pCPA Update as of March 31, 2018

April 12, 2018
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pan-Canadian Pharmaceutical Alliance (pCPA): Negotiation Status Update

 

The March 31, 2018 update has been issued by the pan-Canadian Pharmaceutical Alliance Office (pCPAO). The key highlights since the last update are:

  • Four new drug products have initiated pCPA negotiations, for a total of 40 active negotiations;
  • Two negotiations have been completed (none closed), for a total of 207 joint completed/closed negotiations; and
  • One new drug product was added to the “No pCPA Negotiations” list, for a total of 58 products for which the pCPA has decided not to negotiate collectively or individually at the provincial-territorial level.

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.

This chart shows the average number of months, files are under pCPA Consideration. The number of files under consideration in each month is shown below the x-axis and the line shows the 3-month moving average trend. The bars show the average number of months all files, currently under consideration in that particular month, have been in that phase. This includes files that are either closed without negotiations and files for which negotiations are eventually initiated. Phrased another way, the 27 files under pCPA Consideration in March 2018, have been awaiting a pCPA decision for an average of almost 4 months.

  • Four new drug products received a CDEC or pERC recommendation or notification to implement in March 2018, for a total of approximately 27 products under pCPA Consideration.

 

Brand Name Generic Name Manufacturer Indication Final Recommendation/Notification to Implement
Actemra tocilizumab Hoffmann-La Roche Limited Giant cell arteritis (GCA) Conditional Reimbursement
Keytruda pembrolizumab Merck Canada Inc. metastatic urothelial carcinoma Conditional Reimbursement
Vemlidy tenofovir alafenamide Gilead Sciences Canada, Inc. Hepatitis B, chronic Conditional Reimbursement
Venclexta Venetoclax AbbVie Corporation Chronic Lymphocytic Leukemia Conditional Reimbursement

 

Negotiation Initiation

  • Four new drug products have initiated pCPA negotiations since the last update, for a total of 40 active negotiations

 

Brand Name Generic Name Manufacturer Indication Recommendation/
Notification to Implement Date
Time to Initiation*
Darzalex Daratumumab Janssen Canada Inc. Multiple Myeloma October 23, 2017 143 days
Fiasp Insulin aspart Novo Nordisk Type 1 Diabetes Mellitus N/A N/A
Galafold migalastat Amicus Therapeutics Fabry Disease January 24, 2018 50 days
Pomalyst** Pomalidomide Celgene Inc. Multiple Myeloma August 18, 2014 N/A

*Approximation: Negotiation initiation date assumed to be mid-month for the purposes of the calculation
** This is the second negotiation for Pomalyst, the first was completed in January 2015

Signals Decoded:

The March negotiation initiations continue to be a mix of pCPA-initiated files (including one “line-extension” and one re-negotiation) and new drugs that have been under pCPA Consideration, post-HTA recommendation).

 

Negotiations Completed

  • Two negotiations have been completed since the last update, for a total of 207 joint completed/closed negotiations.

 

Brand Name Generic Name Manufacturer Indication Negotiation Initiation Duration *
Glatect Glatiramer acetate Pendopharm Multiple sclerosis relapsing – remitting September, 2017 181 days
Zykadia Ceritinib Novartis Pharmaceuticals Canada Inc. ALK + Non-small cell lung cancer July, 2017 243 days

*Approximation: Negotiation initiation and completion date assumed to be mid-month for the purposes of the calculation

Signals Decoded:

The March update includes the latest subsequent entry product (Glatect-glatiramer) to be successfully negotiated, while the negotiation for Copaxone (glatiramer) continues.

 

This chart shows the average number of months, files are under active negotiation. The number of files being negotiated during each month is shown below the x-axis and the line shows the 3-month moving average trend. The bars indicate the average number of months all files, currently under active negotiation in that particular month, have been in negotiations. This includes files that are either eventually completed or closed without a Letter of Intent (LOI). Phrased another way, the 40 files under active negotiation in March 2018, have been in negotiations for an average of more than 6 months.

 

No pCPA Negotiation

  • One new drug product was added to the “No pCPA Negotiations” list, for a total of 58 products for which the pCPA has decided not to negotiate collectively or individually at the provincial-territorial level
Brand Name Generic Name Manufacturer Indication Recommendation/
Notification to Implement Date
Time to Decision*
Zinbryta** Daclizumab beta Biogen Canada Inc. Multiple Sclerosis June 20, 2017 268 days

*Approximation: Decision date assumed to be mid-month for the purposes of the calculation
**Manufacturer withdrew this product globally

 

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