| Coverage Policy Manual | |
| Policy #: | 2020029 |
| Category: | Pharmacy |
| Initiated: | December 2020 |
| Last Review: | September 2023 |
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| Covid-19 Monoclonal Antibody Therapy | |
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| Description: |
Bamlanivimab (LY-CoV555) is a neutralizing IgG1 monoclonal antibody that binds to the receptor binding domain of the spike protein of SARS-CoV-2. Bamlanivimab blocks spike protein attachment to the human ACE2 receptor. It is designed to block viral attachment and entry into human cells, potentially neutralizing the virus. Bamlanivimab is an investigational drug and not currently FDA approved for any indication.
Casirivimab and imdevimab are human IgG1 monoclonal antibodies that bind to non-overlapping epitopes of the spike protein receptor binding domain of SARS-CoV-2. The two-drug combination block viral binding to the human ACE2 receptor. Casirivimab and imdevimab are investigational drugs and not currently FDA approved for any indication.
Bamlanivimab and etesevimab are neutralizing IgGI monoclonal antibodies that binds to distinct but overlapping epitopes within the receptor binding domain of the spike protein of SARS-CoV-2. The two-drug combination block viral binding to the human ACE2 receptor. Bamlanivimab and etesevimab are investigational drugs and not currently FDA approved for any indication.
Sotrovimab is a human neutralizing monocloncal antibody with activity against severe acute respiratory syndrome coronavirus 2, known as SARS-CoV-2. It is designed to attach to the spike protein of SARS-CoC-2. Sotrovimab is an investigational drug and not currently FDA approved for any indication.
Tixagevimab and cilgavimab are human monoclonal antibodies targeted against the surface spike protein of SARS-CoV-2 used to prevent COVID-19. It is co-packaged and given as two separate consecutive intramuscular injections (one injection per monoclonal antibody, given in immediate succession). Tixagevimab and cilgavimab are investigational drugs and not currently FDA approved for any indication.
Bebtelovimab is a neutralizing IgG1 monoclonal antibody that binds to an epitope within the receptor binding domain of the spike protein of SARS-CoV-2. Bebtelovimab is not FDA approved for any uses, including use as treatment for COVID-19.
Regulatory Status
The U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) on November 9, 2020 to permit the emergency use of the unapproved product bamlanivimab for the treatment of mild to moderate coronavirus disease 2019 (COVID-19) in adults and pediatric individuals with positive results of direct SARS-CoV-2 viral testing who are 12 years of age and older weighing at least 40 kg, and who are at high risk for progressing to severe COVID-19 and/or hospitalization. This EUA does not constitute FDA approval of bamlanivimab and the NIH has declined to endorse the use of bamlanivimab (see rationale below).
On April 16, 2021, the U.S. FDA revoked the EUA for bamlanivimab when given as a monotherapy for the treatment of mild to moderate COVID-19 in adults and pediatric individuals. Based on its ongoing analysis of scientific data, specifically that pertaining to the sustained increase of SARS-CoV-2 viral variants that are resistant to bamlanivimab alone resulting in the increased risk for treatment failure, it has been determined that the potential benefits of bamlanivimab when administered alone, no longer outweigh the known and potential risks for its authorized use. Therefore, it was determined that the criteria for issuance of an authorization are no longer met and the EUA has been revoked.
The U.S. FDA issued an EUA on November 21, 2020 to permit the emergency use of the unapproved products casirivimab and imdevimab for the treatment of mild to moderate COVID-19 in adults and pediatric individuals with positive results of direct SARS-CoV-2 viral testing who are 12 years of age and older weighing at least 40kg and who are at high risk for progressing to severe COVID-19 and/or hospitalization. This EUA does not constitute FDA approval of casirivimab and imdevimab.
The U.S. FDA issued an EUA on February 25, to permit the emergency use of the unapproved products bamlanivimab and etesevimab administered together for the treatment of mild to moderate coronavirus disease 2019 (COVID-19) in adults and pediatric individuals (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV2 viral testing, and who are at high risk for progressing to severe COVID-19 and/or hospitalization. This EUA does not constitute FDA approval of bamlanivimab and etesevimab.
As of March 24, 2021, the U.S. Department of Health & Human Services on the Public Health Emergency page for Bamlanivimab has posted a notice, “Update on COVID-19 variants and impact on bamlanivimab distribution,” it stated the following “Given the sustained increase in SARS-CoV-2 viral variants in the United States that are resistant to bamlanivimab administered alone, and the availability of other authorized monoclonal antibody therapies that are expected to retain activity to these variants, the U.S. Government, in coordination with Eli Lilly and Company, will stop the distribution of bamlanivimab alone starting today, March 24, 2021.”
The U.S. FDA issued an EUA on May 26, 2021 for the investigational monoclonal antibody therapy sotrovimab (VIR-7831) for the treatment of mild-to-moderate COVID-19 in adult and pediatric individuals (12 years of age and older weighing at least 40 kilograms [about 88 pounds]) with positive results of direct SARS-CoV-2 viral testing and who are at high risk for progression to severe COVID-19, including hospitalization or death. This includes, for example, individuals who are 65 years of age and older or individuals who have certain medical conditions. The safety and effectiveness of this investigational therapy continues to be evaluated for treatment of COVID-19. This EUA does not constitute FDA approval of sotrovimab.
On June 3, 2021, the FDA issued updates to the EUA for casirivimab and imdevimab. These recent updates include the following modifications: A change in the authorized dosage and the addition of subcutaneous route of administration as an alternative route when intravenous infusion is not feasible and would lead to delay in treatment.
On June 25, 2021, the Assistant Secretary for Preparedness and Response (ASPR) and FDA paused all distribution of bamlanivimab and etesevimab. In addition, FDA recommends that health care providers nationwide use alternative authorized monoclonal antibody therapies and not use bamlanivimab and etesevimab administered together at this time.
On July 30, 2021 the FDA reissued the June 3, 2021 letter in it’s entirety, to also authorize casirivimab and imdevimab, administered together for emergency use as post-exposure prophylaxis in certain adults and pediatric individuals.
On August 27, 2021, the FDA reissued the February 25, 2021 letter in it’s entirety, authorizing revisions to the authorized use for bamlanivimab and etesevimab administered together4 clarifying the meaning of “severe COVID-19” and to further limit the use of bamlanivimab and etesevimab authorizing bamlanivimab and etesevimab administered together only in those states, territories, and US jurisdictions in which the combined frequency of variants resistant to bamlanivimab and etesevimab administered together is less than or equal to 5%.
On December 3, 2021, the FDA revised the emergency use authorization (EUA) of bamlanivimab and etesevimab (previously authorize for pediatric individuals 12 years of age and older weighing at least 40 kilograms, or about 88 pounds), to additionally authorize bamlanivimab and etesivimab administered together for the treatment of mild to moderate COVID-19 in all younger pediatric individuals, including newborns, who have a positive COVID-19 test and are at high risk for progression to severe COVID-19, including hospitalization or death. This revision also authorizes bamlanivimab and etesevimab, to be administered together, for post-exposure prophylaxis for prevention of COVID-19 in all pediatric individuals, including newborns, at high risk of progression to severe COVID-19, including hospitalization or death.
On December 8, 2021, the FDA issued an EUA for AstraZeneca’s Evusheld (tixagevimab co-packaged with cilgavimab and administered together) for the pre-exposure prophylaxis (prevention) of COVID-19 in certain adults and pediatric individuals (12 years of age and older weighing at least 40 kilograms [about 88 pounds]).
The product is only authorized for those individuals who are not currently infected with the SARS-CoV-2 virus and who have not recently been exposed to an individual infected with SARS-CoV-2. The authorization also requires that individuals either have:
One dose of Evusheld, administered as two separate consecutive intramuscular injections (one injection per monoclonal antibody, given in immediate succession), may be effective for pre-exposure prevention for six months. Evusheld is not authorized for individuals for the treatment of COVID-19 or for post-exposure prevention of COVID-19.
On January 24, 2022, the U.S. Food and Drug Administration revoked approval of two monoclonal antibodies, Regeneron: bamlanivimab and estesevimab (administered together) and Regen-COV (caseirivimab and imdevimab). This was based on Center for Disease Control and Prevention data that the omicron variant of SARS-CoV-2 is estimated to account for more than 99% of cases in the United States as of January 15, 2022, and also stated that it is highly unlikely that COVID-19 individuals seeking care in the U.S. at this time are infected with a variant other than omicron, and these treatments are not authorized to be used at this time.
February 11, 2022, the FDA issued an EUA for Eli Lilly’s COVID-19 monoclonal antibody (mAB) drug, bebtelovimab, for the treatment of mild to moderate COVID-19 in adults and pediatric individuals (12 years of age and older weighing 40 kg or more) with a positive COVID-19 test, and who are at high risk for progression to severe COVID-19, including hospitalization or death, and for whom alternative COVID-19 treatment options approved or authorized by the FDA are not accessible or clinically appropriate.
On April 5, 2022, the FDA updated the EUA for Sotrovimab as no longer authorized to treat COVID-19 in any U.S. region due to increases in the proportion of COVID-19 cases caused by the Omicron BA.2 sub-variant. This is based on the Centers for Disease Control and Prevention data that estimates that the proportion of COVID-19 cases caused by the Omicron BA.2 variant is above 50% in all Health and Human Services U.S. regions. Data included in the health care provider fact sheet show the authorized dose of sotrovimab is unlikely to be effective against the BA.2 sub-variant.
On November 30, 2022, the Food and Drug Administration announced bebtelovimab is no longer authorized for emergency use in any U.S. region because it is not expected to neutralize the omicron BQ.1 and BQ.1.1 subvariants.
On January 26, 2023, the FDA stated EVUSHELD (tixagevimab co-packaged with cilgavimab) is not currently authorized for Emergency Use for pre-exposure prophylaxis (prevention) of COVID-19 in the US until further notice, due to the sustained high frequency of circulating SARS-CoV-2 variants that Evusheld does not retain in vitro neutralization against.
Coding
M0220 Injection, tixagevimab and cilgavimab, for the pre-exposure prophylaxis only, for certain adult and pediatric individuals (12 years of age and older weighing at least 40 kg) with no known sars-cov-2 exposure, who either have moderate to severely compromised immune systems or for who vaccination with any available covid-19 vaccine is not recommended due to a history of severe adverse reaction to a covid-19 vaccine(s) and/or covid-19 vaccine component(s), includes injection and post administration monitoring.
M0221 Injection, tixagevimab and cilgavimab, for the pre-exposure prophylaxis only, for certain adult and pediatric individuals (12 years of age and older weighing at least 40 kg) with no known sars-cov-2 exposure, who either have moderate to severely compromised immune systems or for who vaccination with any available covid-19 vaccine is not recommended due to a history of severe adverse reaction to a covid-19 vaccine(s) and/or covid-19 vaccine component(s), includes injection and post administration monitoring in the home or residence; this includes a beneficiary’s homes that has been made provider-based to the hospital during the covid-19 public health emergency.
M0239 Intravenous infusion, bamlanivimab-xxxx, includes infusion and post administration monitoring (FDA EUA revoked 04/16/2021)
M0240 Intravenous infusion or subcutaneous injection, casirivimab and imdevimab includes infusion or injection, and post administration monitoring, subsequent repeat doses (FDA EUA revoked 1/24/2022)
M0241 Intravenous infusion or subcutaneous injection, casirivimab and imdevimab includes infusion or injection, and post administration monitoring in the home or residence, this includes a beneficiary's home that has been made provider-based to the hospital during the covid-19 public health emergency, subsequent repeat doses (FDA EUA revoked 1/24/2022)
M0243 Intravenous infusion, casirivimab and imdevimab, includes infusion and post administration monitoring (FDA EUA revoked 1/24/2022)
M0244 Infusion, casirivimab and imdevimab includes infusion and post administration monitoring the home or residence; this includes a beneficiary's home (FDA EUA revoked 1/24/2022)
M0245 Intravenous infusion, bamlanivimab and etesevimab, includes infusion and post administration monitoring (FDA EUA revoked 1/24/2022)
M0246 Infusion, bamlanivimab and etesevimab, includes infusion and post administration monitoring in the home or residence; this includes a beneficiary's home (FDA EUA revoked 1/24/2022)
M0247 Intravenous infusion, sotrovimab, includes infusion and post administration monitoring. (FDA EUA revoked 4/12/2022)
M0248 Intravenous infusion, sotrovimab, includes infusion and post administration monitoring in the home or residence; this includes a beneficiary’s home. (FDA EUA revoked 4/12/2022)
Q0220 Injection, tixagevimab and cilgavimab, for the pre-exposure prophylaxis only, for certain adults and pediatric individuals (12 years of age and older weighing at least 40 mg) with no known sars- cov-2 exposure, who either have moderate to severely compromised immune systems or for who vaccination with any available covid-19 vaccine is not recommended due to a history of severe adverse reaction to a covid-19 vaccine(s) and/or covid-19 vaccine component(s), 300 mg
Q0221 Injection, tixagevimab and cilgavimab, for the pre-exposure prophylaxis only, for certain adults and pediatric individuals (12 years of age and older weighing at least 40kg) with no known sars-cov-2 exposure, who either have moderate to severely compromised immune systems or for whom vaccination with any available covid-19 vaccine is not recommended due to a history of severe adverse reaction to a covid-19 vaccine(s) and/or covid-19 vaccine component(s), 600 mg. (Effective 2/24/2022)
Q0239 Injection, bamlanivimab-xxxx, 700 mg (FDA EUA revoked 04/16/2021)
Q0240 Injection, casirivimab and imdevimab, 600 mg (FDA EUA revoked 1/24/2022)
Q0243 Injection, casirivimab and imdevimab, 2400mg (FDA EUA revoked 1/24/2022)
Q0244 Injection, casirivimab and imdevimab, 1200mg (FDA EUA revoked 1/24/2022)
Q0245 Injection, bamlanivimab and etesevimab, 2100 mg (FDA EUA revoked 1/24/2022)
Q0247 Injection, sotrovimab, 500 mg (FDA EUA revoked 4/12/2022)
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Policy/ Coverage: |
Effective February 15, 2023
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
The use of the following anti-SARS-CoV-2 monoclonal antibody therapies does not meet primary coverage criteria for any indication. There is insufficient evidence of effectiveness that these anti-SARS-CoV-2 monoclonal antibody therapies improve health outcomes in the treatment of COVID-19 or any other indication:
For members with contracts without primary coverage criteria, the use of the following anti-SARS-CoV-2 monoclonal antibody therapies for any indication is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
The administration of COVID-19 monoclonal antibody therapy is not covered for the following:
For member with contracts without primary coverage criteria, the administration of COVID-19 monoclonal antibody therapy for any indication is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Effective December 7, 2022 to February 14, 2023
The use of the following anti-SARS-CoV-2 monoclonal antibody therapies do not meet primary coverage criteria for any indication. There is insufficient evidence of effectiveness that these anti-SARS-CoV-2 monoclonal antibody therapies improve health outcomes in the treatment of COVID-19 or any other indication:
For members with contracts without primary coverage criteria, the use of the following anti-SARS-CoV-2 monoclonal antibody therapies for any indication is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
The use of the following anti-SARS-CoV-2 monoclonal antibody therapies have temporary authorization pursuant to the EUA by the FDA during the COVID-19 pandemic for the treatment of mild to moderate COVID-19 when specific criteria are met.
Pre-Exposure Prevention In Certain Individuals (FDA 2021)
The use of tixagevimab with cilgavimab (e.g., Evusheld) (M0220, M0221) has temporary authorization pursuant to the EUA by the FDA during the COVID-19 pandemic for use in individuals when specific criteria are met.
The administration of tixagevimab with cilgavimab (Evusheld) is covered when administered as pre- exposure prophylaxis of COVID-19 when ALL of the following criteria are met:
Medical conditions or treatments that may result in moderate to severe immune compromise and an inadequate immune response to COVID-19 vaccination include but are not limited to:
*Mild Illness: Individuals who have any of the various signs and symptoms of COVID-19 (e.g., fever, cough, sore throat, malaise, headache, muscle pain, nausea, vomiting, diarrhea, loss of taste and smell) but who do not have shortness of breath, dyspnea, or abnormal chest imaging.
*Moderate Illness: Individuals who show evidence of lower respiratory disease during clinical assessment or imaging and who have saturation of oxygen (SpO2) ≥94% on room air at sea level.
Dosage and Administration
Tixagevimab with cilgavimab (Evusheld) is one dose administered as two separate consecutive intramuscular injections (one injection per monoclonal antibody, given in immediate succession), may be effective for pre-exposure prevention for six months. Tixagevimab with cilgavimab (Evusheld) is not authorized for individuals for the treatment of COVID-19 or for post-exposure prevention of COVID-19. *Patients should talk with their health care provider to determine whether tixagevimab with cilgavimab (Evusheld)is an appropriate pre-exposure prevention option for them.
Please refer to a separate policy on Site of Care or Site of Service Review policy #2018030 for pharmacologic/biologic medications.
The administration of COVID-19 monoclonal antibody therapy is not covered for the following:
Adult or pediatric patients who require oxygen therapy due to COVID-19 in those patients on chronic oxygen therapy due to underlying non-COVID-19-related comorbidity.
Effective October 19, 2022 to December 6, 2022
The use of the following anti-SARS-CoV-2 monoclonal antibody therapies do not meet primary coverage criteria for any indication. There is insufficient evidence of effectiveness that these anti-SARS-CoV-2 monoclonal antibody therapies improve health outcomes in the treatment of COVID-19 or any other indication:
For members with contracts without primary coverage criteria, the use of the following anti-SARS-CoV-2 monoclonal antibody therapies for any indication is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
The use of the following anti-SARS-CoV-2 monoclonal antibody therapies have temporary authorization pursuant to the EUA by the FDA during the COVID-19 pandemic for the treatment of mild to moderate COVID-19 when specific criteria are met.
Mild-Moderate COVID-19 Infection*
Beginning on or after August 15, 2022, Bebtelovimab (Q0222) and its administration (M0222, M0223) is only covered for the duration of the PHE when administered for the treatment of COVID-19 when all the following criteria are met:.
Pre-Exposure Prevention In Certain Individuals (FDA 2021)
The use of tixagevimab with cilgavimab (e.g., Evusheld) (M0220, M0221) has temporary authorization pursuant to the EUA by the FDA during the COVID-19 pandemic for use in individuals when specific criteria are met.
The administration of tixagevimab with cilgavimab (Evusheld) is covered when administered as pre- exposure prophylaxis of COVID-19 when ALL of the following criteria are met:
Medical conditions or treatments that may result in moderate to severe immune compromise and an inadequate immune response to COVID-19 vaccination include but are not limited to:
*Mild Illness: Individuals who have any of the various signs and symptoms of COVID-19 (e.g., fever, cough, sore throat, malaise, headache, muscle pain, nausea, vomiting, diarrhea, loss of taste and smell) but who do not have shortness of breath, dyspnea, or abnormal chest imaging.
*Moderate Illness: Individuals who show evidence of lower respiratory disease during clinical assessment or imaging and who have saturation of oxygen (SpO2) ≥94% on room air at sea level.
Dosage and Administration
Tixagevimab with cilgavimab (Evusheld) is one dose administered as two separate consecutive intramuscular injections (one injection per monoclonal antibody, given in immediate succession), may be effective for pre-exposure prevention for six months. Tixagevimab with cilgavimab (Evusheld) is not authorized for individuals for the treatment of COVID-19 or for post-exposure prevention of COVID-19. *Patients should talk with their health care provider to determine whether tixagevimab with cilgavimab (Evusheld)is an appropriate pre-exposure prevention option for them.
The recommended dose of bebtelovimab is 175 mg administered as a single intravenous injection over at least 30 seconds. Administer bebtelovimab as soon as possible after positive results of direct SARS-CoV-2 viral testing and within 7 days of symptom onset.
Please refer to a separate policy on Site of Care or Site of Service Review policy #2018030 for pharmacologic/biologic medications.
The administration of COVID-19 monoclonal antibody therapy is not covered for the following:
Adult or pediatric patients who require oxygen therapy due to COVID-19 in those patients on chronic oxygen therapy due to underlying non-COVID-19-related comorbidity.
Effective August 15, 2022 to October 18, 2022
The use of the following anti-SARS-CoV-2 monoclonal antibody therapies do not meet primary coverage criteria for any indication. There is insufficient evidence of effectiveness that these anti-SARS-CoV-2 monoclonal antibody therapies improve health outcomes in the treatment of COVID-19 or any other indication:
For members with contracts without primary coverage criteria, the use of the following anti-SARS-CoV-2 monoclonal antibody therapies for any indication is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
The use of the following anti-SARS-CoV-2 monoclonal antibody therapies have temporary authorization pursuant to the EUA by the FDA during the COVID-19 pandemic for the treatment of mild to moderate COVID-19 when specific criteria are met.
Mild-Moderate COVID-19 Infection*
The administration of bebtelovimab (Q0222) is only covered for the duration of the PHE beginning on or after August 15, 2022.
The administration of bebtelovimab (M0222, M0223) is covered when administered for the treatment of COVID-19 when all of the specific criteria are met:
Pre-Exposure Prevention In Certain Individuals (FDA 2021)
The use of tixagevimab with cilgavimab (e.g., Evusheld) (M0220, M0221) has temporary authorization pursuant to the EUA by the FDA during the COVID-19 pandemic for use in individuals when specific criteria are met.
The administration of tixagevimab with cilgavimab (Evusheld) is covered when administered as pre- exposure prophylaxis of COVID-19 when ALL of the following criteria are met:
Medical conditions or treatments that may result in moderate to severe immune compromise and an inadequate immune response to COVID-19 vaccination include but are not limited to:
*Mild Illness: Individuals who have any of the various signs and symptoms of COVID-19 (e.g., fever, cough, sore throat, malaise, headache, muscle pain, nausea, vomiting, diarrhea, loss of taste and smell) but who do not have shortness of breath, dyspnea, or abnormal chest imaging.
*Moderate Illness: Individuals who show evidence of lower respiratory disease during clinical assessment or imaging and who have saturation of oxygen (SpO2) ≥94% on room air at sea level.
Dosage and Administration
Tixagevimab with cilgavimab (Evusheld) is one dose administered as two separate consecutive intramuscular injections (one injection per monoclonal antibody, given in immediate succession), may be effective for pre-exposure prevention for six months. Tixagevimab with cilgavimab (Evusheld) is not authorized for individuals for the treatment of COVID-19 or for post-exposure prevention of COVID-19. *Patients should talk with their health care provider to determine whether tixagevimab with cilgavimab (Evusheld)is an appropriate pre-exposure prevention option for them.
The recommended dose of bebtelovimab is 175 mg administered as a single intravenous injection over at least 30 seconds. Administer bebtelovimab as soon as possible after positive results of direct SARS-CoV-2 viral testing and within 7 days of symptom onset.
Please refer to a separate policy on Site of Care or Site of Service Review policy #2018030 for pharmacologic/biologic medications.
The administration of COVID-19 monoclonal antibody therapy is not covered for the following:
Adult or pediatric patients who require oxygen therapy due to COVID-19 in those patients on chronic oxygen therapy due to underlying non-COVID-19-related comorbidity.
Effective April 13, 2022 to August 14, 2022
The use of the following anti-SARS-CoV-2 monoclonal antibody therapies do not meet primary coverage criteria for any indication. There is insufficient evidence of effectiveness that these anti-SARS-CoV-2 monoclonal antibody therapies improve health outcomes in the treatment of COVID-19 or any other indication:
For members with contracts without primary coverage criteria, the use of the following anti-SARS-CoV-2 monoclonal antibody therapies for any indication is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
The use of the following anti-SARS-CoV-2 monoclonal antibody therapies have temporary authorization pursuant to the EUA by the FDA during the COVID-19 pandemic for the treatment of mild to moderate COVID-19 when specific criteria are met.
Mild-Moderate COVID-19 Infection*
The administration of bebtelovimab (M0222, M0223) is covered when administered for the treatment of COVID-19 when all of the specific criteria are met:
· Member is 12 years of age or older and weighs at least 40kg
· Member is diagnosed with mild to moderate COVID-19 not requiring hospitalization or treatment with high-flow oxygen.
· Member has a positive result of direct SARS-CoV-2 viral testing
· Member is at high risk for progressing to severe COVID-19 and/or hospitalization.
· Member has no prior treatment with another monoclonal antibody approved for COVID for the same episode.
Pre-Exposure Prevention In Certain Individuals (FDA 2021)
The use of tixagevimab with cilgavimab (e.g., Evusheld) (M0220, M0221) has temporary authorization pursuant to the EUA by the FDA during the COVID-19 pandemic for use in individuals when specific criteria are met.
The administration of tixagevimab with cilgavimab (Evusheld) is covered when administered as pre- exposure prophylaxis of COVID-19 when ALL of the following criteria are met:
· Member is 12 years of age and older weighing at least 40 kgs (about 88 pounds) AND
· Member is not currently infected with SARS-COV-2 virus AND
· Member has not recently been exposed to and individual infected with SARS-Co-V-2 AND
· Member must either have:
Medical conditions or treatments that may result in moderate to severe immune compromise and an inadequate immune response to COVID-19 vaccination include but are not limited to:
· Active treatment for solid tumor and hematologic malignancies
· Receipt of solid-organ transplant and taking immunosuppressive therapy
· Receipt of chimeric antigen receptor (CAR)-T-cell or hematopoietic stem cell transplant (within 2 years of transplantation or taking immunosuppression therapy)
· Moderate or severe primary immunodeficiency (e.g., DiGeorge syndrome, Wiskott-Aldrich syndrome)
· Advanced or untreated HIV infection (people with HIV and CD4 cell counts <200/mm3, history of an AIDS-defining illness without immune reconstitution, or clinical manifestations of symptomatic HIV)
· Active treatment with high-dose corticosteroids (i.e., greater than or equal to 20 mg prednisone or equivalent per day when administered for greater than or equal to 2 weeks), alkylating agents, antimetabolites, transplant-related immunosuppressive drugs, cancer chemotherapeutic agents, classified as severely immunosuppressive, tumor-necrosis (TNF) blockers, and other biologic agents that are immunosuppressive or immunomodulatory (e.g., B-cell depleting agents)
*Mild Illness: Individuals who have any of the various signs and symptoms of COVID-19 (e.g., fever, cough, sore throat, malaise, headache, muscle pain, nausea, vomiting, diarrhea, loss of taste and smell) but who do not have shortness of breath, dyspnea, or abnormal chest imaging.
*Moderate Illness: Individuals who show evidence of lower respiratory disease during clinical assessment or imaging and who have saturation of oxygen (SpO2) ≥94% on room air at sea level.
Dosage and Administration
Tixagevimab with cilgavimab (Evusheld) is one dose administered as two separate consecutive intramuscular injections (one injection per monoclonal antibody, given in immediate succession), may be effective for pre-exposure prevention for six months. Tixagevimab with cilgavimab (Evusheld) is not authorized for individuals for the treatment of COVID-19 or for post-exposure prevention of COVID-19. *Patients should talk with their health care provider to determine whether tixagevimab with cilgavimab (Evusheld)is an appropriate pre-exposure prevention option for them.
The recommended dose of bebtelovimab is 175 mg administered as a single intravenous injection over at least 30 seconds. Administer bebtelovimab as soon as possible after positive results of direct SARS-CoV-2 viral testing and within 7 days of symptom onset.
Please refer to a separate policy on Site of Care or Site of Service Review policy #2018030 for pharmacologic/biologic medications.
The administration of COVID-19 monoclonal antibody therapy is not covered for the following:
Adult or pediatric patients who require oxygen therapy due to COVID-19 in those patients on chronic oxygen therapy due to underlying non-COVID-19-related comorbidity.
Effective February 16, 2022 to April 12, 2022
The use of the following anti-SARS-CoV-2 monoclonal antibody therapies do not meet primary coverage criteria for any indication. There is insufficient evidence of effectiveness that these anti-SARS-CoV-2 monoclonal antibody therapies improve health outcomes in the treatment of COVID-19 or any other indication:
For members with contracts without primary coverage criteria, the use of the following anti-SARS-CoV-2 monoclonal antibody therapies for any indication is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
The use of the following anti-SARS-CoV-2 monoclonal antibody therapies have temporary authorization pursuant to the EUA by the FDA during the COVID-19 pandemic for the treatment of mild to moderate COVID-19 when specific criteria are met.
Mild-Moderate COVID-19 Infection*
The administration of sotrovimab (M0247, M0248) and bebtelovimab (M0222, M0223) is covered when administered for the treatment of COVID-19 when all of the specific criteria are met:
· Member is 12 years of age or older and weighs at least 40kg
· Member is diagnosed with mild to moderate COVID-19 not requiring hospitalization or treatment with high-flow oxygen.
· Member has a positive result of direct SARS-CoV-2 viral testing
· Member is at high risk for progressing to severe COVID-19 and/or hospitalization.
· Member has no prior treatment with another monoclonal antibody approved for COVID for the same episode.
Pre-Exposure Prevention In Certain Individuals (FDA 2021)
The use of tixagevimab with cilgavimab (e.g., Evusheld) (M0220, M0221) has temporary authorization pursuant to the EUA by the FDA during the COVID-19 pandemic for use in individuals when specific criteria are met.
The administration of tixagevimab with cilgavimab (Evusheld) is covered when administered as pre- exposure prophylaxis of COVID-19 when ALL of the following criteria are met:
· Member is 12 years of age and older weighing at least 40 kgs (about 88 pounds) AND
· Member is not currently infected with SARS-COV-2 virus AND
· Member has not recently been exposed to and individual infected with SARS-Co-V-2 AND
· Member must either have:
Medical conditions or treatments that may result in moderate to severe immune compromise and an inadequate immune response to COVID-19 vaccination include but are not limited to:
· Active treatment for solid tumor and hematologic malignancies
· Receipt of solid-organ transplant and taking immunosuppressive therapy
· Receipt of chimeric antigen receptor (CAR)-T-cell or hematopoietic stem cell transplant (within 2 years of transplantation or taking immunosuppression therapy)
· Moderate or severe primary immunodeficiency (e.g., DiGeorge syndrome, Wiskott-Aldrich syndrome)
· Advanced or untreated HIV infection (people with HIV and CD4 cell counts <200/mm3, history of an AIDS-defining illness without immune reconstitution, or clinical manifestations of symptomatic HIV)
· Active treatment with high-dose corticosteroids (i.e., greater than or equal to 20 mg prednisone or equivalent per day when administered for greater than or equal to 2 weeks), alkylating agents, antimetabolites, transplant-related immunosuppressive drugs, cancer chemotherapeutic agents, classified as severely immunosuppressive, tumor-necrosis (TNF) blockers, and other biologic agents that are immunosuppressive or immunomodulatory (e.g., B-cell depleting agents)
*Mild Illness: Individuals who have any of the various signs and symptoms of COVID-19 (e.g., fever, cough, sore throat, malaise, headache, muscle pain, nausea, vomiting, diarrhea, loss of taste and smell) but who do not have shortness of breath, dyspnea, or abnormal chest imaging.
*Moderate Illness: Individuals who show evidence of lower respiratory disease during clinical assessment or imaging and who have saturation of oxygen (SpO2) ≥94% on room air at sea level.
Dosage and Administration
The recommended dose of sotrovimab is 500 mg of as a single intravenous infusion over 30 minutes. Sotrovimab should be given as soon as possible after positive results of direct SARS-CoV-2 viral testing and within 10 days of symptom onset. Sotrovimab should be administered by a healthcare professional in a setting in which healthcare providers have immediate access to medications to treat severe infusion reactions.
Tixagevimab with cilgavimab (Evusheld) is one dose administered as two separate consecutive intramuscular injections (one injection per monoclonal antibody, given in immediate succession), may be effective for pre-exposure prevention for six months. Tixagevimab with cilgavimab (Evusheld) is not authorized for individuals for the treatment of COVID-19 or for post-exposure prevention of COVID-19. *Patients should talk with their health care provider to determine whether tixagevimab with cilgavimab (Evusheld)is an appropriate pre-exposure prevention option for them.
The recommended dose of bebtelovimab is 175 mg administered as a single intravenous injection over at least 30 seconds. Administer bebtelovimab as soon as possible after positive results of direct SARS-CoV-2 viral testing and within 7 days of symptom onset.
Please refer to a separate policy on Site of Care or Site of Service Review policy #2018030 for pharmacologic/biologic medications.
The administration of COVID-19 monoclonal antibody therapy is not covered for the following:
Effective January 28, 2022 through February 15, 2022
The use of the following anti-SARS-CoV-2 monoclonal antibody therapies do not meet primary coverage criteria for any indication. There is insufficient evidence of effectiveness that these anti-SARS-CoV-2 monoclonal antibody therapies improve health outcomes in the treatment of COVID-19 or any other indication:
· sotrovimab (Q0247, M0247, M0248)
· tixagevimab and cilgavimab (Q0220, M0220, M0221)
For members with contracts without primary coverage criteria, the use of the following anti-SARS-CoV-2 monoclonal antibody therapies for any indication is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
· sotrovimab (Q0247, M0247, M0248)
· tixagevimab and cilgavimab (Q0220, M0220, M0221)
The use of the following anti-SARS-CoV-2 monoclonal antibody therapies have temporary authorization pursuant to the EUA by the FDA during the COVID-19 pandemic for the treatment of mild to moderate COVID-19 when specific criteria are met.
Mild-Moderate COVID-19 Infection*
The administration of sotrovimab (M0247, M0248, or Q0247) is covered when administered for the treatment of COVID-19 when all of the specific criteria are met:
· Member is 12 years of age or older and weighs at least 40kg
· Member is diagnosed with mild to moderate COVID-19 not requiring hospitalization or treatment with high-flow oxygen.
· Member has a positive result of direct SARS-CoV-2 viral testing
· Member is at high risk for progressing to severe COVID-19 and/or hospitalization.
· Member has no prior treatment with another monoclonal antibody approved for COVID for the same episode.
Pre-Exposure Prevention In Certain Individuals (FDA 2021)
The use of tixagevimab with cilgavimab has temporary authorization pursuant to the EUA by the FDA during the COVID-19 pandemic for use in individuals when specific criteria are met.
The administration of tixagevimab with cilgavimab (Evusheld) is covered when administered as pre- exposure prophylaxis of COVID-19 when ALL of the following criteria are met:
· Member is 12 years of age and older weighing at least 40 kgs (about 88 pounds) AND
· Member is not currently infected with SARS-COV-2 virus AND
· Member has not recently been exposed to and individual infected with SARS-Co-V-2 AND
· Member must either have:
Medical conditions or treatments that may result in moderate to severe immune compromise and an inadequate immune response to COVID-19 vaccination include but are not limited to:
· Active treatment for solid tumor and hematologic malignancies
· Receipt of solid-organ transplant and taking immunosuppressive therapy
· Receipt of chimeric antigen receptor (CAR)-T-cell or hematopoietic stem cell transplant (within 2 years of transplantation or taking immunosuppression therapy)
· Moderate or severe primary immunodeficiency (e.g., DiGeorge syndrome, Wiskott-Aldrich syndrome)
· Advanced or untreated HIV infection (people with HIV and CD4 cell counts <200/mm3, history of an AIDS-defining illness without immune reconstitution, or clinical manifestations of symptomatic HIV)
· Active treatment with high-dose corticosteroids (i.e., greater than or equal to 20 mg prednisone or equivalent per day when administered for greater than or equal to 2 weeks), alkylating agents, antimetabolites, transplant-related immunosuppressive drugs, cancer chemotherapeutic agents, classified as severely immunosuppressive, tumor-necrosis (TNF) blockers, and other biologic agents that are immunosuppressive or immunomodulatory (e.g., B-cell depleting agents)
*Mild Illness: Individuals who have any of the various signs and symptoms of COVID-19 (e.g., fever, cough, sore throat, malaise, headache, muscle pain, nausea, vomiting, diarrhea, loss of taste and smell) but who do not have shortness of breath, dyspnea, or abnormal chest imaging.
*Moderate Illness: Individuals who show evidence of lower respiratory disease during clinical assessment or imaging and who have saturation of oxygen (SpO2) ≥94% on room air at sea level.
Dosage and Administration
The recommended dose of sotrovimab is 500 mg of as a single intravenous infusion over 30 minutes. Sotrovimab should be given as soon as possible after positive results of direct SARS-CoV-2 viral testing and within 10 days of symptom onset. Sotrovimab should be administered by a healthcare professional in a setting in which healthcare providers have immediate access to medications to treat severe infusion reactions.
Tixagevimab with cilgavimab (Evusheld) is one dose administered as two separate consecutive intramuscular injections (one injection per monoclonal antibody, given in immediate succession), may be effective for pre-exposure prevention for six months. Tixagevimab with cilgavimab (Evusheld) is not authorized for individuals for the treatment of COVID-19 or for post-exposure prevention of COVID-19. Patients should talk with their health care provider to determine whether tixagevimab with cilgavimab (Evusheld) is an appropriate pre-exposure prevention option for them.
Please refer to a separate policy on Site of Care or Site of Service Review policy #2018030 for pharmacologic/biologic medications.
The administration of COVID-19 monoclonal antibody therapy is not covered for the following:
· Any other indication
· Adult or pediatric patients who are hospitalized due to COVID-19
· Adult or pediatric patients who require oxygen therapy due to COVID-19 in those patients on chronic oxygen therapy due to underlying non-COVID-19-related comorbidity.
Effective January 13, 2022 to January 27, 2022
The use of the following anti-SARS-CoV-2 monoclonal antibody therapies do not meet primary coverage criteria for any indication. There is insufficient evidence of effectiveness that these anti-SARS-CoV-2 monoclonal antibody therapies improve health outcomes in the treatment of COVID-19 or any other indication:
· bamlanivimab (Q0239) and administration of bamlanivimab (M0239) or
· casirivimab plus imdevimab combination (Q0240, M0240, M0241, Q0243, M0243, M0244, Q0244) or
· bamlanivimab plus etesevimab combination (Q0245, M0245, M0246) or
· sotrovimab (Q0247, M0247, M0248)
· tixagevimab and cilgavimab (Q0220, M0220, M0221)
For members with contracts without primary coverage criteria, the use of the following anti-SARS-CoV-2 monoclonal antibody therapies for any indication is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
· bamlanivimab (Q0239) and administration of bamlanivimab (M0239) or
· casirivimab plus imdevimab combination (Q0240, M0240, M0241, Q0243, M0243, M0244, Q0244) or
· bamlanivimab plus etesevimab combination (Q0245, M0245, M0246) or
· sotrovimab (Q0247, M0247, M0248)
· tixagevimab and cilgavimab (Q0220, M0220, M0221)
The use of the following anti-SARS-CoV-2 monoclonal antibody therapies have temporary authorization pursuant to the EUA by the FDA during the COVID-19 pandemic for the treatment of mild to moderate COVID-19 when specific criteria are met.
The administration of bamlanivimab, M0239 is covered prior to April 16, 2021 when criteria below is met.
Mild-Moderate COVID-19 Infection*
The administration of casirivimab plus imdevimab (FDA, 2020) combination (M0243 or M0244) or sotrovimab (M0247, M0248, or Q0247) is covered when administered for the treatment of COVID-19 when all of the specific criteria are met:
· Member is 12 years of age or older and weighs at least 40kg
· Member is diagnosed with mild to moderate COVID-19 not requiring hospitalization or treatment with high-flow oxygen.
· Member has a positive result of direct SARS-CoV-2 viral testing
· Member is at high risk for progressing to severe COVID-19 and/or hospitalization.
· Member has no prior treatment with another monoclonal antibody approved for COVID for the same episode.
The administration of bamlanivimab plus etesevimab (FDA, 2021) (M0245 or M0246) is covered when administered for the treatment of COVID-19 when all of the specific criteria are met:
· Member is an adult or pediatric patient including neonates,
· Member is diagnosed with mild to moderate COVID-19 not requiring hospitalization or treatment with high-flow oxygen.
· Member has a positive result of direct SARS-CoV-2 viral testing.
· Member is high risk for progression to severe COVID-19, including hospitalization or death.
· Member has no prior treatment with another monoclonal antibody approved for COVID for the same episode.
Pre-Exposure Prevention In Certain Individuals (FDA 2021)
The use of tixagevimab with cilgavimab (Evusheld) have temporary authorization pursuant to the EUA by the FDA during the COVID-19 pandemic for use in individuals when specific criteria are met.
The administration of tixagevimab with cilgavimab (Evusheld) is covered when administered as pre-exposure prophylaxis of COVID-19 when ALL of the following criteria are met:
· Member is 12 years of age and older weighing at least 40 kgs (about 88 pounds) AND
· Member is not currently infected with SARS-COV-2 virus AND
· Member has not recently been exposed to an individual infected with SARS-Co-V-2 AND
· Member must either have:
Medical conditions or treatments that may result in moderate to severe immune compromise and an inadequate immune response to COVID-19 vaccination include but are not limited to:
· Active treatment for solid tumor and hematologic malignancies
· Receipt of solid-organ transplant and taking immunosuppressive therapy
· Receipt of chimeric antigen receptor (CAR)-T-cell or hematopoietic stem cell transplant (within 2 years of transplantation or taking immunosuppression therapy)
· Moderate or severe primary immunodeficiency (e.g., DiGeorge syndrome, Wiskott-Aldrich syndrome)
· Advanced or untreated HIV infection (people with HIV and CD4 cell counts <200/mm3, history of an AIDS-defining illness without immune reconstitution, or clinical manifestations of symptomatic HIV)
· Active treatment with high-dose corticosteroids (i.e., greater than or equal to 20 mg prednisone or equivalent per day when administered for greater than or equal to 2 weeks), alkylating agents, antimetabolites, transplant-related immunosuppressive drugs, cancer chemotherapeutic agents, classified as severely immunosuppressive, tumor-necrosis (TNF) blockers, and other biologic agents that are immunosuppressive or immunomodulatory (e.g., B-cell depleting agents)
Post Exposure Prophylaxis For High-Risk Exposure In A High-Risk Individual
The use of the following anti-SARS-CoV-2 monoclonal antibodies have temporary authorization pursuant to the EUA by the FDA during the COVID-19 pandemic for use as post-exposure prophylaxis of COVID-19 when specific criteria are met.
The administration of casirivimab plus imdevimab (FDA, 2021) combination [(M0243 or M0244; repeat doses (M0240 or M0241)] is covered when administered for use as post-exposure prophylaxis of COVID-19 when ALL the specific criteria are met:
The administration of bamlanivimab plus etesevimab administered together (FDA, 2021) (M0245 or M0246) is covered when administered for use as post-exposure prophylaxis of COVID-19 when ALL the specific criteria are met:
*Mild Illness: Individuals who have any of the various signs and symptoms of COVID-19 (e.g., fever, cough, sore throat, malaise, headache, muscle pain, nausea, vomiting, diarrhea, loss of taste and smell) but who do not have shortness of breath, dyspnea, or abnormal chest imaging.
*Moderate Illness: Individuals who show evidence of lower respiratory disease during clinical assessment or imaging and who have saturation of oxygen (SpO2) ≥94% on room air at sea level.
Dosage and Administration
Casirivimab and imdevimab is available as an intravenous infusion or subcutaneous injection. The recommended treatment dosage for intravenous infusion is a single intravenous infusion over at least 60 minutes of 600 mg casirivimab and 600 mg imdevimab. The recommend treatment dosage for subcutaneous injection is a single subcutaneous injection of 600 mg casirivimab and 600 mg imdevimab. The dose should be given as soon as possible after positive viral test for SARS-CoV-2 and within 10 days of symptom onset. Casirivimab and imdevimab should be administered by a healthcare professional in a setting in which healthcare providers have immediate access to medications to treat severe infusion reactions. The recommended post-exposure prophylaxis dosage is 600 mg of casirivimab and 600 mg of imdevimab administered by subcutaneous injection or together as a single intravenous infusion as soon as possible following exposure to SARS-CoV-2. For individuals in whom repeat dosing is determined to be appropriate for ongoing exposure to SARS-CoV-2 for longer than 4 weeks and who are not expected to mount an adequate immune response to complete SARS-CoV-2 vaccination, the initial dose is 600 mg of casirivimab and 600 mg of imdevimab by subcutaneous injection or intravenous infusion followed by subsequent repeat dosing of 300 mg of casirivimab and 300 mg of imdevimab by subcutaneous injection or intravenous infusion once every 4 weeks for the duration of ongoing exposure.
Bamlanivimab plus etesevimab must be administered together by intravenous infusion only. The authorized dosage for adults (18 years and older) and pediatric patients (<18 years and weighing at least 40 kg) is 700 mg bamlanivimab and 1,400 mg of etesevimab administered together as a single intravenous (IV) infusion. The authorized dosage for pediatric patients weighing less than 40 kg will vary depending on weight. See FDA label for additional dosing information.
Post-Exposure Prophylaxis Dosage -
The authorized dosage for adults (18 years and older) and pediatric individuals (<18 years and weighing at least 40 kg) is 700 mg bamlanivimab and 1,400 mg of etesevimab administered together as a single intravenous (IV) infusion. The authorized dosage for pediatric individuals weighing less than 40 kg will vary depending on weight. See FDA label for additional dosing information.
The recommended dose of sotrovimab is 500 mg of as a single intravenous infusion over 30 minutes. Sotrovimab should be given as soon as possible after positive results of direct SARS-CoV-2 viral testing and within 10 days of symptom onset. Sotrovimab should be administered by a healthcare professional in a setting in which healthcare providers have immediate access to medications to treat severe infusion reactions.
Tixagevimab with cilgavimab (Evusheld) is one dose administered as two separate consecutive intramuscular injections (one injection per monoclonal antibody, given in immediate succession), may be effective for pre-exposure prevention for six months. Tixagevimab with cilgavimab (Evusheld) is not authorized for individuals for the treatment of COVID-19 or for post-exposure prevention of COVID-19. Patients should talk with their health care provider to determine whether tixagevimab with cilgavimab (Evusheld)is an appropriate pre-exposure prevention option for them.
Please refer to a separate policy on Site of Care or Site of Service Review policy #2018030 for
pharmacologic/biologic medications.
The administration of COVID-19 monoclonal antibody therapy is not covered for the following:
· Any other indication
· Adult or pediatric patients who are hospitalized due to COVID-19
Adult or pediatric patients who require oxygen therapy due to COVID-19 in those patients on chronic oxygen therapy due to underlying non-COVID-19-related comorbidity.
Effective December 15, 2021 to January 12, 2022
The use of the following anti-SARS-CoV-2 monoclonal antibody therapies do not meet primary coverage criteria for any indication. There is insufficient evidence of effectiveness that these anti-SARS-CoV-2 monoclonal antibody therapies improve health outcomes in the treatment of COVID-19 or any other indication:
· bamlanivimab (Q0239) and administration of bamlanivimab (M0239) or
· casirivimab plus imdevimab combination (Q0240, Q0243, Q0244) or
· bamlanivimab plus etesevimab combination (Q0245) or
· sotrovimab (Q0247)
For members with contracts without primary coverage criteria, the use of the following anti-SARS-CoV-2 monoclonal antibody therapies for any indication is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
· bamlanivimab (Q0239) and administration of bamlanivimab (M0239) or
· casirivimab plus imdevimab combination (Q0240, Q0243, Q0244) or
· bamlanivimab plus etesevimab combination (Q0245) or
· sotrovimab (Q0247)
The use of the following anti-SARS-CoV-2 monoclonal antibody therapies have temporary authorization pursuant to the EUA by the FDA during the COVID-19 pandemic for the treatment of mild to moderate COVID-19 when specific criteria are met.
The administration of bamlanivimab, M0239 is covered prior to April 16, 2021 when criteria below is met.
Mild-Moderate COVID-19 Infection*
The administration of casirivimab plus imdevimab (FDA, 2020) combination (M0243 or M0244) is covered when administered for the treatment of COVID-19 when all of the specific criteria are met:
· Member is 12 years of age or older and weighs at least 40kg
· Member is diagnosed with mild to moderate COVID-19 not requiring hospitalization or treatment with high-flow oxygen.
· Member has a positive result of direct SARS-CoV-2 viral testing
· Member is at high risk for progressing to severe COVID-19 and/or hospitalization.
· Member has no prior treatment with another monoclonal antibody approved for COVID for the same episode.
The administration of bamlanivimab plus etesevimab (FDA, 2021) (M0245 or M0246) is covered when administered for the treatment of COVID-19 when all of the specific criteria are met:
· Member is an adult or pediatric patient including neonates,
· Member is diagnosed with mild to moderate COVID-19 not requiring hospitalization or treatment with high-flow oxygen.
· Member has a positive result of direct SARS-CoV-2 viral testing.
· Member is high risk for progression to severe COVID-19, including hospitalization or death.
· Member has no prior treatment with another monoclonal antibody approved for COVID for the same episode.
Post Exposure Prophylaxis For High-Risk Exposure In A High-Risk Individual
The use of the following anti-SARS-CoV-2 monoclonal antibodies have temporary authorization pursuant to the EUA by the FDA during the COVID-19 pandemic for use as post-exposure prophylaxis of COVID-19 when specific criteria are met.
The administration of casirivimab plus imdevimab (FDA, 2021) combination [(M0243 or M0244; repeat doses (M0240 or M0241)] is covered when administered for use as post-exposure prophylaxis of COVID-19 when ALL the specific criteria are met:
· Member is 12 years of age or older and weighs at least 40kg AND
· Member is not fully vaccinated against COVID-19 or not expected to mount an adequate immune response to complete SARS-CoV-2 vaccination (for example, individuals with immunocompromising conditions including those taking immunosuppressive medications) AND
· Member has high-risk exposure due to one of the following:
· Member is at high-risk of progression to severe COIVD based on one or more of the following criteria:
The administration of bamlanivimab plus etesevimab administered together (FDA, 2021) (M0245 or M0246) is covered when administered for use as post-exposure prophylaxis of COVID-19 when ALL the specific criteria are met:
· Member is an adult or pediatric patient including neonates, AND
· Member is high risk for progression to severe COVID-19, including hospitalization or death AND
· Member is not fully vaccinated against COVID-19 or not expected to mount an adequate immune response to complete SARS-CoV-2 vaccination (for example, individuals with immunocompromising conditions including those taking immunosuppressive medications) AND
· Member is at high-risk of progression to severe COIVD based on one or more of the following criteria:
*Mild Illness: Individuals who have any of the various signs and symptoms of COVID-19 (e.g., fever, cough, sore throat, malaise, headache, muscle pain, nausea, vomiting, diarrhea, loss of taste and smell) but who do not have shortness of breath, dyspnea, or abnormal chest imaging.
*Moderate Illness: Individuals who show evidence of lower respiratory disease during clinical assessment or imaging and who have saturation of oxygen (SpO2) ≥94% on room air at sea level.
Dosage and Administration
Casirivimab and imdevimab is available as an intravenous infusion or subcutaneous injection. The recommended treatment dosage for intravenous infusion is a single intravenous infusion over at least 60 minutes of 600 mg casirivimab and 600 mg imdevimab. The recommend treatment dosage for subcutaneous injection is a single subcutaneous injection of 600 mg casirivimab and 600 mg imdevimab. The dose should be given as soon as possible after positive viral test for SARS-CoV-2 and within 10 days of symptom onset. Casirivimab and imdevimab should be administered by a healthcare professional in a setting in which healthcare providers have immediate access to medications to treat severe infusion reactions. The recommended post-exposure prophylaxis dosage is 600 mg of casirivimab and 600 mg of imdevimab administered by subcutaneous injection or together as a single intravenous infusion as soon as possible following exposure to SARS-CoV-2. For individuals in whom repeat dosing is determined to be appropriate for ongoing exposure to SARS-CoV-2 for longer than 4 weeks and who are not expected to mount an adequate immune response to complete SARS-CoV-2 vaccination, the initial dose is 600 mg of casirivimab and 600 mg of imdevimab by subcutaneous injection or intravenous infusion followed by subsequent repeat dosing of 300 mg of casirivimab and 300 mg of imdevimab by subcutaneous injection or intravenous infusion once every 4 weeks for the duration of ongoing exposure.
Bamlanivimab plus etesevimab must be administered together by intravenous infusion only. The authorized dosage for adults (18 years and older) and pediatric patients (<18 years and weighing at least 40 kg) is 700 mg bamlanivimab and 1,400 mg of etesevimab administered together as a single intravenous (IV) infusion. The authorized dosage for pediatric patients weighing less than 40 kg will vary depending on weight. See FDA label for additional dosing information.
Post-Exposure Prophylaxis Dosage -
The authorized dosage for adults (18 years and older) and pediatric individuals (<18 years and weighing at least 40 kg) is 700 mg bamlanivimab and 1,400 mg of etesevimab administered together as a single intravenous (IV) infusion. The authorized dosage for pediatric individuals weighing less than 40 kg will vary depending on weight. See FDA label for additional dosing information.
The recommended dose of sotrovimab is 500 mg of as a single intravenous infusion over 30 minutes. Sotrovimab should be given as soon as possible after positive results of direct SARS-CoV-2 viral testing and within 10 days of symptom onset. Sotrovimab should be administered by a healthcare professional in a setting in which healthcare providers have immediate access to medications to treat severe infusion reactions.
Please refer to a separate policy on Site of Care or Site of Service Review policy #2018030 for pharmacologic/biologic medications.
The administration of COVID-19 monoclonal antibody therapy is not covered for the following:
· Any other indication
· Adult or pediatric patients who are hospitalized due to COVID-19
· Adult or pediatric patients who require oxygen therapy due to COVID-19 in those patients on chronic oxygen therapy due to underlying non-COVID-19-related comorbidity.
Due to the detail of the policy statement, the document containing the coverage statements for dates prior to December 15, 2021 are not online. If you would like a hardcopy print, please email: codespecificinquiry@arkbluecross.com
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| Rationale: |
Adult or pediatric patients who require an increase in baseline oxygen flow rate due to COVID-19 The efficacy and safety of bamlanivimab is based on an interim analysis from BLAZE-1 Part A. This was a randomized, double-blind, placebo-controlled clinical trial studying bamlanivimab for the treatment of patients with mild to moderate COVID-19. Adult patients were enrolled if they had at least one or more COVID-19 symptom that was at least mild in severity. Hospitalized patients were not enrolled in the study. Treatment was initiated within three days of obtaining the clinical sample for a positive SARS-CoV-2 viral infection determination. Patients were treated with a single infusion of bamlanivimab (at doses of 700 mg [N=101], 2,800 mg [N=107], or 7,000 mg [N=101]) or placebo.
The primary endpoint was change in SARS-CoV-2 viral load from baseline on Day 11. The secondary endpoints included COVID-19 related hospitalizations or emergency room visits within 28 days after treatment, safety, symptom severity, and time points for viral clearance. The mean decrease from baseline to day 11 in the viral load for the entire population was -3.81. The mean decrease from baseline to day 11 in viral load for 700mg of bamlanivimab was -3.67, 2,800mg of bamlanivimab was -4.00, 7,000mg bamlanivimab was -3.38, and placebo was -3.47. At day 29, 1.6% of patients treated with bamlanivimab had been hospitalized and 6.3% of patients treated with placebo had been hospitalized. Symptoms were assessed each day and change in the symptom score from baseline was better in the bamlanivimab group than the placebo group. There was no substantial difference observed among the three doses of bamlanivimab. One patient in the trial was admitted to the intensive care unit and no deaths were reported. No serious adverse events were reported in any of 309 patient who received bamlanivimab and 1 of the 143 patients in the placebo group experienced a serious adverse event. The most reported adverse event was diarrhea, nausea, and vomiting. Infusion related reactions were reported in 2.3% of bamlanivimab patients and 1.4% of placebo patients. (Chen P, Nirula A, Heller B, et. al., 2020)
The NIH COVID-19 Treatment Guidelines were updated on April 8, 2021 to address the EUA of bamlanivimab. The guidelines were updated to state, “Because clinical outcome data are limited and there are concerns regarding decreased susceptibility of variants, the Panel recommends against the use of bamlanivimab monotherapy (AIII). If combination products are not available, the use of bamlanivimab monotherapy can be considered for people who meet the EUA criteria on a case-by-case basis.” (NIH, 2021).
On April 16, 2021, the U.S. FDA revoked the EUA for bamlanivimab when given as a monotherapy for the treatment of mild to moderate COVID-19 in adults and pediatric patients.
The efficacy and safety of casirivimab and imdevimab combination is based on the analysis of Phase 1 and 2 trial that occurred after 799 enrolled subjects had completed at least 28 days of the study duration. This was a randomized, double-blinded, placebo-controlled trial studying casirivimab and imdevimab for the treatment of adult patients with mild to moderate COVID-19. Adult patients were enrolled in the trial if they had at least 1 or more COVID-19 symptoms that were at least mild in severity. Patients were not enrolled if they were hospitalized. Treatment was initiated within three days of obtaining a positive SARS-CoV-2 viral infection determination. Patients were treated with either a single intravenous infusion of 2,400 mg of casirivimab and imdevimab (1,200 mg of each) (N=266), 8,000 mg of casirivimab and imdevimab (4,000 mg of each) (N=267), or placebo (N=266).
The primary endpoint was the time weighted average change in SARS-CoV-2 viral load from baseline. On Day 7 the difference in the time weighted average for the pooled doses of casirivimab and imdevimab compared to placebo was -0.36 log10 copies/mL. The largest reductions in viral load relative to placebo occurred in patients with high viral load. Reductions occurring from Day 1 through Day 11 were similar to those for Day 1 through Day 7. The secondary endpoint was medical attended visits related to COVID-19. Medically attended visits comprised of hospitalizations, emergency room visits, urgent care visits, or physician office/telemedicine visits for COVID-19. Through Day 29 2.8% of patients who received casirivimab and imdevimab had COVID-19 medically attended visits versus 6.5% of placebo patients. No serious adverse events were noted.
The data supporting the authorization of bamlanivimab and etesevimab are based on interim data from the Phase 2/3 BLAZE-1 trial of ambulatory patients with COVID-19. The BLAZE-1 study is an ongoing randomized, double-blind, placebo-controlled clinical trial studying bamlanivimab and etesevimab administered together for the treatment of adult patients who were not hospitalized and had at least 1 or more COVID-19 symptoms that were at least mild in severity. Treatment was initiated within 3 days of obtaining the clinical sample for the first positive SARS-CoV-2 viral infection determination. There were 1035 enrolled and the primary end point was COVID- 19 related hospitalization (defined as >24 hours of acute care) or death by any cause by day 29. This combination was shown to reduce deaths and hospitalization by 70% among 1035 high-risk patients (p=0.0004) meeting primary endpoint. There were 11 events in (2.1%) in patients receiving therapy and 36 events (7.0%) in patients taking placebo. In the placebo cohort there were 10 total deaths and 0 in group treated with bamlanivimab 2,800 mg and etesevimab 2,800 mg. A secondary endpoint included the mean change in viral load from baseline to Day 3,5, and 7. At Day 7, 29% of subjects treated with placebo and 10% of subjects treated with bamlanivimab 2,800 mg and etesevimab 2,800 mg together had persistently high viral loads >5.27.
BLAZE-4 is an ongoing Phase 2, randomized, double-blind, placebo-controlled clinical trial studying bamlanivimab and etesevimab for the treatment of subjects with mild to moderate COVID-19 (subjects with COVID-19 symptoms who are not hospitalized). BLAZE-4 enrolled adult subjects who were not hospitalized and had at least 1 or more COVID-19 symptoms that were at least mild in severity and excluded subjects ≥65 years old or with BMI ≥35. Treatment was initiated within 3 days of obtaining the clinical sample for the first positive SARS-CoV-2 viral infection determination. Subjects were treated with a single infusion of bamlanivimab 700 mg and etesevimab 1,400 mg (N=158), bamlanivimab 2,800 mg and etesevimab 2,800 mg (N=101), bamlanivimab 32 alone at a dose of 700 mg (N=103), or placebo (N=153). Results are not yet complete for additional arms in this trial.
As of April 8, 2021, the NIH Panel recommends using one of the combination anti-SARS-CoV-2 monoclonal antibodies to treat outpatients with mild to moderate COVID-19 who are at high risk of clinical progression as defined by the EUA criteria:
The efficacy and safety of sotrovimab is based on an interim analysis from the Phase 1/2/3 COMET-ICE trial. The analysis occurred after 583 randomized patients had completed at least 29 days of the trial. This trial is an ongoing, randomized, double-blind, placebo-control trial studying sotrovimab for the treatment of subjects with mild-to-moderate COVID-19. Enrolled patients were 18 years of age and older with at least one of the following comorbidities: diabetes, obesity (BMI >30), chronic kidney disease, congestive heart failure, chronic obstructive pulmonary disease, or moderate to severe asthma, or were 55 years of age and older regardless of comorbidities. Within five days of enrollment, symptomatic patients must have had a positive SARS-CoV-2 infection confirmed by local laboratory tests and/or point of care tests. Patients with severe COVID-19 requiring supplemental oxygen or hospitalization were excluded from the trial. Patients were given treated with a single 500 mg infection of sotrovimab or placebo over one hour. The progression of COVID-19 at Day 29, the primary endpoint, was reduced by 85% in patients who received sotrovimab versus placebo. (Fact sheet for healthcare providers: emergency use authorization (EUA) of sotrovimab, 2021)
As of June 11, 2021, the NIH COVID-19 Treatment Guidelines Panel recommends using one of the following anti-SARS-CoV-2 monoclonal antibodies, listed in alphabetical order, to treat non-hospitalized patients with mild to moderate COVID-19 who are at high risk of clinical progression, as defined by the Emergency Use Authorization (EUA) criteria:
The efficacy and safety of casirivimab plus imdevimab for post-exposure prophylaxis of COVID-19 is based on the analysis of data from the Phase 3 COV-2069 trial. This was a randomized, double-blind, placebo-controlled clinical trial studying casirivimab and imdevimab for post-exposure prophylaxis of COVID-19 in household contacts of individuals infected with SARS-CoV-2. Patients were randomized in a one to one ratio to received a single dose of 600 mg of casirivimab and 600 mg of imdevimab or placebo administered subcutaneously within 96 hours of collection of the index cases’ positive SARS-CoV-2 diagnostic test sample. The primary efficacy endpoint was the proportion of subjects who developed PCR-confirmed COVID-19 through Day 29. In the primary analysis population, there was an 81% risk reduction in the development of COVID-19 with casirivimab plus imdevimab treatment versus placebo. (Fact sheet for healthcare providers: emergency use authorization (EUA) of casirivimab and imdevimab, 2021)
As of August 4, 2021, the NIH COVID-19 Treatment Guidelines Panel recommends using one of the following anti-SARS-CoV-2 monoclonal antibodies, listed in alphabetical order, to treat non-hospitalized patients with mild to moderate COVID-19 who are at high risk of clinical progression, as defined by the Emergency Use Authorization (EUA) criteria:
2022 Update
Annual policy review completed with a literature search using the MEDLINE database through September 2022. No new literature was identified that would prompt a change in the coverage statement.
2023 Update
Annual policy review completed with a literature search using the MEDLINE database through September 2023. No new literature was identified that would prompt a change in the coverage statement.
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Bamlanivimab [prescribing information]. Indianapolis, IN. Eli Lilly and Company. November 2020. Casirivimab and imdevimab [prescribing information]. Tarrytwon, NY. Regeneron Pharmaceuticals, Inc. November 2020. Chen P, Nirula A, Heller B, et al.(2020) SARS-CoV-2 Neutralizing Antibody LY-CoV555 in Outpatients with Covid-19. New England Journal of Medicine. 2020 October 28. Fact sheet for healthcare providers: emergency use authorization (EUA) of sotrovimab. Philadelphia, PA. GlaxoSmithKline, LLC. May 2021. National Institute of Health (NIH). COVID-19 Treatment Guidelines. The COVID-19 Treatment Guidelines Panel’s Statement on the Emergency Use Authorization of Bamlanivimab for the Treatment of COVID-19. Last Update November 18, 2020. Accessed at https://www.covid19treatmentguidelines.nih.gov/statement-on-bamlanivimab-eua/ National Institute of Health (NIH). COVID-19 Treatment Guidelines. The COVID-19 Treatment Guidelines Panel’s Statement on the Emergency Use Authorization of Casirivimab plus Imdevimab Combination for the Treatment of COVID-19. Last Update December 2, 2020. Accessed at https://www.covid19treatmentguidelines.nih.gov/statement-on-casirivimab-plus-imdevimab-eua/ National Institute of Health (NIH).(2021) COVID-19 Treatment Guidelines Panel. Coronavirus Disease 2019 (COVID-19) Treatment Guidelines. National Institutes of Health. https://www.covid19treatmentguidelines.nih.gov/. Accessed September 24, 2021. National Institute of Health (NIH).(2021) COVID-19 Treatment Guidelines. The COVID-19 Treatment Guidelines Panel’s Statement on Bamlanivimab Plus Etesevimab for the Treatment of Mild to Moderate COVID-19 in Nonhospitalized Patients. September 15, 2021. https://www.covid19treatmentguidelines.nih.gov/therapies/statement-on-bamlanivimab-plus-etesevimab/. Last accessed 09/24/2021. U. S. Department of Health and Human Services.(2021) Public Health Emergency, Bamlanivimab: Updated on COVID-19 variants and impact on bamlanivimab distribution. https://www.phe.gov/emergency/events/COVID19/investigation-MCM/Bamlanivimab/Pages/default.aspx. Last accessed 04/13/2021 U.S. Department of Health and Human Services.(2021) Public Health Emergency. HHS Announces State/Territory-coordinated Distribution System for Monoclonal Antibody Therapeutics. https://www.phe.gov/emergency/events/COVID19/investigation-MCM/Bamlanivimab-etesevimab/Pages/Update-13Sept21.aspx. Last Accessed 09/22/2021. U.S. Department of Health and Human Services.(2021) Public Health Emergency. Important Updates: Monoclonal Antibody Therapeutics. https://www.phe.gov/emergency/events/COVID19/therapeutics/Pages/updates.aspx. Last Accessed 09/22/2021. U.S. Food and Drug Administration (FDA).(2020) FDA News Release. Coronavirus (COVID-19) Update: FDA Authorizes Additional Monoclonal Antibody for Treatment of COVID-19. November 21, 2020. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-monoclonal-antibodies-treatment-covid-19. Last accessed 09/24/2021. U.S. Food and Drug Administration (FDA).(2021) FDA authorizes bamlanivimab and etesevimab monoclonal antibody therapy for post-exposure prophylaxis (prevention) for COVID-19. https://www.fda.gov/drugs/drug-safety-and-availability/fda-authorizes-bamlanivimab-and-etesevimab-monoclonal-antibody-therapy-post-exposure-prophylaxis. Last accessed 09/24/2021. U.S. Food and Drug Administration (FDA).(2021) FDA authorizes REGEN-COV monoclonal antibody therapy for post-exposure prophylaxis (prevention) for COVID-19. https://www.fda.gov/drugs/drug-safety-and-availability/fda-authorizes-regen-cov-monoclonal-antibody-therapy-post-exposure-prophylaxis-prevention-covid-19. Last accessed September 24, 2021. U.S. Food and Drug Administration (FDA).(2021) FDA News Release. Coronavirus (COVID-19) Update: FDA Authorizes Additional Monoclonal Antibody for Treatment of COVID-19. May 26, 2021. Coronavirus (COVID-19) Update: FDA Authorizes Additional Monoclonal Antibody for Treatment of COVID-19 | FDA. Last accessed 09/24/2021. U.S. Food and Drug Administration.(2021) Coronavirus (COVID-19) Update: FDA Revokes Emergency Use Authorization for Monoclonal Antibody Bamlanivimab https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-revokes-emergency-use-authorization-monoclonal-antibody-bamlanivimab?utm_medium=email&utm_source=govdelivery. Last accessed 4/16/21 U.S. Food and Drug Administration.(2021)(2021) Coronavirus (COVID-19) Update: FDA Authorizes New Monoclonal Antibody for Treatment of COVID-19 that Retains Activity Against Omicron Variant. . https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-new-monoclonal-antibody-treatment-covid-19-retains. Last accessed 02/14/2022 Weinreich DM, Sivapalasingam S, Norton T, et al.(2020) REGN-COV2, a Neutralizing Antibody Cocktail, in Outpatients with Covid-19. New England Journal of Medicine. 2020 Dec 17. |
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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.
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