pan-Canadian Pharmaceutical Alliance (pCPA): December 2021 Trends and Insights
UPDATE & REQUEST FOR PARTICIPATION IN A SURVEY
MORSE has been providing data analytics and expert insights through our pCPA updates on a monthly basis since 2017. Starting in 2022, MORSE will be publishing the pCPA updates quarterly instead of monthly. By analyzing quarterly vs. monthly data we expect to be able to identify important trends and provide useful insights to the market access community. We value our readers and would like to request your feedback in order to improve our content as we transition to this new format. It would be greatly appreciated if you could complete our 2 minute survey CLICK HERE.
Our next pCPA update will be published in April 2022.
December 2021 Highlights:
- 5 products completed CADTH review
- 2 products initiated pCPA negotiations
- 6 negotiations were completed with an LOI
- 1 negotiation was closed without an LOI
- 0 files were closed without negotiation
Key Take-Aways:
- The average time under pCPA consideration stays at 184, similar to last month’s high of 185 days. Seven files have been under consideration for more than 200 days, and four of those have surpassed 550 days. November and December have the lowest number of files under consideration that we saw in all of 2021.
- The pCPA initiated 2 and completed/closed 7 negotiations in December, reducing the total number of active files to 40. The ratio of files under consideration relative to total volume continues to remain under 50%.
- The pCPA concluded 6 negotiations with an LOI in December, and closed 1 negotiation without an agreement. Notably, all the completed negotiations were equal to or faster than average ranging from 48 to 146 days.
- The volume of files under negotiation decreased to 40 in December, and the average days under negotiation returned to levels observed over the previous quarter. The number of files adjudicated by the pCPA rebounded from last month’s low, with a total of 7 files coming to conclusion.
Files Under pCPA Consideration*:
CADTH issued 5 new recommendations in December 2021 (26 files under pCPA consideration as of December 31st – up from 23 in November).
| PRODUCT | INDICATION | SPONSOR | Reimbursement Recommendation | REC’N* DATE |
|---|---|---|---|---|
| Non-Oncology | ||||
| Reblozyl (luspatercept) | Myelodysplastic syndromes-associated anemia | Celgene Inc. | Conditional Reimbursement | 2021-12-07 |
| Opsynvi (macitentan and tadalafil) | Pulmonary arterial hypertension | Janssen Inc. | Conditional Reimbursement | 2021-12-14 |
| Emgality (galcanezumab) | Prevention of migraine | Eli Lilly Canada Inc. | Conditional Reimbursement | 2021-12-15 |
| Oncology | ||||
| Keytruda (pembrolizumab) | Esophageal carcinoma, gastroesophageal junction adenocarcinoma | Merck Canada Inc. | Conditional Reimbursement | 2021-12-02 |
| Brukinsa (zanubrutinib) | Waldenström’s macroglobulinemia | BeiGene, Ltd. | Conditional Reimbursement | 2021-12-01 |
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’.
*Note: that files that initiated pCPA negotiation prior to receiving a CADTH recommendation were excluded from the under-consideration timeline analysis
Signals Decoded:
The average time under pCPA consideration stays at 184, similar to last month’s high of 185 days. Seven files have been under consideration for more than 200 days, and four of those have surpassed 550 days. The number of files under consideration increased only slightly after 5 new CADTH recommendations and 2 new pCPA negotiation initiations. November and December have the lowest number of files under consideration that we saw in all of 2021
Negotiation Initiation:
The pCPA initiated 2 new negotiations in December, bringing the number of active negotiations to 40 (as of December 31st), down from 45 in November.
| PRODUCT | INDICATION | SPONSOR | INITIATE DATE | TTI* |
|---|---|---|---|---|
| Non-Oncology | ||||
| MAR-Trientine (Trientine Hydrochloride) | Wilson’s Disease | Marcan Pharmaceuticals Inc. | 2021-12-07 | 26 |
| Oncology | ||||
| Inrebic (fedratinib) | Myelofibrosis | Celgene Inc. | 2021-12-21 | 202 |
*Time to Initiation (TTI) – Time between ‘final recommendation issued to sponsor and drug plans’ and ‘pCPA Engagement Letter Issued’
Signals Decoded:
TThe pCPA initiated 2 and completed/closed 7 negotiations in December, reducing the total number of active files to 40. MAR-Trientine (Trientine Hydrochloride), a rare disease drug, was initiated after 26 days under consideration. The ratio of files under consideration relative to total volume continues to remain under 50%.
Completed Negotiations:
The pCPA completed 6 negotiations with a Letter of Intent (LOI) in December 2021, up from 3 in November.
| PRODUCT | INDICATION | Sponsor | Status | LOI DATE | TTN* |
|---|---|---|---|---|---|
| Non-Oncology | |||||
| Ajovy (fremanezumab) | Migraine | Teva Canada Inc. | Completed | 2021-12-03 | 140 |
| Ilumya (tildrakizumab) | Psoriasis, moderate to severe plaque | Sun Pharma Canada Inc. | Completed | 2021-12-20 | 94 |
| Oncology | |||||
| Alunbrig (Brigatinib) | Anaplastic Lymphoma Kinase Positive Non-Small Cell Lung Cancer | Takeda Canada Inc. | Completed | 2021-12-16 | 48 |
| Bavencio (Avelumab) | Urothelial Carcinoma (UC) | EMD Serono | Completed | 2021-12-15 | 146 |
| Polivy (Polatuzumab Vedotin) | Relapsed or refractory diffuse large B-cell lymphoma | Hoffmann-La Roche Limited | Completed | 2021-12-01 | 133 |
| Venclexta (Venetoclax, in combo with azacitidine ) | Acute myeloid leukemia | AbbVie Corporation | Completed | 2021-12-06 | 68 |
* TTN = Time to Negotiate in calendar days
Closed Negotiations:
The pCPA closed 1 negotiation without an LOI in December 2021.
| PRODUCT | INDICATION | Sponsor | Status | Close Date | TTC* |
|---|---|---|---|---|---|
| Non-Oncology | |||||
| Aimovig (erenumab) | Migraine | Novartis Pharmaceuticals Canada Inc | Closed | 2021-12-13 | 322 |
Not Negotiated:
The pCPA did not decline any negotiations in December 2021.
Signals Decoded:
The pCPA concluded 6 negotiations with an LOI in December, and closed 1 negotiation without an agreement. Notably, all the completed negotiations were equal to or faster than average ranging from 48 to 146 days. Aimovig (erenumab) for migraine closed without an LOI after 322 days of negotiation, while another migraine drug Ajovy (fremanezumab) reached an agreement after 140 days.
Signals Decoded:
The volume of files under negotiation decreased to 40 in December, and the average days under negotiation returned to levels observed over the previous quarter.
Reblozyl (luspatercept) for anemia associated with beta-thalassemia surpassed 200 days under consideration by pCPA in December, bringing the number of files under consideration for greater than 6 months to 7. CADTH issued a recommendation for the same drug in December for another anemia indication, which may be impacting pCPA’s approach to the file.
The number of files adjudicated by the pCPA rebounded from last month’s low, with a total of 7 files coming to conclusion.
To receive updates similar to this one please be sure to sign up for MORSE Signals, our free e-mail newsletter service.
