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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
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
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.
August 29, 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
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.
August 29, 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.
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
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.
August 29, 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.
August 29, 2018
Nitisinone Nitisinone Tablets Cycle Pharmaceuticals Ltd. Hereditary tyrosinemia type 1 (CDR) August 15, 2018
Ozenoxacin Ozanex Ferrer Internacional, S.A. Impetigo (CDR) August 7, 2018
Olaratumab Lartruvo Eli Lilly Canada Inc. Advanced soft tissue sarcoma not amenable to curative treatment with radiotherapy or surgery (pCODR) July 31, 2018
AbobotulinumtoxinA Dysport
Therapeutic
Ipsen Biopharmaceuticals
Canada Inc.
Lower limb spasticity (CDR) July 25, 2018
Alectinib Alecensaro Hoffmann-La Roche Limited Non-small cell lung cancer, ALK-positive, locally advanced or metastatic (first-line) (pCODR) July 25, 2018
Dolutegravir/rilpivirine Juluca ViiV Healthcare ULC HIV-1 infection (CDR) July 25, 2018
Fluticasone furoate/
umeclidinium/vilanterol
Trelegy Ellipta GlaxoSmithKline Inc. Chronic obstructive pulmonary disease (COPD) (CDR) July 25, 2018

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