Sildenafil for ED (Viagra) (CP.PCH.07)

Ambetter

Policy updates include:

• Added Vybrique to criteria

Bupropion/Naltrexone (Contrave) (CP.PCH.12)

Ambetter

Policy updates include:

• Replaced by CP.CPA.366 Bupropion/Naltrexone (Contrave) by removing Ambetter line of business due to formulary status change

Phentermine (Adipex-P, Lomaira) (CP.PCH.13)

Ambetter

Policy updates include:

• For continued therapy, clarified positive response as evidenced by weight loss for adults and added reduction of body mass index for pediatrics

Deutetrabenazine (Austedo, Austedo XR) (CP.PCH.42)

Ambetter

• Added Ingrezza Sprinkle to the concurrent use exclusion
• Revised initial approval durations from 6 to 12 months for Ambetter

Phendimetrazine (CP.PCH.47)

Ambetter

Policy updates include:

• For continued therapy, clarified positive response as evidenced by weight loss for adults and added reduction of body mass index for pediatrics

Regorafenib (Stivarga) (CP.PHAR.107)

Ambetter

• Per National Comprehensive Cancer Network (NCCN), revised the following – for colorectal cancer, specified that polymerase epsilon/delta (POLE/POLD1) mutation should have ultra-hypermutated phenotype
• For appendiceal carcinoma, moved out of colorectal cancer criteria to its own criteria set to reflect additional disease-specific recommendations for use
• For gastrointestinal stromal tumor, allowed resectable disease if succinate dehydrogenase (SDH)-deficient, and for combination therapy with Stivarga+everolimus, added disease qualifiers, requirement that disease is imatinib-sensitive KIT or PDGFRA mutant, and requirement for prior use of Stivarga as a single agent
• For soft tissue sarcoma, added borderline/malignant phyllodes tumor of the breast, epithelioid hemangioendothelioma, and pediatric rhabdomyosarcoma
• For uterine sarcoma, corrected “pegoma” to “pecoma”
• Removed off-label criteria for central nervous system cancers
• For all indications for Medicaid and Ambetter, extended initial approval duration from 6 to 12 months

Pomalidomide (Pomalyst) (CP.PHAR.116)

Ambetter

• For Kaposi sarcoma, added option for off-label use in Kaposi sarcoma-associated herpesviru -associated inflammatory cytokine syndrome if prescribed in combination with rituximab per National Comprehensive Cancer Network (NCCN)
• For all indication, extended Medicaid and Ambetter initial approval duration from 6 months to 12 months for this maintenance medication for chronic conditions

Encorafenib (Braftovi) (CP.PHAR.127)

Ambetter

• For melanoma, added option for use in stage III melanoma as neoadjuvant therapy
• For colon and rectal cancer, simplified to combination use with or without chemotherapy (capecitabine- or fluorouracil-based) per National Comprehensive Cancer Network (NCCN)
• Updated Food and Drug Administration (FDA) Approved Indication(s) section for mcrc from accelerated approval to full approval
• Added off-label criteria for small bowel adenocarcinoma and appendiceal neoplasms and cancer per National Comprehensive Cancer Network (NCCN) compendium
• For all indications, extended Medicaid and Ambetter initial approval duration from 6 months to 12 months for this maintenance medication for a chronic condition

Imiglucerase (Cerezyme) (CP.PHAR.154)

Ambetter

• Removed the age restriction for at least 2 years old based on the age group included in the analysis of the International Collaborative Gaucher Group Gaucher Registry which led to the Food and Drug Administration (FDA) approval of Cerezyme for type 3 Gaucher disease but which also included patients with type 1 Gaucher disease
• Updated initial approval duration from 6 months to 12 months
• Updated the Food and Drug Administration (FDA) Approved Indications section to reflect the recently Food and Drug Administration (FDA)-approved status of the type 3 Gaucher disease indication.

Pertuzumab (Perjeta), Pertuzumab-dpzb (Poherdy) (CP.PHAR.227)

Ambetter

• For breast cancer, added option to be prescribed in combination with Enhertu and added option for use of aromatase inhibitor with trastuzumab for postmenopausal or premenopausal receiving ovarian ablation or suppression
• Added off-label indication for brain metastases in breast cancer
• Small bowel adenocarcinoma, appendiceal neoplasms and cancers per National Comprehensive Cancer Network (NCCN)
• For all indications for Medicaid and Ambetter, extended initial approval duration from 6 to 12 months

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

Ambetter

• For gastric, esophageal and esophagogastric junction cancer, added option for use in members who are not surgical candidates per National Comprehensive Cancer Network (NCCN)
• For endometrial carcinoma, added option for carcinosarcoma histology
• Added off-label indication for brain metastasis due to breast cancer
• Appendiceal neoplasms
• And small bowel adenocarcinoma per National Comprehensive Cancer Network (NCCN)
• For all indications for Medicaid and Ambetter, extended initial approval duration from 6 to 12 months

OnabotulinumtoxinA (Botox) (CP.PHAR.232)

Ambetter

Policy updates include:

• For chronic migraine, simplified criteria for concurrent use with calcitonin gene-related peptide (CGRP) to member has had a reduction in the overall migraine headache days per month with calcitonin gene-related peptide (CGRP) monotherapy and provider attestation of a significant number of migraine headache days despite calcitonin gene-related peptide (CGRP) monotherapy.

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), removed “as subsequent treatment” from ampullary adenocarcinoma to allow first-line treatment and clarified requirement that disease is not amenable to radioactive iodine therapy for follicular and papillary thyroid carcinoma only
• For off-label National Comprehensive Cancer Network (NCCN) compendium indications, added pediatric Langerhans cells histiocytosis and pediatric Langerhans cells histiocytosis-associated abnormal central nervous system imaging/neurodegeneration
• For all indications, extended Medicaid and Ambetter initial approval duration from 6 months to 12 months for this maintenance medication for a chronic condition

Trametinib (Mekinist) (CP.PHAR.240)

Ambetter

• For B-Raf proto-oncogene, serine/ threonine kinase (BRAF) V600E mutation-positive solid tumor per National Comprehensive Cancer Network (NCCN), removed “as subsequent treatment” from ampullary adenocarcinoma to allow first-line treatment, clarified small bowel adenocarcinoma is advanced or metastatic, added option for use as a single agent in adult circumscribed glioma, clarified requirement that disease is not amenable to radioactive therapy for follicular and papillary thyroid carcinoma only
• For off-label National Comprehensive Cancer Network (NCCN) compendium indications, added criteria for pediatric Langerhans cells histiocytosis and pediatric Langerhans cells histiocytosis-associated abnormal central nervous system imaging/neurodegeneration, added criteria for epithelioid hemangioendothelioma
• Extended Medicaid and Ambetter initial approval duration from 6 months to 12 months for this maintenance medication for a chronic condition

Vismodegib (Erivedge) (CP.PHAR.273)

Ambetter

• Clarified metastatic basal cell carcinoma does not require additional requirement of disease recurrence following surgery/radiation or that member is not a candidate for surgery or radiation
• Extended Medicaid and Ambetter initial approval duration from 6 months to 12 months for this maintenance medication for a chronic condition

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

Ambetter

• For chronic lymphocytic leukemia, clarified that maximum dose also applies to duration as noted in section V
• For Medicaid and Ambetter, extended initial approval durations from 6 to 12 months for this maintenance medication for a chronic condition

Ipilimumab (Yervoy) (CP.PHAR.319)

Ambetter

• For melanoma, non-small cell lung cancer, malignant pleural mesothelioma, esophageal squamous cell carcinoma, and off-label National Comprehensive Cancer Network (NCCN) compendium indications, extended Medicaid and Ambetter initial approval durations from 6 months to 12 months for this maintenance medication for a chronic condition, extended Commercial initial approval duration is “6 months or to the member’s renewal data, whichever is longer”
• For non-small cell lung cancer, malignant pleural mesothelioma, and esophageal squamous cell carcinoma continued therapy, added criterion for maximum duration of therapy limit of 2 years and extended Commercial approval duration is “6 months or to the member’s renewal data, whichever is longer”
• For esophageal squamous cell carcinoma, added option to be prescribed as induction therapy
• For off-label National Comprehensive Cancer Network (NCCN) compendium indications, removed use as a single agent for soft tissue sarcoma, added off-label indications for appendiceal neoplasms and cancers, small bowel adenocarcinoma with polymerase epsilon/delta (POLE/POLD) mutation, cervical cancer, neuroendocrine and adrenal tumors, uterine neoplasms, vaginal cancer, and vulvar cancer, extended Commercial continued therapy approval duration is “6 months or to the member’s renewal data, whichever is longer”

Nusinersen (Spinraza) (CP.PHAR.327)

Ambetter

• Clarified “at least” 6 months of trial prior to treatment change
• Added Itvisma, a newly approved one-time intrathecal version of Zolgensma, as another example for no concurrent use
• added Hammersmith functional motor scale expanded (HFMSE) as an alternative option for demonstrating prior treatment response

Durvalumab (Imfinzi) (CP.PHAR.339)

Ambetter

• Per National Comprehensive Cancer Network (NCCN), revised the following – for non-small cell lung cancer, added option for use after completion of adjuvant chemoradiation
• For small cell lung, added option for use in combination with etoposide and carboplatin or cisplatin as subsequent treatment for progression or relapse if member had prolonged disease free time
• For biliary tract cancer, added option for use in combination with carboplatin if cisplatin ineligible
• For hepatocellular carcinoma, added option for use as subsequent-line therapy and added requirement for use as a single agent or in combination with Imjudo
• For endometrial cancer, added option for use in mismatch repair proficient (pMMR) disease in combination with Lynparza
• For gastric or gastroesophageal junction adenocarcinoma, removed requirement for programmed death-ligand (PD-L1) combined positive score or tumor area positivity
• Added off-label criteria for small bowel adenocarcinoma

Midostaurin (Rydapt) (CP.PHAR.344)

Ambetter

• For systemic mastocytosis, added off-label use in well-differentiated systemic mastocytosis per National Comprehensive Cancer Network (NCCN)
• For Medicaid and Ambetter, extended initial approval durations from 6 to 12 months

Alectinib (Alecensa) (CP.PHAR.369)

Ambetter

• For resected non-small cell lung cancer, revised cancer staging to include IB per National Comprehensive Cancer Network (NCCN) and removed corresponding tumor and lymph node staging
• For anaplastic large cell lymphoma, added option for subsequent therapy for progressive disease per National Comprehensive Cancer Network (NCCN)
• Revised initial and continued approval durations for Medicaid/Ambetter to 12 months

Cobimetinib (Cotellic) (CP.PHAR.380)

Ambetter

• For histiocytic neoplasms, added option for use in disease that is positive for mitogen-activated protein (MAP) kinase pathway mutation, has no detectable mutation, or testing is not available
• Extended Medicaid and Ambetter initial approval duration from 6 months to 12 months for this maintenance medication for a chronic condition

Lorlatinib (Lorbrena) (CP.PHAR.406)

Ambetter

• For ROS1 positive non-small cell lung cancer, added Ibtrozi as a failure option and clarified that failure is required for one of the listed agents with the addition of “or” per National Comprehensive Cancer Network (NCCN)
• Added maximum dose option of 125 mg per day if receiving a moderate CYP3A4 inducer and removed tablet quantity limit to accommodate dose adjustments
• For anaplastic large cell lymphoma, added clarification that Lorbrena is subsequent therapy for relapsed, or refractory, or progressive disease and added palliative treatment as an option per National Comprehensive Cancer Network (NCCN)
• Revised initial approval durations for Medicaid/Ambetter to 12 months

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

Ambetter

• Moved examples of positive response to therapy from Appendix D into Continued Therapy criteria section
• Revised initial approval duration for Medicaid/Ambetter to 12 months

Cladribine (Mavenclad) (CP.PHAR.422)

Ambetter

• Incorporated existing treatment course limitations from approval duration into criteria
• Added primary progressive multiple sclerosis to section III to align with other multiple sclerosis agents
• References reviewed and updated

Nadofaragene firadenovec-vncg (Adstiladrin) (CP.PHAR.461)

Ambetter

Policy updates include:

• Removed lifetime dose requirement, clarified frequency does not exceed every 3 months, removed specification of “a single dose.”

Sacituzumab Govitecan-hziy (Trodelvy) (CP.PHAR.475)

Ambetter

• For triple-negative breast cancer, added option to be prescribed as first-line therapy per National Comprehensive Cancer Network (NCCN)
• For all indications for Medicaid and Ambetter, extended initial approval duration from 6 to 12 months

Risdiplam (Evrysdi) (CP.PHAR.477)

Ambetter

• Clarified “at least” 6 months of trial prior to treatment change per 2025 American Academy of Neurology (AAN) spinal muscular atrophy update
• Added Itvisma, a newly approved one-time intrathecal version of Zolgensma, as another example for no concurrent use
• Added Hammersmith functional motor scale expanded (HFMSE) as an alternative option for demonstrating prior treatment response2q 2026 annual review:

Selpercatinib (Retevmo) (CP.PHAR.478)

Ambetter

• Added tablet/capsule quantity limit bypass for documentation supporting inability to swallow oral capsules/tablets
• Revised initial approval durations for Medicaid/Ambetter to 12 months

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

Ambetter

• Extended Medicaid and Ambetter initial approval duration from 6 months to 12 months for this maintenance medication for a chronic condition
• Extended Commercial approval duration from 6 months to “6 months or to the member’s renewal date, whichever is longer”
• Added off-label indication for primary therapy in combination with lenalidomide and dexamethasone per National Comprehensive Cancer Network (NCCN)

Binimetinib (Mektovi) (CP.PHAR.50)

Ambetter

• For histiocytic neoplasms, removed age requirement to allow use in pediatric population per National Comprehensive Cancer Network (NCCN)
• For all indications, extended Medicaid and Ambetter initial approval duration from 6 months to 12 months for this maintenance medication for a chronic condition

Insulin Delivery Systems (V-Go, Omnipod, InPen) (CP.PHAR.534)

Ambetter

• Revised insulin administration method criterion to require duration only for multiple daily insulin injections
• For V-Go and Omnipod Pods, revised initial approval duration for Medicaid and Ambetter from 6 to 12 months
• Added exception to prescriber requirement for Oregon requests per health plan request due to endocrinologist shortage
• Reduced duration requirement for insulin administration method for multiple daily insulin injections from 6 months to 3 months, reduced duration requirement for blood glucose monitoring from 6 months to 2 months.

Tivozanib (Fotivda) (CP.PHAR.538)

Ambetter

• Revised “at least 2 prior systemic therapies” to “prior systemic therapy” per National Comprehensive Cancer Network (NCCN)
• For Medicaid and Ambetter, extended initial approval duration from 6 to 12 months

Beremagene Geperpavec (Vyjuvek) (CP.PHAR.592)

Ambetter

Policy updates include:

• For initial approval criteria and continued therapy, added “on the same target wound” to clarify Vyjuvek is not used concurrently on the same wound as Filsuvez and Zevaskyn.

Donanemab-azbt (Kisunla) (CP.PHAR.594)

Ambetter

• Removed the requirement for follow-up magnetic resonance imaging in the Continued Therapy section
• Added Leqembi Iqlik as a recently Food and Drug Administration (FDA)-approved alternative formulation of Leqembi that should not be used concomitantly with Kisunla
• Extended initial and continued approval durations to 6 and 12 months, respectively for Medicaid/Ambetter, with 6 months or renewal date for Commercial reauthorizations.

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

Ambetter

• Removed the requirement for follow-up magnetic resonance imaging in the Continued Therapy section
• Added Leqembi Iqlik as a recently Food and Drug Administration (FDA)-approved alternative formulation of Leqembi that should not be used concomitantly with Kisunla
• Extended initial and continued approval durations to 6 and 12 months, respectively for Medicaid/Ambetter, with 6 months or renewal date for Commercial reauthorizations.

Prademagene Zamikeracel (Zevaskyn) (CP.PHAR.609)

Ambetter

Policy updates include:

• Added criteria “on the same target wound” to clarify Zevaskyn is not used concurrently on the same wound as Vyjuvek and Filsuvez.

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

Ambetter

• Removed requirements for documentation and provider attestations of Concizumab ELISA
• For hemophilia A or B without inhibitors, added clarification that hemophilia severity associated with factor level is taken at baseline prior to use of factor products for routine prophylaxis
• Modified initial approval durations for Medicaid/Ambetter to 12 months and for Commercial to “6 months or to the member’s renewal date, whichever is longer” as this is a maintenance medication for a chronic condition

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

Ambetter

• Added off-label criteria for appendiceal neoplasms and cancers per National Comprehensive Cancer Network (NCCN)
• Simplified National Comprehensive Cancer Network (NCCN) off-label uses under section “National Comprehensive Cancer Network (NCCN) Recommended Uses (off-label)”

Sparsentan (Filspari) (CP.PHAR.631)

Ambetter

Policy updates include:

• Revised criterion for proteinuria at least 0.5 g/day per updated Kidney Disease: Improving Global Outcomes (KDIGO) 2025 guidance

Topotecan (Hycamtin) (CP.PHAR.64)

Ambetter

• For all indications, extended Medicaid and Ambetter initial approval duration from 6 months to 12 months for this maintenance medication for a chronic condition
• For off-label National Comprehensive Cancer Network (NCCN) recommendations, revised neuroblastoma to include non-induction therapy

Aprocitentan (Tryvio) (CP.PHAR.676)

Ambetter

• For initial approval criteria, revised BP threshold from at least 140/90 mmHg to at least 130/80 mmHg per 2025 American College of Cardiology/American Heart Association (ACC/AHA) guideline, added pathway for use in BP less than 130/80 mmHg if adherent to and prescribed concurrently with four or more antihypertensive drug classes
• Extended initial approval duration from 6 months to 12 months for this maintenance medication for a chronic condition

Lenalidomide (Revlimid) (CP.PHAR.71)

Ambetter

• Revised the following per National Comprehensive Cancer Network (NCCN) – for multiple myeloma, added options for use for treatment of monoclonal immunoglobulin
• deposition disease, monoclonal gammopathy of renal, and central nervous system system disease, and simplified use for treatment of polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, skin change (POEMS)
• For marginal zone lymphomas, added option for use for extranodal marginal zone lymphomas
• For follicular lymphoma, added option for use in combination with rituximab and Epkinly
• For off-label uses, added option for use for primary vitreoretinal lymphoma/primary central nervous system
• Lymphoma ocular variant, Rosai-Dorfman disease, Karposi Sarcoma (KS)-associated herpes virus associated inflammatory cytokine syndrome, and mycosis fungoides/Sezary syndrome
• For all indications for Medicaid and Ambetter, extended initial approval duration from 6 to 12 months

Copper Histidinate (Zycubo) (CP.PHAR.714)

Ambetter

• Drug is now Food and Drug Administration (FDA)-approved – criteria updated per Food and Drug Administration (FDA) labeling
• Added upper age limit of 17 years
• Added requirement for documentation of baseline (within the last 30 days) serum copper and ceruloplasmin levels
• Added requirement that member does not have occipital horn syndrome
• For continued therapy positive response, added serum levels or neurologic symptom parameters.

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

Ambetter

• Added criteria for triple-negative breast per National Comprehensive Cancer Network (NCCN)
• For all indications for Medicaid and Ambetter, extended initial approval duration from 6 to 12 months

Dasatinib (Sprycel, Phyrago) (CP.PHAR.72)

Ambetter

• Added National Comprehensive Cancer Network (NCCN) compendium supported use in Grade 4 cytokine release syndromethat is refractory to high-dose corticosteroids and anti-IL-6 therapy
• Generic dasatinib is now available, so clarified generic redirection by removing ‘if available’
• For Medicaid/Ambetter revised initial approval duration from 6 to 12 months

Atrasentan (Vanrafia) (CP.PHAR.727)

Ambetter

• Revised proteinuria criterion from 1 g/day to 0.5 g/day per updated 2025 Kidney Disease: Improving Global Outcomes (KDIGO) guidelines
• Extended initial approval duration from 6 to 12 months for this maintenance medication for a chronic condition

Erlotinib (Tarceva) (CP.PHAR.74)

Ambetter

• For kidney cancer, removed single-agent therapy option per National Comprehensive Cancer Network (NCCN)
• Revised initial approval durations for Medicaid/Ambetter to 12 months

Temozolomide (Temodar) (CP.PHAR.77)

Ambetter

• For off-label National Comprehensive Cancer Network (NCCN) Compendium, added criteria for metastatic Ewing sarcoma, neuroblastoma in combination with irinotecan, naxitamab-gqgk, and sargramostim, borderline/malignant phyllodes tumor of the breast, epithelioid hemangioendothelioma, mucosal melanoma, adult high-grade glioma, and leptomeningeal metastases
• For all indications, extended initial approval duration from 6 months to 12 months for this maintenance medication for a chronic condition

Dalnacogene Ponparvovec (BBM-H901) (CP.PHAR.771)

Ambetter

Policy includes:

• Criteria will mirror the clinical information from the prescribing information once FDA-approved
• Requests for indications not approved by the FDA are reviewed with the off-label use policy for the relevant line of business: HIM.PHAR.154 for Ambetter
• Initial Approval Criteria*
  *Criteria will mirror the clinical information from the prescribing information once FDA-approved
  • Congenital hemophilia B (must meet all):
    • Diagnosis of congenital hemophilia B (factor IX deficiency);*
    • Prescribed by or in consultation with a hematologist;
    • Age at least 18 years;*
    • Member has severe or moderately severe hemophilia (defined as a factor IX level of at most 2%);*
    • Member meets one of the following:
      • Adherence to current use of a factor IX product* (e.g., Alprolix®, Benefix®, Idelvion®, Ixinity®, Rebinyn®, Rixubis®) for routine prophylaxis as assessed and documented by prescriber;
      • Has current or historical life-threatening hemorrhage;
      • Has repeated, serious spontaneous bleeding episodes;
    • Member has been treated with factor IX product for a minimum of 100 exposure days;*
    • Member meets all of the following:*
      • No previous documented history of a detectable factor IX inhibitor;
      • Documentation of inhibitor level assay less than 0.6 Bethesda units (BU) within the last 12 months;
      • If member had an initial positive test result for factor IX inhibitor, member has documentation of a subsequent negative test within 2 weeks;
    • Member has had all of the following baseline liver assessments within the last 3 months:*
      • Documentation of liver enzymes at most 1.5x the upper limit of normal (i.e., alanine aminotransferase [ALT], aspartate aminotransferase [AST], alkaline phosphatase [ALP], and total bilirubin);
      • Documentation of normal hepatic ultrasound and elastography;
      • If member has evidence of radiological liver abnormalities and/or sustained liver enzyme elevations, attestation from hepatologist that member is eligible for BBM-H901;
    • Member does not have a history of allergic reactions to immunoglobulin administration;*
    • Member has not received prior gene therapy;
    • Member has been tested for neutralizing anti-adeno-associated virus serotype 843 (AAV843) antibodies and is deemed a suitable candidate for treatment;*
    • Documentation of member’s body weight in kg;
    • Dose does not exceed a single IV infusion of 5 x 1012 vector genomes (vg) per kg.*
  • Approval duration: 3 months (1 dose only)
• Continued Therapy
  • Congenital Hemophilia B
    • Continued therapy will not be authorized as BBM-H901 is indicated to be dosed one time only

Doruxapapogene Ralaplasmid (INO-3107) (CP.PHAR.772)

Ambetter

Policy includes:

• Criteria will mirror the clinical information from the prescribing information once FDA-approved
• Requests for indications not approved by the FDA are reviewed with the off-label use policy for the relevant line of business: HIM.PHAR.154 for Ambetter
• Initial Approval Criteria*
  *Criteria will mirror the clinical information from the prescribing information once FDA-approved
  • Respiratory Papillomatosis (must meet all):
    • Diagnosis of RRP;
    • Diagnosis is confirmed by tissue biopsy;
    • Prescribed by or in consultation with an otolaryngologist or pulmonologist;
    • Age at least 18 years;
    • In the previous 12 months, member has had at least 2 interventions (surgical resection or laser ablation) aimed at reducing voice and airway symptoms caused by the papilloma;
    • If age at most 45 years, member has previously completed the HPV vaccination series, unless contraindicated or clinically significant adverse effects are experienced;
    • Prior to initiation of INO-3107 treatment, member is scheduled to undergo an endoscopic surgical debulking procedure to remove laryngotracheal papilloma;
    • Member has not previously received treatment with INO-3107 or Papzimeos™;
    • INO-3107 is not prescribed concurrently with Papzimeos;
    • Dose does not exceed four total doses of 6.25 mg.
  • Approval duration: 6 months
• Continued Therapy*
  *Criteria will mirror the clinical information from the prescribing information once FDA-approved
  • Respiratory Papillomatosis
    • Continued therapy will not be authorized as INO-3107 is indicated to be dosed as a single treatment course (four doses lifetime) only.
  • Approval duration: Not applicable

Veligrotug (VRDN-001) (CP.PHAR.773)

Ambetter

Policy includes:

• Criteria will mirror the clinical information from the prescribing information once FDA-approved
• Requests for indications not approved by the FDA are reviewed with the off-label use policy for the relevant line of business: HIM.PHAR.154 for Ambetter
• Initial Approval Criteria*
  *Criteria will mirror the clinical information from the prescribing information once FDA-approved
  • Thyroid Eye Disease (must meet all):
    • Diagnosis of Graves’ disease with associated TED (i.e., Graves’ ophthalmopathy, Graves’ orbitopathy);
    • Prescribed by or in consultation with an ophthalmologist;
    • One of the following:
      • Member is euthyroid with documentation of a recent (within the last 30 days) free thyroxine (FT4) and total triiodothyronine (T3) or free T3 (FT3) levels within the laboratory defined reference range;
      • Member has a recent (within the last 30 days) free thyroxine (FT4) and total triiodothyronine (T3) or free T3 (FT3) levels less than 50% above or below the laboratory defined reference range and is undergoing treatment to correct the mild hypo- or hyperthyroidism to maintain a euthyroid state;
    • Member has not had previous surgical intervention for TED;
    • Member does not require surgical ophthalmological intervention;
    • Failure of a 4-week trial of a systemic corticosteroid (at up to maximally indicated doses), unless one of the following:*
      • Clinically significant adverse effects are experienced or all are contraindicated;
      • Member has significant proptosis (examples may include but are not limited to proptosis at least 3 mm above the upper limit for race and sex, or proptosis that impacts activities of daily life [e.g., reading, driving, computer work, and watching television]);
      • Member has diplopia;
    • VRDN-001 is not prescribed concurrently with Tepezza™;
    • Member has not received at least 5 VRDN-001 infusions;
    • Dose does not exceed a total of five 600 mg infusions given every 3 weeks.
  • Approval duration: 6 months (up to 5 total lifetime infusions)
• Continued Therapy*
  *Criteria will mirror the clinical information from the prescribing information once FDA-approved
  • Thyroid Eye Disease (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 has not had previous surgical intervention for TED;
    • Member does not require surgical ophthalmological intervention;
    • VRDN-001 is not prescribed concurrently with Tepezza™;
    • Member has not received at least 5 VRDN-001 infusions;
    • If request is for a dose increase, new dose does not exceed five 600 mg infusions given every 3 weeks.
  • Approval duration: 1 month (up to 5 total lifetime infusions)

Vusolimogene Oderparepvec (RP1) (CP.PHAR.774)

Ambetter

Policy includes:

• Criteria will mirror the clinical information from the prescribing information once FDA-approved
• Requests for indications not approved by the FDA are reviewed with the off-label use policy for the relevant line of business: HIM.PHAR.154 for Ambetter
• Initial Approval Criteria*
  *Criteria will mirror the clinical information from the prescribing information once FDA-approved
  • Cutaneous Melanoma (must meet all):
    • Diagnosis of unresectable Stage IIIb-IV cutaneous melanoma;*
    • Prescribed by or in consultation with an oncologist;
    • Age at least 18 years;*
    • Documentation of disease progression, inadequate response, or intolerance while on a regimen containing both of the following:*
      • Anti-PD-1 therapy;
      • Anti-CTLA-4 therapy, unless member is not a candidate for anti-CTLA-4 therapy;
    • RP1 is prescribed in combination with nivolumab*;
    • Documentation that member has at least one measurable and injectable lesion comprising at least 1 cm in the longest diameter;*
    • Member has not been previously treated with Imlygic®;*
    • Request meets one of the following:*
      • Dose does not exceed both of the following:*
        • Initial dose of 1 x 106  plaque-forming unit (PFU) per mL followed by 1 x 107 PFU per mL every 2 weeks for a maximum of 8 cycles;
        • Each dose at most 10 mL;
      • 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*
  *Criteria will mirror the clinical information from the prescribing information once FDA-approved
  • Cutaneous Melanoma (must meet all):
    • Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving RP1 for a covered indication and has received this medication for at least 30 days;
    • Member is responding positively to therapy;
    • Maximum duration of therapy does not exceed 8 cycles;
    • Request meets one of the following:*
      • New dose does not exceed both of the following:*
        • 1 x 107 PFU per mL every 2 weeks for a maximum of 8 cycles;
        • Each dose at most 10 mL;
      • 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

Sibeprenlimab-szsi (Voyxact) (CP.PHAR.775)

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 0.75 g/g;
    • Estimated glomerular filtration rate (eGFR) at least 30 mL/min/1.73 m2 ;
  • Member meets both of the following, unless contraindicated or clinically significant adverse effects are experienced:*
    • Failure of a renin-angiotensin-aldosterone system (RAAS) inhibitor (e.g., irbesartan, losartan, lisinopril, benazepril) for at least 12 weeks;
    • RAAS inhibitor therapy dose was at least 50% of maximum labeled dose;
  • Failure of a sodium-glucose cotransporter-2 (SGLT2) inhibitor (e.g., empagliflozin, dapagliflozin) at up to maximally indicated doses, unless clinically significant adverse effects are experienced or all are contraindicated;*
  • Failure of Filspari® or Vanrafia™ at up to maximally indicated doses, unless clinically significant adverse effects are experienced or both are contraindicated;*
  • Dose does not exceed both of the following:
    • 400 mg every 4 weeks;
    • 1 prefilled syringe per 4 weeks.
• 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 evidence by a lower total urine protein per day from baseline;
    • If request is for a dose increase, new dose does not exceed both of the following:
      • 400 mg every 4 weeks;
      • 1 prefilled syringe per 4 weeks.
  • Approval duration: 12 months

Gefurulimab (ALXN1720) (CP.PHAR.776)

Ambetter

Policy includes:

• Criteria will mirror the clinical information from the prescribing information once FDA-approved
• Requests for indications not approved by the FDA are reviewed with the off-label use policy for the relevant line of business: HIM.PHAR.154 for Ambetter
• Initial Approval Criteria*
  *Criteria will mirror the clinical information from the prescribing information once FDA-approved
  • Generalized Myasthenia Gravis (gMG) (must meet all):
    • Diagnosis of gMG;*
    • Prescribed by or in consultation with a neurologist;
    • Age at least 18 years;
    • Myasthenia Gravis-Activities of Daily Living (MG-ADL) score at least 5 at baseline;*
    • Myasthenia Gravis Foundation of America (MGFA) clinical classification of Class II to IV;*
    • Member has positive serologic test for anti-AChR antibodies;*
    • Failure of a corticosteroid, unless contraindicated or clinically significant adverse effects are experienced;*
    • Failure of a cholinesterase inhibitor, unless contraindicated or clinically significant adverse effects are experienced;*
    • Failure of at least one non-steroidal immunosuppressive therapy, unless clinically significant adverse effects are experienced or all are contraindicated;*
    • ALXN1720 is not prescribed concurrently with Imaavy™, Soliris®/Bkemv™/ Epysqli®, Ultomiris®, Rystiggo®, Vyvgart®, Vyvgart® Hytrulo, or Zilbrysq®;
    • Documentation of member’s current weight in kg;*
    • Dose does not exceed the FDA approved maximum.*
  • Approval duration: Medicaid/HIM – 12 months
• Continued Therapy*
  *Criteria will mirror the clinical information from the prescribing information once FDA-approved
  • Generalized Myasthenia Gravis (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 a at least 2-point reduction from baseline in the MG-ADL total score;*
    • ALXN1720 is not prescribed concurrently with Imaavy, Soliris/Bkemv/Epysqli, Ultomiris, Rystiggo, Vyvgart, Vyvgart Hytrulo, or Zilbrysq;
    • Documentation of member’s current weight in kg;*
    • If request is for a dose increase, new dose does not exceed the FDA approved maximum.*
  • Approval duration: 12 months

Pitolisant (Wakix) (CP.PMN.221)

Ambetter

Policy updates include:

• For narcolepsy with cataplexy, revised age and dosing to allow use in patients 6 years of age and older per updated prescribing information

Budesonide (Eohilia, Uceris) (CP.PMN.294)

Ambetter

Policy updates include:

• For eosinophilic esophagitis, revised quantity limit from 20 ml to 2 packets to better reflect product availability and incorporated existing approval duration into criteria by adding requirement that requested duration of treatment does not exceed 12 weeks

Tirzepatide (Zepbound) (CP.PMN.298)

Ambetter

• Revised language for members with concurrent type 2 diabetes mellitus language from "failure" to "member has received optimal diabetic standard of care therapy as evidenced by a trial" to align with drug class
• Modified preferred liraglutide product to state ‘liraglutide (generic Victoza);’ for obstructive sleep apnea continued therapy, clarified “physician directed” weight loss program
• Added new multi-dose vial dosage form and new kwikpen dosage form

Suzetrigine (Journavx) (CP.PMN.301)

Ambetter

Policy updates include:

• Updated Food and Drug Administration (FDA) approved indication to include postoperative pain

Tradipitant (Nereus) (CP.PMN.307)

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
  • Motion Sickness Prevention (must meet all):
    • Prescribed for the prevention of motion-induced vomiting;
    • Age at least 18 years;
    • Member has a planned event expected to cause vomiting induced by motion;
    • Failure of transdermal scopolamine, unless contraindicated or clinically significant adverse effects are experienced;*
    • Failure of at least 2 antihistamines used for motion sickness (e.g., dimenhydrinate, meclizine, promethazine), unless clinically significant adverse effects are experienced or all are contraindicated;*
    • Request is for at most 7 days supply, unless medical justification is provided;
    • Request is for at most 90 doses per 365-day period, unless medical justification is provided;
    • Dose does not exceed 170 mg (2 capsules) per 24-hour period.
  • Approval duration: 7 days
• Continued Therapy
  • Motion Sickness Prevention
    • Re-authorization is not permitted. Members must meet the initial approval criteria.
  • Approval duration: Not applicable

Immune Globulins (HIM.PA.178)

Ambetter

• For Chimeric Antigen Receptor (CAR)-T cell-related toxicities, added use for acute inflammatory demyelinating polyneuropathy-type picture or bilateral facial palsy per National Comprehensive Cancer Network (NCCN)
• Added off-label indications for immune checkpoint inhibitor-related toxicities, Langerhans cell histiocytosis (LCH)- associated abnormal, heparin-induced thrombocytopenia, and pediatric acute lymphoblastic leukemia per National Comprehensive Cancer Network (NCCN)
• Added HCPCS code [J1553]

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

Ambetter

• Added newly approved autoinjector formulation for Pyzchiva
• Added newly approved single-dose vial for subcutaneous injection for Selarsdi
• Applied Idacio’s pediatric age extensions for hidradenitis suppurativa and uveitis

Dupilumab (Dupixent) (HIM.PA.SP69)

Ambetter

Policy updates include:

• Added new indication for allergic fungal rhinosinusitis

Desmopressin (DDAVP, Desmoda, Stimate, Nocdurna) (CP.PHAR.214)

Ambetter

Policy updates include:

• Added new oral solution Desmoda to policy.

Denosumab (Prolia, Xgeva and biosimilars) (CP.PHAR.58)

Ambetter

Policy updates include:

• Added new biosimilar Ponlimsi to criteria. Added state IN to Appendix E

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

Ambetter

Policy updates include:

• Per updated label for Sogroya, added new pediatric indications for short stature born small for gestational age, growth failure associated with Noonan syndrome, and idiopathic short stature