Commercial

Pharmaceutical Treatments of COVID-19 for Independence Commercial Members (Updated October 6, 2021)


Policy Impacted


08.00.85

Purpose

The purpose of this document is to communicate the Company's coverage position for Pharmaceutical Treatment of COVID-19 for Independence commercial members. 


This communication addressing pharmaceutical treatments of COVID-19 is effective from October 22, 2020 through December 31, 2021, or the duration of the Public Health Emergency. 

  • This document includes the following updates to the version that was published on August 5, 2021:

    • ​​The following HCPCS medical codes related to prophylactic use of Casirivimab/Imdevimab were added : Q0240, M0240, M0241. 

Background

Veklury® (remdesivir) 

On October 22, 2020, the U.S. Food and Drug Administration (FDA) approved Veklury® (remdesivir), the first drug to treat suspected or laboratory‑confirmed COVID‑19 in hospitalized individuals 12 years of age and older who weigh at least 40 kilograms (approximately 88 pounds). There continues to be an Emergency Use Authorization (EUA) for Veklury® for suspected or laboratory‑confirmed COVID‑positive children who are younger than 12 years of age and weigh more than 3.5 kilograms (approximately 8 pounds). Veklury® is a SARS-CoV-2 nucleotide analog RNA polymerase inhibitor. This agent was approved through the FDA's Coronavirus Treatment Acceleration Program.  

Bamlanivimab® (LY-CoV555)

On April 16, 2021, the FDA revoked the emergency use authorization (EUA) issued on November 09, 2020 that allowed for the investigational monoclonal antibody therapy, bamlanivimab, when administered alone, to be used for the treatment of mild-to-moderate COVID-19 in adults and certain pediatric patients. Based on its ongoing analysis of emerging scientific data, specifically the sustained increase of SARS-CoV-2 viral variants that are resistant to bamlanivimab alone resulting in the increased risk for treatment failure, the FDA has determined that the known and potential benefits of bamlanivimab, when administered alone, no longer outweigh the known and potential risks for its authorized use. Therefore, the FDA determined that the criteria for issuance of an authorization are no longer met and has revoked the EUA as a single use agent.


Veklury® (remdesivir) in combination with Olumiant® (baricitinib)

On November 19, 2020, the FDA issued an EUA for Olumiant® (baricitinib) in combination with remdesivir for the treatment of suspected or laboratory-confirmed COVID-19 in certain hospitalized adults and pediatric individuals. Baricitinib is an oral janus kinase (JAK) inhibitor aimed at reducing the pro-inflammatory response.

Casirivimab/Imdevimab

On November 21, 2020, Regeneron Pharmaceuticals, Inc. received an EUA from the FDA for the investigational treatment cocktail consisting of two monoclonal antibodies, casirivimab and imdevimab. The EUA allows healthcare providers to administer casirivimab/imdevimab to non-hospitalized individuals with confirmed COVID-19 who are experiencing mild to moderate symptoms and are at high-risk for severe symptoms and hospitalization. Casirivimab and imdevimab are recombinant human IgG1 monoclonal antibodies that target the receptor binding domain of the spike protein of SARS-CoV-2.

On July 30, 2021, 
Regeneron Pharmaceuticals, Inc. received an expanded EUA for post-exposure prophylaxis in adult and pediatric individuals (12 years of age and older weighing at least 40 kg) who are at high risk for progression to severe COVID-19, including hospitalization or death and who are not fully vaccinated or who are 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 are individuals who met one of the following:

Have been exposed to an individual infected with SARS-CoV-2 consistent with close contact criteria per Centers for Disease Control and Prevention (CDC); or 
High risk of exposure to an individual infected with SARSCoV-2 because of occurrence of SARS-CoV-2 infection in other individuals in the same institutional setting (e.g., nursing homes, prisons).



Bamlanivimab® (LY-CoV555) in combination with Etesevimab® (LY-CoV016)

On February 9, 2021, the FDA issued an EUA for Etesevimab® in combination with 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. Both products, Etesevimab® and Bamlanivimab®, are neutralizing IgG1 monoclonal antibodies that bind to the receptor-binding domain of the spike protein of SARS-CoV-2.​​


Sotrovimab® (VIR-7831/GSK4182136)

On May 26, 2021, the FDA issued an EUA for Sotrovimab® 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. Sotrovimab®​ is a recombinant human IgG1 monoclonal antibody that binds to the receptor-binding domain of the spike protein of SARS-CoV-2.​​


Tocilizumab (Actemra®)

On June 24, 2021, the FDA issued an EUA for Tocilizumab for the treatment of coronavirus disease 2019 (COVID-19) for hospitalized adults and pediatric individuals (2 years of age and older) who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO), and when used under the conditions described in the FDA authorization.  Tocilizumab is a recombinant humanized monoclonal antibody that selectively targets the receptor binding domain of the spike protein of SARS-CoV-2.​​



Coverage Statement

Veklury® (remdesivir) 

Veklury® (remdesivir) is covered by the Company per the FDA approval for COVID-19 treatment for confirmed SARS-CoV-2 infection in adult and pediatric individuals (12 years and older and weighing at least 40 kg (88 lbs.)) who require hospitalization. 

Veklury® (remdesivir) is also covered by the Company as part of the FDA's continued EUA to permit the use of Veklury® (remdesivir) for treatment of suspected or laboratory‑confirmed COVID‑positive infection in children who are younger than 12 years of age and weigh more than 3.5 kilograms (approximately 8 pounds) and are hospitalized.

Veklury® (remdesivir) in combination with Olumiant® (baricitinib) is also covered by the Company as part of the FDA's EUA for Olumiant® (baricitinib) to treat suspected or confirmed COVID-19 in hospitalized adults and pediatric individuals 2 years and older requiring supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).

For all other uses of Olumiant® (baricitinib) not included in the FDA's EUA for the treatment of COVID-19, please refer to the Company's Pharmacy Policy, Immune Modulating Therapies for Rheumatologic, Dermatologic, and Gastrointestinal Diseases, Policy # Rx.01.154.

 
Bamlanivimab® (LY-CoV555)

As of April 16, 2021, the FDA revoked the EUA for single use of Bamlanivimab. Due to this regulatory revocation,  Bamlanivimab is only authorized to be administered in combination therapy with Etesevimab. 


Combination of Bamlanivimab®/Etesevimab® 

Distribution of the combination therapy of ​Bamlanivimab® and Etesevimab® (LY-CoV016) will be controlled by the U.S. Government, which will collobrate with local and state governments. On June 25, 2021, the Federal Government communicated all distribution of bamlanivimab and etesevimab together and etesevimab alone (to pair with existing supply of bamlanivimab at a facility) will pause on a national basis until further notice. If the product (combination therapy or etesevimab alone) was initially distributed to healthcare providers at no charge; then, additional reimbursement for either combination therapy or Etesevimab® (LY-CoV016) alone will not be provided by the Company. ​


However, the administration of Bamlanivimab/ Etesevimab® is eligible for reimbursement consideration when FDA EUA criteria for this product are met. Reimbursement for post-administration monitoring is included in the payment for administration of the product. 

 
Combination of Casirivimab/Imdevimab

Distribution of casirivimab/imdevimab will be controlled by the U.S. Government, which will collaborate with local and state governments. It is anticipated that this product will initially be distributed to healthcare providers at no charge and, therefore, additional reimbursement for the combination use of Casirivimab/Imdevimab will not be provided by the Company.

However, the administration of casirivimab/imdevimab is eligible for reimbursement consideration when FDA EUA criteria for this product are met. Reimbursement for post-administration monitoring is included in the payment for administration of the product.


​Sotrovimab 

Sotrovimab is covered by the Company per the FDA Emergency Use Authorization 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. 


Reimbursement for post-administration monitoring is included in the payment for administration of the product.

Tocilizumab (Actemra®) for the Treatment of Coronavirus Disease 2019 (COVID-19)

Tocilizumab (Actemra®)​ is covered by the Company per the FDA Emergency Use Authorization (EUA) for the treatment of coronavirus disease 2019 (COVID-19) in hospitalized adults and pediatric patients (2 years of age and older) who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).


For all other uses of Tocilizumab (Actemra®)​ not included in the FDA's EUA for the treatment of COVID-19, please refer to the Company's Medical Policy, Tocilizumab (Actemra®) for Intravenous Infusion/08.00.85.


REQUIRED DOCUMENTATION

The individual's medical record must reflect that the care provided is according to the pertinent FDA EUAs or FDA-Approval Criteria and Requirements. These medical records may include, but are not limited to: records from the professional provider's office, hospital, nursing home, home health agencies, therapies, and test reports. 

The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the service.​


Coding

Veklury® (remdesivir)

XW033E5 Introduction of Remdesivir Anti-infective into Peripheral Vein, Percutaneous Approach

XW043E5 Introduction of Remdesivir Anti-infective into Central Vein, Percutaneous Approach

 

Veklury® (remdesivir) in combination with Olumiant® (baricitinib)

XW0DXM6 Introduction of Baricitinib into Mouth and Pharynx, External Approach

XW0G7M6 Introduction of Baricitinib into Upper GI, Via Natural or Artificial Opening

XW0H7M6 Introduction of Baricitinib into Lower GI, Via Natural or Artificial Opening

 

Casirivimab/Imdevimab

Q0240 Injection, casirivimab and imdevimab, 600 mg

Q0243   Injection, casirivimab and imdevimab, 2400 mg

Q0244   Injection, casirivimab and imdevimab, 1200 mg

M0240 Intravenous infusion or subcutaneous injection, casirivimab and imdevimab includes infusion or injection, and post administration monitoring, subsequent repeat doses

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

M0243  Intravenous infusion or subcutaneous injection , casirivimab and imdevimab includes infusion and post administration monitoring

M0244  Intravenous infusion or subcutaneous injection, casirivimab and imdevimab includes infusion 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

Bamlanivimab®/Etesevimab®

Q0245 Injection, bamlanivimab and etesevimab, 2100 mg

M0245 intravenous infusion, bamlanivimab and etesevimab, includes infusion and post administration monitoring

M0246  Intravenous infusion, bamlanivimab and etesevimab, includes infusion 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

 

Sotrovimab

Q0247   Injection, sotrovimab, 500 mg

M0247  Intravenous infusion, sotrovimab, includes infusion and post administration monitoring

M0248  Intravenous infusion, sotrovimab, includes infusion 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

 

Tocilizumab

Q0249  Injection, tocilizumab, for hospitalized adults and pediatric patients (2 years of age and older) with covid-19 who are receiving systemic corticosteroids and require supplemental oxygen, non[1] invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO) only, 1 mg

M0249  Intravenous infusion, tocilizumab, for hospitalized adults and pediatric patients (2 years of age and older) with covid-19 who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO) only, includes infusion and post administration monitoring, first dose

M0250  Intravenous infusion, tocilizumab, for hospitalized adults and pediatric patients (2 years of age and older) with covid-19 who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO) only, includes infusion and post administration monitoring, second dose ​

9/13/2021