pan-Canadian Pharmaceutical Alliance (pCPA): February 2021 Trends and Insights
February 2021 Highlights:
- 5 products completed CADTH review
- 7 products initiated pCPA negotiations
- 6 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 5 new recommendations in February (28 files under pCPA consideration as of Feb 28) – down from 29 in January.
| PRODUCT | INDICATION | SPONSOR | Type | REC’N* DATE |
|---|---|---|---|---|
| Pdp-levETIRAcetam (levetiracetam) | Epilepsy | Pendopharm | Non-Oncology | February 3 |
| Rozlytrek (entrectinib) | ROS1-positive Non-Small Cell Lung Cancer | Hoffmann-La Roche | Oncology | February 11 |
| Ofev (nintedanib) | chronic fibrosing interstitial lung diseases | Boehringer Ingelheim | Non-Oncology | February 24 |
| Kynmobi (apomorphine hydrochloride) | Parkinson’s disease | Sunovion | Non-Oncology | February 24 |
| Kesimpta (ofatumumab) | Multiple Sclerosis, relapsing | Novartis | Non-Oncology | February 25 |
Signals Decoded:
The volume of files under consideration is holding relatively steady at 28 after a gradual monthly increase that reached its 12-month peak of 30 in December 2020. The average days under consideration continues to hover around the 150 day range up from 50 days in early 2020.
Negotiation Initiation:
The pCPA initiated 7 new negotiations in February (33 active negotiations as of February 28) – up from 30 in January.
| PRODUCT | INDICATION | SPONSOR | CATEGORY | INITIATE DATE | TTI* |
|---|---|---|---|---|---|
| Adcetris | Primary Cutaneous Anaplastic Large Cell Lymphoma (or CD30- Expressing Mycosis Fungoides) | Seattle Genetics | Oncology | February 5 | 49 |
| Adcetris | Hodgkin’s Lymphoma | Seattle Genetics | Oncology | February 5 | 231 |
| Keytruda** | Head and Neck Squamous Cell Carcinoma (HNSCC) | Merck | Oncology | February 10 | 187 |
| Darzalex | Multiple Myeloma | Janssen | Oncology | February 26 | 343 |
| Darzalex SC | Multiple Myeloma | Janssen | Oncology (Other) | February 26 | N/A |
| Nexplanon | Prevention of Pregnancy | Merck | Non-Oncology | February 24 | 125 |
| Zolgensma | Spinal Muscular Atrophy | Novartis | Other- Gene Therapy | February 19 | N/A |
* time from CADTH final recommendation or notification to implement in calendar days
** Initiated and concluded with LOI on the same day
Signals Decoded:
February also saw the number of active negotiations peak at its 12-month high of 33, perhaps signaling that pCPA’s capacity may be starting to increase. It is notable that Zolgensma, a gene therapy for the treatment of SMA, initiated pCPA negotiations in advance of its CADTH recommendation, however it has received its INESSS recommendation.
Completed/Closed Negotiations:
The pCPA completed 6 negotiations with a Letter of Intent (LOI) in February 2021, the same number of files completed in January.
| PRODUCT | INDICATION | SPONSOR | LOI DATE | TTN* |
|---|---|---|---|---|
| Lonsurf* | Metastatic Gastric Cancer | Taiho | January 11 | 188 |
| Keytruda** | Head and Neck Squamous Cell Carcinoma (HNSCC) | Merck | February 10 | 1 |
| Vyndaqel | Transthyretin-Mediated Amyloidosis | Pfizer | February 4 | 239 |
| Aermony Respiclick | Asthma | Teva | February 2 | 118 |
| Monoferric | Iron Deficiency Anemia | Pharmacosmos A/S | February 2 | 196 |
| Nubeqa | Non-Metastatic Castrate Resistant Prostate Cancer | Bayer | February 18 | 118 |
| Dupixent | Atopic Dermatitis | Sanofi Genzyme | February 25 | 212 |
* TTN = Time to Negotiate in calendar days
* Correction from January
** Initiated and concluded with LOI on the same day
Not Negotiated:
The pCPA declined negotiations on 1 file in January 2021.
| PRODUCT | INDICATION | SPONSOR | DECLINE DATE | TTD* |
|---|---|---|---|---|
| Daurismo | Acute Myeloid Leukemia (AML) | Pfizer | February 23 | 29 |
* TTD = Time to Decline in calendar days
Signals Decoded:
The number of files under consideration for greater than 6 months has plateaued at 10, while the number of files under active negotiation for greater than 12 months is starting to climb. In addition the total files adjudicated by the pCPA by month appears to be stabilizing around the 5-7 mark.
Interestingly, the pCPA negotiation for Keytruda for HNSCC opened and closed on the same day, perhaps indicating the negotiation was only administrative in nature. Daurismo was the only file declined for negotiation and received a Do Not Reimburse recommendation from CADTH and INESSS.
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