Effective January 1, 2025: Pharmacy and Biopharmacy Policies

POLICY

APPLICABLE PRODUCTS

NEW POLICY OVERVIEW OR UPDATED POLICY REVISIONS

Crinecerfont (NBI-74788) (CP.PHAR.692)

Ambetter

Policy includes:

• Criteria will mirror the clinical information from the prescribing information once Food and Drug Administration (FDA) -approved
• Requests for indications not approved by the Food and Drug Administration (FDA)  are reviewed with the off-label use policy for the relevant line of business: HIM.PHAR.154 for Ambetter
• Initial Approval Criteria: Congenital Adrenal Hyperplasia (CAH) (must meet all):
  • Diagnosis of classic CAH;
  • Prescribed by or in consultation with an endocrinologist
  • Age at least 2 years; 
  • Medically confirmed diagnosis of classic 21-hydroxylase deficiency CAH based on one of the following:
    • Elevated 17-hydroxyprogesterone (17-OHP) level;
    • Confirmed CYP21A2 genotype;
    • Positive newborn screening with confirmatory second-tier testing (e.g., liquid chromatography – tandem mass spectrometry);
    • Cosyntropin stimulation test;
  • Member is currently receiving chronic glucocorticoid treatment for CAH (e.g., hydrocortisone, prednisone, prednisolone, methylprednisolone, dexamethasone);
  • NBI-74788 is prescribed in combination with glucocorticoid treatment;
  • Dose does not exceed 200 mg per day.
  • Approval duration: 6 months
• Continued Therapy: Congenital Adrenal Hyperplasia (must meet all):
  • Member meets one of the following:
    • Currently receiving medication via Centene benefit or member has previously met initial approval criteria;
    • Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations; 
  • Member is responding positively to therapy as evidenced by, including but not limited to, improvement in any of the following parameters:
    • Reduction in glucocorticoid dose;
    • Reduction in serum androstenedione (A4);
  • If request is for a dose increase, new dose does not exceed 200 mg per day.
  • Approval duration: 6 months

Glepaglutide (ZP1848) (CP.PHAR.694)

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

Policy includes:

• Criteria will mirror the clinical information from the prescribing information once Food and Drug Administration (FDA) -approved
• Requests for indications not approved by the Food and Drug Administration (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: Short Bowel Syndrome (SBS) (must meet all):
  • Diagnosis of SBS;
  • Prescribed by or in consultation with a gastroenterologist
  • Age at least 18 years;
  • Member is currently receiving parenteral support (i.e., parenteral nutrition and/or intravenous fluids) at least 3 days per week;
  • Glepaglutide is not prescribed concurrently with Gattex;
  • Dose does not exceed 20 mg per week.
  • Approval duration: Ambetter/Medicaid – 12 months
• Continued Therapy: Short Bowel Syndrome (must meet all):
  • Member meets one of the following:
    • Currently receiving medication via Centene benefit or member has previously met initial approval criteria;
    • Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations; 
  • Requirement for parenteral nutrition or other intravenous support has decreased since initiation of glepaglutide;
  • Glepaglutide is not prescribed concurrently with Gattex;
  • If request is for a dose increase, new dose does not exceed 20 mg per week
  • Approval duration: Ambetter/Medicaid – 12 months

Revakinagene Taroretcel (NT-501) (CP.PHAR.697)

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

Policy includes:

• Criteria will mirror the clinical information from the prescribing information once Food and Drug Administration (FDA) -approved
• Requests for indications not approved by the Food and Drug Administration (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: Macular Telangiectasia (MacTel) Type 2 (must meet all):
  • Diagnosis of MacTel type 2 confirmed by one of the following:
    • Fluorescein angiographic leakage of the retinal vessels;
    • Retinal opacification;
    • Crystalline deposits;
    • Right angle vessels;
    • Inner lamellar cavities;
    • Hyperpigmentation not involving the foveal center;
  • Prescribed by or in consultation with a retina specialist
  • Age at least 21 years;
  • Ellipsoid zone (EZ) disruption between 0.16 mm² and 2.00 mm² as measured by optical coherence tomography (OCT);
  • Member has not previously received an ocular implant containing NT-501 in the affected eye(s);
  • Dose does not exceed 1 ocular implant per eye.
  • Approval duration: 3 months (one implant per eye per lifetime)

• Continued Therapy: Macular Telangiectasia Type 2: 
  • Re-authorization is not permitted for previously treated eyes. If request is for treatment of an eye that has not previously received an ocular implant, members must meet the initial approval criteria.
  • Approval duration: Not applicable

Vanzacaftor/Tezacaftor/Deutivacaftor (VX-121/TEZ/VZ-561) (CP.PHAR.700)

Ambetter

Policy includes:

• Criteria will mirror the clinical information from the prescribing information once Food and Drug Administration (FDA) -approved
• Requests for indications not approved by the Food and Drug Administration (FDA)  are reviewed with the off-label use policy for the relevant line of business: HIM.PHAR.154 for Ambetter
• Initial Approval Criteria: Cystic Fibrosis (CF) (must meet all):
  • Diagnosis of CF confirmed by all of the following:
    •  Clinical symptoms consistent with CF in at least one organ system, or positive newborn screen or genetic testing for siblings of patients with CF;
    • Evidence of CFTR dysfunction confirmed by one of the following:
      • Elevated sweat chloride at least 60 mmol/L;
      • Genetic testing confirming the presence of two disease-causing mutations in CFTR gene, one from each parental allele;
    • Confirmation of one of the following:
      • Member has at least one F508del mutation in the CFTR gene;
      • Presence of at least one mutation in the CFTR gene that is responsive to vanzacaftor/tezacaftor/deutivacaftor;
  • Prescribed by or in consultation with a pulmonologist
  • Age at least 6 years; 
  • Documentation of member’s baseline precent predicted forced expiratory volume in 1 second (ppFEV1), performed within the last 90 days;
  • VX-121/TEZ/VX-561 is not prescribed concurrently with other CFTR modulators (e.g., Trikafta^®, Orkambi^®, Kalydeco^®, Symdeko^®)
  • Dose does not exceed one of the following:
    • Age 6 to less than 12 years: Food and Drug Administration (FDA)  maximum dose;
    • Age at least 12 years: vanzacaftor 20 mg/tezacaftor 100 mg/deutivacaftor 250 mg (1 tablet) per day.
  • Approval duration: 6 months
• Continued Therapy: Cystic Fibrosis (must meet all):
  • Member meets one of the following:
    • Currently receiving medication via Centene benefit or member has previously met initial approval criteria;
    • Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations;
  • Member is responding positively to therapy as evidenced by a stabilization or improvement (e.g., increase) in ppFEV1 from baseline;
  • VX-121/TEZ/VX-561 is not prescribed concurrently with other CFTR modulators (e.g., Trikafta, Orkambi, Kalydeco, Symdeko)
  • If request is for a dose increase, new dose does not exceed one of the following:
    • Age 6 to less than 12 years: Food and Drug Administration (FDA)  maximum dose;
    • Age at least 12 years: vanzacaftor 20 mg/tezacaftor 100 mg/deutivacaftor 250 mg (1 tablet) per day.
  • Approval duration: 12 months

Axatilimab-csfr (Niktimvo) (CP.PHAR.691)

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

Policy includes:

• Requests for indications not approved by the Food and Drug Administration (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: Graft-Versus-Host Disease (must meet all):
  • Diagnosis of chronic graft-versus-host disease  (cGVHD) post hematopoietic cell transplantation;
  • Prescribed by or in consultation with an oncologist, hematologist, or bone marrow transplant specialist;
  • Age at least 6 years;
  • Weight at least 40 kg;
  • Failure of a systemic corticosteroid at up to maximally indicated doses, unless contraindicated or clinically significant adverse effects are experienced;
  • Failure of a systemic immunosuppressant at up to maximally indicated doses, unless contraindicated or clinically significant adverse effects are experienced;
    • Prior authorization may be required
  • Niktimvo is not prescribed concurrently with Jakafi^®, Imbruvica^®, or Rezurock^®;
  • Request meets one of the following:
    • Dose does not exceed 0.3 mg/kg (up to maximum of 35 mg) every 2 weeks;
    • Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use. 
  • Approval duration: Medicaid/Ambetter – 6 months
• Continued Therapy: Graft-Versus-Host Disease (must meet all):
  • Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Niktimvo for a covered indication and has received this medication for at least 30 days; 
  • Member is responding positively to therapy;
  • Niktimvo is not prescribed concurrently with Jakafi, Imbruvica, or Rezurock;
  • If request is for a dose increase, request meets one of the following:
    • New dose does not exceed 0.3 mg/kg (up to maximum of 35 mg) every 2 weeks;
    • New dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use.
  • Approval duration: Medicaid/Ambetter – 12 months

Denileukin Diftitox-cxdl (Lymphir) (CP.PHAR.693)

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

Policy includes:

• Requests for indications not approved by the Food and Drug Administration (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: Cutaneous T-Cell Lymphoma (CTCL) (must meet all):
  • Diagnosis of CTCL
  • Prescribed by or in consultation with an oncologist or hematologist;
  • Age at least 18 years;
  • For CTCL subtypes that are not mycosis fungoides (MF) or Sezary syndrome, all of the following:
    • Disease is relapsed or refractory;
    • Disease is stage I, III, or III;
    • Failure of at least one prior systemic therapy;
  • Request meets one of the following:
    • Dose does not exceed 9 mcg/kg per day on days 1 to 5 of a 21-day cycle;
    • Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use. 
  • Approval duration: 6 months
• Continued Therapy: Cutaneous T-Cell Lymphoma (must meet all):
  • Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Lymphir 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 9 mcg/kg per day on days 1 to 5 of a 21-day cycle;
    • New dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use.
  • Approval duration: 6 months

Lazertinib (Lazcluze) (CP.PHAR.695)

Ambetter

Policy includes:

• Requests for indications not approved by the Food and Drug Administration (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 (NSCLC) (must meet all):
  • Diagnosis of locally advanced or metastatic NSCLC;
  • Prescribed by or in consultation with an oncologist;
  • Age at least 18 years; 
  • Disease is positive for EGFR exon 19 deletion(s) or exon 21 L858R substitution mutation(s);
  • Lazcluze is prescribed in combination with Rybrevant^® as first-line treatment;
  • For Lazcluze requests, member must use lazertinib, if available, unless contraindicated or clinically significant adverse effects are experienced;
  • Request meets one of the following:
    • Dose does not exceed both:
      • 240 mg per day;
      • 2 tablets per day;
    • Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use. 
  • Approval duration: 6 months
• Continued Therapy: Non-Small Cell Lung Cancer (must meet all):
  • Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Lazcluze for a covered indication and has received this medication for at least 30 days; 
  • Member is responding positively to therapy
  • For Lazcluze requests, member must use lazertinib, if available, unless contraindicated or clinically significant adverse effects are experienced;
  • If request is for a dose increase, request meets one of the following:
    • New dose does not exceed both:
      • 240 mg per day;
      • 2 tablets per day;
    • New dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use.
  • Approval duration: 12 months

Palopegteriparatide (Yorvipath) (CP.PHAR.696)

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

Policy includes:

• Requests for indications not approved by the Food and Drug Administration (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: Hypoparathyroidism (must meet all):
  • Diagnosis of hypoparathyroidism;
  • Prescribed by or in consultation with an endocrinologist;
  • Age at least 18 years;
  • At therapy initiation, Yorvipath is prescribed as an adjunct to calcium supplements and active forms of vitamin D (e.g., calcitriol), unless contraindicated or clinically significant adverse effects are experienced;
  • Recent (dated within the last 30 days) albumin-corrected serum calcium level is at least 7.8 mg/dL;
  • Recent (dated within the last 30 days) lab result shows serum 25-hydroxyvitamin D (25(OH)D) is within the laboratory defined normal range (e.g., 30-100 ng/mL, 75-250 nmol/L);
  • Failure of a 12-week trial of calcium supplements and active forms of vitamin D (e.g., calcitriol) at up to maximally indicated doses, unless contraindicated or clinically significant adverse events are experienced;
    • Prescriber must indicate that the hypocalcemia is not well controlled with calcium supplements and active forms of vitamin D. 
  • Dose does not exceed both of the following:
    • 30 mcg per day, administered as a single injection;
    • 2 pens per 28 days.
  • Approval duration: Medicaid/Ambetter – 6 months
• Continued Therapy: Hypoparathyroidism (must meet all):
  • Member meets one of the following:
    • Currently receiving medication via Centene benefit or member has previously met initial approval criteria;
    • Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations; 
  • Member is responding positively to therapy as evidenced by, including but not limited to, improvement in any of the following parameters:
    • Albumin-corrected serum calcium in the normal range (e.g., 8.3 to 10.6 mg/dL);
    • Independence from conventional therapy (e.g., no active vitamin D and elemental calcium supplementation ≤ 600 mg/day);
  • If request is for a dose increase, new dose does not exceed both of the following.
    • 30 mcg per day, administered as a single injection;
    • 2 pens per 28 days.
  • Approval duration: Medicaid/Ambetter – 6 months

Seladelpar (Livdelzi) (CP.PHAR.698)

Ambetter

Policy includes:

• Requests for indications not approved by the Food and Drug Administration (FDA)  are reviewed with the off-label use policy for the relevant line of business: HIM.PHAR.154 for Ambetter
• Initial Approval Criteria: Primary Biliary Cholangitis (PBC)(must meet all):
  • Diagnosis of PBC;
  • Prescribed by or in consultation with a hepatologist or gastroenterologist;
  • Age at least 18 years;
  • Failure (as evidenced by sustained elevation in ALP at least 1.67 times the upper limit of normal) of at least 12 month trial of UDCA (ursodiol) at a dose of at least 13 mg/kg/day, unless contraindicated or clinically significant adverse effects are experienced;
  • Prescribed in combination with UDCA, unless contraindicated or clinically significant adverse effects are experienced;
  • Dose does not exceed 10 mg (1 capsule) per day.
  • Approval duration: 6 months
• Continued Therapy: Primary Biliary Cholangitis (must meet all):
  • Member meets one of the following:
    • Currently receiving medication via Centene benefit or member has previously met initial approval criteria;
    • Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations; 
  • Member is responding positively to therapy as evidenced by one of the following:
    • Initial reauthorization: reduction in ALP level from pretreatment level;
    • Subsequent reauthorization: continued reduction or maintenance of initial reduction in ALP level;
  • If request is for a dose increase, new dose does not exceed 10 mg (1 capsule) per day.
  • Approval duration: 12 months

Vorasidenib (Voranigo) (CP.PHAR.699)

Ambetter

Policy includes:

• Requests for indications not approved by the Food and Drug Administration (FDA)  are reviewed with the off-label use policy for the relevant line of business: HIM.PHAR.154 for Ambetter
• Initial Approval Criteria: Glioma (must meet all):
  • Diagnosis of astrocytoma or oligodendroglioma;
  • Prescribed by or in consultation with an oncologist;
  • Age at least 12 years;
  • Disease is positive for an IDH1 or IDH2 mutation;
  • Disease is World Health Organization (WHO) grade 2 (i.e., a low-grade glioma);
  • Member has received surgery including biopsy, sub-total resection, or gross total resection;
  • Prescribed as a single agent;
  • For Voranigo requests, member must use vorasidenib, if available, unless contraindicated or clinically significant adverse effects are experienced;
  • Request meets one of the following:
    • For adults and pediatric patients with body weight at least 40 kg: Dose does not exceed both of the following:
      • 40 mg per day;
      • 1 tablet per day;
    • For pediatric patients with body weight less than 40 kg: Dose does not exceed both of the following:
      • 20 mg per day;
      • 2 tablets per day;
    • Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use.
  • Approval duration: 6 months
• Continued Therapy: Glioma (must meet all):
  • Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Voranigo for a covered indication and has received this medication for at least 30 days;
  •  Member is responding positively to therapy;
  • For Voranigo requests, member must use vorasidenib, if available, unless contraindicated or clinically significant adverse effects are experienced;
  • If request is for a dose increase, request meets one of the following:
    • For adults and pediatric patients with body weight at least 40 kg: Dose does not exceed both of the following:
      • 40 mg per day;
      • 1 tablet per day;
    • For pediatric patients with body weight less than 40 kg: Dose does not exceed both of the following:
      • 20 mg per day;
      • 2 tablets per day;
    • New dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use.
  • Approval duration: 12 months

Benralizumab (Fasenra) (HIM.PA.SP70)

Ambetter

Policy includes:

• Requests for indications not approved by the Food and Drug Administration (FDA)  are reviewed with the off-label use policy for the relevant line of business: HIM.PHAR.154 for Ambetter
• Initial Approval Criteria: Severe Asthma (must meet all):
  • Diagnosis of asthma;
  • Member has an absolute blood eosinophil count at least 150 cells/mcL within the past 3 months;
  • Prescribed by or in consultation with a pulmonologist, immunologist, or allergist;
  • Age at least 6 years;
  • Member has experienced at least 1 exacerbation within the last 12 months, requiring one of the following, despite adherent use of controller therapy (i.e., medium- to high-dose inhaled corticosteroid [ICS] plus a long-acting beta₂ agonist [LABA] or ICS plus one additional asthma controller medication):
    • Oral/systemic corticosteroid treatment (or increase in dose if already on oral corticosteroid);
    • Urgent care/emergency room (ER) visit or hospital admission;
  • Fasenra is prescribed concurrently with an ICS plus either a LABA or one additional asthma controller medication;
  • Fasenra is not prescribed concurrently with Cinqair^®, Nucala^®, Dupixent^®, Xolair^®, or Tezspire^®;
  • Dose does not exceed:
    • Age 6 to 11 years and weight less than 35 kg: 10 mg every 4 weeks for the first 3 doses, then 10 mg every 8 weeks thereafter;
    • Age at least 6 years and weight at least 35 kg: 30 mg every 4 weeks for the first 3 doses, then 30 mg every 8 weeks thereafter.
  • Approval duration: 6 months
• Continued Therapy: Severe Asthma (must meet all):
  • Member meets one of the following:
    • Currently receiving medication via Centene benefit or member has previously met initial approval criteria;
    • Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations;
  •  Demonstrated adherence to asthma controller therapy (an ICS plus either a LABA or one additional asthma controller medication) as evidenced by proportion of days covered (PDC) of 0.8 in the last 6 months (i.e., member has received asthma controller therapy for at least 5 of the last 6 months);
  • Member is responding positively to therapy (examples may include but are not limited to: reduction in exacerbations or corticosteroid dose, improvement in forced expiratory volume over one second since baseline, reduction in the use of rescue therapy);
  • Fasenra is not prescribed concurrently with Cinqair, Nucala, Dupixent, Xolair, or Tezspire;
  • If request is for a dose increase, new dose does not exceed:
    • Age 6 to 11 years  and  weight less than 35 kg: 10 mg every 4 weeks for the first 3 doses, then 10 mg every 8 weeks thereafter;
    • Age at least 6 years and weight at least 35 kg: 30 mg every 4 weeks for the first 3 doses, then 30 mg every 8 weeks thereafter.
  • Approval duration: 12 months

Naltrexone (Vivitrol) (CP.PHAR.96)

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

Policy updates include:

• For alcohol dependence, removed requirement for alcohol screening test and revised to “member has abstained from drinking prior to Vivitrol therapy”

Venetoclax (Venclexta) (CP.PHAR.129)

Ambetter

Policy updates include:

• For chronic lymphocytic leukemia/small lymphocytic lymphoma, added Gazyva as combination therapy option for relapsed/refractory disease per National Comprehensive Cancer Network (NCCN)
• For acute myeloid leukemia, removed medical justification for inability to use intensive induction chemotherapy criterion as National Comprehensive Cancer Network (NCCN) additionally supports member declining or being generally ineligible for intensive induction therapy
• For mantle cell lymphoma, added option for combination with Gazyva and Imbruvica scenario per National Comprehensive Cancer Network (NCCN)
• Added chronic myelomonocytic leukemia (CMML)-2, hairy cell leukemia, myeloproliferative neoplasm, and pediatric acute lymphoblastic leukemia as off-label recommended indications per National Comprehensive Cancer Network (NCCN)

Ivosidenib (Tibsovo) (CP.PHAR.137)

Ambetter

Policy updates include:

• Renamed section I.E. from “Oligodendroglioma” to “Glioma,” removed qualifiers of “recurrent or progressive” from oligodendroglioma, and added astrocytoma as potential diagnosis per National Comprehensive Cancer Network (NCCN)

Ribavirin (Rebetol, Ribasphere RibaPak) (CP.PHAR.141)

Ambetter

Policy updates include:

• Removed references to brand Rebetol and Ribasphere Ribapak as ribavirin brands are no longer available
• Removed generic redirection criterion
• Removed requirement for “chronic” in hepatitis C virus (HCV) diagnosis as ribavirin and HCV antiviral combinations are also recommended for acute HCV infections per American Association for the Study of Liver Diseases (AASLD) guidance
• Removed specialist criterion and accompanying Appendix E
• Added disclaimer that medical management techniques, including quantity management, beyond step therapy are not allowed for members in Nevada per Senate Bill 439

Baclofen (Fleqsuvy, Gablofen, Lioresal, Lyvispah, Ozobax) (CP.PHAR.149)

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

Policy updates include:

• Added Ozobax DS formulation to policy
• For requests for Fleqsuvy, Lyvispah or Ozobax/Ozobax DS, removed requirement for compounded baclofen oral solution or baclofen crushed or split tablets and added requirement for generic baclofen oral solution

Irinotecan Liposome (Onivyde) (CP.PHAR.304)

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

Policy updates include:

• Updated Food and Drug Administration (FDA)  approved indications section to align with prescriber information
• Updated continued therapy section from “pancreatic adenocarcinoma” to “all indications in Section I”
• Added ampullary adenocarcinoma off-label criteria as supported by National Comprehensive Cancer Network (NCCN) compendium and guideline

Obinutuzumab (Gazyva) (CP.PHAR.305)

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

Policy updates include:

• Added Commercial line of business for use in medical coverage determinations
• For chronic lymphocytic leukemia/small lymphocytic lymphoma removed requirement for del(17p)/TP53-negative status per National Comprehensive Cancer Network (NCCN) Compendium
• For B-cell lymphomas, added option for Gazyva monotherapy prior to Columvi administration for specific lymphomas and for follicular lymphoma removed requirement for combination chemotherapy in second line and subsequent therapy per National Comprehensive Cancer Network (NCCN)
• For hairy cell leukemia, clarified that member must be unable to tolerate purine analogs per National Comprehensive Cancer Network (NCCN) and removed active infection as an option for criteria consolidation

Romidepsin (Istodax) (CP.PHAR.314)

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

Policy updates include:

• For initial therapy, added criteria option “unless peripheral T-cell lymphoma and request is for palliative therapy” under criteria “Failure of at least one prior systemic therapy” to align with National Comprehensive Cancer Network (NCCN) compendium and guideline
• For Appendix D, updated subtypes for World Health Organization–European Organization for Research and Treatment of Cancer (WHO-EORTC) Classification of cutaneous T-cell lymphoma with Primary Cutaneous Manifestations
• For Appendix E, updated subtypes for Peripheral T-Cell Lymphomas

Temsirolimus (Torisel) (CP.PHAR.324)

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

Policy updates include:

• Updated “Endometrial Carcinoma” indication to “Uterine Neoplasms” per National Comprehensive Cancer Network (NCCN) compendium as Uterine Neoplasms include both endometrial carcinoma and uterine sarcoma

Pasireotide (Signifor, Signifor LAR) (CP.PHAR.332)

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

Policy updates include:

• For acromegaly, revised initial criteria from “(growth hormone) level at least 1 μg/ml” to “(growth hormone) level at least 1 μg/L” per PS/ES practice guidelines and Acromegaly Consensus Group

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

Ambetter

Policy updates include:

• For hypogonadism serum testosterone requirement added allowance for levels less than the lab reference range

Abemaciclib (Verzenio) (CP.PHAR.355)

Ambetter

Policy updates include:

• Added criteria for endometrial carcinoma as off-label indication is supported by National Comprehensive Cancer Network (NCCN) compendium and guidelines
• For Appendix D, updated high risk breast cancer definition to align with National Comprehensive Cancer Network (NCCN) compendium

Gemtuzumab Ozogamicin (Mylotarg) (CP.PHAR.358)

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

Policy updates include:

• For acute myeloid leukemia, collapsed combination therapy options for newly diagnosed disease to “combination with chemotherapy” as there are various recommended combinations per National Comprehensive Cancer Network (NCCN)
• Revised Commercial approval duration to “6 months or to the member’s renewal date, whichever is longer” for this injectable drug

Inotuzumab Ozogamicin (Besponsa) (CP.PHAR.359)

Ambetter

Policy updates include:

• Removed criterion that Besponsa is prescribed as induction therapy for Philadelphia chromosome-negative disease per National Comprehensive Cancer Network (NCCN)
• Revised Commercial approval durations to “6 months or to the member’s renewal date, whichever is longer;”

Enasidenib (Idhifa) (CP.PHAR.363)

Ambetter

Policy updates include:

• Consolidated National Comprehensive Cancer Network (NCCN) Compendium scenarios and removed age at least 60 years requirement for use in non-relapsed/refractory disease per National Comprehensive Cancer Network (NCCN)
• Added Idhifa combination with azacitidine per National Comprehensive Cancer Network (NCCN)

Neratinib (Nerlynx) (CP.PHAR.365)

Ambetter

Policy updates include:

• For initial criteria, added “paclitaxel” as an option to criterion “prescribed in combination with capecitabine or paclitaxel for central nervous system brain metastases” as supported by National Comprehensive Cancer Network (NCCN) compendium and guidelines

Pegvisomant (Somavert) (CP.PHAR.389)

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

Policy updates include:

• For acromegaly, revised initial criteria from “(growth hormone) level at least 1 µg/ml” to “(growth hormone) level at least 1 µg/L” per PS/ES practice guidelines and Acromegaly Consensus Group
• Removed inactive HCPCS code C9399 and updated J3590 HCPCS code description to “unclassified biologics”

Lanreotide (Somatuline Depot and Unbranded) (CP.PHAR.391)

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

Policy updates include:

• For acromegaly, revised initial criteria from “(growth hormone) level at least 1 µg/ml” to “(growth hormone) level at least 1 µg/L” per PS/ES practice guidelines and Acromegaly Consensus Group
• For neuroendocrine tumors, added to initial criteria “diagnosis of diffuse idiopathic pulmonary neuroendocrine cell hyperplasia” and revised “bronchopulmonary neuroendocrine tumor (NET)” to “lung neuroendocrine tumor (NET)” per National Comprehensive Cancer Network (NCCN) compendium and guideline
• Updated Appendix D “National Comprehensive Cancer Network (NCCN) guidelines - Neuroendocrine and Adrenal Tumors” supplemental information

Cemiplimab-rwlc (Libtayo) (CP.PHAR.397)

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

Policy updates include:

• For cutaneous squamous cell carcinoma, added option for disease is recurrent and prescribed in neoadjuvant setting
• non-small cell lung cancer, added option for disease is recurrent
• For basal cell carcinoma, removed criterion requiring previous treatment with a hedgehog pathway inhibitor per National Comprehensive Cancer Network (NCCN)
• Added National Comprehensive Cancer Network (NCCN) supported recommended uses (off-label) section to include: cervical cancer, vaginal, vulvar cancer

Antithymocyte Globulin (Atgam, Thymoglobulin) (CP.PHAR.506)

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

• Added National Comprehensive Cancer Network (NCCN) supported recommended uses (off-label) section to include immunotherapy-related cardiovascular toxicity, CAR t-cell-related toxicity, graft-verus-host disease, and myelodysplastic syndrome

Belzutifan (Welireg) (CP.PHAR.553)

Ambetter

Policy updates include:

• Added options for combination therapy for indication of von Hippel-Lindau -associated pancreatic neuroendocrine tumors per National Comprehensive Cancer Network (NCCN) Compendium
• Removed single-agent therapy criterion for continued therapy

Efgartigimod alfa, efgartigimod-hyaluronidase (Vyvgart, Vyvgart Hytrulo) (CP.PHAR.555)

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

Policy updates include:

• Added new indication of chronic inflammatory demyelinating polyneuropathy for Vyvgart Hytrulo
• Updated Commercial approval durations from 6/12 months to “6 months or to the member’s renewal date, whichever is longer” since this is an injectable agent.

Fidanacogene Elaparvovec-dzkt (Beqvez) (CP.PHAR.643)

Ambetter

Policy updates include:

• Revised baseline severity and treatment history criteria from required use of a factor IX product for at least 6 months with at least 1 serious spontaneous bleed to current use of a factor IX product with timeframe removal, added option of current or historical life-threatening hemorrhage, and modified option of repeated, serious spontaneous bleeding episodes to align with Food and Drug Administration (FDA)  labeling and Hemgenix criteria

Quizartinib (Vanflyta) (CP.PHAR.646)

Ambetter

Policy updates include:

• Removed exclusion for use as maintenance monotherapy following allogeneic hematopoietic stem cell transplantation as this is supported for off-label use per National Comprehensive Cancer Network (NCCN)

Resmetirom (Rezdiffra) (CP.PHAR.647)

Ambetter

Policy updates include:

• Revised “biomarkers” to more broadly applicable “assessments”
• Added example of magnetic resonance elastography to imaging-based assessment
• Removed redirection to pioglitazone per competitor analysis

Request for Medically Necessary Drug Not on the PDL (CP.PMN.16)

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

Policy updates include:

• Added bypass of preferred agent and combination products redirection if request is for treatment associated with cancer for a State with regulations against step therapy in certain oncology settings along with Appendix E
• Added depression and transplant to list of continuity of care programs per current Centene standard approach.

Cyclosporine (Cequa, Restasis, Verkazia, Vevye, Klarity-C) (CP.PMN.48)

Ambetter

Policy updates include:

• Added Klarity-C to policy

Quantity Limit Override and Dose Optimization (CP.PMN.59)

Ambetter

Policy updates include:

• Added depression and transplant to list of continuity of care programs per current Centene standard approach.

Isotretinoin (Absorica, Absorica LD, Amnesteem, Claravis, Myorisan, Zenatane) (CP.PMN.143)

Ambetter

Policy updates include:

• In initial approval criteria, clarified that combination products may require prior authorization, removed redirection to specific concentrations for benzoyl peroxide and tretinoin, removed redirection to trimethoprim-sulfamethoxazole per acne guideline
• Updated Appendix B per Clinical Pharmacology

Ciprofloxacin/Dexamethasone (Ciprodex) (CP.PMN.248)

Ambetter

Policy updates include:

• For otitis media with tympanostomy tubes, revised oral antibiotic requirement to systemic antibiotic
• Removed commercial unavailable brand therapeutic alternatives

No Coverage Criteria, Recent Label Changes Pending Clinical Policy Update (CP.PMN.255)

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

Policy updates include:

• Added depression and transplant to list of continuity of care programs

Inhaled Agents for Asthma and COPD (CP.PMN.259)

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

Policy updates include:

• Added newly approved agent Ohtuvayre with redirections

Finerenone (Kerendia) (CP.PMN.266)

Ambetter

Policy updates include:

• For initial criteria, removed upper estimated glomerular filtration rate (Egfr) limit of 75 ml/min/1.73 m2 and added concurrent sodium-glucose co-transporter 2 (SGLT) inhibitor use as an option to failure of an SGLT2 inhibitor per competitor analysis and guidelines

Ulcer Therapy Products (CP.PMN.277)

Ambetter

Policy updates include:

• Added criteria for Voquezna’s new indication of non-erosive gastroesophageal reflux disease

Insulin Glargine (Rezvoglar, Semglee, Toujeo) (HIM.PA.09)

Ambetter

Policy updates include:

• Removed age restriction to align with class approach for other insulin products

Methoxsalen (Uvadex) (HIM.PA.17)

Ambetter

Policy updates include:

• Per National Comprehensive Cancer Network (NCCN), added peginterferon alfa-2a as an alternative prior therapy option
• For continued therapy, revised total allowable courses of therapy from 7 to 20 per Food and Drug Administration (FDA)  labeling and consistent with the limit specified in the approval duration

Testosterone (Androderm) (HIM.PA.87)

Ambetter

Policy updates include:

• For hypogonadism serum testosterone requirement added allowance for levels less than the lab reference range

Brand Name Override and Non-Formulary Medications (HIM.PA.103)

Ambetter

Policy updates include:

• Added bypass of formulary agent and combination products redirection if request is for treatment associated with cancer for a State with regulations against step therapy in certain oncology settings along with Appendix F

Azelaic Acid (Finacea Topical Gel/Foam) (HIM.PA.119)

Ambetter

Policy updates include:

• Removed redirection to topical ivermectin per non-formulary status
• In Appendix B, clarified oral minocycline is used off-label for rosacea

Inhaled Agents for Asthma and COPD (HIM.PA.153)

Ambetter

Policy updates include:

• Added newly approved agent Ohtuvayre with redirections

Off-Label Drug Use (HIM.PA.154)

Ambetter

Policy updates include:

• Added bypass to all redirections for States with regulations against redirections in certain mental health settings
• Added depression and transplant to list of continuity of care programs per current Centene standard approach
• For pharmacy benefit criteria, added option for trial of alternative agents to be for an appropriate duration of treatment

Asfotase Alfa (Strensiq) (CP.PHAR.328)

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

Policy updates include:

• Added elevated inorganic pyrophosphate (PPi) level as an additional biochemical marker of decreased alkaline phosphatase (ALP) activity based on the pathophysiology of hypophosphatasia
• Added information regarding the need to stop pyridoxine supplementation one week prior to measuring plasma pyridoxal 5’-phosphate (PLP) to ensure accurate assessments of endogenous PLP levels
• Added new Boxed Warning from a recent label update

Continuous Glucose Monitors (CP.PMN.214)

Ambetter

Policy updates include:

• For continued therapy, added option for member to have previously met the initial approval criteria

Leuprolide Acetate (Lupron, Eligard, Lupaneta Pack, Fensolvi, Camcevi) (CP.PCH.53)

Ambetter

Policy includes:

• Requests for indications not approved by the Food and Drug Administration (FDA) are reviewed with the off-label use policy for the relevant line of business: HIM.PHAR.154 for Ambetter
• Initial Approval Criteria:
  • Prostate Cancer (must meet all):
    • Diagnosis of prostate cancer;
    • Request is for one of the following:
      • Leuprolide acetate injection;
      • Camcevi;
      • Eligard;
      • Lupron Depot;
    • Prescribed by or in consultation with an oncologist or urologist;
    • Age ≥ 18 years;
    • Request meets one of the following:
      • Leuprolide acetate injection (SC): Dose does not exceed 1 mg per day;
      • Camcevi (SC): Dose does not exceed 42 mg per 6 months;
        • Eligard (SC)/Lupron Depot (IM): Dose does not exceed 7.5 mg per month, 22.5 mg per 3 months, 30 mg per 4 months, 45 mg per 6 months;
        • 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: HIM – 12 months
  • Endometriosis (must meet all:
    •  Diagnosis of endometriosis;
    • Request is for Lupron Depot (3.75 mg, 11.25 mg);
    • Prescribed by or in consultation with a gynecologist;
    • Age ≥ 18 years;
    • Endometriosis as a cause of pain is one of the following:
      • Surgically confirmed;
      • Both of the following:
        • Clinically suspected;
        • Failure of a 3-month trial of one of the following within the last year, unless clinically adverse effects are experienced or all are contraindicated:
          • A nonsteroidal anti-inflammatory drug;
          • An oral or injectable depot contraceptive;
          • A progestin;
        • For members currently receiving treatment with leuprolide, total duration of therapy has not exceeded 12 months;
        • Dose does not exceed 3.75 mg per month or 11.25 mg per 3 months
    • Approval duration: HIM – 6 months
  • Uterine Fibroids (must meet all):
    • Diagnosis of anemia secondary to uterine leiomyomata (fibroids);
    • Diagnosis is confirmed by ultrasound;
    • Request is for Lupron Depot (3.75 mg, 11.25 mg); 
    • Prescribed by or in consultation with gynecologist;
    • Age ≥ 18 years;
    • Lupron Depot is prescribed concurrently with iron therapy;
    • Prescribed preoperatively to reduce fibroid size and improve hematologic control;
    • For members currently receiving treatment with leuprolide, total duration of therapy has not exceeded 3 months per treatment course;
    • Dose does not exceed 3.75 mg per month or 11.25 mg per 3 months.
    • Approval duration: 3 months
  • Central Precocious Puberty (CPP) (must meet all):
    • Member meets one of the following:
      • Diagnosis of CPP confirmed by all of the following:
        • Elevated basal luteinizing hormone (LH) level > 0.2 - 0.3 mIU/mL (dependent on type of assay used) and/or elevated leuprolide-stimulated LH level > 3.3 - 5 IU/L (dependent on type of assay used);
        • Difference between bone age and chronological age was > 1 year (bone age-chronological age);
        • Age at onset of secondary sex characteristics:
          • Female: < 8 years;
          • Male: < 9 years;
    • Request is for diagnostic use;
  • Request is for one of the following:
    • Fensolvi;
    • Leuprolide acetate;
    • Lupron Depot-Ped: 7.5 mg, 11.25 mg, 15 mg, 30 mg, 45 mg;
    • Prescribed by or in consultation with a pediatric endocrinologist;
    • Member meets one of the following age requirements:
      • Female: 2 - 11 years;
      • Male: 2 - 12 years;
    • Dose does not exceed the following:
      • Diagnostic use: Leuprolide acetate: 20 mcg/kg or as needed;
      • Therapeutic use: Fensolvi: 45 mg per 6 months;
      • Therapeutic use: Leuprolide acetate (SC): Initial: 50 mcg/kg per day; titrate dose upward by 10 mcg/kg per day if down-regulation is not achieved (higher mg/kg doses may be required in younger children).
      • Therapeutic use: Lupron Depot-Ped (IM): 15 mg per month (1-month formulation), 30 mg per 3 months (3-month formulation) or 45 mg per 6 months (6-month formulation) (dosing is weight-based for a 1-month and a 3-month formulations).
    • Approval duration: HIM – 12 months
  • Breast and Ovarian Cancer (off-label) (must meet all): 
    • Diagnosis of hormone receptor-positive breast cancer or ovarian cancer (including fallopian tube and primary peritoneal cancer);
    • Request is for Lupron Depot;
    • Prescribed by or in consultation with an oncologist
    • Age ≥ 18 years;
    • Request meets one of the following:*
      • Breast or ovarian cancer: Dose does not exceed 3.75 mg per month or 11.25 mg per 3 months;
      • Ovarian cancer: Dose does not exceed 7.5 mg per month, 11.25 mg per 3 months, 22.5 mg per 3 months;
      • 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: HIM – 12 months
  • Gender Dysphoria, Gender Transition (off-label) (must meet all):
    • Diagnosis of gender dysphoria or request is for gender transition;
    • Prescribed by or in consultation with both of the following:
      • An endocrinologist;
      • A provider with expertise in gender dysphoria and transgender medicine based on a certified training program or affiliation with local transgender health services (e.g., mental health professional such as psychologist, psychiatrist, see Appendix D);
    • Age and pubertal development - meets one of the following:
      • Member is < 18 years of age and has reached or passed through Tanner Stage 2*; *Age ranges approximating Tanner Stage 2 pubertal development extend from 8 to 13 years of age in girls and 9 to 14 years of age in boys.
      • Member is ≥ 18 years of age and has failed to achieve physiologic hormone levels with gender-affirming hormonal therapy (e.g., estrogen, testosterone) unless contraindicated or clinically significant adverse effects are experienced;
    • Member demonstrates understanding of expected gonadotropin-releasing hormone (GnRH) analogue treatment outcomes and has given consent for such treatment;
    • If member has a psychiatric comorbidity, member is followed by mental health provider;
    • Psychosocial support will be provided during treatment;
    • Dose is within FDA maximum limit for any FDA-approved indication (see Section V) or is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).
    • Approval duration: HIM – 12 months
  • Salivary Gland Tumors (off-label) (must meet all):
    • Diagnosis of salivary gland tumors;
    • Disease is androgen receptor positive and recurrent, unresectable, or metastatic;
    • Prescribed by or in consultation with an oncologist;
    • Request is for one of the following:
      • Eligard;
      • Lupron Depot;
    • Dose is within FDA maximum limit for any FDA-approved indication (see Section V) or 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: HIM – 12 months

• Continued Therapy:
  • Prostate Cancer (must meet all):
    • Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving leuprolide acetate injection, Camcevi, Eligard, or Lupron Depot for prostate cancer and has received this medication for at least 30 days;
    • Request is for one of the following:
      • Leuprolide acetate injection;
      • Camcevi;
      • Eligard;
      • Lupron Depot;
    • Member is responding positively to therapy;
    • If request is for a dose increase, request meets one of the following:*
      • Leuprolide acetate injection (SC): New dose does not exceed 1 mg per day;
      • Camcevi (SC): New dose does not exceed 42 mg per 6 months;
      • Eligard (SC)/Lupron Depot (IM): New dose does not exceed 7.5 mg per month, 22.5 mg per 3 months, 30 mg per 4 months, 45 mg per 6 months;
      • 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: HIM – 12 months
    • Endometriosis (must meet all):
      • meets one of the following:
        • Currently receiving medication via Centene benefit or member has previously met initial approval criteria;
        • Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations;
      • Request is for Lupron Depot (3.75 mg, 11.25 mg); 
      • Member is responding positively to therapy as evidenced by improvement in any of the following parameters, including but not limited to: dysmenorrhea, dyspareunia, pelvic pain/induration/tenderness, or size of endometrial lesions;
      • Total duration of leuprolide therapy has not exceeded 12 months;
      • If request is for a dose increase, new dose does not exceed 3.75 mg per month or 11.25 mg per 3 months.
      • Approval duration:  HIM – up to a total treatment duration of 12 months
  • Uterine Fibroids:
    • Re-authorization is not permitted. Members must meet the initial approval criteria.
    • Approval duration: Not applicable
  • Central Precocious Puberty (must meet all):
    • Member meets one of the following:
      • Currently receiving medication via Centene benefit or member has previously met initial approval criteria;
      • Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations;
    • Request is for one of the following:
      • Fensolvi;
      • Leuprolide acetate;
      • Lupron Depot-Ped: 7.5 mg, 11.25 mg, 15 mg, 30 mg, 45 mg;
    • Member is responding positively to therapy as evidenced by, including but not limited to, improvement in any of the following parameters: decreased growth velocity, cessation of menses, softening of breast tissue or testes, arrested pubertal progression;
    • Member meets one of the following age requirements:
      •  Female: ≤ 11 years;
      • Male: ≤ 12 years;
    • If request is for a dose increase, new dose does not exceed one of the following (a, b or c):
      • Leuprolide acetate (SC): Initial: 50 mcg/kg per day; titrate dose upward by 10 mcg/kg per day if down-regulation is not achieved (higher mg/kg doses may be required in younger children);
      • Lupron Depot-Ped (IM): 15 mg per month (1-month formulation), 30 mg per 3 months (3-month formulation) or 45 mg per 6 months (6-month formulation) (dosing is weight-based for a 1-month and a 3-month formulations);
      • Fensolvi: 45 mg per 6 months.
    • Approval duration: HIM – 12 months
  • Breast and Ovarian Cancer (off-label) (must meet all): 
    •  Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Lupron Depot for hormone receptor-positive breast cancer or ovarian cancer and has received this medication for at least 30 days;
    • Request is for Lupron Depot;
    • Member is responding positively to therapy;
    • If request is for a dose increase, request meets one of the following:*
      • Breast or ovarian cancer: New dose does not exceed 3.75 mg per month or 11.25 mg per 3 months;
      • Ovarian cancer: New dose does not exceed 7.5 mg per month, 11.25 mg per 3 months, 22.5 mg per 3 months;
      • 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: HIM – 12 months
  • Gender Dysphoria, Gender Transition (off-label) (must meet all):
    • Member meets one of the following:
      • Currently receiving medication via Centene benefit or member has previously met initial approval criteria;
      • Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations;
    • Member is responding positively to therapy (e.g., member continues to meet their individual goals of therapy for gender dysphoria);
    • If request is for a dose increase, new dose is within FDA maximum limit for any FDA-approved indication (see Section V) or is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).
    • Approval duration: HIM – 12 months
  • Salivary Gland Tumors (off-label) (must meet all):
    • Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Eligard or Lupron Depot for salivary gland tumors and has received this medication for at least 30 days ;
    • Request is for one of the following:
      • Eligard;
      • Lupron Depot;
    • Member is responding positively to therapy;
    • If request is for a dose increase, new dose is within FDA maximum limit for any FDA-approved indication (see Section V) or is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).
    • Approval duration: HIM – 12 months

Inavolisib (Itovebi) (CP.PHAR.702)

Ambetter

Policy includes:

• Requests for indications not approved by the Food and Drug Administration (FDA) are reviewed with the off-label use policy for the relevant line of business: HIM.PHAR.154 for Ambetter
• Initial Approval Criteria: Breast Cancer (must meet all):
  • Diagnosis of breast cancer;
  • Prescribed by or in consultation with an oncologis;
  • Age ≥ 18 years;
  •  Disease has all of the following characteristics:
    • HR-positive (i.e., estrogen or progesterone receptor [ER/PR]-positive);
    • HER2-negative;
    • Locally advanced or metastatic;
    • Positive for PIK3CA mutation;
  • Itovebi is prescribed in combination with palbociclib and fulvestrant;
  • Disease progression or recurrence on or after adjuvant endocrine therapy;
  • Member has been treated with ovarian ablation or is receiving ovarian suppression, unless member is post-menopausal woman;
  • For Itovebi requests, member must use inavolisib, if available, unless contraindicated or clinically significant adverse effects are experienced;
  • Request meets one of the following:
    • Dose does not exceed both of the following:
      • 9 mg per day;
      • 2 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

• Continued Therapy: Breast Cancer (must meet all):
  • Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Itovebi for breast cancer and has received this medication for at least 30 days;
  •  Member is responding positively to therapy;
  • For Itovebi requests, member must use inavolisib, if available, unless contraindicated or clinically significant adverse effects are experienced;
  • If request is for a dose increase, request meets one of the following:
    • New dose does not exceed both of the following:
      • 9 mg per day;
      • 2 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

Nemolizumab-ito (Nemluvio) (CP.PHAR.703)

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

Policy includes:

• Requests for indications not approved by the Food and Drug Administration (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: Prurigo Nodularis (PN) (must meet all):
  • Diagnosis of PN with documentation of both of the following:
    • Numeric rating scale ≥ 7 on a scale of 0 (“no itch”) to 10 (“worst imaginable itch”) (e.g., Peak Pruritus Numeric Rating Scale, Worst Itch-Numeric Rating Scale);
    • ≥ 20 nodular lesions total on both legs, and/or both arms and/or trunk;
  • Prescribed by or in consultation with a dermatologist;
  • Age ≥ 18 years;
  •  Failure of a ≥ 2-week course of a medium to very high potency topical corticosteroid, unless contraindicated or clinically significant adverse effects are experienced;
  • Nemluvio is not prescribed concurrently with another biologic immunomodulator (e.g., Dupixent^®) or JAK inhibitor (e.g., Olumiant^®, Rinvoq^®, Cinbinqo^®, Opzelura^®);
  • Dose does not exceed one of the following:
    • Weight < 90 kg: 60 mg once, followed by 30 mg every 4 weeks;
    • Weight ≥ 90 kg: 60 mg once, followed by 60 mg every 4 weeks.
  • Approval duration: Medicaid/HIM – 6 months

• Continued Therapy: Prurigo Nodularis (must meet all):
  • Member meets one of the following:
    • Currently receiving medication via Centene benefit or member has previously met initial approval criteria;
    • Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations;
  • Member is responding positively to therapy (examples may include but are not limited to: improvement in itching or skin pain, reduction in number of nodules);
  •  Nemluvio is not prescribed concurrently with another biologic immunomodulator (e.g., Dupixent) or JAK inhibitor (e.g., Olumiant, Rinvoq, Cinbinqo, Opzelura);
  • If request is for a dose increase, new dose does not exceed one of the following:
    • Weight < 90 kg: 30 mg every 4 weeks;
    • Weight ≥ 90 kg: 60 mg every 4 weeks.
  • Approval duration: Medicaid/HIM – 12 months

Brivaracetam (Briviact) (CP.PMN.297)

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

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, and CP.PMN.53 for Medicaid and CHIP
• Initial Approval Criteria: Partial-Onset Seizure (must meet all):
  • Diagnosis of partial-onset seizure;
  • Age ≥ 1 month;
  • Failure of two preferred agents* for partial-onset seizures (see Appendix B), unless  clinically significant adverse effects are experienced or all are contraindicated;
    • *May require prior authorization.
  • If request is for intravenous (IV) Briviact, oral Briviact administration is temporarily not feasible (e.g., status epilepticus, reliance on gastrostomy tube, recent oral or neck surgery, esophageal condition or intraoral infection, myasthenia gravis or other neuromuscular condition);
  • Documentation of member’s current weight, for dose calculation purposes;
  • Dose does not exceed any of the following (a-d):
    • For adults and pediatric members weighing ≥ 50 kg:
      • 200 mg per day;
      • One of the following:
  • 2 tablets per day;
  • 20 mL per day;
    • For pediatric members weighing 20 kg to < 50 kg: 4 mg/kg per day;
    • For pediatric members weighing 11 kg to < 20 kg: 5 mg/kg per day;
    • For pediatric members weighing < 11 kg: 6 mg/kg per day.
  • Approval duration: 12 months (oral formulation); 1 month (IV formulation)

• Continued Therapy: Partial-Onset Seizure (must meet all):
  • Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Briviact for a covered indication and has received this medication for at least 30 days;
  •  Member is responding positively to therapy;
  • If request is for intravenous (IV) Briviact, oral Briviact administration is temporarily not feasible (e.g., status epilepticus, reliance on gastrostomy tube, recent oral or neck surgery, esophageal condition or intraoral infection, myasthenia gravis or other neuromuscular condition);
  •  Documentation of member’s current weight, for dose calculation purposes;
  • Dose does not exceed any of the following (a-d):
    • For adults and pediatric members weighing ≥ 50 kg:
      • 200 mg per day;
      • One of the following:
        • 2 tablets per day;
        • 20 mL per day;
      • For pediatric members weighing 20 kg to < 50 kg: 4 mg/kg per day;
      • For pediatric members weighing 11 kg to < 20 kg: 5 mg/kg per day;
      • For pediatric members weighing < 11 kg: 6 mg/kg per day.
  • Approval duration: 12 months (oral formulation); 1 month (IV formulation)

Diazoxide Choline (DCCR) (CP.PHAR.701)

Ambetter

Policy includes:

• Requests for indications not approved by the Food and Drug Administration (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 with a pediatric endocrinologist or geneticist;
  • Age ≥ 4 years;
  • Weight ≥ 20 kg and ≤ 135 kg;
  • Documentation of baseline hyperphagia questionnaire for clinical trials (HQ-CT) score ≥ 13;
  • Dose does not exceed both of the following
    • 5.8 mg/kg per day;
    • 525 mg per day.
  • Approval duration: 6 months

• Continued Therapy: Prader-Willi Syndrome (must meet all):
  • Member meets one of the following:
    • Currently receiving medication via Centene benefit or member has previously met initial approval criteria;
    • Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations;
  •  Member is responding positively to therapy as evidenced by, including but not limited to, improvement in any of the following parameters:
    • Reduction in overall HQ-CT total score from baseline;
    • Disease severity improvement as assessed by clinical global impression of improvement (CGI-I) scores or caregiver global impression of change (GI-C) score between 1-3;
    • Body composition improvements as evidenced by changes in body fat mass, lean body mass or lean body mass/fat mass ratio;
    • Behavioral improvements (e.g., aggressive behaviors, anxiety, compulsivity, irritability, etc.);
  • If request is for a dose increase, new dose does not exceed both of the following
    • 5.8 mg/kg per day;
    • 525 mg per day.
  • Approval duration: 6 months

Tirzepatide (Zepbound) (CP.PMN.298)

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:
  • Obstructive Sleep Apnea (OSA) (must meet all):
    • Diagnosis of moderate to severe OSA confirmed by polysomnography with an apnea-hypopnea index (AHI) ≥ 15 respiratory events per hour;
    • Age ≥ 18 years;
    •  Body mass index ≥ 30 kg/m²;
    • Member does not have central or mixed sleep apnea;
    • For members with concurrent type 2 diabetes mellitus, both of the following:
      • Failure of ≥ 3 consecutive months of Ozempic^®, Trulicity^®, and Victoza^®, unless clinically significant adverse effects are experienced or all are contraindicated;* *Prior authorization may be required
      • If member is currently receiving a glucagon-like peptide-1 (GLP-1) receptor agonist and is requesting to switching to Zepbound, medical justification* supports necessity for Zepbound; *Intolerance due to common adverse effects of the GLP-1 receptor agonists class such as gastrointestinal symptoms is not considered acceptable medical justification
    • Documentation supports member’s participation in a physician-directed weight loss program that involves a reduced calorie diet, increased physical activity, and behavioral modification adjunct to therapy;*
    • Member meets one of the following:*
      • History of non-adherence to positive airway pressure (PAP) therapy;
      • Zepbound is prescribed concurrently with PAP therapy, unless contraindicated or clinically significant adverse effects are experienced;
    • Zepbound is not prescribed concurrently with other tirzepatide-containing products or any other GLP-1 receptor agonist(s);
    • Documentation of member’s baseline body weight in kg;
    • Dose does not exceed the following:
      • Week 1 through 4: 2.5 mg once weekly;
      • Week 5 through 8: 5 mg once weekly;
      • Week 9 through 12: 7.5 mg once weekly;
      • Week 13 through 16: 10 mg once weekly;
      • Week 17 through 20: 12.5 mg once weekly;
      • Week 21 through 24: 15 mg once weekly;
      • One pen or vial per week.
    • Approval duration: 6 months
  • Weight Management
    • Use of Zepbound for the treatment of weight management is a benefit exclusion and will not be authorized.
    • Approval duration: Not applicable

• Continued Therapy
  • Obstructive Sleep Apnea (must meet all):
    • Member meets one of the following:
      • Currently receiving medication via Centene benefit or member has previously met initial approval criteria;
      • Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations;
    • Member is responding positively to therapy as evidenced by one of the following:
      • If this is the first renewal request, both of the following:
      • Member has lost ≥ 5% of baseline body weight;
      • Any of the following parameters:
        • AHI reduction from baseline;
        • Improvement from baseline in the sleep apnea-specific hypoxic burden (SASHB) score;
        • Improvement from baseline in any one of the sleep-related patient reported outcomes scores (e.g., Epworth sleepiness scale (ESS), Calgary sleep apnea QOL index (SAQLI), functional outcomes of sleep Questionnaire (FOSQ), patient-reported outcomes measurement information system (PROMIS) sleep-related impairment or sleep disturbance);
      • If this is a second or subsequent renewal request, both of the following:
        • Member has lost weight and/or maintained weight loss on therapy;
        • Stabilization or improvement in any of the following parameters:
          • AHI;
          • SASHB;
          • Sleep-related patient reported outcomes scores (e.g., Epworth sleepiness scale (ESS), Calgary sleep apnea QOL index (SAQLI), functional outcomes of sleep Questionnaire (FOSQ), patient-reported outcomes measurement information system (PROMIS) sleep-related impairment or sleep disturbance);
    • Zepbound is not prescribed concurrently with other tirzepatide-containing products or any other GLP-1 receptor agonist(s);
    • Documentation that member is actively enrolled in a weight loss program that involves a reduced calorie diet, increased physical activity, and behavioral modification adjunct to therapy;
    • Request meets all the following (a, b, and c):
      • Dose does not exceed 15 mg once weekly;
      • After the initial dose escalation period, maintenance dose is ≥ 5 mg once weekly;
      • Requested quantity does not exceed one pen or vial per week.
    • Approval duration: 6 months
  • Weight Management
    • Use of Zepbound for the treatment of weight management is a benefit exclusion and will not be authorized.
    • Approval duration: Not applicable

Mepolizumab (Nucala)  (CP.PHAR.200)

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

Policy updates include:

• For eosinophilic granulomatosis with polyangiitis: revised eosinophilia requirement from “blood eosinophil count at least 150 cells/mcL” to “eosinophils > 1 x 109/L and/or > 10% of leukocytes” in alignment with pivotal study design and American College of Rheumatology (ACR) eosinophilic granulomatosis with polyangiitis classification criteria and management guidelines
• Replaced requirements for asthma and 2 additional characteristics of eosinophilic granulomatosis with polyangiitis with requirement for active, non-severe disease
• Removed requirements for refractory or relapsed disease

Certolizumab (Cimzia)  (CP.PHAR.247)

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

Policy updates include:

• Added criteria for newly approved indication for polyarticular juvenile idiopathic arthritis
• Added Appendix H with 10-joint clinical juvenile arthritis disease activity score (cJADAS-10) scores

Ustekinumab (Stelara and biosimilars)  (CP.PHAR.264)

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

Policy updates include:

• Added newly approved biosimilar Otulfi to criteria

Guselkumab (Tremfya)  (CP.PHAR.364)

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

Policy updates include:

• Added criteria for newly approved indication for ulcerative colitis
• Added appendix E with Mayo Score supplemental information
• Added new subcutaneous formulations [single-dose prefilled syringe 200 mg/2 ml
• Single-dose prefilled pen (Tremfya Pen) 200 mg/2 ml] and intravenous formulation [single-dose vial 200 mg/20 ml]

Biologic and Non-biologic DMARDs (HIM.PA.SP60)

Ambetter

Policy updates include:

• For Tremfya, added criteria for newly approved indication for ulcerative colitis
• Added new subcutaneous formulations [single-dose prefilled syringe 200 mg/2 ml
• Single-dose prefilled pen (Tremfya Pen) 200 mg/2 ml] and intravenous formulation [single-dose vial 200 mg/20 ml]
• For Cimzia, added criteria for newly approved indication for polyarticular juvenile idiopathic
• arthritis
• For Bimzelx, added criteria for newly approved indications for psoriatic arthritis, ankylosing spondylitis, and non-radiographic axial spondyloarthritis
• Added newly approved biosimilar Otulfi to criteria
• Added Yuflyma with specific ndcs to list of preferred adalimumab products
• Removed Hadlima and adalimumab-adaz from list of preferred adalimumab products.
• For Bimzelx, added new strength [320 mg/2 ml] for single-dose prefilled syringe and single-dose prefilled autoinjector
• Added newly approved biosimilar Imuldosa to criteria
• For Selarsdi, added newly approved indications for Crohn’s disease and ulcerative colitis
• Added new dosage formulation [single-dose vial for intravenous infusion 130 mg/26 ml]
• For continued therapy, removed redirection to Stelara for Stelara biosimilars

Lazertinib (Lazcluze) (CP.PHAR.695)

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 recurrent, advanced, or metastatic non-small cell lung cancer;
  • Prescribed by or in consultation with an oncologist;
  • Age ≥ 18 years;
  •  Disease is positive for EGFR exon 19 deletion(s) or exon 21 L858R substitution mutation(s);
  • Lazcluze is prescribed in combination with Rybrevant in one of the following ways:
    • As first-line treatment;
    • As continuation of therapy following disease progression on the combination of Rybrevant and Lazcluze for asymptomatic disease, symptomatic brain lesions, or symptomatic systemic limited progression;
  • For Lazcluze requests, member must use lazertinib, if available, unless contraindicated or clinically significant adverse effects are experienced;
  • Request meets one of the following:
    • Dose does not exceed both:
      • 240 mg per day;
      • 2 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

• Continued Therapy: Non-Small Cell Lung Cancer (must meet all):
  • Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Lazcluze for a covered indication and has received this medication for at least 30 days;
  •  Member is responding positively to therapy
  • For Lazcluze requests, member must use lazertinib, if available, unless contraindicated or clinically significant adverse effects are experienced;
  • If request is for a dose increase, request meets one of the following:
    • New dose does not exceed both:
      • 240 mg per day;
      • 2 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

Lanreotide (Somatuline Depot) (CP.PHAR.391)

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

Policy updates include:

• For acromegaly, revised initial criteria from “(growth hormone [GH]) level ≥ 1 µg/ml” to “(growth hormone  [GH]) level ≥ 1 µg/L” per Pituitary Society (PS) and Endocrine society (ES) practice guidelines and ACG
• For neuroendocrine tumors, added to initial criteria “diagnosis of diffuse idiopathic pulmonary neuroendocrine cell hyperplasia” and revised “bronchopulmonary neuroendocrine tumor” to “lung neuroendocrine tumor” per National Comprehensive Cancer Network (NCCN) compendium and guideline
• Updated Appendix D “National Comprehensive Cancer Network (NCCN) guidelines - Neuroendocrine and Adrenal Tumors” supplemental information
• For unbranded lanreotide, added newly approved carcinoid syndrome indication to FDA Approved Indication(s) section

Respiratory Syncytial Virus Vaccine (Abrysvo) (CP.PHAR.658)

Ambetter

Policy updates include:

• The recently Food and Drug Administration (FDA)-approved indication for use in people aged 18-59 at high risk for lower respiratory tract disease due to respiratory syncytial virus

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

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

Policy updates includes:

• Added criteria for new indication in combination with carboplatin and pemetrexed for non-small cell lung cancer with epidermal growth factor receptor                (EGFR) exon 19 deletions or exon 21 L858R substitution mutations after progression on EGFR tyrosine kinase inhibitor
• To align with the new labeled indication, revised requirement for progression on “Tagrisso” to be progression on “an EGFR tyrosine kinase inhibitor” and specified that requirement for presence of symptomatic systemic disease with multiple lesions only applies to the off-label EGFR mutations
• Per National Comprehensive Cancer Network (NCCN) Compendium, added option of combination Rybrevant + Lazcluze as continuation of therapy

Sodium Oxybate (Xyrem, Lumryz) and Calcium Magnesium Potassium Sodium Oxybate (Xywav)  (CP.PMN.42)

Ambetter

Policy updates includes:

• Updated criteria to reflect newly approved pediatric extension for Lumryz

CarbidopaLevodopa (Crexont, Rytary,Duopa, Dhivy), Foscar-bidopaLevodopa (Vyalev)  (CP.PMN.238)

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

Policy updates includes:

• Added newly approved Vyalev to the policy

Deferiprone (Ferriprox) (CP.PHAR.147)

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

Policy updates include:

• Added Ambetter line of business

Lebrikizumab (Ebglyss) (CP.PHAR.704)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and 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, and CP.PMN.53 for Medicaid and CHIP
• Initial Approval Criteria: Atopic Dermatitis (must meet all):
  • Diagnosis of atopic dermatitis affecting one of the following:
    • At least 10% of the member’s body surface area (BSA);
    • Hands, feet, face, neck, scalp, genitals/groin, and/or intertriginous areas;
  • Prescribed by or in consultation with a dermatologist or allergist;
  • Age at least 12 years;
  • Weight at least 40 kg;
  • Failure of both of the following, unless contraindicated or clinically significant adverse effects are experienced:
    • Two formulary medium to very high potency topical corticosteroids of different molecular identities, each used for ≥ 2 weeks;
    • One non-steroidal topical therapy* used for ≥ 4 weeks: topical calcineurin inhibitor (e.g., tacrolimus 0.03% ointment, pimecrolimus 1% cream) or Eucrisa®; *These agents may require prior authorization
  • Ebglyss is not prescribed concurrently with another biologic immunomodulator (e.g., Dupixent ®, Adbry ®, Cinqair ®, Fasenra ®, Nucala ®, Tezspire ®, Xolair ®) or a JAK inhibitor (e.g., Olumiant ®, Rinvoq ®, Cibinqo ®, Opzelura ®);
  • Dose does not exceed any of the following:
    • Loading dose: 500 mg (two 250 mg/2 mL injections) at Week 0 and Week 2;
    • Initial dose: 250 mg injection every 2 weeks until Week 16 or clinical response;
    • Maintenance dose: 250 mg every 4 weeks.
  • Approval duration: 6 months
• Continued Therapy: Atopic Dermatitis (must meet all):
  • Member meets one of the following (a or b):
    • Currently receiving medication via Centene benefit or member has previously met initial approval criteria;
    • Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations;
  • Member is responding positively to therapy as evidenced by:
    • Reduction in itching or scratching
• Ebglyss is not prescribed concurrently with another biologic immunomodulator (e.g., Dupixent, Adbry, Cinqair, Fasenra, Nucala, Tezspire, Xolair) or a JAK inhibitor (e.g., Olumiant, Rinvoq, Cibinqo, Opzelura);
  • Dose does not exceed 250 mg injection every 4 weeks.
  • Approval duration: 12 months

Zolbetuximab-clzb (Vyloy) (CP.PHAR.705)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and 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, and CP.PMN.53 for Medicaid and CHIP
• Initial Approval Criteria: Gastric or Gastroesophageal Junction Adenocarcinoma (must meet all):
  • Diagnosis of gastric or gastroesophageal junction adenocarcinoma;
  • Prescribed by or in consultation with an oncologist;
  • Age at least 18 years;
  • Disease is locally advanced unresectable or metastatic;
  • Disease is human epidermal growth factor receptor 2 (HER2)-negative;
  • Tumor is claudin (CLDN) 18.2 positive;
  • Request is for first-line treatment;
  • Vyloy is prescribed in combination with both of the following:
    • Fluoropyrimidine (e.g., capecitabine, fluorouracil)-containing chemotherapy;
    • Platinum (e.g., oxaliplatin)-containing chemotherapy;
  • Request meets one of the following:
    • Dose does not exceed an initial 800 mg/m2 dose followed by either 600 mg/m2 every 3 weeks or 400 mg/m2 every 2 weeks;
    • 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
• Continued Therapy: Gastric or Gastroesophageal Junction Adenocarcinoma (must meet all):
  • Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Vyloy 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 600 mg/m2 every 3 weeks or 400 mg/m2 every 2 weeks;
    • 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

Diazepam (Libervant, Valtoco) (CP.PMN.216)

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

Policy updates include:

• Removed redirection to diazepam rectal gel

Insulin Glargine (Basaglar, Rezvoglar, Toujeo, unbranded Semglee) (HIM.PA.09)

Ambetter

Policy updates include:

• Removed Basaglar redirection and added redirection to branded Semglee
• Added Semglee as therapeutic alternative option
• Added Basaglar to criteria
• For continued therapy requests, added redirection to preferred products
• Added Insulin Glargine-yfgn to policy and clarified that criteria apply to unbranded Semglee

Insulin Detemir (Levemir) (HIM.PA.171)

Ambetter

Policy updates include:

• Removed Basaglar redirection and added redirection to branded Semglee
• For continued therapy requests, added redirection to preferred products

Donanemab-azbt (Kisunla) (CP.PHAR.594)

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

Policy updates include:

• Drug is now Food and Drug Administration (FDA)-approved – criteria updated per Food and Drug Administration (FDA) labeling: clarified that the initial 3 month auth duration covers the first 3 monthly infusions instead of the first 4 monthly infusions
• For Continued Therapy updated the required follow-up MRI schedule, treatment discontinuation thresholds, and MRI-contingent reauth durations

Elafibranor (Iqirvo) (CP.PHAR.688)

Ambetter

Policy includes:

• Requests for indications not approved by the Food and Drug Administration (FDA) are reviewed with the off-label use policy for the relevant line of business: HIM.PHAR.154 for Ambetter
• Initial Approval Criteria: Primary Biliary Cholangitis (PBC) (must meet all):
  • Diagnosis of PBC;
  • Prescribed by or in consultation with a hepatologist or gastroenterologist;
  • Age ≥ 18 years;
  • Failure (as evidenced by sustained elevation in alkaline phosphatase (ALP) ≥ 1.67 times the upper limit of normal) of ≥ 12 month trial of ursodeoxycholic acid (UDCA) (ursodiol) at a dose of ≥ 13 mg/kg/day, unless contraindicated or clinically significant adverse effects are experienced;
  • Prescribed in combination with ursodeoxycholic acid (UDCA), unless contraindicated or clinically significant adverse effects are experienced;
  • Dose does not exceed 80 mg (1 tablet) per day.
  • Approval duration: 6 months

• Continued Therapy: Primary Biliary Cholangitis (must meet all):
  • Member meets one of the following (a or b):
    • Currently receiving medication via Centene benefit or member has previously met initial approval criteria;
    • Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations;
  • Member is responding positively to therapy as evidenced by one of the following (a or b):
    • Initial reauthorization: reduction in alkaline phosphatase (ALP) level from pretreatment level;
    • Subsequent reauthorization: continued reduction or maintenance of initial reduction in alkaline phosphatase (ALP) level;
  • If request is for a dose increase, new dose does not exceed 80 mg (1 tablet) per day.
  • Approval duration: 12 months

Ketamine (Ketalar) (CP.PMN.296)

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

Policy includes:

• Requests for indications not approved by the Food and Drug Administration (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: Requests for Ketamine (must meet all):
  • Diagnosis of one of the following:
    • An Food and Drug Administration (FDA) approved indication;
    • A use supported by one of the following:
      • Micromedex DrugDex with strength of recommendation Class I or IIa;
      • Evidence from at least two high-quality, published studies in reputable peer-reviewed journals or evidence-based clinical practice guidelines that provide all of the following:
        • Adequate representation of the member’s clinical characteristics, age, and diagnosis;
        • Adequate representation of the prescribed drug regimen;
        • Clinically meaningful outcomes as a result of the drug therapy in question;
        • Appropriate experimental design and method to address research questions;
    • One of the following off-label indications:
      • Treatment-resistant depression (TRD);
      • Major depressive disorder (MDD);
  • If request is for brand Ketalar, member must use generic ketamine, unless contraindicated or clinically significant adverse effects are experienced;
  • For TRD and MDD, all of the following:
    • Request is for intravenous (IV) ketamine;
    • Prescribed by or in consultation with a psychiatrist;
    • Age ≥ 18 years;
    • Member meets one of the following:
      • Request is for the treatment of a member in a State with limitations on step therapy in certain mental health settings;
      • For all other requests, both of the following:
        • Failure of TWO antidepressants from the following, each tried for ≥ 4 weeks at up to maximally indicated doses, unless clinically significant adverse effects are experienced or all are contraindicated: selective serotonin reuptake inhibitor (SSRI), serotonin norepinephrine reuptake inhibitor  (SNRI), bupropion, mirtazapine, vilazodone;
        • Failure of ONE of the following antidepressant augmentation therapies, each used for ≥ 4 weeks, unless clinically significant adverse effects are experienced or all are contraindicated: second-generation antipsychotic, lithium, thyroid hormone, buspirone;
    • Request meets one of the following:
      • Dose does not exceed 0.5 mg/kg IV for up to 8 doses;
      • Dose does not exceed 1 mg/kg IV as a single dose;
      • Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).
  • Approval duration: 3 months
• Continued Therapy: All Indications in Section I
  • Re-authorization is not permitted. Members must meet the initial approval criteria.
  • Approval duration: Not applicable

Imetelstat (Rytelo) (CP.PHAR.690)

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

Policy includes:

• Requests for indications not approved by the Food and Drug Administration (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: Myelodysplastic Syndromes (MDS) (must meet all):
  • Diagnosis of MDS with transfusion-dependent anemia;
  • Prescribed by or in consultation with a hematologist or oncologist;
  • Age ≥ 18 years;
  • Member has low risk or intermediate-1 risk MDS disease as classified by International Prognostic Scoring System (IPSS);
  • Documentation of at least 4 red blood cell (RBC) units transfused over 8 weeks;
  • Member does not have del(5q) cytogenetic abnormality;
  • Member meets one of the following :
    •  Inadequate response to or ineligible for ESA therapy;
    • One of the following:
      • Failure of Retacrit^™, unless contraindicated or clinically significant adverse effects are experienced; *Prior authorization may be required for Retacrit
      • If Retacrit is unavailable due to shortage, member must use Epogen^®, unless contraindicated or clinically significant adverse effects are experienced;  *Prior authorization may be required for Epogen
  • Rytelo is not prescribed concurrently with Reblozyl^®;
  • Request meets one of the following :*
    • Dose does not exceed 7.1 mg/kg every 4 weeks;
    • 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 Food and Drug Administration (FDA)-approved or recommended by National Comprehensive Cancer Network (NCCN)
  • Approval duration: 6 months

• Continued Therapy: Myelodysplastic Syndromes (must meet all):
  • Member meets one of the following :
    • Currently receiving medication via Centene benefit or member has previously met initial approval criteria;
    • Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations;
  • Member is responding positively to therapy as evidence by decrease of red blood cell (RBC) transfusions requirement;
  • Rytelo is not prescribed concurrently with Reblozyl;
  • If request is for a dose increase, request meets one of the following :
    • Dose does not exceed 7.1 mg/kg every 4 weeks;
    • 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 Food and Drug Administration (FDA)-approved or recommended by National Comprehensive Cancer Network (NCCN)
  • Approval duration: 6 months

Olezarsen (CP.PHAR.689)

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

Policy includes:

• Criteria will mirror the clinical information from the prescribing information once Food and Drug Administration (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 Food and Drug Administration (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:  Familial Chylomicronemia Syndrome (FCS) (must meet all):* *Criteria will mirror the clinical information from the prescribing information once Food and Drug Administration (FDA)-approved
  • Diagnosis of FCS;*
  • Genetic testing confirms the presence of one of the following loss-of-function
  • mutations in FCS-causing genes (e.g., lipoprotein lipase (LPL), apolipoprotein C-II (APOC2), apolipoprotein C-VI (APOA5),  glycosylphosphatidylinositol-anchored high-density lipoprotein1binding protein 1 (GPIHBP1), lipase maturation factor 1 (LMF1) (a, b, or c):
    • Homozygote;
    • Compound heterozygote;
    • Double heterozygote;
  • Prescribed by or in consultation with a cardiologist, endocrinologist, or lipid specialist;
  • Age ≥ 18 years;*
  • Fasting triglycerides ≥ 880 mg/dL or ≥ 10 mmol/L (lab must be dated within 90 days);
  • Failure of both of the following at up to maximally indicated doses, unless clinically significant adverse effects are experienced or all are contraindicated (a and b);
    • Fibrates (e.g., fenofibric acid, fenofibrate, fenofibrate micronized, gemfibrozil);
    • Omega-3 fatty acids (e.g., omega-3-acid ethyl esters, icosapent ethyl);
  • Dose does not exceed 80 mg every 4 weeks.*
  • Approval duration:  Medicaid/HIM – 6 months
• Continued Therapy: Familial Chylomicronemia Syndrome (must meet all):* *Criteria will mirror the clinical information from the prescribing information once Food and Drug Administration (FDA)-approved
  • Member meets one of the following (a or b):
    • Currently receiving medication via Centene benefit or member has previously met initial approval criteria;
    • Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations;
  • Member is responding positively to therapy as evidenced by reduction in fasting triglycerides from baseline;
  • If request is for a dose increase, new dose does not exceed 80 mg every 4 weeks.*
  • Approval duration: Medicaid/HIM – 12 months

Carbetocin (CP.PHAR.546)

Ambetter

Policy update includes:

• No significant changes as drug is not yet Food and Drug Administration (FDA)-approved
• Expanded age ranges to reflect on-going phase 3 study eligibility

Hyaluronate derivatives (CP.PHAR.05)

Ambetter-Medical Benefit

Policy updates include:

• Added physiatrist to specialist options

Imatinib (Gleevec, Imkeldi) (CP.PHAR.65)

Ambetter

Policy updates include:

• Added new oral solution formulation Imkeldi to criteria requiring redirection to generic imatinib with an additional bypass if member is unable to swallow tablets
• Revised policy/criteria section to also include generic imatinib

Eculizumab (Soliris, Bkemv, Epysqli) (CP.PHAR.97)

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

Policy updates include:

• Updated Food and Drug Administration (FDA) approved indication for Epysqli to include adult patients with gmg who are achr antibody positive
• For generalized myasthenia gravis continuation of therapy requests, extended continuity of care allowance to Bkemv and Epysqli
• For neuromyelitis optica spectrum disorder, clarified relapse requirements

Methotrexate (Otrexup, Rasuvo, Xatmep, Reditrex, Jylamvo) (CP.PHAR.134)

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

Policy updates include:

• Added criteria for Jylamvo polyarticular juvenile idiopathic arthritis indication per new Food and Drug Administration (FDA)-approved indication
• Removed acute lymphoblastic leukemia age requirement for Xatmep and Jylamvo per Food and Drug Administration (FDA) pediatric expansion

Atezolizumab (Tecentriq), Atezolizumab-Hyaluronidase (Tecentriq Hybreza) (CP.PHAR.235)

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

Policy updates include:

• Added newly approved Hybreza formulation

Ustekinumab (Stelara), Ustekinumab-aauz, Ustekinumab-srlf (Imuldosa), (Otulfi), Ustekinumab-ttwe (Pyzchiva), Ustekinumab-aekn (Selarsdi), Ustekinumab-auub (Wezlana)  (CP.PHAR.264)

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

Policy updates include:

• Added newly approved biosimilar Imuldosa to criteria
• For Selarsdi, added newly approved indications for Crohn’s disease and ulcerative colitis
• Added new dosage formulation [single-dose vial for intravenous infusion 130 mg/26 ml]

Filgrastim (Neupogen), Filgrastim-sndz (Zarxio), Tbo-filgrastim (Granix), Filgrastim-aafi (Nivestym), Filgrastim-ayow (Releuko), Filgrastim-txid (Nypozi) (CP.PHAR.297)

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

Policy updates include:

• Updated Food and Drug Administration (FDA) -approved indications for Zarxio to include use in hematopoietic syndrome of acute radiation syndrome per updated prescribing information

Sotorasib (Lumakras) (CP.PHAR.549)

Ambetter

Policy updates include:

• Added newly approved 240 mg strength tablet

Minocycline ER (Emrosi, Solodyn, Ximino, Minolira), Microspheres (Arestin), Foam (Zilxi) (CP.PMN.80)

Ambetter

Policy updates include:

• Added Emrosi to criteria with corresponding criteria set for rosacea indication

Osimertinib (Tagrisso) (CP.PHAR.294)

Ambetter

Policy updates include:

• Added new indication for Tagrisso

Ocrelizumab (Ocrevus) (CP.PHAR.335)

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

Policy updates include:

• Added new dosage form for Ocrevus Zunovo

Isatuximab-irfc (Sarclisa) (CP.PHAR.482)

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

Policy updates include:

• Added newly Food and Drug Administration (FDA)-approved indication for primary therapy for multiple myeloma not eligible for autologous stem cell transplant