Effective September 1, 2024: Pharmacy and Biopharmacy Policies

POLICY

APPLICABLE PRODUCTS

NEW POLICY OVERVIEW OR UPDATED POLICY REVISIONS

Elamipretide (MTP-131) (CP.PHAR.680)

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

Policy includes:

• Criteria will mirror the clinical information from the prescribing information once Food and Drug Administration (FDA)-approved
• Criteria is only applicable for Medicaid and CHIP when the drug is added to the formulary for coverage
• Requests for indications not approved by the Food and Drug Administration (FDA) are reviewed with the off-label use policy for the relevant line of business: HIM.PHAR.154 for Ambetter, and CP.PMN.53 for Medicaid and CHIP
• Initial Approval Criteria:  Barth Syndrome (must meet all):
  • Diagnosis of Barth syndrome confirmed by DNA testing for the presence of a mutation in the tafazzin (TAZ) gene;
  • Prescribed by or in consultation with a clinical geneticist, metabolic disease specialist, endocrinologist, cardiologist, hematologist, or neurologist;
  • Age ≥ 12 years;
  • Dose does not exceed 40 mg per day.
  • Approval duration: 6 months
• Continued Therapy: Barth Syndrome (must meet all):
  • Member meets one of the following:
    • Currently receiving medication via Centene benefit or member has previously met initial approval criteria;
    • Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state specific  addendums of CC.PHARM.03A and CC.PHARM.03B);
  • Member is responding positively to therapy as evidenced by improvement in the individual member’s Barth syndrome manifestation profile;
  • If request is for a dose increase, new dose does not exceed 40 mg per day.
  • Approval duration: Medicaid/HIM – 12 months

Govorestat (AT-007) (CP.PHAR.681)

Ambetter

Policy includes:

• Criteria will mirror the clinical information from the prescribing information once Food and Drug Administration (FDA)-approved
• Requests for indications not approved by the Food and Drug Administration (FDA) are reviewed with the off-label use policy for the relevant line of business: HIM.PHAR.154 for Ambetter
• Initial Approval Criteria: Classic Galactosemia (must meet all):
  • Diagnosis of classic galactosemia confirmed by reduced (≤ 3% of normal) galactose-1-phosphate uridyltransferase (GALT)
  • activity;
  • Prescribed by or in consultation with a geneticist or metabolic specialist;
  • Age ≥ 2 years;
  • Dose does not exceed the Food and Drug Administration (FDA) approved maximum.
  • Approval duration: 6 months
• Continued Therapy: Classic Galactosemia (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 the Food and Drug Administration (FDA) approved
  • maximum
  • Approval duration: 12 months

N-Acetyl-L-Leucine (IB1001) (CP.PHAR.682)

Ambetter

Policy includes:

• Criteria will mirror the clinical information from the prescribing information once Food and Drug Administration (FDA)-approved
• Requests for indications not approved by the Food and Drug Administration (FDA) are reviewed with the off-label use policy for the relevant line of business: HIM.PHAR.154 for Ambetter
• Initial Approval Criteria: Niemann-Pick Disease Type C (NPC) (must meet all):
  • Diagnosis of NPC confirmed by one of the following:
    • Genetic analysis indicating mutation in both alleles of NPC1 or NPC2;
    • Genetic analysis indicates mutation in one allele of NPC1 or NPC2, along with one of the followin:
      • Positive filipin staining test result;
      • Positive biomarker result (e.g., oxysterol, lyso-sphingolipid, bile acid);
  • Prescribed by or in consultation with an endocrinologist or metabolic disease specialist;
  • Age ≥ 4 years;
  • Documentation of member’s current body weight in kg and weight is ≥ 15 kg;
  • Member presents with ≥ 2 neurological signs or symptoms of the disease (e.g., hearing loss, vertical supranuclear gaze palsy, ataxia, dementia, dystonia, seizures, dysarthria, dysphagia);
  • Scale for the Assessment and Rating of Ataxia (SARA) baseline score ≥ 7 and ≤ 34;
  • Dose does not exceed 4 g per day.
  • Approval duration: 12 weeks
• Continued Therapy: Niemann-Pick Disease Type C (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 a decrease or stabilization in the SARA score from baseline;
  • If request is for a dose increase, new dose does not exceed 4 g per day.
  • Approval duration: 6 months

Acoramidis (AG10) (CP.PHAR.683)

Ambetter

Policy includes:

• Criteria will mirror the clinical information from the prescribing information once Food and Drug Administration (FDA)-approved
• Requests for indications not approved by the Food and Drug Administration (FDA) are reviewed with the off-label use policy for the relevant line of business: HIM.PHAR.154 for Ambetter
• Initial Approval Criteria: Transthyretin Amyloid Cardiomyopathy (must meet all):
  • Diagnosis of transthyretin amyloidosis
  • Cardiomyopathy (ATTR-CM) as supported by one of the following
    • Tissue biopsy amyloid protein is identified as transthyretin via mass spectrometry or immunohistochemistry, and:
      • Tissue biopsy is of endomyocardial origin;
    • Member meets all of the following:
      • Echocardiography (Echo), cardiac magnetic resonance imaging (CMR), or positron emission tomography (PET) findings are consistent with cardiac amyloidosis;
      • Cardiac uptake is Grade 2 or 3 on a radionuclide scan utilizing one of the following radiotracers (1, 2, or 3):
  • 99m technetium (Tc)-labeled 3,3-diphosphono-1,2-propanodicarboxylicacid (DPD);
  • 99mTc-labeled pyrophosphate (PYP);
  • 99mTc-labeled hydroxymethylene diphosphonate (HMDP);
• Each of the following laboratory tests is negative for monoclonal protein:
  • Serum kappa/lambda free light chain ratio analysis;
  • Serum protein immunofixation;
  • Urine protein immunofixation;
  • Prescribed by or in consultation with a cardiologist;
  • Age ≥ 18 years;
  • Member has heart failure of New York Heart Association (NHYA) Class I, II, or III;
  • Member has one of the following
    • At least 1 prior hospitalization for heart failure;
    • Current (within the last 30 days) clinical evidence of heart failure (i.e., signs and symptoms,;
  • AG10 is not prescribed concurrently with Vyndaqel®/Vyndamax™, Onpattro®, Amvuttra®, or Wainua™;
  • Dose does not exceed 1,600 mg (2 tablets) per day
  • Approval duration: 6 months
• Continued Therapy: Transthyretin Amyloid Cardiomyopathy (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 or stabilization in any of the following parameters:
    • Walking ability;
    • Cardiac related hospitalization;
    • Cardiac procedures or laboratory tests (e.g., Holter monitoring, echocardiography, electrocardiogram, plasma BNP or NT-proBNP, serum troponin);
  • AG10 is not prescribed concurrently with Vyndaqel/Vyndamax, Onpattro, Amvuttra, or Wainua;
  • If request is for a dose increase, new dose does not exceed 1,600 mg (2 tablets) per day
  • Approval duration: 12 months

Sacubitril/Valsartan (Entresto) (CP.PCH.52)

Ambetter

Policy includes:

• Requests for indications not approved by the Food and Drug Administration (FDA) are reviewed with the off-label use policy for the relevant line of business: HIM.PHAR.154 for Ambetter
• Initial Approval Criteria: Heart Failure (must meet all):
  • Diagnosis of chronic heart failure of New York Heart Association (NYHA) Class II, III, or IV;
  • Prescribed by or in consultation with a cardiologist;
  • Age ≥ 1 year;
  • At the time of request, member has none of the following contraindications:
    • Concomitant use with angiotensin-converting enzyme (ACE) inhibitors;
    • If member has a diagnosis of diabetes, concomitant use with aliskiren;
  • For members with left ventricular ejection fraction (LVEF) ≥ 41% (i.e., heart failure with mildly reduced or preserved ejection fraction), failure of Jardiance® or dapagliflozin (Farxiga®), unless  contraindicated or clinically significant adverse effects are experienced;
  • Dose does not exceed both of the following:
    • Sacubitril 194 mg/valsartan 206 mg per day;
    • 2 tablets for adults per day
  • Approval duration: 12 months
• Continued Therapy: Heart Failure (must meet all):
  • Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Entresto for heart failure 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 both of the following:
    • Sacubitril 194 mg/valsartan 206 mg per day;
    • 2 tablets for adults per day.
  • Approval duration: 12 months

Nogapendekin alfa inbakicept-pmln (Anktiva) (CP.PHAR.684)

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

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 Food and Drug Administration (FDA) are reviewed with the off-label use policy for the relevant line of business: HIM.PHAR.154 for Ambetter, and CP.PMN.53 for Medicaid and CHIP
• Initial Approval Criteria: Non-muscle Invasive Bladder Cancer (must meet all):
  • Diagnosis of NIMBC characterized as one of the following:
    • carcinoma in situ (CIS) only;
    • Ta/T1 high-grade disease with concomitant CIS;
  • Prescribed by or in consultation with an oncologist;
  • Age ≥ 18 years;
  • Member is refractory to Bacillus Calmette-Guérin (BCG) treatment;
  • Anktiva is prescribed in combination with BCG;
  • Request meets one of the following:
  • Dose does not exceed 400 mcg (1 vial) administered per week for up to 12 doses;
  • Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence). *Prescribed regimen must be Food and Drug Administration (FDA)-approved or recommended by National Comprehensive Cancer Network (NCCN)
  • Approval duration: 6 months (up to 12 doses)
• Continued Therapy: Non-muscle Invasive Bladder Cancer must meet all):
  • Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Anktiva for a covered indication and has received this medication for at least 30 days;
  • Member is responding positively to therapy as evidenced by lack of disease recurrence or progression;
  • Total treatment duration does not exceed 37 months;
  • If request is for a dose increase, request meets one of the following:
  • New dose does not exceed 400 mcg (1 vial) per week for up to 24 doses;
  • 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 (FDA)-approved or recommended by National Comprehensive Cancer Network (NCCN)
  • Approval duration: 12 months (up to 24 doses)

Tarlatamab-dlle (Imdelltra) (CP.PHAR.685)

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

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 Food and Drug Administration (FDA) are reviewed with the off-label use policy for the relevant line of business: HIM.PHAR.154 for Ambetter, and CP.PMN.53 for Medicaid and CHIP
• Initial Approval Criteria: Small Cell Lung Cancer (must meet all):
  • Diagnosis of extensive stage small cell lung cancer (ES-SCLC);
  • Prescribed by or in consultation with an oncologist;
  • Age ≥ 18 years;
  • Disease has progressed on or after receiving platinum based therapy;
  • Request meets one of the following:
    • Dose does not exceed:
      • Cycle 1, step-up dose: 1 mg on Day 1, and 10 mg on Day 8 and Day 15;
      • Cycle 2 and beyond: 10 mg on Day 1 and Day 15 of each cycle;
    • Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence). *Prescribed regimen must be Food and Drug Administration (FDA)-approved or recommended by National Comprehensive Cancer Network (NCCN)
  • Approval duration: 6 months

• Continued Therapy: Small Cell Lung Cancer (must meet all):
  • Currently receiving medication via Centene benefit, or documentation supports that
  • member is currently receiving Imdelltra 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 10 mg on Days 1 and 15 of each cycle;
    • 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 (FDA)-approved or recommended by National Comprehensive Cancer Network (NCCN)
  • Approval duration: 12 months

Tislelizumab-jsgr (Tevimbra) (CP.PHAR.686)

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

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 Food and Drug Administration (FDA) are reviewed with the off-label use policy for the relevant line of business: HIM.PHAR.154 for Ambetter, and CP.PMN.53 for Medicaid and CHIP
• Initial Approval Criteria: Esophageal Cancer (must meet all):
  • Diagnosis of unresectable, locally advanced, recurrent, or metastatic esophageal squamous cell
  • Carcinoma (ESCC);
  • Prescribed by or in consultation with an oncologist;
  • Age ≥18 years;
  • For ESCC, both of the following:
    • Member has had previous treatment with a fluoropyrimidine-based (e.g., 5-fluorouracil, capecitabine) and platinum-based (e.g., carboplatin, cisplatin, oxaliplatin) chemotherapy;
    • Prior systemic chemotherapy did NOT include a PD-1 or PD-(L)1 inhibitor (e.g.,nivolumab, ipilimumab, pembrolizumab);
  • Tevimbra is used as a single-agent;
  • Request meets one of the following:
  • Dose does not exceed 200 mg IV every 3 weeks;
  • Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence). *Prescribed regimen must be Food and Drug Administration (FDA)-approved or recommended by National Comprehensive Cancer Network (NCCN)
  • Approval duration: 6 months

• Continued Therapy Esophageal cancer (must meet all):
• Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Tevimbra 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 200 mg IV every 3 weeks;
• New dose is supported by practice guidelines or peer-re New dose does not exceed 10 mg on Days 1 and 15 of each cycle;
  • viewed literature for the relevant off-label use (prescriber must submit supporting evidence). *Prescribed regimen must be Food and Drug Administration (FDA)-approved or recommended by National Comprehensive Cancer Network (NCCN)
• Approval duration: 12 months

Tovorafenib (Ojemda) (CP.PHAR.687)

Ambetter

Policy includes:

• Requests for indications not approved by the Food and Drug Administration (FDA) are reviewed with the off-label use policy for the relevant line of business: HIM.PHAR.154 for Ambetter
• Initial Approval Criteria: Pediatric Low-Grade Glioma (LGG)(must meet all):
  • Diagnosis of relapsed or refractory LGG;
  • Prescribed by or in consultation with an oncologist;
  • Age ≥ 6 months;
  • Disease is positive for one of the following:
    • BRAF fusion or rearrangement;
    • BRAF V600 mutation;
  • Failure of at least one line of prior systemic therapy;
  • Documentation of the member’s current body surface area (BSA)(m2);
  • Request meets one of the following:
    • Dose does not exceed both of the following:
      • 380 mg per m2 of BSA;
      • 600 mg once weekly;
    • Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence). *Prescribed regimen must be Food and Drug Administration (FDA)-approved or recommended by National Comprehensive Cancer Network (NCCN)
  • Approval duration: 12 months
• Continued Therapy: Pediatric Low-Grade Glioma (must meet all):
  • Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Ojemda 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:*
    • Both of the following:
    • Documentation of the member’s current body surface area (BSA)(m2);
    • Dose does not exceed both of the following:
      • 380 mg per m2 of BSA;
      • 600 mg once weekly;
    • Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence). *Prescribed regimen must be Food and Drug Administration (FDA)-approved or recommended by National Comprehensive Cancer Network (NCCN)
  • Approval duration: 12 months

Ketamine (Ketalar) (CP.PMN.296)

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

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 Food and Drug Administration (FDA) are reviewed with the off-label use policy for the relevant line of business: HIM.PHAR.154 for Ambetter, and CP.PMN.53 for Medicaid and CHIP
• Initial Approval Criteria: Requests for Ketamine (must meet all):
  • Diagnosis of one of the following:
  • An Food and Drug Administration (FDA) approved indication;
  • A use supported by one of the following:
    • Micromedex DrugDex with strength of recommendation Class I or IIa;
    • Evidence from at least two high-quality, published studies in reputable peer-reviewed journals or evidence-based clinical practice guidelines that provide all of the following:
      • Adequate representation of the member’s clinical characteristics, age, and diagnosis;
      • Adequate representation of the prescribed drug regimen;
      • Clinically meaningful outcomes as a result of the drug therapy in question;
      • Appropriate experimental design and method to address research questions;
    • One of the following off-label indications:
      • Treatment-resistant depression (TRD);
      • Major depressive disorder (MDD);
  • If request is for brand Ketalar, member must use generic ketamine, unless contraindicated or clinically significant adverse effects are experienced;
  • For TRD and MDD, all of the following:
    • Request is for intravenous (IV) ketamine;
    • Prescribed by or in consultation with a psychiatrist;
    • Age ≥ 18 years;
    • Member meets one of the following:
      • Request is for the treatment of a member in a State with limitations on step therapy in certain mental health settings;
      • Failure of TWO antidepressants from the following, each tried for ≥ 4 weeks at up to maximally indicated doses, unless clinically significant adverse effects are experienced or all are contraindicated: selective serotonin reuptake (SSRI), serotonin norepinephrine reuptake inhibitor (SNRI), bupropion, mirtazapine, vilazodone;
    • Request meets one of the following;
      • Dose does not exceed 0.5 mg/kg IV for up to 8 doses;
      • Dose does not exceed 1 mg/kg IV as a single dose;
      • Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).
  • Approval duration: 3 months
• Continued Therapy: All Indications in Section I
  • Re-authorization is not permitted. Members must meet the initial approval criteria.
  • Approval duration: Not applicable

Aripiprazole Orally Disintegrating Tablet (CP.PCH.37)

Ambetter

Policy updates include:

• Revised continued therapy criteria to allow continuity of care for all indications

Pazopanib (Votrient) (CP.PHAR.81)

Ambetter

Policy updates include:

• Revised policy/criteria section to also include generic pazopanib
• For soft tissue sarcoma, added bypass of prior therapy or ineligibility for extraskeletal myxoid chondrosarcoma and epithelioid hemangioendothelioma per National Comprehensive Cancer Network (NCCN)

Peginterferon Alfa-2a (Pegasys) (CP.PHAR.89)

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

Policy updates include:

• Updated definition of significant fibrosis from stage 3-4 to stage 2-4 per 2024 World Health Organization (WHO) chronic hepatitis B guidelines

Aztreonam (Cayston) (CP.PHAR.209)

Ambetter

Policy updates include:

• For initial criteria, added Kitabis Pak to list of preferred tobramycin inhalation agents

Ivacaftor (Kalydeco) (CP.PHAR.210)

Ambetter

Policy updates include:

• For continued therapy, clarified positive response as an “improvement” (e.g., decrease) of LCL and improvement of percent predicted forced expiratory volume in 1 second (ppFEV1) as an "increase from baseline”
• For Appendix D, updated lung clearance index (LCI) supplemental information

Lumacaftor/Ivacaftor (Orkambi) (CP.PHAR.213)

Ambetter

Policy updates include:

• For initial therapy, removed criterion “percent predicted forced expiratory volume in 1 second (ppFEV1) that is between 40 – 90%” from documentation of member’s percent predicted forced expiratory volume in 1 second (ppFEV1)” to align with other cystic fibrosis transmembrane (CFTR) modulator criteria
• For continued therapy, clarified positive response as an “improvement” (e.g., decrease) of lung clearance index (LCI) and improvement of percent predicted forced expiratory volume in 1 second (ppFEV1) as an "increase from baseline”
• For Appendix D, updated lung clearance index (LCI) supplemental information and removed supplemental pediatric extension clinical trial information for patients ages 12 months to < 24 months

Ixazomib (Ninlaro) (CP.PHAR.302)

Ambetter

Policy updates include:

• Per National Comprehensive Cancer Network (NCCN) Compendium for  multiple myeloma added additional use in combination with Venclexta and dexamethasone for patients with t(11:14)
• For systemic light chain amyloidosis added additional use in combination with cyclophosphamide and dexamethasone

Daratumumab (Darzalex), Daratumumab/Hyaluronidase-fihj (Darzalex Faspro) (CP.PHAR.310)

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

Policy updates include:

• Per National Comprehensive Cancer Network (NCCN) Compendium for systemic light chain amyloidosis added off-label use as a single agent for newly diagnosed disease if member has significant neuropathy or has Mayo stage IIIb disease
• Added off-label use for T-cell acute lymphoblastic leukemia
• For multiple myeloma as subsequent therapy added combination use with dexamethasone and Venclexta
• For multiple myeloma maintenance therapy added combination use with lenalidomide

Tezacaftor/Ivacaftor; Ivacaftor (Symdeko)  (CP.PHAR.377)

Ambetter

Policy updates include:

• For initial approval criteria, removed “chart notes showing percent predicted forced expiratory volume in 1 second (ppFEV1) that is between 40 – 90%” and revised criteria to “documentation of member’s baseline precent predicted forced expiratory volume in 1 second (ppFEV1)” to align with other cystic fibrosis transmembrane (CFTR) modulator criteria
• For continued therapy, revised criteria from “stabilization in percent predicted forced expiratory volume in 1 second (ppFEV1) if baseline was > 70%, or increase in percent predicted forced expiratory volume in 1 second (ppFEV1) if baseline was <70%” to “stabilization or improvement (e.g., increase) in percent predicted forced expiratory volume in 1 second (ppFEV1) from baseline” to align with other cystic fibrosis transmembrane (CFTR) modulator criteria
• Revised Appendix D to remove information on advanced Cystic Fibrosis disease

Lutetium Lu 177 Dotatate (Lutathera) (CP.PHAR.384)

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

Policy updates include:

• Updated neuroendocrine tumor criteria to reflect newly approved pediatric expansion

Erdafitinib (Balversa) (CP.PHAR.423)

Ambetter

Policy updates include:

• Updated “gemcitabine chemotherapy” to “other chemotherapy” for previous therapies to align with National Comprehensive Cancer Network (NCCN) Compendium
• Revised Commercial approval durations to align with Medicaid and Ambetter for this oral oncology agent

Selinexor (Xpovio) (CP.PHAR.431)

Ambetter

Policy updates include:

• For diffuse large B-cell lymphoma, revised header to the umbrella diagnosis of B-cell lymphoma and added monomorphic post-transplant lymphoproliferative disorder (B-cell type) per National Comprehensive Cancer Network (NCCN)

Polatuzumab Vedotin-piiq (Polivy) (CP.PHAR.433)

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

Policy updates include:

• Consolidated Food and Drug Administration (FDA) and National Comprehensive Cancer Network (NCCN) recommended uses into one criteria set under the umbrella diagnosis of B-cell lymphoma
• For first-line use, added stage modified International Prognostic Index (IPI) score as an alternate pathway per National Comprehensive Cancer Network (NCCN)
• Allowed first-line use in histologic transformation of indolent lymphoma to diffuse large B-cell lymphoma per National Comprehensive Cancer Network (NCCN)
• Removed follicular lymphoma as a coverable off-label use as it is no longer supported by National Comprehensive Cancer Network (NCCN)

Elexacaftor/Ivacaftor/Tezacaftor; Ivacaftor (Trikafta) (CP.PHAR.440)

Ambetter

Policy updates include:

• For continued therapy, clarified positive response as an “improvement” (e.g., decrease) of lung clearance index (LCI) and improvement of percent predicted forced expiratory volume in 1 second (ppFEV1) as an "increase from baseline”
• For Appendix D, updated lung clearance index (LCI) supplemental information

Capmatinib (Tabrecta) (CP.PHAR.494)

Ambetter

Policy updates include:

• For initial criteria: added option for “if epidermal growth factor receptor (EGFR) mutant with high-level mesenchymal-epithelial transition amplifications, Tabrecta is used with Tagrisso” per National Comprehensive Cancer Network (NCCN)
• Removed “member does not have symptomatic CNS metastases” as Tabrecta may be used in CNS brain metastases per National Comprehensive Cancer Network (NCCN)

Loncastuximab Tesirine-lpyl (Zynlonta) (CP.PHAR.539)

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

Policy updates include:

• Revised language from “AIDS-related diffuse large B-cell lymphoma” to “HIV-related diffuse large B-cell lymphoma” to align with National Comprehensive Cancer Network (NCCN)
• Added post-transplant lymphoproliferative disorders (PTLD) and histologic transformation of indolent lymphomas related to diffuse large B-cell lymphoma as additional examples of large B-cell lymphoma

Dostarlimab-gxly (Jemperli) (CP.PHAR.540)

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

Policy updates include:

• Revised solid tumors criteria per National Comprehensive Cancer Network (NCCN) – added additional disease qualifiers of early stage or unresectable for gastric cancer and locally unresectable or medically inoperable for colon and rectal cancers, added pathway to allow members who are not surgical candidates for gastric and esophageal/esophagogastric junction cancers, added POLE/POLD1 mutation for colon and rectal cancers, and added bypass of prior therapies for colon cancer, esophageal/esophagogastric junction cancer with planned esophagectomy or if request is for palliative therapy, gastric cancer that is early stage or surgically unresectable or if request is for palliative therapy, and rectal cancer

Talimogene laherepvec (Imlygic) (CP.PHAR.542)

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

Policy updates include:

• Added criteria for metastatic melanoma and off label criteria for combination use with Yervoy per National Comprehensive Cancer Network (NCCN) compendium
• In continued therapy, clarified criteria to require documentation of the type, quantity, and size of new or remaining lesions

Sotorasib (Lumakras) (CP.PHAR.549)

Ambetter

Policy updates include:

• Added disclaimer that indication is approved under accelerated approval to Food and Drug Administration (FDA) Approved Indications section
• Added National Comprehensive Cancer Network (NCCN) recommended off-label use criteria for ampullary adenocarcinoma, pancreatic adenocarcinoma, rectal cancer, appendiceal adenocarcinoma, and colon cancer

Budesonide (Tarpeyo) (CP.PHAR.572)

Ambetter

Policy updates include:

• Revise redirection to require one alternative systemic corticosteroid.

Nivolumab and Relatlimab-rmbw (Opdualag) (CP.PHAR.588)

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

Policy updates include:

• Added off label indication for resectable or limited resectable melanoma per National Comprehensive Cancer Network (NCCN) 2A recommendation
• Revised weight criteria to apply only to pediatric patients

Atidarsagene autotemcel (Lenmeldy) (CP.PHAR.602)

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

Policy updates include:

• Drug is now Food and Drug Administration (FDA) approved – criteria updated per Food and Drug Administration (FDA) labeling: clarified diagnostic criteria to only require 24-hour urine collection if novel alleles are identified, added coverage for children between 7 to 17 years of age as long as onset of symptoms began before age 7, revised metachromatic leukodystrophy forms to align with terminology used in the package insert, clarified that walking independently means without support and modified intelligence quotient (IQ) requirement from 70 to 85, updated dosing to include minimum and maximum recommendations
• Added physician specialized in bone marrow transplantation as a prescriber option per specialist feedback
• Added allowance for prior receipt of allogeneic hematopoietic stem cell transplant in alignment with study protocol

Epcoritamab-bysp (Epkinly) (CP.PHAR.634)

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

Policy updates include:

• Added National Comprehensive Cancer Network (NCCN) Compendium supported off-label use for classic follicular lymphoma
• Updated Food and Drug Administration (FDA) approved indications to include follicular lymphoma

Glofitamab-gxbm (Columvi) (CP.PHAR.636)

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

Policy updates include:

• Added National Comprehensive Cancer Network (NCCN) Compendium supported off-label use in histologic transformation of follicular or marginal zone lymphoma to diffuse large B-cell lymphoma
• Added allowances for partial response, no response, or progressive disease after prior therapy

Brexpiprazole (Rexulti) (CP.PMN.68)

Ambetter

Policy updates include:

• For Schizophrenia, changed to “failure of one of the following generic atypical antipsychotics…” (previously was failure of two) to align with other atypical antipsychotics
• Revised continued therapy criteria to allow continuity of care for major depressive disorder
• For Appendix C, updated boxed warnings language to align with prescriber information

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

Ambetter

Policy updates include:

• Added off-label criteria for hidradenitis suppurativa per local market request.

Lacosamide (Motpoly XR, Vimpat) (CP.PMN.155)

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

Policy updates include:

• Added revisions for the newly Food and Drug Administration (FDA)-approved indication for Motpoly XR for generalized tonic-clonic seizures which align with the existing criteria for the same indication for Vimpat

Lumateperone (Caplyta) (CP.PMN.232)

Ambetter

Policy updates include:

• For Schizophrenia, changed to “failure of one of the following generic atypical antipsychotics…” (previously was failure of two) to align with other atypical antipsychotics

Progesterone (Crinone, Endometrin, Milprosa) (CP.PMN.243)

Ambetter

Policy updates include:

• Removed Milprosa from policy due to product discontinuation
• Evidence of coverage for infertility/fertility preservation language added for Ambetter line of business (AR, CA, Il, LA, NV, NJ, NC, and all other states)

Sofosbuvir/Velpatasvir (Epclusa) (HIM.PA.SP1)

Ambetter

Policy updates include:

• Revised policy/criteria section to also include generic sofosbuvir/velpatasvir
• Removed qualifier of “chronic” from hepatitis C virus (HCV) criteria as American Association for the Study of Liver Diseases - Infectious Diseases Society of America (AASLD-IDSA) recommends treatment of both acute and chronic hepatitis C virus (HCV)
• Added prescriber exception for Ambetter Georgia per plan request
• Added Appendix G for guidance on incomplete adherence and American Association for the Study of Liver Diseases - Infectious Diseases Society of America (AASLD-IDSA) recommended management of treatment interruptions

Sofosbuvir (Sovaldi) (HIM.PA.SP2)

Ambetter

Policy updates include:

• Removed qualifier of “chronic” from hepatitis C virus (HCV) criteria as American Association for the Study of Liver Diseases - Infectious Diseases Society of America (AASLD-IDSA) recommends treatment of both acute and chronic hepatitis C virus (HCV)
• Added prescriber exception for HIM Georgia per plan request
• Added “if applicable for the requested indication” to the Epclusa authorized generic redirection in the other diagnoses/indications section
• Added Appendix G for guidance on incomplete adherence and American Association for the Study of Liver Diseases - Infectious Diseases Society of America (AASLD-IDSA) recommended management of treatment interruptions

Ledipasvir/Sofosbuvir (Harvoni) (HIM.PA.SP3)

Ambetter

Policy updates include:

• Revised policy/criteria section to also include generic ledipasvir/sofosbuvir
• Removed qualifier of “chronic” from hepatitis C virus (HCV) criteria as American Association for the Study of Liver Diseases - Infectious Diseases Society of America (AASLD-IDSA) recommends treatment of both acute and chronic hepatitis C virus (HCV)
• Added prescriber exception for HIM Georgia per plan request
• Added “if applicable for the requested indication” to the Epclusa authorized generic redirection in the other diagnoses/indications section
• Added Appendix G for guidance on incomplete adherence and American Association for the Study of Liver Diseases - Infectious Diseases Society of America (AASLD-IDSA) recommended management of treatment interruptions

Glecaprevir/Pibrentasvir (Mavyret) (HIM.PA.SP36)

Ambetter

Policy updates include:

• Removed qualifier of “chronic” from hepatitis C virus (HCV) criteria as American Association for the Study of Liver Diseases - Infectious Diseases Society of America (AASLD-IDSA) recommends treatment of both acute and chronic hepatitis C virus (HCV)
• Added prescriber exception for HIM Georgia per plan request
• Added “if applicable for the requested indication” to the Epclusa authorized generic redirection in the other diagnoses/indications section
• Added Appendix G for guidance on incomplete adherence and American Association for the Study of Liver Diseases - Infectious Diseases Society of America (AASLD-IDSA) recommended management of treatment interruptions

Dasabuvir/Ombitasvir/Paritaprevir/Ritonavir (Viekira Pak) (HIM.PA.SP61)

Ambetter

Policy updates include:

• Removed qualifier of “chronic” from hepatitis C virus (HCV) criteria as American Association for the Study of Liver Diseases - Infectious Diseases Society of America (AASLD-IDSA) recommends treatment of both acute and chronic hepatitis C virus (HCV)
• Added prescriber exception for HIM Georgia per plan request
• Added “if applicable for the requested indication” to Epclusa authorized generic redirection in the Other diagnoses/indications section
• Added Appendix G for guidance on incomplete adherence and American Association for the Study of Liver Diseases - Infectious Diseases Society of America (AASLD-IDSA) recommended management of treatment interruptions

Elbasvir/Grazoprevir (Zepatier) (HIM.PA.SP62)

Ambetter

Policy updates include:

• Removed qualifier of “chronic” from hepatitis C virus (HCV) criteria as American Association for the Study of Liver Diseases - Infectious Diseases Society of America (AASLD-IDSA) recommends treatment of both acute and chronic hepatitis C virus (HCV)
• Added prescriber exception for HIM Georgia per plan request
• Added “if applicable for the requested indication” to Epclusa authorized generic redirection in the Other diagnoses/indications section
• Added Appendix G for guidance on incomplete adherence and American Association for the Study of Liver Diseases - Infectious Diseases Society of America (AASLD-IDSA) recommended management of treatment interruptions

Sofosbuvir/Velpatasvir/Voxilaprevir (Vosevi) (HIM.PA.SP63)

Ambetter

Policy updates include:

• Removed qualifier of “chronic” from hepatitis C virus (HCV) criteria as American Association for the Study of Liver Diseases - Infectious Diseases Society of America (AASLD-IDSA) recommends treatment of both acute and chronic hepatitis C virus (HCV)
• Added prescriber exception for HIM Georgia per plan request
• Added Epclusa authorized generic redirection to other diagnoses/indications section
• Added Appendix G for guidance on incomplete adherence and American Association for the Study of Liver Diseases - Infectious Diseases Society of America (AASLD-IDSA) recommended management of treatment interruptions

Alpelisib (Piqray, Vijoice) (CP.PHAR.430)

Ambetter

Policy updates include:

• Added oral granules dosage form per updated prescribing information

Mavacamten (Camzyos) (CP.PMN.272)

Ambetter

Policy updates include:

• Removed upper limit for left ventricular thickness for familial disease or positive genetic test as thickness above 15 mm is diagnostic regardless of familial status/genetic testing
• Added Appendix D with examples of genes that can cause familial hypertrophic cardiomyopathy

Anakinra (Kineret) (CP.PHAR.244)

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

Policy updates include:

• For Rheumatoid arthritis, added Simlandi to listed examples of preferred adalimumab products
• For Rheumatoid arthritis, added unbranded adalimumab-aaty to listed examples of preferred adalimumab products

Human Growth Hormone (Somapacitan, Somatrogon, Somatropin, Lonapegsomatropin-tcgd) (CP.PHAR.517)

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

Policy updates include:

• Added Skytrofa to policy
• Added redirection to Omnitrope vial to co-prefer Zomacton and Omnitrope vial
• Revised Omnitrope vial to Omnitrope pen cartridge if Zomacton and Omnitrope vial are not available (e.g., due to drug shortage)
• Added redirection to other diagnoses/indications sections for both initial and continuation requests

Vigabatrin (Sabril) (CP.PHAR.169)

Ambetter

Policy updates include:

• Added newly Food and Drug Administration (FDA) -approved Vigafyde oral solution to the criteria

Ustekinumab (Stelara, Wezlana, Selarsdi) (CP.PHAR.264)

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

Policy updates include:

• Added Simlandi to listed examples of preferred adalimumab products
• Added newly approved biosimilar Pyzchiva to criteria
• Added unbranded adalimumab-aaty to listed examples of preferred adalimumab products

Tadalafil BPH - ED (Cialis) (CP.PMN.132)

Ambetter

Policy updates include:

• Added Chewtadzy to policy

Peanut Allergen Powder-dnfp (Palforzia) (CP.PMN.220)

Ambetter

Policy updates include:

• Updated minimum age from 4 years to 1 year (along with corresponding dosing) per newly approved pediatric extension

Roflumilast (Daliresp, Zoryve) (CP.PMN.46)

Ambetter

Policy updates include:

• Added criteria for newly Food and Drug Administration (FDA)-approved dosage form (Zoryve 0.15% cream) and indication of atopic dermatitis; specified that only the 0.3% cream should be used for plaque psoriasis per updated FDA labeling

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

Ambetter

Policy updates include:

• Added criteria for chronic rhinosinusitis without nasal polyps (CRSsNP) and requiring trial of two intranasal corticosteroids and one intranasal saline agent
• Updated Appendix B with therapeutic alternatives for chronic rhinosinusitis without nasal polyps (CRSsNP) and intranasal saline agents.

Human Growth Hormone (Somapacitan, Somatrogon, Somatropin, Lonapegsomatropin-tcgd)  (HIM.PA.161)

Ambetter

Policy updates include:

• Added Skytrofa to policy and updated policy references to the relevant line of business
• Added Genotropin/Genotropin Miniquick as co-preferred drugs with Norditropin and Humatrope, added redirection to Zomacton if preferred drugs are not available (i.e., due to drug shortages).

Ambetter

Policy Updates include:

• Added new strengths of Austedo XR extended-release tablets (18 mg, 30 mg, 36 mg, 42 mg, 48 mg)

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

Policy Updates include:

• Added Yimmugo to policy

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

Policy Updates include:

• Added criteria for National Comprehensive Cancer Network (NCCN)-supported indication of cancer- and chemotherapy-induced anemia with redirection to preferred iron products

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

Policy Updates include:

• Added Eylea biosimilars Opuviz, Yesafili, and Ahzantive
• Separated macular edema following retinal vein occlusion into new section with specification that request is for Eylea, Opuviz, Yesafili, or Ahzantive

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

Policy Updates include:

• Added new vial strength of 2 mg

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

Policy Updates include:

• Added criteria for National Comprehensive Cancer Network (NCCN)-supported indication of cancer- and chemotherapy-induced anemia with redirection to preferred iron products

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

Policy Updates include:

• Added criteria for newly Food and Drug Administration (FDA)-approved indication of mismatch repair deficient   (dMMR) endometrial cancer

Ambetter

Policy Updates include:

• Added new Food and Drug Administration (FDA)-approved indication for the treatment of colorectal cancer
• updated Appendix B
• Added off-label criteria for ampullary adenocarcinoma and biliary tract cancers as subsequent therapy per National Comprehensive Cancer Network (NCCN) compendium

Ambetter

Policy Updates include:

• Added new solid tumor indication with criteria and new strength 160 mg capsule

Ambetter

Policy Updates include:

• Removed product-specification for cardiovascular prophylaxis in continued therapy section

Ambetter

Policy Updates include:

• Added pediatric extension for excessive daytime sleepiness with narcolepsy

Ambetter

Policy Updates include:

• Criteria updated to reflect the revised indication for primary hyperlipidemia which now includes forms other than heterozygous familial hypercholesterolemia (HeFH) and the new indication for reducing the cardiovascular risk reduction in adults who are unable to take recommended statin therapy (including those not taking a statin) with established CVD or a high risk for a cardiovascular disease (CVD) event but without established cardiovascular disease (CVD)
• Reduced statin adherence duration from 4 months to 8 weeks, simplified statin trial and failure criteria for moderate- and low-intensity statin regimens to require insufficient therapeutic response to one high intensity statin for 8 weeks or reversible muscle-related symptoms associated with both rosuvastatin and atorvastatin
• Removed criteria restricting coadministration with Repatha or Praluent

Ambetter

Policy updates include:

• Updated Food and Drug Administration (FDA)
  approved indications with conversion from accelerated approval to full approval
  for patients with ≥ 4 years of age and ambulatory plus expansion to
  non-ambulatory patients (accelerated approval)
• Revised age restrictions to ≥ 4 years
  (previously ≥ 4 and ≤ 5 years)
• Added treatment of non-ambulatory duchenne
  muscular dystrophy patients to section iii diagnosis/indications not covered
  based on current available evidence

Medicaid

Policy update includes:

• For rheumatoid arthritis, added Simlandi to
  listed examples of preferred adalimumab products.
• Added newly approved polyarticular juvenile
  idiopathic arthritis indication
• For rheumatoid
  arthritis and polyarticular juvenile idiopathic arthritis, added unbranded
  adalimumab-aaty to listed examples of preferred adalimumab products

Medicaid

Policy update includes:

• Added Simlandi to listed examples of preferred
  adalimumab products
• Added newly approved Ulcerative Colitis
  indication to criteria
• Added unbranded
  adalimumab-aaty to listed examples of preferred adalimumab products

Ambetter

Policy update includes:

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