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pCPA Under Consideration Backlog Starting to Form

December 9, 2020
-
Market Access News
-
Posted by MORSE - 3 min read.

pan-Canadian Pharmaceutical Alliance (pCPA): November 2020 Trends and Insights

 

November 2020 Highlights:

  • 4 products completed CADTH review
  • 8 products initiated pCPA negotiation
  • 5 negotiations were completed with an LOI
  • 0 negotiations were closed without an LOI
  • 0 files were closed without negotiation

 

Files Under pCPA Consideration:

CADTH issued 4 new recommendations & notifications to implement in November (24 files under pCPA consideration as of November 30) – down slightly from 5 in October.

PRODUCT INDICATION SPONSOR Type REC’N* DATE
Luxturna
(voretigene neparvovec)
Vision loss due to inherited retinal dystrophy Novartis Non-oncology
(Gene therapy)
November 12
Blincyto
(blinatumomab)
MRD Positive B-cell precursor ALL Amgen Oncology November 13
Enerzair Breezhaler
(Indacaterol/ glycopyrronium/ mometasone furoate)
Asthma maintenance, adults Novartis Non-oncology November 24
Atectura Breezhaler
(indacaterol/mometasone furoate)
Asthma maintenance, adults children 12 or older Novartis Non-oncology November 24

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

 

 

Signals Decoded:

 

The number of files under consideration has more than doubled since this time last year (Nov 2019 n = 9) and these files have been pending pCPA initiation/decline for an average of 5 months. In comparison, in Nov 2019 the 9 files had been under consideration for an average of 2 months.

 

Negotiation Initiation:

The pCPA initiated 8 new negotiations in November (32 active negotiations as of November 30, 2020) – up from 7 in October.

PRODUCT INDICATION SPONSOR CATEGORY INITIATE DATE TTI*
Redesca
(enoxaparin)
Deep Vein Thrombosis (treatment), without Symptomatic Pulmonary Embolism Valeo Pharma Biosimilar November 2 N/A
Hulio
(adalimumab)
Ankylosing spondylitis, plaque psoriasis, psoriatic arthritis, rheumatoid arthritis, Crohn’s disease and Ulcerative Colitis BGP Pharma Biosimilar November 9 N/A
Idacio
(adalimumab)
Ankylosing spondylitis, plaque psoriasis, psoriatic arthritis, rheumatoid arthritis, Crohn’s disease and Ulcerative Colitis Fresenius Kabi Biosimilar November 9 N/A
Hyrimoz
(adalimumab)
Ankylosing spondylitis, plaque psoriasis, psoriatic arthritis, rheumatoid arthritis, Crohn’s disease and Ulcerative Colitis Sandoz Canada Biosimilar November 9 N/A
Amgevita
(adalimumab)
Ankylosing spondylitis, plaque psoriasis, psoriatic arthritis, rheumatoid arthritis, Crohn’s disease and Ulcerative Colitis AMGEN CANADA Biosimilar November 9 N/A
Hadlima
(adalimumab)
Ankylosing spondylitis, plaque psoriasis, psoriatic arthritis, rheumatoid arthritis, Crohn’s disease and Ulcerative Colitis Merck Biosimilar November 9 N/A
Zejula
(niraparib)
Ovarian Cancer GlaxoSmithKline Oncology November 13 53
Cabometyx
(cabozantinib)
Hepatocellular carcinoma Ipsen Biopharmaceuticals Oncology November 24 201

 

Additionally, the following negotiation was added to the Active list, however it was initiated in June 2020.

PRODUCT INDICATION SPONSOR CATEGORY INITIATE DATE TTI*
Blood glucose test strips Diabetes Mellitus, Type 1 and 2 Multiple Manufacturers Other June 24 N/A

 

 

Signals Decoded:

Although the pCPA initiated 8 negotiations this past month, six of those initiations were for biosimilars, including five adalimumab biosimilars. The ratio of files under consideration relative to the total volume of files under pCPA management (active + under consideration) has risen from 24% last November 2019 to 43% as of this November 2020.

A category negotiation for blood glucose test strips was also added to the pCPA website this month, however it was initiated in June 2020.

 

Completed/Closed Negotiations:

The pCPA completed 5 negotiations with a Letter of Intent (LOI) in November 2020 – consistent with October.

PRODUCT INDICATION SPONSOR LOI DATE TTN*
Avsola
(infliximab)
Inflammatory Conditions Amgen November 2 171
Libtayo
(cemiplimab)
Cutaneous Squamous Cell Carcinoma Sanofi Genzyme November 4 149
Kadcyla
(trastuzumab emtansine)
Early Breast Cancer Hoffmann-La Roche November 5 168
Verkazia
(cyclosporine)
Severe vernal keratoconjunctivitis Santen November 20 192
Onpattro
(patisiran)
Hereditary transthyretin mediated amyloidosis Alnylam November 30 381

* TTN = Time to Negotiate in calendar days

 

 

 

 

Signals Decoded:

 

The average time under negotiation for files which are currently active has decreased since November 2019 from approximately 5.5 months to 3.8 months in November 2020. However, this may in part be due to pCPA’s completion of several long outstanding negotiations this calendar year. The number of files under consideration for more than 6 months has seen a steady increase since March 2020 when there were none, to a high of 10 in November 2020.

 

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Biosimilars
CADTH
CDEC
Oncology
Pan Canadian Pharmaceutical Alliance
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pCPAO
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pCPA Under Consideration Backlog Starting to Form