pan-Canadian Pharmaceutical Alliance (pCPA): June 2021 Trends and Insights
June 2021 Highlights:
- 8 products completed CADTH review
- 12 products initiated pCPA negotiations
- 3 negotiations were completed with an LOI
- 0 negotiations were closed without an LOI
- 2 files were closed without negotiation
Key Take-Aways:
- The volume of files under consideration remains stable with a slight decrease in the days under consideration in June relative to the last 6 months. With 8 recommendations coming out of CADTH this month, this has kept the volume of files under consideration stable, despite pCPA initiating a high number of negotiations this month (12).
- June has been the most productive month for pCPA over the past 12 months with respect to number of negotiations initiated, as well as the number of active negotiations. This has led to a slight drop in the ratio of under consideration to active files.
- The pCPA has been making strides to deal with files that have been under their purview for extended periods of time. May saw the conclusion of 3 protracted negotiations while June saw similar output with Orkambi and Kalydeco being completed with a LOI after close to a year.
- With the closure of a number of protracted negotiations over the last 2 months, and the addition of 12 new negotiations initiated, the average duration of negotiation has also dropped to its lowest point (~125 days) over the last 12 months.
Files Under pCPA Consideration*:
CADTH issued 8 new recommendations in June (31 files under pCPA consideration as of June 30th – same as 31 in May).
| PRODUCT | INDICATION | SPONSOR | Reimbursement Decision | Type | REC’N* DATE |
|---|---|---|---|---|---|
| Zeposia (ozanimod) | Multiple Sclerosis, relapsing – remitting | Celgene Inc. | Do not reimburse | Non-oncology | 2021-06-23 |
| Ilumya (tildrakizumab) | Psoriasis, moderate to severe plaque | Sun Pharma Canada | Conditional Reimbursement | Non-oncology | 2021-06-21 |
| Tafinlar & Mekinist in combo (Dabrafenib & Trametinib in combo) | NSCLC BRAF V600 | Novartis Pharmaceuticals Canada Inc. | Conditional Reimbursement | Oncology | 2021-06-14 |
| Veltassa (patiromer) | Hyperkalemia, adults (chronic kidney disease) | Otsuka Canada Pharmaceuticals Inc. | Conditional Reimbursement | Non-oncology | 2021-06-08 |
| Reblozyl (luspatercept) | beta-thalassemia associated anemia | Celgene Inc. / Bristol-Myers Squibb Canada Co. | Conditional Reimbursement | Non-oncology | 2021-06-08 |
| Rybelsus (semaglutide) | diabetes mellitus, type 2 | Novo Nordisk Canada Inc. | Conditional Reimbursement | Non-oncology | 2021-06-08 |
| Dupixent (dupilumab) | Asthma | Sanofi-Genzyme | Conditional Reimbursement | Non-oncology | 2021-06-08 |
| Inrebic (fedratinib) | Myelofibrosis | Celgene Inc. / Bristol-Myers Squibb Canada Co. | Conditional Reimbursement | Oncology | 2021-06-02 |
*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.
Signals Decoded:
The volume of files under consideration remains stable with a slight decrease in the days under consideration in June relative to the last 6 months. With eight recommendations coming out of CADTH this month, this has kept the volume of files under consideration stable, despite pCPA initiating a high number of negotiations this month (12).
Negotiation Initiation:
The pCPA initiated 12 new negotiations in June (41 active negotiations as of June 30th) – up from 32 in May.
| PRODUCT | INDICATION | SPONSOR | CATEGORY | INITIATE DATE | TTI* |
|---|---|---|---|---|---|
| Zejula (niraparib) | First Line Ovarian Cancer | GlaxoSmithKline Inc. | Oncology | 2021-06-01 | 18 |
| Remsima SC (Infliximab SC) | Rheumatoid arthritis | Celltrion Healthcare Canada Ltd. | Biosimilar | 2021-06-04 | 43 |
| Enspryng (satralizumab) | Neuromyelitis optica spectrum disorder | Hoffmann-La Roche Ltd. | Non-oncology | 2021-06-30 | 70 |
| Forxiga (Dapagliflozin) | Heart failure with reduced ejection fraction | AstraZeneca Canada Inc. | Non-oncology | 2021-06-17 | 176 |
| Enerzair Breezhaler (indacaterol glycopyrronium mometasone furoate) | Asthma maintenance, adults | Novartis Pharma Canada Inc. | Non-oncology | 2021-06-23 | 211 |
| Atectura Breezhaler (indacaterol/mometasone furoate) | Asthma maintenance (adults, children 12 or older) | Novartis Pharma Canada Inc. | Non-oncology | 2021-06-23 | 211 |
| Insulin pumps and pump supplies | Diabetes Mellitus, Type 1 & 2 | Multiple manufacturers | Other | 2021-06-29 | N/A |
| Riabni (rituximab) | Non-Hodgkin’s Lymphoma (NHL), Chronic Lymphocytic Leukemia (CLL), Rheumatoid Arthritis (RA), Granulomatosis with Polyangitis (GPA), Microscopic Polyangitis (MPA) | Amgen Canada Inc. | Biosimilar | 2021-06-11 | N/A |
| Osnuvo (teriparatide) | osteoporosis | AVIR Pharma Inc. | Biosimilar | 2021-06-04 | N/A |
| Bambevi (bevacizumab) | Metastatic Colorectal Cancer (mCRC) Locally Advanced, Metastatic or Recurrent Non-Small Cell Lung Cancer (NSCLC) Platinum-Resistant Recurrent Epithelial Ovarian, Fallopian Tube and Primary Peritoneal Cancer Malignant Glioma (WHO Grade IV) – Glioblastoma | Apotex Inc. | Biosimilar | 2021-06-11 | N/A |
| Abevmy (bevacizumab) | Metastatic colorectal cancer (mCRC), locally advanced, metastatic or recurrent non-small cell lung Cancer (NSCLC), platinum-resistant recurrent epithelial ovarian, fallopian tube and primary peritoneal cancer, and glioblastoma | BGP Pharma ULC | Biosimilar | 2021-06-11 | N/A |
| Foquest (methylphenidate hydrochloride CR)** | Treatment of adult hyperactivity in adults | Elvium Life Sciences | Other | 2021-06-29 | N/A |
*Time to Initiation (TTI) – Time from final recommendation or notification to implement to pCPA initiation in calendar days
**Initiated and completed on the same day
Signals Decoded:
June has been the most productive month for pCPA over the past 12 months with respect to number of negotiations initiated, as well as the number of active negotiations. This has led to a slight drop in the ratio of under consideration to active files.
Initiated files include: 5 biosimilars, including the first biosimilar for teriparatide, and a category negotiation including multiple manufacturers for insulin pumps and insulin pump supplies. This follows a previous category negotiation on blood glucose test strips.
Completed/Closed Negotiations:
The pCPA completed 3 negotiations with a Letter of Intent (LOI) in June 2021, the same number as in May.
| PRODUCT | INDICATION | Sponsor | Type | Status | LOI DATE | TTN* |
|---|---|---|---|---|---|---|
| Orkambi (lumacaftor/ivacaftor) | Cystic Fibrosis, F508del CFTR mutation | Vertex Pharmaceuticals (Canada) Incorporated | Other | Completed | 2021-06-03 | 356 |
| Kalydeco (Ivacaftor) | cystic fibrosis in patients with CFTR gating mutations or the R117H gating mutation | Vertex Pharmaceuticals (Canada) Incorporated | Other | Completed | 2021-06-03 | 356 |
| Foquest (methylphenidate hydrochloride CR)** | Treatment of adult hyperactivity in adults | Elvium Life Sciences | Other | Completed | 2021-06-29 | 1 |
* TTN = Time to Negotiate in calendar days
**Initiated and completed on the same day
Not Negotiated:
The pCPA declined negotiations on 2 files in June 2021.
| PRODUCT | INDICATION | Sponsor | Type | Status | Negotiation End DATE | TTD* |
|---|---|---|---|---|---|---|
| Odomzo (sonidegib) | Basal Cell Carcinoma (BCC) | Sun Pharma Canada Inc. | Oncology | Not Negotiated | 2021-06-04 | 21 |
| Pomalyst (Pomalidomide) | Multiple Myeloma (second-line or beyond) | Celgene Inc. | Oncology | Not Negotiated | 2021-06-04 | 610 |
*TTD = Time to Decline in calendar days
Signals Decoded:
The pCPA has been making strides to deal with files that have been under their purview for extended periods of time. May saw the conclusion of 3 protracted negotiations while June saw similar output with Orkambi and Kalydeco being completed with a LOI after close to a year.
Pomalyst being declined for negotiation after almost 2 years. Pomalyst received a conditional reimbursement recommendation from CADTH in September 2019 and has been under consideration since that time (610 days). It is unclear why it remained under consideration for this extended time period and what prompted the recent closure. Typically, decisions on declining files for negotiation are made relatively quickly (59 days on average in 2020).
Foquest, a new formulation of methylphenidate, initated and successfully achieved an LOI in the same day.
Signals Decoded:
With the closure of a number of protracted negotiations over the last 2 months, and the addition of 12 new negotiations initiated, the average duration of negotiation has also dropped to its lowest point (~125 days) over the last 12 months.
Similarly, several files under consideration for extended periods were initiated/declined leading to a drop in the files under consideration for greater than 6 months.
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