Adalimumab (Humira), Adalimumab-atto (Amjevita), Adalimumab-adbm (Cyltezo), Adalimumab-bwwd (Hadlima), Adalimumab-adaz (Hyrimoz) (CP.PHAR.242)

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

Policy updates include:

• Updated FDA approved indications to reflect pediatric extensions for Cyltezo in JIA and CD

Agalsidase Beta (Fabrazyme) (CP.PHAR.158)

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

Policy updates include:

• Added other specialist types who might be involved in a Fabry patient’s care

ALN-TTRsc02 (Vutrisiran) (CP.PHAR.550)

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

Policy includes:

• Criteria will mirror the clinical information from the prescribing information once FDA-approved
• Criteria is only applicable for Medicaid and CHIP when the drug is added to the formulary for coverage
• Requests for indications not approved by the FDA are reviewed with the off-label use policy for the relevant line of business: HIM.PHAR.154 for Ambetter, and CP.PMN.53 for Medicaid and CHIP
  • Initial Approval Criteria, Hereditary Transthyretin-Mediated Amyloidosis (must meet all):
  • Diagnosis of hATTR with polyneuropathy
  • Prescribed by or in consultation with a neurologist
  • Age ≥ 18 years
  • Documentation confirms presence of a transthyretin (TTR) mutation
  • Biopsy is positive for amyloid deposits or medical justification is provided as to why treatment should be initiated despite a negative biopsy or no biopsy
  • Member has not had a prior liver transplant
  • Member has not received prior treatment with Onpattro™ or Tegsedi™
  • ALN-TTRsc02 is not prescribed concurrently with Onpattro and/or Tegsedi
  • Dose does not exceed 25 mg every 3 months
  • Approval duration: 6 months
• Continued Therapy, Hereditary Transthyretin-Mediated Amyloidosis (must meet all):
  • Currently receiving medication via Centene benefit or member has previously met initial approval criteria
  • Member is responding positively to therapy [e.g., improved measures of polyneuropathy (e.g., motor strength, sensation, and reflexes), improvement in quality of life, motor function, walking ability (e.g., as measured by timed 10-m walk test), and nutritional status (e.g., as evaluated by modified mass index)]
  • Member has not had a prior liver transplant
  • ALN-TTRsc02 is not prescribed concurrently with Onpattro and/or Tegsedi
  • If request is for a dose increase, new dose does not exceed 25 mg every 3 months
  • Approval duration: 12 months

Anifrolumab-fnia (Saphnelo) (CP.PHAR.551)

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

Policy includes:

• Criteria is only applicable for Medicaid and CHIP when the drug is added to the formulary for coverage
• Requests for indications not approved by the FDA are reviewed with the off-label use policy for the relevant line of business: HIM.PHAR.154 for Ambetter, and CP.PMN.53 for Medicaid and CHIP
• Initial Approval Criteria, Systemic Lupus Erythematosus (must meet all):
  • Diagnosis of SLE
  • Prescribed by or in consultation with a rheumatologist
  • Age ≥ 18 years;
  • Documentation confirms that member is positive for an SLE autoantibody (e.g., anti-nuclear antibody (ANA), anti-double-stranded DNA (anti-dsDNA), anti-Smith (anti-Sm), anti-ribonucleoprotein (anti-RNP), anti-Ro/SSA, anti-La/SSB, antiphospholipid antibody)
  • Prescribed in combination with standard therapy for SLE that includes one or more of the following agents, unless all agents are contraindicated: glucocorticoids (e.g., prednisone), antimalarial (e.g., hydroxychloroquine or chloroquine), non-biologic immunosuppressants (e.g., azathioprine, methotrexate, mycophenolate)
  • Dose does not exceed 300 mg every 4 weeks.
  • Approval duration: 6 months
• Continued Therapy, Systemic Lupus Erythematosus (must meet all):
  • Currently receiving medication via Centene benefit or member has previously met initial approval criteria
  • Member is responding positively to therapy;
  • Prescribed in in combination with standard therapy for SLE that includes one or more of the following agents, unless all agents are contraindicated: glucocorticoids (e.g., prednisone), antimalarial (e.g., hydroxychloroquine or chloroquine), non-biologic immunosuppressants (e.g., azathioprine, methotrexate, mycophenolate)
  • If request is for a dose increase, new dose does not exceed 300 mg every 4 weeks.
  • Approval duration: 12 months

Avalglucosidase alfa-ngpt (Nexviazyme) (CP.PHAR.521)

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

Policy includes:

• Criteria is only applicable for Medicaid and CHIP when the drug is added to the formulary for coverage
• Requests for indications not approved by the FDA are reviewed with the off-label use policy for the relevant line of business: HIM.PHAR.154 for Ambetter, and CP.PMN.53 for Medicaid and CHIP
• Initial Approval Criteria, Pompe Disease (must meet all):
  • Diagnosis of late-onset Pompe disease confirmed by one of the following:
    • Enzyme assay confirming low GAA activity
    • DNA testing
  • Age ≥ 1 year
  • Nexviazyme is not prescribed concurrently with Lumizyme^®
  • Dose does not exceed any of the following:
    • Patients weighing ≥ 30 kg: 20 mg/kg every 2 weeks
    • Patients weighing < 30 kg: 40 mg/kg every 2 weeks
  • Approval duration: 6 months
• Continued Therapy, Pompe Disease (must meet all):
  • Currently receiving medication via Centene benefit or member has previously met initial approval criteria
  • Member is responding positively to therapy as evidenced by improvement in the individual member’s Pompe disease manifestation profile
  • Nexviazyme is not prescribed concurrently with Lumizyme
  • If request is for a dose increase, new dose does not exceed any of the following:
    • Patients weighing ≥ 30 kg: 20 mg/kg every 2 weeks
    • Patients weighing < 30 kg: 40 mg/kg every 2 weeks 20 mg/kg every 2 weeks
  • Approval duration: 12 months

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

Ambetter

Policy updates include:

• Added ivermectin 1% cream as an option for failure

Bamlanivimab-etesevimab (LY-CoV555-LY-CoV016) (CP.PHAR.532)

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

Policy includes:

• Criteria will mirror the clinical information from the prescribing information once FDA-approved
• Criteria is only applicable for Medicaid and CHIP when the drug is added to the formulary for coverage
• Requests for indications not approved by the FDA are reviewed with the off-label use policy for the relevant line of business: HIM.PHAR.154 for Ambetter, and CP.PMN.53 for Medicaid and CHIP
• Initial Approval Criteria, COVID-19 (must meet all):
  • Diagnosis of COVID-19 infection via a positive viral test for SARS-CoV-2 within the last 3 days
  • Member has one or more mild or moderate COVID-19 symptoms;
  • Member is within 10 days of symptom onset
  • Age ≥ 12 years
  • Member’s body weight is ≥ 40 kg
  • Member meets one of the following criteria for being at high risk for progressing to severe COVID-19 and/or hospitalization:
    • Body mass index (BMI) ≥ 35
    • Has chronic kidney disease
    • Has type 1 or type 2 diabetes
    • Has immunosuppressive disease
    • Currently receiving immunosuppressive treatment;
    • ≥ 65 years of age
    • ≥ 55 years of age AND has one of the following;
      • Cardiovascular disease
      • Hypertension
      • Chronic obstructive pulmonary disease/other chronic respiratory disease
    • Is 12 – 17 years of age AND has one of the following;
      • BMI ≥ 85th percentile for their age and gender based on CDC growth charts
      • Sickle cell disease
      • Congenital or acquired heart disease
      • Neurodevelopmental disorders (e.g., cerebral palsy)
      • Medical-related technological dependence (e.g., tracheostomy, gastrostomy, or positive pressure ventilation [not related to COVID-19])
      • Asthma, reactive airway or other chronic respiratory disease that requires daily medication for control;
  • At the time of request, member does not have any of the following EUA-specified limitations against use:
    • Member is hospitalized due to COVID-19
    • Member requires oxygen therapy due to COVID-19
    • Members is on chronic oxygen therapy due to underlying non-COVID-19 related comorbidity and requires an increase in baseline oxygen flow rate due to COVID-19
  • Bamlanivimab and etesevimab will be administered together as a single intravenous infusion
  • Bamlanivimab and etesevimab will be administered to the member in a setting in which health care providers have immediate access to medications to treat a severe infusion reaction, such as anaphylaxis, and the ability to activate the emergency medical system, as necessary
  • Dose does not exceed bamlanivimab 700 mg (1 vial) with etesevimab 1,400 mg (2 vials) one time.
  • Approval duration: One time
• Initial approval criteria, Post-exposure Prophlyaxis of COVID-19 (must meet all):
  • Member meets one of the following:
    • Member has been exposed to an individual infected with SARS-CoV-2 consistent with close contact criteria per Centers for Disease Control and Prevention (CDC)
    • Member is at high risk of exposure to an individual infected with SARS-CoV-2 because of occurrence of SARS-CoV-2 infection in other individuals in the same institutional setting (e.g., nursing homes and prisons)
  • Age ≥ 12 years old;
  • Member’s body weight ≥ 40 kg;
  • Documentation of one of the following:
    • Member is not fully vaccinated;
    • Member is not expected to mount adequate immune reponse to complete SARS-CoV-2 vaccination (e.g., individuals with immunocompromising conditions including those taking immunosuppressive medications)
  • Member meets one of the following criteria for being at high risk for progressing to severe COVID-19 and/or hospitalization:
    • Age ≥ 65 years
    • BMI of > 25 kg/m², or if age 12-17 years old, BMI ≥ 85th percentile for their age and gender based on CDC growth charts
    • Pregnant
    • Chronic kidney disease
    • Type 1 or 2 Diabetes Mellitus;
    • Immunosuppressive disease or immunosuppressive treatment
    • Cardiovascular disease or hypertension
    • Chronic lung disease (e.g., COPD, moderate-to-severe asthma, interstitial lung disease, cystic fibrosis, pulmonary hypertension)
    • Sickle cell disease
    • Neurodevelopmental disorders (e.g., cerebral palsy)
    • Medical-related technological dependence (e.g. tracheostomy, gastrostomy, possibitive pressure ventilation not related to COVID-19)
  • At the time of request, member does not have any of the following EUA-specified limitations against use:
    • Member is hospitalized due to COVID-19
    • Member requires oxygen therapy due to COVID-19
    • Members is on chronic oxygen therapy due to underlying non-COVID-19 related comorbidity and requires an increase in baseline oxygen flow rate due to COVID-19
  • Bamlanivimab and etesevimab will be administered together as a single intravenous infusion
  • Bamlanivimab and etesevimab will be administered to the member in a setting in which health care providers have immediate access to medications to treat a severe infusion reaction, such as anaphylaxis, and the ability to activate the emergency medical system, as necessary
  • Dose does not exceed bamlanivimab 700 mg (1 vial) with etesevimab 1,400 mg (2 vials) one time.
• Approval duration: One time
• Continued therapy, COVID-19
  • Re-authorization not permitted

Bardoxolone methyl (RTA 402) (CP.PHAR.560)

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
• nitial Approval Criteria, Chronic Kidney Disease of Alport Syndrome (must meet all):
  • Diagnosis of Alport syndrome confirmed by one of the following:
    • Genetic testing with variants in the COL4A3, COL4A4, or COL4A5 genes
    • Kidney biopsy with one of the following:
      • Electron microscopy results show abnormalities of the glomerular basement membrane that are consistent with Alport syndrome
      • Immunohistochemical staining confirms low to no levels of type IV collagen alpha-3, alpha-4, or alpha-5 chains
    • Skin biopsy with immunohistochemical staining confirms low to no levels of type IV collagen alpha-5 chains
  • Member has CKD with an estimated glomerular filtration rate (eGFR) of 30-90 mL/min/1.73 m2
  • Member has a urinary albumin to creatinine ratio (UACR) of ≤ 3,500 mg/g
  • Prescribed by or in consultation with a nephrologist;
  • Age ≥ 12 years
  • RTA 402 is prescribed in combination with an angiotensin converting enzyme (ACE) inhibitor or an angiotensin receptor blocker (ARB) unless clinically significant adverse effects are experienced or all are contraindicated
  • Member has not had a kidney transplant
  • Dose does not exceed 30 mg per day
  • Approval duration: 6 months
• Continued Therapy, Chronic Kidney Disease of Alport Syndrome (must meet all):
  • Currently receiving medication via Centene benefit or member has previously met initial approval criteria
  • Member is responding positively to therapy as evidenced by stabilization or improvement in the member’s baseline eGFR
  • Member has not had a kidney transplant;
  • If request is for a dose increase, new dose does not exceed 30 mg per day
  • Approval duration: 12 months

Belumosudil (Rezurock) (CP.PHAR.552)

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, Chronic Graft-Versus-Host Disease (must meet all):
  • Diagnosis of cGVHD
  • Prescribed by or in consultation with an oncologist, hematologist, or bone marrow transplant specialis
  • Age ≥ 12 years;
  • Member has a history of allogenic hematopoietic cell transplant (HCT);
  • 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
  • Rezurock is not prescribed concurrently with Imbruvica^® or Jakafi^®
  • Dose does not exceed 400 mg (2 tablets) per day.
  • Approval duration: 12 months
• Continued Therapy, All Indications in Section I (must meet all):
  • Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Rezurock 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, new dose does not exceed 400 mg (2 tablets) per day.
  • Approval duration: 12 months

Belzutifan (Welireg) (CP.PHAR.553)

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, Von Hippel-Lindau Disease (must meet all):
  • Diagnosis of VHL disease who require therapy for associated RCC, CNS hemangioblastomas, or pNET, not requiring immediate surgery
  • Prescribed by or in consultation with an oncologist
  • Age ≥ 18 years
  • For Welireg requests, member must use belzutifan, if available, unless contraindicated or clinically significant adverse effects are experienced
  • Request meets one of the following:
    • Dose does not exceed 120 mg once daily;
    • 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, Von Hippel-Lindau Disease (must meet all):
  • Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Welireg for a covered indication and has received this medication for at least 30 days
  • Member is responding positively to therapy
  • For Welireg requests, member must use belzutifan, if available, unless contraindicated or clinically significant adverse effects are experienced
  • If request is for a dose increase, request meets one of the following:
    • Member meets both of the following:
      • New dose does not exceed 120 mg once daily
      • Dose is at least 40 mg once daily
    • 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: 6 months

Bremelanotide (Vyleesi) (CP.PHAR.434)

Ambetter

Policy retired

Brodalumab (Siliq) (CP.PHAR.375)

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

Policy includes:

• Removed redirection to Taltz

Casirivimab and imdevimab (REGEN-COV) (CP.PHAR.520)

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

Policy includes:

• Criteria will mirror the clinical information from the prescribing information once FDA-approved
• Criteria is only applicable for Medicaid and CHIP when the drug is added to the formulary for coverage
• Requests for indications not approved by the FDA are reviewed with the off-label use policy for the relevant line of business: HIM.PHAR.154 for Ambetter, and CP.PMN.53 for Medicaid and CHIP
• Initial Approval Criteria, Treatment of COVID-19 (must meet all):
  • Diagnosis of COVID-19 infection via a positive viral test for SARS-CoV-2 within the last 3 days
  • Member has one or more mild or moderate COVID-19 symptoms
  • Member is within 10 days of symptom onset
  • Age ≥ 12 years
  • Member’s body weight is ≥ 40 kg
  • Member meets at least one of the criteria for being at high risk for progressing to severe COVID-19 and/or hospitalization
  • At the time of request, member meets all of the following:
    • Member is not hospitalized due to COVID-19
    • Member does not require oxygen therapy due to COVID-19
    • For members on chronic oxygen therapy due to underlying non-COVID-19 related comorbidity: Member does not require an increase in baseline oxygen flow rate due to COVID-19
  • Casirivimab and imdevimab will be administered together as a single intravenous infusion
  • Casirivimab and imdevimab will be administered to the member in a setting in which health care providers have immediate access to medications to treat a severe infusion reaction, such as anaphylaxis, and the ability to activate the emergency medical system, as necessary
  • Dose does not exceed casirivimab 600 mg and imdevimab 600 mg, one time.
  • Approval duration: One time
• Initial Approval Criteria, Post-exposure Prophylaxis of COVID-19 (must meet all):
  • Member meets one of the following:
    • Member is not fully vaccinated
    • Member is not expected to mount an adequate immune response to complete SARS-CoV-2 vaccination (e.g., individuals with immunocompromising conditions including those taking immunosuppressive medications)
  • Member meets one of the following:
    • Member has been exposed to an individual infected with SARS-CoV-2 consistent with close contact criteria per CDC
    • Member is at high risk of exposure to an individual infected with SARS-CoV-2 because of occurrence of SARS-CoV-2 infection in other individuals in the same institutional setting (e.g., nursing homes, prisons)
  • Age ≥ 12 years
  • Member’s body weight is ≥ 40 kg
  • REGEN-COV is not being used for pre-exposure prophylaxis for prevention of COVID-19
  • Casirivimab and imdevimab will be administered together as a single intravenous infusion
  • Casirivimab and imdevimab will be administered to the member in a setting in which health care providers have immediate access to medications to treat a severe infusion reaction, such as anaphylaxis, and the ability to activate the emergency medical system, as necessary
  • Dose does not exceed casirivimab 600 mg and imdevimab 600 mg for the initial infusion, followed by no more than casirivimab 300 mg and imdevimab 300 mg repeat dosing every 4 weeks.
  • Approval duration: 3 months
• Continued Therapy, Treatment of COVID-19:
  • Re-authorization is not permitted
• Continued Therapy, Post-exposure Prophylaxis of COVID-19 (must meet all):
• Currently receiving medication via Centene benefit or member has previously met initial approval criteria;
  • Member will have ongoing exposure to SARS-COV-2 and is not expected to mount an adequate immune response to complete SARS-CoV-2 vaccination
  • Dose does not exceed casirivimab 300 mg and imdevimab 300 mg every 4 weeks.
  • Approval duration: 3 months

Compounded Medications (CP.PCH.27)

EXAMPLE:

Policy updates include:

• Added to I.A.1.a., “and practicing within an integrated and regulated health system”
• Added to I.E that singleton pregnancy “is estimated to be appropriate for gestational age”
• Added criteria in I.B. that 2 caregivers are planned to attend the birth, and that the one responsible for providing care to the infant is trained in NRP
• Revised criteria in I.H: Changed “Spontaneous labor in a pregnancy that has lasted at least 38 weeks” to specify 37 0/7 weeks clarified that no more than 41 weeks is no more than 41 6/7 weeks. Added separate criteria for home birth in a pregnancy induced as an outpatient
• Updated background section, American Academy of Pediatrics (AAP), with most current recommendations
• Replaced “members” with “members/enrollees” in all instances

Compounded Medications (CP.PCH.27)

Ambetter

Policy updates include:

• Allows NCCN 2B as acceptable compendia and evidence rating

Daunorubicin-cytarabine (Vyxeos) (CP.PHAR.352)

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

Policy updates include:

• Updated diagnosis of coverage for t-AML, AML-MRC and antecedent MDS/CMML as per PI and NCCN Compendium

Efgartigimod (ARGX-113) (CP.PHAR.555)

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

Policy includes:

• Criteria will mirror the clinical information from the prescribing information once FDA-approved
• Criteria is only applicable for Medicaid and CHIP when the drug is added to the formulary for coverage
• Requests for indications not approved by the FDA are reviewed with the off-label use policy for the relevant line of business: HIM.PHAR.154 for Ambetter, and CP.PMN.53 for Medicaid and CHIP
• Initial Approval Criteria, Generalized Myasthenia Gravis (must meet all):
  • Diagnosis of gMG
  • Prescribed by or in consultation with a neurologist
  • Age ≥ 18 years
  • Myasthenia Gravis-Activities of Daily Living (MG-ADL) score ≥ 5 at baseline
  • Greater than 50% of the baseline MG-ADL score is due to non-ocular symptoms
  • Myasthenia Gravis Foundation of America (MGFA) clinical classification of Class II to IV
  • Member has positive serologic test for anti-AChR antibodies
  • Failure of a cholinesterase inhibitor, unless contraindicated or clinically significant adverse effects are experienced
  • Failure of a corticosteroid unless contraindicated or clinically significant adverse effects are experienced
  • Failure of two immunosuppressive therapies unless clinically significant adverse effects are experienced or all are contraindicated
  • ARGX-113 is not prescribed concurrently with Soliris
  • Dose does not exceed 10 mg/kg once weekly for the first 4 weeks of every 8-week cycle
  • Approval duration: 6 months
• Continued Therapy, Generalized Myasthenia Gravis (must meet all):
  • Currently receiving medication via Centene benefit or member has previously met initial approval criteria
  • Member is responding positively to therapy as evidenced by a 2-point reduction in MG-ADL total score
  • If request is for a dose increase, dose does not exceed 10 mg/kg once weekly for the first 4 weeks of every 8-week cycle
• Approval duration: 6 months

Elagolix (Orilissa), elagolix-estradiol-norethindrone (Oriahnn) (CP.PHAR.136)

Ambetter

Policy updates include:

• Removed the requirement for confirmation that the member does not have osteoporosis for both Orilissa and Oriahnn

Elivaldogene autotemcel (CP.PHAR.556)

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

Policy includes:

• Criteria will mirror the clinical information from the prescribing information once FDA-approved
• Criteria is only applicable for Medicaid and CHIP when the drug is added to the formulary for coverage
• Requests for indications not approved by the FDA are reviewed with the off-label use policy for the relevant line of business: HIM.PHAR.154 for Ambetter, and CP.PMN.53 for Medicaid and CHIP
• Initial Approval Criteria, Cerebral Adrenoleukodystrophy (must meet all):
  • Diagnosis of adrenoleukodystrophy with genetic confirmation of ABCD1 mutation
  • Prescribed by or in consultation with an endocrinologist or neurologist
  • Member is a male of age < 18 years
  • Active CALD as evidenced by both of the following (a and b)
  • Elevated levels of very long chain fatty acids (VLCFA)
  • Active CNS disease established by brain magnetic resonance imaging (MRI) demonstrating both of the following:
    • Loes score ≥ 0.5 and ≤ 9 on the 34-point scale
    • Gadolinium enhancement on MRI of demyelinating lesions
  • Neurologic function score (NFS) ≤ 1
  • Member has not received prior allogeneic HSCT or gene therapy
  • Dose does not exceed 38.2 x 10⁶ CD34+ cells per kg
  • Approval duration: 3 months (one time infusion per lifetime)

Enasidenib (Idhifa) (CP.PHAR.363)

Ambetter

Policy updates include:

• Added coverage for age ≥ 60 with either not candidate for induction therapy or used for post-induction therapy with previous lower intensity therapy per NCCN

Erwinia Asparaginase (Erwinaze, Rylaze) (CP.PHAR.301)

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

Policy updates include:

• Added Rylaze to policy with new criteria set for LBL indication

Fedratinib (Inrebic) (CP.PHAR.442)

Ambetter

Policy updates include:

• Removed requirement for failure of HCT, hydroxyurea, and concurrent treatment with Jakafi within 14 days

Finerenone (Kerendia)  (CP.PMN.266)

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, Chronic Kidney Disease (must meet all):
  • Diagnosis of both of the following:
    • CKD
    • T2D
  • Age ≥ 18 years
  • Both of the following:
    • eGFR between 25 and 74 mL/min/1.73 m²
    • Urine albumin creatinine ratio (UACR) ≥ 30 mg/g
  • Member is currently receiving an angiotensin converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) at maximally tolerated doses for ≥ 4 weeks, unless clinically significant adverse effects are experienced or all are contraindicated
  • Dose does not exceed 20 mg (1 tablet) per day.
  • Approval duration: 12 months
• Continued Therapy, Chronic Kidney Disease (must meet all):
  • Currently receiving medication via Centene benefit or member has previously met initial approval criteria
  • Member is responding positively to therapy
  • If request is for a dose increase, new dose does not exceed 20 mg (1 tablet) per day.
  • Approval duration: 12 months

Human Growth Hormone (Somapacitan, Somatropin) (CP.PCH.39)

Ambetter

Policy retired

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

Ambetter

Policy updates include:

• Added additional pathway for use as induction therapy and revised requirement for use as single agent therapy to only apply to pediatric ALL per NCCN

Ivosidenib (Tibsovo) (CP.PHAR.137)

Ambetter

Policy updates include:

• Added coverage for age ≥ 60 with either not candidate for induction therapy or used for post-induction therapy with previous lower intensity therapy per NCCN

Leuprolide Acetate (Lupron, Lupron Depot, Eligard, Lupaneta Pack, Fensolvi) (CP.PHAR.173)

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

Policy updates include:

• Added Camcevi, a new dosage form of existing product [Lupron Depot] with same indication for prostate cancer
• Added gender transition to gender dysphoria criteria set

Levodopa Inhalation Powder (Inbrija)

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, Parkinson’s Disease (must meet all):
  • Diagnosis of PD
  • Prescribed by or in consultation with neurologist
  • Age ≥ 18 years
  • Inbrija will be used as intermittent treatment for OFF episodes
  • Prescribed concurrently with carbidopa/levodopa at a dose not exceeding 1,600 mg levodopa per day
  • Member is experiencing motor fluctuations with a minimum of 2 hours of average daily "off" time per waking day (excluding early morning "off" time) while on carbidopa/levodopa therapy
  • Failure of at least two anti-Parkinson agents from different therapeutic classes, unless clinically significant adverse effects are experienced or all are contraindicated:
    • MAO-B inhibitor: rasagiline;
    • COMT inhibitor: entacapone (Comtan^®/Stalevo^®), tolcapone;
    • Dopamine agonist: ropinirole/ropinirole ER, pramipexole/pramipexole ER;
  • Dose does not exceed two 42 mg capsules (84 mg) for inhalation up to 5 times a day (420 mg per day).
  • Approval duration: 12 months
• Continued Therapy, Parkinson’s Disease (must meet all):
  • Currently receiving medication via Centene benefit or member has previously met initial approval criteria
  • Member is responding positively to therapy
  • Member continues to receive concurrent treatment with carbidopa/levodopa
  • If request is for a dose increase, new dose does not exceed two 42 mg capsules (84 mg) for inhalation up to 5 times a day (420 mg per day).
  • Approval duration: 12 months

Mepolizumab (Nucala) (CP.PHAR.200)

Ambetter

Policy updates include:

• Criteria added for newly FDA-approved indication of  Chronic rhinosinusitis with nasal polyps (CRSwNP)

Migalastat (Galafold) (CP.PHAR.394)

Ambetter

Policy updates include:

• Added other specialist types who might be involved in a Fabry patient’s care

Mitapivat (CP.PHAR.558)

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, Pyruvate Kinase Deficiency (must meet all):
  • Diagnosis of PK deficiency confirmed by one of the following:
    • Presence of at least 2 mutant alleles in the PKLR gene, of which at least 1 is a missense mutation
    • Hemolytic anemia with laboratory evidence of reduced red blood cell PK enzymatic activity
  • Prescribed by or in consultation with a hematologist
  • Age ≥ 18 years
  • Member is not homozygous for the R479H mutation or have 2 non-missense mutations (without the presence of another missense mutation)
  • If member received no more than 4 blood transfusions in the last 12 months, recent (within the last 30 days) hemoglobin concentration ≤ 10 g/dL
  • Prescribed concurrently with oral folic acid
  • Dose does not exceed 100 mg per day
  • Approval duration: 6 months
• Continued Therapy, Pyruvate Kinase Deficiency (must meet all):
  • Currently receiving medication via Centene benefit or member has previously met initial approval criteria
  • Member is responding positively to therapy as evidenced by, including but not limited to, improvement in any of the following parameters:
    • Reduced transfusion burden
    • Increase in hemoglobin of at least 1.5 g/dL
    • If request is for a dose increase, new dose does not exceed 100 mg per day
  • Approval duration: 12 months

Mobocertinib (Exkivity) (CP.PHAR.559)

Ambetter

Policy includes:

• Requests for indications not approved by the FDA are reviewed with the off-label use policy for the relevant line of business: HIM.PHAR.154 for Ambetter
• Initial Approval Criteria, Non-Small Cell Lung Cancer (must meet all):
  • Diagnosis of locally advanced or metastatic NSCLC
  • Prescribed by or in consultation with an oncologist
  • Age ≥ 18 years
  • Disease is positive for epidermal growth factor receptor (EGFR) exon 20 insertion mutations
  • Member has progressed on or after platinum-based therapy
  • Request meets one of the following:
    • Dose does not exceed 160 mg (4 capsules) per day
    • Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence)
  • 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 Exkivity for NSCLC and has received this medication for at least 30 days
  • Member is responding positively to therapy
  • If request is for a dose increase, request meets one of the following:
    • New Dose does not exceed 160 mg (4 capsules) per day
    • New dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence)
  • Approval duration: 12 months

Naltrexone (Vivitrol) (CP.PHAR.96)

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

Policy updates include:

• Expanded the bypass for currently hospitalized patients to include those who are being treated at a residential addiction treatment facility
• Added a bypass of the naloxone challenge test or urine drug screen requirement for members who are currently being treated at an addiction treatment center with daily oral naltrexone

Palivizumab (Synagis) (CP.PHAR.16)

Ambetter

Policy updates include:

• For CLD requests, clarified chronic corticosteroid does not need to be systemic

Pegademase Bovine (Adagen) (CP.PHAR.392)

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

Policy retired

Pembrolizumab (Keytruda) (CP.PHAR.322)

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

Policy updates include:

• Criteria added for new FDA approved indication: cervical cancer in combination with chemotherapy with or without bevacizumab

Pilocarpine (AGN-190584) (CP.PMN.270)

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, Presbyopia (must meet all):
  • Diagnosis of presbyopia
  • Prescribed by or in consultation with an optometrist or ophthalmologist
  • Age between 40 and 55 years at the time of therapy initiation
  • Failure of corrective eyeglasses or contact lenses to resolve the presbyopia symptoms, unless contraindicated or clinically significant adverse effects are experienced
  • Member does not have glaucoma or ocular hypertension
  • AGN-190584 is not prescribed concurrently with any other ophthalmic pilocarpine formulation
  • Dose does not exceed 1 drop per eye per day.
  • Approval duration: 6 months
• Continued Therapy, Presbyopia (must meet all):
  • Currently receiving medication via Centene benefit or member has previously met initial approval criteria
  • Member is responding positively to therapy
  • If request is for a dose increase, new dose does not exceed 1 drop per eye per day.
  • Approval duration: 12 months

Plasminogen, human-tvmh (Ryplazim) (CP.PHAR.513)

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

Policy includes:

• Criteria is only applicable for Medicaid and CHIP when the drug is added to the formulary for coverage
• Requests for indications not approved by the FDA are reviewed with the off-label use policy for the relevant line of business: HIM.PHAR.154 for Ambetter, and CP.PMN.53 for Medicaid and CHIP
• Initial Approval Criteria, Plasminogen Deficiency Type 1 (must meet all):
  • Diagnosis of symptomatic congenital plasminogen deficiency (C-PLGD) as evidenced by documentation of all of the following:
    • Presence of a PLG mutation
    • Plasminogen activity level ≤ 45%
    • Signs or symptoms consistent with C-PLGD
  • Prescribed by or in consultation with a hematologist
  • Age ≥ 2 years
  • Dose does not exceed 6.6 mg/kg every second, third, or fourth day (based upon individual pharmacokinetics).
  • Approval duration: 6 month
• Continued Therapy, Plasminogen Deficiency Type 1 (must meet all):
  • Currently receiving medication via Centene benefit or member has previously met initial approval criteria
  • If member has received at least 3 months of Ryplazim treatment, increased trough plasminogen activity by at least 10% from baseline
  • Member is responding positively to therapy as evidenced by, including but not limited to, improvement in C-PLGD-associated signs or symptoms (e.g., improvement in the size of visible lesions, imaging of nonvisible lesions, or spirometry if pulmonary involvement
  • If request is for a dose increase, new dose does not exceed 6.6 mg/kg every second, third, or fourth day (based upon individual pharmacokinetics).
  • Approval duration: 12 months

Pralatrexate (Folotyn) (CP.PHAR.313)

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

Policy updates include:

• Added option for use as initial palliation for PTCL and clarified use as a single-agent therapy per NCCN
• Added BI-ALCL indication to criteria per NCCN

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

Ambetter

Policy updates include:

• Criteria added for new FDA indication of IH for Xywav
• Revised bypassing of redirections for age 65 years and older to apply only to TCAs for narcolepsy with cataplexy

Temsirolimus (Torisel) (CP.PHAR.324)

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

Policy updates include:

• Use as single agent added to Endometrial Carcinoma section

Tisotumab vedotin-tftv (Tivdak) (CP.PHAR.561)

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

Policy includes:

• Criteria will mirror the clinical information from the prescribing information once FDA-approved
• Criteria is only applicable for Medicaid and CHIP when the drug is added to the formulary for coverage
• Requests for indications not approved by the FDA are reviewed with the off-label use policy for the relevant line of business: HIM.PHAR.154 for Ambetter, and CP.PMN.53 for Medicaid and CHIP
• Initial Approval Criteria, Cervical Cancer (must meet all):
• Diagnosis of cervical cancer;
  • Disease is recurrent or metastatic
  • Prescribed by or in consultation with an oncologist
  • Age ≥ 18 years
  • Member has received no more than two prior systemic regimens in the recurrent or metastatic setting
  • Failure of single-agent or combination chemotherapy regimen, with or without bevacizumab (e.g., cisplatin/paclitaxel/bevacizumb, cisplatin/paclitaxel, cisplatin alone), unless contraindicated or clinically significant adverse effects are experienced
  • Documentation of member’s current weight in kilograms
  • Request meets one of the following:
    • Dose does not exceed 2 mg/kg (up to a maximum dose of 200 mg for members ≥ 100 kg) every 3 weeks
    • Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence)
  • Approval duration: 6 months
• Continued Therapy, Cervical Cancer (must meet all):
  • Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Tivdak for a covered indication and has received this medication for at least 30 days
  • Member is responding positively to therapy;
  • Member is receiving at least 0.9 mg/kg every 3 weeks
  • Documentation of member’s current weight in kilograms
  • If request is for a dose increase, request meets one of the following:
    • New dose does not exceed 2 mg/kg (up to a maximum dose of 200 mg for patients ≥ 100 kg) every 3 weeks;
    • New dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence)
  • Approval duration: 12 months

Tocilizumab (Actemra) (CP.PHAR.263)

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

Policy updates include:

• For RA removed redirection to alternative bDMARDs
• For Xeljanz redirection requirements added bypass for members with cardiovascular risk and qualified redirection to apply only for member that has not responded or is intolerant to one or more TNF blockers

Triptorelin pamoate (Trelstar, Triptodur) (CP.PHAR.175)

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

Policy updates include:

• Added gender transition to gender dysphoria criteria set

Udenafil (CP.PHAR.557)

Ambetter

Policy includes:

• Criteria will mirror the clinical information from the prescribing information once FDA-approved
• Requests for indications not approved by the FDA are reviewed with the off-label use policy for the relevant line of business: HIM.PHAR.154 for Ambetter
• Initial Approval Criteria, Single Ventricle Heart Disease (must meet all):
  • Diagnosis of SVHD
  • Prescribed by or in consultation with a cardiologist
  • Age ≥ 12 years and ≤ 18 years at therapy initiation
  • Member has undergone Fontan palliation
  • Documentation of baseline peak oxygen consumption
  • Peak oxygen consumption > 50% of predicted for age and sex
  • Respiratory exchange ratio ≥ 1.10 at peak exercise during cardiopulmonary exercise test
  • At the time of request, member meets all of the following:
    • No hospitalization for acute decompensated heart failure within the last 12 months
    • Member does not have a diagnosis of active protein losing enteropathy or plastic bronchitis within the last 3 years, or history of liver cirrhosis
    • Member does not have Fontan baffle obstruction, branch pulmonary artery or vein stenosis, severe ventricular dysfunction, or atrioventricular valve regurgitation assessed by echocardiography within the last six months
  • Dose does not exceed 175 mg per day
  • Approval duration: 6 months
• Continued Therapy, Single Ventricle Heart Disease (must meet all):
  • Currently receiving medication via Centene benefit or member has previously met initial approval criteria
  • Member is responding positively as evidenced by, including but not limited to, improvement or maintenance of positive peak oxygen consumption compared to baseline
  • If request is for a dose increase, new dose does not exceed 175 mg per day
  • Approval duration: 12 months