pan-Canadian Pharmaceutical Alliance (pCPA): November 2020 Trends and Insights
November 2020 Highlights:
- 4 products completed CADTH review
- 8 products initiated pCPA negotiation
- 5 negotiations were completed with an LOI
- 0 negotiations were closed without an LOI
- 0 files were closed without negotiation
Files Under pCPA Consideration:
CADTH issued 4 new recommendations & notifications to implement in November (24 files under pCPA consideration as of November 30) – down slightly from 5 in October.
| PRODUCT | INDICATION | SPONSOR | Type | REC’N* DATE |
|---|---|---|---|---|
| Luxturna (voretigene neparvovec) |
Vision loss due to inherited retinal dystrophy | Novartis | Non-oncology (Gene therapy) |
November 12 |
| Blincyto (blinatumomab) |
MRD Positive B-cell precursor ALL | Amgen | Oncology | November 13 |
| Enerzair Breezhaler (Indacaterol/ glycopyrronium/ mometasone furoate) |
Asthma maintenance, adults | Novartis | Non-oncology | November 24 |
| Atectura Breezhaler (indacaterol/mometasone furoate) |
Asthma maintenance, adults children 12 or older | Novartis | Non-oncology | November 24 |
* REC’N DATE = Date of CDEC Final Recommendation (non-oncology), Date Notification to Implement Issued (oncology).
Signals Decoded:
The number of files under consideration has more than doubled since this time last year (Nov 2019 n = 9) and these files have been pending pCPA initiation/decline for an average of 5 months. In comparison, in Nov 2019 the 9 files had been under consideration for an average of 2 months.
Negotiation Initiation:
The pCPA initiated 8 new negotiations in November (32 active negotiations as of November 30, 2020) – up from 7 in October.
| PRODUCT | INDICATION | SPONSOR | CATEGORY | INITIATE DATE | TTI* |
|---|---|---|---|---|---|
| Redesca (enoxaparin) |
Deep Vein Thrombosis (treatment), without Symptomatic Pulmonary Embolism | Valeo Pharma | Biosimilar | November 2 | N/A |
| Hulio (adalimumab) |
Ankylosing spondylitis, plaque psoriasis, psoriatic arthritis, rheumatoid arthritis, Crohn’s disease and Ulcerative Colitis | BGP Pharma | Biosimilar | November 9 | N/A |
| Idacio (adalimumab) |
Ankylosing spondylitis, plaque psoriasis, psoriatic arthritis, rheumatoid arthritis, Crohn’s disease and Ulcerative Colitis | Fresenius Kabi | Biosimilar | November 9 | N/A |
| Hyrimoz (adalimumab) |
Ankylosing spondylitis, plaque psoriasis, psoriatic arthritis, rheumatoid arthritis, Crohn’s disease and Ulcerative Colitis | Sandoz Canada | Biosimilar | November 9 | N/A |
| Amgevita (adalimumab) |
Ankylosing spondylitis, plaque psoriasis, psoriatic arthritis, rheumatoid arthritis, Crohn’s disease and Ulcerative Colitis | AMGEN CANADA | Biosimilar | November 9 | N/A |
| Hadlima (adalimumab) |
Ankylosing spondylitis, plaque psoriasis, psoriatic arthritis, rheumatoid arthritis, Crohn’s disease and Ulcerative Colitis | Merck | Biosimilar | November 9 | N/A |
| Zejula (niraparib) |
Ovarian Cancer | GlaxoSmithKline | Oncology | November 13 | 53 |
| Cabometyx (cabozantinib) |
Hepatocellular carcinoma | Ipsen Biopharmaceuticals | Oncology | November 24 | 201 |
Additionally, the following negotiation was added to the Active list, however it was initiated in June 2020.
| PRODUCT | INDICATION | SPONSOR | CATEGORY | INITIATE DATE | TTI* |
|---|---|---|---|---|---|
| Blood glucose test strips | Diabetes Mellitus, Type 1 and 2 | Multiple Manufacturers | Other | June 24 | N/A |
Signals Decoded:
Although the pCPA initiated 8 negotiations this past month, six of those initiations were for biosimilars, including five adalimumab biosimilars. The ratio of files under consideration relative to the total volume of files under pCPA management (active + under consideration) has risen from 24% last November 2019 to 43% as of this November 2020.
A category negotiation for blood glucose test strips was also added to the pCPA website this month, however it was initiated in June 2020.
Completed/Closed Negotiations:
The pCPA completed 5 negotiations with a Letter of Intent (LOI) in November 2020 – consistent with October.
| PRODUCT | INDICATION | SPONSOR | LOI DATE | TTN* |
|---|---|---|---|---|
| Avsola (infliximab) |
Inflammatory Conditions | Amgen | November 2 | 171 |
| Libtayo (cemiplimab) |
Cutaneous Squamous Cell Carcinoma | Sanofi Genzyme | November 4 | 149 |
| Kadcyla (trastuzumab emtansine) |
Early Breast Cancer | Hoffmann-La Roche | November 5 | 168 |
| Verkazia (cyclosporine) |
Severe vernal keratoconjunctivitis | Santen | November 20 | 192 |
| Onpattro (patisiran) |
Hereditary transthyretin mediated amyloidosis | Alnylam | November 30 | 381 |
* TTN = Time to Negotiate in calendar days
Signals Decoded:
The average time under negotiation for files which are currently active has decreased since November 2019 from approximately 5.5 months to 3.8 months in November 2020. However, this may in part be due to pCPA’s completion of several long outstanding negotiations this calendar year. The number of files under consideration for more than 6 months has seen a steady increase since March 2020 when there were none, to a high of 10 in November 2020.
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