pan-Canadian Pharmaceutical Alliance (pCPA): Negotiation Status Update
The August 31, 2018 update has been issued by the pan-Canadian Pharmaceutical Alliance. The key highlights since the last update are:
- 7 negotiations were completed, while none were closed for a total of 235 completed/closed negotiations;
- 9 new drug products have initiated pCPA negotiations, for a total of 48 active negotiations;
- No new drug products were added to the “No pCPA Negotiations” list, for a total of 54 products for which the pCPA has declined to negotiate – collectively or at the provincial-territorial level.
- 9 new drug products have initiated pCPA negotiations since the last update, for a total of 48 active negotiations
|Brand Name||Generic Name||Manufacturer||Indication||Recommendation/
Notification to Implement Date
|Time to Initiation*|
|Nitisinone||nitisinone||Cycle Pharmaceuticals Ltd.||Hereditary tyrosinemia type 1||Reimburse with clinical criteria/conditions||0 days|
|Juluca||Dolutegravir rilpivirine||ViiV Healthcare ULC||HIV infection||Reimburse with clinical criteria/conditions||56 days|
|Kisqali||ribociclib||Novartis Pharmaceuticals Canada Inc.||Advanced or Metastatic Breast Cancer||Conditional Reimbursement||104 days|
|MDK-Nitisinone||nitisinone||MendeliKABS Inc||Hereditary tyrosinemia type||Reimburse with clinical criteria/conditions||112 days|
|Keytruda||pembrolizumab||Merck Canada Inc.||metastatic urothelial carcinoma||Conditional Reimbursement||149 days|
|Orfadin||nitisinone||Sobi Canada Inc.||Hereditary tyrosinemia type 1||Reimburse with clinical criteria/conditions||175 days|
|Faslodex||Fulvestrant||AstraZeneca Canada Inc.||Locally Advanced or Metastatic Breast Cancer||Conditional Reimbursement||180 days|
|Praluent||Alirocumab||Sanofi-aventis Canada Inc.||prevention of cardiovascular events in patients with atherosclerotic cardiovascular disease (ASCVD)||Reimburse with clinical criteria/conditions||756 days|
|Repatha||evolocumab||Amgen Canada||prevention of cardiovascular events in patients with atherosclerotic cardiovascular disease (ASCVD)||List with clinical criteria and/or conditions||908 days|
*Approximation: Negotiation initiation date assumed to be mid-month for the purposes of the calculation
With the completion of negotiations for Praluent’s HeFH indication, the pCPA has initiated new negotiations for both Praluent and Repatha to deal with the larger indication for use in patients with atherosclerotic cardiovascular disease. Also, the initiation of negotiations on the three products indicated for Hereditary tyrosinemia type 1 is the latest example of pCPA waiting to initiate talks with “first entrants” and waiting for anticipated competition in order to conduct concurrent negotiations in competitive therapeutic spaces.
- 7 negotiations were completed since the last update, for a total of 209 completed negotiations.
|Brand Name||Generic Name||Manufacturer||Indication||Negotiation Initiation||Duration *|
|Rituxan SC||Rituximab||Hoffman-La Roche Limited||Chronic lymphocytic leukemia||June 2018||61 days|
|Enstilar||calcipotriol/betamethasone||Leo Pharma Inc.||Psoriasis||May 2018||92 days|
|Galafold||Migalastat||Amicus Therapeutics||Fabry Disease||March 2018||153 days|
|Actikerall||Fluorouracil and Salicylic Acid||Cipher Pharmaceuticals Inc.||Hyperkeratotic actinic keratosis||February 2018||181 days|
|Revestive||Teduglutide||Shire Pharma Canada ULC/NPS Pharma Holdings Limited||Short bowel syndrome||June 2017||426 days|
|Lancora||Ivabradine||Servier Canada Inc.||Heart failure, NYHA class II or III||December 2017||243 days|
|Praluent||Alirocumab||Sanofi-Aventis Canada Inc.||lowering of low density lipoprotein cholesterol (LDL-C) in patients with heterozygous familial hypercholesterolemia (HeFH)||August 2016||730 days|
*Approximation: Negotiation initiation and completion date assumed to be mid-month for the purposes of the calculation
- No negotiations were closed since the last update, for a total of 26 closed negotiations.
With 7 completed negotiations in August, pCPA has successfully completed LOI’s for 16 files over the summer months, including several that had been active discussion for extended periods of time. Even with this significant summer progress, the number of total files under active pCPA management (files under pCPA consideration + active negotiations) is at an all-time high of 74 files, and remains over 70 for the 5th consecutive month.
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.
- Nine new drug products received a CDEC or pERC recommendation or notification to implement in August 2018, for a total of approximately 26 products under pCPA Consideration.
|Brand Name||Generic Name||Manufacturer||Indication||Final Recommendation/
Notification to Implement
|Alecensaro||Alectinib||Hoffmann-La Roche Limited||Non-Small Cell Lung Cancer (first line)||Reimburse if cost-effectiveness is improved to an acceptable level|
|Duodopa*||Levodopa / carbidopa||AbbVie Corporation||Parkinson’s disease||Reimburse with clinical criteria and/or conditions|
|Dysport Therapeutic||abobotulinumtoxinA||Ipsen Biopharmaceuticals Canada Inc.||lower limb spasticity||Reimburse with clinical criteria and/or conditions|
|Fasenra||benralizumab||AstraZeneca Canada Inc.||Asthma, severe eosinophilic||Reimburse with clinical criteria and/or conditions|
|Nitisinone||Nitisinone||Cycle Pharmaceuticals Ltd.||Hereditary tyrosinemia type 1||Reimburse with clinical criteria and/or conditions|
|Probuphine||buprenorphine hydrochloride||Knight Therapeutics Inc.||Opioid drug dependence, treatment||Reimburse with clinical criteria and/or conditions|
|Taltz||ixekizumab||Eli Lilly Canada Inc.||Arthritis, psoriatic||Reimburse with clinical criteria and/or conditions|
|Trelegy Ellipta||fluticasone furoate umeclidinium vilanterol||GlaxoSmithKline Inc.||Chronic obstructive pulmonary disease (COPD)||Reimburse with clinical criteria and/or conditions|
|Viberzi||eluxadoline||Allergan Pharma Co.||Irritable bowel syndrome with diarrhea||Do not reimburse|
*Drug plan submission
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