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pCPA Monthly Trends & Insights – August 31, 2018

September 14, 2018
-
Market Access News
-
Posted by MORSE Team - 3 min read.

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.

Negotiation Initiation

  • 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

Signals Decoded:

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.

Negotiatons Completed/Closed

  • 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.

Signals Decoded:

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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pCPA Monthly Trends & Insights – August 31, 2018
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