BlueCross BlueShield of Tennessee Medical Policy Manual

Remdesivir (Veklury®) as an Outpatient Treatment of COVID-19 (Intravenous)

IMPORTANT REMINDER

We develop Medical Policies to provide guidance to Members and Providers.  This Medical Policy relates only to the services or supplies described in it.  The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy.  For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed.  If there is a conflict between the Medical Policy and a health plan or government program (e.g., TennCare), the express terms of the health plan or government program will govern.

DESCRIPTION

Remdesivir (Veklury®) is a SARS-CoV-2 nucleotide analog RNA polymerase inhibitor for the treatment of coronavirus disease 2019 (Covid-19).  Covid-19 is the illness caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and was first identified in December 2019 and progressed to a global pandemic.

Older persons and those with pre-existing conditions such as obesity, diabetes mellitus, hypertension, immune compromise, etc. are at increased risk of hospitalization or death from Covid-19.

Prior to mid-December 2021, the anti-SARS-CoV-2 monoclonal antibodies (mAbs) bamlanivimab plus etesevimab, casirivimab plus imdevimab, and sotrovimab were the only therapies recommended by the National Institute of Health (NIH) COVID-19 Treatment Guidelines Panel (the Panel) for non-hospitalized patients with mild to moderate COVID-19 who are at high risk of progressing to severe disease. Currently Omicron has become the dominant variant in many parts of the United States. This variant is predicted to have markedly reduced susceptibility to bamlanivimab plus etesevimab and casirivimab plus imdevimab. Amidst the Omicron surge and its transmissibility, the need for early COVID-19 treatments has increased. Because sotrovimab is the only available anti-SARS-CoV-2 mAb that is anticipated to have activity against the Omicron VOC, the National Institute of Health (NIH) Panel and U.S. Food and Drug administration (FDA) recently added remdesivir as another treatment option for this group of patients.

In December 2021, the NIH issued an updated guidance for Remdesivir (Veklury®) among outpatients at increased risk of hospitalization for severe Covid 19. The panel added a 3-day course of intravenous (IV) Remdesivir as one of the treatment options for High-Risk, Non-hospitalized Patients With Mild to Moderate COVID-19. Also, in December The Infectious Disease Society of America (IDSA) issued a special update alert on December 24, 2021 updating the Guidelines on TX and Management of COVID-19 which include guidance for ambulatory patients with mild to moderate COVID-19 at high risk for progression to severe disease which include the updated guidance on the use of treatment options including Remdesivir.     

Remdesivir was originally approved in October, 2020, by the U.S. Food and Drug Administration (FDA), to treat adult and pediatric patients 12 years of age and older and weighing at least 40 kilograms for the treatment of COVID-19 requiring hospitalization. In January of 2022 the FDA expanded the approval uses for Remdesivir expanding the use for treatment to include non-hospitalized patients with mild- to moderate covid that are at high risk for progression to severe COVID-19, including hospitalization or death. On April 25, 2022, the FDA approved Remdesivir (Veklury®) for the treatment of adult & pediatric patients who are older than 28 days, weighing at least 3 kilograms (kg), and are either hospitalized with COVID-19 or have mild-to-moderate COVID-19 and are considered high risk for progression to severe COVID-19, including hospitalization or death. This approval removed the need for a previously issued Emergency Use Authorization granted by the FDA (see Additional information for archived EUA information).

Note: This policy addresses the use of Remdesivir (Veklury®) in the outpatient setting.

POLICY

·         Remdesivir (Veklury®) for the treatment of high-risk, non-hospitalized patients with mild to moderate coronavirus disease 2019 (COVID-19) is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)

MEDICAL APPROPRIATENESS

INITIAL APPROVAL CRITERIA

·         Patient is 28 days of age and older and weighing at least 3 kilograms; AND

·         Mild to moderate COVID-19 who are at high risk of progression* to severe disease; AND

·         Positive results of direct severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) confirmed by molecular test (e.g., PCR, NAAT, etc.); AND

·         The treatment course of remdesivir should be initiated as soon as possible after diagnosis of symptomatic COVID-19 has been made and within 7 days of symptom onset: AND

·         Patient has GFR greater than or equal to 30mL/min; AND

·         Renal function, hepatic function and PT have been taken prior to starting Remdesivir and will be monitored while receiving therapy as clinically appropriate.   

* high risk of progression (e.g., obesity, diabetes mellitus, hypertension, immune compromise, chronic lung disease etc.) or age 60 years or older

RENEWAL CRITERIA

Coverage cannot be renewed.

DOSAGE/ADMINISTRATION   

·         Remdesivir may only be administered in a healthcare or hospital setting where severe hypersensitivity reactions, such as anaphylaxis, can be managed at a similar level of care as an inpatient setting. Patients should be monitored during the infusion and observed for at least 1 hour after infusion.

·         The recommended total treatment duration for non-hospitalized patients diagnosed with mild-to moderate COVID-19 who are at high risk for progression to severe COVID-19, including hospitalization or death, is 3 days.

LENGTH OF AUTHORIZATION

Coverage will be provided for 3 infusions and may not be renewed.

APPLICABLE TENNESSEE STATE MANDATE REQUIREMENTS

BlueCross BlueShield of Tennessee’s Medical Policy complies with Tennessee Code Annotated Section 56-7-2352 regarding coverage of off-label indications of Food and Drug Administration (FDA) approved drugs when the off-label use is recognized in one of the statutorily recognized standard reference compendia or in the published peer-reviewed medical literature.

ADDITIONAL INFORMATION  

On January 21, 2022  the FDA took two actions to expand the use of the antiviral drug Remdesivir (Veklury®) to certain non-hospitalized adults and pediatric patients for the treatment of mild-to-moderate COVID-19 disease. In addition to expanding the approved indication the agency also revised the Emergency Use Authorization (EUA) for Remdesivir (Veklury®).  As of April 25, 2022, Veklury (Remdesivir) is approved for the treatment of COVID-19 in adults and pediatric patients (28 days of age and older and weighing at least 3 kilograms) with positive results of direct SARS-CoV-2 viral testing, who are:

·         hospitalized, or

·         not hospitalized and have mild-to-moderate COVID-19 and are at high risk for progression to severe COVID-19, including hospitalization or death.

For additional information, also see:

FDA’s approval of Veklury (remdesivir) for the treatment of COVID-19—The Science of Safety and Effectiveness https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization-archived-information#:~:text=hospitalization%20or%20death.-,For%20additional%20information%2C%20also%20see%3A%20FDA%E2%80%99s%20approval%20of%20Veklury%20(remdesivir)%20for%20the%20treatment%20of%20COVID%2D19%E2%80%94The%20Science%20of%20Safety%20and%20Effectiveness,-Federal%20Register%20notices

EUA –Archived Information https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization-archived-information#:~:text=Authorization%2D%2DArchived%20Information-,Emergency%20Use%20Authorization%2D%2DArchived%20Information,-Share

SOURCES  

1.     Bhimraj A, Morgan RL, Shumaker AH, Lavergne V, Baden L, Cheng VC, Edwards KM, Gandhi R, Gallagher J, Muller WJ, O'Horo JC, Shoham S, Murad MH, Mustafa RA, Sultan S, Falck-Ytter Y. Infectious Diseases Society of America Guidelines on the Treatment and Management of Patients with COVID-19. Infectious Diseases Society of America 2021; Version 9.0.1. Updated June 29, 2022 Available at idsa-covid-19-gl-tx-and-mgmt-v9.0.1.pdf (idsociety.org)  . Accessed June 30, 2022

2.     COVID-19 Treatment Guidelines Panel. Coronavirus Disease 2019 (COVID-19) Treatment Guidelines. National Institutes of Health. The COVID-19 Treatment Guidelines Panel’s Statement on Therapies for High-Risk, Non-hospitalized Patients With Mild to Moderate COVID-19  Available at https://www.covid19treatmentguidelines.nih.gov/. Accessed January 6, 2022.

3.     Gottlieb RL, Vaca CE, Paredes R, et al. Early Remdesivir to Prevent Progression to Severe Covid-19 in Outpatients. N Engl J Med 2021: Available at: https://doi.org/10.1056/nejmoa2116846

4.     Lexicomp Online. (2022, March). AHFS DI. Remdesivir. Retrieved May 2022 from Lexicomp Online with AHFS.

5.     MICROMEDEX Healthcare Series. Drugdex Evaluations. (2022, July). Remdesivir. Retrieved June 2022

6.     U. S. Food and Drug Administration. (2022, June). Center for Drug Evaluation and Research. Product Information. VEKLURY® (remdesivir) for injection, for intravenous use. Retrieved July 2022 from https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/214787Orig1s000lbl.pdf

7.     https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-with-medicalconditions.html. Healthcare providers should consider the benefit-risk for an individual patient.

8.     U.S. Food and Drug Administrations (FDA). Press Announcements. https://www.fda.gov/news-events/press-announcements/fda-takes-actions-expand-use-treatment-outpatients-mild-moderate-covid-19. Retrieved January 25, 2022

9.     U.S. Food and Drug Administrations (FDA) - EUA –Archived Information https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization-archived-information#:~:text=Authorization%2D%2DArchived%20Information-,Emergency%20Use%20Authorization%2D%2DArchived%20Information,-Share  Retrieved January 25, 2022

ORIGINAL EFFECTIVE DATE: 11/18/2022

MOST RECENT REVIEW DATE: 11/30/2022

ID_BT

Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.

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