Highly productive August with pCPA completing 10 negotiations

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

August 2021 Highlights:

• 8 products completed CADTH review
• 4 products initiated pCPA negotiations
• 10 negotiations were completed with an LOI
• No negotiations were closed without an LOI
• No files were closed without negotiation

Key Take-Aways:

• The output of the pCPA in August was a high number of completed negotiations and slightly less files initiated for negotiations than usual.
• Partly due to the high volume of CADTH recommendations finalized in August, pCPA’s under consideration count stands at its highest (35) over this past year. In addition, the number of oncology files under consideration follows the same trend, with a considerable rise and the highest we have seen over the last 12 months, sitting at 16.
• Four new files initiated negotiations, with 2 of the files being initiated relatively quickly (22, 33 days) while the other two files took 5-6 months to initiate (Entresto which already has a LOI in place and Kesimpta, for MS). The number of active files under negotiation dropped from the annual highs (over 40) seen over the last 2 months, mainly due to the high number of negotiations completed in August. The overall total volume of files under pCPA purview continues to be high with 71 files either under consideration or in active negotiations.
• The pCPA completed a higher than average number of negotiations in August, including: 3 non-oncology files; 5 oncology files; 2 biosimilar files.
• There is some consistency being seen for the average time under negotiation which has hovered around the 4-5 month range for the last year. The last 3 months show a trend of more active negotiations compared to previous quarters this year, perhaps signalling increased capacity. As of August 31st, there were 10 files under consideration for greater than 6 months, with two files added to this total in August. In addition, there remain two files under negotiation for greater than 1 year (Darzalex and Botox). Overall, there have been more files adjudicated by the pCPA in August than seen over the past year.

Files Under pCPA Consideration*:

CADTH issued 8 new recommendations in August (35 files under pCPA consideration as of Aug. 31^st – up from 31 in July).

*Correction: Opdivo & Yervoy (Nivolumab & Ipilimumab in combo) received a final recommendation on July 16, 2021 but were not included in MORSE’s July pCPA update because it wasn’t published on the CADTH website until August.

*Note: MORSE defines “Rec’n date” as the time of‘final recommendation issued to sponsor and drug plans’, and the ‘Time to Initiate’ as the time between ‘final recommendation issued to sponsor and drug plans’ and ‘pCPA Engagement Letter Issued’.
 

Signals Decoded:

 

Partly due to the high volume of CADTH recommendations finalized in August, pCPA’s under consideration count stands at its highest (35) over this past year.  In addition, the number of oncology files under consideration follows the same trend, with a considerable rise and the highest we have seen over the last 12 months, sitting at 16.

Negotiation Initiation:

The pCPA initiated 4 new negotiations in August bringing the number of active negotiations to 36 (as of August 31^st), down from 42 in July.

*Time to Initiation (TTI) – Time between ‘final recommendation issued to sponsor and drug plans’ and ‘pCPA Engagement Letter Issued’
**initiated and completed pCPA negotiation on the same day
***received CADTH rec’ and initiated pCPA negotiation in the same month

 

Signals Decoded:
 
Four new files initiated negotiations, with 2 of the files being initiated relatively quickly (22, 33 days) while the other two files took 5-6 months to initiate (Entresto which already has a LOI in place and Kesimpta, for MS).
 
The 2 files initiated quickly were:

• Keytruda (for colorectal cancer) which opened and closed on the same day, the same as occurred with their last indication in head and neck squamous cell carcinoma in Feb 2021; and
• Evrysdi, the third therapy for treatment of SMA, which will join Zolgensma which is currently under active negotiation as well.

The number of active files under negotiation dropped from the annual highs (over 40) seen over the last 2 months, mainly due to the high number of negotiations completed in August. The overall total volume of files under pCPA purview continues to be high with 71 files either under consideration or in active negotiations.

Completed Negotiations:

The pCPA completed 10 negotiations with a Letter of Intent (LOI) in August 2021, up from 3 in July.

* TTN = Time to Negotiate in calendar days
 

Closed Negotiations:

The pCPA did not close any negotiations without an LOI in August 2021.
 

Not Negotiated:

The pCPA did not decline any negotiations in August 2021.

Signals Decoded:
 
The pCPA completed a higher than average number of negotiations in August, including:

• 3 non-oncology files (2 negotiations for Entyvio SC with differing CDEC recommendation dates concluding at the same time, and a new entrant Beovu in wet AMD);
• 5 oncology files (Cabometyx which may have been the impetus for a recent CADTH provisional algorithm in HCC, 2 negotiations for Zejula in ovarian cancer with differing pERC recommendation dates concluding at the same time, Erleada for castration-sensitive prostate cancer which joins Xtandi for this indication which completed pCPA in July, and Keytruda for colorectal cancer)
• 2 biosimilar files (the first insulin aspart biosimilar and the 4th bevacizumab biosimilar completed).

Signals Decoded:
 
There is some consistency being seen for the average time under negotiation which has hovered around the 4-5 month range for the last year.
 
The last 3 months show a trend of more active negotiations compared to previous quarters this year, perhaps signalling increased capacity.
 
As of August 31st, there were 10 files under consideration for greater than 6 months, with two files added to this total in August. In addition, there remain two files under negotiation for greater than 1 year (Darzalex and Botox).

 
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