Commercial

Pharmaceutical Treatments of COVID-19 for AmeriHealth Pennsylvania Members (Updated May 4, 2021)


Purpose

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


This communication addressing pharmaceutical treatments of COVID-19 is effective from October 22, 2020 through June 30, 2021, or the duration of the Public Health Emergency. 


This document includes the following updates to the version that was published on March 19, 2021:

  • Bamlanivimab and related applicable codes were removed as a single use agent. ​

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.


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.​​


Indications

Veklury® (remdesivir) 

The FDA approved Veklury® (remdesivir) for use in adult and pediatric individuals 12 years of age and older and weighing at least 40 kilograms (about 88 pounds) for the treatment of COVID-19 requiring hospitalization.

In order to ensure continued access to the pediatric population previously covered under the EUA, the FDA revised the EUA for Veklury® to authorize the drug's use for treatment of suspected or laboratory- confirmed COVID-19 in hospitalized pediatric individuals weighing 3.5 kg to less than 40 kg or hospitalized pediatric individuals younger than 12 years of age weighing at least 3.5 kg. Clinical trials assessing the safety and efficacy of Veklury® in this pediatric population are ongoing.

Combination of Bamlanivimab® (LY-CoV555)/Etesevimab® (LY-CoV016)

The  FDA has issued an EUA to permit the emergency use of the unapproved products Bamlanivimab® / Etesevimab®(LY-CoV016)  to be administered together 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 40 kg, and who are at high risk for progressing to severe COVID-19 and/or hospitalization.

High risk is defined as meeting at least one of the following criteria: 

  • Body mass index (BMI) ≥35
  • Chronic kidney disease
  • Diabetes
  • Immunosuppressive disease
  • Currently receiving immunosuppressive treatment
  • ≥65 years of age
  • ≥55 years of age AND

    • cardiovascular disease, OR
    • hypertension, OR
    • chronic obstructive pulmonary disease/other chronic respiratory disease. 
  • 12 – 17 years of age AND

    • BMI ≥85th percentile for their age and gender based on CDC growth charts (available at  https://www.cdc.gov/growthcharts/clinical_charts.htm), OR
    • sickle cell disease, OR
    • congenital or acquired heart disease, OR
    • neurodevelopmental disorders, for example, cerebral palsy, OR
    • a medical-related technological dependence, for example, tracheostomy, gastrostomy, or positive-pressure ventilation (not related to COVID-19), OR
    • asthma, reactive airway, or other chronic respiratory disease that requires daily medication for control.

 
Combination of Casirivimab/Imdevimab

The FDA has issued an EUA to permit the emergency use of the unapproved products casirivimab and imdevimab to be administered together for the treatment of mild to moderate COVID-19 in adults and pediatric individuals (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progressing to severe COVID-19 and/or hospitalization.


High risk is defined as meeting at least one of the following criteria: 

  • Body mass index (BMI) ≥35
  • Chronic kidney disease
  • Diabetes
  • Immunosuppressive disease
  • Currently receiving immunosuppressive treatment
  • ≥65 years of age
  • ≥55 years of age AND

    • cardiovascular disease, OR
    • hypertension, OR
    • chronic obstructive pulmonary disease/other chronic respiratory disease.  
  • 12 – 17 years of age AND

    • BMI ≥85th percentile for their age and gender based on CDC growth charts (available at https://www.cdc.gov/growthcharts/clinical_charts.htm) OR
    • sickle cell disease, OR
    • congenital or acquired heart disease, OR
    • neurodevelopmental disorders, for example, cerebral palsy, OR
    • a medical-related technological dependence, for example, tracheostomy, gastrostomy, or positive pressure ventilation (not related to COVID-19), OR
    • asthma, reactive airway or other chronic respiratory disease that requires daily medication for control.

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 collaborate with local and state governments. It is anticipated that this product will initially be distributed to healthcare providers at no charge; therefore, additional reimbursement for Etesevimab® (LY-CoV016) 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.


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.​


Dosing And Administration

Veklury® (remdesivir) 

The recommended dosage for adults and pediatric individuals 12 years of age and older and weighing at least 40 kg is a single loading dose of Veklury® 200 mg on Day 1 via intravenous infusion followed by a once-daily maintenance dose of Veklury® 100 mg from Day 2 via intravenous infusion. 


For individuals not requiring invasive mechanical ventilation and/or extracorporeal membrane oxygenation (ECMO), the recommended total treatment duration is 5 days. If an individual does not demonstrate clinical improvement, treatment may be extended for up to 5 additional days for a total treatment duration of up to 10 days.


For individuals requiring invasive mechanical ventilation and/or ECMO, the recommended total treatment duration is 10 days. 


The recommended dosage for pediatric individuals weighing 3.5 kg to less than 40 kg is a single loading dose of Veklury® 5 mg/kg on Day 1 followed by Veklury® 2.5 mg/kg once daily from Day 2.


The recommended treatment duration for individuals not requiring invasive mechanical ventilation and/or ECMO is 5 days. If an individual does not demonstrate clinical improvement, treatment may be extended for up to 5 additional days for a total treatment duration of up to 10 days.


The recommended total treatment duration for individuals requiring invasive mechanical ventilation and/or ECMO is 10 days.

Veklury® should only be administered in a hospital or in a healthcare setting capable of providing acute care comparable to inpatient hospital care.

 

Combination of Bamlanivimab®)/Etesevimab®

The recommended dosage is 700 mg Bamlanivimab® and 1400 mg of Etesevimab® administered together as a single intravenous (IV) infusion as soon as possible after a positive viral test for SARS-CoV-2 and within 10 days of symptom onset.


Bamlanivimab® and Etesevimab® ​ may only be administered in settings in which healthcare providers have immediate access to medications to treat a severe infusion reaction, such as anaphylaxis, and the ability to activate the emergency medical system (EMS), as necessary.
 

Combination of Casirivimab/Imdevimab

The recommended dosage is 1,200 mg of casirivimab and 1,200 mg of imdevimab administered together as a single intravenous (IV) infusion as soon as possible after a positive viral test for SARS-CoV-2 and within 10 days of symptom onset.


Casirivimab and imdevimab may only be administered in settings in which healthcare providers have immediate access to medications to treat a severe infusion reaction, such as anaphylaxis, and the ability to activate the emergency medical system (EMS), as necessary.​


Black Box Warnings and/or Contraindications

Veklury® (remdesivir) 


Veklury® is contraindicated in individuals with a history of clinically significant hypersensitivity reactions to Veklury® or any components of the product. Veklury® is not recommended in individuals with eGFR less than 30 mL per minute. 

Combination of Bamlanivimab® (LY-CoV555)/Etesevimab® (LY-CoV016)​


LIMITATIONS OF AUTHORIZED USE

Bamlanivimab®/Etesevimab®​ are not authorized for use in individuals:

  • who are hospitalized due to COVID-19, OR
  • who require oxygen therapy due to COVID-19, OR
  • who require an increase in baseline oxygen flow rate due to COVID-19 in those on chronic oxygen therapy due to underlying non-COVID-19 related comorbidity.

The benefit of treatment with Bamlanivimab® and Etesevimab® has not been observed in individuals hospitalized due to COVID-19. Monoclonal antibodies, such as Bamlanivimab® and Etesevimab®, may be associated with worse clinical outcomes when administered to hospitalized individuals with COVID-19 requiring high-flow oxygen or mechanical ventilation.

Bamlanivimab® and Etesevimab®​ have been authorized by FDA only for the emergency uses described above.
 

Bamlanivimab® and Etesevimab®​ ​are authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of Bamlanivimab® and Etesevimab® under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.​


Combination of Casirivimab/Imdevimab


LIMITATIONS OF AUTHORIZED USE

Casirivimab and imdevimab are not authorized by the FDA for use in individuals:

  • who are hospitalized due to COVID-19, OR
  • who require oxygen therapy due to COVID-19, OR
  • who require an increase in baseline oxygen flow rate due to COVID-19 in those on chronic oxygen therapy due to underlying non-COVID-19 related comorbidity.

The benefit of treatment with casirivimab and imdevimab has not been observed in individuals hospitalized due to COVID-19. Monoclonal antibodies, such as casirivimab and imdevimab, may be associated with worse clinical outcomes when administered to hospitalized individuals requiring high- flow oxygen or mechanical ventilation with COVID-19.

Casirivimab and imdevimab have been authorized by FDA only for the emergency uses described above.


Casirivimab and imdevimab are authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of casirivimab and imdevimab under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.​​


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

Q0243   Injection, casirivimab and imdevimab, 2400 mg
M0243  Intravenous infusion, casirivimab and imdevimab includes infusion and post administration monitoring


Bamlanivimab®/Etesevimab® 

Q0245 Injection, bamlanivimab and etesevimab, 2100 mg
M0245 intravenous infusion, bamlanivimab and etesevimab, includes infusion and post administration monitoring ​​​


4/16/2021