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Ministry Status: Routine Monitoring and Engagement

Patient Evidence Submissions

Drug Review Schedule

The Ontario Public Drug Program is currently accepting submissions of patient evidence on the following drug products which will undergo review by the Committee to Evaluate Drugs within the next 12 months.

Drug products on this list include new chemical entities, new combination products and existing drug products with a new indication recently approved by Health Canada. At this time, drug products that are line extensions (such as additional strengths and new dosage forms) and drug products that are undergoing reconsideration (second review, etc.) will not be considered for patient submissions. The Ministry will re-evaluate this once additional experience on the process is gained.

For drug products accepted for Rapid Review process, best efforts will be made to provide maximal time for patient submissions. However, in view of the intent of Rapid Review, the review of a drug product accepted for Rapid Review will not be held if only to include presentation of patient submissions.

Registered patient groups are invited to provide patient evidence on any of the drugs listed below.

All submissions must be received by 5:00pm of the deadline date.

 

Generic Name Brand Name Manufacturer Indication / Type of Review Deadline for Patient Submissions
Dabrafenib &
trametinib in combination
Tafinlar &
Mekinist in combination
Novartis Pharmaceuticals Canada Inc. Melanoma with a BRAF V600 mutation, adjuvant treatment (pCODR) February 20, 2019
Blinatumomab Blincyto Amgen Canada Inc. Philadelphia chromosome positive (Ph+) B-cell precursor (BCP) acute lymphoblastic leukemia (ALL) (pCODR) January 16, 2019
Efinaconazole Jublia Valeant Canada LP Onychomycosis (CDR) January 16, 2019
Triamcinolone hexacetonide Triamcinolone Hexacetonide Injectable Suspension Medexus Inc. Symptomatic treatment of subacute and chronic inflammatory joint diseases, including rheumatoid arthritis, juvenile idiopathic arthritis, osteoarthritis, post-traumatic arthritis, synovitis, tendinitis, bursitis and epicondylitis December 28, 2018
Lenvatinib Lenvima Eisai Limited Renal cell carcinoma (in combination with everolimus) (pCODR) December 5, 2018
Crisaborole Eucrisa Pfizer Canada Inc. Atopic dermatitis (CDR) November 14, 2018
Lixisenatide/insulin glargine Soliqua Sanofi Aventis Canada Inc. Diabetes mellitus, type 2 (CDR) November 14, 2018
Rivaroxaban Xarelto Bayer Inc. Prevention of stroke and cardiovascular events in coronary and peripheral artery disease (CDR) November 14, 2018
Mesalamine Mezera Avir Pharma Inc. Ulcerative colitis, sigmoid colon and rectum, mildly active (rectal foam enema formulation) October 31, 2018
Mesalamine Mezera Avir Pharma Inc. Ulcerative proctitis, mild to moderate, acute (rectal suppository formulation) October 31, 2018
Osimertinib Tagrisso AstraZeneca Canada Inc. Non-small cell lung cancer, EGFR mutation-positive (first-line) (pCODR) October 31, 2018
Adalimumab Humira AbbVie Corporation

Inflammatory bowel disease reimbursement criteria review to consider use:

  • At higher than standard doses (e.g., either increased dose or decreased dosing interval) in patients who have a partial initial response, or secondary loss of response, to standard doses;
  • As first-line therapy (i.e., no requirement for prior use of antibiotics and immunosuppressive therapy) in patients with fistulising Crohn’s disease;
  • For patients with moderate to severe luminal Crohn’s disease who have not received trials of both glucocorticoids and immunosuppressants; and
  • For patients with ulcerative colitis who have not received prior immunosuppressant therapy.
October 24, 2018
Golimumab Simponi Janssen Inc.

Inflammatory bowel disease reimbursement criteria review to consider use:

  • At higher than standard doses (e.g., either increased dose or decreased dosing interval) in patients who have a partial initial response, or secondary loss of response, to standard doses; and
  • For patients with ulcerative colitis who have not received prior immunosuppressant therapy.
October 24, 2018
Bictegravir/emtricitabine/
tenofovir alafenamide
Biktarvy Gilead Sciences Canada, Inc. HIV-1 infection (CDR) October 24, 2018
Infliximab Remicade Janssen

Inflammatory bowel disease reimbursement criteria review to consider use:

  • At higher than standard doses (e.g., either increased dose or decreased dosing interval) in patients who have a partial initial response, or secondary loss of response, to standard doses;
  • As first-line therapy (i.e., no requirement for prior use of antibiotics and immunosuppressive therapy) in patients with fistulising Crohn’s disease;
  • For patients with moderate to severe luminal Crohn’s disease who have not received trials of both glucocorticoids and immunosuppressants; and
  • For patients with ulcerative colitis who have not received prior immunosuppressant therapy.
October 24, 2018
Pertuzumab-trastuzumab Perjeta-Herceptin Combo Pack Hoffmann-La Roche Limited Breast cancer, early, HER2-positive, high recurrence risk (node-positive or hormone receptor-negative) (for 18 cycles as adjuvant treatment) (pCODR) October 24, 2018
Vedolizumab Entyvio Takeda Canada Inc.

Inflammatory bowel disease reimbursement criteria review to consider use:

  • At higher than standard doses (e.g., either increased dose or decreased dosing interval) in patients who have a partial initial response, or secondary loss of response, to standard doses;
  • As first-line therapy (i.e., no requirement for prior use of antibiotics and immunosuppressive therapy) in patients with fistulising Crohn’s disease;
  • For patients with moderate to severe luminal Crohn’s disease who have not received trials of both glucocorticoids and immunosuppressants; and
  • For patients with ulcerative colitis who have not received prior immunosuppressant therapy.
October 24, 2018
Ustekinumab Stelara Janssen Inc.

Inflammatory bowel disease reimbursement criteria review to consider use:

  • At higher than standard doses (e.g., either increased dose or decreased dosing interval) in patients who have a partial initial response, or secondary loss of response, to standard doses;
  • As first-line therapy (i.e., no requirement for prior use of antibiotics and immunosuppressive therapy) in patients with fistulising Crohn’s disease; and
  • For patients with moderate to severe luminal Crohn’s disease who have not received trials of both glucocorticoids and immunosuppressants.
October 24, 2018
Ertugliflozin/metformin
hydrochloride
Segluromet Merck Canada Inc. Diabetes mellitus, type 2 (CDR) October 17, 2018
Nivolumab Opdivo Bristol-Myers Squibb Canada Hepatocellular carcinoma, advanced or metastatic (after intolerance to/progression on sorafenib) (pCODR) October 4, 2018
Apalutamide Erleada Janssen Inc. Prostate cancer, castrate resistant, non-metastatic (pCODR) September 19, 2018
Ertugliflozin Steglatro Merck Canada Inc. Diabetes mellitus, type 2 (CDR) September 19, 2018
Nivolumab Opdivo Bristol-Myers Squibb Canada Renal cell carcinoma, advanced or metastatic, intermediate/poor-risk (in combo with ipilimumab) (pCODR) September 19, 2018
Obinutuzumab Gazyva Hoffmann-La Roche Limited Follicular lymphoma, previously untreated, stage II bulky (>7cm), III or IV (pCODR) September 19, 2018
Rituximab Rituxan Hoffmann-La Roche Limited Myasthenia gravis, refractory to standard therapy September 19, 2018
Tapentadol Nucynta
Extended-Release
Paladin Labs Inc. Pain, severe (CDR) September 19, 2018
Trastuzumab Herceptin SC Hoffmann-La Roche Limited Breast cancer, HER2-positive, early or metastatic (request for funding new subcutaneous dosage form [intravenous formulation currently funded]) September 12, 2018
Benralizumab Fasenra AstraZeneca Canada Inc. Asthma, severe eosinophilic (CDR) August 29, 2018
Eluxadoline Viberzi Allergan Inc. Irritable bowel syndrome with diarrhea (CDR) August 29, 2018
Ixekizumab Taltz Eli Lilly Canada Inc. Arthritis, psoriatic (CDR) August 29, 2018
Lumacaftor/ivacaftor Orkambi Vertex Pharmaceuticals Canada Inc. Cystic Fibrosis, F508del CFTR mutation in patients 6 years and older (CDR) August 29, 2018
Nitisinone Orfadin Swedish Orphan Biovitrum Canada Inc. Hereditary tyrosinemia type 1 (request for funding a new oral liquid dosage form [capsules currently under consideration]) August 29, 2018
Rituximab Rituxan Hoffmann-La Roche Limited Rheumatoid arthritis (regular maintenance therapy dosing) August 29, 2018
Rituximab Rituxan Hoffmann-La Roche Limited Granulomatosis with polyangiitis or microscopic polyangiitis (regular maintenance therapy dosing) August 29, 2018

See also:

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