pan-Canadian Pharmaceutical Alliance (pCPA): November 2019 Trends and Insights
The pan-Canadian Pharmaceutical Alliance (pCPA) has issued the November 30, 2019 status of brand negotiations. Highlights since the last update include:
- 6 products completed CADTH review, for a total of 9 files under consideration;
- 4 products initiated pCPA negotiations, for a total of 34 active negotiations;
- 12 negotiations completed for a total of 294 completed negotiations;
- No negotiations closed, for a total of 47 closed negotiations; and
- 2 files closed without negotiations, for a total of 72 declined negotiations.
Files Under pCPA Consideration
6 new drug products received a CDEC recommendation or pERC notification to implement in November 2019, for a total of approximately 9 products under pCPA Consideration.
| Brand Name | Generic Name | Manufacturer | Indication | Recommendation |
|---|---|---|---|---|
| Cimzia | certolizumab pegol | UCB Canada | Psoriasis, moderate to severe plaque | Conditional |
| Revestive | teduglutide | Shire | Short Bowel Syndrome (SBS), pediatrics | Conditional |
| Takhzyro | lanadelumab | Shire | Hereditary angioedema, prevention | Conditional |
| Verkazia | cyclosporine | Santen | Severe vernal keratoconjunctivitis, pediatric (≥4 years) | Conditional |
| Idhifa | Enasidenib | Celgene | Acute Myeloid Leukemia (AML) |
Does not recommend
|
| Vitrakvi | Larotrectinib | Bayer | Neurotrophic Tyrosine Receptor Kinase (NTRK) Locally Advanced or Metastatic Solid Tumours |
Does not recommend
|
Negotiation Initiation
The pCPA initiated 4 new negotiations since the last update, for a total of 34 active negotiations.
| Brand Name | Generic Name | Manufacturer | Indication | CADTH Date | Time to Initiate |
|---|---|---|---|---|---|
| Darzalex | Daratumumab | Janssen | Multiple Myeloma (newly diagnosed) | 16 Sep 19 | 60 |
| Onpattro | Patisiran | Alnylam Netherlands BV | Polyneuropathy in hereditary transthyretin-mediated amyloidosis (hATTR) | 25 Jul 19 | 113 |
| Tegsedi | Inotersen | Akcea | Stage 1 or 2 polyneuropathy in adult patients with hereditary transthyretin amyloidosis (hATTR) | 11 Sep 19 (INESSS) CDEC Rec’n Pending | 65
(INESSS) |
| Triamcinolone Hexacetonide | Triamcinolone Hexacetonide | Medexus | subacute and chronic inflammatory joint diseases | N/A | N/A |
*Negotiation initiation and completion/closed date assumed to be mid-month; approximate calendar days calculated.
Signals Decoded:
The pCPA has initiated negotiations for two products indicated to treat polyneuropathy in hereditary transthyretin-mediated amyloidosis (hATTR) – Onpattro, which had been the file under current pCPA Consideration for the longest duration, and Tegsedi, based on a List with conditions recommendation from INESSS. Of the new files under pCPA consideration, two (Cimzia, Revestive) have been previously negotiated for other indications.
Completed
| Brand Name | Generic Name | Manufacturer | Indication | Initiated | Duration* |
|---|---|---|---|---|---|
| Dovato | Dolutegravir
lamivudine |
ViiV Healthcare | HIV infection | Oct 2019 | 31 days |
| Lenvima | Lenvatinib | Eisai | unresectable hepatocellular carcinoma, 1st line | Sep 2019 | 61 days |
| Vyzulta | latanoprostene bunod | Bausch & Lomb | open-angle glaucoma or ocular hypertension | Aug 2019 | 92 days |
| Cabometyx | Cabozantinib | Ipsen | Renal cell carcinoma | Jun 2019 | 153 days |
| Skyrizi | risankizumab | AbbVie | Plaque psoriasis | Jun 2019 | 153 days |
| Cresemba | isavuconazole | AVIR Pharma | Treatment of invasive aspergillosis and mucormycosis | Jul 2019 | 123 days |
| Herzuma | trastuzumab | Teva | early and metastatic breast cancer, gastric cancer | May 2019 | 184 days |
| Soliqua | Lixisenatide
insulin glargine |
Sanofi-Aventis | Diabetes mellitus, Type 2 | Apr 2019 | 214 days |
| Tagrisso | Osimertinib | AstraZeneca | locally advanced or metastatic NSCLC, 1st line | Mar 2019 | 245 days |
| Xarelto | rivaroxaban | Bayer | prevention of cardiovascular events in CAD/PAD | Mar 2019 | 245 days |
| Mavenclad | Cladribine | EMD Serono | relapsing-remitting multiple sclerosis | Feb 2019 | 273 days |
| Adlyxine | lixisenatide | Sanofi-Aventis | Diabetes mellitus, Type 2 | Apr 2018 | 579 days |
*Negotiation initiation and completion/closed date assumed to be mid-month; approximate calendar days calculated.
Signals Decoded:
November saw the pCPA complete 12 negotiations, including 3 that were completed within 3 months, reducing the number of active negotiations by ~20% (42 to 34) in a single month. After completing the first successful negotiation for a GLP-1 receptor agonist (Ozempic) in July of this year, the pCPA has signed a Letter of Intent for a second product (Adlyxine, lixisenatide) from this drug class, ending negotiations that had been ongoing for over a year-and-a-half. At the same time, a deal was also reached for Soliqua which combines lixisenatide with insulin glargine. The pCPA also completed negotiations for the third trastuzumab biosimilar (Herzuma), after signing deals for the first two (Ogivri, Trazimera) last month.
Not Negotiated
| Brand Name | Generic Name | Manufacturer | Indication | CADTH Date | Time to Decision* |
|---|---|---|---|---|---|
| Illuvien | fluocinolone acetonide intravitreal implant | Knight Therapeutics | Diabetic Macular Edema | 26 Sep 19 | 50 days |
| Keytruda | Pembrolizumab | Merck | Metastatic Urothelial Carcinoma, 1st line | 21 Oct 19 | 25 days |
*Negotiation initiation and completion/closed date assumed to be mid-month; approximate calendar days calculated.
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