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COVID Impact on the pCPA Continues with Ongoing Capacity Challenges

April 26, 2021
-
Market Access News
-
Posted by MORSE - 3 min read.

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

 

March 2021 Highlights:

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

 

Key Take-Aways:

  • The average duration that files are under consideration reaches an annual peak of ~160 days. In addition, the number of files under consideration matches its highest for the past year at 30. Even with the introduction of the Targeted Negotiation Process (TNP), these metrics appear to signal that pCPA continues to have capacity challenges.
  • The ratio of active to under consideration files remains relatively constant at around 1:1. The number of active negotiations has hovered around the 30 mark since June 2020 which signals this may be around the maximum capacity for active negotiations with the pCPA’s reduced capacity.
  • March saw the first enoxaparin biosimilar reach a LOI and 3 negotiations closed quickly (within 63-65 days). Otezla negotiations were not driven by a new HTA recommendation. Taltz was under consideration for just under 300 days prior to pCPA initiation in January. As such, although speculative, Taltz and Otezla may be the first window into outcome of files going through the TNP.
  • There has been an increase in the number of files under negotiation for over a year which sits at 5, relative to 1 at this time last year. The number of total files adjudicated per month remains low and continues to signal reduced capacity within the pCPA.

 

Files Under pCPA Consideration*:

CADTH issued 5 new recommendations in March (30 files under pCPA consideration as of March 31st) – up from 28 in February. One of the 5 new recommendations was for Vonvendi (von Willebrand Factor) which went through the Interim Plasma-Protein Products Review Process and will go to Canadian Blood Services (CBS) and not pCPA for next steps (see CADTH CBS PPP Process)

PRODUCT INDICATION SPONSOR Type REC’N* DATE
Ajovy (fremanezumab) migraine Teva Canada Innovation Non-oncology 2021-03-24
Zolgensma (onesemnogene abeparvovec) Spinal muscular atrophy (SMA), pediatrics Novartis Pharmaceuticals Canada Inc. Non-oncology 2021-03-24
Entresto (Sacubitril/valsartan) Heart failure, NYHA Class II or III Novartis Pharmaceuticals Canada Inc. Non-oncology 2021-03-24
Opdivo & Yervoy (Nivolumab & Ipilimumab in combo) Non-Small Cell Lung Cancer (NSCLC) BMS Oncology 2021-03-19

 

 

Signals Decoded:

 

The average duration that files are under consideration reaches an annual peak of ~160 days. In addition, the number of files under consideration matches its highest for the past year at 30. Even with the introduction of the Targeted Negotiation Process (TNP), these metrics appear to signal that pCPA continues to have capacity challenges.

*Note: Since MORSE began issuing pCPA updates, we have defined “under pCPA consideration” as the time between receipt of a final recommendation or notification to implement from CADTH. This does not match the date that the pCPA website has recently started to publish (which starts after issuance of the acknowledgement letter which is not publicly available). This is to ensure consistency of data analysis historically.

Negotiation Initiation:

The pCPA initiated 3 new negotiations in March (31 active negotiations as of March 31st) – down from 33 in February.

PRODUCT INDICATION SPONSOR CATEGORY INITIATE DATE TTI*
Tecentriq & Avastin (Atezolizumab & Bevacizumab) Hepatocellular Carcinoma (HCC) Hoffmann-LA Roche Limited Oncology 2021-03-26 114
Soliris (Eculizumab) Neuromyelitis optica spectrum disorder Alexion Pharma GMBH Non-oncology 2021-03-02 195
Suboxone (film) (Buprenorphine/naloxone) Opioid drug dependence (substitution treatment) Indivior UK Limited Other 2021-03-02 N/A

 

 

Signals Decoded:

The ratio of active to under consideration files remains relatively constant at around 1:1. The number of active negotiations has hovered around the 30 mark since June 2020 which signals this may be around the maximum capacity for active negotiations with the pCPA’s reduced capacity.

Completed/Closed Negotiations:

The pCPA completed 2 negotiations with a Letter of Intent (LOI) and closed 3 negotiations without an LOI in March 2021.

 

Completed Negotiations

PRODUCT INDICATION Sponsor Type Status LOI DATE TTN*
Xospata (Gilteritinib) Acute Myeloid Leukemia (AML) Astellas Pharma Inc. Oncology Completed 2021-03-15 210
Redesca (enoxaparin) Deep Vein Thrombosis (treatment), without Symptomatic Pulmonary Embolism Valeo Pharma Inc. Biosimilar Completed 2021-03-24 142

* TTN = Time to Negotiate in calendar days

Closed Negotiations

PRODUCT INDICATION Sponsor Type Status LOI DATE TTN*
Taltz (Ixekizumab) Ankylosing spondylitis Eli Lilly Canada Inc. Non-oncology Closed 2021-03-19 65
Otezla (Apremilast) Psoriasis, moderate to severe plaque Amgen Canada Inc. Other Closed 2021-03-17 63
Otezla (Apremilast) Psoriatic Arthritis Amgen Canada Inc. Other Closed 2021-03-17 63

* TTN = Time to Negotiate in calendar days

 

 

Signals Decoded:

 

March saw the first enoxaparin biosimilar reach a LOI and 3 negotiations closed quickly (within 63-65 days). Otezla negotiations were not driven by a new HTA recommendation. Taltz was under consideration for just under 300 days prior to pCPA initiation in January. As such, although speculative, Taltz and Otezla may be the first window into outcome of files going through the TNP.

 

 

Signals Decoded:

 

There has been an increase in the number of files under negotiation for over a year which sits at 5, relative to 1 at this time last year. The number of total files adjudicated per month remains low and continues to signal reduced capacity within the pCPA.

To receive updates similar to this one please be sure to sign up for MORSE Signals, our free e-mail newsletter service.

 

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Pan Canadian Pharmaceutical Alliance
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