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Action Being Taken to Reduce the Growing Number of Files Under Consideration

January 11, 2021
-
Market Access News
-
Posted by MORSE - 3 min read.

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

 

December 2020 Highlights:

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

Beginning this month and over the next few months, the pCPA is introducing a Targeted Negotiation Process (TNP) to address selected files that have been on hold for several months. The TNP is a structured process that streamlines negotiations in order to reach resolution in a defined time period. Manufacturers will be informed by the pCPA by means of a modified Letter of Engagement and will have the opportunity to decline participation.

Files Under pCPA Consideration:

CADTH issued 8 new recommendations & notifications to implement in December (30 files under pCPA consideration as of December 31) – up from 4 in November.

PRODUCT INDICATION SPONSOR Type REC’N* DATE
Venclexta
(venetoclax Obinutuzumab)
Chronic Lymphocytic Leukemia AbbVie Oncology December 2
Calquence
(acalabrutinib)
Chronic Lymphocytic Leukemia AstraZeneca Oncology December 2
Tecentriq & Avastin
(atezolizumab & bevacizumab)
Hepatocellular Carcinoma Hoffmann-La Roche Oncology December 2
Spravato
(esketamine hydrochloride)
Major Depressive Disorder, Adults Janssen
Non-Oncology
December 16
Adcetris
(brentuximab vedotin)
Primary Cutaneous Anaplastic Large Cell Lymphoma or CD30-Expressing Mycosis Fungoides Seattle Genetics Oncology December 18
Adcetris
(brentuximab vedotin)
Stage IV Hodgkin lymphoma (HL) in combination with doxorubicin, vinblastine, and dacarbazine (AVD) Seattle Genetics Oncology December 18
Hemlibra
(emicizumab)
Hemophilia A – patients with or without factor VIII inhibitors Hoffmann-La Roche
Non-Oncology
December 21
Forxiga
(dapagliflozin)
Heart Failure with reduced ejection fraction AstraZeneca
Non-Oncology
December 23

* 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 increased to 30 files in December 2020, the highest under consideration count in the past 3 years. This includes 21 non-oncology files and 9 oncology files.

 

Negotiation Initiation:

The pCPA initiated 2 new negotiations in December (29 active negotiations as of December 31) – down from 8 in November.

PRODUCT INDICATION SPONSOR CATEGORY INITIATE DATE TTI*
Baqsimi
(glucagon)
Severe hypoglycemia Eli Lilly
Non-Oncology
December 14 327
Blincyto
(blinatumomab)
MRD Positive B-Cell Precursor Acute Lymphoblastic Leukemia Amgen Oncology December 17 34

 

 

Signals Decoded:

The volume of files at pCPA is hovering at almost 60, with the Under Consideration files now representing just over 50% of the volume of files within the pCPA’s workload. For comparison, at this time last year, the Under Consideration files only represented 24% of the pCPA workload.

 

Completed/Closed Negotiations:

The pCPA completed 4 negotiations with a Letter of Intent (LOI) in December 2020 – down from 5 in November.

PRODUCT INDICATION SPONSOR LOI DATE TTN*
Keytruda
(pembrolizumab)
Renal cell carcinoma Merck Canada December 1 204
Trintellix
(vortioxetine)
Major Depressive Disorder Lundbeck December 3 150
Blood Glucose Test Strips Diabetes Mellitus, Type 1 and 2 Multiple Manufacturers December 9 168
Opsumit
(macitentan)
Pulmonary Arterial Hypertension Janssen December 23 511

* TTN = Time to Negotiate in calendar days

 

 

The pCPA closed 1 negotiation without agreement in December 2020.

PRODUCT INDICATION SPONSOR CLOSURE TTC*
Darzalex SC
(daratumumab)
Multiple Myeloma Janssen December 16 159

* TTC = Time to Close in calendar days

 

Signals Decoded:

 

The pCPA completed a category negotiation for blood glucose test strips and a re-activation of Opsumit for the treatment of pulmonary arterial hypertension which was previously closed without an LOI in December 2015. The number of files under consideration for six or more months has remained at 10 for the past 3 months and the number of files under active negotiation for more than 12 months remains relatively low at 2 in December.

 

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Biosimilars
CADTH
CDEC
Oncology
Pan Canadian Pharmaceutical Alliance
pCPA
pCPAO
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Action Being Taken to Reduce the Growing Number of Files Under Consideration