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Files Under pCPA Consideration for Greater Than 6 Months is the Highest its Been in a Year

June 17, 2021
-
Market Access News
-
Posted by MORSE - 4 min read.

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

 

May 2021 Highlights:

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

 

Key Take-Aways:

  • May sees continued consistency in both the volume of files under consideration and the average days under consideration which is hovering around the 5-month mark.
  • All 3 files initiated in May were oncology products. Two of those files were indications for Calquence (treatment of CLL). Interestingly, CADTH completed a provisional algorithm for CLL on May 18th with pCPA initiating negotiations on Calquence for CLL shortly after that.
  • The ratio of under consideration to active files has been very consistent over the last year at around 50% compared to the pre-COVID ratio closer to 20%. In addition, the volume of active negotiations during COVID remains consistently under 35 compared to numbers pre-COVID that were in the mid-40s. This may signal that the pCPA’s current capacity for active negotiations is 30-35 at a given time.
  • Two protracted negotiations were completed in May – one successfully (Olumiant after almost 20 months) and the other without an agreement (Cimzia for plaque psoriasis after 15 months). The 3rd biosimilar enoxaparin also completed negotiation in May.
  • Since March, there was a significant drop in the number of active negotiations under negotiation for longer than a year, going from 5 to 2. However, after a brief dip in the number of files under consideration for greater than 6 months in April, in May, this number spiked again as 5 more files moved into this category, which now sits at 11.
  • May also saw a slight drop in completed/closed files relative to the last few months.

 

Files Under pCPA Consideration*:

CADTH issued 6 new recommendations in May (31 files under pCPA consideration as of May 31th) – up from 28 in April.

Note: Hemlibra (emicizumab) received a CADTH recommendation in December 2020 and was categorized as under consideration. However, since it is a plasma protein-related product, it will not go through pCPA and thus was removed from our under-consideraton file list.

PRODUCT INDICATION SPONSOR Reimbursement Decision Type REC’N* DATE
Corzyna (ranolazine) Stable angina pectoris, adults KYE Pharmaceutical Do Not Reimburse Non-oncology 2021-05-27
Odomzo (sonidegib) Basal Cell Carcinoma (BCC) Sun Pharma Canada Inc. Do Not Reimburse Oncology 2021-05-14
Polivy (Polatuzumab Vedotin) relapsed or refractory diffuse large B-cell lymphoma Hoffmann-La Roche Limited Conditional Reimbursement Oncology 2021-05-06
Alunbrig (Brigatinib) Anaplastic Lymphoma Kinase Positive Non-Small Cell Lung Cancer Takeda Canada Inc. Conditional Reimbursement Oncology 2021-05-06
Zejula (niraparib) First Line Ovarian Cancer GlaxoSmithKline Inc. Conditional Reimbursement Oncology 2021-05-14
Lynparza (olaparib) Metastatic Castration-Resistant Prostate Cancer (mCRPC) AstraZeneca Canada Inc. Conditional Reimbursement Oncology 2021-05-06

*Note: Since MORSE began issuing pCPA updates, we have defined “under pCPA consideration” as the time between receipt of a final recommendation or notification to implement from CADTH. This does not match the date that the pCPA website has recently started to publish (which starts after issuance of the acknowledgement letter which is not publicly available). This is to ensure consistency of data analysis historically.

 

Signals Decoded:

 

May sees continued consistency in both the volume of files under consideration and the average days under consideration which is hovering around the 5-month mark.

Negotiation Initiation:

The pCPA initiated 3 new negotiations in May (32 active negotiations as of May 31st) – down from 33 in April.

PRODUCT INDICATION SPONSOR CATEGORY INITIATE DATE TTI*
Calquence (acalabrutinib) Chronic Lymphocytic Leukemia (CLL) (previously untreated) AstraZeneca Canada Inc Oncology 2021-05-27 122
Calquence (acalabrutinib) Chronic Lymphocytic Leukemia (CLL) AstraZeneca Canada Inc Oncology 2021-05-27 176
Rozlytrek (entrectinib) ROS1-positive Non-Small Cell Lung Cancer Hoffmann-La Roche Limited Oncology 2021-05-04 82

*Time to Initiation (TTI) – Time from final recommendation or notification to implement to pCPA initiation in calendar days

*Time to Initiation (TTI) – Time from final recommendation or notification to implement to pCPA initiation in calendar days
**Correction from February

Signals Decoded:

All 3 files initiated in May were oncology products. Two of those files were indications for Calquence (treatment of CLL). Interestingly, CADTH completed a provisional algorithm  for CLL on May 18th with pCPA initiating negotiations on Calquence for CLL shortly after that.

The ratio of under consideration to active files has been very consistent over the last year at around 50% compared to the pre-COVID ratio closer to 20%. In addition, the volume of active negotiations during COVID remains consistently under 35 compared to numbers pre-COVID that were in the mid-40s. This may signal that the pCPA’s current capacity for active negotiations is 30-35 at a given time.

 

Completed/Closed Negotiations:

The pCPA completed 4 negotiations, 3 negotiations with a Letter of Intent (LOI) and 1 closed without an LOI in May 2021.

Completed Negotiations

PRODUCT INDICATION Sponsor Type Status LOI DATE TTN*
Cimzia (Certolizumab pegol) Psoriasis, moderate to severe plaque UCB Canada Inc. Non-oncology Closed 2021-05-07 465
Blincyto (Blinatumomab) Minimal Residual Disease (MRD)-Positive B-Cell Precursor Acute Lymphoblastic Leukemia (BCP ALL) Amgen Canada Inc. Oncology Completed 2021-05-21 155
Olumiant (baricitinib) Arthritis, Rheumatoid Eli Lilly Canada Inc. Non-oncology Completed 2021-05-10 598
Noromby (enoxaparin) Deep vein thrombosis (treatment and prevention) Juno Pharmaceuticals Biosimilar Completed 2021-05-27 119

 

Signals Decoded:

Two protracted negotiations were completed in May – one successfully (Olumiant after almost 20 months) and the other without an agreement (Cimzia for plaque psoriasis after 15 months). The 3rd biosimilar enoxaparin also completed negotiation in May.

Signals Decoded:

Since March, there was a significant drop in the number of active negotiations under negotiation for longer than a year, going from 5 to 2. However, after a brief dip in the number of files under consideration for greater than 6 months in April, in May, this number spiked again as 5 more files moved into this category, which now sits at 11.

May also saw a slight drop in completed/closed files relative to the last few months.

To receive updates similar to this one please be sure to sign up for MORSE Signals, our free e-mail newsletter service.

 

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Files Under pCPA Consideration for Greater Than 6 Months is the Highest its Been in a Year