News

Effective June 1, 2025: Pharmacy and Biopharmacy Policies

Fecha: 10/04/25

Magnolia Health Plan has added, updated or retired certain pharmacy and biopharmacy policies to ensure medical necessity review criteria is current and appropriate for members and the scope of services provided. As a result, the following policies are effective on June 1, 2025, at 12:00AM.

POLICY

APPLICABLE PRODUCTS

NEW POLICY OVERVIEW OR UPDATED POLICY REVISIONS

Revumenib (Revuforj) (CP.PHAR.707)

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: Acute Leukemia (must meet all):
    • Diagnosis of relapsed or refractory acute leukemia (e.g. acute myeloid leukemia [AML], acute lymphoblastic leukemia [ALL], and mixed phenotype acute leukemia [MPAL]);
    • Prescribed by or in consultation with an oncologist or hematologist;
    • Age ≥ 1 year;
    • Disease is positive for a KMT2A gene translocation;
    • For Revuforj requests, member must use revumenib, if available, unless contraindicated or clinically significant adverse effects are experienced;
    • Request meets one of the following:
      • Dose does not exceed one of the following:
        • Weight ≥ 40 kg: both of the following:
          • 540 mg per day;
          • 4 tablets per day;
        • Weight < 40 kg: 160 mg/m2
      • 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: Acute Leukemia (must meet all):
    • Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Revuforj for a covered indication and has received this medication for at least 30 days;
    • Member is responding positively to therapy;
    • For Revuforj requests, member must use revumenib, if available, unless contraindicated or clinically significant adverse effects are experienced;
    • If request is for a dose increase, request meets one of the following:
      • Dose does not exceed one of the following:
        • Weight ≥ 40 kg: both of the following:
          • 540 mg per day;
          • 4 tablets per day;
        • Weight < 40 kg: 160 mg/m2
      • 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

Zanidatamab-hrii (Ziihera) (CP.PHAR.709)

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: Biliary Tract Cancer (BTC) (must meet all):
    • Diagnosis of BTC;
    • Prescribed by or in consultation with an oncologist;
    • Age ≥ 18 years;
    • Disease is HER2-positive (IHC 3+);
    • Disease is unresectable, resected gross residual (R2), or metastatic
    • Failure of at least one prior systemic treatment;
    • Prescribed as a single agent;
    • Request meets one of the following:
      • Dose does not exceed 20 mg/kg every 2 weeks;
      • Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).

*Prescribed regimen must be FDA-approved or recommended by NCCN

  • Approval duration: 6 months
  • Continued Therapy: Biliary Tract Cancer (must meet all):
    • Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Ziihera for a covered indication and has received this medication for at least 30 days;
    • Member is responding positively to therapy;
    • Prescribed as a single agent;
    • Dose requested is ≥ 15 mg/kg;
    • If request is for a dose increase, request meets one of the following:
      • New dose does not exceed 20 mg/kg every 2 weeks;
      • 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

Xanomeline-trospium chloride (Cobenfy) (CP.PMN.299)

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: Schizophrenia (must meet all):
    • Diagnosis of schizophrenia;
    • Age ≥ 18 years;
    • Prescribed by or in consultation with a psychiatrist or mental health specialist;
    • Member meets one of the following:
      • Request is for the treatment of a member in a State with limitations on step therapy in certain mental health settings;
      • Failure of a ≥ 4-week trial of one of the following generic atypical antipsychotics at up to maximally indicated doses, unless clinically significant adverse effects are experienced or all are contraindicated: risperidone, quetiapine, olanzapine, ziprasidone;
      • Member has diabetes mellitus or body mass index (BMI) > 30;
    • Member meets one of the following:
      • Request is for the treatment of a member in a State with limitations on step therapy in certain mental health settings (see Appendix D);
      • Failure of a ≥ 4-week trial of aripiprazole at up to maximally indicated doses, unless contraindicated or clinically significant adverse effects are experienced;
    • Dose does not exceed both of the following:
      • 250 mg/60 mg per day;
      • 2 capsules per day.
    • Approval duration: 12 months
  • Continued Therapy: Schizophrenia (must meet all):
    • Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Cobenfy for schizophrenia and has received this medication for at least 30 days;
    • Member is responding positively to therapy;
    • If request is for a dose increase, new dose does not exceed both of the following:
      • 250 mg/60 mg per day;
      • 2 capsules per day.
    • Approval duration: 12 months

Cosibelimab-Ipdl (Unloxcyt) (CP.PHAR.711)

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: Cutaneous Squamous Cell Carcinoma (must meet all):
    • Diagnosis of CSCC;
    • Prescribed by or in consultation with an oncologist;
    • Age ≥ 18 years;
    • Disease is locally advanced or metastatic;
    • Member is not a candidate for curative surgery or radiation;
    • Request meets one of the following:
      • Dose does not exceed 1,200 mg (4 vials) every 3 weeks;
      • Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).
      • *Prescribed regimen must be FDA-approved or recommended by NCCN
    • Approval duration: 6 months
  • Continued Therapy: Cutaneous Squamous Cell Carcinoma (must meet all):
    • Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Unloxcyt 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 1,200 mg (4 vials) every 3 weeks;
    • 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

Ensartinib (Ensacove) (CP.PHAR.712)

Ambetter

Policy created:

  • 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: Non-Small Cell Lung Cancer (must meet all):
    • Diagnosis of locally advanced or metastatic NSCLC;
    • Prescribed by or in consultation with an oncologist;
    • Age ≥ 18 years;
    • Disease is ALK-positive;
    • Prescribed as a single agent;
    • For Ensacove requests, member must use ensartinib, if available, unless contraindicated or clinically significant adverse effects are experienced;
    • Member has not previously received an ALK-inhibitor (e.g., Alecensa®, Alunbrig®, Lorbrena®, Zykadia®, Xalkori®);
    • Request meets one of the following:
      • Dose does not exceed 225 mg per day;
      • 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: Non-Small Cell Lung Cancer (must meet all):
    • Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Ensacove for a covered indication and has received this medication for at least 30 days;
    • Member is responding positively to therapy;
    • Dose of Ensacove is ≥ 150 mg per day;
    • For Ensacove requests, member must use ensartinib, 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 225 mg per day;
      • 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

Zenocutuzumab-zbco (Bizengri) (CP.PHAR.713)

Ambetter

Policy created:

  • Requests for indications not approved by the FDA are reviewed with the off-label use policy HIM.PHAR.154 for Ambetter.
  • Initial Approval Criteria:
    • Non-Small Cell Lung Cancer (must meet all):
      • Diagnosis of advanced, unresectable, or metastatic NSCLC;
      • Prescribed by or in consultation with an oncologist;
      • Age ≥ 18 years;
      • Disease is positive for NRG1 gene fusion;
      • Failure of at least one prior systemic therapy (see Appendix B for examples);
      • Request meets one of the following:
        • Dose does not exceed 750 mg every 2 weeks;
        • Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).

*Prescribed regimen must be FDA-approved or recommended by NCCN

  • Approval duration: 6 months 
    • Pancreatic Adenocarcinoma (must meet all):
      • Diagnosis of advanced, unresectable, or metastatic pancreatic adenocarcinoma;
      • Prescribed by or in consultation with an oncologist;
      • Age ≥ 18 years;
      • Disease is positive for NRG1 gene fusion;
      • Failure of at least one prior systemic therapy (see Appendix B for examples);
      • Request meets one of the following:
        • Dose does not exceed 750 mg every 2 weeks;
        • Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).

*Prescribed regimen must be FDA-approved or recommended by NCCN

  • Approval duration: 6 months
  • Continued Therapy: All Indications in Section I (must meet all):
    • Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Bizengri 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 750 mg every 2 weeks;
      • 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

Amifampridine (Firdapse) (CP.PHAR.411)

Ambetter

Policy updates include:

  • Modified maximum dose per updated prescribing information

Pirfenidone (Esbriet) (CP.PHAR.286)

Ambetter

Policy updates include:

  • Revised generic redirection to generic tablet or capsule by removing specific formulations.

Axitinib (Inlyta) (CP.PHAR.100)

Ambetter

Policy updates include:
  • Collapsed off-label indications of thyroid carcinoma and soft tissue sarcoma under one off-label section
  • Per National Comprehensive Cancer Network (NCCN) Compendium added indication of thymic carcinoma

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

Ambetter

Policy updates include:
  • For National Comprehensive Cancer Network (NCCN) recommended uses criteria, added off label indications for metastases and soft tissue sarcoma (e.g. Alveolar soft part sarcoma, extra skeletal myxoid chondrosarcoma) as supported by National Comprehensive Cancer Network (NCCN) compendium
  • For hepatocellular carcinoma, added alternative 1st-line systemic therapy regimens per National Comprehensive Cancer Network (NCCN) in Appendix B

Ramucirumab (Cyramza) (CP.PHAR.119)

Ambetter

Policy updates include:
  • For colorectal cancer, added criteria for off label use in appendiceal adenocarcinoma as second-line or subsequent therapy
  • For hepatocellular carcinoma , removed confirmation of Child-Pugh class A status per National Comprehensive Cancer Network (NCCN)
  • Revised Appendix B to list only redirections

Alglucosidase Alfa (Lumizyme) (CP.PHAR.160)

Ambetter

Policy updates include:

  • Added increased lysosomal glycogen as an additional option for confirming a Pompe disease diagnosis

Miglustat (Zavesca) (CP.PHAR.164)

Ambetter

Policy updates include:

  • Added criteria for use in Niemann-Pick Disease Type C.

Eltrombopag (Alvaiz, Promacta) (CP.PHAR.180)

Ambetter

Policy updates include:
  • Added disclaimer that for Ambetter line of business Alvaiz is non-formulary
  • Per National Comprehensive Cancer Network (NCCN) Compendium, for myelodysplastic syndromes (MDS) removed that request must be for Promacta and for myelodysplastic syndromes (MDS) with symptomatic anemia removed requirement for no del(5q) and serum erythropoietin

Ranibizumab (Byooviz, Cimerli, Lucentis, Susvimo) (CP.PHAR.186)

Ambetter

Policy updates include:
  • Simplified Food and Drug Administration (FDA) approved indications to show Lucentis and Cimerli are additionally indicated from Byooviz for diabetic macular edema and diabetic retinopathy
  • Added quantity limit of 1 vial/syringe for Lucentis and biosimilars
  • Revised Susvimo maximum dose to 100 mg (1 vial) per 6 months
  • In Appendix B per Clinical Pharmacology, removed dosing for neovascular glaucoma, updated dosing regimens, clarified off-label indications
  • Removed Lucentis single-use glass vials  in Section VI

Verteporfin (Visudyne) (CP.PHAR.187)

Ambetter

Policy updates include:
  • For choroidal neovascularization due to pathologic myopia, revised failure of Avastin or Lucentis to bevacizumab and ranibizumab
  • In Appendix B, added aflibercept and ranibizumab biosimilars

Trabectedin (Yondelis) (CP.PHAR.204)

Ambetter

Policy updates include:

  • For myxoid liposarcoma, added option for unresectable primary disease and Stage IV disease that is amendable to local therapy

Reslizumab (Cinqair) (CP.PHAR.223)

Ambetter

Policy updates include:

  • For initial approval criteria, added allowance for emergency room visit

Dalteparin (Fragmin) (CP.PHAR.225)

Ambetter

Policy updates include:
  • Added newly approved pediatric extension for pediatric patients from birth (gestational age at least 35 weeks) for treatment of symptomatic venous thromboembolism
  • Updated Appendix D with current National Comprehensive Cancer Network (NCCN) compendium language

Siltuximab (Sylvant) (CP.PHAR.329)

Ambetter

Policy updates include:

  • In cytokine release syndrome initial criteria, added Sylvant may be used to replace the second dose of Tyenne per National Comprehensive Cancer Network (NCCN) and added Carvykti as an additional example of a CAR-T therapy

Avelumab (Bavencio) (CP.PHAR.333)

Ambetter

Policy updates include:
  • Per National Comprehensive Cancer Network (NCCN) guidelines added criteria for off-label use for thymic carcinoma and extranodal NK/T-cell lymphomas
  • For off-label use for salivary gland tumors, removed the requirement for combination use with Inlyta since Bavencio also has a 2A rec for use without Inlyta

Rucaparib (Rubraca) (CP.PHAR.350)

Ambetter

Policy updates include:
  • For ovarian cancer, updated criteria for “newly diagnosed stage II-IV disease (e.g., grade 2-3 endometroid carcinoma)” as supported by National Comprehensive Cancer Network (NCCN)
  • Added off-label criteria for pancreatic adenocarcinoma and uterine neoplasms as supported by National Comprehensive Cancer Network (NCCN) compendium and guidelines

Olaparib (Lynparza)  (CP.PHAR.360)

Ambetter

Policy updates include:
  • For ovarian cancer, updated criteria for “newly diagnosed stage II-IV disease (e.g., grade 2-3 endometroid carcinoma)” and completed first-line platinum-based chemotherapy regimen and is in a complete or partial response” as supported by National Comprehensive Cancer Network (NCCN)
  • Added off-label criteria for uterine neoplasms as supported by National Comprehensive Cancer Network (NCCN)
  • Removed National Comprehensive Cancer Network (NCCN) supplemental information in Appendix D

Niraparib (Zejula) (CP.PHAR.408)

Ambetter

Policy updates include:
  • For ovarian cancer, updated criteria for “newly diagnosed stage II-IV disease (e.g., grade 2-3 endometroid carcinoma)” as supported by National Comprehensive Cancer Network (NCCN) and removed “for platinum-sensitive persistent disease or recurrence” for use in combination with bevacizumab criteria as National Comprehensive Cancer Network (NCCN) compendium supports combination with bevacizumab use in various settings
  • Added off-label criteria for uterine neoplasms as supported by National Comprehensive Cancer Network (NCCN) compendium and guideline

Talazoparib (Talzenna)  (CP.PHAR.409)

Ambetter

Policy updates include:
  • For breast cancer, removed “documentation of HER2-negative disease” as use for HER2-positive disease is supported by National Comprehensive Cancer Network (NCCN) compendium and guideline
  • Updated Appendix D to align with current National Comprehensive Cancer Network (NCCN) compendium

Bortezomib (Velcade) (CP.PHAR.410)

Ambetter

Policy updates include:
  • For National Comprehensive Cancer Network (NCCN) recommended uses (off-label) initial criteria: added mantle cell lymphoma (B-cell lymphoma) and Human immunodeficiency virus (HIV)-related B-cell lymphoma as supported by National Comprehensive Cancer Network (NCCN) compendium
  • Updated “acquired immunodeficiency syndrome (AIDS)-related Kaposi Sarcoma” to “Kaposi Sarcoma” per National Comprehensive Cancer Network (NCCN) compendium

Afamelanotide (Scenesse) (CP.PHAR.444)

Ambetter

Policy updates include:

  • Removed requirement for gene sequencing per consensus guidelines as not required for primary diagnosis and recommended as follow-up tests

Luspatercept-aamt (Reblozyl) (CP.PHAR.450)

Ambetter

Policy updates include:
  • For myelodysplastic syndromes (MDS), removed requirement for ineligibility, inadequate response, or failure of an erythropoiesis-stimulating agent for serum erythropoietin ≤ 500 mu/ml per National Comprehensive Cancer Network (NCCN)
  • Added criteria for myelofibrosis-associated anemia per National Comprehensive Cancer Network (NCCN) Compendium

Tazemetostat (Tazverik) (CP.PHAR.452)

Ambetter

Policy updates include:

  • For EZH2 mutation status is negative or unknown, removed option for redirection to Aliqopa as this is no longer National Comprehensive Cancer Network (NCCN) recommended, per National Comprehensive Cancer Network (NCCN) compendium clarified if member has relapsed/refractory disease and no satisfactory alternative treatment options that request is for second-line therapy, added additional option for third-line and subsequent therapy

Avapritinib (Ayvakit)  (CP.PHAR.454)

Ambetter

Policy updates include:

  • Added oncology bypass language to existing redirections

Fam-Trastuzumab Deruxtecan-nxki (Enhertu) (CP.PHAR.456)

Ambetter

Policy updates include:

  • Per National Comprehensive Cancer Network (NCCN) guidelines for HER2-low breast cancer added a bypass of prior endocrine therapy for HR-positive disease if the member has visceral crisis

Lumasiran (Oxlumo) (CP.PHAR.473)

Ambetter

Policy updates include:
  • For initial criteria, added medical geneticist
  • References reviewed and updated. 

Teplizumab-mzwv (Tzield) (CP.PHAR.492)

Ambetter

Policy updates include:
  • Added znt8a and IA-2A as additional diabetes-related autoantibody options per pivotal study design and specialist feedback
  • Removed requirement for familial history of type 1 diabetes as lack of familial history does not preclude the diagnosis
  • Added information about PROTECT trial to Appendix D

Avacopan (Tavneos) (CP.PHAR.515)

Ambetter

Policy updates include:
  • Added nephrologist, immunologist, and pulmonologist to specialists
  • Removed criterion for documentation of baseline Birmingham vasculitis activity score (BVAS) and added requirement for a diagnosis of severe active ANCA-associated vasculitis per competitor analysis
  • Revised positive response criteria from Birmingham vasculitis activity score (BVAS) of 0 and no glucocorticoid use to improvement in at least one objective measure from baseline

Interferon Gamma- 1b (Actimmune) (CP.PHAR.52)

Ambetter

Policy updates include:
  • For chronic granulomatous disease, added immunologist as an additional prescriber specialist option
  • For mycosis fungoides and Sezary syndrome, added hematologist as an additional prescriber specialist option

Avalglucosidase Alfa-ngpt (Nexviazyme) (CP.PHAR.521)

Ambetter

Policy updates include:

  • Added increased lysosomal glycogen as an additional option for confirming a Pompe disease diagnosis

Margetuximab-cmkb (Margenza) (CP.PHAR.522)

Ambetter

Policy updates include:

  • Added criteria for fourth-line use for recurrent unresectable disease and for patients with no response to preoperative systemic therapy to align with National Comprehensive Cancer Network (NCCN) 2A recommendations

Cipaglucosidase Alfa-atga + Miglustat (Pombiliti + Opfolda) (CP.PHAR.567)

Ambetter

Policy updates include:
  • Added criteria for off-label use of Opfolda for Niemann-Pick disease type C (NPC) to align with coverage guidelines in the Zavesca (miglustat) and Miplyffa criteria
  • Added increased lysosomal glycogen as an additional option for confirming a Pompe disease diagnosis

Faricimab-svoa (Vabysmo) (CP.PHAR.581)

Ambetter

Policy updates include:
  • Simplified initial approval criteria for diabetic macular edema max dosing to 6 mg every 4 weeks for the first 6 doses
  • For retinal vein occlusion, removed “for 6 months” from max dosing and clarified Vabysmo treatment for greater than 6 months was not evaluated
  • Simplified continued therapy criteria for diabetic macular edema max dosing to 6 mg every 4 weeks
  • In Appendix B per Clinical Pharmacology, updated dosing regimens and clarified off-label indications

Futibatinib (Lytgobi) (CP.PHAR.604)

Ambetter

Policy updates include:
  • Removed “intrahepatic” for diagnosis of cholangiocarcinoma criteria as National Comprehensive Cancer Network (NCCN) supports both intrahepatic and extrahepatic cholangiocarcinoma use
  • Removed Truseltiq as a fibroblast growth factor receptor (FGFR) inhibitor example as product is discontinued
  • Updated Appendix B with examples of primary treatment regimens as supported by National Comprehensive Cancer Network (NCCN) guidelines

Teclistamab-cqyv (Tecvayli) (CP.PHAR.611)

Ambetter

Policy updates include:
  • Decreased serum M-protein criteria option from ≥ 1 g/dl to ≥ 0.5 g/dl for multiple myeloma criteria alignment
  • Added additional option to currently required measurable disease requirement to allow for progressive disease as defined by International Myeloma Working Group (IMWG)
  • Removed exclusion for previous treatment with anti- B-cell maturation antigen (BCMA) targeted therapy

Mirvetuximab Soravatansine-gynx (Elahere)  (CP.PHAR.617)

Ambetter

Policy updates include:
  • Added platinum-sensitive ovarian cancer option to platinum-resistant cancer criterion per National Comprehensive Cancer Network (NCCN)
  • Appendix D updated with definitions of platinum-resistant and sensitive cancer per National Comprehensive Cancer Network (NCCN)

Nedosiran (Rivfloza) (CP.PHAR.619)

Ambetter

Policy updates include:

  • Added HCPC codes [C9399, J3490], added medical geneticist to initial approval criteria

Everolimus (Afinitor, Afinitor Disperz, Zortress) (CP.PHAR.63)

Ambetter

Policy updates include:
  • For neuroendocrine tumor, removed bronchopulmonary per National Comprehensive Cancer Network (NCCN) the terms have been revised to lung
  • For subepndymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis complex (TSC), removed criterion member is not a candidate for curative surgical resection given that National Comprehensive Cancer Network (NCCN) allows for usage as adjuvant therapy if symptomatic or growing
  • For gastrointestinal stromal tumor, added Qinlock as an additional therapy for disease progression after per National Comprehensive Cancer Network (NCCN)
  • Added off label indication for osteosarcoma prescribed in combination with Nexavar and meningiomas prescribed in combination with bevacizumab or octreotide acetate LAR per National Comprehensive Cancer Network (NCCN)

Sotatercept (Winrevair) (CP.PHAR.657)

Ambetter

Policy updates include:
  • Added bypass to use Winrevair with pulmonary arterial hypertension monotherapy if intolerant to two or more pulmonary arterial hypertension drug classes
  • In Appendix B per Clinical Pharmacology, removed commercially unavailable branded products, updated dosing regimens
  • Clarified drugs used for off-label indications

Repotrectinib (Augtyro) (CP.PHAR.667)

Ambetter

Policy updates include:
  • For non-small cell lung cancer (NSCLC), added recurrent non-small cell lung cancer (NSCLC) per National Comprehensive Cancer Network (NCCN) compendium recommendation
  • Revised neurotrophic tyrosine receptor kinase (NTRK) fusion-positive solid tumor section to neurotrophic tyrosine receptor kinase (NTRK) fusion-positive cancer to include off-label non-solid tumor indications
  • For neurotrophic tyrosine receptor kinase (NTRK) fusion-positive cancer, added histiocytic neoplasm indication per National Comprehensive Cancer Network (NCCN) 2A recommendation with allowance for hematology specialty, revised “prescribed as subsequent therapy” to “disease has progressed following treatment”, added bypass for gastrointestinal stromal tumors, salivary gland tumors, histiocytic neoplasms, pancreatic adenocarcinoma, soft tissue sarcoma, and anaplastic thyroid carcinoma per National Comprehensive Cancer Network (NCCN)
  • In Appendix D, updated examples of solid tumors with listed indications from National Comprehensive Cancer Network (NCCN)

Abiraterone (Zytiga, Yonsa) (CP.PHAR.84)

Ambetter

Policy updates include:
  • For non-metastatic disease added the following additional off-label uses per National Comprehensive Cancer Network (NCCN) Compendium: PSA recurrence or positive digital rectal exam after radiation therapy if studies are positive for regional lymph nodes, initial therapy and member is considered very-high-risk or has regional prostate cancer (any T, N1, M0) (off-label)
  • Revised policy/criteria section to also include generic abiraterone

Ruxolitinib (Jakafi, Opzelura) (CP.PHAR.98)

Ambetter

Policy updates include:

  • Added off-label indications - immune-checkpoint-inhibitor-associated concomitant myositis/myocarditis and t-cell lymphoma per National Comprehensive Cancer Network (NCCN)

Colchicine (Colcrys, Lodoco) (CP.PMN.123)

Ambetter

Policy updates include:
  • For cardiovascular event prophylaxis, added options of peripheral aterial disease and acute coronary syndrome per competitor analysis and Food and Drug Administration (FDA) approved indication of atherosclerotic disease and updated the criteria “ secondary prevention regimen for myocardial infarction or stroke” to “treatment for atherosclerotic disease” with examples of standard of care therapy
  • Updated cardiovascular risk factor examples in Appendix D

Aspirin/Dipyridamole (Aggrenox) (CP.PMN.20)

Ambetter

Policy updates include:
  • Clarified criteria applies to generic aspirin-dipyridamole
  • Removed “member must use generic” requirement because drug is not commercially available as brand

Bedaquiline (Sirturo) (CP.PMN.212)

Ambetter

Policy updates include:

  • For continuation of therapy added option for up to 9 month approval duration if request is for Sirturo prescribed in combination with linezolid, moxifloxacin, and pyrazinamide per World Health Organization (WHO) updates to the treatment of drug-resistant tuberculosis

Quetiapine Extended-Release (Seroquel XR) (CP.PMN.64)

Ambetter

Policy updates include:

  • For schizophrenia and bipolar disorder,  removed requirement for trial and failure of immediate release quetiapine

Alendronate (Binosto, Fosamax Plus D) (CP.PMN.88)

Ambetter

Policy updates include:
  • Added alendronate oral solution to policy
  • Clarified redirection to generic alendronate should be a formulary/preferred drug list (PDL) product

Evolocumab (Repatha) (HIM.PA.156)

Ambetter

Policy updates include:
  • Revised Food and Drug Administration (FDA) approved indication wording to align cardiovascular disease wording
  • For homozygous familial hypercholesterolemia, lowered untreated low density lipoprotein (LDL) requirement to 400 mg/dl and revised evidence of heterozygous familial hypercholesterolemia in both parents to evidence of familial hypercholesterolemia in at least one parent per 2022 American College of Cardiology (ACC) expert consensus decision pathway
  • In Appendix B, added pravastatin and fluvastatin as therapeutic alternatives
  • In Section VI, clarified non-latex and latex formulations

Evinacumab-dgnb (Evkeeza) (HIM.PA.166)

Ambetter

Policy updates include:
  • Per 2022 American College of Cardiology (ACC) expert consensus decision pathway, lowered untreated low density lipoprotein (LDL) requirement to 400 mg/dl and revised evidence of heterozygous familial hypercholesterolemia in both parents to evidence of familial hypercholesterolemia in at least one parent
  • Modified redirection to Repatha to apply only to age ≥ 10 years old per Repatha Food and Drug Administration (FDA)-approved indication for homozygous familial hypercholesterolemia

Mepolizumab (Nucala) (HIM.PA.175)

Ambetter

Policy update includes:
  • Adapted from CP.PHAR.200
  • For chronic rhinosinusitis with nasal polyposis (CRSwNP), changed intranasal corticosteroid redirection from double to single step
  • For asthma, changed requirement of two to one exacerbation, removed intubation option and added emergency room visit option despite adherent use of controller therapy
  • For hypereosinophilic syndrome (HES), removed requirement of corticosteroid and changed requirement to “member has tried at least one other HES treatment for a minimum of 4 weeks

Zilucoplan (Zilbrysq) (CP.PHAR.616)

Ambetter

Policy update includes:

  • Added Bkemv, Epysqli, and Rystiggo to the list of therapies that Zilbrysq should not be prescribed concurrently with

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

Ambetter

Policy update includes:
  • For policy/criteria description added references to products available generically
  • For Fosrenol added contraindication per updated prescribing information for hypersensitivity to Fosrenol or to any ingredient in the formulation

Mifepristone (Korlym) (CP.PHAR.101)

Ambetter

Policy update includes:
  • Added redirection to generic 300 mg tablet for brand Korlym requests
  • Revised policy/criteria section to also include generic mifepristone 

Adagrasib (Krazati) (CP.PHAR.605)

Ambetter

Policy update includes:
  • Added generic redirection for initial and continued therapy per template
  • Per National Comprehensive Cancer Network (NCCN), for non-small cell lung cancer (NSCLC) removed “locally” from “locally advanced” non-small cell lung cancer (NSCLC) option and for colorectal cancer added monotherapy option
  • For non-small cell lung cancer (NSCLC), added redirection to lumakras for members without brain metastases
  • For all indications, removed requirement that member has not received prior treatment with lumakras

Prucalopride (Motegrity) (HIM.PA.159)

Ambetter

Policy update includes:
  • Added redirection to Trulance
  • For continued therapy added similar step requirements to those listed for initial approval requests.

Tenapanor (Ibsrela, Xphozah) (HIM.PA.174)

Ambetter

Policy update includes:
  • Removed Xphozah 10 mg strength due to product discontinuation
  • References reviewed and updated
  • For irritable bowel syndrome with constipation revised redirection to Trulance to not be step-wise
  • For continued therapy in irritable bowel syndrome with constipation added similar step requirements to those listed for initial approval requests.

GLP-1 receptor agonists (HIM.PA.53)

Ambetter

Policy update includes:
  • Added the following clarification under the description and initial approval criteria sections: “These criteria do NOT apply to California Exchange Plans. Requests for California Exchange Plans should be reviewed using HIM.PA.159”
  • For continued therapy added similar step requirements to those listed for initial approval requests

Dupilumab (Dupixent) (HIM.PA.SP69)

Ambetter

Policy update includes:
  • For immunotherapy-related pruritus per National Comprehensive Cancer Network (National Comprehensive Cancer Network (NCCN)), removed “refractory” for G3 pruritus, added requirement for no response to 1 month of gabapentinoid therapy for severe pruritus, removed requirement for increased ige level, and added indication for immunotherapy-related bullous dermatitis
  • For chronic rhinosinusitis with nasal polyposis (CRSwNP), changed intranasal corticosteroid redirection from double to single step

Omalizumab (Xolair) (CP.PCH.49)

Ambetter

Policy update includes:
  • For asthma initial approval criteria, added allowance for Emergency room visit
  • For immune checkpoint inhibitor-related severe pruritis, added requirement for no response to 1 month of gabapentinoid therapy per National Comprehensive Cancer Network (National Comprehensive Cancer Network (NCCN))
  • Updated Appendix D to include information about atopic dermatitis

Nivolumab (Opdivo) (CP.PHAR.121)

Ambetter

Policy update includes:
  • For melanoma, added resected stage IV melanoma
  • For classic Hodgkin lymphoma, added option for disease stage III-IV prescribed as primary treatment in combination with AVD (doxorubicin, vinblastine, darcarbazine) per National Comprehensive Cancer Network (NCCN)
  • For squamous cell carcinoma of the head and neck, for combination with Erbitux added option for subsequent-line therapy option and added option to be prescribed in combination with Yervoy as first-line therapy per National Comprehensive Cancer Network (NCCN)
  • For hepatocellular carcinoma, removed child-pugh classifications, removed specific treatment regimens member has had disease progression following from and revised to prescribed as subsequent line systemic therapy, added member has not been previously treated with immune checkpoint inhibitor therapy, unless following atezolizumab and bevacizumab if prescribed in combination with Yervoy per National Comprehensive Cancer Network (NCCN)
  • For esophageal cancer, esophagogastric junction cancer or esophageal adenocarcinoma, added option for planned esophagectomy and to be prescribed as a single agent for microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) cancers per National Comprehensive Cancer Network (NCCN)
  • Added off-label criteria per National Comprehensive Cancer Network (NCCN): for pediatric classic Hodgkin lymphoma – option to be used as re-induction therapy, vaginal cancer for second-line or subsequent therapy as a single agent, chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) with histologic (Richter) transformation to diffuse B-cell lymphoma – prescribed as a single agent for small cell lung cancer, peritoneal, pericardial and tunica vaginalis testis mesothelioma – as single agent or in combination with Yervoy, single agent usage for Kaposi sarcoma
  • Clarified small bowel adenocarcinoma be advanced or metastatic per National Comprehensive Cancer Network (NCCN)
  • For off-label recurrent or progressive intermediate trophoblastic tumor, removed requirement for following treatment with platinum-based regimen per National Comprehensive Cancer Network (NCCN)

Ibrutinib (Imbruvica) (CP.PHAR.126)

Ambetter

Policy update includes:

  • Per National Comprehensive Cancer Network (NCCN) guidelines added combo use with Venclexta for chronic lymphocytic leukemia (CLL) / small lymphocytic lymphoma (SLL), for histologic transformation of chronic lymphocytic leukemia (CLL) / small lymphocytic lymphoma (SLL) to diffuse large B-cell lymphoma (DLBCL) added requirement for combo use with Opdivo or Keytruda, replaced the terms “Gastric and Nongastric mucosa-associated lymphoid tissue (MALT) lymphoma” with “Extranodal marginal zone lymphoma (MZL) (noncutaneous)” to align with National Comprehensive Cancer Network (NCCN) nomenclature, for Nodal and Extranodal marginal zone lymphoma (MZL) added the requirement for relapsed, refractory, or progressive disease

Cosyntropin (Cortrosyn) (CP.PHAR.203)

Ambetter

Policy update includes:

  • Updated maximum dosing in those age 2 years and older to 0.25 mg as a single-dose per updated prescribing information

Carglumic Acid (Carbaglu) (CP.PHAR.206)

Ambetter

Policy update includes:
  • For N-acetyl glutamate synthetase (NAGS) deficiency, added requirement if request is for treatment of acute hyperammonemia, prescribed as adjunctive therapy with other ammonia lowering therapies (e.g., alternative pathway drugs, hemodialysis, and dietary protein restriction)
  • To support weight based dosing added requirement for documentation of member’s current weight and/or BSA

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

Ambetter

Policy update includes:
  • Added the generic versions of Desmopressin Acetate (DDAVP) and Stimate to the “Policy/Criteria” section to clarify that criteria are applicable to the generic versions
  • For brand DDAVP injection requests, added redirection to generic desmopressin injection for both initial and continued criteria
  • Added Appendix D reference for Stimate brand shortage

Factor VIII/von Willebrand Factor Complex (Human – Alphanate, Humate-P, Wilate)

von Willebrand Factor (Recombinant – Vonvendi) (CP.PHAR.216)

Ambetter

Policy update includes:
  • Revised desmopressin acetate trial to apply only for age ≥ 2 years
  • Initial therapy approval durations revised to from 3 months to 3 months for surgical/acute bleeding and to 6 months for prophylaxis, and continued therapy approval durations revised from 3 months to 3 months for surgical/acute bleeding and 12 months for prophylaxis

Factor VIIa, Recombinant (NovoSeven RT, SevenFact) (CP.PHAR.220)

Ambetter

Policy update includes:
  • Clarified that acquired hemophilia indication is applicable to NovoSeven RT only
  • Updated HCPCS code

Atezolizumab (Tecentriq), Atezolizumab-Hyaluronidase (Tecentriq Hybreza) (CP.PHAR.235)

Ambetter

Policy update includes:
  • For Tecentriq Hybreza, updated dosing to include hyaluronidase component and updated contraindications
  • For non-squamous non-small cell lung cancer (NSCLC), removed requirement for negative or unknown epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) mutation status per National Comprehensive Cancer Network (NCCN)
  • For non-small cell lung cancer (NSCLC), added Tecentriq/Tecentriq Hybreza may be continued for maintenance therapy as a single agent (if given as single agent first line therapy or atezolizumab/ carboplatin/albumin-bound paclitaxel combination) or in combination with bevacizumab (if atezolizumab/carboplatin/paclitaxel/bevacizumab given) per National Comprehensive Cancer Network (NCCN)
  • For small cell lung cancer and cervical cancer, added Tecentriq/Tecentriq Hybreza may be continued as a single agent for maintenance therapy per National Comprehensive Cancer Network (NCCN)
  • For hepatocellular carcinoma, added option to be prescribed as adjuvant therapy and removed criteria requiring confirmation of Child-Pugh class A or B status requirement per National Comprehensive Cancer Network (NCCN)
  • For melanoma, revised requirement for member B-Raf proto-oncogene, serine/threonine kinase (BRAF) V600 mutation positive to apply to all circumstances (not just metastatic or unresectable disease) per National Comprehensive Cancer Network (NCCN)
  • For mesotheliomas, added option for usage originating from the pericardium or the tunica vaginalis per National Comprehensive Cancer Network (NCCN)

Buprenorphine Injection (Sublocade, Brixadi) (CP.PHAR.289)

Ambetter

Policy update includes:

  • Added pain management to section III as diagnoses/indication for which coverage is not authorized

Tisagenlecleucel (Kymriah) (CP.PHAR.361)

Ambetter

Policy update includes:
  • Per National Comprehensive Cancer Network (NCCN) Compendium for LBCL added off-label use for disease relapsed more than 12 months after completion of first-line therapy and partial response following second-line therapy
  • Added the following to Appendix C per updated prescribing information: T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19- directed genetically modified autologous T cell immunotherapies, including Kymriah. Kymriah is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the Kymriah REMS

Axicabtagene Ciloleucel (Yescarta) (CP.PHAR.362)

Ambetter

Policy update includes:
  • Per National Comprehensive Cancer Network (NCCN) Compendium for LBCL added off-label use for disease relapsed more than 12 months after completion of first-line therapy and partial response following second-line therapy
  • Consolidated extranodal marginal zone lymphoma of the stomach with gastric mucosa-associated lymphoid tissue (MALT) lymphoma and extranodal marginal zone lymphoma of nongastric sites with nongastric mucosa-associated lymphoid tissue (MALT) lymphoma as they refer to the same condition
  • Added the following to Appendix C per updated prescribing information: T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies, including Yescarta

Acalabrutinib (Calquence) (CP.PHAR.366)

Ambetter

Policy update includes:

  • Per National Comprehensive Cancer Network (NCCN) guidelines added use as induction or maintenance therapy or use as pretreatment for chronic lymphocytic leukemia (CLL) / small lymphocytic lymphoma (SLL), for Waldenstrom macroglobulinemia (WM) clarified that Calquence is to be used as a single agent, replaced the terms “Gastric and Nongastric mucosa-associated lymphoid tissue (MALT) lymphoma” with “Extranodal marginal zone lymphoma (MZL) (noncutaneous)” to align with National Comprehensive Cancer Network (NCCN) nomenclature, for Nodal and Extranodal marginal zone lymphoma (MZL) added the requirement for relapsed, refractory, or progressive disease

Pemetrexed (Alimta, Pemfexy) (CP.PHAR.368)

Ambetter

Policy update includes:
  • For cervical cancer, removed hematologist as prescriber option
  • Added off-label indications for vaginal cancer and non-nasopharyngeal cancers per National Comprehensive Cancer Network (NCCN)
  • For continued therapy revised language from “has had at least one dose in the last 90 days” to our standard language of “received this medication for at least 30 days”
  • Updated HCPCS code descriptions for [J9297 and J9323]

Triamcinolone ER Injection (Zilretta) (CP.PHAR.371)

Ambetter

Policy update includes:
  • Added requirement that member is not receiving re-treatment of knee(s) previously treated with Zilretta
  • Clarified approval duration for one dose per knee lifetime

Octreotide Acetate (Sandostatin, Sandostatin LAR Depot, Mycapssa) (CP.PHAR.40)

Ambetter

Policy update includes:
  • For Sandostatin, added must use generic octreotide language to continued therapy
  • For Sandostatin LAR, added must use generic octreotide language, if available to both initial and continued therapy

Brolucizumab-dbll (Beovu) (CP.PHAR.445)

Ambetter

Policy update includes:
  • Revised initial approval duration to 6 months for all indications
  • Revised initial criteria maximum dosage to include dosing schedule after loading doses
  • Revised continued therapy to only apply to requests for dose increase
  • In Appendix B per Clinical Pharmacology, updated dosing regimens and clarified off-label indications

Selumetinib (Koselugo) (CP.PHAR.464)

Ambetter

Policy update includes:
  • For all indications, added weight-based limitation (25 mg/m2) to max dose requirement
  • For off-label National Comprehensive Cancer Network (NCCN) compendium recommended indications, updated the following per National Comprehensive Cancer Network (NCCN): added pleomorphic xanthoastrocytoma (PXA) and neurofibromatosis type 1 (NF-1) mutated circumscribed glioma as coverable diagnoses
  • Specified that B-Raf proto-oncogene, serine/threonine kinase (BRAF) fusion or B-Raf proto-oncogene, serine/threonine kinase (BRAF) V600E activating mutation applies only to circumscribed glioma and that Langerhans cell histiocytosis must be mitogen-activated protein (MAP) kinase positive or have no detectable/actionable mutation unless testing is not available
  • Added that Koselugo must be prescribed as a single agent

Zanubrutinib (Brukinsa) (CP.PHAR.467)

Ambetter

Policy update includes:
  • For mantle cell lymphoma (MCL), added option to be prescribed in combination with Gazyva and Venclexta
  • For Waldenstrom macroglobulinemia (WM)/ lymphoplasmacytic lymphoma (LPL), added criterion  prescribed as a single agent or in combination with rituximab
  • For chronic lymphocytic leukemia (CLL) / small lymphocytic lymphoma (SLL), added option to be prescribed with Tevimbra® for histolotic (Richter) transformation to difusse large B-cell lymphoma
  • For hairy cell leukemia, added criterion that disease is relapsed or refractory per National Comprehensive Cancer Network (NCCN)

Efgartigimod Alfa-fcab, Efgartigimod/Hyaluronidase-qvfc (Vyvgart, Vyvgart Hytrulo) (CP.PHAR.555)

Ambetter

Policy update includes:
  • For generalized myasthenia gravis, added exclusion for concurrent therapy with Bkemv, Epysqli, Zilbrysq, and an neonatal Fc receptor (FcRn) antagonist
  • For chronic inflammatory demyelinating polyneuropathy, added exclusion for concurrent therapy with a complement inhibitor or fcrn antagonist

Asciminib (Scemblix)  (CP.PHAR.565)

Ambetter

Policy update includes:
  • Added criteria for off-label use for chronic myeloid leukemia (CML) in accelerated phase (AP), per National Comprehensive Cancer Network (NCCN) guidelines
  • Added exclusion against use in members with the M244V mutation per National Comprehensive Cancer Network (NCCN) guidelines
  • Added new Food and Drug Administration (FDA)-approved indication for newly diagnosed Ph+ chronic myeloid leukemia in chronic phase.

Denosumab (Prolia, Xgeva), Denosumab-bbdz (Jubbonti, Wyost) (CP.PHAR.58)

Ambetter

Policy update includes:
  • Per updated prescribing information for Prolia and Jubbonti added boxed warnings for severe hypocalcemia in patients with advanced kidney disease
  • For prostate and breast cancer added requirement that member does not have bone metastasis
  • For giant cell tumor of bone localized disease removed option for combination use with interferon alfa per National Comprehensive Cancer Network (NCCN)

Zoledronic Acid (Reclast) (CP.PHAR.59)

Ambetter

Policy update includes:
  • For brand Reclast requests added redirection to generic
  • For initial requests for oncology indications other than prostate and breast cancer, added clarification that request is for zoledronic acid 4 mg/5 ml or 4 mg/100 ml (formerly Zometa)

Exagamglogene Autotemcel (Casgevy) (CP.PHAR.603)

Ambetter

Policy update includes:

  • For both sickle cell disease and transfusion dependent β-thalassemia indications, added criterion for documentation of member’s body weight for verification of weight-based dose

Tremelimumab-actl (Imjudo) (CP.PHAR.612)

Ambetter

Policy update includes:
  • Per National Comprehensive Cancer Network (NCCN) compendium– for non-small cell lung cancer (NSCLC), added recommended uses for present and negative actionable molecular biomarkers
  • Revised National Comprehensive Cancer Network (NCCN) recommended uses section to Gastric, Esophageal, and Esophagogastric Junction Cancer, added requirement that disease is microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), and added provider attestation that member is medically fit for surgery
  • Clarified prior authorization may be required for durvalumab

Lovotibeglogene Autotemcel (Lyfgenia) (CP.PHAR.627)

Ambetter

Policy update includes:

  • Added criterion for documentation of member’s body weight for verification of weight-based dose

Birch Triterpenes (Filsuvez) (CP.PHAR.669)

Ambetter

Policy update includes:

  • For initial approval criteria, added “member does not have current evidence or history of squamous cell carcinoma in the area that will undergo treatment” per competitor analysis and EASE study trial design

Vemurafenib (Zelboraf) (CP.PHAR.91)

Ambetter

Policy update includes:

  • Per National Comprehensive Cancer Network (NCCN) guidelines added coverage for neuroglioma and glioneuronal tumor as category 2A-supported indications, updated the types of gliomas to circumscribed gliomas and H3-mutated high-grade glioma, removed coverage of the following conditions as not National Comprehensive Cancer Network (NCCN)-supported (oligodendroglioma, astrocytoma), removed coverage of the following conditions that have category 2B recs (thyroid carcinoma, brain metastases)

Risedronate (Actonel, Atelvia) (CP.PMN.100)

Ambetter

Policy update includes:

  • Added generic redirection to continuation of therapy requests

Lasmiditan (Reyvow) (CP.PMN.218)

Ambetter

Policy update includes:

  • For requests for quantities greater than two doses per month modified to require both specialist prescribing and use of prophylactic therapy to align with criteria requirements of other acute migraine therapy

CNS Stimulants (CP.PMN.92)

Ambetter

Policy update includes:
  • Removed Adzenys ER from criteria as drug has been discontinued
  • For Adhansia XR, removed discontinued strengths [25 mg, 45 mg, 55 mg, 70 mg, 80 mg]
  • Updated Adhansia XR quantity limit to 3 tablets per day
  • For Adzenys XR-ODT, split dosing based on 6 to 12 years and > 13 years per prescriber information

Aripiprazole Orally Disintegrating Tablet, Oral Film (Opipza) (CP.PMN.300)

Ambetter

Policy updates include:
  • Adapted from previously approved policy CP.PCH.37 (retired)
  • Added new formulation Opipza to policy with step therapy requirement for generic aripiprazole tablet, oral solution, and oral disintegrating tablet

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

Ambetter

Policy updates include:
  • For rheumatoid arthritis and polyarticular juvenile idiopathic arthritis, revised Actemra redirection to require only a single step through preferred formulary products
  • for Bimzelx, added criteria for newly approved indication for hidradenitis suppurativa
  • Added newly approved biosimilar Yesintek to criteria
  • For Pyzchiva, added new dosage formulation [single-dose vial for subcutaneous injection 45 mg/0.5 ml]
  • Added Pyzchiva to “weight < 60 kg: 0.75 mg/kg per dose” pediatric dosing for plaque psoriasis and psoriatic arthritis
  • For Wezlana, added new dosage formulation [single-dose prefilled autoinjector (confipen) 45 mg/0.5 ml, 90 mg/ml]
  • Added newly approved biosimilar Steqeyma to criteria
  • For ankylosing spondylitis, Crohn’s disease, hidradenitis suppurativa, plaque psoriasis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, rheumatoid arthritis, ulcerative colitis, and uveitis, added adalimumab-aacf, adalimumab-aaty, adalimumab-bwwd, and adalimumab-ryvk to criteria
  • For giant cell arteritis, removed criteria for failure of “≥ 3 consecutive month trial” of a systemic corticosteroid and “in conjunction with methotrexate or azathioprine”
  • For polyarticular juvenile idiopathic arthritis: removed criteria for minimum clinical juvenile arthritis disease activity score (cJADAS)-10 score ≥ 8.5 for documentation of high disease activity and “baseline 10-joint clinical juvenile arthritis disease activity score” in initial criteria
  • Removed criteria for “member is responding positively to therapy as evidenced by a decrease in cJADAS -10 from baseline” in continued therapy
  • For Appendix K, added polyarticular juvenile idiopathic arthritis disease activity information per 2019 American College of Rheumatology (ACR) guidelines.
  • For Bimzelx, added new strength [320 mg/2 ml] for single-dose prefilled syringe and single-dose prefilled autoinjector
  • Added newly approved biosimilar Imuldosa to criteria
  • For Selarsdi, added newly approved indications for Crohn’s disease and ulcerative colitis
  • Added new dosage formulation [single-dose vial for IV infusion 130 mg/26 ml]
  • For continued therapy, removed redirection to Stelara for Stelara biosimilars.
  • Added HCPCS codes [J0139, Q5140, Q5141, Q5142, Q5143, Q5144, Q5145, Q9996, Q9997, Q9998] and removed [J0135, Q5131, Q5132].

 

Cabotegravir (Apretude), Cabotegravir/Rilpivirine (Cabenuva) (CP.PHAR.573)

Ambetter

Policy updates include:
  • Revised Food and Drug Administration (FDA) approved indication language for Apretude to align with wording
  • In Appendix C, added Apretude contraindication for UGT enzyme inducing drugs
  • In Appendix D, updated wording in panel’s recommendation for Cabenuva per United States Department of Health and Human Services guideline
  • Per United States Preventive Services Task Force (USPSTF) prep recommendation, removed redirection to generic Truvada

Continuous Glucose Monitors (CP.PMN.214)

Ambetter

Policy updates include:

  • Removed requirement for participation in a comprehensive diabetes management program

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

Ambetter

Policy updates include:
  • Removed lung clearance index from criteria to align with competitor analysis and standard of care
  • For initial approval criteria, updated approval duration from 4 months to 6 months.
  • Added new indication to criteria for non-f508del mutation responsive to Trikafta based on clinical data
  • For Appendix E, updated list of CFTR gene mutations responsive to Trikafta per prescriber information

Emtricitabine-tenofovir alafenamide (Descovy) (CP.PMN.235)

Ambetter

Policy updates include:

  • Removed redirection to generic Truvada per United States Preventive Services Task Force (USPSTF) PrEP recommendation

Inhaled Agents for Asthma and COPD (HIM.PA.153)

Ambetter

Policy updates include:
  • Updated Appendix D with latest Global Initiative for Chronic Obstructive Lung Disease (GOLD) guideline recommendations on Ohtuvayre
  • Added brand Spiriva Handihaler to the policy requiring step through of the generic and revised “All other long acting muscarinic antagonist” redirection from “Spiriva Handihaler” to “tiotropium bromide monohydrate (generic Spiriva Handihaler)”

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

Ambetter

Policy updates include:

  • Removed requirement for participation in a comprehensive diabetes management program

Ivacaftor (Kalydeco) (CP.PHAR.210)

Ambetter

Policy updates include:

  • Removed lung clearance index from criteria to align with competitor analysis and standard of care

Lumacaftor-ivacaftor (Orkambi) (CP.PHAR.213)

Ambetter

Policy updates include:

  • Removed lung clearance index from criteria to align with competitor analysis and standard of care

Eladocagene Exuparvovec-tneq (Kebilidi) (CP.PHAR.595)

Ambetter

Policy updates include:
  • Criteria updated per Food and Drug Administration (FDA) labeling: reduced the age requirement to 16 months to align with PI and pivotal study minimum age
  • Added criterion “documentation that member has achieved skull maturity by neuroimaging”
  • Removed redirection to symptomatic relief therapies
  • Updated Food and Drug Administration (FDA) maximum dose and dosing regimen
  • Added disclaimer “all requests reviewed under this policy require medical director review.”

Ivabradine (Corlanor) (CP.PMN.70)

Ambetter

Policy updates include:
  • Updated Section V to include specific weight-based maximum doses for pediatric patients
  • Revised policy/criteria section to also include generic ivabradine and added redirection to generic for brand requests per formulary status

Nemolizumab-ilto (Nemluvio) (CP.PHAR.703)

Ambetter

Policy updates include:
  • For prurigo nodularis initial criteria, added redirection to Dupixent
  • Added criteria for new indication of atopic dermatitis

Lofexidine (Lucemyra) (CP.PMN.152)

Ambetter

Policy updates include:

  • Added redirection to generic lofexidine

Insulin detemir (Levemir) (HIM.PA.171)

Ambetter

Policy updates include:
  • Added disclaimer that Novo Nordisk discontinued Levemir products
  • Added requirement for provider attestation acknowledging the discontinuation of Levemir products
  • Added Appendix E regarding discontinuation of Levemir products

Leuprolide Acetate (Eligard, Fensolvi, Lupron Depot, Lupron Depot-Ped), Leuprolide mesylate (Camcevi) (CP.PCH.53)

Ambetter

Policy updates include:

  • For gender dysphoria and gender transition, added requirement for provider attestation of understanding current State regulations regarding transgender-related health care and such care is coverable under the State regulations, added to Appendix D link and notation that the Movement Advancement Project can be referenced to confirm transgender-related health care is coverable under the State regulations

Goserelin Acetate (Zoladex) (CP.PHAR.171)

Ambetter

Policy updates include:

  • For gender dysphoria and gender transition, added requirement for provider attestation of understanding current State regulations regarding transgender-related health care and such care is coverable under the State regulations, added to Appendix D link and notation that the Movement Advancement Project can be referenced to confirm transgender-related health care is coverable under the State regulations

Histrelin Acetate (Vantas, Supprelin LA) (CP.PHAR.172)

Ambetter

Policy updates include:

  • For gender dysphoria and gender transition, added requirement for provider attestation of understanding current State regulations regarding transgender-related health care and such care is coverable under the State regulations, added to Appendix D link and notation that the Movement Advancement Project can be referenced to confirm transgender-related health care is coverable under the State regulations

Nafarelin Acetate (Synarel) (CP.PHAR.174)

Ambetter

Policy updates include:

  • For gender dysphoria and gender transition, added requirement for provider attestation of understanding current State regulations regarding transgender-related health care and such care is coverable under the State regulations, added to Appendix D link and notation that the Movement Advancement Project can be referenced to confirm transgender-related health care is coverable under the State regulations

Triptorelin Pamoate (Trelstar, Triptodur) (CP.PHAR.175)

Ambetter

Policy updates include:

  • For gender dysphoria and gender transition, added requirement for provider attestation of understanding current State regulations regarding transgender-related health care and such care is coverable under the State regulations, added to Appendix D link and notation that the Movement Advancement Project can be referenced to confirm transgender-related health care is coverable under the State regulations

Testosterone (Testopel, Jatenzo, Kyzatrex, Tlando  ) (CP.PHAR.354)

Ambetter

Policy updates include:

  • For gender dysphoria and gender transition, added requirement for provider attestation of understanding current State regulations regarding transgender-related health care and such care is coverable under the State regulations, added to Appendix D link and notation that the Movement Advancement Project can be referenced to confirm transgender-related health care is coverable under the State regulations

Testosterone (Androderm) (HIM.PA.87)

Ambetter

Policy updates include:

  • For gender dysphoria and gender transition, added requirement for provider attestation of understanding current State regulations regarding transgender-related health care and such care is coverable under the State regulations, added to Appendix D link and notation that the Movement Advancement Project can be referenced to confirm transgender-related health care is coverable under the State regulations

To review all policies, please visit Magnolia's Clinical & Payment Policies webpage.

Prior to updates, pharmacy and biopharmacy clinical policies are reviewed and approved by the Pharmacy and Therapeutics (P&T) Committee.

For questions or additional information, please contact Magnolia’s Pharmacy Department at 1-866-912-6285, ext. 66409.