Effective April 1, 2025: Pharmacy and Biopharmacy Policies

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

Medicaid

Policy includes:

·         Requests for indications not approved by the FDA are reviewed with the off-label use policy MS.PMN.53 for Medicaid.

·         Initial Approval Criteria: Biliary Tract Cancer (BTC) (must meet all):

o   Diagnosis of BTC;

o   Prescribed by or in consultation with an oncologist;

o   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;

o   Prescribed as a single agent;

o   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

o   Approval duration: 6 months

·         Continued Therapy: Biliary Tract Cancer (must meet all):

o   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;

o   If request is for a dose increase, request meets one of the following:

o   New dose does not exceed 20 mg/kg every 2 weeks;

o   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

o   Approval duration: 12 months

Marstacimab-hncq (Hympavzi)

(CP.PHAR.674)

Medicaid

Policy includes:

• Requests for indications not approved by the FDA are reviewed with the off-label use policy MS.PMN.53 for Medicaid.

·         Initial Approval Criteria: Congenital Hemophilia A or B (must meet all):

o   Prescribed for routine prophylaxis of bleeding episodes in members with one of the following:

§  Congenital hemophilia A (FVIII deficiency);

§  Congenital hemophilia B (FIX deficiency);

o   Prescribed by or in consultation with a hematologist;

o   Age ≥ 12 years;

o   Member meets one of the following:

§  For hemophilia A: Member has severe hemophilia, defined as FVIII level of < 1%;

§  For hemophilia B: Member has moderately severe to severe hemophilia, defined as FIX level of ≤ 2%;

§  Member has experienced at least one serious spontaneous bleed (see Appendix D);

o   One of the following:

§  For hemophilia A, both:

·         Failure of a FVIII product used for routine prophylaxis as assessed and documented by prescriber, unless clinically significant adverse effects are experienced or all are contraindicated;*

·         Failure of Hemlibra® as assessed and documented by prescriber, unless contraindicated or clinically significant adverse effects are experienced;

§  For hemophilia B: Failure of a FIX product used for routine prophylaxis as assessed and documented by prescriber, unless clinically significant adverse effects are experienced or all are contraindicated;

o   No documented history of inhibitors;

o   Provider confirms that member will discontinue any use of FVIII or FIX products as prophylactic therapy while on Hympavzi (on-demand usage may be continued);

o   Dose does not exceed both:

§  Loading dose of 300 mg (2 pens or syringes);

§  Maintenance dose of 150 mg (1 pen or syringe) per week thereafter.

o   Approval Duration: 6 months

·         Continued Therapy: Congenital Hemophilia A or B (must meet all):

o   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;

o   Member is responding positively to therapy (e.g., reduction in the number of all bleeds, joint bleeds, and/or target joint bleeds over time);

o   Provider confirms that member has discontinued any use of FVIII or FIX products as prophylactic therapy while on Hympavzi (on-demand usage may be continued);

o   If request is for a dose increase, new maintenance dose does not exceed:

§  150 mg (1 pen or syringe) per week;

§  300 mg (2 pens or syringes) per week AND documentation of both:

·         Member’s weight ≥ 50 kg;

·         Control of bleeding events on a maintenance dose of 150 mg per week is judged to be inadequate by the provider.

o   Approval Duration: 12 months

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

Medicaid

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, extraskeletal 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)

Medicaid  

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

Evolocumab (Repatha) (CP.PHAR.123)

Medicaid

Policy updates include:

·         Revised FDA approved indication 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

Alirocumab (Praluent) (CP.PHAR.124)

Medicaid

Policy updates include:

·         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

·         For all indications, revised continued therapy criteria to require provider attestation rather than documentation

·         In Appendix B, added pravastatin and fluvastatin as therapeutic alternatives

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

Medicaid

Policy updates include:

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

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

Medicaid

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)

Medicaid

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)

Medicaid

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)

Medicaid

Policy updates include:

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

Dalteparin (Fragmin) (CP.PHAR.225)

Medicaid

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)

Medicaid

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)

Medicaid

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

Bortezomib (Velcade) (CP.PHAR.410)

Medicaid

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 NCCN compendium

·         Updated “acquired immunodeficiency syndrome (AIDS)-related Kaposi Sarcoma” to “Kaposi Sarcoma” per NCCN compendium

Afamelanotide (Scenesse) (CP.PHAR.444)

Medicaid

Policy updates include:

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

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

Medicaid

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)

Medicaid

Policy updates include:

·         For initial criteria, added medical geneticist

·         References reviewed and updated

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

Medicaid

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

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

Medicaid

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)

Medicaid

Policy updates include:

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

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

Medicaid

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)

Medicaid

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

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

Medicaid

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

Nedosiran (Rivfloza) (CP.PHAR.619)

Medicaid

Policy updates include:

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

Sotatercept (Winrevair) (CP.PHAR.657)

Medicaid

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

Repository Corticotropin Injection (Acthar Gel, Purified Cortrophin Gel) (CP.PHAR.168)

Medicaid

Policy update includes:

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

Mepolizumab (Nucala) (CP.PHAR.200)

Medicaid

Policy update includes:

·         For asthma initial approval criteria, added allowance for emergency room visit

·         Ambetter line of business removed as separate criteria is required

·         For asthma removed intubation option for alignment purposes as a hospital admission would encompass intubation.

Dupilumab (Dupixent) (CP.PHAR.336)

Medicaid

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

Omalizumab (Xolair) (CP.PHAR.01)

Medicaid

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 (NCCN)

·         Updated Appendix D to include information about atopic dermatitis

Nivolumab (Opdivo) (CP.PHAR.121)

Medicaid

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 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 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 NCCN

·         Added off-label criteria per 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 NCCN

·         For off-label recurrent or progressive intermediate trophoblastic tumor, removed requirement for following treatment with platinum-based regimen per NCCN

Cosyntropin (Cortrosyn) (CP.PHAR.203)

Medicaid

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

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

Medicaid

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)

Medicaid

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)

Medicaid

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)

Medicaid

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 NCCN

·         For small cell lung cancer and cervical cancer, added Tecentriq/Tecentriq Hybreza may be continued as a single agent for maintenance therapy per 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 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 NCCN

·         For mesotheliomas, added option for usage originating from the pericardium or the tunica vaginalis per NCCN

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

Medicaid

Policy update includes:

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

Tisagenlecleucel (Kymriah) (CP.PHAR.361)

Medicaid

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)

Medicaid

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

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

Medicaid

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; J9323]

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

Medicaid

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)

Medicaid

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)

Medicaid

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

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

Medicaid

Policy update includes:

·         For generalized myasthenia gravis, added exclusion for concurrent therapy with Bkemv, Epysqli, Zilbrysq, and a neonatal Fc receptor (FcRn) antagonist

·         For chronic inflammatory demyelinating polyneuropathy, added exclusion for concurrent therapy with a complement inhibitor or fcrn antagonist

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

Medicaid

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)

Medicaid

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)

Medicaid

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

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

Medicaid

Policy update includes:

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