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15 Oncology Files either Completed, Initiated or new Under Consideration

September 10, 2019
-
Market Access News
-
Posted by MORSE - 3 min read.

pan-Canadian Pharmaceutical Alliance (pCPA): August 2019 Trends and Insights

 

The pan-Canadian Pharmaceutical Alliance (pCPA) has issued the August 31, 2019 status of brand negotiations.  Highlights since the last update include:

  • 5 products completed CADTH review, for a total of 13 files under consideration;
  • 8 products initiated pCPA negotiations, for a total of 47 active negotiations;
  • 7 negotiations completed for a total of 270 completed negotiations;
  • 1 negotiation closed, for a total of 44 closed negotiations; and
  • 1 file closed without negotiations, for a total of 68 declined negotiations.

 

Completed

 

Brand Name Generic Name Manufacturer Indication Initiation Duration*
Imfinzi durvalumab AstraZeneca Non-small cell lung cancer Jul 2019 31 days
Cystadrops Cysteamine Recordati Rare Diseases corneal cystine crystal deposits Jun 2019 61 days
Tafinlar/Mekinist Dabrafenib & Trametinib Novartis Melanoma Jun 2019 61 days
Lonsurf Trifluridine & Tipiracil Taiho Pharma Metastatic colorectal cancer May 2019 92 days
Unituxin Dinutuximab United Therapeutics In combination with GM-CSF, IL-2 and Retinoic acid (RA) for the treatment of pediatric patients with high-risk neuroblastoma May 2019 92 days
Zirabev Bevacizumab Pfizer Metastatic Colorectal Cancer Mar 2019 153 days
Fibristal ulipristal acetate Allergan Intermittent treatment of moderate to severe signs and symptoms of uterine fibroids Sep 2018 334 days

*Negotiation initiation and completion/closed date assumed to be mid-month; approximate calendar days calculated.

 

Closed

 

Brand Name Generic Name Manufacturer Indication Initiation Duration*
Monoprost Latanoprost Laboratoires Théa Glaucoma and ocular hypertension Sep 2018 334 days

 

Signals Decoded:

August saw the completion of the second bevacizumab biosimilar, along with 4 other oncology files – all reaching agreement within 2-3 months of negotiations. Two files that had been under negotiations for almost a year were also finalized, resulting in a completed agreement for Fibristal, and closed negotiations for Monoprost.

 

 

Negotiation Initiation

The pCPA initiated 8 new negotiations since the last update, for a total of 47 active negotiations.

 

Brand Name Generic Name Manufacturer Indication CADTH Date Initiation Time*
Bosulif Bosutinib Pfizer Chronic Myeloid Leukemia 2 Aug 19 13 days
Emerade Epinephrine bitartrate Bausch Health Emergency treatment of anaphylactic reactions N/A N/A
Ibrance/Faslodex palbociclib/fulvestrant Pfizer Advanced or Metastatic Breast Cancer 21 May 19 86 days
Keytruda Pembrolizumab Merck Metastatic non-squamous non-small cell lung cancer 17 Jun 19 59 days
Orfadin Oral Suspension Nitisinone SOBI Hereditary tyrosinemia type 1 (HT-1) N/A N/A
Vizimpro Dacomitinib Pfizer Locally advanced/metastatic non‑small cell lung cancer with epidermal growth factor receptor-activating mutations 17 Jun 19 59 days
Vyzulta Latanoprostene bunod Bausch Health Open-angle glaucoma or ocular hypertension 24 Jul 19 22 days
Xalkori Crizotinib Pfizer ROS1-positive advanced Non-Small Cell Lung Cancer 7 Jun 19 69 days

*Negotiation initiation and completion/closed date assumed to be mid-month; approximate calendar days calculated.

 

Signals Decoded:

Keytruda is now being negotiated for 3 different indications and is under consideration for a fourth. Negotiations for Bosulif were initiated the same month as the recommendation was issued – a review triggered by a Drug Program Request for Advice. Finally, Ibrance, Xalkori and Orfadin have all completed previous pCPA negotiations.

 

 

Files Under pCPA Consideration

6 new drug products, including one initiated by a Drug Program Request for Advice, received a CDEC recommendation or pERC notification to implement in August 2019, for a total of approximately 13 products under pCPA Consideration.

 

Brand Name Generic Name Manufacturer Indication Recommendation
Alunbrig Brigatinib Takeda Non-Small Cell Lung Cancer (NSCLC)  

Do not reimburse
Lenvima lenvatinib Eisai Hepatocellular Carcinoma Conditional
Lutathera Lutetium Lu 177 dotatate Advanced Accelerator Applications Gastroenteropancreatic neuroendocrine tumors Conditional
Olumiant baricitinib Eli Lilly Rheumatoid Arthritis Conditional
Bosulif* bosutinib Pfizer Chronic Myeloid Leukemia Recommend
Keytruda Pembrolizumab Merck Melanoma Adjuvant Treatment Conditional
Onpattro** patisiran Alnylam Netherlands BV Polyneuropathy in hereditary transthyretin-mediated amyloidosis Conditional

*Request for Advice

**Correction: Onpattro received a final recommendation in July and was not included in the MORSE July pCPA Update

 

Not Negotiated

 

Brand Name Generic Name Manufacturer Indication CADTH Date Time to Decision*
Ninlaro Ixazomib Takeda Multiple Myeloma (2nd-beyond) July 22, 2019 24 days

*Negotiation initiation and completion/closed date assumed to be mid-month; approximate calendar days calculated.

 

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15 Oncology Files either Completed, Initiated or new Under Consideration