pCPA Update as of July 31, 2017

pan-Canadian Pharmaceutical Alliance (pCPA): Negotiation Status Update

The latest update as of July 31, 2017 has been issued by the pan-Canadian Pharmaceutical Alliance Office (pCPAO). The key highlights from the pCPAO update are as follows:

• Seven new drug products have initiated pCPA negotiations since the last update, for a total of 46 active negotiations
• Three negotiations have been completed since the last update, for a total of 163 joint negotiations.
• Three new drug products were added to the “No pCPA Negotiations” list, for a total of 53 products for which the pCPA has decided not to negotiate collectively or individually at the provincial-territorial level

In addition to the information above, MORSE Consulting is tracking the number of products reviewed by CADTH that have yet to initiate negotiations with the pCPA – which we refer to as “under pCPA Consideration”. The latest update since June 30^th, 2017 is:

• Five new drug products have received recent CDEC or pERC recommendations, for a total of approximately 23 products under pCPA Consideration

Please see below for more details.

• Seven new drug products have initiated pCPA negotiations since the last update, for a total of 46 active negotiations
  • Cinqair (reslizumab; TEVA Canada Innovation) – Asthma, eosinophilic
  • Giotrif (afatinib; Boehringer Ingelheim Canada Inc.) – Advanced Non Small Cell Lung Cancer
  • Humira (adalimumab; AbbVie Corporation) – Hidradenitis suppurativa
  • Kevzara (sarilumab; Sanofi Genzyme ) – Rheumatoid Arthritis
  • Methadose (methadone; Mallinckrodt Pharmaceuticals) – Opioid dependence
  • Trulicity (dulaglutide; Eli Lilly Canada Inc.) – Diabetes mellitus, Type 2
  • Zykadia (ceritinib, Novartis Pharmaceuticals Canada Inc.) – Non-small cell lung cancer

• Three negotiations have been completed since the last update, for a total of 163 joint negotiations.
  • Basaglar (insulin glargine; Eli Lilly Canada Inc.) – Diabetes mellitus, Type 1 and 2
  • Mifegymiso (mifepristone/misoprostol; Celopharma Inc.) – Medical termination of pregnancy
  • Votrient (pazopanib; pazopanib hydrochloride; GlaxoSmithKline Inc.) – Genitourinary metastatic renal cell carcinoma [second letter of intent]

• Three new drug products were added to the “No pCPA Negotiations” list, for a total of 53 products for which the pCPA has decided not to negotiate collectively or individually at the provincial-territorial level
  • Alecensaro (alectinib; Hoffman-la Roche Ltd.) – Non-small cell lung cancer (with CNS metastases)
  • Cortiment (budesonide; Ferring Inc.) – Ulcerative Colitis
  • Viacoram (perindopril arginine/amlodipine; Servier Canada Inc.) – Hypertension
    • The manufacturers and pCPA jurisdictions have engaged in thorough discussions regarding criteria and conditions as recommended through the HTA review and both recognize that a Letter of Intent (LOI) could not be reached at the current time.

Based on information collected by MORSE Consulting:

• Five new drug products have received recent CDEC or pERC recommendations or notifications to implement since the last update, for a total of approximately 23 products under pCPA Consideration.

Please note; the date provided is the date of the Final Recommendation or Notification to Implement where applicable.

• Cerdelga (eliglustat; Sanofi Genzyme; July 26, 2017) – Gaucher Disease
• Dysport Therapeutic (abobotulinumtoxinA; IPSEN Biopharmaceuticals Canada, Inc; July 26, 2017) – Cervical dystonia
• Glatect (glatiramer acetate; Pendopharm; July 25, 2017) – Multiple Sclerosis, relapsing- remitting
• Ninlaro (ixazomib; Takeda Pharmaceutical Company Limited; July 17, 2017) – Multiple Myeloma
• Ocaliva (obeticholic acid; Intercept Pharma Canada Inc; July 25, 2017) – Primary Biliary Cholangitis

Deciphering this Signal

1. Basaglar – Completed its negotiations with the pCPA marking the first insulin glargine biosimilar product through the pCPA process.
2. No pCPA Negotiations – After several months of having no products added to this list, in July the pCPA added 3 drugs to this list with additional details for Viacoram on the rationale for why a Letter of Intent could not be reached.

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