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.
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.)
CRITERIA FOR INITIAL APPROVAL
For adults and pediatric members (birth to less than 18 years of age weighing at least 1.5 kg): 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
Hepatic function and PT have been taken prior to starting Remdesivir and will be monitored while receiving therapy as clinically appropriate.
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 refer to prescribing information for dosing and administration)
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
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
REFERENCES
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 11.0.0. Updated June 26, 2023 Available at idsa-covid-19-gl-tx-and-mgmt-v9.0.1.pdf (idsociety.org) . Accessed April 8, 2024
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; Sections: Therapeutic Management of Nonhospitalized Adults with Covid 19, Therapeutic Management of Nonhospitalized Children with Covid 19 updated February 29, 2024 Available at https://www.covid19treatmentguidelines.nih.gov/. Accessed April 8, 2024.
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. (2024, April). AHFS DI. Remdesivir. Retrieved April 2024 from Lexicomp Online with AHFS.
5. MICROMEDEX Healthcare Series. Drugdex Evaluations. (2024, March). Remdesivir. Retrieved April 2024
6. U. S. Food and Drug Administration. (2024, February). Center for Drug Evaluation and Research. Product Information. VEKLURY® (remdesivir) for injection, for intravenous use. Retrieved March 2024 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: 1/18/2022
MOST RECENT REVIEW DATE: 8/30/2024
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.
This document has been classified as public information