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Early Insights into pCPA Prioritization

May 22, 2020
-
Market Access News
-
Posted by MORSE - 3 min read.

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

 

April Highlights:

  • 6 products completed CADTH review
  • 4 products initiated pCPA negotiations
  • 11 negotiations were completed with an LOI
  • 2 negotiations were closed without an LOI
  • 2 files were closed without negotiation

In keeping with pCPA’s communication to industry associations, early trends into their management of files during the challenges associated with COVID indicate that initial priority has been on completing ongoing negotiations that were close to completion and negotiating files with potential cost savings. Not surprisingly, the number of files waiting to initiate negotiations is growing and is at its highest level in over a year despite the high level of overall pCPA activity in April.

 

Files Under pCPA Consideration:

CADTH issued 6 new recommendations in April (20 files under consideration as of April 30th)

PRODUCT INDICATION SPONSOR HTA REC’N* DATE TUC**
Benlysta
(belimumab)
Systemic lupus erythematosus GlaxoSmithKline CDR 22 Apr 8
Dupixent
(dupilumab)
Atopic Dermatitis Sanofi Genzyme CDR 22 Apr 8
Keytruda
(pembrolizumab)
Renal Cell Carcinoma Merck pCODR 20 Apr 10
Mylotarg
(gemtuzumab ozogamicin)
Acute Myeloid Leukemia Pfizer pCODR 20 Apr 10
Rydapt
(midostaurin)
Systemic Mastocytosis Novartis pCODR 20 Apr 10
Lonsurf
(trifluridine-tipiracil)
Gastric Cancer Taiho pCODR 8 Apr 22

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

** TUC = Time Under Consideration in calendar days

 

 

Negotiation Initiation:

The pCPA initiated 4 new negotiations in April (20 active negotiations as of April 30th)

PRODUCT INDICATION SPONSOR CATEGORY INITIATE DATE TTI*
Nivestym
(filgrastim)
Prevention or treatment of neutropenia in various indications Pfizer Biosimilar 27 Apr N/A
Ziextenzo
(pegfilgrastim)
Febrile neutropenia in non-myeloid malignancies Sandoz Biosimilar 27 Apr N/A
Riximyo
(rituximab)
Rheumatoid arthritis, chronic lymphocytic leukemia, and non-Hodgkin’s lymphoma Sandoz Biosimilar 24 Apr N/A
Ruxience
(rituximab)
Non-Hodgkin’s Lymphoma, Chronic Lymphocytic Leukemia, Rheumatoid Arthritis, Granulomatosis with Polyangitis, Microscopic Polyangitis Pfizer Biosimilar 24 Apr N/A

* TTI = Time to Initiate in calendar days

 

 

Signals Decoded:

As expected, the number of files under pCPA consideration has increased as the pCPA deals with limited capacity to support new negotiations. The 4 negotiations started in April were all for biosimilar versions of products where biosimilars are already available.

 

Completed Negotiations:

The pCPA completed 11 negotiations with a Letter of Intent (LOI) in April 2020.

PRODUCT INDICATION SPONSOR LOI DATE TTN*
Tegsedi
(inotersen)
Hereditary transthyretin-mediated amyloidosis Akcea 30 Apr 153
Mezera
(mesalazine)
Ulcerative Colitis AVIR Pharma 21 Apr 173
Kanjinti
(trastuzumab)
Early/metastatic breast cancer, metastatic gastric cancer Amgen 16 Apr 23
Keytruda
(pembrolizumab)
Squamous Non-Small Cell Lung Cancer Merck 15 Apr 84
Keytruda
(pembrolizumab)
Melanoma adjuvant therapy Merck 15 Apr 215
Keytruda
(pembrolizumab)
Non-squamous non-small cell lung cancer Merck 15 Apr 246
Keytruda
(pembrolizumab)
Metastatic Urothelial Carcinoma Merck 15 Apr 597
Keytruda
(pembrolizumab)
Classic Hodgkin’s Lymphoma Merck 15 Apr 553
Radicava
(edaravone)
Amyotrophic lateral sclerosis Mitsubishi 15 Apr 204
Ibrance/Faslodex
(palbociclib/fulvestrant)
Advanced or Metastatic Breast Cancer Pfizer 8 Apr 238
Sublocade
(buprenorphine)
Opioid Use Disorder Indivior 2 Apr 268

* TTN = Time to Negotiate in calendar days

 

 

Signals Decoded:

While the large number of completed negotiations may be somewhat tempered by the fact that 5 of the 11 files were for various Keytruda indications, the pCPA has reduced the number of active negotiations to its lowest point in well over a year. April also saw the completion or closure of 3 negotiations that had been ongoing for over 12 months.

 

Closed Negotiations:

The pCPA closed 2 negotiations without an agreement in April 2020.

PRODUCT INDICATION SPONSOR CLOSE DATE TTC*
Humira (citrate free)
(adalimumab)
Multiple Indications AbbVie 16 Apr 442
Verzenio
(abemaciclib)
Advanced or Metastatic Breast Cancer Eli Lilly 9 Apr 192

* TTC = Time to Close in calendar days

 

 

 

Signals Decoded:

Of the 13 files completed or closed in April, 9 had been in active negotiations for more than 6 months. The chart above shows that the 20 active files as of April 30th had been in negotiations for an average of under 4 months.

 

Not Negotiated:

The pCPA declined negotiations on 2 files in April 2020.

PRODUCT INDICATION SPONSOR DECLINE DATE TTD*
Lorbrena
(lorlatinib)
Non-small cell lung cancer (ALK+) Pfizer 21 Apr 67
Lokelma
(sodium zirconium cyclosilicate)
Hyperkalemia AstraZeneca 16 Apr 22

* TTD = Time to Decline in calendar days

 

 

Signals Decoded:

Both of the files closed without negotiations in April received “do not list” recommendations from CADTH.

 

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Early Insights into pCPA Prioritization