pan-Canadian Pharmaceutical Alliance (pCPA): April 2020 Trends and Insights
April Highlights:
- 6 products completed CADTH review
- 4 products initiated pCPA negotiations
- 11 negotiations were completed with an LOI
- 2 negotiations were closed without an LOI
- 2 files were closed without negotiation
In keeping with pCPA’s communication to industry associations, early trends into their management of files during the challenges associated with COVID indicate that initial priority has been on completing ongoing negotiations that were close to completion and negotiating files with potential cost savings. Not surprisingly, the number of files waiting to initiate negotiations is growing and is at its highest level in over a year despite the high level of overall pCPA activity in April.
Files Under pCPA Consideration:
CADTH issued 6 new recommendations in April (20 files under consideration as of April 30th)
| PRODUCT | INDICATION | SPONSOR | HTA | REC’N* DATE | TUC** |
|---|---|---|---|---|---|
| Benlysta (belimumab) |
Systemic lupus erythematosus | GlaxoSmithKline | CDR | 22 Apr | 8 |
| Dupixent (dupilumab) |
Atopic Dermatitis | Sanofi Genzyme | CDR | 22 Apr | 8 |
| Keytruda (pembrolizumab) |
Renal Cell Carcinoma | Merck | pCODR | 20 Apr | 10 |
| Mylotarg (gemtuzumab ozogamicin) |
Acute Myeloid Leukemia | Pfizer | pCODR | 20 Apr | 10 |
| Rydapt (midostaurin) |
Systemic Mastocytosis | Novartis | pCODR | 20 Apr | 10 |
| Lonsurf (trifluridine-tipiracil) |
Gastric Cancer | Taiho | pCODR | 8 Apr | 22 |
* REC’N DATE = Date of CDEC Final Recommendation (CDR), Date Notification to Implement Issued (pCODR)
** TUC = Time Under Consideration in calendar days
Negotiation Initiation:
The pCPA initiated 4 new negotiations in April (20 active negotiations as of April 30th)
| PRODUCT | INDICATION | SPONSOR | CATEGORY | INITIATE DATE | TTI* |
|---|---|---|---|---|---|
| Nivestym (filgrastim) |
Prevention or treatment of neutropenia in various indications | Pfizer | Biosimilar | 27 Apr | N/A |
| Ziextenzo (pegfilgrastim) |
Febrile neutropenia in non-myeloid malignancies | Sandoz | Biosimilar | 27 Apr | N/A |
| Riximyo (rituximab) |
Rheumatoid arthritis, chronic lymphocytic leukemia, and non-Hodgkin’s lymphoma | Sandoz | Biosimilar | 24 Apr | N/A |
| Ruxience (rituximab) |
Non-Hodgkin’s Lymphoma, Chronic Lymphocytic Leukemia, Rheumatoid Arthritis, Granulomatosis with Polyangitis, Microscopic Polyangitis | Pfizer | Biosimilar | 24 Apr | N/A |
* TTI = Time to Initiate in calendar days
Signals Decoded:
As expected, the number of files under pCPA consideration has increased as the pCPA deals with limited capacity to support new negotiations. The 4 negotiations started in April were all for biosimilar versions of products where biosimilars are already available.
Completed Negotiations:
The pCPA completed 11 negotiations with a Letter of Intent (LOI) in April 2020.
| PRODUCT | INDICATION | SPONSOR | LOI DATE | TTN* |
|---|---|---|---|---|
| Tegsedi (inotersen) |
Hereditary transthyretin-mediated amyloidosis | Akcea | 30 Apr | 153 |
| Mezera (mesalazine) |
Ulcerative Colitis | AVIR Pharma | 21 Apr | 173 |
| Kanjinti (trastuzumab) |
Early/metastatic breast cancer, metastatic gastric cancer | Amgen | 16 Apr | 23 |
| Keytruda (pembrolizumab) |
Squamous Non-Small Cell Lung Cancer | Merck | 15 Apr | 84 |
| Keytruda (pembrolizumab) |
Melanoma adjuvant therapy | Merck | 15 Apr | 215 |
| Keytruda (pembrolizumab) |
Non-squamous non-small cell lung cancer | Merck | 15 Apr | 246 |
| Keytruda (pembrolizumab) |
Metastatic Urothelial Carcinoma | Merck | 15 Apr | 597 |
| Keytruda (pembrolizumab) |
Classic Hodgkin’s Lymphoma | Merck | 15 Apr | 553 |
| Radicava (edaravone) |
Amyotrophic lateral sclerosis | Mitsubishi | 15 Apr | 204 |
| Ibrance/Faslodex (palbociclib/fulvestrant) |
Advanced or Metastatic Breast Cancer | Pfizer | 8 Apr | 238 |
| Sublocade (buprenorphine) |
Opioid Use Disorder | Indivior | 2 Apr | 268 |
* TTN = Time to Negotiate in calendar days
Signals Decoded:
While the large number of completed negotiations may be somewhat tempered by the fact that 5 of the 11 files were for various Keytruda indications, the pCPA has reduced the number of active negotiations to its lowest point in well over a year. April also saw the completion or closure of 3 negotiations that had been ongoing for over 12 months.
Closed Negotiations:
The pCPA closed 2 negotiations without an agreement in April 2020.
| PRODUCT | INDICATION | SPONSOR | CLOSE DATE | TTC* |
|---|---|---|---|---|
| Humira (citrate free) (adalimumab) |
Multiple Indications | AbbVie | 16 Apr | 442 |
| Verzenio (abemaciclib) |
Advanced or Metastatic Breast Cancer | Eli Lilly | 9 Apr | 192 |
* TTC = Time to Close in calendar days
Signals Decoded:
Of the 13 files completed or closed in April, 9 had been in active negotiations for more than 6 months. The chart above shows that the 20 active files as of April 30th had been in negotiations for an average of under 4 months.
Not Negotiated:
The pCPA declined negotiations on 2 files in April 2020.
| PRODUCT | INDICATION | SPONSOR | DECLINE DATE | TTD* |
|---|---|---|---|---|
| Lorbrena (lorlatinib) |
Non-small cell lung cancer (ALK+) | Pfizer | 21 Apr | 67 |
| Lokelma (sodium zirconium cyclosilicate) |
Hyperkalemia | AstraZeneca | 16 Apr | 22 |
* TTD = Time to Decline in calendar days
Signals Decoded:
Both of the files closed without negotiations in April received “do not list” recommendations from CADTH.
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