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January 2021 Brings a Substantial Jump in the Number of Files Initiated by the pCPA

February 16, 2021
-
Market Access News
-
Posted by MORSE - 3 min read.

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

 

January 2021 Highlights:

  • 4 products completed CADTH review
  • 9 products initiated pCPA negotiations
  • 5 negotiations were completed with an LOI
  • 0 negotiations were closed without an LOI
  • 1 file was closed without negotiation

Files Under pCPA Consideration:

CADTH issued 4 new recommendations & notifications to implement in January (29 files under pCPA consideration as of January 31) – down from 8 in December.

PRODUCT INDICATION SPONSOR Type REC’N* DATE
Keytruda
(pembrolizumab)
Head and Neck Squamous Cell Carcinoma Merck Oncology January 14
Entyvio
(vedolizumab)
Crohn’s Disease Takeda
Non-Oncology
January 21
Calquence
(acalabrutinib)
Chronic Lymphocytic Leukemia (previously untreated) AstraZeneca Oncology January 25
Daurismo
(glasdegib)
Acute Myeloid Leukemia Pfizer Oncology January 25

* REC’N DATE = Date of CDEC Final Recommendation (non-oncology), Date Notification to Implement Issued (oncology).

 

 

Signals Decoded:

 

The under consideration remains relatively high with 29 files in January 2021.  The number of oncology files under consideration is at 12, the highest number in the last year. The time all these files have been pending initiation has held steady at an average of approximately 146 calendar days (median: 94 calendar days) as of month end.

Negotiation Initiation:

The pCPA initiated 9 new negotiations in January (33 active negotiations as of January 31) – up from 2 in December.

PRODUCT INDICATION SPONSOR CATEGORY INITIATE DATE TTI*
Nyvepria
(pegfilgrastim)
febrile neutropenia in non-myeloid malignancies Pfizer
Biosimilar
January 13 N/A
Noromby
(enoxaparin)
Deep vein thrombosis (treatment and prevention) Juno Pharmaceuticals
Biosimilar
January 28 N/A
Inclunox
(enoxaparin)
Deep vein thrombosis (treatment and prevention) Sandoz
Biosimilar
January 28 N/A
Otezla
(apremilast)
Psoriasis, moderate to severe plaque Celgene Other
Re-activation
January 13 N/A
Otezla
(apremilast)
Psoriatic arthritis Celgene Other
Re-activation
January 13 N/A
Vascepa
(icosapent ethyl)
Ischemic events in statin treated patients HLS Therapeutics
Non-Oncology
January 29 197
Aimovig
(erenumab)
Migraine, chronic Novartis
Non-Oncology
January 25 187
Taltz
(ixekizumab)
Ankylosing spondylitis Eli Lilly
Non-Oncology
January 13 295
Rinvoq
(upadacitinib)
Subacute and chronic inflammatory joint diseases AbbVie
Non-Oncology
January 21 352

*time from final recommendation or notification to implement in calendar days

 

 

Signals Decoded:
 
January saw the number of active negotiations reach 33 files, a level not seen since February 2020. Of the 9 initiated, 3 were biosimilars (a pegfilgrastim and two enoxaparin biosimilars), 2 were re-activations for Otezla (previously closed without LOI in September 2017), and three non-oncology files which had received recommendations in early to mid 2020 were initiated for negotiation. It is possible these files are being considered through the pCPA’s recently initiated Targeted Negotiation Process. These engagements indicate that the capacity for non-oncology files seems to be increasing to levels seen in early 2020.

Completed/Closed Negotiations:

The pCPA completed 5 negotiations with a Letter of Intent (LOI) in January 2021, up from 4 in December. All the negotiations were for adalimumab biosimilars.

PRODUCT INDICATION SPONSOR LOI DATE TTN*
Hyrimoz
(adalimumab)
Inflammatory Conditions ** Sandoz January 20 72
Amgevita
(adalimumab)
Inflammatory Conditions ** AMGEN January 20 72
Hulio
(adalimumab)
Inflammatory Conditions ** BGP Pharma January 20 72
Hadlima
(adalimumab)
Inflammatory Conditions ** Merck January 22 74
Idacio
(adalimumab)
Inflammatory Conditions ** Fresenius Kabi January 26 78

* TTN = Time to Negotiate in calendar days

**Rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, hidradenitis suppurative, plaque psoriasis, uveitis

 

 

Not Negotiated:

The pCPA declined negotiations on 1 file in January 2021.

PRODUCT INDICATION SPONSOR DECLINE DATE TTD*
Spravato
(esketamine hydrochloride)
Major Depressive Disorder Janssen January 27 42

* TTD = Time to Decline in calendar days

 

Signals Decoded:

 

Spravato received a “do not reimburse” recommendation from CADTH and was declined without negotiations in January 2021, which is the first file declined since October 2020.

 

 

Signals Decoded:

 

The number of files under consideration for more than six months stays steady at 10 files for the fourth month in a row, despite the initiation of negotiations for 3 files that were under consideration since early mid 2020.

 

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Biosimilars
CADTH
CDEC
Oncology
Pan Canadian Pharmaceutical Alliance
pCPA
pCPAO
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January 2021 Brings a Substantial Jump in the Number of Files Initiated by the pCPA