Veklury

For treatment of coronavirus disease 2019 (COVID-19) in non-hospitalized individuals who:

• have a diagnosis of COVID-19 based on a positive Rapid Antigen Test or PCR test; AND
• are at high-risk for progression to severe COVID-19 due to:
  • being moderately or severely immunocompromised (see below), or
  • being 65 years of age or older, or
  • having one or more risk factors (see below); AND
• will not be using remdesivir in combination with any other antiviral medication for COVID-19 (e.g. Paxlovid).

Remdesivir is an alternative option for patients who cannot receive nirmatrelvir-ritonavir (Paxlovid) due to contraindications, intolerance, potential drug-drug interactions, and/or greater than 5 days since symptom onset.
Remdesivir should be initiated as soon as possible after a diagnosis of COVID-19 based on a positive Rapid Antigen Test or PCR test, and within 7 days of symptom onset.

The funded treatment duration is up to 3 days, unless the prescriber has prescribed treatment for up to 5 days in consultation with an infectious disease specialist and this is documented by the pharmacy, in which case the funded treatment duration is up to 5 days.

Pharmacists and prescribers should be informed of and stay current with a drug product's official indications in accordance with Health Canada's approved product monograph. Some aspects of the above criteria may differ from the official indications as described in the product monograph for remdesivir. The Executive Officer's funding of drug products is informed by advice from expert committees that consider evidence regarding the safety, clinical efficacy, and cost-effectiveness of drug products.

Examples of moderately or severely immunocompromised individuals include those with:

• Advanced untreated human immunodeficiency virus (HIV) or treated HIV with a CD4 count equal or less than 200 per mm3 or CD4 fraction equal or less than 15%
• Bone marrow or stem cell transplant
• Solid organ transplant
• Active hematological malignancy or recently received treatment for hematological malignancy E.g., have received treatment with any anti-CD20 agents or B-cell depleting agents in the last 2 years
• Chimeric antigen receptor (CAR) T-cell therapy in the last 6 months
• Treatment for cancer (including solid tumors), limited to: systemic therapy in the last 6 months (e.g., chemotherapy, molecular therapy, immunotherapy, targeted therapies, monoclonal antibodies, excluding those receiving adjunctive hormonal therapy only) or radiation therapy in the last 3 months
• Prednisone use equal to or greater than 20mg/day (or corticosteroid equivalent) for 14 days or more, or other moderately or severely immunosuppressive therapies (e.g., alkylating agents)
• Primary immunodeficiencies. For example:
  • Hypogammaglobulinemia
  • Combined immune deficiencies affecting T-cells
  • Immune dysregulation (e.g., familial hemophagocytic lymphohistiocytosis)
  • Type 1 interferon defects caused by a genetic primary immunodeficiency disorder or secondary to anti-interferon autoantibodies
  • Diagnosed by an immunologist and requires ongoing immunoglobulin replacement therapy (IVIg or SCIg)
  • Primary immunodeficiency with a confirmed genetic cause (e.g., DiGeorge syndrome, Wiskott-Aldrich syndrome)

The risk of progression to severe COVID-19 depends on the quantity of underlying chronic comorbidities and how controlled the conditions are. When assessing risk factors, prescribers may want to consult the most recent Ontario Health COVID-19 clinical guidance. Examples of risk factors include:

• Has never received a COVID-19 vaccine
• Active tuberculosis (treated or untreated)
• Cerebrovascular disease
• Chronic kidney disease (CKD), especially CKD stage 4 or 5 and dialysis
• Chronic lung diseases (asthma, bronchiectasis, chronic obstructive pulmonary disease, interstitial lung disease, pulmonary embolism, pulmonary hypertension)
• Chronic liver diseases (cirrhosis, non-alcoholic fatty liver disease, alcoholic liver disease, autoimmune hepatitis)
• Cystic fibrosis
• Diabetes mellitus type 1 or type 2
• Disabilities and developmental delay, including Down syndrome
• Heart conditions, e.g., heart failure, coronary artery disease, cardiomyopathies)
• Mental health conditions, e.g., mood disorders (including depression), schizophrenia spectrum disorders
• Neurologic conditions that cause an inability to control respiratory secretions or communicate disease progression (e.g., cognitive disorders such as Alzheimer-type dementia)
• Obesity (body mass index above 30kg per metre squared)
• Pregnancy or recent pregnancy (42 days post-partum/end of pregnancy)

LU Authorization Period: Length of funded treatment duration (see above)