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Some Positive Indicators as Number of Files Under Consideration Remains Flat – June 2020

July 28, 2020
-
Market Access News
-
Posted by MORSE - 2 min read.

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

 

June Highlights:

  • 4 products completed CADTH review
  • 7 products initiated pCPA negotiations
  • 4 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 in June (23 files as of June 30).

PRODUCT INDICATION SPONSOR HTA REC’N* DATE
Cuvposa
(glycopyrrolate)
Chronic severe drooling, neurologic (pediatric) MEDEXUS CDR June 24
Adcetris
(brentixumab vedotin)
Peripheral T-Cell Lymphoma Seattle Genetics pCODR June 19
Kisqali
(ribociclib)
Advanced or Metastatic Breast Cancer Novartis pCODR June 19
Xospata
(gilteritinib)
Acute Myeloid Leukemia Astellas pCODR June 4

* REC’N DATE = Date of CDEC Final Recommendation (CDR), Date Notification to Implement Issued (pCODR)

Kisqali (ribociclib) was initiated in the same month that the recommendation issued and therefore is not included in the Under-Consideration count.

 

Signals Decoded:
 
While the Average Time Under Consideration continues to creep upwards, the volume of files in this process phase leveled off in June.  Although pCPA initiated negotiations for Kisqali (Advanced or Metastatic Breast Cancer) after just 3 days, it is worth noting that this molecule, in combination with fulvestrant, was already in active negotiations for the same indication.

 

Negotiation Initiation:

The pCPA initiated 7 new negotiations in June (28 active negotiations as of June 30).

PRODUCT INDICATION SPONSOR CATEGORY INITIATE DATE TTI*
Kisqali
(ribociclib)
Advanced or Metastatic Breast Cancer Novartis pCODR June 22 3
Myltotarg
(Gemtuzumab Ozogamicin)
Acute Myeloid Leukemia Pfizer pCODR June 17 58
Vyndaqel
(tafamidis)
Transthyretin-mediated amyloidosis Pfizer CDR June 10 112
Libtayo
(cemiplimab)
Cutaneous Squamous Cell Carcinoma Sanofi Genzyme pCODR June 8 123
Lynparza
(olaparib)
Advanced or Metastatic Breast Cancer AstraZeneca pCODR June 18 181
Kalydeco
(ivacaftor)
Cystic Fibrosis in patients with CFTR gating mutations or the R117H gating mutation Vertex Other June 12 N/A
Orkambi
(lumacaftor/ivacaftor)
Cystic Fibrosis, F508del CFTR mutation Vertex Other June 12 N/A

* TTI = Time to Initiate in calendar days

 

Signals Decoded:
 
For the second consecutive month, the newly initiated pCPA negotiations associated with recent HTA reviews has focused on oncology.  By initiating negotiations on Kalydeco and Orkambi, the pCPA has provided some insight into its immediate priority while showing that some negotiating capacity is still available for non-HTA files.

 

Completed/Closed Negotiations:

The pCPA completed 4 negotiations with a Letter of Intent (LOI) in June 2020.

PRODUCT INDICATION SPONSOR LOI DATE TTN*
Ruxience
(rituximab)
Non-Hodgkin’s Lymphoma (NHL), Chronic Lymphocytic Leukemia (CLL), Rheumatoid Arthritis (RA), Granulomatosis with Polyangitis (GPA), Microscopic Polyangitis (MPA) Pfizer June 12 49
Nivestym
(filgrastim)
Prevention or treatment of neutropenia in various indications Pfizer June 17 51
Revlimid
(lenalidomide)
Multiple Myeloma Celgene June 10 58
Riximyo
(rituximab)
Rheumatoid arthritis, chronic lymphocytic leukemia, and non-Hodgkin’s lymphoma Sandoz June 19 113

* TTN = Time to Negotiate in calendar days

 

Signals Decoded:
 
June saw the completion of three more biosimilar negotiations, including the second and third version of rituximab and the second version of filgrastim.  While the number of active negotiations is up to 28 from a low of 20 in April, the average time spent in this process phase continues to decline.

 

Signals Decoded:
 
The files under consideration (Pomalyst and Idhifa) and in active negotiation (Kanuma) for an extended duration remain relatively low and unchanged since last month.

 

 

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Biosimilars
CADTH
CDEC
Oncology
Pan Canadian Pharmaceutical Alliance
pCPA
pCPAO
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Some Positive Indicators as Number of Files Under Consideration Remains Flat - June 2020