pan-Canadian Pharmaceutical Alliance (pCPA): January 2021 Trends and Insights
January 2021 Highlights:
- 4 products completed CADTH review
- 9 products initiated pCPA negotiations
- 5 negotiations were completed with an LOI
- 0 negotiations were closed without an LOI
- 1 file was closed without negotiation
Files Under pCPA Consideration:
CADTH issued 4 new recommendations & notifications to implement in January (29 files under pCPA consideration as of January 31) – down from 8 in December.
| PRODUCT | INDICATION | SPONSOR | Type | REC’N* DATE |
|---|---|---|---|---|
| Keytruda (pembrolizumab) |
Head and Neck Squamous Cell Carcinoma | Merck | Oncology | January 14 |
| Entyvio (vedolizumab) |
Crohn’s Disease | Takeda |
Non-Oncology
|
January 21 |
| Calquence (acalabrutinib) |
Chronic Lymphocytic Leukemia (previously untreated) | AstraZeneca | Oncology | January 25 |
| Daurismo (glasdegib) |
Acute Myeloid Leukemia | Pfizer | Oncology | January 25 |
* REC’N DATE = Date of CDEC Final Recommendation (non-oncology), Date Notification to Implement Issued (oncology).
Signals Decoded:
The under consideration remains relatively high with 29 files in January 2021. The number of oncology files under consideration is at 12, the highest number in the last year. The time all these files have been pending initiation has held steady at an average of approximately 146 calendar days (median: 94 calendar days) as of month end.
Negotiation Initiation:
The pCPA initiated 9 new negotiations in January (33 active negotiations as of January 31) – up from 2 in December.
| PRODUCT | INDICATION | SPONSOR | CATEGORY | INITIATE DATE | TTI* |
|---|---|---|---|---|---|
| Nyvepria (pegfilgrastim) |
febrile neutropenia in non-myeloid malignancies | Pfizer |
Biosimilar
|
January 13 | N/A |
| Noromby (enoxaparin) |
Deep vein thrombosis (treatment and prevention) | Juno Pharmaceuticals |
Biosimilar
|
January 28 | N/A |
| Inclunox (enoxaparin) |
Deep vein thrombosis (treatment and prevention) | Sandoz |
Biosimilar
|
January 28 | N/A |
| Otezla (apremilast) |
Psoriasis, moderate to severe plaque | Celgene | Other Re-activation |
January 13 | N/A |
| Otezla (apremilast) |
Psoriatic arthritis | Celgene | Other Re-activation |
January 13 | N/A |
| Vascepa (icosapent ethyl) |
Ischemic events in statin treated patients | HLS Therapeutics |
Non-Oncology
|
January 29 | 197 |
| Aimovig (erenumab) |
Migraine, chronic | Novartis |
Non-Oncology
|
January 25 | 187 |
| Taltz (ixekizumab) |
Ankylosing spondylitis | Eli Lilly |
Non-Oncology
|
January 13 | 295 |
| Rinvoq (upadacitinib) |
Subacute and chronic inflammatory joint diseases | AbbVie |
Non-Oncology
|
January 21 | 352 |
*time from final recommendation or notification to implement in calendar days
Signals Decoded:
January saw the number of active negotiations reach 33 files, a level not seen since February 2020. Of the 9 initiated, 3 were biosimilars (a pegfilgrastim and two enoxaparin biosimilars), 2 were re-activations for Otezla (previously closed without LOI in September 2017), and three non-oncology files which had received recommendations in early to mid 2020 were initiated for negotiation. It is possible these files are being considered through the pCPA’s recently initiated Targeted Negotiation Process. These engagements indicate that the capacity for non-oncology files seems to be increasing to levels seen in early 2020.
Completed/Closed Negotiations:
The pCPA completed 5 negotiations with a Letter of Intent (LOI) in January 2021, up from 4 in December. All the negotiations were for adalimumab biosimilars.
| PRODUCT | INDICATION | SPONSOR | LOI DATE | TTN* |
|---|---|---|---|---|
| Hyrimoz (adalimumab) |
Inflammatory Conditions ** | Sandoz | January 20 | 72 |
| Amgevita (adalimumab) |
Inflammatory Conditions ** | AMGEN | January 20 | 72 |
| Hulio (adalimumab) |
Inflammatory Conditions ** | BGP Pharma | January 20 | 72 |
| Hadlima (adalimumab) |
Inflammatory Conditions ** | Merck | January 22 | 74 |
| Idacio (adalimumab) |
Inflammatory Conditions ** | Fresenius Kabi | January 26 | 78 |
* TTN = Time to Negotiate in calendar days
**Rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, hidradenitis suppurative, plaque psoriasis, uveitis
Not Negotiated:
The pCPA declined negotiations on 1 file in January 2021.
| PRODUCT | INDICATION | SPONSOR | DECLINE DATE | TTD* |
|---|---|---|---|---|
| Spravato (esketamine hydrochloride) |
Major Depressive Disorder | Janssen | January 27 | 42 |
* TTD = Time to Decline in calendar days
Signals Decoded:
Spravato received a “do not reimburse” recommendation from CADTH and was declined without negotiations in January 2021, which is the first file declined since October 2020.
Signals Decoded:
The number of files under consideration for more than six months stays steady at 10 files for the fourth month in a row, despite the initiation of negotiations for 3 files that were under consideration since early mid 2020.
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