pan-Canadian Pharmaceutical Alliance (pCPA): September 2021 Trends and Insights
September 2021 Highlights:
- 5 products completed CADTH review
- 7 products initiated pCPA negotiations
- 7 negotiations were completed with an LOI
- 1 negotiation was closed without an LOI
- 1 file was closed without negotiation
Key Take-Aways:
- The number of files under consideration at pCPA decreased slightly to 34 from last month’s high, while the average days under consideration had a moderate increase. With 1 new oncology recommendation from CADTH, the number of oncology files under consideration remains higher than usual at 14, but less so than last month.
- The number of files under active negotiation (35) continued to trend downward following June and July’s highs. While seven new files were initiated in September (up from four last month), seven files completed negotiations with LOIs and one negotiation closed. Three of the newly initiated files had been under pCPA consideration for longer than 6 months: Kynmobi for Parkinson’s disease, Duobrii for moderate to severe plaque psoriasis, and Tecentriq for small cell lung cancer (despite a “Do not reimburse” recommendation from CADTH). Conversely, Trikafta for cystic fibrosis was initiated quickly after 18 days and also completed negotiations within the same day.
- The pCPA once again completed a high number of negotiations in September, consisting of six non-oncology files and one biosimilar (the first biosimilar teriparatide). Two asthma products from the same manufacturer, Enerzair Breezhaler and Atectura Breezhaler, were negotiated relatively quickly under identical timelines (99 days) . One file, Trikafta for cystic fibrosis, was initiated and completed on the same day signalling that pCPA consideration occurred in advance of the final recommendation.
- The overall volume and average negotiation time of files has returned to the levels seen throughout most of the year. The total number of files adjudicated by pCPA was again high at 9.
Files Under pCPA Consideration*:
CADTH issued 5 new recommendations in September (34 files under pCPA consideration as of Sept. 30th – down from 37 in August).
*Correction: Vitrakvi (Larotrectinib), Breztri Aerosphere (budesonide/ glycopyrronium /formoterol fumarate), and Trikafta (elexacaftor / tezacaftor / ivacaftor and ivacaftor) received a final recommendation in August but were not included in MORSE’s August pCPA update because the final recommendations were not published on the CADTH website until mid-September.
| PRODUCT | INDICATION | SPONSOR | Reimbursement Recommendation | REC’N* DATE |
|---|---|---|---|---|
| Non-Oncology | ||||
| Givlaari (givosiran) | Acute hepatic porphyria (AHP) in adults | Alnylam Netherlands B.V. | Conditional Reimbursement | 2021-09-08 |
| Perseris (risperidone) | Schizophrenia, adults | HLS Therapeutics Inc. | Conditional Reimbursement | 2021-09-08 |
| Xeomin (incobotulinumtoxinA) | Chronic sialorrhea associated with neurological disorders | Merz Pharmaceuticals GMBH | Conditional Reimbursement | 2021-09-09 |
| Saxenda (liraglutide) | Chronic weight management in adults | Novo Nordisk Canada Inc. | Do Not Reimburse | 2021-09-20 |
| Oncology | ||||
| Inqovi (Decitabine-Cedazuridine) | Myelodysplastic Syndromes (MDS) | Taiho Pharma Canada, Inc. | Conditional Reimbursement | 2021-09-22 |
*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:
The number of files under consideration at pCPA decreased slightly to 34 from last month’s high, while the average days under consideration had a moderate increase. With 1 new oncology recommendation from CADTH, the number of oncology files under consideration remains higher than usual at 14, but less so than last month.
Negotiation Initiation:
The pCPA initiated 7 new negotiations in September bringing the number of active negotiations to 35 (as of September 30th), down from 36 in August.
| PRODUCT | INDICATION | SPONSOR | INITIATE DATE | TTI* |
|---|---|---|---|---|
| Non Oncology | ||||
| Kynmobi (apomorphine hydrochloride) | Parkinson’s Disease | Sunovion Pharmaceuticals Canada Inc. | 2021-09-03 | 191 |
| Ilumya (tildrakizumab) | Psoriasis, moderate to severe plaque | Sun Pharma Canada Inc. | 2021-09-17 | 88 |
| Duobrii (Halobetasol propionate and tazarotene) | Psoriasis, moderate to severe plaque | Bausch Health Canada Inc. | 2021-09-17 | 324 |
| Trikafta (elexacaftor / tezacaftor / ivacaftor and ivacaftor) | Cystic fibrosis, F508del CFTR mutation | Vertex Pharmaceuticals (Canada) Incorperated | 2021-09-17 | 18 |
| Oncology | ||||
| Tafinlar & Mekinist in combo (Dabrafenib & Trametinib in combo) | NSCLC BRAF V600 | Novartis Pharmaceuticals Canada Inc. | 2021-09-10 | 88 |
| Tecentriq (atezolizumab) | Small Cell Lung Cancer (SCLC) | Hoffmann-La Roche | 2021-09-27 | 591 |
| Venclexta (Venetoclax, in combo with azacitidine ) | Acute myeloid leukemia | AbbVie Corporation | 2021-09-29 | 56 |
*Time to Initiation (TTI) – Time between ‘final recommendation issued to sponsor and drug plans’ and ‘pCPA Engagement Letter Issued’
Signals Decoded:
The number of files under active negotiation (35) continued to trend downward following June and July’s highs. While seven new files were initiated in September (up from four last month), seven files completed negotiations with LOIs and one negotiation closed.
Three of the newly initiated files had been under pCPA consideration for longer than 6 months: Kynmobi for Parkinson’s disease, Duobrii for moderate to severe plaque psoriasis, and Tecentriq for small cell lung cancer (despite a “Do not reimburse” recommendation from CADTH). Conversely, Trikafta for cystic fibrosis was initiated quickly after 18 days and also completed negotiations within the same day.
Completed Negotiations:
The pCPA completed 7 negotiations with a Letter of Intent (LOI) in September 2021, down from 10 in August.
| PRODUCT | INDICATION | Sponsor | Status | LOI DATE | TTN* |
|---|---|---|---|---|---|
| Non-Oncology | |||||
| Vocabria and Cabenuva (cabotegravir-rilpivirine cabotegravir sodium) | HIV-1 infection | ViiV Healthcare ULC | Completed | 2021-09-07 | 320 |
| Crysvita (burosumab) | Treatment of X-Linked Hypophosphatemia | Ultragenyx Canada Inc. | Completed | 2021-09-10 | 336 |
| Trikafta (elexacaftor / tezacaftor / ivacaftor and ivacaftor)** | Cystic fibrosis, F508del CFTR mutation | Vertex Pharmaceuticals (Canada) Incorperated | Completed | 2021-09-17 | 0 |
| Nexplanon (etonogestrel) | Prevention of Pregnancy | Merck Canada Inc. | Completed | 2021-09-20 | 208 |
| Enerzair Breezhaler (indacaterol glycopyrronium mometasone furoate) | Asthma maintenance, adults | Valeo Pharma Inc. | Completed | 2021-09-30 | 99 |
| Atectura Breezhaler (indacaterol/mometasone furoate) | Asthma maintenance (adults, children 12 or older) | Valeo Pharma Inc. | Completed | 2021-09-30 | 99 |
| Oncology | |||||
| None | |||||
| Biosimilar | |||||
| Osnuvo (teriparatide) | osteoporosis | AVIR Pharma Inc. | Completed | 2021-09-15 | 103 |
* TTN = Time to Negotiate in calendar days
**initiated and completed pCPA negotiation on the same day
Closed Negotiations:
The pCPA closed 1 negotiation without an LOI in September 2021.
| PRODUCT | INDICATION | Sponsor | Status | Closing date | TTN* |
|---|---|---|---|---|---|
| Non-Oncology | |||||
| Botox (OnabotulinumtoxinA) | migraine, chronic | Allergan Inc. | Closed | 2021-09-17 | 575 |
Not Negotiated:
The pCPA declined 1 negotiation in September 2021.
| PRODUCT | INDICATION | Sponsor | Status | Decision Date | Time Under Consideration |
|---|---|---|---|---|---|
| Oncology | |||||
| Venclexta (Venetoclax, in combo with cytarabine) | Acute myeloid leukemia | AbbVie Corperation | Not Negotiated | 2021-09-28 | 54 |
Signals Decoded:
The pCPA once again completed a high number of negotiations in September, consisting of six non-oncology files and one biosimilar (the first biosimilar teriparatide). Two asthma products from the same manufacturer, Enerzair Breezhaler and Atectura Breezhaler, were negotiated relatively quickly under identical timelines (99 days) . One file, Trikafta for cystic fibrosis, was initiated and completed on the same day signalling that pCPA consideration occurred in advance of the final recommendation.
Botox for chronic migraine was closed without an LOI after 575 days of active negotiation. The pCPA did not pursue negotiations for Venclexta for acute myeloid leukemia following a “Do not reimburse” recommendation from CADTH.
Signals Decoded:
The overall volume and average negotiation time of files has returned to the levels seen throughout most of the year.
The number of files under consideration for greater than 6 months was reduced to eight in September after three long-term under consideration files were initiated, with one new file surpassing the 6 month mark. One file that had been under protracted negotiation closed without an LOI, leaving only one remaining in that category.
The total number of files adjudicated by pCPA was again high at 9.
To receive updates similar to this one please be sure to sign up for MORSE Signals, our free e-mail newsletter service.
