik Canada Inc. | Non-oncology | 2021-04-20 |
| Sarclisa (isatuximab) | Multiple Myeloma | Sanofi Genzyme | Oncology | 2021-04-19 |
| Bavencio (Avelumab) | Urothelial Carcinoma (UC) | EMD Serono a Division of EMD Inc. Canada | Oncology | 2021-04-08 |
| Remsima SC (Infliximab SC) | Rheumatoid arthritis | Celltrion Healthcare Co., Ltd | Biosimilar** | 2021-04-22 |
*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.
**CADTH stopped reviewing biosimilars since June 1st, 2019. Remsima SC represents a new route of administration for infliximab (subcutaneous) for which there is no reference product authorized in Canada. As such Remsima SC was reviewed by CADTH through the tailored review process.
Signals Decoded:
The volume of files under consideration has remained relatively high and stable for the last 5 months (27-30), although the ratio of oncology to non-oncology files shifted slightly. The average time under consideration dropped slightly in April but remains high compared to the same time last year.
Negotiation Initiation:
The pCPA initiated 6 new negotiations in April (33 active negotiations as of April 30th) – up from 32 in March.
| PRODUCT | INDICATION | SPONSOR | CATEGORY | INITIATE DATE | TTI* |
|---|---|---|---|---|---|
| Trurapi (insulin aspart) | Diabetes Mellitus, Type 1 & 2 | Sanofi-Aventis | Biosimilar | 2021-04-27 | N/A |
| Entyvio SC (Vedolizumab) | Crohn’s Disease | Takeda Canada Inc. | Non-oncology | 2021-04-15 | 84 |
| Soliris (Eculizumab) | Generalized Myasthenia Gravis (gMG) | Alexion Pharma GMBH | Non-oncology | 2021-04-01 | 164 |
| Mayzent (siponimod) | Secondary progressive Multiple sclerosis (SPMS) | Novartis Pharma Canada Inc. | Non-oncology | 2021-04-27 | 280 |
| Stelara (Ustekinumab) | Ulcerative colitis | Janssen Inc. | Non-oncology | 2021-04-27 | 285 |
| Beovu (brolucizumab) | Macular degeneration, age-related | Novartis Pharma Canada Inc. | Non-oncology | 2021-04-27 | 341 |
| Venclexta (venetoclax)** | In combination with obinutuzumab for the treatment of Chronic Lymphocytic Leukemia | AbbVie Corporation | Oncology | 2021-02-23 | 83 |
*Time to Initiation (TTI) – Time from final recommendation or notification to implement to pCPA initiation in calendar days
**Correction from February
Signals Decoded:
The pCPA initiated negotiations for 6 files, more than we have seen in the last few months. Of those files, 3 had been under consideration for more than 6 months (Beovu, Stelara and Mayzent), perhaps signalling uptake through the Targeted Negotiation Process (TNP) (although that is speculative). Two of the files picked up in less than 6 months, Soliris and Stelara, are already under negotiation for other indications. The workload of the pCPA remains high with 62 files under their purview.
Completed/Closed Negotiations:
The pCPA completed 4 negotiations with a Letter of Intent (LOI) and closed 1 negotiation without an LOI in April 2021.
Completed Negotiations
| PRODUCT | INDICATION | Sponsor | Type | Status | LOI DATE | TTN* |
|---|---|---|---|---|---|---|
| Adcetris (Brentuximab Vedotin) | Hodgkin lymphoma (HL) in combination with doxorubicin, vinblastine, and dacarbazine (AVD) | Seattle Genetics Inc. | Oncology | Completed | 2021-04-28 | 82 |
| Adcetris (Brentuximab Vedotin) | Primary Cutaneous Anaplastic Large Cell Lymphoma (or CD30- Expressing Mycosis Fungoides) | Seattle Genetics Inc. | Oncology | Completed | 2021-04-28 | 82 |
| Inclunox (enoxaparin) | Deep Vein Thrombosis (treatment), without Symptomatic Pulmonary Embolism | Sandoz Canada Inc. | Biosimilar | Completed | 2021-04-15 | 77 |
| Nyvepria (pegfilgrastim) | febrile neutropenia in non-myeloid malignancies | Pfizer Canada Inc. | Biosimilar | Completed | 2021-04-05 | 82 |
* TTN = Time to Negotiate in calendar days
Closed Negotiations
| PRODUCT | INDICATION | Sponsor | Type | Status | LOI DATE | TTN* |
|---|---|---|---|---|---|---|
| Xultophy (insulin degludec + liraglutide) | Diabetes mellitus, Type 2 | Novo Nordisk | Non-oncology | Closed | 2021-04-26 | 451 |
* TTN = Time to Negotiate in calendar days
Signals Decoded:
The 4 successfully completed files in April were all negotiated quite quickly. Adcetris, with previous LOIs, had 2 indications negotiated in 82 days. Two biosimilars, the second enoxaparin and the 4th pegfilgrastim, negotiated in 77 and 82 days, respectively. April also saw the close of Xultophy, which had been under negotiation for well over a year.
Signals Decoded:
April saw the highest number of non-oncology files under negotiation this past year. This finding, coupled with the significant drop in files under consideration over the last few months, may signal utilization of the TNP.
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