Effective July 1, 2025: Pharmacy and Biopharmacy Policies

POLICY

APPLICABLE PRODUCTS

New policy overview or updated policy revisions

Fingolimod (Gilenya, Tascenso ODT) (CP.PCH.38)

Ambetter

• Removed requirements for documentation of baseline relapses/expanded disability status score and specific measures of positive response
• For continued therapy, modified approval duration from “if member has received less than 1 year of total treatment – up to a total of 12 months of treatment and if member has received greater than 1 year of total treatment – 12 months” to “12 months”

Teriflunomide (Aubagio) (CP.PCH.40)

Ambetter

Policy updates include:

• Removed requirements for documentation of baseline relapses/expanded disability status score and specific measures of positive response
• For continued therapy, modified approval duration from “if member has received less than 1 year of total treatment – up to a total of 12 months of treatment and if member has received greater than 1 year of total treatment – 12 months” to “12 months”

Apalutamide (Erleada) (CP.PCH.45)

Ambetter

Policy updates include:

• Per National Comprehensive Cancer Network (National Comprehensive Cancer Network (NCCN)) Compendium, added off-label use in non-metastatic and castration-sensitive disease
• For continuation of therapy requests modified quantity limit to allow up to 3 tablets per day for dose adjustments

Interferon Beta-1b (Betaseron, Extavia) (CP.PCH.46)

Ambetter

Policy updates include:

• Removed requirements for documentation of baseline relapses/expanded disability status score and specific measures of positive response
• For continued therapy, modified HIM approval duration from “if member has received less than 1 year of total treatment – up to a total of 12 months of treatment and if member has received greater than 1 year of total treatment – 12 months” to “12 months”

Epinephrine (Epipen, Epipen Jr, Neffy, Auvi-Q) (CP.PCH.55)

Ambetter

Policy updates include:

• Added Ambetter line of business, added Auvi-Q to criteria
• Updated Neffy indication and weight minimum and added new 1 mg strength to Section VI

Regorafenib (Stivarga) (CP.PHAR.107)

Ambetter

Policy updates include:

• For hepatocellular carcinoma, removed requirement for Child-Pugh class A disease per National Comprehensive Cancer Network (NCCN)
• Added off-label criteria set for uterine sarcoma per National Comprehensive Cancer Network (NCCN)

Ponatinib (Iclusig) (CP.PHAR.112)

Ambetter

Policy updates include:

• For acute lymphoblastic leukemia per National Comprehensive Cancer Network (NCCN) Compendium added option for combination use with corticosteroid for newly diagnosed disesase, added option for use in pediatric patients (age at most 18 years) for relapsed or refractory BCR::ABL1-positive B-cell-acute lymphoblastic leukemia or T-cell-acute lymphoblastic leukemia with ABL-class translocation

Palivizumab (Synagis) (CP.PHAR.16)

Ambetter

Policy updates include:

• For preterm infants added clarification regarding maternal vaccine exclusion if administered at least 14 days prior to delivery per American Academy of Pediatrics (AAP) / Advisory Committee on Immunization Practices (ACIP) recommendations
• Removed statement regarding redirection to Beyfortus “For the 2023-2024 RSV season, supply issues are anticipated” as the American Academy of Pediatrics (AAP) states shortage of Beyfortus is not expected this coming season
• Removed statements referencing elevated interseasonal activity as per the Centers for Disease Control and Prevention (CDC) regular seasonal patterns are now expected

Paclitaxel, Protein-Bound (Abraxane) (CP.PHAR.176)

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

Policy updates include:

• For ovarian cancer, breast cancer and non-small cell lung cancer, added option for Abraxane usage for members with history of taxane hypersensitivity per National Comprehensive Cancer Network (NCCN)
• For gallbladder cancer, added option to be prescribed as neoadjuvant therapy in combination with gemcitabine per National Comprehensive Cancer Network (NCCN)
• For ampullary adenocarcinoma, clarified prescribed in combination with gemcitabine per National Comprehensive Cancer Network (NCCN)
• Added vaginal cancer, prescribed as a single agent to additional National Comprehensive Cancer Network (NCCN) recommended uses (off-label) section per National Comprehensive Cancer Network (NCCN) Added the following ICD-10 codes in the ICD-10 Code Table: C53.0, C53.1, C53.8, and C53.9.

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

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

Policy updates include:

• For gallbladder cancer or cholangiocarcinoma, added option to be prescribed with tucatinib per National Comprehensive Cancer Network (NCCN)

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

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

Policy updates include:

• Added bypass of prior use of trastuzumab-based therapy and a taxane if prescribed in the adjuvant setting per National Comprehensive Cancer Network (NCCN)

AbobotulinumtoxinA (Dysport) (CP.PHAR.230)

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

Policy updates include:

• For upper and lower limb spasticity, removed verbiage “staying within per limb dosing guidelines”
• For focal dystonia and essential tremor, added prescriber option for orofacial pain specialist
• Updated Appendix B with additional agents for overactive bladder

IncobotulinumtoxinA (Xeomin) (CP.PHAR.231)

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

Policy updates include:

• For focal dystonia and essential tremor, added prescriber option for orofacial pain specialist
• Updated Appendix B with additional agents for overactive bladder

OnabotulinumtoxinA (Botox) (CP.PHAR.232)

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

Policy updates include:

• For focal dystonia and essential tremor, added prescriber option for orofacial pain specialist
• Updated Appendix B with additional agents for overactive bladder

Epoetin Alfa (Epogen, Procrit), Epoetin Alfa-epbx (Retacrit) (CP.PHAR.237)

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

Policy updates include:

• Extended continuation of therapy approval duration from 6 to 12 months for Medicaid/Ambetter for anemia due to chronic kidney disease and zidovudine in human immunodeficiency virus (HIV)-infected patients
• For all indications, separated redirection criteria for Epogen and Procrit
• Revised Procrit redirection language to also require use of Epogen if member is unable to use Retacrit.

Dabrafenib (Tafinlar) (CP.PHAR.239)

Ambetter

Policy updates include:

• For B-Raf proto-oncogene, serine/ threonine kinase (BRAF) V600E mutation-positive solid tumor per National Comprehensive Cancer Network (NCCN), consolidated types of biliary tract cancers, added neuroglioma and glioneuronal tumor, added recurrent or progressive adult high-grade gliomas, clarified listed types of ovarian cancer are acceptable diagnoses in addition to ovarian cancer, fallopian tube cancer, and peritoneal cancer
• Consolidated criterion for recurrent ovarian cancer, fallopian tube cancer, and peritoneal cancer
• Consolidated gastric, esophageal, or esophagogastric cancers for anaplastic thyroid cancer, updated Food and Drug Administration (Food and Drug Administration (FDA))-approved indication to include detection by an Food and Drug Administration (Food and Drug Administration (FDA)) approved test.

Trametinib (Mekinist) (CP.PHAR.240)

Ambetter

Policy updates include:

• For all indications, revised quantity limit for adults from 1 tablet to 3 tablets to allow for dose modifications
• For B-Raf proto-oncogene, serine/ threonine kinase (BRAF) V600E mutation-positive solid tumor per National Comprehensive Cancer Network (NCCN), consolidated types of biliary tract cancers, added neuroglioma and glioneuronal tumor, added recurrent or progressive adult high-grade gliomas, clarified listed types of ovarian cancer are acceptable diagnoses in addition to ovarian cancer, fallopian tube cancer, and peritoneal cancer
• Consolidated criterion for recurrent ovarian cancer, fallopian tube cancer, and peritoneal cancer
• Consolidated gastric, esophageal, or esophagogastric cancers  for anaplastic thyroid cancer, updated Food and Drug Administration (FDA)-approved indication to include detection by an Food and Drug Administration (FDA) approved test.

Alemtuzumab (Lemtrada) (CP.PHAR.243)

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

Policy updates include:

• Removed requirements for documentation of baseline relapses/expanded disability status score and specific measures of positive response
• Removed notation that Extavia is the preferred interferon beta-1b product for the Medicaid line of business as it is no longer available on market

Dimethyl Fumarate (Tecfidera), Diroximel Fumarate (Vumerity), Monomethyl Fumarate (Bafiertam) (CP.PHAR.249)

Ambetter

Policy updates include:

• Removed requirements for documentation of baseline relapses/expanded disability status score and specific measures of positive response
• Removed notation that Extavia is the preferred interferon beta-1b product for the Medicaid line of business as it is no longer available on market
• For continued therapy, updated approval duration from “if member has received less than 1 year of total treatment – up to a total of 12 months of treatment and if member has received greater than 1 year of total treatment – 12 months” to “12 months”

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

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

Policy updates include:

• Removed requirements for documentation of baseline relapses/expanded disability status score and specific measures of positive response
• Updated Appendix C with new boxed warning for anaphylactic reactions
• For continued therapy, modified Ambetter and Medicaid approval duration from “if member has received less than 1 year of total treatment – up to a total of 12 months of treatment and if member has received greater than 1 year of total treatment – 12 months” to “12 months”

Interferon Beta-1a (Avonex, Rebif) (CP.PHAR.255)

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

Policy updates include:

• Removed requirements for documentation of baseline relapses/expanded disability status score and specific measures of positive response
• For continued therapy, modified Ambetter and Medicaid approval duration from “if member has received less than 1 year of total treatment – up to a total of 12 months of treatment and if member has received greater than 1 year of total treatment – 12 months” to “12 months”

Interferon Beta-1b (Betaseron, Extavia) (CP.PHAR.256)

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

Policy updates include:

• Removed requirements for documentation of baseline relapses/expanded disability status score and specific measures of positive response
• For continued therapy, modified approval duration from “if member has received less than 1 year of total treatment – up to a total of 12 months of treatment and if member has received greater than 1 year of total treatment – 12 months” to “12 months”

Mitoxantrone (CP.PHAR.258)

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

Policy updates include:

• For multiple sclerosis, removed requirements for documentation of baseline relapses/expanded disability status score and specific measures of positive response removed notation that Extavia is the preferred interferon beta-1b product for the Medicaid line of business as it is no longer available on market
• And increased the Medicaid/Ambetter continued approval duration from 6 to 12 months for this chronic condition
• For pediatric acute lymphoblastic leukemia, revised “Ph” to “BCR::ABL1” per National Comprehensive Cancer Network (NCCN)

Natalizumab (Tysabri), Natalizumab-sztn (Tyruko) (CP.PHAR.259)

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

Policy updates include:

• For multiple sclerosis, removed requirements for documentation of baseline relapses/expanded disability status score and specific measures of positive response  and removed notation that Extavia is the preferred interferon beta-1b product for the Medicaid line of business as it is no longer available on market
• For multiple sclerosis continued therapy, modified Ambetter and Medicaid approval duration from “if member has received less than 1 year of total treatment – up to a total of 12 months of treatment and if member has received greater than 1 year of total treatment – 12 months” to “12 months”

Peginterferon Beta-1a (Plegridy) (CP.PHAR.271)

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

Policy updates include:

• Removed requirements for documentation of baseline relapses/expanded disability status score and specific measures of positive response
• For continued therapy, modified Ambetter and Medicaid approval duration from “if member has received less than 1 year of total treatment – up to a total of 12 months of treatment and if member has received greater than 1 year of total treatment – 12 months” to “12 months”

Cabazitaxel (Jevtana) (CP.PHAR.316)

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

Policy updates include:

• Added an additional bypass to required prior use of docetaxel-containing treatment regimen for members with small cell/neuroendocrine prostate cancer per National Comprehensive Cancer Network (NCCN) Compendium

Nusinersen (Spinraza) (CP.PHAR.327)

Ambetter

Policy updates include:

• For initial criteria stating four copies of SMN2 gene, removed “documentation indicates presence of spinal muscular atrophy symptoms” as four copies of SMN2 gene without symptoms is supported by practice guidelines

Ocrelizumab (Ocrevus) (CP.PHAR.335)

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

Policy updates include:

• Removed requirements for documentation of baseline relapses/expanded disability status score and specific measures of positive response
• Removed notation that Extavia is the preferred interferon beta-1b product for the Medicaid line of business as it is no longer available on market
• Updated Appendix C to include Ocrevus Zunovo’s hypersensitivity contraindication
• For continued therapy, modified Ambetter and Medicaid approval duration from “if member has received less than 1 year of total treatment – up to a total of 12 months of treatment and if member has received greater than 1 year of total treatment – 12 months” to “12 months”

Midostaurin (Rydapt) (CP.PHAR.344)

Ambetter

Policy updates include:

• For acute myeloid leukemia, added use as maintenance therapy for those who have previously received a FLT3 inhibitor and do not have an allogeneic hematopoietic cell transplantation planned per National Comprehensive Cancer Network (NCCN)
• For systemic mastocytosis, revised to include off-label use in indolent systemic mastocytosis and smoldering systemic mastocytosis per National Comprehensive Cancer Network (NCCN)

Alectinib (Alecensa) (CP.PHAR.369)

Ambetter

Policy updates include:

• For stage IIIB non-small cell lung cancer, clarified tumor status is T3-T4 per National Comprehensive Cancer Network (NCCN) Compendium
• Added pediatric diffuse high-grade glioma to National Comprehensive Cancer Network (NCCN)-supported off-label indications

Cobimetinib (Cotellic) (CP.PHAR.380)

Ambetter

Policy updates include:

• For melanoma per National Comprehensive Cancer Network (NCCN), removed criterion for re-induction therapy as this is covered by unresectable or metastatic melanoma
• For histiocytic neoplasms, revised diagnosis to allow a broad range of histiocytic neoplasm types
• For central nervous system cancers per National Comprehensive Cancer Network (NCCN), added circumscribed ganglioglioma/neuroglioma/glioneuronal tumor, recurrent or progressive glioblastoma, recurrent or progressive high-grade glioma, and brain metastases

Patisiran (Onpattro) (CP.PHAR.395)

Ambetter

Policy updates include:

• Removed criteria “member has not received prior treatment with Amvuttra, Tegsedi, or Wainua”  and to allow alternative therapy as a result of Tegsedi market withdrawal

Inotersen (Tegsedi) (CP.PHAR.405)

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

Policy updates include:

• Removed criteria “member has not received prior treatment with Amvuttra, Onpattro, or Wainua”

Elapegademase-lvlr (Revcovi) (CP.PHAR.419)

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

Policy updates include:

• Added an additional diagnostic option to genetic testing of both deficient adenosine deaminase (ADA) catalytic activity and increase in adenosine or deoxyadenosine nucleotide levels

Onasemnogene Abeparvovec (Zolgensma) (CP.PHAR.421)

Ambetter

Policy updates include:

• For initial approval criteria, added option of “four copies of SMN2 gene, determined by a quantitative assay that is able to distinguish between four SMN2 gene copies and five or more SMN2 gene copies” to SMN2 gene copy criteria as supported by practice guidelines

Cladribine (Mavenclad) (CP.PHAR.422)

Ambetter

Policy updates include:

• Removed requirements for documentation of baseline relapses/expanded disability status score and specific measures of positive response
• Removed notation that Extavia is the preferred interferon beta-1b product for the Medicaid line of business as it is no longer available on market

Siponimod (Mayzent) (CP.PHAR.427)

Ambetter

Policy updates include:

• Removed requirements for documentation of baseline relapses/expanded disability status score and specific measures of positive response
• Removed notation that Extavia is the preferred interferon beta-1b product for the Medicaid line of business as it is no longer available on market
• For continued therapy, modified approval duration from “if member has received less than 1 year of total treatment – up to a total of 12 months of treatment and if member has received greater than 1 year of total treatment – 12 months” to “12 months”

Ozanimod (Zeposia) (CP.PHAR.462)

Ambetter

Policy updates include:

• For multiple sclerosis, removed requirements for documentation of baseline relapses/expanded disability status score and specific measures of positive response  and removed notation that Extavia is the preferred interferon beta-1b product for the Medicaid line of business as it is no longer available on market
• For multiple sclerosis continued therapy, modified approval duration from “if member has received less than 1 year of total treatment – up to a total of 12 months of treatment and if member has received greater than 1 year of total treatment – 12 months” to “12 months”
• For ulcerative colitis, added option for documentation of modified Mayo Score at least 5
• Removed redirection to preferred adalimumab products as adalimumab is not recommended due to low efficacy per 2024 American Gastroenterological Association (AGA) guidelines
• For Appendix E, added supplemental information on modified Mayo Score

Remestemcel-L (Ryoncil) (CP.PHAR.474)

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

Policy updates include:

• Drug is now Food and Drug Administration (FDA) approved – criteria updated per Food and Drug Administration (FDA) labeling: for continued therapy, added pathway for use in cases of graft-versus-host disease recurrence following complete response and revised total number of doses allowed from 12 to 16
• For both initial and continued therapy, added requirement for documentation of member’s current weight

Risdiplam (Evrysdi) (CP.PHAR.477)

Ambetter

Policy updates include:

• For initial criteria stating four copies of SMN2 gene, removed “documentation indicates presence of spinal muscular atrophy symptoms” as four copies of SMN2 gene without symptoms is supported by practice guidelines
•  Added new tablet dosage formulation [5 mg] to criteria with requirement that member must be age at least 2 years and weight at least 20 kg

Selpercatinib (Retevmo) (CP.PHAR.478)

Ambetter

Policy updates include:

• For rearranged during transfection (RET) fusion-positive solid tumors indication, added biliary tract cancer and uterine sarcoma as options for 1st line therapy per National Comprehensive Cancer Network (NCCN)

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

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

Policy updates include:

• Added off-label indication for primary therapy in combination with Kryprolis, lenalidomide, and dexamethasone per National Comprehensive Cancer Network (NCCN) Compendium

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

Ambetter

Policy updates include:

• Added bypass for age requirement for primary mediastinal large B-cell lymphoma per National Comprehensive Cancer Network (NCCN) Guidelines in Pediatric Aggressive Mature B-Cell Lymphomas
• Added National Comprehensive Cancer Network (NCCN) Compendium supported use in human immunodeficiency virus (HIV)-related plasmablastic lymphoma

Tepotinib (Tepmetko) (CP.PHAR.530)

Ambetter

Policy updates include:

• Added option for combination with continued Tagrisso if member has high-level mesenchymal-epithelial transition (MET) amplification and an epidermal growth factor receptor (EGFR) mutation per National Comprehensive Cancer Network (NCCN) Compendium

Ponesimod (Ponvory) (CP.PHAR.537)

Ambetter

Policy updates include:

• Removed requirements for documentation of baseline relapses/expanded disability status score and specific measures of positive response
• Removed notation that Extavia is the preferred interferon beta-1b product for the Medicaid line of business as it is no longer available on market
• For continued therapy, modified approval duration from “if member has received less than 1 year of total treatment – up to a total of 12 months of treatment and if member has received greater than 1 year of total treatment – 12 months” to “12 months”

Vutrisiran (Amvuttra) (CP.PHAR.550)

Ambetter

Policy updates include:

• Removed criteria “member has not received prior treatment with Onpattro, Tegsedi, or Wainua” and to allow alternative therapy as a result of Tegsedi market withdrawal
• Added new indication for cardiomyopathy of transthyretin-mediated amyloidosis

Pacritinib (Vonjo) (CP.PHAR.583)

Ambetter

Policy updates include:

• Revised section I.B title to National Comprehensive Cancer Network (NCCN) Compendium Indications
• Added off-label diagnosis for accelerated/blast please myeloproliferative neoplasms per National Comprehensive Cancer Network (NCCN)

Lecanemab-irmb (Leqembi) (CP.PHAR.596)

Ambetter

Policy updates include:

• Updated the maintenance dosing regimen to include the option for every 4 week dosing after the initial 18 months of therapy

Capecitabine (Xeloda) (CP.PHAR.60)

Ambetter

Policy updates include:

• Added National Comprehensive Cancer Network (NCCN)-supported indication of cervical cancer and vaginal cancer into off-label criteria set
• For extrapulmonary neuroendocrine carcinoma, revised “and” to “or” for large or small carcinoma

Trofinetide (Daybue) (CP.PHAR.600)

Ambetter

Policy updates include:

• Removed the requirement from the Initial Approval Criteria and the Continued Therapy sections for symptom rating scales such as the Rett Syndrome Behavioral Questionnaire and the Clinical Global Impressions-Severity and -Improvement scales as providers do not routinely use these scales in clinical practice for Rett syndrome management

Pirtobrutinib (Jaypirca) (CP.PHAR.620)

Ambetter

Policy updates include:

• Added criteria for marginal zone lymphoma and waldenstrom macroglobulinemia per National Comprehensive Cancer Network (NCCN)
• In Appendix B, updated example therapies per National Comprehensive Cancer Network (NCCN)

Ublituximab-xiiy (Briumvi) (CP.PHAR.621)

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

Policy updates include:

• Removed requirements for documentation of baseline relapses/expanded disability status score and specific measures of positive response
• Removed notation that Extavia is the preferred interferon beta-1b product for the Medicaid line of business as it is no longer available on market
• For continued therapy, modified Ambetter and Medicaid approval duration from “if member has received less than 1 year of total treatment – up to a total of 12 months of treatment and if member has received greater than 1 year of total treatment – 12 months” to “12 months”
• Reviewed and updated.

Retifanlimab-dlwr (Zynyz) (CP.PHAR.629)

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

Policy updates include:

• Added criteria for small bowel adenocarcinoma, colon cancer, and rectal cancer per National Comprehensive Cancer Network (NCCN) 2A recommendation
• For anal carcinoma, added option to be prescribed in combination with carboplatin and paclitaxel

Eplontersen (Wainua) (CP.PHAR.633)

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

Policy updates include:

• Removed criteria “member has not received prior treatment with, Onpattro or Amvuttra”

Topotecan (Hycamtin) (CP.PHAR.64)

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

Policy updates include:

• For off-label National Comprehensive Cancer Network (NCCN) recommendations, added pediatric medulloblastoma and vaginal cancer criteria

Vanzacaftor/Tezacaftor/Deutivacaftor (Alyftrek) (CP.PHAR.700)

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: Cystic Fibrosis (CF) (must meet all):
    • Diagnosis of CF confirmed by all of the following:
      • Clinical symptoms consistent with CF in at least one organ system, or positive newborn screen or genetic testing for siblings of patients with CF;
        • Evidence of CFTR dysfunction confirmed by one of the following:
        • Elevated sweat chloride at least 60 mmol/L;
          • Genetic testing confirming the presence of two disease-causing mutations in CFTR gene, one from each parental allele;
            • Confirmation of one of the following:
            • Member has at least one F508del mutation in the CFTR gene;
              • Member has at least one mutation in the CFTR gene that is responsive to Alyftrek;
  • Prescribed by or in consultation with a pulmonologist;
  • Age at least 6 years;
    • Documentation of member’s baseline precent predicted forced expiratory volume in 1 second (ppFEV1), performed within the last 90 days;
      • Failure of Trikafta^®, unless member meets one of the following:
      • Presence of mutation in CFTR gene that is not responsive to Trikafta;
      • Contraindicated or clinically significant adverse effects are experienced;*Prior authorization may be required for Trikafta
        •  
  • Alyftrek is not prescribed concurrently with other CFTR modulators (e.g., Trikafta, Orkambi^®, Kalydeco^®, Symdeko^®);
  • Dose does not exceed one of the following:
    • Age 6 to less than 12 years and weight less than 40 kg:
      • Vanzacaftor 12 mg/tezacaftor 60 mg/deutivacaftor 150 mg per day;
      • 3 tablets (vanzacaftor 4 mg/tezacaftor 20 mg/deutivacaftor 50 mg) per day;
    • Age 6 to less than 12 years and weight at least 40 kg:
      • Vanzacaftor 20 mg/tezacaftor 100 mg/deutivacaftor 250 mg per day;
      • 2 tablets (vanzacaftor 10 mg/tezacaftor 50 mg/deutivacaftor 125 mg) per day;
    • Age at least 12 years:
      • Vanzacaftor 20 mg/tezacaftor 100 mg/deutivacaftor 250 mg per day;
      • 2 tablets (vanzacaftor 10 mg/tezacaftor 50 mg/deutvacaftor 125 mg) per day.
  • Approval duration: 6 months
• Continued Therapy: Cystic Fibrosis (must meet all):
  • Member meets one of the following:
    • Currently receiving medication via Centene benefit or member has previously met initial approval criteria;
    • Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state specific addendums for CC.PHARM.03A and CC.PHARM.03B);
  • Member is responding positively to therapy as evidenced by a stabilization or improvement (e.g., increase) in ppFEV1 from baseline;
  • Alyftrek is not prescribed concurrently with other CFTR modulators (e.g., Trikafta, Orkambi, Kalydeco, Symdeko);
  • If request is for a dose increase, new dose does not exceed one of the following:
    • Age 6 to less than 12 years and weight less than 40 kg:
      • Vanzacaftor 12 mg/tezacaftor 60 mg/deutivacaftor 150 mg per day;
      • 3 tablets (vanzacaftor 4 mg/tezacaftor 20 mg/deutivacaftor 50 mg) per day;
    • Age 6 to less than 12 years and weight > 40 kg:
      • Vanzacaftor 20 mg/tezacaftor 100 mg/deutivacaftor 250 mg per day;
      • 2 tablets (vanzacaftor 10 mg/tezacaftor 50 mg/deutivacaftor 125 mg) per day;
    • Age at least 12 years:
      • Vanzacaftor 20 mg/tezacaftor 100 mg/deutivacaftor 250 mg per day;
      • 2 tablets (vanzacaftor 10 mg/tezacaftor 50 mg/deutvacaftor 125 mg) per day.
  • Approval duration: 12 months

Datopotamab Deruxtecan-dlnk (Datroway) (CP.PHAR.715)

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: Breast Cancer (must meet all):
  • Diagnosis of unresectable or metastatic breast cancer;
  • Prescribed by or in consultation with an oncologist;
  • Age at least 18 years;
  • Documentation of hormone receptor (HR)-positive disease;
  • Documentation of HER2-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) disease;
  • Member received prior endocrine based therapy (see Appendix B);
  • Member received prior chemotherapy for unresectable or metastatic disease;
  • Prescribed as a single agent;
  • Request meets one of the following:*
    • Dose does not exceed both of the following once every 3 weeks (21-day cycle):
      • 6 mg/kg;
      • 540 mg;
    • Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence). *Prescribed regimen must be FDA-approved or recommended by NCCN
  • Approval duration: 6 months
• Continued Therapy: Breast Cancer (must meet all):
  • Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Datroway 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 both of the following once every 3 weeks (21-day cycle):
      • 6 mg/kg;
      • 540 mg;
  • 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

Mirdametinib (Gomekli) (CP.PHAR.718)

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: Neurofibromatosis Type 1(NF1) (must meet all):
  • Diagnosis of NF1;
  • Prescribed by or in consultation with an oncologist or neurologist;
  • Age at least 2;
  • For Gomekli requests, member must use mirdametinib, if available, unless contraindicated or clinically significant adverse effects are experienced;
  • Member has body surface area at least 0.40 m²;
  • Member meets one of the following:
    • Positive genetic testing for NF1;
    • Member has at least one other diagnostic criterion for NF1;
  • Member has at least one inoperable and measurable PN, defined as a lesion at least 5 mL in volume;
  • Complete resection of plexiform neurofibroma (PN) is not considered to be feasible without substantial risk or morbidity (e.g., due to encasement of, or close proximity to, vital structures, invasiveness, or high vascularity of the PN);
  • Gomekli is not prescribed concurrently with Koselugo^®;
  • Dose does not exceed both of the following:
    • 4 mg/m² (up to a maximum of 8 mg) per day for the first 21 days of each 28-day cycle;
    • 6 capsules or 8 tablets per day for the first 21 days of each 28-day cycle.
  • Approval duration: 6 months
• Continued Therapy: Neurofibromatosis Type 1 (must meet all):
  • Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Gomekli for a covered indication and has received this medication for at least 30 days;
  • Member is responding positively to therapy as evidenced by decreased or maintained volume of PN(s) from baseline;
  • For Gomekli requests, member must use mirdametinib, if available, unless contraindicated or clinically significant adverse effects are experienced;
  • If request is for a dose increase, new dose does not exceed both of the following:
    • 4 mg/m² (up to a maximum of 8 mg) per day for the first 21 days of each 28-day cycle;
    • 6 capsules or 8 tablets per day for the first 21 days of each 28-day cycle.
  • Approval duration: 12 months

Vimseltinib (Romvimza) (CP.PHAR.726)

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: Tenosynovial Giant Cell Tumor (TGCT) (must meet all):
  • Diagnosis of TGCT (also known as giant cell tumor of the tendon sheath [GCT-TS] or pigmented villonodular synovitis [PVNS]);
  • Prescribed by or in consultation with oncologist;
  • Age at least 18 years;
  • Disease is associated with severe morbidity or functional limitations and is not amenable to improvement with surgery;
  • Prescribed as a single agent;
  • For Romvimza requests, member must use vimseltinib, 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:
      • 30 mg twice weekly;
      • 2 capsules per week;
  • 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: Tenosynovial Giant Cell Tumor (must meet all):
  • Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Romvimza for a covered indication and has received this medication for at least 30 days;
  • Member is responding positively to therapy;
  • For Romvimza requests, member must use vimseltinib, 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:
      • 30 mg twice weekly;
      • 2 capsules per week;
  • 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

Bexarotene (Targretin Capsules, Gel) (CP.PHAR.75)

Ambetter

Policy updates include:

• Modified Medicaid/Ambetter continued approval duration from 6 months to 12 months per standard oncology approach

Crizotinib (Xalkori) (CP.PHAR.90)

Ambetter

Policy updates include:

• Added option for combination with continued Tagrisso if member has high-level mesenchymal-epithelial transition (MET) amplification and an epidermal growth factor receptor (EGFR) mutation per National Comprehensive Cancer Network (NCCN) Compendium

Age Limit Override (Codeine, Tramadol, Hydrocodone) (CP.PMN.138)

Ambetter

Policy updates include:

• Added by-passing of redirection if state regulations do not allow step therapy in certain oncology settings along with Appendix D

Brimonidine Tartrate (Mirvaso) (CP.PMN.192)

Ambetter

Policy updates include:

• Removed the 30 mg/month max dose restriction

Esketamine (Spravato) (CP.PMN.199)

Ambetter

Policy updates include:

• Revised treatment-resistant depression requirement for failure of antidepressant augmentation therapies from two to one
• Revised continued approval duration from 6 months to 12 months

Suzetrigine (Journavx) (CP.PMN.301)

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: Moderate to Severe Acute Pain (must meet all):
  • Diagnosis of moderate to severe acute pain;
  • Age at least 18 years;
  • Member meets one of the following:
    • Recent (within the last 7 days) major surgery or traumatic injury (e.g., crush injuries, spinal cord injury, burns, broken or dislocated bones);
    • Member has plans to undergo a surgical procedure, and one of the following:
      • Member has one or more risk factors for increased post-operative pain (see Appendix D);
      • Surgical procedure is classified as major and associated with moderate to severe post-operative pain;
    • Failure of at least two analgesic medications (e.g., non-steroidal anti-inflammatory drugs [NSAIDs], aspirin, acetaminophen, tramadol, opioids; see Appendix B), unless clinically significant adverse effects are experienced or all are contraindicated;
  • Prescribed as a component of multimodal analgesia (see Appendix B), unless contraindicated or clinically significant adverse effects are experienced;
  • Dose does not exceed 150 mg (3 tablets) on day 1, then 100 mg (2 tablets) per day.
  • Approval duration: 14 days
• Continued Therapy: Moderate to Severe Acute Pain (must meet all):
  • Member meets one of the following:
  • Currently receiving medication via Centene benefit or member has previously met initial approval criteria;
  • Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations;
  • Member is responding positively to therapy
  • Total duration of therapy does not exceed 14 days;
  • If request is for a dose increase, new dose does not exceed 100 mg (2 tablets) per day.
  • Approval duration: 14 days

Pregabalin (Lyrica, Lyrica CR) (CP.PMN.33)

Ambetter

Policy updates include:

• For neuropathic pain associated with treatment of cancer, revised maximum dosage from 300 mg/day to 600 mg/day per National Comprehensive Cancer Network (NCCN)
• Added off-label criteria for restless leg syndrome

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

Ambetter

Policy updates include:

• For narcolepsy with cataplexy: clarified if member is greater than 65 years then trial of tricyclic antidepressants are not required apply to clomipramine and protriptyline only, added “if member is at least 18 years of age” to trial of Wakix
• For narcolepsy with excessive daytime sleepiness: added “if member is at least 18 years of age” to trial of Sunosi
• For idiopathic hypersomnia, removed criteria requiring minimal scoring for Epworth Sleepiness Scale or Idiopathic Hypersomnia Severity Scale (IHSS) to align with competitor analysis
• For Appendix D, removed supplemental information on Epworth Sleepiness Scale and Idiopathic Hypersomnia Severity Scale (IHSS)

Oxymetazoline (Rhofade, Upneeq) (CP.PMN.86)

Ambetter

Policy updates include:

• For Upneeq revised the approval duration for Commercial line of business from length of benefit to 12 months or duration of request, whichever is less
• For Rhofade removed the 30 mg/month max dose restriction within the approval criteria since this doesn’t reflect the actual recommended dosing of Rhofade
• Removed the 30 gm pump and the 60 gm pump and tube formulations of Rhofade from Product Availability

Entecavir (Baraclude) (HIM.PA.08)

Ambetter

Policy updates include:

• For initial criteria removed hepatitis B virus diagnostic criteria to align with other Centene hepatitis B virus policies

Opioid Analgesics* (HIM.PA.139)

Ambetter

Policy updates include:

• Added by-passing of redirection if state regulations do not allow step therapy in certain oncology settings along with Appendix E

Butorphanol Nasal Spray (HIM.PA.46)

Ambetter

Policy updates include:

• Added option to bypass redirection if prescribed by or in consultation with a pain management specialist, an oncologist, or for use in palliative care or hospice care
• Added by-passing of redirection if state regulations do not allow step therapy in certain oncology settings along with Appendix D

Fingolimod (Gilenya, Tascenso ODT) (CP.PHAR.251)

Ambetter

Policy updates include:

• Removed requirements for documentation of baseline relapses/expanded disability status score and specific measures of positive response
• For continued therapy, modified approval duration from “if member has received less than 1 year of total treatment – up to a total of 12 months of treatment and if member has received greater than 1 year of total treatment – 12 months” to “12 months”
• Removed redirection to generic tecfidera
• Added commercial and Ambetter lines of business

Tafamidis (Vyndaqel, Vyndamax) (CP.PHAR.432)

Ambetter

Policy updates include:

• Removed Amvuttra from list of excluded agents for concurrent use
• Added requirements to requests for concurrent use with Amvuttra, requiring positive but inadequate response to monotherapy

Lutetium Lu 177 Vipivotide Tetraxetan (Pluvicto) (CP.PHAR.582)

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

Policy updates  include:

• Revised Food and Drug Administration (FDA) -approved indications to include use in those that are considered appropriate to delay taxane-based chemotherapy per updated prescribing information
• Updated criteria requiring use of taxane to allow bypass in those where delay may be appropriate

Iptacopan (Fabhalta) (CP.PHAR.656)

Ambetter

Policy updates include:

• Added newly approved Food and Drug Administration (FDA) indication of complement 3 glomerulopathy

Revakinagene Taroretcel-lwey (Encelto) (CP.PHAR.697)

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: Idiopathic Macular Telangiectasia Type 2 (must meet all):
  • Diagnosis of MacTel confirmed by both of the following:
    • Fluorescein angiographic leakage of the retinal vessels;
    • One of the following:
      • Retinal opacification;
      • Crystalline deposits;
      • Right angle vessels;
      • Inner/outer lamellar cavities;
      • Hyperpigmentation not involving the foveal center;
  • Prescribed by or in consultation with a retina specialist;
  • Age at least 18 years;
  • Ellipsoid zone (EZ) disruption between 0.16 mm² and 2.00 mm² as measured by optical coherence tomography (OCT);
  • Best corrected visual acuity (BCVA) of 54 letters or better on Early Treatment Diabetic Retinopathy Study (ETDRS) charts (approximately 20/80 Snellen equivalent);
  • Member does not have intraretinal or subretinal neovascularization;
  • Member has not previously received an ocular implant containing Encelto in the affected eye(s);
  • Dose does not exceed 1 ocular implant per eye.
  • Approval duration: 3 months (one implant per eye per lifetime)

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

Diazoxide Choline (Vykat XR) (CP.PHAR.701)

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: Prader-Willi Syndrome (PWS) (must meet all):
  • Diagnosis of PWS confirmed by genetic testing;
  • Prescribed by or in consultation with a pediatric endocrinologist or geneticist;
  • Age at least 4 years;
  • Weight at least 20 kg;
  • Documentation of baseline hyperphagia questionnaire for clinical trials (HQ-CT) score at least 13;
  • Dose does not exceed both of the following:
  • 5.8 mg/kg per day;
  • 525 mg per day.
  • Approval duration: 6 months

• Continued Therapy: Prader-Willi Syndrome (must meet all):
  • Member meets one of the following:
    • Currently receiving medication via Centene benefit or member has previously met initial approval criteria;
    • Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations;
  • Member is responding positively to therapy as evidenced by reduction in overall HQ-CT total score from baseline;
  • If request is for a dose increase, new dose does not exceed both of the following:
    • 5.8 mg/kg per day;
    • 525 mg per day.
  • Approval duration: 12 months

Atrasentan (Vanrafia) (CP.PHAR.727)

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: Immunoglobulin A Nephropathy (IgAN) (must meet all):
  • Diagnosis of IgAN confirmed via kidney biopsy;
  • Prescribed by or in consultation with a nephrologist;
  • Age at least 18 years;
  • Documentation of both of the following:
    • Proteinuria of at least 1 g/day or urine protein-to-creatinine ratio (UPCR) at least 1.5 g/g;
    • Estimated glomerular filtration rate (eGFR) at least 30 mL/min/1.73 m²;
  • Member is currently receiving therapy with a renin-angiotensin-aldosterone system (RAAS) inhibitor (e.g., irbesartan, losartan, lisinopril, benazepril) at up to maximally tolerated doses for at least 12 weeks, unless contraindicated or clinically significant adverse effects are experienced;
  • Vanrafia is prescribed in combination with a RAAS inhibitor, unless contraindicated or clinically significant adverse effects are experienced;
  • Dose does not exceed 0.75 mg (1 tablet) per day
  • Approval duration: 6 months

• Continued Therapy: Immunoglobulin A Nephropathy (must meet all):
  • Member meets one of the following:
    • Currently receiving medication via Centene benefit or member has previously met initial approval criteria;
    • Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations
  • Member is responding positively to therapy as evidenced by one of the following:
    • Decrease in UPCR from baseline;
    • Reduction of proteinuria as evidenced by a lower total urine protein per day from baseline;
  • If request is for a dose increase, new dose does not exceed 0.75 mg (1 tablet) per day.
  • Approval duration: 12 months

Cabozantinib (Cabometyx, Cometriq) (CP.PHAR.111)

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

Policy updates include:

• Added new neuroendocrine tumors indication and updated differentiated thyroid carcinoma dosing for Cabometyx

Ramucirumab (Cyramza) (CP.PHAR.119)

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

Policy updates include:

• Clarified Food and Drug Administration (FDA)-Approved Indications section to specify use in adults per updated Food and Drug Administration (FDA) labeling

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

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

Policy updates include:

• Updated to include new Vyvgart Hytrulo prefilled syringe formulation

Furosemide (Furoscix) (CP.PHAR.608)

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

Policy updates include:

• Updated Food and Drug Administration (FDA) indication and criteria to include chronic kidney disease including nephrotic syndrome
• Added nephrologist as an option for the prescriber specialty requirement

Vorasidenib (Voranigo) (CP.PHAR.699)

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

Policy updates include:

• Updated Food and Drug Administration (FDA) Approved Indication(s) section to include “as detected by an Food and Drug Administration (FDA)-approved test”
• Added Appendix D with link for information on Food and Drug Administration (FDA)-approved tests for detection of IDH1 or IDH2 mutations in Grade 2 astrocytoma or oligodendroglioma
• Added additional uses for Grade 2 disease as well as coverage for Grade 3 and 4 disease per National Comprehensive Cancer Network (NCCN)

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

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

Policy updates include:

• Added new dosage strength of 300 mg

Continuous Glucose Monitors (CP.PMN.214)

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

Policy updates include:

• Added Coding Implications section

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

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

Policy updates include:

• Revised Valtoco lower age limit to 2 years and relevant dosing per the updated Food and Drug Administration (FDA) labeling

Palbociclib (Ibrance) (HIM.PA.173)

Ambetter

Policy updates include:

• For breast cancer, added newly approved indication for endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer to criteria