Effective September 1, 2021: Pharmacy and Biopharmacy Policies

Amivantamab-vmjw (Rybrevant) (CP.PHAR.544)

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

Policy includes:

• 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: Non-Small Cell Lung Cancer (must meet all):
  • Diagnosis of locally advanced or metastatic NSCLC
  • Prescribed by or in consultation with an oncologist
  • Age ≥ 18 years
  • Disease is positive for epidermal growth factor receptor (EGFR) exon 20 insertion mutations;
  • Member has progressed on or after platinum-based therapy
  • Request meets one of the following:*
    • Dose does not exceed the appropriate weight-based dose per week for 4 weeks, then every 2 weeks thereafter:
      • Body weight < 80 kg: 1,050 mg (3 vials)
      • Body weight ≥ 80 kg: 1,400 mg (4 vials)
    • Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).
  • *Prescribed regimen must be FDA-approved or recommended by NCCN
  • Approval duration: 6 months
• Continuation Approval Criteria: Non-Small Cell Lung Cancer (must meet all):
  • Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Rybrevant for NSCLC and has received this medication for at least 30 days
  • Member is responding positively to therapy
  • If request is for a dose increase, request meets one of the following:
    • New Dose does not exceed the appropriate weight-based dose every 2 weeks:
      • Body weight < 80 kg: 1,050 mg (3 vials)
      • Body weight ≥ 80 kg: 1,400 mg (4 vials)
    • New dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).
    • *Prescribed regimen must be FDA-approved or recommended by NCCN
• Approval duration: 12 months

Avapritinib (Ayvakit) (CP.PHAR.454)

Ambetter

Policy updates include:

• Added criteria for newly approved indication of advanced systemic mastocytosis

Betibeglogene autotemcel (CP.PHAR.545)

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

Policy includes:

• 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
• Criteria will mirror the clinical information from the prescribing information once FDA-approved
• Initial Approval Criteria: Transfusion-Dependent β-Thalassemia (must meet all):
  • Diagnosis of TDT with genetic confirmation
  • Prescribed by or in consultation with a hematologist;
  • Member meets one of the following:
    • Age ≥ 5 years and ≤ 50 years;
    • If age < 5 years, member meets both of the following:
      • Weight ≥ 6 kg
      • Provider submits medical rationale that member is anticipated to be able to provide at least the minimum number of cells required to initiate the manufacturing process
  • Documentation of one of the following in the two previous years:
    • Receipt of ≥ 8 transfusions of packed red blood cells (pRBC) per year
    • Receipt of ≥ 100 mL/kg pRBC per year
  • Member is eligible for an allogeneic hematopoietic stem cell transplantation (HSCT)
  • Member has not received prior allogeneic HSCT or gene therapy
  • Member does not have advanced liver disease
  • Member is not positive for the presence of HIV type 1 or 2, hepatitis B virus, or hepatitis C virus
  • Member does not have any prior or current malignancy
  • Dose does not exceed 20 x 106 CD34+ cells per kg.
  • Approval duration: 3 months (one time infusion per lifetime)
• Continuation Approval Criteria: Transfusion-Dependent β-Thalassemia
  • Re-authorization is not permitted.
  • Approval duration: Not applicable

Brexucabtagene Autoleucel (Tecartus) (CP.PHAR.472)

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

Policy updates include:

• Added preemptive criteria for the pending FDA approval of ALL indication
• Clarified Actemra authorization may be considered if requested.

Carbetocin (CP.PHAR.546)

Ambetter

Policy includes:

• 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
• Criteria will mirror the clinical information from the prescribing information once FDA-approved
• Initial Approval Criteria: Prader-Willi Syndrome (must meet all):
  • Diagnosis of PWS confirmed by genetic testing
  • Prescribed by or in consultation an endocrinologist or expert in rare genetic disorders of obesity
  • Age ≥ 7 years and ≤ 18 years
  • Objective signs of PWS nutritional phase 3 as evidenced by persistent hyperphagia
  • Documentation of current (within the last month) body mass index (BMI)
  • Documentation that member is actively enrolled in a weight loss program that involves a reduced calorie diet and increased physical activity adjunct to therapy
  • Dose does not exceed 9.6 mg of carbetocin per dose, three times daily
  • Approval duration: 8 weeks
• Continuation Approval Criteria: Prader-Willi Syndrome (must meet all):
  • Currently receiving medication via Centene benefit or member has previously met initial approval criteria
  • Member is responding positively to therapy evidenced by decrease in hyperphagia and decrease in BMI since baseline
  • If request is for a dose increase, new dose does not exceed 9.6 mg of carbetocin per dose, three times daily
  • Approval duration: 6 months

Fluticasone Propionate (Xhance) (CP.PMN.95)

Ambetter

Policy updates include:

• Modified requirement from 3 intranasal steroids including fluticasone to any 2 intranasal steroids
• Removed criteria requiring medical justification since 2021 consensus panel treatment algorithm now recommends Xhance after traditional intranasal steroids due to its unique delivery method and improved deposition of fluticasone

Infigratinib (Truseltiq) (CP.PHAR.547)

Ambetter

Policy includes:

• 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
• Initial Approval Criteria: Cholangiocarcinoma (must meet all):
  • Diagnosis of unresectable locally advanced or metastatic cholangiocarcinoma
  • Prescribed by or in consultation with an oncologist
  • Age ≥ 18 years
  • Documentation of FGFR2 fusion or rearrangement
  • Member has not previously received a selective FGFR inhibitor (e.g., Stivarga®, Pemazyre™)
  • Failure of at least one previous systemic cancer therapy
  • Request meets one of the following*:
    • Dose does not exceed 125 mg (2 capsules) per day
    • Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence)
  • *Prescribed regimen must be FDA-approved or recommended by NCCN
  • Approval duration: 6 months
• Continuation Approval Criteria: Cholangiocarcinoma (must meet all):
  • Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Truseltiq for a covered indication and has received this medication for at least 30 days
  • Member is responding positively to therapy
  • If request is for a dose increase, request meets one of the following:*
    • New dose does not exceed 125 mg (2 capsules) per day
    • New dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).
    • *Prescribed regimen must be FDA-approved or recommended by NCCN
  •  Approval duration: 12 months

Lisocabtagene maraleucel (Breyanzi) (CP.PHAR.483)

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

Policy updates include:

• Clarified per NCCN Compendium additional DLBCL transformed disease
• Added supported use for AIDS-related primary effusion lymphoma

Lumasiran (Oxlumo) (CP.PHAR.473)

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

Policy updates include:

• Revised requirement for a minimum response to pyridoxine treatment from “> 30% reduction in UOx excretion” to “normalization of UOx excretion levels”
• For reauthorization added improvement in spot UOx:Cr molar ratio along with symptomatic improvement as a pathway for reauthorization

Odevixibat (CP.PHAR.528)

Ambetter

Policy updates include:

• ·Drug is now FDA approved - criteria updated per FDA labeling: modified age restriction; removed minimum body weight restriction; updated dosing requirements to include allowable escalations

Ozanimod (Zeposia) (CP.PHAR.462)

Ambetter

Policy updates include:

• Added criteria for newly FDA-approved indication for ulcerative colitis

Palovarotene (CP.PHAR.548)

Ambetter

Policy includes:

• Criteria will mirror the clinical information from the prescribing information once FDA-approved
• 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
• Initial Approval Criteria: Fibrodysplasia Ossificans Progressive (must meet all):
  • Diagnosis of FOP
  • Prescribed by or in consultation with a pediatric or adult orthopedics, orthopedic surgery, rheumatology, endocrinology, or metabolic disease specialist
  • Age ≥ 4 years at therapy initiation
  • Presence of R206H ACVR1 mutation
  • Documentation of baseline HO volume assessed by low-dose whole body computed tomography (WBCT) scan, excluding the head
  • If this is the first request for use as flare-up treatment, failure of both of the following at up to maximally indicated doses, unless contraindicated or clinically significant adverse effects are experienced:
    • Corticosteroids used for flare-ups;
    • At least 2 nonsteroidal anti-inflammatory drugs (NSAIDs) between flare-ups;
  • Dose does not exceed the following:
    • Chronic treatment: 5 mg per day
    • Flare-up treatment: 20 mg per day for 28 days followed by 10 mg per daily 8 weeks
  • Approval duration: Chronic treatment – 6 months; Flare-up treatment – 3 months
• Continuation Approval Criteria: Fibrodysplasia Ossificans Progressive (must meet all):
  • Currently receiving medication via Centene benefit or member has previously met initial approval criteria
  • Member is responding positively to therapy as evidenced by one of the following:
    • Reduction in flare-ups;
    • Improvement in HO volume as assessed by low-dose WBCT scan;
  • If this is the first request for use as flare-up treatment, failure of both of the following at up to maximally indicated doses, unless contraindicated or clinically significant adverse effects are experienced:
    • Corticosteroids used for flare-ups
    • At least 2 nonsteroidal anti-inflammatory drugs (NSAIDs) between flare-ups
  • If request is for a dose increase, new dose does not exceed the following:
    • Chronic treatment: 5 mg per day
    • Flare-up treatment: 20 mg per day for 28 days followed by 10 mg per day for 8 weeks
  • Approval duration: Chronic treatment – 6 months; Flare-up treatment – 3 months

Risdiplam (Evrysdi) (CP.PHAR.477)

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

Policy updates include:

• Removed requirement for symptoms for members with SMN2 copies of 1 to 3

Sotorasib (Lumakras) (CP.PHAR.549)

Ambetter

Policy includes:

• 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
• Initial Approval Criteria: Non-Small Cell Lung Cancer (must meet all):
  • Diagnosis of locally advanced or metastatic NSCLC
  • Prescribed by or in consultation with an oncologist
  • Age ≥ 18 years
  • Disease is positive for KRAS G12C mutation
  • Failure of at least one systemic therapy, unless clinically significant adverse effects are experienced or all are contraindicated
  • Request meets one of the following:*
    • Dose does not exceed 960 mg (8 tablets) per day;
    • Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).
    • *Prescribed regimen must be FDA-approved or recommended by NCCN
  • Approval duration: 6 months
• Continuation Approval Criteria: Non-Small Cell Lung Cancer (must meet all):
  • Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Lumakras for a covered indication and has received this medication for at least 30 days
  • Member is responding positively to therapy
  • If request is for a dose increase, request meets one of the following:*
    • New dose does not exceed 960 mg (8 tablets) per day;
    • New dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).
    • *Prescribed regimen must be FDA-approved or recommended by NCCN
  • Approval duration: 12 months