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

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”
• Removed redirection to generic tecfidera
• Added commercial and Ambetter lines of business

Teriflunomide (Aubagio) (CP.PCH.40)

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”

Apalutamide (Erleada) (CP.PCH.45)

Ambetter

• 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

• 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

• 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

• 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

• 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

• 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)

Ambetter

• 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)

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)

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)

Ambetter

• 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)

Ambetter

• 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)

Ambetter

• 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)

Ambetter

• 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

• 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

• 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)

Ambetter

• 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

• 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)

Ambetter

• 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)

Ambetter

• 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”

Mitoxantrone (CP.PHAR.258)

Ambetter

• 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)

Ambetter

• 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”
• For Crohn’s disease, added criteria requiring use of one preferred Stelara biosimilar (Otulfi, Pyzchiva (branded), Selarsdi, Yesintek, and Steqeyma are preferred)

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

Ambetter

• 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)

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)

Ambetter

• 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

• 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

• 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

• 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)

Ambetter

Policy updates include:

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

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

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

• 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

• 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

• 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
• For ulcerative colitis, added criteria requiring use of one preferred Stelara biosimilar (Otulfi, Pyzchiva (branded), Selarsdi, Yesintek, and Steqeyma are preferred) or one preferred adalimumab product

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

Ambetter

• 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

• 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)

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

• 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

• 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

Pacritinib (Vonjo) (CP.PHAR.583)

Ambetter

• 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

• Updated the maintenance dosing regimen to include the option for every 4-week dosing after the initial 18 months of therapy
• In the Continued Therapy section, removed the word “baseline” in reference to the required cognitive and functional tests to ensure that Leqembi therapy is not continued in those who have progressed to the moderate stage of disease severity

Capecitabine (Xeloda) (CP.PHAR.60)

Ambetter

• 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

• 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)

Ambetter

• 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)

Ambetter

• 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)

Ambetter

Policy updates include:

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

Topotecan (Hycamtin) (CP.PHAR.64)

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)

Ambetter

 Policy includes:

• Requests for indications not approved by the FDA are reviewed with the off-label use policy HIM.PHAR.154 for Ambetter.
• 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

• 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

• 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

• 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

• 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

• 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

Immune Globulins (CP.PHAR.103)

Ambetter

• For chronic inflammatory demyelinating polyneuropathy (CIDP), revised diagnostic criteria from “atypical CIDP” to “CIPD variants” aligning with 2021 EAN/PNS CIDP guidelines
• Applied redirection language to other diagnoses/indications section
• For Section III, clarified usage for “maintenance or chronic” treatment of secondary immunodeficiencies induced by biologic therapies
• For Arkansas, added reference to state-specific PANS/PANDAS AR.CP.PHAR.103 policy;

Omacetaxine (Synribo) (CP.PHAR.108)

Ambetter

Policy update includes:

• Removed off-label use in T315I mutation as this is no longer supported by National Comprehensive Cancer Network Guidelines (NCCN) Compendium;

Nivolumab, Nivolumab Hyaluronidase-nvhy (Opdivo, Opdivo Qvantig) (CP.PHAR.121)

Ambetter

• For squamous cell carcinoma of the head and neck, added redirection for nasopharyngeal carcinoma to Loqtorzi
• Added Appendix F to include states with regulations against redirections in cancer

Cysteamine oral (Cystagon, Procysbi) (CP.PHAR.155)

Ambetter

Policy update includes:

• Added prescriber requirement for nephrologist or a metabolic disease specialist experienced in management of nephropathic cystinosis (e.g., endocrinologist or urologist)

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

Ambetter

Policy update includes:

• Added requirement for documentation of member’s weight for dose calculation purposes;

Miglustat (Zavesca) (CP.PHAR.164)

Ambetter

Policy update includes:

• Added generic redirection

Pertuzumab (Perjeta) (CP.PHAR.227)

Ambetter

Policy update includes:

• For continued therapy, added criterion for maximum duration for neoadjuvant or adjuvant breast cancer treatment, does not exceed a total of 1 year treatment (up to 18 cycles)

Darbepoetin Alfa (Aranesp) (CP.PHAR.236)

Ambetter

• Extended continuation of therapy approval duration from 6 to 12 months for Medicaid/Ambetter for anemia due to chronic kidney disease
• Removed 300 mg vial from product availability per updated prescribing information
• For all indications, revised Retacrit and Epogen redirection language from “failure of” to “member must use” and revised criteria from “member meets one of the following” to “member must meet both of the following”, clarified members must use Epogen if member is unable to use Retacrit.

Methoxy Polyethylene Glycol-Epoetin Beta (Mircera) (CP.PHAR.238)

Ambetter

• Extended continuation of therapy approval duration from 6 to 12 months for Medicaid/Ambetter
• For all indications, revised Retacrit and Epogen redirection language from “failure of” to “member must use” and revised criteria from “member meets one of the following” to “member must meet both of the following”, clarified members must use Epogen if member is unable to use Retacrit.

Canakinumab (Ilaris) (CP.PHAR.246)

Ambetter

• For systemic juvenile idiopathic arthritis, added redirection to nonsteroidal anti-inflammatory drugs (NSAID) as an option per clinical practice guidelines and competitor analysis
• Updated section III.B with Spevigo and biosimilar verbiage;

Rituximab (Rituxan), Rituximab-arrx (Riabni), Rituximab-pvvr (Ruxience), Rituximab-abbs (Truxima), Rituximab-Hyaluronidase (Rituxan Hycela) (CP.PHAR.260)

Ambetter

• For B-cell lymphomas initial criteria, added extranodal marginal zone (stomach or nongastric sites), histologic transformation of indolent lymphomas to diffuse large B-cell lymphoma, primary mediastinal large B-cell lymphoma and removed low-grade B-cell lymphoma for non-Hodgkin’s lymphoma subtypes per National Comprehensive Cancer Network Guidelines (NCCN) compendium
• For National Comprehensive Cancer Network Guidelines (NCCN) compendium indications, removed “in patients who are CD20 positive” for acute lymphoblastic leukemia per National Comprehensive Cancer Network Guidelines (NCCN) compendium
• For neuromyelitis optica spectrum disorder initial criteria, added Bkemv, Epysqli, and Ultomiris to list of drugs not prescribed concurrently with Rituxan/Riabni/Ruxience/Truxima
• For granulomatosis with polyangiitis (Wegener’s granulomatosis) and microscopic polyangiitis, updated age to allow option for Riabni, Ruxience, Truxima: age at least 18 years
• For continued therapy section, updated approval duration from 6 months to 12 months
• Updated section III.B with Spevigo and biosimilar verbiage;

Rilonacept (Arcalyst) (CP.PHAR.266)

Ambetter

Policy update includes:

• Updated section III.B with Spevigo and biosimilar verbiage;

Ofatumumab (Arzerra, Kesimpta) (CP.PHAR.306)

Ambetter

• For Arzerra, removed Waldenstrom’s macroglobulinemia/lymphoplasmacytic lymphoma criteria as this off-label use is no longer supported by National Comprehensive Cancer Network Guidelines (NCCN) and removed primary therapeutic examples for Appendix B
• For Kesimpta (multiple sclerosis), removed requirements for documentation of baseline relapses/ expanded disability status score and specific measures of positive response per competitor analysis 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
• Updated Appendix C to include Kesimpta’s new hypersensitivity contraindication
• For multiple sclerosis continued therapy, modified Ambetter and Medicaid approval duration from “if member has received < 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”;

Ipilimumab (Yervoy) (CP.PHAR.319)

Ambetter

• Updated Food and Drug Administration (Food and Drug Administration (FDA)) indication for renal cell carcinoma and hepatocellular carcinoma
• For melanoma, clarified combination use with Keytruda is off-label use per National Comprehensive Cancer Network Guidelines (NCCN) and revised adjuvant treatment maximum dosage
• For non-small cell lung cancer (NSCLC) per National Comprehensive Cancer Network Guidelines (NCCN), added criteria for NRG1 gene fusion positive
• Removed criteria for the following mutations: RET rearrangement, epidermal growth factor receptor (EGFR) exon 19 deletion, exon 21 L858R, ALK rearrangement, ROS1 rearrangement
• For ESCC per National Comprehensive Cancer Network Guidelines (NCCN), added off-label indication for prescribed as induction systemic therapy
• For off-label National Comprehensive Cancer Network Guidelines (NCCN) compendium indications, consolidated microsatellite instability-high mut/Mb: mutations/megabase (MSI-H)/mismatch repair deficient (dMMR) cancers, revised biliary tract cancer criteria to allow primary treatment
• In Appendix B, removed entries that are not redirections (Opdivo and Keytruda)
• In Appendix D, added no longer recommended indications
• In Section V, clarified dosing regimen wording

Pembrolizumab (Keytruda) (CP.PHAR.322)

Ambetter

• For head and neck squamous cell carcinoma (HNSCC), added redirection for nasopharyngeal carcinoma to Loqtorzi
• Added Appendix G to include states with regulations against redirections in cancer.

Durvalumab (Imfinzi) (CP.PHAR.339)

Ambetter

• Per National Comprehensive Cancer Network Guidelines (NCCN) – for non-small cell lung cancer (NSCLC), added that Imfinzi must be prescribed as a single agent and that disease does not have epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R mutation if stage II-III
• Added use as first-line therapy for NRG1 gene fusion positive tumors
• Removed use as subsequent therapy for epidermal growth factor receptor (EGFR) exon 19 deletion, exon 21 deletion, exon 21 L858R tumors, ALK1 rearrangement, and ROS1 rearrangement positive tumors
• For hepatocellular carcinoma, added additional qualifier of extrahepatic
• For endometrial cancer, added additional qualifiers of metastatic, stage III, and stage IV
• For cervical cancer, added that Imfinzi can be used as a single agent for maintenance therapy following combination use
• For ampullary adenocarcinoma, removed qualifiers of unresectable localized and stage IV resected
• For biliary tract cancer, added “with curative intent” for recurrent definition to align with National Comprehensive Cancer Network Guidelines (NCCN) compendium wording
• Updated Food and Drug Administration (FDA) approved indication for mismatch repair deficient (dMMR) endometrial cancer to include Food and Drug Administration (FDA) approved testing language;

Edaravone (Radicava, Radivaca ORS) (CP.PHAR.343)

Ambetter

• Added edaravone to the Policy/Criteria applicability section
• Added generic redirection for intravenous Radicava request to initial and continued criteria
• In initial criteria and Appendix D, clarified that “El Escorial” refers to revised El Escorial or Airlie House;

Ceritinib (Zykadia) (CP.PHAR.349)

Ambetter

Policy update includes:

• Removed criteria option for ROS1-positive non-small cell lung cancer (NSCLC) per National Comprehensive Cancer Network Guidelines (NCCN) update;

Lorlatinib (Lorbrena) (CP.PHAR.406)

Ambetter

• Removed Zykadia from list of ROS1-positive non-small cell lung cancer (NSCLC) failure agents per National Comprehensive Cancer Network Guidelines (NCCN) update
• Added pediatric diffuse high-grade glioma to National Comprehensive Cancer Network Guidelines (NCCN)-supported off-label indications;

Dexrazoxane (Totect) (CP.PHAR.418)

Ambetter

• Removed brand Totect from criteria as product has been discontinued and obsolete
• For doxorubicin-induced cardiomyopathy, clarified anthracycline-induced extravasation is an off-label use now that Totect has been discontinued
• Removed Hodgkin lymphoma in adults age greater than 60 years per National Comprehensive Cancer Network Guidelines (NCCN)
• Removed redirections to generic dexrazoxane now that product is only available as generic

Sapropterin Dihydrochloride (Kuvan, Javygtor) (CP.PHAR.43)

Ambetter

• Added requirement for a redirection from Javygtor (branded generic) to unbranded generic sapropterin per an SDC recommendation
• Added a requirement for documentation of member’s current weight for dose calculation purposes

Pegunigalsidase alfa-iwxj (Elfabrio) (CP.PHAR.512)

Ambetter

• Added concomitant use exclusion to the Continued Therapy section to echo the exclusion which currently exists in the Initial Approval Criteria
• Added requirement for documentation of member’s weight for dose calculation purposes;

Odevixibat (Bylvay) (CP.PHAR.528)

Ambetter

• For initial and continued therapy, added exclusion for concurrent use with other ileal bile acid transporter inhibitors
• For exclusion of pathologic variations of the ABCB11 gene that predict complete absence of the BSEP protein, clarified this is specific to progressive familial intrahepatic cholestasis type 2;

Spesolimab-sbzo (Spevigo) (CP.PHAR.606)

Ambetter

Policy update includes:

• Updated section III.B with Spevigo and biosimilar verbiage;

Elacestrant (Orserdu) (CP.PHAR.623)

Ambetter

• In continued therapy, added minimum dose of 172 mg per prescribing information
• In Appendix B, updated therapeutic alternative dosing regimens per Clinical Pharmacology;

Concizumab-tci (Alhemo) (CP.PHAR.625)

Ambetter

• Added Hemlibra redirection for hemophilia A with inhibitors indication
• Moved Appendix D examples of positive response to therapy into continued therapy criteria section;

Pozelimab-bbfg (Veopoz) (CP.PHAR.626)

Ambetter

Policy update includes:

• Added criterion to prevent duplicative therapy with other complement inhibitors;

Sparsentan (Filspari) (CP.PHAR.631)

Ambetter

Policy update includes:

• Added to continuation of therapy requirement that Filspari is not prescribed concurrently with renin-angiotensin-aldosterone system (RAAS) inhibitors, endothelin receptor antagonists (ERAs), or aliskiren;

Vadadustat (Vafseo) (CP.PHAR.677)

Ambetter

• Added requirement that Vafseo is not prescribed concurrently with Jesduvroq
• Extended continuation of therapy approval duration from 6 to 12 months for Medicaid/Ambetter
• Modified to require redirection to both Retacrit and Epogen (if member is unable to use Retacrit).

Sorafenib (Nexavar) (CP.PHAR.69)

Ambetter

• Revised policy/criteria section to also include generic sorafenib
• Revised the following per National Comprehensive Cancer Network Guidelines (NCCN) – for hepatocellular carcinoma, removed requirement for confirmation of Child-Pugh class A or B7 status and added requirement for use as a single agent
• For renal cell carcinoma, removed qualifiers of “relapsed” and “stage IV”
• For differentiated thyroid carcinoma, added coverage for symptomatic disease
• For medullary thyroid carcinoma, specified that disease must be metastatic
• For acute myeloid leukemia, restricted combination use to relapsed/refractory disease and removed allowance for single agent use for induction/consolidation therapy;

Lenalidomide (Revlimid) (CP.PHAR.71)

Ambetter

• Revised policy/criteria section to also include generic lenalidomide
• Per National Comprehensive Cancer Network Guidelines (NCCN) – for multiple myeloma, added use as primary therapy for high-risk smoldering multiple myeloma and symptomatic multiple myeloma
• For myelodysplastic syndrome, clarified recommended uses for no deletion 5q abnormality depending on ring sideroblasts (including addition of trial of Reblozyl or Rytelo for ring sideroblasts at least 15% [or at least 5% if SF3B1 mutation]), added that member has poor probability to respond to immunosuppressive therapy for serum erythropoietin greater than 500 mu/ml, and removed allowance for myelodysplastic syndrome/myeloproliferative overlap neoplasms that are wild-type for SF3B1 mutation
• For marginal zone lymphomas, added use as first-line therapy in combination with rituximab and removed use in combination with Monjuvi
• For follicular lymphoma, added use as first-line in combination with Gazyva, specified use as a single agent or combination therapy for second-line or subsequent therapy, and removed specific requirements surrounding combination use with Monjuvi in non-transplant candidates
• For classic Hodgkin lymphoma, removed requirement for use as fourth-line or later therapy and added use as single agent palliative subsequent therapy
• For adult T-cell leukemia/lymphoma and hepatosplenic gamma-delta T-cell lymphoma, specified use must be as a single agent
• For chronic lymphocytic leukemia/small lymphocytic lymphoma, specified use must be as a single agent or in combination with rituximab and specified prior therapies that must be tried
• For B-cell lymphomas, clarified that Monjuvi can also be used in non-CAR T-cell therapy candidates and added additional pathways for use;

Sunitinib (Sutent) (CP.PHAR.73)

Ambetter

• Revised policy/criteria section to also include generic sunitinib
• Per National Comprehensive Cancer Network Guidelines (NCCN), revised the following – for gastrointestinal stromal tumor, added tumor rupture as an acceptable qualifier
• For pancreatic neuroendocrine tumor, added that tumor must be well-differentiated and removed requirement for use as a single agent
• For off-label indications, added extraskeletal myxoid chondrosarcoma as a covered use and updated myeloid/lymphoid neoplasms to include mixed phenotype
• Modified Medicaid/Ambetter continued approval duration from 6 months to 12 months per standard oncology approach;

Temozolomide (Temodar) (CP.PHAR.77)

Ambetter

Policy update includes:

• For off-label National Comprehensive Cancer Network Guidelines (NCCN) Compendium, added criteria for well-differentiated grade 3 neuroendocrine tumors, added criteria for pediatric medulloblastoma, revised the following off-label indications to align with National Comprehensive Cancer Network Guidelines (NCCN) recommended category 1 or 2A ratings: cutaneous melanoma, pediatric diffuse high-grade gliomas, intracranial and spinal ependymoma, and medulloblastoma;

Thalidomide (Thalomid) (CP.PHAR.78)

Ambetter

• Consolidated criteria for multicentric Castleman’s disease, Kaposi sarcoma, and histiocytic neoplasms into one section of off-label National Comprehensive Cancer Network Guidelines (NCCN) Compendium Indications
• In off-label National Comprehensive Cancer Network Guidelines (NCCN) compendium indications, added criteria for pediatric medulloblastoma per National Comprehensive Cancer Network Guidelines (NCCN) 2A recommendation
• In continued therapy, clarified continuity of care does not apply to erythema nodosum leprosum, aphthous stomatitis, or aphthous ulcers and only applies to oncological indications
• Updated Appendix B per Clinical Pharmacology;

Milnacipran (Savella) (CP.PMN.125)

Ambetter

Policy update includes:

• Added gabapentin redirection option to fibromyalgia criteria;

Overactive Bladder Agents (CP.PMN.198)

Ambetter

• For brand Myrbetriq, added redirection to generic mirabegron;
• Added fesoterodine and solifenacin to list of examples of formulary generic overactive bladder agents

Solriamfetol (Sunosi) (CP.PMN.209)

Ambetter

• For narcolepsy, updated indication in initial approval criteria to Food and Drug Administration (FDA)-approved indication of “Narcolepsy with excessive daytime sleepiness” to align with prescriber information and competitor analysis
• Added criteria for documentation of multiple sleep latency test (MSLT) with mean sleep latency ≤ 8 minutes with evidence of two or more soremps or at least one sleep-onset rapid eye movement period (SOREMP) on MSLT and a SOREMP (less than 15 minutes) on the preceding overnight PSG and daily periods of irrepressible need to sleep or daytime lapses into sleep occurring for at least 3 months to align with other narcolepsy with excessive daytime sleepiness criteria;

Tenapanor (Ibsrela, Xphozah) (CP.PMN.224)

Ambetter

• Removed Commercial and added HIM line of business
• For irritable bowel syndrome with constipation added redirection to Linzess and Trulance (adapted from HIM.PA.174 that will be retired to align Medicaid with the existing Ambetter strategy), applied similar redirections from initial to continuation of therapy requests.

Ulcer Therapy Products (CP.PMN.277)

Ambetter

• For H. Pylori infection, removed required redirection to generic Prevpac for all agents except for Omeclamox-Pak
• For Talicia, added redirection to bismuth quadruple therapy
• For Voquezna and Voquezna Triple/Dual Pak if request is for a clarithromycin-containing regimens, added requirement that H. Pylori is clarithromycin-sensitive
• For Voquezna, added requirement that it is prescribed in combination with amoxicillin or amoxicillin and clarithromycin;

Tirzepatide (Zepbound) (CP.PMN.298)

Ambetter

• Added Rybelsus as option for step therapy
• For documentation of weight loss program, added member has been actively enrolled for at least 6 months and continues to be actively enrolled while concomitantly prescribed Zepbound
• For continued therapy, modified approval duration for first reauthorization as 6 months and subsequent reauthorization as 12 months;

Prucalopride (Motegrity) (HIM.PA.159)

Ambetter

Policy update includes:

• Added redirection to generic prucalopride for initial approval criteria and continued therapy.

Repository Corticotropin Injection (H.P. Acthar Gel, Purified Cortrophin Gel) (HIM.PA.168)

Ambetter

Policy update includes:

• For infantile spasm added requirement for documentation of member’s current body surface area (BSA) in m2;

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

Ambetter

• For ulcerative colitis initial criteria, 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 guidelines
• For Appendix F, added supplemental information on modified Mayo Score
• For Omvoh, added criteria for newly approved indication for Crohn’s disease and added new dosage forms [single-dose prefilled pen 200 mg/2 ml and single-dose syringe 200 mg/2 ml]
• Added newly approved biosimilar Avtozma to criteria
• For Simlandi, added new single-dose autoinjector strength [80 mg/0.8 ml]
• For systemic juvenile idiopathic arthritis, added redirection to nonsteroidal anti-inflammatory drugs (NSAID) as an option per clinical practice guidelines and competitor analysis
• For Crohn’s disease, allowed redirection to preferred agent Rinvoq after tumor necrosis factor (TNF) blocker per Food and Drug Administration (Food and Drug Administration (FDA)) labeling
• For cytokine release syndrome, revised criteria from “member has developed refractory cytokine release syndrome related to blinatumomab therapy” to “used as supportive care in severe cytokine release syndrome related to blinatumomab therapy” and added criteria “used as prophylaxis to reduce the risk of cytokine release syndrome when administering teclistamab-cqyv” per National Comprehensive Cancer Network Guidelines (NCCN) compendium
• For Appendix D, removed supplemental information on Enbrel in hidradenitis suppurativa,
• Updated section III.B with Spevigo and biosimilar verbiage
• For Kawasaki disease, updated dose in section V from 5 mg/kg given over 2 hours to 10 mg/kg given over 2 hours
• For Appendix M, removed supplemental information on COVID-19 therapeutic alternatives;
• For Tyenne, added newly approved cytokine release syndrome and COVID-19 indications to criteria
• for Appendix D, removed psoriatic arthritis and plaque psoriasis supplemental information on Otezla
• for Tremfya, added criteria for newly approved indication for Crohn’s disease
• for Tremfya, added new strength [100 mg/mL] for single-dose prefilled pen (Tremfya Pen)
• for Otulfi, added new dosage formulation [single-dose vial for subcutaneous injection: 45 mg/0.5 mL]
• added Otulfi to “weight < 60 kg: 0.75 mg/kg per dose” pediatric dosing in section V for psoriatic arthritis and plaque psoriasis
• for ulcerative colitis, revised redirection to include adalimumab product in criteria for “three of the following: Stelara, Skyrizi, Tremfya, adalimumab product [Humira/Cyltezo/Yuflyma]”
• For Rinvoq, added newly approved giant cell arteritis indication to criteria.
• Added HCPCS codes [Q5098, Q5099, and Q5100]

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

Ambetter

• 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

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)

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 HIM.PHAR.154 for Ambetter
• 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

Bevacizumab (Alymsys, Avastin, Avzivi, Jobevne, Mvasi, Vegzelma, Zirabev) (CP.PHAR.93)

Ambetter

• Added newly Food and Drug Administration (FDA)-approved biosimilar Jobevne to criteria
• For cervical cancer, added Tecentriq as an option to combination therapy for paclitaxel/cisplatin and paclitaxel/carboplatin, and clarified topotecan is used with paclitaxel per National Comprehensive Cancer Network (NCCN)
• For hepatocellular carcinoma, removed option for use as adjuvant therapy following resection or ablation and member is at high risk for recurrence and added option for use as subsequent-line systemic therapy if progression on or after systemic therapy per National Comprehensive Cancer Network (NCCN)

Belzutifan (Welireg) (CP.PHAR.553)

Ambetter

Policy updates include:

• For renal cell carcinoma, revised indication and criteria to specify clear cell histology per updated Food and Drug Administration (FDA) labeling and National Comprehensive Cancer Network (NCCN), and added bypass of prior PD-1 or PD-L1 inhibitor therapy per National Comprehensive Cancer Network (NCCN)

Nedosiran (Rivfloza) (CP.PHAR.619)

Ambetter

Policy updates include:

• Revised age and dosing criteria for updated pediatric extension to include children aged at least 2 years and added requirement that request must be for a prefilled syringe unless the monthly dose is less than 128 mg

Non-Calcium Phosphate Binders (CP.PMN.04)

Ambetter

• For brand Auryxia requests added redirection to generic
• added references to generic product names for Auryxia, Fosrenol, Renagel, Renvela.

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

Ambetter

Policy updates include:

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

Ramucirumab (Cyramza) (CP.PHAR.119)

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)

Ambetter

Policy updates include:

• Updated to include new Vyvgart Hytrulo prefilled syringe formulation

Furosemide (Furoscix) (CP.PHAR.608)

Ambetter

• 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)

Ambetter

• 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)

Ambetter

Policy updates include:

• Added new dosage strength of 300 mg

Continuous Glucose Monitors (CP.PMN.214)

Ambetter

Policy updates include:

• Added Coding Implications section

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

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