Inqovi® – A New Oral Treatment Option for Myelodysplastic Syndromes

Drug Review: Volume 22, Issue 3

Myelodysplastic syndromes (MDS) are a group of bone marrow disorders characterized by ineffective blood cell production which can lead to many blood-related complications. Approximately one-third of MDS patients progress to acute myeloid leukemia (AML), which is a type of cancer. Patients with low-risk MDS (LR-MDS) are asymptomatic and have near-normal life expectancy. In comparison, high-risk MDS (HR-MDS) patients are more likely to experience complications such as infections, fatigue, excessive bruising, and progression to AML. In 2016, it was estimated that MDS affected 10,000 to 40,000 Canadians aged 65 and older.


The current treatment options for MDS are based on a patient’s risk category. LR-MDS patients are managed with supportive care which treat the current complications that the patients present with. However, patients with intermediate-1 MDS (INT-1) often fail supportive care and are recommended to be treated with a hypomethylating agent (HMA). Currently there are two marketed HMAs, Inqovi® and Vidaza®; however, Vidaza® is not approved for use in INT-1 patients but only for HR-MDS patients. For HR-MDS patients, hematopoietic stem cell transplantation (HSCT) and HMA therapy are used. Although HSCT is the only curative option, most HR-MDS patients are not eligible due to advanced age, comorbidities, or a lack of a viable donor, and thus HMAs are used instead.


Prior to the approval of Inqovi®, Vidaza® was the only available option. Vidaza® is given as a subcutaneous injection that requires patients to visit a hospital for seven consecutive days during each 28-day cycle. Therefore, there remains an unmet need for another HMA for MDS patients that is more convenient to use and can also be used in INT-1 patients.


Inqovi® is the second HMA approved for use in HR-MDS patients and the only HMA approved for use in INT-1 patients. Unlike Vidaza®, Inqovi® is conveniently dosed orally. The most common side effects include decreased levels of white and red blood cells, which can cause fatigue.


Inqovi® is an effective and non-invasive, oral treatment option that provides improvements in the quality of life for MDS patients. The annual cost of Inqovi® is $76,180. Inqovi® addresses an unmet need and offers clinical benefits in an oral formulation. Therefore, Inqovi® will be placed under Special Authorization for ClaimSecure groups subscribing to Managed formularies.

Drug Name Inqovi®
Drug Ingredients
Decitabine and cedazuridine
Annual Cost
$76,180
Coverage Details
Special Authorization for Managed and Open Formularies

ClaimSecure Inc. reserves the right to amend in part, or in its entirety, its Special Authorization guidelines.

References:

  1. Inqovi® Product Monograph. Taiho Pharma Canada Inc. 2020
  2. Savona M, McCloskey J, Griffiths EA, et al. Clinical Efficacy and Safety of Oral Decitabine/Cedazuridine in 133 Patients with Myelodysplastic Syndromes (MDS) and Chronic Myelomonocytic Leukemia (CMML) [Abstract]. Blood. 2020;136(Supplement 1):37-38.

 

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