Abaloparatide (Tymlos) (CP.PHAR.345)

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

Policy updates include:

• Added option (in addition to contraindications or adverse effects) to bypass bisphosphonate trial if member has experienced a loss of BMD, lack of BMD increase, or has had an osteoporotic fracture or fragility fracture while receiving bisphosphonate therapy
• Clarified use is limited to ≤ 2 years cumulative abaloparatide therapy (rather than reference PTH analogs generally, as Forteo label was updated to allow use beyond 2 years)

AbobotulinumtoxinA (Dysport) (CP.PHAR.230)

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

Policy updates include:

• Revised max dose for blepharospasm from 60 units to 120 units per literature review

Ado-Trastuzumab Emtansine (Kadcyla) (CP.PHAR.229)

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

Policy updates include:

• Added criterion for single-agent therapy for off-label indications of NSCLC and salivary gland tumor per NCCN

Afatinib (Gilotrif) (CP.PHAR.298)

Ambetter

Policy updates include:

• Added criteria for single-agent therapy and combination therapy with Erbitux per NCCN

Anti-inhibitor Coagulant Complex (Feiba) (CP.PHAR.217)

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

Policy updates include:

• Removed the requirement for factor VIII activity level or documentation of bleed history since inhibitors would only be present after previous use of factor VIII products, and substantiation of severe disease is not necessary

Binimetinib (Mektovi) (CP.PHAR.50)

Ambetter

Policy updates include:

• For melanoma, added adjuvant therapy category 2A indication per NCCN

Brodalumab (Siliq) (CP.PHAR.375)

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

Policy updates include:

• For PsO, allowed phototherapy as alternative to systemic conventional DMARD if contraindicated or clinically significant adverse effects are experienced

Capecitabeine (Xeloda) (CP.PHAR.60)

Ambetter

Policy updates include:

• Added “maintenance therapy” and “unresponsive to preoperative systemic therapy” uses of Xeloda in breast cancer per NCCN

Cobimetinib (Cotellic) (CP.PHAR.380)

Ambetter

Policy updates include:

• Added NCCN-supported indications criteria for histiocytic neoplasms and central nervous system cancers

Denosumab (Prolia Xgeva) (CP.PHAR.58)

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

Policy updates include:

• For osteoporosis added option (in addition to contraindications or adverse effects) to bypass bisphosphonate trial if member has experienced a loss of BMD, lack of BMD increase, or has had an osteoporotic fracture or fragility fracture while receiving bisphosphonate therapy.

Dexrazoxane (Zinecard, Totect) (CP.PHAR.418)

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

Policy updates include:

• Per NCCN added off-label supported uses in patients under 18 years of age in Ph-negative ALL, aggressive mature B-cell lymphomas, Hodgkin lymphoma, or Wilms Tumor (nephroblastoma)

Emicizumab-kxwh (Hemlibra) (CP.PHAR.370)

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

Policy updates include:

• For hemophilia A with inhibitors: removed the requirement for factor VIII activity level or documentation of bleed history since inhibitors would only be present after previous use of factor VIII products, and substantiation of severe disease is not necessary
• For hemophilia A without inhibitors: clarified that the requirement for factor VIII activity level or documentation of bleed history only applies to requests for new starts to Hemlibra without previous factor VIII use for routine prophylaxis.

Encorafenib (Braftovi) (CP.PHAR.127)

Ambetter

Policy updates include:

• For melanoma, added option for Braftovi monotherapy in melanoma if Mektovi is contraindicated and adjuvant therapy category 2A indication per NCCN

Etanercept (Enbrel) (CP.PHAR.250)

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

Policy updates include:

• For PsO, allowed phototherapy as alternative to systemic conventional DMARD if contraindicated or clinically significant adverse effects are experienced

Factor IX (Human, Recombinant) (CP.PHAR.218)

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

Policy updates include:

• Clarified requirement for coverage of factor IX for routine prophylaxis: the requirement for factor IX activity level or documentation of bleed history only applies to requests for new starts to routine prophylactic therapy

Factor VIII (Human, Recombinant) (CP.PHAR.215)

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

Policy updates include:

• Clarified requirement for coverage of factor VIII for routine prophylaxis: the requirement for factor VIII activity level or documentation of bleed history only applies to requests for new starts to routine prophylactic therapy

Factor VIII/von Willebrand Factor Complex (Human – Alphanate, Humate-P, Wilate); von Willebrand Factor (Recombinant – Vonvendi) (CP.PHAR.216)

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

Policy updates include:

• Clarified requirement for coverage of factor VIII for routine prophylaxis: the requirement for factor VIII activity level or documentation of bleed history only applies to requests for new starts to routine prophylactic therapy

Factor XIII, Human (Corifact) (CP.PHAR.221)

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

Policy updates include:

• Clarified requirement for coverage of factor XIII for routine prophylaxis: the requirement for factor XIII activity level or documentation of bleed history only applies to requests for new starts to routine prophylactic therapy

Factor XIIIa_Recombinant (Tretten) (CP.PHAR.222)

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

Policy updates include:

• Clarified requirement for coverage of factor XIIIa for routine prophylaxis: the requirement for factor XIII activity level or documentation of bleed history only applies to requests for new starts to routine prophylactic therapy

Fibrinogen concentrate (human) (Fibryga, RiaSTAP) (CP.PHAR.526)

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

Policy updates include:

• Updated RiaSTAP indication to align with FDA-approved language clarifying use in pediatric patients
• Clarified requirement for documentation of fibrinogen level and prolonged prothrombin time and activated partial thromboplastin time only applies to new starts on Fibryga/Riastap therapy

Guselkumab (Tremfya) (CP.PHAR.364)

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

Policy updates include:

• For PsO, allowed phototherapy as alternative to systemic conventional DMARD if contraindicated or clinically significant adverse effects are experienced

Human Growth Hormone (Somapacitan, Somatropin) (CP.PHAR.517)

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

Policy updates include:

• Added additional stepwise redirection to Omnitrope vial if Zomacton is not available (e.g., due to drug shortages)

Hydroxyurea (Siklos) (CP.PMN.193)

Ambetter

Policy updates include:

• Langerhans Cell Histiocytosis added as option for off-label oncology indication per NCCN-supported category 2A recommendation

IncobotulinumtoxinA (Xeomin) (CP.PHAR.231)

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

Policy updates include:

• Removed the statement The treatment of hyperhidrosis is a benefit exclusion for Ambetter

Ixekizumab (Taltz) (CP.PHAR.257)

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

Policy updates include:

• For PsO, allowed phototherapy as alternative to systemic conventional DMARD if contraindicated or clinically significant adverse effects are experienced

Levoketoconazole (Recorlev) (CP.PMN.275)

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: Cushing’s Syndrome (must meet all):
  • Diagnosis of CS
  • Prescribed by or in consultation with an endocrinologist
  • Age ≥ 18 years
  • Member meets one of the following:
    • Surgery has not been curative
    • Member is not eligible for surgery
  • Failure of ketoconazole, unless contraindicated or clinically significant adverse effects are experienced
  • Dose does not exceed 1,200 mg per day.
  • Approval duration: 6 months
• Continued Therapy: Cushing’s Syndrome (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 1,200 mg per day
  • Approval duration: 12 months

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

Ambetter

Policy updates include:

• Per NCCN added additional AIDS-related uses in diffuse large B-cell lymphoma and HHV8-positive diffuse large B-cell lymphoma

Midostaurin (Rydapt) (CP.PHAR.344)

Ambetter

Policy updates include:

• Per NCCN in AML added option for post-induction therapy prescribed in combination with cytarabine, for myeloid/lymphoid neoplasm added option for use in the chronic phase

Miglustat (Zavesca) (CP.PHAR.164)

Ambetter

Policy updates include:

• Removed the requirement for mild to moderate GD1 severity for coverage based on subjectivity of defining disease severity

Omecetaxine (Synribo) (CP.PHAR.108)

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

Policy updates include:

• Added additional prior therapy option requirement for T315I mutation that member has received prior treatment with Iclusig and Scemblix as other TKIs are contraindicated in this specific mutation

OnabotulinumtoxinA (Botox) (CP.PHAR.232)

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

Policy updates include:

• Removed the statement The treatment of hyperhidrosis is a benefit exclusion for Ambetter
• Removal of required 2 week trial duration of nitroglycerin and nifedipine/diltiazem for chronic anal fissures
• Adjusted Xeomin blepharospasm dose from 25 units to 50 units per PI

Ponatinib (Iclusig) (CP.PHAR.112)

Ambetter

Policy updates include:

• Per NCCN for CML clarified 2TKI requirement is for chronic phase CML and added additional option for accelerated or blast phase CML for members whom no other TKI therapy is indicated
• For ALL removed 2 TKI requirement and replaced with requirement that either member has BCR-ABL T315I mutation or no other TKI therapy is indicated
• Added off-label criteria set for lymphoid, myeloid or mixed lineage neoplasms with redirection to imatinib for ABL1 rearrangement positive unless state regulations do not allow step therapy in certain oncology settings

Regorafenib (Stivarga) (CP.PHAR.107)

Ambetter

Policy updates include:

• Added criteria set for off-label use in glioblastoma

Romosozumab-aqqg (Evenity) (CP.PHAR.428)

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

Policy updates include:

• Added option (in addition to contraindications or adverse effects) to bypass bisphosphonate trial if member has experienced a loss of BMD, lack of BMD increase, or has had an osteoporotic fracture or fragility fracture while receiving bisphosphonate therapy

Sebelipase Alfa (Kanuma) (CP.PHAR.159)

Ambetter

Policy updates include:

• Updated max recommended dose for members with rapidly progressive disease presenting within the first 6 months of life per the Prescribing Information and clarified documentation requirements for max dose requests for this population

Sonidegib (Odomzo) (CP.PHAR.272)

Ambetter

Policy updates include:

• Expanded BCC indication to include local recurrence and added indication of diffuse basal cell carcinoma (BCC) formation per NCCN

Sorafenib (Nexavar) (CP.PHAR.69)

Ambetter

Policy updates include:

• For RCC added additional diagnosis options for relapsed or stage IV disease
• For DTC added additional diagnosis options for unresectable or persistent disease
• For AML removed requirement that disease is relapsed or refractory as Nexevar can be used for induction
• For AML added additional option for use as a single agent for maintenance therapy for member in remission post-allogeneic stem cell transplantation
• For soft tissue sarcoma clarified desmoid tumors requests should be used as single-agent therapy
• For GIST added Sprycel as a possible prior therapy option
• Added off-label criteria set for lymphoid, myeloid or mixed lineage neoplasms

Tebentafusp-tebn (Kimmtrak) (CP.PHAR.575)

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: Uveal Melanoma (must meet all):
  • Diagnosis of unresectable or metastatic uveal melanoma
  • Prescribed by or in consultation with an oncologist
  • Age ≥ 18 years;
  • Disease is HLA-A*02:01-positive
  • Request meets one of the following:*
    • Dose does not exceed 20 mcg (1 vial) on Day 1, 30 mcg (1 vial) on Day 8, 68 mcg (1 vial) on Day 15, and 68 mcg (1 vial) weekly thereafter;
    • 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: Uveal Melanoma (must meet all):
  • Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Kimmtrak for a covered indication and has received this medication for at least 30 days
  • Member is responding positively to therapy
  • If request is for a dose increase, request meets one of the following:*
    • New dose does not exceed 68 mcg (1 vial) weekly
    • 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

Temozolomide (Temodar) (CP.PHAR.77)

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

Policy updates include:

• Added indication of low-grade (WHO grade 1 or II) recurrent or progressive disease
• Removed “recurrent” from brain metastases indication
• Added mucosal melanoma
• Modified cutaneous melanoma indication use from second line to subsequent therapy
• Added neuroendocrine tumor of the lung

Tepotinib (Tepmetko) (CP.PHAR.530)

Ambetter

Policy updates include:

• Added indication of high-level MET amplification in NSCLC per NCCN category 2A
• Added qualifier for recurrent NSCLC
• Removed criteria for EGFR wild-type and ALK negative statuses and exclusion for CNS metastases neither NCCN nor the FDA labeling support this restriction

Teriparatide (Forteo) (CP.PHAR.188)

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

Policy updates include:

• Per updated prescribing information regarding length of therapy, removed criteria and approval duration requirements that limited therapy to 2 years cumulative PTH analog therapy, added requirement if request is for continuation of cumulative PTH analog therapy beyond 2 years, provider attestation that member remains at or has returned to having a high risk for fracture (e.g., history of osteoporotic fracture or multiple risk factors for fracture) and that the risk versus benefit of continued therapy has been reviewed with the member
• Added option (in addition to contraindications or adverse effects) to bypass bisphosphonate trial if member has experienced a loss of BMD, lack of BMD increase, or has had an osteoporotic fracture or fragility fracture while receiving bisphosphonate therapy

Tezepelumab-ekko (Tezspire) (CP.PHAR.576)

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: Severe Asthma (must meet all):
  • Diagnosis of asthma
  • Prescribed by or in consultation with an allergist, immunologist, or pulmonologist
  • Age ≥ 12 years;
  • Member has experienced ≥ 2 exacerbations with in the last 12 months, requiring any of the following despite adherent use of controller therapy (i.e., medium- to high-dose inhaled corticosteroid [ICS] plus either a long acting beta-2 agonist [LABA] or leukotriene modifier [LTRA] if LABA contraindication/intolerance):
    • Oral/systemic corticosteroid treatment (or increase in dose if already on oral corticosteroid);
    • Urgent care visit or hospital admission;
    • Intubation;
  • Tezspire is prescribed concurrently with an ICS plus either a LABA or LTRA
  • Tezspire is not prescribed concurrently with Cinqair®, Dupixent®, Fasenra®, Nucala®, or Xolair®
  • Dose does not exceed 210 mg every 4 weeks.
  • Approval duration: 6 months
• Continued Therapy: Severe Asthma (must meet all):
  • Currently receiving medication via Centene benefit or member has previously met initial approval criteria
  • Demonstrated adherence to asthma controller therapy (an ICS plus either a LABA or LTRA) as evidenced by proportion of days covered (PDC) of 0.8 in the last 6 months (i.e., member has received asthma controller therapy for at least 5 of the last 6 months)
  • Member is responding positively to therapy (examples may include but are not limited to: reduction in exacerbations or corticosteroid dose, improvement in forced expiratory volume over one second since baseline, reduction in the use of rescue therapy)
  • Tezspire is not prescribed concurrently with Cinqair, Dupixent, Fasenra, Nucala, or Xolair
  • If request is for a dose increase, new dose does not exceed 210 mg every 4 weeks
  • Approval duration: 12 months

Thalidomide (Thalomid) (CP.PHAR.78)

Ambetter

Policy updates include:

• For myeloproliferative neoplasms added notation that Retacrit is the preferred ESA
• Per NCCN modified KS requirements to allow use in non-AIDs related KS
• Added off-label criteria set for histiocytic neoplasms
• Added off-label use for aphthous stomatitis or ulcers

Tildrakizumab-asmn (Ilumya) (CP.PHAR.386)

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

Policy updates include:

• For PsO, allowed phototherapy as alternative to systemic conventional DMARD if contraindicated or clinically significant adverse effects are experienced

Tocilizumab (Actemra) (CP.PHAR.263)

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

Policy updates include:

• For pJIA, removed redirections to Enbrel and Xeljanz

Tralokinumab-ldrm (Adbry) (CP.PHAR.577)

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: Atopic Dermatitis (must meet all):
  • Diagnosis of atopic dermatitis affecting one of the following:
    • At least 10% of the member’s body surface area (BSA)
    • Hands, feet, face, neck, scalp, genitals/groin, and/or intertriginous areas
  • Prescribed by or in consultation with a dermatologist or allergist
  • Age ≥ 18 years
  • Failure of all of the following, unless contraindicated or clinically significant adverse effects are experienced:
    • Two formulary medium to very high potency topical corticosteroids, each used for ≥ 2 weeks
    • One non-steroidal topical therapy* used for ≥ 4 weeks: topical calcineurin inhibitor (e.g., tacrolimus 0.03% ointment, pimecrolimus 1% cream) or Eucrisa®
    • *These agents may require prior authorization
    • One systemic agent used for ≥ 3 months: azathioprine, methotrexate, mycophenolate mofetil, or cyclosporine
  • Adbry is not prescribed concurrently with another biologic medication (e.g., Dupixent®) or a JAK inhibitor (e.g., Olumiant®, Rinvoq®, Cibinqo®, Opzelura™)
  • Dose does not exceed the following:
    • Initial (one-time) dose of 600 mg (four injections)
    • Maintenance dose of 300 mg (two injections) every 2 weeks
  • Approval duration: 4 months (18 injections)
• Continued Therapy:Atopic Dermatitis (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, reduction in itching and scratching
  • Adbry is not prescribed concurrently with another biologic medication (e.g., Dupixent) or a JAK inhibitor (e.g., Olumiant, Rinvoq, Cibinqo, Opzelura)
  • For members with weight < 100 kg: Request is for 300 mg every 4 weeks, unless documentation supports member has not achieved clear or almost clear skin
  • If request is for a dose increase, new dose does not exceed 300 mg every 2 weeks.
• Approval duration: 12 months

Trametinib (Mekinist) (CP.PHAR.240)

Ambetter

Policy updates include:

• Added “limited resectable” melanoma classification per NCCN
• Added indications of central nervous system cancers, hepatobiliary cancers, and histiocytic neoplasms per NCCN

Trastuzumab/Biosimilars, Trastuzumab-Hyaluronidase (CP.PHAR.228)

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

Policy updates include:

• Added qualifiers of “advanced” and “recurrent” for gastric, esophageal, or EGJ adenocarcinoma

Ulcer Therapy Combinations (CP.PMN.277)

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:Helicobacter pylori Infection (must meet all):
  • Diagnosis of H. pylori infection
  • Prescribed by or in consultation with a gastroenterologist or infectious disease specialist
  • Age ≥ 18 years
  • One of the following:
    • Member must instead use the individual components concurrently (i.e., for Talicia generic rifabutin, amoxicillin, omeprazole), unless contraindicated or clinically significant adverse effects are experienced
    • Member must use generic Prevpac (lansoprazole, amoxicillin, clarithromycin), unless contraindicated or clinically significant adverse effects are experienced
  • For Pylera requests, prescribed in combination with a proton pump inhibitor (e.g., omeprazole)
  • Dose does not exceed one of the following:
    • Omeclamox-Pak: two omeprazole capsules, two clarithromycin tablets, and four amoxicillin capsules per day for 10 days
    • Pylera: 12 capsules per day for 10 days
    • Talicia: 150 mg rifabutin (12 capsules) per day for 14 days
  • Approval duration: Omeclamox-Pak, Pylera – 10 days; Talicia – 14 days
• Continued Therapy: Helicobacter pylori Infection:
  • Re-authorization is not permitted. Members must meet the initial approval criteria.
  • Approval duration: Not applicable

Ustekinumab (Stelara) (CP.PHAR.264)

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

Policy updates include:

• For PsO, allowed phototherapy as alternative to systemic conventional DMARD if contraindicated or clinically significant adverse effects are experienced

Vismodegib (Erivedge) (CP.PHAR.273)

Ambetter

Policy updates include:

• Added indication of diffuse basal cell carcinoma (BCC) formation per NCCN category 2A recommendation