Policy

Applicable Products

New Policy Overview or Updated Policy Revisions

Axicabtagene Ciloleucel (Yescarta) (CP.PHAR.362)

Ambetter

Policy updates include:

• Follicular lymphoma criteria added for newly approved indication
• Added criteria to LBCL indication for exclusion of concurrent and previous administration of CAR T-cell immunotherapy

Bamlanivimab + Etesevimab (LY-CoV555 + LY-CoV016) (CP.PHAR.532)

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:

• Diagnosis of COVID-19 infection via a positive viral test for SARS-CoV-2 within the last 3 days;
• Member has one or more mild or moderate COVID-19 symptoms;
• Member is within 10 days of symptom onset;
• 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:
  • Body mass index (BMI) ≥ 35;
  • Has chronic kidney disease;
  • Has type 1 or type 2 diabetes;
  • Has immunosuppressive disease;
  • Currently receiving immunosuppressive treatment;
  • ≥ 65 years of age;
  • ≥ 55 years of age AND has one of the following:
    • Cardiovascular disease;
    • Hypertension;
    • Chronic obstructive pulmonary disease/other chronic respiratory disease;
  • Is 12 – 17 years of age AND has one of the following:
    • BMI ≥ 85th percentile for their age and gender based on CDC growth charts (https://www.cdc.gov/growthcharts/clinical_charts.htm);
    • Sickle cell disease;
    • Congenital or acquired heart disease;
    • Neurodevelopmental disorders (e.g., cerebral palsy);
    • Medical-related technological dependence (e.g., tracheostomy, gastrostomy, or positive pressure ventilation [not related to COVID-19]);
    • Asthma, reactive airway or other chronic respiratory disease that requires daily medication for control;
• At the time of request, member does not have any of the following EUA-specified limitations against use:
  • Member is hospitalized due to COVID-19;
  • Member requires oxygen therapy due to COVID-19;
  • Members is on chronic oxygen therapy due to underlying non-COVID-19 related comorbidity and requires an increase in baseline oxygen flow rate due to COVID-19;
• Bamlanivimab and etesevimab will be administered together as a single intravenous infusion;
• Bamlanivimab and etesevimab 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 bamlanivimab 700 mg (1 vial) with etesevimab 1,400 mg (2 vials) one time.
• Approval duration: One time

• Continued Therapy Criteria:
• Re-authorization is not permitted.
• Approval duration: Not applicable

Ciltacabtagene Autoleucel (CP.PHAR.533)

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:

• Multiple Myeloma* (must meet all):
• *Only for initial treatment dose; subsequent doses will not be covered.
• Diagnosis of MM;*
• Prescribed by or in consultation with an oncologist or hematologist;
• Age ≥ 18 years;*
• Member has measureable disease as evidenced by one of the following assessed within the last 30 days:
  • Serum M-protein ≥ 1 g/dL;
  • Urine M-protein ≥ 200 mg/24 h;
  • Serum free light chain (FLC) assay: involved FLC level ≥ 10 mg/dL (100 mg/L) provided serum FLC ratio is abnormal;
• Member has received as part of previous therapy all of the following:
• A PI (e.g., bortezomib, Kyprolis®, Ninlaro®);
  • An IMiD (e.g., thalidomide, lenalidomide);
  • An anti-CD38 antibody (e.g., Darzalex®/Darzalex Faspro™, Sarclisa®);
• One of the following:
  • Member has received ≥ 3 prior lines of therapy;
  • Member is double refractory to an IMiD and PI;
• Member has not previously received treatment with anti-BCMA targeted therapy (e.g., Blenrep™);
• Member has not previously received treatment with CAR T-cell immunotherapy (e.g., Breyanzi®, Kymriah™, Yescarta™);
• Ciltacabtagene autoleucel is not prescribed concurrently with other CAR T-cell immunotherapy (e.g., Breyanzi, Kymriah, Yescarta);
• Member does not have active, or prior history of central nervous system (CNS) involvement or exhibit clinical signs of meningeal involvement of multiple myeloma;*
• Dose does not exceed 1 x 106 CAR-positive viable T cells per kg.
• Approval duration: 3 months (1 dose only, with 4 doses of tocilizumab (Actemra) if requested at up to 800 mg per dose)

• Continued Therapy Criteria:
• Re-authorization is not permitted.
• Approval duration: Not applicable

Hyaluronate Derivatives (CP.PHAR.05)

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

Policy updates include:

• Clarified physical therapy should be supervised by a physical therapist
• Added hyaluronate product preferencing in continued therapy section

Immune Globulins (CP.PHAR.103)

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

Policy updates include:

• Added guidance language regarding optimal dose calculations for adults based on ideal or total body weight, whichever is less and regarding using adjusted body weight for dosing for obese members.
• For AIDP/GBS/CIDP: separated existing criteria to clearly delineate which apply to AIDP/GBS and which apply to CIDP
• Added criteria for confirmation of CIDP diagnosis, per 2010 EFNS/PNS guidelines
• Added requirement for a prior trial of corticosteroid therapy
• Added newly approved indication for Panzyga for CIDP

Lubiprostone (Amitiza) (CP.PMN.142)

Ambetter

Policy updates include:

• Added requirement for use of generic lubiprostone

Pitolisant (Wakix) (CP.PMN.221)

Ambetter

Policy updates include:

• Added diagnostic criteria for narcolepsy with cataplexy and narcolepsy associated with excessive daytime sleepiness
• For narcolepsy with excessive daytime sleepiness, added requirement for combination use of preferred agents if request is for concomitant use

Plecanatide (Trulance) (HIM.PA.158)

Ambetter

Policy updates include:

• Policy created (HIM line of business removed from CP.PMN.87)
• Added redirection to generic lubiprostone and Linzess.

Tocilizumab (Actemra) (CP.PHAR.263)

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

Policy updates include:

• Added combination of bDMARDs exclusion under Section III
• Added criteria for new FDA indication, SSc-ILD