pan-Canadian Pharmaceutical Alliance (pCPA): April 2019 Negotiation Status Update
The pan-Canadian Pharmaceutical Alliance (pCPA) has issued the status of brand negotiations as of April 30, 2019. Highlights since the last update include:
- 4 negotiations completed for a total of 251 completed negotiations
- No negotiations closed, for a total of 35 closed negotiations
- 1 file closed without negotiations, for a total of 64 declined negotiations
- 4 products completed CADTH review, for a total of 13 files under consideration.
- 5 products initiated pCPA negotiations, for a total of 45 active negotiations
Negotiation Initiation
The pCPA initiated 5 new negotiations since the last update, for a total of 45 active negotiations.
| Brand Name | Generic Name | Manufacturer | Indication | CADTH Date | Initiation Time* |
|---|---|---|---|---|---|
| Arbesda RespiClick | fluticasone propionate / salmeterol xinafoate | TEVA Canada Innovation | Asthma | 19 Dec 2018 | 117 days |
| Aermony RespiClick | fluticasone propionate | TEVA Canada Innovation | Asthma | 19 Dec 2018 | 117 days |
| Soliqua | lixisenatide + insulin glargine | Sanofi-Aventis Canada Inc. | Diabetes mellitus, Type 2 | 24 Dec 2018 | 112 days |
| Velphoro | sucroferric oxyhydroxide | Vifor Fresenius Medical Care | Hyperphosphatemia, end-stage renal disease | 4 Jan 2019 | 101 days |
| Spinraza | Nusinersen | Biogen Canada Inc. | Spinal muscular atrophy | 27 Feb 2019 | 47 days |
*Negotiation initiation and completion/closed date assumed to be mid-month; approximate calendar days calculated.
Signals Decoded:
The pCPA has initiated a second round of negotiations for Spinraza, based on a resubmission by the manufacturer. The pCPA may link negotiations for Soliqua with that of Adlyxine which has been ongoing since April 2018. Finally, it will be interesting to monitor the progress of negotiations for the dry powder inhalers, Arbesda and Aermony RespiClick as these products are entering a busy therapeutic space and will likely be viewed by the pCPA as potentially less expensive alternatives to similar established products..
Completed
| Brand Name | Generic Name | Manufacturer | Indication | Initiation | Duration* |
|---|---|---|---|---|---|
| Akynzeo | netupitant/palonosetron | Purdue | Chemo induced nausea & vomiting prevention | Sep 2018 | 212 days |
| Duodopa | Levodopa/carbidopa | AbbVie | Parkinson’s Disease | Dec 2018 | 121 days |
| Kisqali | Ribociclib | Novartis | Advanced or Metastatic Breast Cancer | Aug 2018 | 243 days |
| Stivarga | Regorafenib | Bayer | Unresectable Hepatocellular Carcinoma (HCC) | Sep 2018 | 212 days |
*Negotiation initiation and completion/closed date assumed to be mid-month; approximate calendar days calculated.
Signals Decoded:
The three completed negotiations that were initiated in response to a CADTH Recommendation (Akynzeo, Kisqali, Stivarga) took approximately 6-7 months post initiation, which remains above the proposed pCPA Process Guideline aspirational target of 4-5 months or 90 business days. Duodopa, a drug plan submission to CADTH, completed negotiation within the pCPA target.
Not Negotiated
| Brand Name | Generic Name | Manufacturer | Indication | CADTH Date | Time to Decision* |
|---|---|---|---|---|---|
| Eucrisa | Crisaborole | Pfizer | Atopic Dermatitis | 27 Mar 2019 | 19 days |
*Negotiation initiation and completion/closed date assumed to be mid-month; approximate calendar days calculated.
Signals Decoded:
CADTH recommended that Eucrisa not be reimbursed for topical treatment of mild to moderate atopic dermatitis in patients two years of age and older.
Files Under pCPA Consideration
The products “under pCPA Consideration” have been reviewed by CADTH but have not yet been initiated for negotiation or closed without negotiations.
Four new drug products received a CDEC recommendation or pERC notification to implement in April 2019, for a total of approximately 13 products under pCPA Consideration.
| Brand Name | Generic Name | Manufacturer | Indication | pERC Recommendation |
|---|---|---|---|---|
| Blincyto | Blinatumomab | Amgen | Philadelphia chromosome positive (Ph+) B-cell precursor (BCP) acute lymphoblastic leukemia | Conditional upon improving cost-effectiveness |
| Folotyn | Pralatrexate | Servier | Peripheral T-Cell Lymphoma (PTCL) | Conditional upon improving cost-effectiveness and that the public drug plan cost not exceed the public drug plan cost of romidepsin |
| Unituxin | Dinutuximab | United Therapeutics | Neuroblastoma | Conditional upon improving cost-effectiveness |
| Xtandi | Enzalutamide | Astellas | Non-metastatic castration-resistant prostate cancer | Conditional upon improving cost-effectiveness and feasibility of adoption being addressed |
Signals Decoded:
All four of the new files under pCPA consideration are for oncology indications, including new indications for both Blincyto and Xtandi.
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