Effective December 1, 2023: Pharmacy and Biopharmacy Policies

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

Ambetter

Policy updates include:

• For Stelara, removed redirection criteria for requests that are above the labeled maximum dose.

Valbenazine (Ingrezza) (CP.PCH.48)

Ambetter

• Added newly approved indication chorea associated with Huntington’s disease
• Appendix H added with UHDRS details

Aflibercept (Eylea, Eylea HD) (CP.PHAR.184)

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

Policy updates include:  

• Added new Eylea HD formulation
• For macular edema following retinal vein occlusion and retinopathy of prematurity indications, added criteria that request is for Eylea
• For continued use of Eylea in diabetic macular edema and diabetic retinopathy, added option for every 4 week dosing to align with neovascular (wet) age-related macular degeneration

Trifluridine-tipiracil (Lonsurf) (CP.PHAR.383)

Ambetter

Policy updates include:  

• Added new indication for metastatic colorectal carcinoma  in combination with bevacizumab to FDA-approved indications section

Inclisiran (Leqvio) (CP.PHAR.568)

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

• Added expanded indication to include patients with primary hyperlipidemia
• For Commerical LOB, approval duration revised to “6 months or to the member’s renewal date, whichever is longer”

Nirsevimab (Beyfortus) (CP.PHAR.614)

Ambetter

• Added the following clarification to ensure Synagis is not continued following Beyfortus administration: “Synagis should no longer be administered following Beyfortus. Existing Synagis authorizations should be termed.”
• Added the following bypass to the exclusion for prior use of maternal RSV vaccination: “unless infant is born < 14 days after maternal RSV vaccination.”

Crizotinib (Xalkori) (CP.PHAR.90)

Ambetter

• Added new oral pellet dose form per updated prescribing information
• Added indication specific quantity limits for pellets.

Isavuconazonium (Cresemba) (CP.PMN.154)

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

Policy updates include:  

• Added 74.5 mg capsule due to recent market launch.

GLP-1 receptor agonists (HIM.PA.53)

Ambetter

Policy updates include:

• Added newly approved Mounjaro vial formulations.

Colchicine (Lodoco) (CP.PHAR.640)

Ambetter

Policy includes:

• Requests for indications not approved by the Food and Drug Administration are reviewed with the off-label use policy for the relevant line of business: HIM.PHAR.154 for Ambetter 
• Initial Approval Criteria: Cardiovascular Event Prophylaxis (must meet all):
  • Member meets one of the following:
    • History of myocardial infarction;
    • History of stroke;
    • History of coronary revascularization;
    • Has multiple risk factors for cardiovascular disease;
    • Diagnosis of stable coronary artery disease;
  • Prescribed by or in consultation with a cardiologist;
  • Age ≥ 18 years;
  •  Documentation that member has been clinically stable for at least 6 months;
  • Prescriber attestation that member is concurrently receiving standard of care for one of the following:
    • Secondary prevention prophylaxis regimen for MI or stroke;
    • Treatment for stable coronary artery disease; 
  • Dose does not exceed 0.5 mg (1 tablet) per day.
  • Approval duration: 12 months
• Continued Therapy: Cardiovascular Event Prophylaxis (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 (refer to state specific addendums for CC.PHARM.03A and CC.PHARM.03B); 
  • Member is responding positively to therapy (e.g. no drug-related adverse events such as myotoxicity, rhabdomyolysis, abdominal pain, acute renal impairment);
  • If request is for a dose increase, new dose does not exceed 0.5 mg (1 tablet) per day.
  • Approval duration: 12 months

Avacincaptad pegol (Izervay) (CP.PHAR.641)

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

Policy includes:

• Requests for indications not approved by the Food and Drug Administration 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: Geographic Atrophy (must meet all):
  • Diagnosis of geographic atrophy with all of the following characteristics:
    • geographic atrophy is secondary to age-related macular degeneration;
    • Total geographic atrophy area ≥ 2.5 and ≤ 17.5 mm2 (1 and 7 disk areas [DA], respectively);
    • If geographic atrophy is multifocal, at least one focal lesion ≥ 1.25 mm2 (0.5 DA);
    • Presence of hyperautofluorescence in the junctional zone of geographic atrophy;
    • geographic atrophy is not centered in the fovea;
  • Prescribed by or in consultation with an ophthalmologist;
  • Age ≥ 50 years;
  • Best corrected visual acuity (BCVA) between 20/25 and 20/320;
  • Member does not have either of the following (a and b):
    • Signs of diabetic retinopathy in either eye;
    • Evidence of choroidal neovascularization in the eye(s) affected by geographic atrophy;
  • Dose does not exceed 2 mg (0.1 mL of 20 mg/mL solution) in each affected eye every 21 days.
  • Approval duration: 6 months
• Continued Therapy: Geographic Atrophy (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 (refer to state specific addendums for CC.PHARM.03A and CC.PHARM.03B);
  • Member is responding positively to therapy;
  • Treatment has not exceeded 12 months in the affected eye;
  • If request is for a dose increase, new dose does exceed 2 mg (0.1 mL of 20 mg/mL solution) in each affected eye every 21 days.
  • Approval duration: 6 months (up to 12 months of treatment per eye)

Niraparib and Abiraterone (Akeega) (CP.PHAR.645)

Ambetter

Policy includes:

• Requests for indications not approved by the Food and Drug Administration 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 metastatic castration-resistant prostate cancer (mCRPC);
  • Prescribed by or in consultation with an oncologist or urologist;
  • Age ≥ 18 years;
  • Documentation of a deleterious or suspected deleterious germline or somatic BRCA 1/2 mutation as confirmed on a CLIA approved diagnostic test (e.g., Foundation One CDx, or BRAC Analysis CDx);
  • One of the following:
    • Member has BRCA 1/2 mutation, and Akeega is prescribed in combination with prednisone;
    • Documentation of disease progression despite bilateral orchiectomy or other androgen deprivation therapy (ADT);
  • For brand Akeega requests, member must use generic niraparib/abiraterone, if available, unless contraindicated or clinically significant adverse effects are experienced;
  • Prescribed concurrently with a gonadotropin-releasing hormone (GnRH) analog or member has had a bilateral orchiectomy;
  • Member has not previously received a PARP inhibitor (e.g., Rubraca®, Talzenna®, Zejula®);
  • Request meets one of the following:
    • Dose does not exceed both of the following:
      • 200 mg niraparib/1,000 mg abiraterone acetate 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 Food and Drug Administration-approved or recommended by National Comprehensive Cancer Network
  • Approval duration: 6 months
• Continued Therapy: Prostate Cancer (must meet all):
  • Currently receiving medication via Centene benefit or documentation supports that member is currently receiving Akeega for a covered indication and has received this medication for at least 30 days;
  • Member is responding positively to therapy;
  • For brand Akeega requests, member must use generic niraparib/abiraterone, if available, unless contraindicated or clinically significant adverse effects are experienced;
  • If request is for a dose increase, request meets one of the following (a or b):*
  • Dose does not exceed both of the following:
    • 200 mg niraparib/1,000 mg abiraterone acetate 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 Food and Drug Administration-approved or recommended by National Comprehensive Cancer Network
  • Approval duration: 12 months

Quizartinib (Vanflyta) (CP.PHAR.646)

Ambetter

Policy includes:

• Requests for indications not approved by the Food and Drug Administration are reviewed with the off-label use policy for the relevant line of business: HIM.PHAR.154 for Ambetter Initial
• Approval Criteria:  Acute Myeloid Leukemia (must meet all):
  • Diagnosis of acute myeloid leukemia;
  • Prescribed by or in consultation with an oncologist or hematologist;
  • Age ≥ 18 years;
  • Vanflyta is prescribed as any of the following:
    • Induction therapy in combination with cytarabine and an anthracycline (e.g., daunorubicin, idarubicin);
    • Consolidation therapy in combination with cytarabine;
    • Maintenance therapy as a single agent following consolidation chemotherapy;
  • Presence of FLT3 ITD mutation;
  • Vanflyta is not prescribed for maintenance monotherapy following allogeneic hematopoietic stem cell transplantation (HSCT);
  • For Vanflyta requests, member must use generic quizartinib, if available, unless contraindicated or clinically significant adverse effects are experienced;
  • Request meets one of the following:
    • Dose does not exceed 2 tablets and one of the following:
      •  For induction therapy: 35.4 mg on days 8-21 for two 28-day cycles;
      • For consolidation therapy: 35.4 mg on days 6-19 for four 28-day cycles;
      • For maintenance monotherapy: 53 mg 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 Food and Drug Administration-approved or recommended by National Comprehensive Cancer Network
  • Approval duration: 6 months
• Continued Therapy:  Acute Myeloid Leukemia (must meet all):
  • Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Vanflyta for a covered indication and has received this medication for at least 30 days;
  • Member is responding positively to therapy;
  • For Vanflyta requests, member must use generic quizartinib, 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:
      • 53 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 Food and Drug Administration-approved or recommended by National Comprehensive Cancer Network
  • Approval duration: 12 months

Rozanolixizumab-noli (Rystiggo) (CP.PHAR.648)

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

Policy includes:

• Requests for indications not approved by the Food and Drug Administration 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 generalized myasthenia gravis;
  • Prescribed by or in consultation with a neurologist;
  • Age ≥ 18 years;
  • Myasthenia Gravis-Activities of Daily Living (MG-ADL) ≥ 3 from non-ocular symptoms at baseline;
  • Myasthenia Gravis Foundation of America (MGFA) clinical classification of Class II to IVa;
  • Member has positive serologic test for one of the following (a or b):
    • Anti-AChR antibodies;
    • Anti-MuSK antibodies;
  • If 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 at least one immunosuppressive therapy, unless clinically significant adverse effects are experienced or all are contraindicated;
  • Rystiggo is not prescribed concurrently with Vyvgart®, Vyvgart® Hytrulo, Soliris®, or Ultomiris®;
  • Documentation of member’s current weight (in kg);
  • Dose does not exceed one of the following once weekly for the first 6 weeks of every 9-week cycle:
    • Weight < 50 kg and both:
      • 420 mg;
      • 2 vials;
    • Weight 50 kg to < 100 kg and both:
      • 560 mg;
      • 2 vials;
    • Weight ≥ 100 kg and both:
      • 840 mg;
      • 3 vials;
  • Approval duration: 6 months
• Continued Therapy: Generalized Myasthenia Gravis (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 (refer to state specific addendums for CC.PHARM.03A and CC.PHARM.03B);
  • Member is responding positively to therapy as evidenced by a 2-point reduction in MG-ADL total score from baseline;
  • Rystiggo is not prescribed concurrently with Vyvgart, Vyvgart Hytrulo, Soliris, or Ultomiris;
  • Documentation of member’s current weight (in kg);
  • If request is for a dose increase, new dose does not exceed one of the following once weekly for the first 6 weeks of every 9-week cycle:
    • Weight < 50 kg and both (i and ii):
      • 420 mg;
      • 2 vials;
    • Weight 50 kg to < 100 kg and both:
      • 560 mg;
      • 2 vials;
    • Weight ≥ 100 kg and both:
      • 840 mg;
      • 3 vials;
  • Approval duration: 6 months

Talquetamab-tgvs (Talvey) (CP.PHAR.649)

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

Policy includes:

• Requests for indications not approved by the Food and Drug Administration are reviewed with the off-label use policy for the relevant line of business: HIM.PHAR.154 for Ambetter, and CP.PMN.53 for Medicaid and CHIP
• Initial Approval Criteria: Multiple Myeloma (must meet all):
  • Diagnosis of multiple myeloma;
  • Prescribed by or in consultation with an oncologist or hematologist;
  • Age ≥ 18 years;
  • Disease is relapsed or refractory;
  • Member has received or has documented intolerance to ≥ 4 prior lines of therapiesthat include all of the following:
    • One proteasome inhibitors (e.g., bortezomib, Kyprolis®, Ninlaro®)
    • One immunomodulatory drugs (e.g., Thalomid®, lenalidomide, pomalidomide)
    • One anti-CD38 monoclonal antibodies (e.g., Darzalex®, Sarclisa®)
    • Prior authorization may be required
  • Request meets one of the following:
    • Dose does not exceed 0.4 mg/kg once weekly;
    • Dose does not exceed 0.8 mg/kg 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 Food and Drug Administration-approved or recommended by National Comprehensive Cancer Network
  • Approval duration: 6 months
•  Continued Therapy: Multiple Myeloma (must meet all):
  • Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Talvey 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:
    • Dose does not exceed 0.4 mg/kg once weekly;
    • Dose does not exceed 0.8 mg/kg 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 Food and Drug Administration-approved or recommended by National Comprehensive Cancer Network
  • Approval duration: 12 months

Zuranolone (Zurzuvae) (CP.PHAR.650)

Ambetter

Policy includes:

• Requests for indications not approved by the Food and Drug Administration are reviewed with the off-label use policy for the relevant line of business: HIM.PHAR.154 for Ambetter Initial Approval Criteria: Postpartum Depression (must meet all)
  • Diagnosis of a major depressive episode that began no earlier than the third trimester and no later than the first 4 weeks following delivery, as diagnosed by Structured Clinical Interview for DSM-5;
  • Prescribed by or in consultation with psychiatrist;
  • Age ≥ 18 years;
  • Member meets one of the following:
    • HAMD score is ≥ 24 (severe depression)
    • MADRS score is ≥ 35 (severe depression);
    •  PHQ-9 score is ≥ 20 (severe depression);
    •  If member does not have severe depression as demonstrated by at least one of the depression scores above (a, b, or c), documentation of severe depression as evidenced by a psychiarist clinical interview;
  • Failure of an 4-week trial of one of the following oral antidepressants at up to maximally indicated dose but no less than the commonly recognized minimum therapeutic dose, unless clinically significant adverse effects are experienced or all are contraindicated: selective serotonin reuptake inhibitor (SSRI), serotonin-norepinephrine reuptake inhibitor (SNRI), tricyclic antidepressant (TCA), bupropion, mirtazapine;
  • No more than 12 months have passed since member has given birth;
  • Member has not received prior treatment with Zulresso™ or Zurzuvae for the current pregnancy;
  •  Dose does not exceed a 14 day treatment course and both of the following:
    •  50 mg per day;
    •  2 capsules per day.
  •  Approval duration: 30 days (one 14 day treatment course per pregnancy)
• Continued Therapy: Postpartum Depression
  • Re-authorization is not permitted. Members must meet the initial approval criteria.
  • Approval duration: Not applicable

DaxibotulinumtoxinA-lanm (Daxxify) (CP.PHAR.651)

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

Policy includes:

• Requests for indications not approved by the Food and Drug Administration 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 Dystonia (must meet all)
  • Diagnosis of cervical dystonia;
  • Prescribed by or in consultation with a neurologist, orthopedist, or physiatrist;
  • Age ≥ 18 years;
  • Member is experiencing involuntary contractions of the neck and shoulder muscles (e.g., splenius capitis, sternocleidomastoid, levator scapulae, scalene, trapezius, semispinalis capitis) resulting in abnormal postures or movements of the neck, shoulders or head;
  • Contractions are causing pain and functional impairment;
  • Failure of Botox® and Dysport®, unless clinically significant adverse effects are experienced, or both are contraindicated;
  • Daxxify is not prescribed concurrently with other botulinum toxin products;
  • Botulinum toxin therapy for cosmetic or medical conditions has not been administered within the last 12 weeks;
  • Treatment plan provided detailing number of Units per indication and treatment session;
  • Dose does not exceed 250 Units per treatment session;
  • Approval duration:12 months
•    Continued Therapy: Cervical Dystonia (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 (refer to state specific addendums for CC.PHARM.03A and CC.PHARM.03B);
  • Member is responding positively to therapy;
  • Daxxify is not prescribed concurrently with other botulinum toxin products;
  • Botulinum toxin therapy for cosmetic or medical conditions has not been administered within the last 12 week;
  • Treatment plan provided detailing number of Units per indication and treatment session;
  • If request is for a dose increase, new dose does not exceed 250 Units per treatment session;
  • Approval duration:12 months

Elranatamab-bcmm (Elrexfio) (CP.PHAR.652)

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

Policy includes:

• Requests for indications not approved by the Food and Drug Administration are reviewed with the off-label use policy for the relevant line of business: HIM.PHAR.154 for Ambetter, and CP.PMN.53 for Medicaid and CHIP
• Initial Approval Criteria: Multiple Myeloma (must meet all):
  • Diagnosis of multiple myeloma;
  • Prescribed by or in consultation with an oncologist or hematologist;
  • Age ≥ 18 years;
  • Disease is relapsed or refractory;
  • One of the following:
    • Member has measurable disease as evidenced by one of the following assessed within the last 30 days:
      • Serum M-protein ≥ 0.5 g/dL;
      • Urine M-protein ≥ 200 mg/24 h;
      • Serum free light chain (FLC) assay: involved FLC level ≥ 10 mg/dL (100 mg/L) provided serum FLC ratio is abnormal;
    • Member has progressive disease, as defined by the International Myeloma Working Group response criteria, assessed within 60 days following the last dose of the last anti-myeloma drug regimen received;
  • Elrexfio is prescribed as monotherapy;
  • Member has received or has documented intolerance to ≥ 4 prior lines of therapy that include all of the following:
    • One proteasome inhibitor (e.g., bortezomib, Kyprolis®, Ninlaro®
    • One immunomodulatory drug (e.g., Revlimid®, pomalidomide, Thalomid®
    • One anti-CD38 antibody (e.g., Darzalex®/Darzalex Faspro®, Sarclisa®)
    • *Prior authorization may be require
  • Request meets one of the following:
    • Dose does not exceed 12 mg on day 1, 32 mg on day 4, 76 mg on day 8 and weekly thereafter through week 24;
    • 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-approved or recommended by National Comprehensive Cancer Network
  • Approval duration: 6 months

• Continued Therapy: Multiple Myeloma (must meet all
  • Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Elrexfio 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:
    • Dose does not exceed one of the following:
      • Up to week 24 of therapy: 76 mg weekly;
      • Week 25 of therapy and beyond: 76 mg 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 Food and Drug Administration-approved or recommended by National Comprehensive Cancer Netwo
  •    Approval duration: 12 months.

Melphalan (Hepzato) (CP.PHAR.653)

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

Policy includes:

• Requests for indications not approved by the Food and Drug Administration 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: Uveal Melanoma (must meet all)
  • Diagnosis of unresectable or metastatic uveal melanoma
  • Prescribed by or in consultation with an oncologist;
  • Age ≥ 18 year   Weight ≥ 35 kg;
  • Histologically or cytologically-proven ocular melanoma metastases affecting 50% or less of the parenchyma of the liver;
  • Member has one of the following:
    • No extrahepatic disease;
    • Extrahepatic disease limited to the bone, lymph nodes, subcutaneous tissues, or lung that is amenable to resection or radiation;
  • Recent (within the last 30 days) hematologic testing demonstrating all the following (a, b, and c):
    • Platelet count ≥ 100,000/µL;
    • Hemoglobin ≥ 10 g/dL;
    • Neutrophils > 2,000/µL;
  • Member does not have Child-Pugh Class B or C cirrhosis;
  • Request meets one of the following:
    • Dose does not exceed both of the following:
      • 3 mg/kg based on ideal body weight every 6 weeks for up to 6 total infusions;
      • 220 mg per infusion;
    • 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-approved or recommended by National Comprehensive Cancer Network
  • Approval duration: 6 months
• Continued Therapy: Uveal Melanoma (must meet all):
  • Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Hepzato for a covered indication and has received this medication for at least 30 days;
  • Member is responding positively to therapy;
  • Member has not received ≥ 6 total Hepzato infusions;
  • If request is for a dose increase, request meets one of the following:
    • New dose does not exceed both of the following:
      • 3 mg/kg based on ideal body weight every 6 weeks for up to 6 total infusions;
      • 220 mg per infusion;
    • 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 Food and Drug Administration-approved or recommended by National Comprehensive Cancer Network
  • Approval duration: 12 months (up to 6 total infusions)

Lotilaner (Xdemvy) (CP.PMN.291)

Ambetter

Policy includes:

• Requests for indications not approved by the Food and Drug Administration are reviewed with the off-label use policy for the relevant line of business: HIM.PHAR.154 for Ambetter
• Initial Approval Criteria
  • Demodex Blepharitis (must meet all):
    • Diagnosis of Demodex blepharitis;
    • Age ≥ 18 years;
    • Request does not exceed 1 bottle per 6 weeks.
  • Approval duration: 6 weeks
• Continued Therapy: Demodex Blepharitis (must meet all):
  • Re-authorization is not permitted. Members must meet the initial approval criteria.
  • Approval duration: Not applicable

Dasiglucagon (ZP4207) (CP.PHAR.642)

Ambetter

Policy includes:

• Criteria will mirror the clinical information from the prescribing information once Food and Drug Administration-approved
• Requests for indications not approved by the Food and Drug Administration 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: Congenital Hyperinsulinism (must meet all):
  • Diagnosis of CHI as evidence by any one of the following:
    • Plasma insulin detection during an event of hypoglycemia;
    •  Plasma free fatty acid < 1.7 mmol/L;
    •  Beta-hydroxybutyrate < 1.8 mmol/L;
    •  Plasma glucose > 30 mg/dL after one administration of glucagon administration;
  •  Prescribed by or in consultation with an endocrinologist or geneticist;
  •  Age ≥ 7 days;
  •  Body weight ≥ 2 kg; 
  • Documentation of number of hypoglycemic events per week; 
  • Failure of diazoxide, unless member has a mutation in the ABCC8 or KCNJ11 genes or contraindicated or clinically significant adverse effects are experienced;
  • Member has previously undergone near-total pancreatectomy or is not eligible for pancreatic surgery; 
  • Prescriber attestation that member is concurrently receiving standard of care for CHI intensive medical therapy (e.g. continuous dextrose administration, somatotstatin analog);
  • Dose does not exceed Food and Drug Administration maximum dose.
  • Approval duration: 3 months
• Continued Therapy: Congenital Hyperinsulinism (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 (refer to state specific addendums for CC.PHARM.03A and CC.PHARM.03B);
  • Member is responding positively to therapy as evidenced by, including but not limited to, improvement in any of the following parameters:
    • Decrease in number of hypoglycemic events per week;
    • Reduction of time in hypoglycemic events;
  • If request is for a dose increase, new dose does not exceed Food and Drug Administration maximum dose.
  • Approval duration: 6 months

Fidanacogene Elaparvovec (CP.PHAR.643)

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-approved
• Requests for indications not approved by the Food and Drug Administration 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: Congenital Hemophilia B (must meet all):
  • Diagnosis of congenital hemophilia B (factor IX deficiency);
  • Prescribed by or in consultation with a hematologist;
  • Age ≥ 18 years;
  • Member has severe or moderately severe hemophilia (defined as a factor IX level of ≤ 2%);
  • Member meets both of the following:
    • Member has been adherent with use of a factor IX product* (e.g., Alprolix®, Benefix®, Idelvion®, Ixinity®, Rebinyn®, Rixubis®) for routine prophylaxis for at least 6 months as assessed and documented by prescriber;
    • Occurrence of at least one serious spontaneous bleeding event while on routine prophylaxis;
    • *Prior authorization may be required
  • Member has been treated with factor IX product for a minimum of 50 exposure days;
  • Member meets all the following:
    • No previous documented history of a detectable factor IX inhibitor;
    • Documentation of inhibitor level assay < 0.6 Bethesda units (BU) within the last 12 months;
    • If member had an initial positive test result for factor IX inhibitor, member has documentation of a subsequent negative test within 2 weeks;
  • Member has had all of the following baseline liver assessments within the last 3 months:
    • Documentation of liver enzymes within normal limits (i.e., alanine aminotransferase [ALT], aspartate aminotransferase [AST], alkaline phosphatase [ALP] and total bilirubin);
    • Documentation of normal hepatic ultrasound and elastography;
    • If member has evidence of radiological liver abnormalities and/or sustained liver enzymes elevations, attestation from hepatologist that member is eligible for Brand Name;
  • Member has not received prior gene therapy;
  • Member has documentation of anti-AAV-Spark100 neutralizing antibody titer < 1:1;
  • Dose does not exceed 5 x 1011 vector genomes (vg) per kg.
  • Approval duration: 3 months (1 dose only)
• Continued Therapy: Congenital Hemophilia B (must meet all):
  • Continued therapy will not authorized as Brand Name is indicated to be dosed one time only.
  • Approval duration: Not applicable

Givinostat (ITF2357) (CP.PHAR.644)

Ambetter

Policy includes:

• Criteria will mirror the clinical information from the prescribing information once Food and Drug Administration-approved
• Requests for indications not approved by the Food and Drug Administration are reviewed with the off-label use policy for the relevant line of business: HIM.PHAR.154 for Ambetter
• Initial Approval Criteria: Duchenne Muscular Dystrophy (must meet all):
  • Diagnosis of Duchenne Muscular Dystrophy  confirmed by genetic testing;
  • Prescribed by or in consultation with a neurologist;
  • Age ≥ 6 years and < 18 years at therapy initiation;
  • Ambulatory function (e.g., ability to walk with or without assistive devices, not wheelchair dependent) with a timed 4-stair climb (4SC) ≤ 8 seconds;
  • At the time of the request, member has none of the following contraindications:
    • Baseline QTcF > 450 msec;
    • Platelet count < 150 x 109/L;
    • Triglycerides > 300 mg/dL;
    • Left ventricular ejection fraction (LVEF) < 50%;
  • Member has been on a stable dose of an oral corticosteroid (e.g., prednisone, Emflaza®*) for ≥ 6 months, unless contraindicated or clinically significant adverse effects are experienced;
    • *Prior authorization is required for Emflaza
  • ITF2357 is prescribed concurrently with an oral corticosteroid, unless contraindicated or clinically significant adverse effects are experienced;
  • Documentation of member’s body weight in kg;
  • Dose does not exceed the Food and Drug Administration-approved maximum based on body weight.
  • Approval duration: 6 months
• Continued Therapy: Duchenne Muscular Dystrophy (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 (refer to state specific addendums for CC.PHARM.03A and CC.PHARM.03B);
  • Member is responding positively to therapy;
  • Member has been assessed by a neurologist within the last 6 months;
  • ITF2357 is prescribed concurrently with an oral corticosteroid, unless contraindicated or clinically significant adverse effects are experienced;
  • If request is for a dose increase, new dose does not exceed Food and Drug Administration-approved maximum based on body weight.
  • Approval duration: 12 months

Resmetirom (CP.PHAR.647)

Ambetter

Policy includes:

• Criteria will mirror the clinical information from the prescribing information once Food and Drug Administration-approved
• Requests for indications not approved by the Food and Drug Administration are reviewed with the off-label use policy for the relevant line of business: HIM.PHAR.154 for Ambetter, and CP.PMN.53 for Medicaid and CHIP
• Initial Approval Criteria: Non-Alcoholic Steatohepatitis (must meet all):
  • Diagnosis of non-alcoholic steatohepatitis;
  • Prescribed by or in consultation with a hepatologist or gastroenterologist;
  •  Age ≥ 18 years;
  • Fibrosis stage 2 or 3 as confirmed by one of the following:
    • Liver biopsy;
    • Transient elastography or magnetic resonance elastography;
  • If body mass index (BMI) ≥ 27 kg/m2, documentation of adherence to lifestyle modification, including participation in a physician-directed diet and exercise program, for at least the last 6 months;
  • For members with type 2 diabetes: Failure of a 6-month trial of pioglitazone at up to maximally indicated doses, unless contraindicated or clinically significant adverse effects are experienced;
  • Dose does not exceed the Food and Drug Administration-labeled maximum dose.
  • Approval duration: 6 months
• Continued Therapy: Non-Alcoholic Steatohepatitis (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 (refer to state specific addendums for CC.PHARM.03A and CC.PHARM.03B);
  • Member is responding positively to therapy as evidenced by, including but not limited to, improvement in any of the following parameters:
    • Improvement in non-alcoholic steatohepatitis fibrosis ≥ 1-stage from baseline with no worsening of non-alcoholic steatohepatitis (i.e., no worsening of hepatocellular ballooning, lobular inflammation, or steatosis);
    • No increase in non-alcoholic steatohepatitis fibrosis stage and no worsening of non-alcoholic steatohepatitis from baseline;
  • If request is for a dose increase, new dose does not exceed the Food and Drug Administration-labeled maximum dose.
  • Approval duration: 12 months

Maralixibat (Livmarl) (CP.PHAR.543)

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-approved
• Requests for indications not approved by the Food and Drug Administration 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: Progressive Familial Intrahepatic Cholestasis (must meet all):
  • Diagnosis of genetically confirmed progressive familial intrahepatic cholestasis (formerly known as Byler disease or syndrome) with presence of both of the following:
    • Has moderate to severe pruritis (e.g., ≥ 2 on 0 to 4 scale);
    • Serum bile acid (sBA) levels > 3 times the upper limit of normal (ULN) for age;
  • Prescribed by or in consultation with a hepatologist or gastroenterologist;
  • Age ≥ 2 months and < 18 years of age at therapy initiation;
  • Body weight ≥ 5 kg; 
  • For progressive familial intrahepatic cholestasis type 2, member does not have ABCB11 gene variants resulting in non-functional or complete absence of bile salt export pump (BSEP) protein;
  • Failure of ursodeoxycholic acid, unless clinically significant adverse effects are experienced or contraindicated;
  • Failure of an agent used for symptomatic relief of pruritus (e.g., antihistamine, rifampin, cholestyramine), unless clinically significant adverse effects are experienced or all are contraindicated;
  • Livmarli is not prescribed concurrently with other IBAT inhibitors (e.g., Bylvay™);
  • Documentation of member’s current weight in kg;
  • Dose does not exceed 570 mcg/kg twice daily.
  • Approval duration: 6 months
• Continued Therapy: Progressive Familial Intrahepatic Cholestasis (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 (refer to state specific addendums for CC.PHARM.03A and CC.PHARM.03B);
  • Member is responding positively to therapy as evidenced by, including but not limited to, improvement in any of the following parameters:
    • Improvement in pruritis;
    • Reduction of sBA from baseline;
  • Documentation of member’s current weight in kg;
  • If request is for a dose increase, new dose does not exceed 570 mcg/kg twice daily.
  • Approval duration: 12 months

Colonoscopy Preparation Products (CP.PCH.43)

Ambetter

Policy updates include:

• Removed discontinued products Prepopik and Colyte; added GaviLyte-C and Suflave to policy

Venetoclax (Venclexta) (CP.PHAR.129)

Ambetter

Policy updates include:

• for chronic lymphocytic leukemia/ small lymphocytic lymphoma indication, added option of treatment for relapse in combination with Gazyva if previously used as first-line treatment per National Comprehensive Cancer Network

Ivosidenib (Tibsovo) (CP.PHAR.137)

Ambetter

Policy updates include:

• Per National Comprehensive Cancer Network, added oligodendroglioma as a coverable off-label diagnosis

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

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

Policy updates include:

• per National Comprehensive Cancer Network compendium and Pancreatic Adenocarcinoma guidelines version 2.2023, updated “FOLFIRINOX” to “fluoropyrimidine-based therapy and no prior irinotecan” and added “component of NALIRIFOX regimen”
• Updated Appendix B to include examples of fluoropyrimidine-based therapy

Obinutuzumab (Gazyva) (CP.PHAR.305)

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

• For chronic lymphocytic leukemia/ small lymphocytic lymphoma added combination therapy option with Venclexta per National Comprehensive Cancer Network
• for follicular lymphoma added “in combination with chemotherapy” for second-line or subsequent therapy
• For follicular lymphoma and marginal zone lymphoma simplified combination regimens and agents to “chemotherapy” to align with New Century Health criteria
• Added criteria for National Comprehensive Cancer Network-supported indication of hairy cell leukemia
• Revised terminology from “AIDS-Related B-Cell Lymphomas” to “HIV-Related B-Cell Lymphomas” per National Comprehensive Cancer Network

Temsirolimus (Torisel) (CP.PHAR.324)

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

Policy updates include:

• Per National Comprehensive Cancer Network, added “uterine sarcoma” under Uterine Neoplasms criteria

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

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

Policy updates include:

• Added combination therapy option for relapsed/refractory acute myeloid leukemia per National Comprehensive Cancer Network-supported off-label use

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

Ambetter

• Removed monotherapy requirement since Besponsa also indicated as combination therapy for age ≤ 18 years per National Comprehensive Cancer Network Compendium
• Corrected “and” to “or” for scenarios of either relapsed/refractory disease or Philadelphia chromosome-negative disease

Enasidenib (Idhifa) (CP.PHAR.363)

Ambetter

Policy updates include:

• Clarified use as a single agent for all acute myeloid leukemia indications per National Comprehensive Cancer Network

Moxetumomab pasudotox-tdfk (Lumoxiti) (CP.PHAR.398)

Ambetter

Policy updates include:

• Removed initial approval criteria for hairy cell leukemia due to manufacturer withdrawal, added Appendix E with details of market withdrawal

Fedratinib (Inrebic) (CP.PHAR.442)

Ambetter

• Continuation of car applied to continuation of therapy section
• Added definition of intermediate-2 or high-risk disease to Appendix D

Voxelotor (Oxbryta) (CP.PHAR.451)

Ambetter

• Removed Adakveo redirection due to STAND trial results announced by Novartis with rationale added to Appendix D
• Rationale for sickle cell disease therapy redirections added to Appendix D with references

Omaveloxolone (Skyclarys) (CP.PHAR.590)

Ambetter

Policy updates include:

• Removed requirement of “maximal exercise testing on a recumbent stationary bicycle” as not required per package insert.

Delandistrogene moxeparvovec-rokl (Elevidys) (CP.PHAR.593)

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

• For members currently on exon skipping therapies, removed requirement of “significant decline while on exon skipping therapies” and revised to “member must discontinue exon skipping therapy prior to Elevidys and not-reinitiate exon skipping therapy after Elevidys”
• Added bypass of stable dose of corticosteroids with option for provider attestation that member will be initiated on standard of care oral corticosteroid prior to and following Elevidys
• For concurrent corticosteroid clarified that it is a “prophylactic” corticosteroid regimen.

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

Ambetter

Policy updates include:

• In section I.D for dose optimization, added reference to Section I.A for quantity limit exception requests

Linaclotide (Linzess) (CP.PMN.71)

Ambetter

• References reviewed and updated.
• New indication functional pediatric constipation added
• Contraindications updated per package insert

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 requirement that request is not for a benefit excluded use

No Coverage Criteria, Recent Label Changes Pending Clinical Policy Update (HIM.PA.33)

Ambetter

Policy updates include:

• Added requirement that request is not for a benefit excluded use

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

Ambetter

Policy updates include:

• Added requirement that request is not for a benefit excluded use

Belatacept (Nulojix) (CP.PHAR.201)

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

Policy updates include:

• Continuation of care applied as a transplant-related indication in continued therapy section

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

Ambetter

• Updated Food and Drug Administration approved indications section to align with Absorica/ Absorica LD prescriber information
• Removed commercially unavailable brand therapeutic alternatives

Glatiramer (Copaxone, Glatopa) (CP.PHAR.252)

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

Policy updates include:

• Added health insurance marketplace line of business (HIM.PA.SP68 retired).

Momelotinib (Ojjaara) (CP.PHAR.654)

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: Myelofibrosis (must meet all):
  • Diagnosis of myelofibrosis (includes primary myelofibrosis, post-PV myelofibrosis, post-essential thrombocythemia myelofibrosis);
  • Prescribed by or in consultation with a hematologist or oncologist;
  • Age ≥ 18 years;
  • Documentation of a recent (within the last 30 days) hemoglobin level < 10 g/dL;
  • For brand Ojjaara requests, member must use generic momelotinib, 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:
      • 200 mg per day;
      • 1 tablet 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: Myelofibrosis (must meet all):
  • Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Ojjaara for a covered indication and has received this medication for at least 30 days;
  • Member is responding positively to therapy;
  • For brand Ojjaara requests, member must use generic momelotinib, 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:
    • 200 mg per day;
    • 1 tablet 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

Motixafortide (Aphexda) (CP.PHAR.655)

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: Mobilization of Hematopoietic Stem Cell (must meet all)
  • Diagnosis of multiple myeloma;
  • Prescribed by or in consultation with an oncologist or hematologist;
  •  Age ≥ 18 years;
  •  Prescribed in combination with a formulary G-CSF (i.e., Zarxio®);
  • *Prior authorization may be required for G-CSF.
  • Member is scheduled to receive autologous stem cell transplantation;
  • Dose does not exceed one of the following: 
    • The request meets both of the following:
      • Dose does not exceed 1.25 mg per kg of actual body weight;
      • Aphexda is prescribed to be administered for up to 2 doses per autologous stem cell transplantation;
  • 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: 3 months
• Continued Therapy: Mobilization of Hematopoietic Stem Cell (must meet all):
  • Re-authorization is not permitted. Members must meet the initial approval criteria.  
  • Approval duration: Not applicable

Gepirone (Exxua) (CP.PMN.292)

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: Major Depressive Disorder (must meet all):
  • Diagnosis of MDD;
  • 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;
    • Failure of TWO of the following, each tried for ≥ 4 weeks at up to maximally indicated doses, unless clinically significant adverse effects are experienced or all are contraindicated: SSRI, SNRI, bupropion, mirtazapine, vilazodone;
  • At the time of request, member has none of the following contraindications:
    • Prolonged QTc interval > 450 msec at baseline;
      • Congenital long QT syndrome;
  • Dose does not exceed one of the following:
    • Age between 18 and 64 years: 72.6 mg (1 tablet) per day;
    • Age at or above 65 years: 36.3 mg (1 tablet).
  • Approval duration: 12 months
• Continued Therapy: Major Depressive Disorder (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 (refer to state specific addendums for CC.PHARM.03A and CC.PHARM.03B);
  • Member is responding positively to therapy;
  • If request is for a dose increase, new dose does not exceed one of the following:
    • Age between 18 and 64 years: 72.6 mg (1 tablet) per day;
    • Age at or above 65 years: 36.3 mg (1 tablet).
  • Approval duration: 12 months

Iptacopan (LNP023) (CP.PHAR.656)

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: Paroxysmal Nocturnal Hemoglobinuria (must meet all):
  • Diagnosis of paroxysmal nocturnal hemoglobinuria;
  • Prescribed by or in consultation with an hematologist;
  • Age ≥ 18 years;
  • Flow cytometry shows detectable glycosylphosphatidylinositol (GPI)-deficient hematopoietic clones or ≥ 10% paroxysmal nocturnal hemoglobinuria cells;
  • Documentation of hemoglobin < 10 g/dL;
  • LNP023 is not prescribed concurrently with another FDA-approved product for paroxysmal nocturnal hemoglobinuria (e.g., Soliris®, Ultomiris®, Empaveli®);
  • Dose does not exceed 400 mg (2 tablets) per day.
  • Approval duration: 6 months
• Continued Therapy: Paroxysmal Nocturnal Hemoglobinuria (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 (refer to state specific addendums for CC.PHARM.03A and CC.PHARM.03B);
    • Member is responding positively to therapy as evidenced by, including but not limited to, improvement in any of the following parameters:
      • Improved measures of intravascular hemolysis (e.g., normalization of lactate dehydrogenase);
      • Reduced need for red blood cell transfusions;
      • Increased or stabilization of hemoglobin levels;
      • Less fatigue;
      • Improved health-related quality of life;
      • Fewer thrombotic events;
    • LNP023 is not prescribed concurrently with another FDA-approved product for paroxysmal nocturnal hemoglobinuria (e.g., Soliris, Ultomiris, Empaveli);
    • If request is for a dose increase, new dose does not exceed 400 mg (2 tablets) per day.
    • Approval duration: 6 months

Sotatercept (ACE-011) (CP.PHAR.657)

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

• 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, and CP.PMN.53 for Medicaid and CHIP
• Initial Approval Criteria: Pulmonary Arterial Hypertension (must meet all):
  • Diagnosis of pulmonary arterial hypertension;
  • Prescribed by or in consultation with a cardiologist or pulmonologist;
  • Age ≥ 18 years;
  • Failure of a calcium channel blocker , unless member meets one of the following:
    • Inadequate response or contraindication to acute vasodilator testing;
    • Contraindication or clinically significant adverse effects to calcium channel blockers are experienced;
  • ACE-011 is prescribed concurrently with TWO or more of the following drug classes, unless clinically significant adverse effects are experienced for all or all are contraindicated:
    • Endothelin-receptor antagonist (e.g., ambrisentan, bosentan, Opsumit®);
    • Phosphodiesterase-5 inhibitor (e.g., sildenafil, tadalafil) or soluble guanylate cyclase stimulator (e.g., Adempas®);
    • Prostacyclin analogue or receptor agonist (e.g., epoprostenol, Ventavis®, Uptravi®, treprostinil);
  • Dose does not exceed 0.7 mg/kg per 21 days.
  • Approval duration: 6 months
• Continued Therapy: Pulmonary Arterial Hypertension (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 (refer to state specific addendums for CC.PHARM.03A and CC.PHARM.03B);
• Member is responding positively to therapy;
• ACE-011 is prescribed concurrently with TWO or more of the following drug classes, unless clinically significant adverse effects are experienced for all or all are contraindicated:
  • Endothelin-receptor antagonist (e.g., ambrisentan, bosentan, Opsumit®);
  • Phosphodiesterase-5 inhibitor (e.g., sildenafil, tadalafil) or soluble guanylate cyclase stimulator (e.g., Adempas®);
  • Prostacyclin analogue or receptor agonist (e.g., epoprostenol, Ventavis®, Uptravi®, treprostinil);
• If request is for a dose increase, new dose does not exceed 0.7 mg/kg per 21 days.
• Approval duration: 6 months

Canakinumab (Ilaris) (CP.PHAR.246)

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

Policy updates include:

• Added criteria for newly approved gout flare indication

Luspatercept-aamt (Reblozyl) (CP.PHAR.450)

Ambetter

• added new indication for MDS treatment in ESA naïve patients;
• removed MDS transfusion requirement for ≥ 2 RBC units per 8 weeks;
• revised ESA redirection to apply only to MDS with ring sideroblasts < 15% (or ring sideroblasts < 5% with SFB3B1 mutation) per NCCN.

Overactive Bladder Agents (CP.PMN.198)

Ambetter

Policy updates include:

• Added Gemtesa to policy.

Pegfilgrastim (Neulasta and biosimilars) (CP.PHAR.296)

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

Policy updates include:

• Removed redirection to Ziextenzo.