Lumateperone (Caplyta) (CP.PMN.232)

Ambetter

Policy updates include:

• New strengths [10.5 mg, 21 mg] added

Olaparib (Lynparza) (CP.PHAR.360)

Ambetter

Policy updates include:

• Added newly FDA-approved indication: For the adjuvant treatment of HER-2 negative, high risk metastatic breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy

Sotrovimab (VIR-7831) (CP.PHAR.541)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter

Policy includes:

• Criteria will mirror the clinical information from the prescribing information once FDA-approved
• Criteria is only applicable for Medicaid and CHIP when the drug is added to the formulary for coverage
• Requests for indications not approved by the FDA are reviewed with the off-label use policy for the relevant line of business: HIM.PHAR.154 for Ambetter, and CP.PMN.53 for Medicaid and CHIP
• Initial Approval Criteria, COVID-19 (must meet all):
  • Diagnosis of COVID-19 infection via a positive viral test for SARS-CoV-2 within the last 5 days
  • Member has one or more mild or moderate COVID-19 symptoms;
    • Member is within 7 days of symptom onset;
    • Prescribed by or in consultation with an infectious disease specialist;
  • Age ≥ 12 years
  • Member’s body weight is ≥ 40 kg
  • Member meets one of the following criteria for being at high risk for progressing to severe COVID-19 and/or hospitalization:
    • Age ≥ 65 years
    • Obesity or overweight (e.g., adults with body mass index (BMI) > 25, or if aged 12-17 years, have BMI ≥ 85th percentile for their age and gender based on CDC growth charts (https://www.cdc.gov/growthcharts/clinical_charts.htm)
    • Pregnancy
    • Chronic kidney disease
    • Diabetes
    • Immunosuppressive disease
    • Currently receiving immunosuppressive treatment
    • Cardiovascular disease (including congenital heart disease)
    • Hypertension
    • Chronic lung diseases (e.g., chronic obstructive pulmonary disease, asthma [moderate to severe], interstitial lung disease, cystic fibrosis, pulmonary hypertension)
    • Sickle cell disease
    • Neurodevelopmental disorders (e.g., cerebral palsy) or other conditions that confer medical complexity (e.g., genetic or metabolic syndromes and severe congenital anomalies)
    • Having a medical-related technological dependence (e.g., tracheostomy, gastrostomy, or positive pressure ventilation [not related to COVID-19])
    • Other medical conditions or factors that may place individual patients at high risk for progression to severe COVID-19
  • At the time of request, member has none of the following EUA-specified limitations against use:
    • Member is hospitalized due to COVID-19
    • Member requires oxygen therapy due to COVID-19
    • For members on chronic oxygen therapy due to underlying non-COVID-19 related comorbidity: member requires an increase in baseline oxygen flow rate due to COVID-19
    • Member is in a geographic region where infection is likely caused by non-susceptible COVID-19 variant based on variant susceptibility to this drug and regional variant frequency
  • Sotrovimab will be administered to the member in a setting in which health care providers have immediate access to medications to treat a severe infusion reaction, such as anaphylaxis, and the ability to activate the emergency medical system, as necessary
  • Dose does not exceed 500 mg one time.
  • Approval duration: One time
• Continued Therapy; COVID-19 (must meet all):
  • Re-authorization is not permitted.
  • Approval duration: Not applicable

Testosterone (Testopel, Jatenzo, Tlando) (CP.PHAR.354)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter

Policy updates include:

• Added newly approved Tlando to the policy