pan-Canadian Pharmaceutical Alliance (pCPA): February 2019 Negotiation Status Update
The pan-Canadian Pharmaceutical Alliance Office (pCPAO) has issued the status of brand negotiations as of February 28, 2019. The key highlights since the last update are:
- 8 negotiations were completed for a total of 242 completed negotiations
- No negotiations were closed, for a total of 33 closed negotiations
- The pCPA decided to decline negotiations on 1 file, for a total of 63 declined negotiations
- 3 products have received a final HTA recommendation/completed an HTA review, for a total of 12 files under consideration.
- 6 products have initiated pCPA negotiations, for a total of 43 active negotiations
Completed
| Brand Name | Generic Name | Manufacturer | Indication | Initiation | Duration* |
|---|---|---|---|---|---|
| Lapelga Biosimilar |
pegfilgrastim | Apobiologix | Febrile neutropenia | Oct 2018 | 151 days |
| Besponsa | Inotuzumab Ozogamicin | Pfizer | Acute Lymphoblastic Leukemia (ALL) | Sep 2018 | 181 days |
| Juluca | Dolutegravir/rilpivirine | ViiV Healthcare | HIV-1 Infection | Aug 2018 | 212 days |
| Lixiana NVAF | Edoxaban | Daiichi Sankyo | prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation | Jul 2018 | 243 days |
| Lixiana VTE | Edoxaban | Daiichi Sankyo | prevention and treatment of venous thromboembolism | Jul 2018 | 243 days |
| Ocrevus | ocrelizumab | Roche | relapsing-remitting multiple sclerosis | Jul 2018 | 243 days |
| Ocrevus | ocrelizumab | Roche | primary progressive multiple sclerosis | Jul 2018 | 243 days |
| Kevzara | Sarilumab | Sanofi Genzyme | Rheumatoid Arthritis | Jun 2018 | 273 days |
Declined
| Brand Name | Generic Name | Manufacturer | Indication | HTA Date | Time to Decision* |
|---|---|---|---|---|---|
| Orkambi | Lumacaftor/ivacaftor | Vertex Pharmaceuticals | Cystic Fibrosis, F508del CFTR mutation in patients 6 years and older | September 26, 2018 | 142 days |
*Approximation: Negotiation initiation and completion date assumed to be mid-month for the purposes of the calculation (calendar days)
Signals Decoded:
Kevzara becomes the latest file to successfully complete negotiations after having previously been closed without an agreement. In addition, negotiations have also been completed for two multi-indication products (Lixiana and Ocrevus), both of which had been in negotiations for approximately 8 months.
Negotiation Initiation
The pCPA has initiated 6 new negotiations since the last update, for a total of 43 active negotiations.
| Brand Name | Generic Name | Manufacturer | Indication | CADTH Date | Time to Initiation* |
|---|---|---|---|---|---|
| Fulphila Biosimilar |
pegfilgrastim | BGP PHARMA | Febrile neutropenia in non-myeloid malignancies | 22 Feb 2019 | 0 days |
| Mvasi Biosimilar |
bevacizumab | Amgen | Metastatic Colorectal Cancer/ Non-small cell lung cancer | 14 Jan 2019 | 32 days |
| Biktarvy | bictegravir/emtricitabine/ tenofovir alafenamide |
Gilead | HIV Infection | 25 Oct 2018 | 113 days |
| Mavenclad | cladribine | EMD Serono | Multiple Sclerosis, Relapsing | 24 Oct 2018 | 114 days |
| Symtuza | darunavir/cobicistat/ emtricitabine/tenofovir alafenamide |
Janssen | HIV Infection | 25 Jul 2018 | 205 days |
| Ella | ulipristal acetate | Laboratoire HRA | Prevention of Pregnancy | N/A | N/A |
*Approximation: Negotiation initiation date assumed to be mid-month for the purposes of the calculation (Calendar days)
Signals Decoded:
Having just completed negotiations for Lapelga, the pCPA has immediately initiated negotiations on the second biosimilar version of pegfilgrastim. In addition, negotiations have been initiated for a biosimilar version of Avastin – the first oncology “active treatment” biosimilar product negotiated by the pCPA. Although the final HTA recommendations were issued three months apart, negotiations for both Symtuza and Biktarvy for HIV infection were initiated in February.
Files Under pCPA Consideration
The products “under pCPA Consideration” have been reviewed by CADTH but have not yet been initiated for negotiation or closed without negotiations.
Three new drug products received a CDEC recommendation or pERC notification to implement in February 2019, for a total of approximately 12 products under pCPA Consideration.
| Brand Name | Generic Name | Manufacturer | Indication | HTA Recommendation |
|---|---|---|---|---|
| Spinraza | Nusinersen | Biogen | Spinal Muscular Atrophy | Reimburse with clinical criteria and/or conditions |
| Xeljanz | tofacitinib | Pfizer | Ulcerative colitis | Reimburse with clinical criteria and/or conditions |
| Fulphila* Biosimilar |
pegfilgrastim | BGP PHARMA | Febrile neutropenia in non-myeloid malignancies | Biosimilar Dossier Issued |
*Was initiated by the pCPA in the same month and is therefore not included in the count of products under consideration.
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