pan-Canadian Pharmaceutical Alliance (pCPA): September 2018 Negotiation Status Update
The pan-Canadian Pharmaceutical Alliance Office (pCPAO) has issued the status of brand negotiations as of September 30, 2018. This month, MORSE Consulting Inc. provides our standard update along with two charts demonstrating the trends for the average time under consideration and average duration of negotiation for completed and closed files from August 2017 to September 2018. Of note:
- Average Time Under Consideration decreased from 6 months in August 2017 to 4 months in September 2018
- Average Duration of Negotiation increased slightly from 5 months in August 2017 to 6 months in September 2018
As a new addition, the MORSE pCPA updates will now include a review of Institut national d’excellence en santé et en services sociaux (INESSS) files which received a Notice to the Minister during the previous month.
The key highlights since the August update are:
- 10 new drug products have initiated pCPA negotiations, for a total of 54 active negotiations;
- 5 negotiations were completed for a total of 214 completed negotiations; and
- 1 negotiation was closed since the last update, for a total of 27 closed negotiations.
Negotiation Initiation
- 10 new drug products have initiated pCPA negotiations since the last update, for a total of 54 active negotiations
Brand Name | Generic Name | Manufacturer | Indication | Recommendation/ Notification to Implement Date |
Time to Initiation* |
---|---|---|---|---|---|
Dysport Therapeutic | abobotulinumtoxin A | Ipsen Biopharmaceuticals Canada Inc. | lower limb spasticity in pediatric patients | Reimburse with clinical criteria and/or conditions | 23 days |
Alecensaro | alectinib | Hoffmann-La Roche Limited | Locally advanced or metastatic non-small cell lung cancer | Recommends conditional on the cost-effectiveness being improved to an acceptable level | 36 days |
Besponsa | inotuzumab ozogamicin | Pfizer Canada Inc. | acute lymphoblastic leukemia | Recommends conditional on the cost-effectiveness being improved to an acceptable level | 54 days |
Akynzeo | netupitant / palonosetron | Purdue Pharma | Nausea and vomiting (chemotherapy induced) prevention | Reimburse with clinical criteria and/or conditions | 87 days |
Stivarga | regorafenib | Bayer Inc. | unresectable hepatocellular carcinoma | Recommends conditional on the cost-effectiveness being improved to an acceptable level | 135 days |
Monoprost | latanoprost | Laboratoires Théa | glaucoma and ocular hypertension | Reimburse with clinical criteria and/or conditions | 144 days |
Alecensaro | alectinib | Hoffmann-La Roche Limited | Locally advanced or metastatic non-small cell lung cancer (second line) | Recommends conditional on the cost-effectiveness being improved to an acceptable level | 152 days |
Vemlidy | tenofovir alafenamide | Gilead Sciences Canada, Inc. | chronic hepatitis B infection | Reimburse with clinical criteria and/or conditions | 173 days |
Fibristal | ulipristal acetate | Allergan Inc. | intermittent treatment of moderate to severe signs and symptoms of uterine fibroids | Reimburse with clinical criteria and/or conditions | 297 days |
Synjardy | Empagliflozin and metformin | Boehringer Ingelheim (Canada) Ltd. | Diabetes mellitus (Type 2) | Reimburse with clinical criteria and/or conditions | 690 days |
*Approximation: Negotiation initiation date assumed to be mid-month for the purposes of the calculation
Signals Decoded:
After peaking in July of this year, both the average time to initiation and average duration of negotiation measures have been trending downward for two consecutive months. With 10 newly initiated files in September, the pCPA has an all-time high of 54 active negotiations, while the number of files under consideration has been reduced to less than 20 for the first time since October 2017.
Negotiations Completed/Closed
- 5 negotiations were completed since the last update, for a total of 214 completed negotiations.
Brand Name | Generic Name | Manufacturer | Indication | Negotiation Initiation | Duration * |
---|---|---|---|---|---|
Dysport Therapeutic | abobotulinumtoxin A | Ipsen Biopharmaceuticals Canada Inc. | Lower limb spasticity in pediatrics | September 2018 | 0 Days |
Synjardy | Empagliflozin and metformin | Boehringer Ingelheim (Canada) Ltd. | Diabetes mellitus (Type 2) | September 2018 | 0 Days |
Toujeo | Insulin glargine | Sanofi | Diabetes mellitus type 1 and 2 | June 2018 | 92 days |
Spinraza | nusinersen | Biogen Canada Inc. | Spinal Muscular Atrophy | January 2018 | 243 days |
Jardiance | Empagliflozin | Boehringer Ingelheim (Canada) Ltd. | Diabetes mellitus, type 2 with high cardiovascular risk | August 2016 | 761 days |
*Approximation: Negotiation initiation and completion date assumed to be mid-month for the purposes of the calculation
- One negotiation was closed since the last update, for a total of 27 closed negotiations.
Brand Name | Generic Name | Manufacturer | Indication | Negotiation Initiation | Duration * |
---|---|---|---|---|---|
Fibristal | ulipristal acetate | Actavis Specialty Pharmaceuticals Co. | uterine fibroids (2nd cycle pre-surgery) | September 2017 | 365 days |
Signals Decoded:
After more than two years of active negotiations, the pCPA has reached an agreement for Jardiance in patients with high cardiovascular risk – an agreement which presumably included reimbursement of Synjardy which had been under consideration for almost two years. The pCPA has also reached an agreement for Toujeo (a new version of insulin glargine). As Basaglar (biosimilar to Lantus) is widely reimbursed, the pCPA has signaled that the presence of a biosimilar insulin product does not preclude the reimbursement of a new brand product in that space.
Files Under pCPA Consideration
In addition to the monthly updates to the pCPA website, MORSE Consulting tracks the number of products “under pCPA Consideration” which have been reviewed by CADTH but have not yet been initiated for negotiation or closed without negotiations.
- Two new drug products received a CDEC or pERC recommendation or notification to implement in September 2018, for a total of approximately 19 products under pCPA Consideration.
As a new section of the update, MORSE is now providing an update on the files which have been reviewed by INESSS and received a Notice to the Minister during the previous month. Twelve products received an INESSS recommendation in September 2018. *
Brand Name | Generic Name | Manufacturer | Indication | INESSS Recommendation | Minister Decision |
---|---|---|---|---|---|
Alecensaro | alectinib | Roche | Non-small cell lung cancer (ALK positive advanced or metastatic) | List as an Exception Medicine with Conditions | Pending |
Besponsa | Inotuzumab Ozogamicin | Pfizer | Acute lymphoblastic leukemia | Modification to an indication on the Exception Medicine List with Conditions | Pending |
Fasenra | benralizumab | AstraZeneca Canada Inc. | Severe eosinophilic asthma | List as an Exception Medicine with Conditions | Pending |
Lynparza | olaparib | AstraZeneca Canada Inc. | ovarian cancer | List as an Exception Medicine with Conditions | Listed as an Exception Medicine
(September 27, 2018) |
Nucala | mepolizumab | GlaxoSmithKline Inc. | Severe eosinophilic asthma | Modification to an indication on the Exception Medicine List with Conditions | Pending |
Ozempic | semaglutdie | Novo Nordisk | Type 2 Diabetes | List as an Exception Medicine with Conditions | Pending |
Procysbi | cysteamine bitartrate | Horizon Therapeutics Canada | nephropathic cystinosis | List as an Exception Medicine with Conditions | Listed as an Exception Medicine
(September 27, 2018) |
Rekovelle | Follitropin delta | Ferring | Controlled Ovarian Stimulation | List as an Exception Medicine with Conditions | Listed as an Exception Medicine
(September 27, 2018) |
Stivarga | regorafenib | Bayer Inc. | Unresectable Hepatocellular Carcinoma (HCC) | Addition to an indication on the Exception Medicine List with Conditions | Pending |
Taltz | ixekizumab | Lilly | psoriatic arthritis | Addition to an indication on the Exception Medicine List with Conditions | Pending |
Trelegy Ellipta | fluticasone furoate/umeclidinium/
vilanterol |
GlaxoSmithKline Inc. | COPD | List as an Exception Medicine with Conditions | Pending |
Xeljanz XR | tofacitinib | Pfizer | rheumatoid arthritis | List as an Exception Medicine with Conditions | Pending |
*Note this does not include generic drug products, or those files which would not comparable to those reviewed by CADTH.
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