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Jury Still out on Whether the Targeted Negotiations Process (TNP) Impacts pCPA Metrics

March 17, 2021
-
Market Access News
-
Posted by MORSE - 3 min read.

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

 

February 2021 Highlights:

  • 5 products completed CADTH review
  • 7 products initiated pCPA negotiations
  • 6 negotiations were completed with an LOI
  • 0 negotiations were closed without an LOI
  • 1 file was closed without negotiation

 

Files Under pCPA Consideration:

CADTH issued 5 new recommendations in February (28 files under pCPA consideration as of Feb 28) – down from 29 in January.

PRODUCT INDICATION SPONSOR Type REC’N* DATE
Pdp-levETIRAcetam (levetiracetam) Epilepsy Pendopharm Non-Oncology February 3
Rozlytrek (entrectinib) ROS1-positive Non-Small Cell Lung Cancer Hoffmann-La Roche Oncology February 11
Ofev (nintedanib) chronic fibrosing interstitial lung diseases Boehringer Ingelheim Non-Oncology February 24
Kynmobi (apomorphine hydrochloride) Parkinson’s disease Sunovion Non-Oncology February 24
Kesimpta (ofatumumab) Multiple Sclerosis, relapsing Novartis Non-Oncology February 25

Signals Decoded:

 

The volume of files under consideration is holding relatively steady at 28 after a gradual monthly increase that reached its 12-month peak of 30 in December 2020. The average days under consideration continues to hover around the 150 day range up from 50 days in early 2020.

Negotiation Initiation:

The pCPA initiated 7 new negotiations in February (33 active negotiations as of February 28) – up from 30 in January.

PRODUCT INDICATION SPONSOR CATEGORY INITIATE DATE TTI*
Adcetris Primary Cutaneous Anaplastic Large Cell Lymphoma (or CD30- Expressing Mycosis Fungoides) Seattle Genetics Oncology February 5 49
Adcetris Hodgkin’s Lymphoma Seattle Genetics Oncology February 5 231
Keytruda** Head and Neck Squamous Cell Carcinoma (HNSCC) Merck Oncology February 10 187
Darzalex Multiple Myeloma Janssen Oncology February 26 343
Darzalex SC Multiple Myeloma Janssen Oncology (Other) February 26 N/A
Nexplanon Prevention of Pregnancy Merck Non-Oncology February 24 125
Zolgensma Spinal Muscular Atrophy Novartis Other- Gene Therapy February 19 N/A

* time from CADTH final recommendation or notification to implement in calendar days
** Initiated and concluded with LOI on the same day

Signals Decoded:

February also saw the number of active negotiations peak at its 12-month high of 33, perhaps signaling that pCPA’s capacity may be starting to increase. It is notable that Zolgensma, a gene therapy for the treatment of SMA, initiated pCPA negotiations in advance of its CADTH recommendation, however it has received its INESSS recommendation.

Completed/Closed Negotiations:

The pCPA completed 6 negotiations with a Letter of Intent (LOI) in February 2021, the same number of files completed in January.

PRODUCT INDICATION SPONSOR LOI DATE TTN*
Lonsurf* Metastatic Gastric Cancer Taiho January 11 188
Keytruda** Head and Neck Squamous Cell Carcinoma (HNSCC) Merck February 10 1
Vyndaqel Transthyretin-Mediated Amyloidosis Pfizer February 4 239
Aermony Respiclick Asthma Teva February 2 118
Monoferric Iron Deficiency Anemia Pharmacosmos A/S February 2 196
Nubeqa Non-Metastatic Castrate Resistant Prostate Cancer Bayer February 18 118
Dupixent Atopic Dermatitis Sanofi Genzyme February 25 212

* TTN = Time to Negotiate in calendar days
* Correction from January
** Initiated and concluded with LOI on the same day

 

Not Negotiated:

The pCPA declined negotiations on 1 file in January 2021.

PRODUCT INDICATION SPONSOR DECLINE DATE TTD*
Daurismo Acute Myeloid Leukemia (AML) Pfizer February 23 29

* TTD = Time to Decline in calendar days

Signals Decoded:

 

The number of files under consideration for greater than 6 months has plateaued at 10, while the number of files under active negotiation for greater than 12 months is starting to climb. In addition the total files adjudicated by the pCPA by month appears to be stabilizing around the 5-7 mark.

 

Interestingly, the pCPA negotiation for Keytruda for HNSCC opened and closed on the same day, perhaps indicating the negotiation was only administrative in nature. Daurismo was the only file declined for negotiation and received a Do Not Reimburse recommendation from CADTH and INESSS.

 

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Jury Still out on Whether the Targeted Negotiations Process (TNP) Impacts pCPA Metrics