Canada’s Drug Agency recommends OJJAARA for public reimbursement

  • Ojjaara received a reimburse recommendation from Canada’s Drug Agency, a decisive achievement in advancing access to rare blood cancer treatments.

MISSISSAUGA, ON - Ojjaara (momelotinib) has received a reimburse with conditions recommendation from Canada’s Drug Agency (CDA-AMC). The recommendation is an important milestone towards securing public reimbursement, following Ojjaara’s approval from Health Canada in November 2024.

CDA-AMC is recommending that Ojjaara be reimbursed, with conditions, for the treatment of splenomegaly and/or disease-related symptoms, in adult patients with intermediate or high-risk primary myelofibrosis (MF), post polycythemia vera MF or post essential thrombocythemia MF who have moderate to severe anemia.

“We welcome CDA-AMC’s recommendation on Ojjaara, as it represents a fundamental step in advancing access for this treatment option, which addresses an unmet need in myelofibrosis patients, namely anemia,” said Michelle Horn, Country Medical Director, GSK Canada. “We are excited to continue working to ensure timely access to Ojjaara, and we look forward to the next step in this process as we collaborate with the pan-Canadian Pharmaceutical Alliance (pCPA) to support reimbursement across Canada.”

Anemia is one of the most common and serious complications of myelofibrosis, with approximately 40% of MF patients being anemic at the time of diagnosis and nearly all MF patients eventually developing anemia1. Ojjaara is the only approved medication option that treats the anemia and other key manifestations of MF, including splenomegaly and/or disease-related symptoms (treatment naive or previously treated with a JAK inhibitor)2.

“This is hopeful news for myelofibrosis patients. Having access to additional treatment options for this rare disease is quite significant, as it could make a difference in improving their quality of life. We applaud CDA-AMC for their diligence in making this recommendation and we are optimistic that this treatment will become available promptly through public reimbursement,” added Cheryl Petruk, CEO, Heal Canada.

About Myelofibrosis

Myelofibrosis is a condition where too many abnormal blood cells are produced in the bone marrow – the spongy insides of bone where blood cells develop, causing scar tissue to build up in the marrow, eventually leading to a decrease in normal red blood cells, white blood cells, and platelets production.3 To compensate, the spleen and liver may enlarge as these organs take on the role of making more blood cells.4 In Canada, 1,400 to 2,177 patients have been diagnosed with myelofibrosis.5 It is typically diagnosed in people between 50 and 80 years old but can occur at any age.6

 About Ojjaara

Ojjaara is the only once-a-day, oral JAK1/JAK2 and activin A receptor type 1 (ACVR1) inhibitor.7

 In Canada, Ojjaara is indicated for the treatment of splenomegaly and/or disease-related symptoms, in adult patients with intermediate or high-risk primary myelofibrosis (MF), post polycythemia vera MF or post essential thrombocythemia MF who have moderate to severe anemia.8

 GSK in Oncology

GSK is committed to maximising patient survival through transformational medicines, with a current focus on breakthroughs in immuno-oncology and tumour-cell targeting therapies, and development in hematologic malignancies, gynaecologic cancers and other solid tumours.

 About GSK

GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at gsk.ca.

References

  1. Naymagon L, Mascarenhas J. Myelofibrosis-Related Anemia: Current and Emerging Therapeutic Strategies. Hemasphere. 2017;1(1):e1-9. doi: 10.1097/HS9.0000000000000001
  2. Harrison C, et al. Presented at: European Hematology Association; June 2022. Poster EP1113.
  3. The Chronic Myelogenous Leukemia Society of Canada. Myelofibrosis – FACT Sheet. Available at: https://cmlsociety.org/myelofibrosis-fact-sheet/#_edn8 Accessed on October 1, 2024.
  4. Ibid.
  5. Heppner et al. BMC Res Notes (2019) 12:286.
  6. The Leukemia & Lymphoma Society. Idiopathic myelofibrosis. 2007. Available at http://www.lls.org/content/nationalcontent/resourcecenter/freeeducationmaterials/mpd/pdf/idiopathicmyelofibrosis.pdf
  7. Ojjaara Canadian Product Monograph
  8. Ibid.