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Remdesivir (e.g., Veklury) | |
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Description: |
Remdesivir is an inhibitor of the SARS-CoV-2 RNA-dependent RNA polymerase (RdRp), which is essential for viral replication. Remdesivir is an adenosine nucleotide prodrug that is metabolized to the pharmacologically active nucleoside triphosphate metabolite after being distributed into cells. Remdesivir triphosphate (GS-443902) acts as an adenosine triphosphate analog and competes for incorporation into RNA chains by the SARS-CoV-2 RdRp, resulting in delayed chain termination during viral RNA replication. Remdesivir triphosphate can also inhibit viral RNA synthesis due to incorporation into the viral RNA template.
Regulatory
On January 21, 2022, the Food and Drug Administration expanded the approved Remdesivir (Veklury) to include its use in adults and pediatric individuals (12 years of age and older who weigh at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are not hospitalized and have mild-to-moderate COVID-19 and are at high risk for progression to severe COVID-19, including hospitalization or death.
On April 25, 2022, the FDA expanded the approval of remdesivir (e.g., Veklury) to include children 28 days of age and older weighing at least 3 kg with positive results of direct SARS-Co-2 viral testing who are:
This FDA approval is based on the results from the CARAVAN (NCT04431453) phase 2/3 single arm, open-label study which demonstrated that Veklury was generally well-tolerated among pediatric individuals hospitalized with COVID-19.
On February 28, 2024, the Food and Drug Administration expanded the approval of Remdesivir (e.g., Veklury) to include pediatric individuals from birth to less than 28 days of age weighing at least 1.5 kg to less than 3 kg.
Coding
See CPT/HCPCS Code section below.
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Policy/ Coverage: |
Effective May 15, 2024
The use of remdesivir (J0248) is covered when administered for the treatment of COVID-19 when ALL the following specific criteria are met:
*Mild symptoms of COVID-19 (NIH, 2021):Fever
**Moderate symptoms of COVID-19 (NIH, 2021):
***At risk for progression to severe COVID-19 (CDC, 2020):
Please refer to a separate policy on Site of Care or Site of Service Review policy #2018030 for pharmacologic/biologic medications.
Dosage and Administration
Dosing per FDA Guidelines
Adults and pediatric individuals weighing at least 40 kg:
Pediatric individuals (birth to less than 18 years of age) weighing 1.5 kg to less than 40 kg:
Dosage based on weight:
Remdesivir is available as 100 mg lyophilized powder in a single dose vial.
Effective May 4, 2022 to May 14, 2024
The use of remdesivir (J0248) is covered when administered for the treatment of COVID-19 when ALL the following specific criteria are met:
*Mild symptoms of COVID-19 (NIH, 2021):
**Moderate symptoms of COVID-19 (NIH, 2021):
***At risk for progression to severe COVID-19 (CDC, 2020):
Please refer to a separate policy on Site of Care or Site of Service Review policy #2018030 for pharmacologic/biologic medications.
Dosage and Administration
Dosing per FDA Guidelines
Adults and pediatric individuals 12 years of age and older and weighing at least 40 kg:
Pediatric individuals 28 days of age and older and weighing 3 kg to less than 40 kg:
Remdesivir is available as 100 mg lyophilized powder in a single dose vial.
Effective February 2, 2022 to May 3, 2022
The use of remdesivir (J0248) is covered when administered for the treatment of COVID-19 when ALL the following specific criteria are met:
Please refer to a separate policy on Site of Care or Site of Service Review policy #2018030 for pharmacologic/biologic medications.
*Mild symptoms of COVID-19 (NIH, 2021):
**Moderate symptoms of COVID-19 (NIH, 2021):
***At risk for progression to severe COVID-19 (CDC, 2020):
Dosage and Administration
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Rationale: |
A randomized, double-blind, placebo-controlled trial involving nonhospitalized patients with Covid-19 who had symptom onset within the previous 7 days and who had at least one risk factor for disease progression (age ≥60 years, obesity, or certain coexisting medical conditions) was conducted. Patients were randomly assigned to receive intravenous remdesivir (200 mg on day 1 and 100 mg on days 2 and 3) or placebo. The primary efficacy end point was a composite of Covid-19-related hospitalization or death from any cause by day 28. The primary safety end point was any adverse event. A secondary end point was a composite of a Covid-19-related medically attended visit or death from any cause by day 28.
A total of 562 patients who underwent randomization and received at least one dose of remdesivir or placebo were included in the analyses: 279 patients in the remdesivir group and 283 in the placebo group. The mean age was 50 years, 47.9% of the patients were women, and 41.8% were Hispanic or Latinx. The most common coexisting conditions were diabetes mellitus (61.6%), obesity (55.2%), and hypertension (47.7%). Covid-19-related hospitalization or death from any cause occurred in 2 patients (0.7%) in the remdesivir group and in 15 (5.3%) in the placebo group (hazard ratio, 0.13; 95% confidence interval [CI], 0.03 to 0.59; P = 0.008). A total of 4 of 246 patients (1.6%) in the remdesivir group and 21 of 252 (8.3%) in the placebo group had a Covid-19-related medically attended visit by day 28 (hazard ratio, 0.19; 95% CI, 0.07 to 0.56). No patients had died by day 28. Adverse events occurred in 42.3% of the patients in the remdesivir group and in 46.3% of those in the placebo group.
Among nonhospitalized patients who were at high risk for Covid-19 progression, a 3-day course of remdesivir had an acceptable safety profile and resulted in an 87% lower risk of hospitalization or death than placebo. (NCT04501952).
May 2022 Update
The primary objectives of the Phase 2/3 single-arm, open-label clinical study (Study GS-US-540-5823) were to evaluate pharmacokinetics and safety of up to 10 days of treatment with VEKLURY in pediatric subjects. A total of 53 pediatric subjects at least 28 days of age and weighing at least 3 kg with confirmed SARS-CoV-2 infection and mild, moderate, or severe COVID-19 was evaluated in five cohorts: subjects ≥12 years and weighing ≥40 kg (n=12); subjects <12 years and weighing ≥40 kg (n=5); subjects ≥28 days and weighing ≥20 to <40 kg (n=12); subjects ≥28 days and weighing ≥12 to
<20 kg (n=12); and subjects ≥28 days and weighing ≥3 to <12 kg (n=12). Subjects weighing ≥40 kg received 200 mg of VEKLURY on Day 1 followed by VEKLURY 100 mg once daily on subsequent days: subjects weighing ≥3 kg to <40 kg received VEKLURY 5 mg/kg on Day 1 followed by VEKLURY 2.5 mg/kg once daily on subsequent days. Assessments occurred at the following intervals: Screening; Day 1 (Baseline); Days 2-10, or until discharge, whichever came earlier; Follow-Up on Day 30 (±5). Treatment with VEKLURY was stopped in subjects who were discharged from the hospital prior to the completion of 10 days of treatment.
At baseline, median age was 7 years (Q1, Q3: 2 years, 12 years); 57% were female, 70% were White, 30% were Black, and 44% were Hispanic or Latino; median weight was 25 kg (range: 4 to 192 kg). Subjects in this trial were unvaccinated. A total of 12 subjects (23%) were on invasive mechanical ventilation, 18 (34%) were on non-invasive ventilation or high-flow oxygen; 10 (19%) were on low-flow oxygen; and 13 (25%) were on room air, at baseline. The overall median (Q1, Q3)
duration of symptoms and hospitalization prior to first dose of VEKLURY was 5 (3, 7) days and 1 (1, 3) day, respectively.
The descriptive outcome analyses showed treatment with VEKLURY for up to 10 days resulted in an overall median (Q1, Q3) change from baseline in clinical status (assessed on a 7-point ordinal scale ranging from death [score of 1] to ventilatory support and decreasing levels of oxygen to hospital discharge [score of 7]) of +2.0 (1.0, 4.0) points on Day 10.
Recovery (defined as an improvement from a baseline clinical status score of 2 through 5 to a score of 6 or 7, or an improvement from a baseline score of 6 to a score of 7) was reported for 62% of subjects on Day 10; median (Q1, Q3) time to recovery was 7 (5, 16) days.
Overall, 60% of subjects were discharged by Day 10, and 83% of subjects were discharged by Day 30. Three subjects (6%) died during the study. (FDA, 2022)
2023 Update
Annual policy review completed with a literature search using the MEDLINE database through May 2023. No new literature was identified that would prompt a change in the coverage statement.
2024 Update
The primary objectives of the Phase 2/3 single-arm, open-label clinical trial (Study GS-US-540-5823) were to evaluate pharmacokinetics and safety of up to 10 days of treatment with VEKLURY in pediatric subjects. A total of 58 pediatric subjects from birth (including preterm to term infants) to <18 years of age and weighing at least 1.5 kg with confirmed SARS-CoV-2 infection and mild, moderate, or severe COVID-19 was evaluated in eight cohorts:
Assessments occurred at the following intervals: Screening; Day 1 (Baseline); Days 2-10, or until discharge, whichever came earlier; Follow-Up on Day 30 (±5). Treatment with VEKLURY was stopped in subjects who were discharged from the hospital prior to the completion of 10 days of treatment.
Infants, children, and adolescents: At baseline, median age was 7 years (Q1, Q3: 2 years, 12 years); 57% were female, 70% were White, 30% were Black, and 44% were Hispanic or Latino; median weight was 25 kg (range: 4 to 192 kg). Subjects in this trial were unvaccinated. A total of 12 subjects (23%) were on invasive mechanical ventilation, 18 (34%) were on non-invasive ventilation or high flow oxygen; 10 (19%) were on low-flow oxygen; and 13 (25%) were on room air, at baseline. The overall median (Q1, Q3) duration of symptoms and hospitalization prior to first dose of VEKLURY was 5 (3, 7) days and 1 (1, 3) day, respectively.
The descriptive outcome analyses showed treatment with VEKLURY for up to 10 days resulted in an overall median (Q1, Q3) change from baseline in clinical status (assessed on a 7-point ordinal scale ranging from death [score of 1] to ventilatory support and decreasing levels of oxygen to hospital discharge [score of 7]) of +2.0 (1.0, 4.0) points on Day 10.
Recovery (defined as an improvement from a baseline clinical status score of 2 through 5 to a score of 6 or 7, or an improvement from a baseline score of 6 to a score of 7) was reported for 62% of subjects on Day 10; median (Q1, Q3) time to recovery was 7 (5, 16) days.
Overall, 60% of subjects were discharged by Day 10, and 83% of subjects were discharged by Day 30. Three subjects (6%) from Cohorts 1-4 and Cohort 8 died during the study.
Neonates and infants: At baseline, subjects ranged in age from 12 to 30 days; 3/5 were female, 4/5 were White, 1/5 was Black; weight ranged from 2.2 to 3.5 kg. Three subjects were on invasive mechanical ventilation and 2 were on high-flow oxygen. The duration of symptoms and hospitalization prior to first dose of VEKLURY ranged from 2 to 9 days and 1 to 9 days, respectively.
The descriptive outcome analyses showed treatment with VEKLURY for up to 10 days resulted in recovery (defined as an improvement from a baseline clinical status score of 2 through 5 to a score of 6 or 7, or an improvement from a baseline score of 6 to a score of 7) for 3 subjects, including for one subject by Day 10. Time to recovery ranged from 9 to 19 days.
Overall, a total of 3 subjects were discharged by Day 30, of which one subject was discharged by Day 10. No subjects from Cohorts 5-7 died during the study.(Velkury, 2024)
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CPT/HCPCS: | |
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References: |
Centers for Disease Control and Prevention.(2020) COVID-19 (coronavirus disease): people with certain medical conditions. Available at: https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-with-medical-conditions.html. Accessed January 28, 2022. Gottlieb RL, Vaca CE, Paredes R, et al; GS-US-540-9012 (PINETREE) Investigators.(2021) Early remdesivir to prevent progression to severe Covid-19 in outpatients. N Engl J Med. Published online December 22, 2021. doi:10.1056/NEJMoa2116846 National Institutes of Health (NIH).(2021) Clinical Spectrum of SARS-CoV-2 Infection. www.covid19treatmetnguidelines.nih.gov. accessed on January 28, 2022. National Institutes of Health (NIH).(2021) COVID-19 Treatment Guidelines Panel. Coronavirus disease 2019 (COVID-19) treatment guidelines. https://www.covid19treatmentguidelines.nih.gov/. Updated December 23, 2021. Accessed December 27, 2021. U.S. Food and Drug Administration (FDA).(2021) Veklury (remdesivir) for injection. Prescribing Information. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/214787Orig1s010Lbl.pdf. Last accessed January 26, 2022. U.S. Food and Drug Administration (FDA).(2021) Veklury (remdesivir) for injection. Prescribing Information. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/214787s011lbl.pdf. Last accessed 4/28/2022. |
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Group specific policy will supersede this policy when applicable. This policy does not apply to the Wal-Mart Associates Group Health Plan participants or to the Tyson Group Health Plan participants.
CPT Codes Copyright © 2025 American Medical Association. |