Pirfenidone (Esbriet) (CP.PHAR.286)

Ambetter

Policy updates include:

• For other indications/diagnoses, revised generic redirection to allow either tablet or capsule by removing specific formulations

Aripiprazole Long-Acting Injections (Abilify Maintena, Abilify Asimtufii, Aristada, Aristada Initio) (CP.PHAR.290)

Ambetter

• For Abilify Maintena added criterion option for 800 mg once-time dose followed by 400 mg per month for new dosing regimen for 1-day initiation regimen
• Updated Section V for Abilify Maintena and Abilify Asimtufii

Pegfilgrastim (Neulasta, Neulasta Onpro), Pegfilgrastim-jmdb (Fulphila), Pegfilgrastim-pbbk (Fylnetra), Pegfilgrastim-apgf (Nyvepria), Eflapegrastim-xnst (Rolvedon), Efbemalenograstim alfa-vuxw (Ryzneuta), Pegfilgrastim-fpgk (Stimufend), Pegfilgrastim-cbqv (Udenyca, Udenyca Autoinjector, Udenyca Onbody), Pegfilgrastim-bmez (Ziextenzo) (CP.PHAR.296)

Ambetter

Policy updates include:

• Added Fylnetra to indication for acute exposure to myelosuppressive doses of radiation per updated prescribing information

Filgrastim (Neupogen), Filgrastim-sndz (Zarxio), Tbo-filgrastim (Granix), Filgrastim-aafi (Nivestym), Filgrastim-ayow (Releuko), Filgrastim-txid (Nypozi) (CP.PHAR.297)

Ambetter

Policy updates include:

• Per updated prescribing information, added Releuko to indications for mobilizing autologous hematopoietic progenitor cells for collection by leukapheresis and to increase survival in patients acutely exposed to myelosuppressive doses of radiation

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

Ambetter

• For systemic light chain amyloidosis added National Comprehensive Cancer Network (NCCN) Compendium supported use in combination with lenalidomide and dexamethasone
• For multiple myeloma added National Comprehensive Cancer Network (NCCN) Compendium supported use as subsequent therapy in combination with carfilzomib, pomalidomide, and dexamethasone

Abaloparatide (Tymlos) (CP.PHAR.345)

Ambetter

Policy updates include:

• Revised initial approval duration to 12 months for Medicaid/Ambetter

Mechlorethamine Gel (Valchlor) (CP.PHAR.381)

Ambetter

• For National Comprehensive Cancer Network (NCCN) recommended uses (off-label), removed “failure of at least one skin-directed therapy” as National Comprehensive Cancer Network (NCCN) compendium allows for primary treatment
• For Appendix B, added UVA1 as phototherapy option per National Comprehensive Cancer Network (NCCN) guideline

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

Ambetter

Policy updates include:

• Added option for first-line use in gastrointestinal or pancreas neuroendocrine tumor with Ki-67 at least 10% and clinically significant tumor burden per National Comprehensive Cancer Network (NCCN)

Corticosteroids for Ophthalmic Injection (Dextenza, Iluvien, Ozurdex, Retisert, Xipere, Yutiq) (CP.PHAR.385)

Ambetter

• For allergic conjunctivitis, added bypass of redirection for members unable to manage regular eye drop use
• For macular edema following retinal vein occlusion and diabetic macular edema clarified failure of a single intravitreal anti- vascular endothelial growth factor (VEGF) agent
• For non-infectious uveitis, added examples of trial and failure agents and clarified non-biologic “systemic” immunosuppressive therapy
• For Dextenza, removed age requirement for ocular inflammation per Food and Drug Administration (FDA) pediatric expansion and updated age requirement for allergic conjunctivitis from at least 18 years to at least 2 years per Food and Drug Administration (FDA) pediatric expansion
• In Appendix B, consolidated non-biologic systemic immunosuppressive therapies
• Updated HCPCS code description for Xipere
• In Section V, updated Ozurdex and Iluvien indications and updated Ozurdex maximum dose from every 6 months to every 3 months

Erdafitinib (Balversa) (CP.PHAR.423)

Ambetter

Policy updates include:

• Per National Comprehensive Cancer Network (NCCN) Compendium, added off-label indications of pancreatic adenocarcinoma, cholangiocarcinoma, and non-small cell lung cancer

Osilodrostat (Isturisa) (CP.PHAR.487)

Ambetter

• Revised Food and Drug Administration (FDA) Approved Indication(s) to reflect expanded approval in Cushing’s syndrome (previously only Cushing’s disease) and modified criteria to reflect updated labeling language
• Removed 10 mg tablet strength as it is no longer on market

Capmatinib (Tabrecta) (CP.PHAR.494)

Ambetter

• For initial criteria: added option for “used as a single-agent for brain metastases” per National Comprehensive Cancer Network (NCCN)
• Updated epidermal growth factor receptor mutant with high-level mesenchymal-epithelial transition amplifications criteria from “Tabrecta is used with Tagrisso” to “Tabrecta can be administered with continuation of Tagrisso” per National Comprehensive Cancer Network (NCCN) guideline

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

Ambetter

Policy updates include:

• Added off-label criteria for Merkel cell carcinoma per National Comprehensive Cancer Network (NCCN)

Amivantamab-vmjw (Rybrevant) (CP.PHAR.544)

Ambetter

Policy updates include:

• For initial criteria, removed “for disease that is positive for epidermal growth factor receptor mutation in exon 18 (G719X), exon 20 (S768I), or exon 21 (L861Q): Presence of symptomatic systemic disease with multiple lesions” as not supported in National Comprehensive Cancer Network (NCCN) compendium and guideline update

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

Ambetter

• Per National Comprehensive Cancer Network (NCCN) Compendium – added use in second-line and subsequent therapy in combination with gemcitabine and oxaliplatin
• Removed specific criteria requirements for histologic transformation of indolent lymphoma to diffuse large B-cell lymphoma
• Added Appendix D to specify diffuse large B-cell lymphoma subtypes per National Comprehensive Cancer Network (NCCN)

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

Ambetter

• Added National Comprehensive Cancer Network (NCCN) Compendium supported off-label use in human immunodeficiency virus-related B-cell lymphomas, and post-transplant lymphoproliferative disorders
• Added option for use as second-line therapy in combination with GemOx (gemcitabine, oxaliplatin)

Tislelizumab-jsgr (Tevimbra) (CP.PHAR.687)

Ambetter

• For hepatocellular carcinoma, clarified criterion as first-line systemic therapy and added option to be prescribed as subsequent-line systemic therapy
• Updated Appendix B

Avutometinib, Defactinib (Avmapki Fakzynja Co-Pack) (CP.PHAR.731)

Ambetter

Policy includes:

• Requests for indications not approved by the Food and Drug Administration (FDA) are reviewed with the off-label use policy for the relevant line of business: HIM.PHAR.154 for Ambetter
• Initial Approval Criteria: Ovarian Cancer (must meet all):
  • Diagnosis of low-grade serous ovarian cancer (LGSOC);
  • Prescribed by or in consultation with an oncologist;
  • Age at least 18 years;
  • Disease is recurrent;
  • Disease is positive for KRAS mutation;
  • Avmapki Fakzynja Copack is not prescribed concurrently with any other agents for LGSOC;
  • Member has received prior systemic therapy;
  • For Avmapki Fakzynja Co-Pack requests, member must use avutometinib and defactinib, if available, unless contraindicated or clinically significant adverse effects are experienced;
  • Request meets one of the following:
    • Dose does not exceed the following for the first 3 weeks of every 4-week cycle:
    • Avmapki: 6.4 mg (8 capsules) per week;
    • Fakzynja: 400 mg (2 tablets) 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 Food and Drug Administration (FDA)-approved or recommended by National Comprehensive Cancer Network (NCCN)

• Approval duration: 6 months
• Continued Therapy Ovarian Cancer (must meet all):
  • Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Avmapki Fakzynja Co-Pack for a covered indication and has received this medication for at least 30 days;
  • Member is responding positively to therapy;
  • Avmapki Fakzynja Copack is not prescribed concurrently with any other agents for LGSOC;
  • For Avmapki Fakzynja Co-Pack requests, member must use avutometinib and defactinib, 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 the following for the first 3 weeks of every 4-week cycle:
      • Avmapki: 6.4 mg (8 capsules) per week;
      • Fakzynja: 400 mg (2 tablets) 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 Food and Drug Administration (FDA)-approved or recommended by National Comprehensive Cancer Network (NCCN)

• 6. Approval duration: 12 months

Penpulimab-kcqx (CP.PHAR.732)

Ambetter

Policy includes:

• Requests for indications not approved by the Food and Drug Administration (FDA) are reviewed with the off-label use policy for the relevant line of business: HIM.PHAR.154 for Ambetter.
• Initial Approval Criteria: Non-Keratinizing Nasopharyngeal Carcinoma (NPC) (must meet all):
  • Diagnosis of non-keratinizing NPC;
  • Prescribed by or in consultation with an oncologist;
  • Age at least 18 years;
  • Disease is recurrent or metastatic;
  • Penpulimab-kcqx is prescribed in one of the following ways:
    • In combination with cisplatin or carboplatin and gemcitabine;
    • As a single agent for disease that has progressed on or after both of the following:
      • Platinum-containing chemotherapy;
      • At least one other prior line of therapy;
        • Member has not received prior treatment with an anti-PD-(L)1 antibody;
        • Request meets one of the following:
          • In combination with cisplatin or carboplatin and gemcitabine: Dose does not exceed 200 mg every three weeks;
          • As a single agent: Dose does not exceed 200 mg every two weeks;
          • Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).

*Prescribed regimen must be Food and Drug Administration (FDA)-approved or recommended by National Comprehensive Cancer Network (NCCN).

• Approval duration: 6 months
• Continued Therapy: Non-Keratinizing Nasopharyngeal Carcinoma (must meet all):
  • Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving penpulimab-kcqx 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:
    • In combination with cisplatin or carboplatin and gemcitabine: New dose does not exceed 200 mg every three weeks for up to total maximum of 24 months;
    • As a single agent: New dose does not exceed 200 mg every two weeks for up to total maximum of 24 months;
    • Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).

*Prescribed regimen must be Food and Drug Administration (FDA)-approved or recommended by National Comprehensive Cancer Network (NCCN).

• Approval duration: 12 months

Telisotuzumab Vedotin-tllv (Emrelis) (CP.PHAR.733)

Ambetter

Policy includes:

• Requests for indications not approved by the Food and Drug Administration (FDA) are reviewed with the off-label use policy for the relevant line of business: HIM.PHAR.154 for Ambetter.
• Initial Approval Criteria: Non-Small Cell Lung Cancer (NSCLC)(must meet all):
  • Diagnosis of NSCLC;
  • Disease is recurrent, locally advanced, or metastatic;
  • Disease has all of the following characteristics:
    • Non-squamous;
    • High c-Met/MET protein overexpression, defined as at least 50% of tumor cells;
    • Strong (3+) immunohistochemistry staining (IHC 3+);
    • Epidermal growth factor receptor (EGFR) wild-type;
  • Prescribed by or in consultation with an oncologist;
  • Age at least 18 years;
  • Member has received prior systemic therapy for NSCLC;
  • Request is for single agent therapy;
  • Request meets one of the following:
    • Dose does not exceed 1.9 mg/kg, up to a maximum of 190 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 Food and Drug Administration (FDA)-approved or recommended by National Comprehensive Cancer Network (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 Emrelis 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 1.9 mg/kg, up to a maximum of 190 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 Food and Drug Administration (FDA)-approved or recommended by National Comprehensive Cancer Network (NCCN)

• Approval duration: 12 months

Acoltremon (Tryptyr) (CP.PHAR.739)

Ambetter

Policy includes:

• Requests for indications not approved by the Food and Drug Administration (FDA) are reviewed with the off-label use policy for the relevant line of business: HIM.PHAR.154 for Ambetter
• Initial Approval Criteria: Dry Eye Disease (DED) (must meet all):
  • Diagnosis of DED;
  • Age at least 18 years;
  • Failure of an artificial tears, unless clinically significant adverse effects are experienced or all are contraindicated;
  • Failure of at least one ophthalmic anti-inflammatory agent at up to maximally indicated doses, unless clinically significant adverse effects are experienced or all are contraindicated;
  • Failure of generic ophthalmic cyclosporine emulsion 0.05% (generic Restasis®), unless contraindicated or clinically significant adverse effects are experienced;
  • Request does not exceed 60 vials (1 carton) per 30 days.
  • Approval duration: 12 months
• Continued Therapy: Dry 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 is responding positively to therapy;
  • If request is for a dose increase, request does not exceed 60 vials (1 carton) per 30 days.
  • Approval duration: 12 months

Vorinostat (Zolinza) (CP.PHAR.83)

Ambetter

Policy updates include:

• Added off-label criteria for use in Hodgkin lymphoma per National Comprehensive Cancer Network (NCCN)

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

Ambetter

• For prevention of preterm birth, removed criterion regarding concurrent usage with Makena due to product discontinuation
• Evidence of coverage for infertility/fertility preservation language added for Ambetter line of business (AZ, DE, GA, IN, KS, KY, MI, MO, NE, NY, NH, OH, OK, PA, SC, TN, TX)

Mavacamten (Camzyos) (CP.PMN.272)

Ambetter

Policy updates include:

• Per labeling updates, revised Appendix C (removed contraindication with moderate CYP2C19 inhibitors and strong CYP3A4 inhibitors) and Section V (for maintenance dosing, revised frequency of required echo monitoring from once every 12 weeks to every 6 months for left ventricular ejection fraction (LVEF) at least 55% and a Valsalva left ventricular outflow tract (LVOT) gradient less than 30 mmhg)

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

Ambetter

• Added newly Food and Drug Administration (FDA)-approved indication of plaque psoriasis for Zoryve foam
• Removed econazole, luliconazole, oxiconazole, and sulconazole from Appendix B as there is insufficient evidence for the use of these agents in seborrheic dermatitis

Tedizolid (Sivextro) (CP.PMN.62)

Ambetter

• Added pediatric extension to include use in members at least 26 weeks gestational age and weight at least 1 kg
• Updated to include pediatric specific weight-based dosing

Galcanezumab-gnlm (Emgality) (HIM.PA.SP67)

Ambetter

Policy updates include:

• For episodic cluster headaches, changed approval duration from 3 months to 12 months for initial approval criteria and continued therapy, removed the following verbiage from continued therapy approval duration: “up to a total of 12 months per cluster period”

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

Ambetter 

• Updated Auvi-Q indication and added weight minimum in initial criteria per Food and Drug Administration (Food and Drug Administration (FDA)) labeled indication
• Updated criteria from “for Neffy requests only, has manual dexterity limitations that preclude use of an auto-injector” to “for Neffy requests only, has limitations (e.g., manual dexterity, needle phobia) that preclude use of an auto-injector”
• For section VI, updated Auvi-Q dose from 0.15 mg/0.3 ml to 0.15 mg/0.15 ml

Burosumab-twza (Crysvita) (CP.PHAR.11)

Ambetter

Policy updates include:

• For X-linked hypophosphatemia, modified to allow diagnostic confirmation of PHEX gene in member or first-degree relative per competitor analysis, added requirement for documentation of member’s current weight, for dose calculation purposes

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

Ambetter

Policy updates include:

• For esophageal squamous cell carcinoma and gastric or gastroesophageal junction adenocarcinoma adenocarcinoma, added redirection to Tevimbra

Deferasirox (Exjade, Jadenu) (CP.PHAR.145)

Ambetter

Policy updates include:

• For chronic iron overload, revised concurrent iron chelator bypass threshold from cardiact2* < 20 ms to mt2* ≤ 10 ms per Thalassaemia International Federation (TIF) guidelines

Deferoxamine (Desferal) (CP.PHAR.146)

Ambetter

Policy updates include:

• For chronic iron overload, revised concurrent iron chelator bypass threshold from cardiac T2* < 20 ms to mt2* ≤ 10 ms per Thalassaemia International Federation (TIF) guidelines

Deferiprone (Ferriprox) (CP.PHAR.147)

Ambetter

Policy updates include:

• For chronic iron overload, revised concurrent iron chelator bypass threshold from  cardiac T2* < 20 ms to mt2* ≤ 10 ms per Thalassaemia International Federation (TIF) guidelines

Vigabatrin (Sabril, Vigafyde) (CP.PHAR.169)

Ambetter

Policy updates include:

• Added a generic redirection for brand Sabril

Ivacaftor (Kalydeco) (CP.PHAR.210)

Ambetter

Policy updates include:

• Added Alyftrek to list of cystic fibrosis transmembrane conductance regulator (CFTR) modulator concurrent exclusion criteria

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

Ambetter

Policy updates include:

• Added Alyftrek to list of cystic fibrosis transmembrane conductance regulator (CFTR) modulator concurrent exclusion criteria

Tolvaptan (Jynarque, Samsca) (CP.PHAR.27)

Ambetter

• For autosomal dominant polycystic kidney disease, added requirements for minimum egfr and high risk for rapidly progressive disease per 2025 Kidney Disease: Improving Global Outcomes (KDIGO) guidelines and in alignment with pivotal study design and Food and Drug Administration (FDA) labeling, respectively
• For Jynarque, added redirection to generic tolvaptan

Sargramostim (Leukine) (CP.PHAR.295)

Ambetter

• Per National Comprehensive Cancer Network (NCCN) Compendium for neuroblastoma removed requirement for relapse or refractory disease, clarified combination with Danyelza should also include temozolomide and irinotecan
• Updated Appendix E with revised language and exception for Tennessee

Ixazomib (Ninlaro) (CP.PHAR.302)

Ambetter

• Added National Comprehensive Cancer Network (NCCN) Compendium supported use as primary treatment as a substitute for bortezomib or carfilzomib
• Clarified for combination with dexamethasone and Pomalyst, member is lenalidomide- or anti-CD-38-refractory

Brentuximab Vedotin (Adcetris) (CP.PHAR.303)

Ambetter

• Per National Comprehensive Cancer Network (NCCN) – for classical Hodgkin lymphoma, added option for use with CHP (cyclophosphamide, doxorubicin, prednisone) as alternative to with AVD (doxorubicin, vinblastine, and dacarbazine) if vinblastine is unavailable due to shortage, added option for use with nivolumab for age > 60 years, revised requirements around use as component of BrECADD (brentuximab vedotin, etoposide, cyclophosphamide, doxorubicin, dacarbazine, dexamethasone) (removed requirement for stage III-IV disease, added option for use with Deauville score 4-5, added requirement for use with granulocyte colony-stimulating factor)
• For pediatric classical Hodgkin lymphoma, added option for use as a component of brecadd and Bv-AVD (brentuximab vedotin, doxorubicin, vinblastine, dacarbazine) for stage III-IV disease, specified that only use following high-dose therapy and autologous stem cell rescue has to be in high-risk disease, and modified requirement for high risk disease for nearly all requests to instead require risk factors only for stage I-II disease
• For mycosis fungoides/Sezary syndrome, removed option for combination use with bendamustine

Blinatumomab (Blincyto) (CP.PHAR.312)

Ambetter

• Per National Comprehensive Cancer Network (NCCN) – clarified that Philadelphia chromosome (Ph) refers to adult disease and added the term BCR::ABL1 for pediatric disease
• For pediatrics, removed pathways for use after consolidation therapy and added combination therapy option for BCR::ABL1-negative/like disease
• For infant acute lymphoblastic leukemia, removed requirement for KMT2A status (11q23 rearranged)

Pembrolizumab (Keytruda) (CP.PHAR.322)

Ambetter

• For non-small cell lung cancer, updated targeted therapies for epidermal growth factor receptor (EGFR) exon 19 deletion, L858R, and ROS proto-oncogene 1 (ROS1) rearrangement positive disease
• For head and neck squamous cell carcinoma added option to be prescribed in combination with Erbitux as first-line therapy or subsequent-line therapy
• For classical Hodgkin lymphoma, added option to be prescribed in combination with decitabine and vorinostat, for post-allogenic hematopoietic cell transplant or post autologous stem cell rescue, and members not candidate for anthracycline therapy and revised for relapsed disease for both adults and pediatrics after at least 1 line of systemic therapy (previously at least 2 lines of systemic therapy for pediatrics)
• For urothelial carcinoma, added option to be prescribed in combination with Inlyta or Lenvima, usage for relapsed disease, and prescribed as a single agent for adjuvant therapy
• For cervical cancer, added International Federation of Gynecology and Obstetrics (FIGO) 2018 stage III-IVA in combination with chemoradiotherapy and added option to be prescribed in combination with Tivdak for tumors expressing PD-L1 and has not received prior immune-oncology therapy, recurrent or metastatic disease, and disease as progressed on or after at least 1 line of systemic therapy
• For hepatocellular carcinoma, removed specific treatment regimens member has had disease progression following from and revise to prescribed as subsequent line therapy
• For biliary tract cancer, added option for disease is resectable locoregionally advanced and prescribed as neoadjuvant therapy for gallbladder cancer
• For triple-negative breast cancer, added option to be prescribed as preoperative systemic therapy in combination with carboplatin and docetaxel
• Added off-label usage for central nervous (CNS) cancer, thyroid carcinoma, peritoneal mesothelioma, penile cancer
• For mycosis fungoides, revised stage to Stage IA – III
• For thymic carcinoma, removed metastatic or unresectable requirement
• Updated Food and Drug Administration (FDA) Approved Indication(s) section and criteria to reflect revised indication that limits use to tumors expressing PD-L1 (combined positive score (CPS) at least 1) for esophageal or gastroesophageal junction carcinoma in combination with chemotherapy and HER2-negative gastric or gastroesophageal junction adenocarcinoma as first-line therapy in combination with chemotherapy (previously approved regardless of PD-L1 status)
• Updated Food and Drug Administration (FDA) Approved Indications(s) section for cervical cancer to clarify International Federation of Gynecology and Obstetrics (FIGO) 2014 Stage III-IVA per updated PI
• Updated Appendix E with addition of soft tissue sarcoma as an example for microsatellite instability-high mut/Mb: mutations/megabase (MSI-H) solid tumors and small bowel adenocarcinoma for tumor mutational burden-high solid tumors
• Updated Appendix G with revised language and exception for Tennessee
• Added redirection to Tevimbra for HER2-negative gastric or gastroesophageal junction adenocarcinoma and esophageal carcinoma or gastroesophageal junction squamous cell carcinoma
• Added new Food and Drug Administration (FDA) approved indication for usage in the neoadjuvant/adjuvant setting for locally advanced head and neck squamous cell cancer

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

Ambetter

Policy updates include:

• Added Alyftrek to list of cystic fibrosis transmembrane conductance regulator (CFTR) modulator concurrent exclusion criteria

Ravulizumab-cwvz (Ultomiris) (CP.PHAR.415)

Ambetter

• Updated the list of therapies that Ultomiris should not be prescribed concurrently with to include Epysqli for all indications and Piasky for paroxysmal nocturnal hemoglobinuria
• For generalized myasthenia gravis, clarified that the required immunosuppressive therapy should be non-steroidal
• Revised continued approval duration from 6 to 12 months for all indications as they are chronic conditions

Fulvestrant (Faslodex Injection) (CP.PHAR.424)

Ambetter

• For breast cancer, added triple negative disease option per National Comprehensive Cancer Network (NCCN)
• For ovarian, fallopian tube, and primary peritoneal cancer, endometrial carcinoma, and uterine cancer, added requirement for monotherapy per National Comprehensive Cancer Network (NCCN)

Romosozumab-aqqg (Evenity) (CP.PHAR.428)

Ambetter

• Revised initial approval duration to 12 months for Medicaid/Ambetter
• Revised continuation of therapy to state member must meet the initial approval criteria

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

Ambetter

Policy updates include:

• For breast cancer, removed requirement for “locally” in “locally recurrent” and added for premenopausal female member to be treated with ovarian ablation/suppression per National Comprehensive Cancer Network (NCCN)

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

Ambetter

• Per National Comprehensive Cancer Network (NCCN) – for post-transplant lymphoproliferative disorder, removed specification that disease must be monomorphic and added option for use in combination with rituximab product, cyclophosphamide, doxorubicin, and prednisone (R-CHP) for disease with International Prognostic Index (IPI) score at least 2
• For second-line use, added that member is either not a candidate for chimeric antigen receptor (CAR) T-cell therapy or Polivy is prescribed as bridging therapy until chimeric antigen receptor (CAR) T-cell therapy becomes available and added option for use in combination with Lunsumio for non-transplant/chimeric antigen receptor (CAR) T-cell therapy candidates

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

Ambetter

Policy updates include:

• Added Alyftrek to list of cystic fibrosis transmembrane conductance regulator (CFTR) modulator concurrent exclusion criteria

Crizanlizumab-tmca (Adakveo) (CP.PHAR.449)

Ambetter

• For hydroxyurea trial, added that documentation supports adherence to hydroxyurea for at least the past 6 months, examples of hydroxyurea contraindications and intolerances, and a bypass option requiring provider attestation of past adherence to hydroxyurea for at least 6 months at the maximum tolerated dose and at least 1 vasoocclusive crises while on the maximum tolerated dose
• Removed ICD-10-CM Codes section

Inebilizumab-cdon (Uplizna) (CP.PHAR.458)

Ambetter

• For neuromyelitis optica spectrum disorder, added Epysqli to the list of therapies that Uplizna should not be prescribed concurrently with, and revised continued approval duration from 6 to 12 months as neuromyelitis optica spectrum disorder is a chronic condition
• Added criteria for the newly approved indication of immunoglobulin G4-related disease

Satralizumab-mwge (Enspryng) (CP.PHAR.463)

Ambetter

• Added Epysqli to the list of therapies that Enspryng should not be prescribed concurrently with
• Revised continued approval duration from 6 to 12 months as neuromyelitis optica spectrum disorder is a chronic condition

Mitomycin for Pyelocalyceal Solution (Jelmyto) (CP.PHAR.495)

Ambetter

• Removed requirement for cancer location above the ureteropelvic junction per National Comprehensive Cancer Network (NCCN)
• Removed exclusion for “recent history of carcinoma in situ in the urinary tract, invasive urothelial carcinoma, or high-grade papillary urothelial carcinoma” as this is not excluded per National Comprehensive Cancer Network (NCCN) or the Food and Drug Administration (FDA) indication
• Added requirement for use as monotherapy per National Comprehensive Cancer Network (NCCN)
• Added criteria for newly approved Zusduri

Pemigatinib (Pemazyre) (CP.PHAR.496)

Ambetter

Policy updates include:

• Updated regimens in Appendix B

Pegcetacoplan (Empaveli, Syfovre) (CP.PHAR.524)

Ambetter

• For paroxysmal nocturnal hemoglobinuria, added Epysqli and Piasky to the list of therapies that Empaveli should not be prescribed concurrently with, added improvement of extravascular hemolysis as an example of positive response to therapy, and revised continued approval duration from 6 to 12 months as paroxysmal nocturnal hemoglobinuria is a chronic condition
• Updated Syfovre contraindications in Appendix C to include hypersensitivity per updated prescribing information

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

Ambetter

• For endometrial carcinoma, added that combination use with carboplatin/paclitaxel for advanced/recurrent disease may be followed by single agent use per Food and Drug Administration (FDA) labeling and National Comprehensive Cancer Network (NCCN)
• For solid tumors, removed option for early-stage gastric cancer, added option for locally unresectable, medically inoperable, or polymerase epsilon/delta (POLE/POLD1) mutated small bowel adenocarcinoma, and clarified that polymerase epsilon/delta (POLE/POLD1) mutation should have ultra-hypermutated phenotype per National Comprehensive Cancer Network (NCCN)
• Added off-label criteria for anal carcinoma per National Comprehensive Cancer Network (NCCN)

Maralixibat (Livmarli) (CP.PHAR.543)

Ambetter

• For Alagille syndrome initial and continued therapy and progressive familial intrahepatic cholestasis continued therapy, added exclusion for concurrent use with other IBAT inhibitors
• Added new tablet formulation [10 mg, 15 mg, 20 mg, 30 mg] for Alagille syndrome and progressive familial intrahepatic cholestasis
• For Alagille syndrome, updated criteria from “request is for oral solution 9.5 mg/ml” to “if request is for oral solution, request is for 9.5 mg/ml strength”
• For progressive familial intrahepatic cholestasis, updated criteria from “request is for oral solution 19 mg/ml” to “request is for oral solution, request is for 19 mg/ml strength”
• For both indications, added criteria “if request is for tablets, documentation of member’s current body weight at least 25 kg”
• For section V, updated Alagille syndrome and progressive familial intrahepatic cholestasis sections with tablet dosage by weight

Betibeglogene Autotemcel (Zynteglo) (CP.PHAR.545)

Ambetter

• Added template statement requiring medical director review
• Added criterion for documentation of member’s body weight for verification of weight-based dose

Beremagene geperpavec-svdt (Vyjuvek) (CP.PHAR.592)

Ambetter,

Policy updates include:

• Added exclusion of concomitant use with Zevaskyn

Cinacalcet (Sensipar) (CP.PHAR.61)

Ambetter

• For primary hyperparathyroidism, added requirement that member has failed or is unable to undergo a parathyroidectomy per Food and Drug Administration (FDA)-labeled indication
• Included Parsabiv as an example of a calcimimetic that should not be prescribed concurrently with cinacalcet

Iptacopan (Fabhalta) (CP.PHAR.656)

Ambetter

• For paroxysmal nocturnal hemoglobinuria, added Epysqli and Piasky to the list of therapies that Fabhalta should not be prescribed concurrently with, and revised continued approval duration from 6 to 12 months as paroxysmal nocturnal hemoglobinuria is a chronic condition
• For immunoglobulin A nephropathy, added redirection to Filspari or Vanrafia in initial approval criteria

Danicopan (Voydeya) (CP.PHAR.665)

Ambetter

• Added Epysqli (Soliris biosimilar) as another C5 inhibitor option
• Added requirement for no concurrent use with Empaveli, Fabhalta, or Piasky

Pazopanib (Votrient) (CP.PHAR.81)

Ambetter

• For thyroid carcinoma, removed requirement for iodine-refractory disease for oncocytic carcinoma, added requirement for progressive or symptomatic disease for medullary carcinoma, and updated trial options for medullary carcinoma to include Retevmo per National Comprehensive Cancer Network (NCCN)
• Added off-label criteria for Merkel cell carcinoma per National Comprehensive Cancer Network (NCCN)

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

Ambetter

Policy updates include:

• For primary cutaneous CD30+ T-cell lymphoproliferative disorder, clarified diagnosis as primary cutaneous anaplastic large cell lymphoma and added requirement for monotherapy use per National Comprehensive Cancer Network (NCCN)

Eculizumab (Soliris), Eculizumab-aeeb (Bkemv), Eculizumab-aagh (Epysqli) (CP.PHAR.97)

Ambetter

• Updated Food and Drug Administration (FDA) approved indication for Bkemv to include adult patients with generalized myasthenia gravis who are acetylcholine receptor (AchR) antibody positive
• For paroxysmal nocturnal hemoglobinuria, added Piasky to the list of therapies that Soliris/Bkemv/Epysqli should not be prescribed concurrently with
• For generalized myasthenia gravis, clarified that the required immunosuppressive therapy should be non-steroidal
• Revised continued approval duration from 6 to 12 months for all indications as they are chronic conditions

Rufinamide (Banzel) (CP.PMN.157)

Ambetter

Policy updates include:

• Generic redirection added to Continued Therapy section

Chenodiol (Chenodal) (CP.PMN.239)

Ambetter

Policy updates include:

• For cerebrotendinous xanthomatosis, added that diagnosis must be confirmed by genetic testing and added specialist prescriber requirement for this rare genetic disease

Gabapentin ER (Gralise, Horizant) (CP.PMN.240)

Ambetter

• For postherpetic neuralgia, added member must use generic Gralise if available
• In Appendix B, updated dosing regimens and clarified listed therapeutics alternatives have evidence supporting their use in the indications covered by this policy

Compounded Medications (CP.PMN.280)

Ambetter

Policy updates include:

• Added route of administration, in addition to the indication, for requirement that acceptable compendium supports efficacy and safety

Topiramate Extended-Release (Qudexy XR, Trokendi XR) (CP.PMN.281)

Ambetter

Policy updates include:

• Extended the generic redirection requirement to the Continued Therapy section for seizures

Pyrimethamine (Daraprim) (CP.PMN.44)

Ambetter

• For initial therapy for toxoplasmosis active disease, for toxoplasmosis prophylaxis, clarified member must use trimethoprim/sulfamethoxazole unless contraindicated or clinically significant adverse effects are experienced
• In continued therapy for chronic maintenance following initial therapy for active disease, increased duration of approval from 6 months to 12 months
• In Appendix B, clarified dosing regimen per guideline
• Updated Section V per guidelines

Vortioxetine (Trintellix) (CP.PMN.65)

Ambetter

• Clarified failure of two antidepressants from at least two different drug classes
• In Appendix B, updated therapeutic alternative per Clinical Pharmacology

Levomilnacipran (Fetzima) (HIM.PA.125)

Ambetter

• Clarified failure of two antidepressants from at least two different drug classes
• In Appendix B, updated therapeutic alternatives per Clinical Pharmacology

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

Ambetter

Policy updates include:

• For continued therapy criteria, added “Prescribed regimen is consistent with an Food and Drug Administration (FDA) or American Association for the Study of Liver Diseases - Infectious Diseases Society of America (AASLD-IDSA) recommended regimen”

Sofosbuvir (Sovaldi) (HIM.PA.SP2)

Ambetter

Policy updates include:

• For continued therapy criteria, added “Prescribed regimen is consistent with an Food and Drug Administration (FDA) or American Association for the Study of Liver Diseases - Infectious Diseases Society of America (AASLD-IDSA) recommended regimen”

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

Ambetter

Policy updates include:

• For continued therapy criteria, added “Prescribed regimen is consistent with an Food and Drug Administration (FDA) or American Association for the Study of Liver Diseases - Infectious Diseases Society of America (AASLD-IDSA) recommended regimen”

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

Ambetter

• For continued therapy criteria, added “Prescribed regimen is consistent with an Food and Drug Administration (FDA) or American Association for the Study of Liver Diseases - Infectious Diseases Society of America (AASLD-IDSA) recommended regimen”
• Updated indication to include acute hepatitis C virus
• For continued therapy criteria, revised option for treatment duration minimum from 40 days to 28 days and removed requirement for specific confirmed genotype

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

Ambetter

Policy updates include:

• Added “Prescribed regimen is consistent with an Food and Drug Administration (FDA) or American Association for the Study of Liver Diseases - Infectious Diseases Society of America (AASLD-IDSA) recommended regimen”

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

Ambetter

Policy updates include:

• For continued therapy criteria, added “Prescribed regimen is consistent with an Food and Drug Administration (FDA) or American Association for the Study of Liver Diseases - Infectious Diseases Society of America (AASLD-IDSA) recommended regimen”

Nitisinone (Orfadin, Nityr, Harliku) (CP.PHAR.132)

Ambetter

Policy updates include:

• Added Harliku to criteria along with new criteria set for alkaptonuria.

Emapalumab-lzsg (Gamifant) (CP.PHAR.402)

Ambetter

Policy updates include:

• Added new indication for hemophagocytic lymphohistiocytosis / macrophage activation syndrome per updated prescribing information.

Clesrovimab-cfor (Enflonsia) (CP.PHAR.740)

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
  • Preterm, Late Preterm or Term Infant (must meet all):
    • Age at onset of respiratory syncytial virus (RSV) season at most 12 mo;
    • Request is for RSV prophylaxis;
    • Medical justification supports requests for RSV prophylaxis outside the identified season* duration for the specific region;

*Requests for RSV prophylaxis outside of the typical season (e.g., September through May) by region may be considered. Traditionally RSV season onset was defined by consecutive weeks when RSV antigen-based tests exceeded 10% positivity. Due to the increased use of PCR testing, alternative statistical methods are used to determine seasonality in real time. Local and State health departments should be consulted to determine the real-time RSV season. Additional information on RSV trends by state can be found by visiting: https://www.cdc.gov/nrevss/php/dashboard/index.html.

• Member has not previously received Enflonsia or other RSV monoclonal antibody or any RSV vaccine, including maternal RSV vaccination (unless infant is born less than 14 days after maternal RSV vaccination);
• If member previously received Synagis® for the current RSV season, less than 5 Synagis doses were administered;*

*Synagis should no longer be administered following Enflonsia. Existing Synagis authorizations should be termed.

• Member has not been hospitalized or previously infected with RSV disease during the current RSV season;
• Dose does not exceed a 105 mg single dose.
• Approval duration: 4 weeks (1 dose per lifetime)
• Chronic Lung Disease of Prematurity (must meet all):
  • Diagnosis of chronic lung disease (CLD) of prematurity (i.e., bronchopulmonary dysplasia [BPD]) defined as both of the following:
    • Gestational age less than 32 weeks;
    • Requirement for greater than 21% oxygen for at least 28 days after birth;
  • Medical management (i.e., supplemental oxygen, bronchodilators, diuretics, or chronic corticosteroid therapy) of CLD was required within the previous 6 months;
  • Age at onset of respiratory syncytial virus (RSV) season at most 12 months;
  • Request is for RSV prophylaxis;
  • Medical justification supports requests for RSV prophylaxis outside the identified season* duration for the specific region;
  • Member has not previously received Enflonsia or other RSV monoclonal antibody or any RSV vaccine, including maternal RSV vaccination (unless infant is born less than 14 days after maternal RSV vaccination);
  • If member previously received Synagis for the current RSV season, less than 5 Synagis doses were administered;*
  • Member has not been hospitalized or previously infected with RSV disease during the current RSV season;
  • Dose does not exceed a 105 mg single dose.
  • Approval duration: 4 weeks (1 dose per lifetime)
• Congenital Heart Disease (must meet all):
  • Diagnosis of hemodynamically significant congenital heart disease (CHD) and one of the following:
    • CHD is unoperated or partially corrected;
    • Presence of acyanotic cardiac lesions and one of the following:
      • Pulmonary hypertension with at least 40 mmHg measured pressure in the pulmonary artery;
      • Requirement of daily medication therapy to manage CHD;
    • Age at onset of respiratory syncytial virus (RSV) season at most 12 months;
    • Request is for RSV prophylaxis;
    • Medical justification supports requests for RSV prophylaxis outside the identified season* duration for the specific region;
    • Member has not previously received another RSV monoclonal antibody or any RSV vaccine, including maternal RSV vaccination (unless infant is born less than 14 days after maternal RSV vaccination);
    • If member is undergoing cardiac surgery with cardiopulmonary bypass, member has not previously received at least 2 doses of Enflonsia;
    • If member previously received Synagis, one of the following:
      • Request for Enflonsia is not within the same RSV season in which Synagis was administered;
      • Less than 5 Synagis doses were administered for the current RSV season;
    • Member has not been hospitalized or previously infected with RSV disease during the current RSV season;
    • Dose does not exceed one of the following:
      • 105 mg single dose;
      • Member is undergoing cardiac surgery with cardiopulmonary bypass: an additional 105 mg dose (2 doses total).
    • Approval duration:
      • Cardiac surgery with cardiopulmonary bypass – 12 months (2 doses total per lifetime)
      • All other requests – 4 weeks (1 dose per lifetime)
  • Anatomic Pulmonary Abnormalities, Neuromuscular Disorders, Infants Profoundly Immunocompromised (off-label) (must meet all):
    • Member has anatomic pulmonary abnormalities, neuromuscular disorders, or is profoundly immunocompromised;
    • Age and diagnosis at onset of respiratory syncytial virus (RSV) season at most 12 months;
    • Request is for RSV prophylaxis;
    • Medical justification supports requests for RSV prophylaxis outside the identified season* duration for the specific region;
    • Member has not previously received Enflonsia or other RSV monoclonal antibody or any RSV vaccine, including maternal RSV vaccination (unless infant is born less than 14 days after maternal RSV vaccination);
    • If member previously received Synagis for the current RSV season, less than 5 Synagis doses were administered;*
    • Member has not been hospitalized or previously infected with RSV disease during the current RSV season;
    • Dose does not exceed a 105 mg single dose.
    • Approval duration: 4 weeks (1 dose per lifetime)
  • Cystic Fibrosis (off-label) (must meet all):
    • Diagnosis of cystic fibrosis and one of the following:
      • Clinical evidence of nutritional compromise;
      • Diagnosis of chronic lung disease (CLD) of prematurity defined as both of the following:
        • Gestational age less than 32 weeks;
        • Requirement for greater than 21% oxygen for at least 28 days after birth;
      • Age at onset of respiratory syncytial virus (RSV) season at most 12 mo;
      • Request is for RSV prophylaxis;
      • Medical justification supports requests for RSV prophylaxis outside the identified season* duration for the specific region;
      • Member has not previously received Enflonsia or other RSV monoclonal antibody or any RSV vaccine, including maternal RSV vaccination (unless infant is born less than 14 days after maternal RSV vaccination);
      • If member previously received Synagis for the current RSV season, less than 5 Synagis doses were administered;*
      • Member has not been hospitalized or previously infected with RSV disease during the current RSV season;
      • Dose does not exceed a 105 mg single dose.
      • Approval duration: 4 weeks (1 dose per lifetime)
  • Alaska Native and Other American Indian Infants (off-label) (must meet all):
    • Medical director consultation is required for requests relating to Alaska native and other American Indian infants that fall outside the criteria outlined above;
    • Alaska native infants: Eligibility for prophylaxis may differ from the remainder of the U.S. on the basis of epidemiology of respiratory syncytial virus (RSV) in Alaska, particularly in remote regions where the burden of RSV disease is significantly greater than in the general U.S. population;
    • Other American Indian infants: Limited information is available concerning the burden of RSV disease among American Indian populations. However, special consideration may be prudent for Navajo and White Mountain Apache infants.
    • Age at onset of RSV season at most 12 mo;
    • Request is for RSV prophylaxis;
    • Medical justification supports requests for RSV prophylaxis outside the identified season* duration for the specific region;
    • Member has not previously received Enflonsia or other RSV monoclonal antibody or any RSV vaccine, including maternal RSV vaccination (unless infant is born less than 14 days after maternal RSV vaccination);
    • If member previously received Synagis for the current RSV season, less than 5 Synagis doses were administered;*
    • Member has not been hospitalized or previously infected with RSV disease during the current RSV season;
    • Dose does not exceed a 105 mg single dose.
    • Approval duration: 4 weeks (1 dose per lifetime)
• Continued Therapy: All Indications in Section I
  • Continued therapy will not be authorized as Enflonsia is indicated to be dosed once, unless member is undergoing cardiac surgery with cardiopulmonary bypass, in which case an additional dose may be administered (2 doses total per lifetime).
  • Approval duration: Not applicable

Taletrectinib (Ibtrozi) (CP.PHAR.741)

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: Non-Small Cell Lung Cancer (NSCLC) (must meet all):
  • Diagnosis of NSCLC;
  • Prescribed by or in consultation with an oncologist;
  • Age at least 18 years;
  • Disease has both of the following characteristics:
    • Recurrent, locally advanced, or metastatic;
    • ROS1-positive;
  • For Ibtrozi requests, member must use taletrectinib, if available, unless contraindicated or clinically significant adverse effects are experienced;
  • Request meets one of the following:*
    • Both of the following:
      • Dose does not exceed 600 mg (3 capsules) per day;
      • Dose is at least 200 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 Ibtrozi for a covered indication and has received this medication for at least 30 days;
  • Member is responding positively to therapy;
  • For Ibtrozi requests, member must use taletrectinib, if available, unless contraindicated or clinically significant adverse effects are experienced;
  • If request is for a dose increase, request meets one of the following:*
  • Both of the following:
    • New dose does not exceed 600 mg (3 capsules) per day;
    • New dose is at least 200 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

Sunvozertinib (Zegfrovy) (CP.PHAR.742)

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: Non-small Cell Lung Cancer (must meet all):
  • Diagnosis of recurrent, advanced, or metastatic NSCLC;
  • Prescribed by or in consultation with an oncologist;
  • Age at least 18 years;
  • Disease is positive for EGFR exon 20 insertion mutations;
  • Zegrovy is prescribed as subsequent therapy;
  • Zegfrovy is prescribed as a single agent;
  • For Zegfrovy requests, member must use sunvozertinib, if available, unless contraindicated or clinically significant adverse effects are experienced;
  • Request meets one of the following (a, b, or c):*
    • Dose does not exceed:
      • 200 mg per day;
      • 1 tablet per day;
    • Both of the following:
      • Dose does not exceed both of the following (1 and 2):
        • 400 mg per day;
        • 2 tablets per day;
      • Prescriber attestation of member’s inability to avoid concomitant use of CYP3A inducer (e.g., carbamazepine, rifampin, ritonavir, St. John’s wort);
    • 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
• Continued Therapy: Non-small Cell Lung Cancer (must meet all):
  • Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Zegfrovy for a covered indication and has received this medication for at least 30 days;
  • Member is responding positively to therapy;
  • For Zegfrovy requests, member must use sunvozertinib, if available, unless contraindicated or clinically significant adverse effects are experienced;
  • Zegfrovy is prescribed as a single agent;
  • If request is for a dose increase, request meets one of the following (a, b, or c):*
  • New dose does not exceed:
    • 200 mg per day;
    • 1 tablet per day;
  • Both of the following
    • New dose does not exceed both of the following (1 and 2):
      • 400 mg per day;
      • 2 tablets per day;
    • Prescriber attestation of member’s inability to avoid concomitant use of CYP3A inducer (e.g., carbamazepine, rifampin, ritonavir, St. John’s wort);
  • 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

Linvoseltamab-gcpt (Lynozyfic) (CP.PHAR.743)

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: Multiple Myeloma (must meet all):
  • Diagnosis of MM;
  • Prescribed by or in consultation with an oncologist or hematologist;
  • Age at least 18 years;
  • Disease is relapsed or refractory;
  • One of the following:
    • Member has measurable disease as evidenced by one of the following assessed within the last 28 days (i, ii, or iii):
      • Serum M-protein at least 0.5 g/dL;
      • Urine M-protein at least 200 mg/24 h;
      • Serum free light chain (FLC) assay: involved FLC level at least 10 mg/dL (100 mg/L) provided serum kappa lambda FLC ratio is abnormal;
    • Member has progressive disease, as defined by the International Myeloma Working Group (IMWG) response criteria (see Appendix D), assessed within 60 days following the last dose of the last anti-myeloma drug regimen received;
  • Member has received or has documented intolerance to at least 4 prior lines of therapy (see Appendix B for examples) that include all of the following (a, b, and c):
    • One proteasome inhibitor (e.g., bortezomib, Kyprolis®, Ninlaro®);
    • One immunomodulatory agent (e.g., Revlimid®, Pomalyst®, Thalomid®);
    • One anti-CD38 monoclonal antibody (e.g., Darzalex®/Darzalex Faspro™, Sarclisa®);
    • *Prior authorization may be required
  • Member does not have known multiple myeloma brain lesions or meningeal involvement;
  • Request meets one of the following:*
    • Dose does not exceed all of the following (i–v):
      • Day 1: 5 mg;
      • Day 8: 25 mg;
      • Day 15: 200 mg;
      • One week after Day 15 treatment dose and once weekly from week 4 to week 13 for 10 treatment doses: 200 mg per week;
      • Week 14 and every 2 weeks thereafter: 200 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: Multiple Myeloma (must meet all):
  • Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Lynozyfic 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 one of the following:
  • 200 mg every 2 weeks;
  • For members that have achieved and maintained very good partial response (VGPR) or better at or after week 24 and received at least 17 doses of 200 mg: 200 mg every 4 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

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

Ambetter

Policy updates include:

• Added brand Phyrago for pediatric use to all indications per pediatric extension in positive Philadelphia chromosome (Ph+) chronic myelogenous leukemia and acute lymphoblastic leukemia

Inclisiran (Leqvio) (CP.PHAR.568)

Ambetter

• Updated indication to reflect revised use as an adjunct to exercise (rather than statin therapy) for hypercholesterolemia
• Revised hyperlipidemia to hypercholesterolemia throughout the criteria

Cyclosporine ophthalmic emulsion (Cequa, Klarity-C, Restasis, Verkazia, Vevye) (CP.PMN.48)

Ambetter

• Removed “at up to maximally indicated doses” for failure of artificial tears
• In Appendix B per Clinical Pharmacology, clarified ophthalmic anti-inflammatory agents and artificial tears examples

Mepolizumab (Nucala) (HIM.PA.175)

Ambetter

Policy updates include:

• For chronic obstructive pulmonary disease, revised blood eosinophil count requirement from “at least 300 cells/µl” to “at least 150 cells/µl at time of request or at least 300 cells/µl in the past 12 months”