The pCPA initiated 15 negotiations, the highest in 2021

pan-Canadian Pharmaceutical Alliance (pCPA): November 2021 Trends and Insights

November 2021 Highlights:

• 3 products completed CADTH review
• 15 products initiated pCPA negotiations
• 3 negotiations were completed with an LOI
• 0 negotiations were closed without an LOI
• 1 file was closed without negotiation

Key Take-Aways:

• The number of files under consideration was reduced substantially from 31 in October to 22 as of November 30th, driven by relatively few CADTH recommendations and a large volume of pPCA negotiation initiations. Meanwhile, the average time under pCPA consideration increased from 155 days in August to a high of 190 days in November.
• The pCPA initiated 15 negotiations in November, bringing the total number of files under active negotiation up to 45, the highest number seen in the past year. 3 more negotiations for adalimumab biosimilars were initiated in November, bringing the total number of adalimumab biosimilars to have entered pCPA negotiations to 8.
• The pCPA concluded 3 negotiations with an LOI in November, a relatively low number compared to recent months. All 3 were non-oncology products that were under active negotiation within average timelines.
• The number of files under consideration for greater than 6 months decreased to 6 in November from 8 in October. Corzyna (ranolazine), which received a “Do not reimburse” recommendation from CADTH and a conditional reimbursement recommendation from INESSS, entered the long-term under-consideration files with 187 days as of Nov. 30th 2021. Meanwhile, 3 files initiated negotiation after lengthy consideration: pdp-levETIRAcetam (293 days), Luxturna (378 days), and Opdivo & Yervoy (227 days). The total number of files adjudicated by the pCPA decreased considerably to 4, following 3 months of higher than average numbers (10 in August, 9 in September, and 8 in October).

Files Under pCPA Consideration*:

CADTH issued 3 new recommendations in November (22 files under pCPA consideration as of November 30^th – down from 31 in October).

Note: MORSE defines “Rec’n date” as the time of‘final recommendation issued to sponsor and drug plans’, and the ‘Time to Initiate’ as the time between ‘final recommendation issued to sponsor and drug plans’ and ‘pCPA Engagement Letter Issued’.
**Cell and gene therapy
 


*Note: that files that initiated pCPA negotiation prior to receiving a CADTH recommendation were excluded from the under-consideration timeline analysis
 

Signals Decoded:

 

The number of files under consideration was reduced substantially from 31 in October to 22 as of November 30th, driven by relatively few CADTH recommendations and a large volume of pPCA negotiation initiations. Meanwhile, the average time under pCPA consideration increased from 155 days in August to a high of 190 days in November, primarily due to four files remaining under consideration for 525 to 747 days: Cuvposa for chronic severe drooling, Benlysta for systemic lupus erythematosus, Onstryv for Parkinson’s Disease and Idhifa for Acute Myeloid Leukemia. All four of these files under prolonged consideration received negative recommendations from CADTH, but 3 received positive recommendations from INESSS.

Negotiation Initiation:

The pCPA initiated 15 new negotiations in November, bringing the number of active negotiations to 45 (as of November 30^th), up from 33 in October.

*Time to Initiation (TTI) – Time between ‘final recommendation issued to sponsor and drug plans’ and ‘pCPA Engagement Letter Issued’
**CAR T-cell therapy
 

Signals Decoded:
 
The pCPA initiated 15 negotiations in November, bringing the total number of files under active negotiation up to 45, the highest number seen in the past year. Three negotiations completed with an LOI and one file was closed with no negotiation.
 
Three more negotiations for adalimumab biosimilars were initiated in November, bringing the total number of adalimumab biosimilars to have entered pCPA negotiations to eight. Zaxine for Hepatic Encephalopathy entered active negotiations, having previously concluded with an LOI in 2016, signaling a renegotiation.

Completed Negotiations:

The pCPA completed 3 negotiations with a Letter of Intent (LOI) in November 2021, down from 8 in October.

* TTN = Time to Negotiate in calendar days
**Cell and Gene Therapy
 

Closed Negotiations:

The pCPA did not close any negotiations without an LOI in November 2021.
 

Not Negotiated:

The pCPA declined 1 negotiation in November 2021.

Signals Decoded:
 
The pCPA concluded 3 negotiations with an LOI in November, a relatively low number compared to recent months. All 3 were non-oncology products that were under active negotiation within average timelines.
 
The pCPA declined to negotiate Saxenda for chronic weight management in adults, which received a negative HTA recommendation from CADTH.

Signals Decoded:
 
The overall volume and average negotiation time of files continues to trend at levels seen throughout 2021.
The volume of files under negotiation spiked in November (45). The average days under negotiation fell due to the high number of newly initiated files (15).
 
The number of files under consideration for greater than 6 months decreased to 6 in November from 8 in October. Corzyna (ranolazine), which received a “Do not reimburse” recommendation from CADTH and a conditional reimbursement recommendation from INESSS, entered the long-term under-consideration files with 187 days as of Nov. 30th 2021. Meanwhile, 3 files initiated negotiation after lengthy consideration: pdp-levETIRAcetam (293 days), Luxturna (378 days), and Opdivo & Yervoy (227 days).
 
The total number of files adjudicated by the pCPA decreased considerably to 4, following 3 months of higher than average numbers (10 in August, 9 in September, and 8 in October).

 
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