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
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Zanidatamab-hrii (Ziihera) (CP.PHAR.709)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and 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, and CP.PMN.53 for Medicaid and CHIP
- 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
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Amifampridine (Firdapse) (CP.PHAR.411)
| Ambetter
| Policy updates include:
- Modified maximum dose per updated prescribing information
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Pirfenidone (Esbriet) (CP.PHAR.286)
| Ambetter
| Policy updates include:
- Revised generic redirection to generic tablet or capsule by removing specific formulations.
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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
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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, 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
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Ramucirumab (Cyramza) (CP.PHAR.119)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and 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
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Evolocumab (Repatha) (CP.PHAR.123)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS) and CHIP
| 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
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Alirocumab (Praluent) (CP.PHAR.124)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS) and CHIP
| 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
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Alglucosidase Alfa (Lumizyme) (CP.PHAR.160)
| Ambetter
| Policy updates include:
- Added increased lysosomal glycogen as an additional option for confirming a Pompe disease diagnosis
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Miglustat (Zavesca) (CP.PHAR.164)
| Ambetter
| Policy updates include:
- Added criteria for use in Niemann-Pick Disease Type C.
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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
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Ranibizumab (Byooviz, Cimerli, Lucentis, Susvimo) (CP.PHAR.186)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and 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
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Verteporfin (Visudyne) (CP.PHAR.187)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and 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
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Trabectedin (Yondelis) (CP.PHAR.204)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter
| Policy updates include:
- Added Commercial line of business
- For myxoid liposarcoma, added option for unresectable primary disease and Stage IV disease that is amendable to local therapy
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Reslizumab (Cinqair) (CP.PHAR.223)
| Ambetter
| Policy updates include:
- For initial approval criteria, added allowance for emergency room visit
- Removed intubation option for alignment purposes as a hospital admission would encompass intubation
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Dalteparin (Fragmin) (CP.PHAR.225)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and 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
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Siltuximab (Sylvant) (CP.PHAR.329)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and 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
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Avelumab (Bavencio) (CP.PHAR.333)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and 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
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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
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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
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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
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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
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Bortezomib (Velcade) (CP.PHAR.410)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and 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
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Afamelanotide (Scenesse) (CP.PHAR.444)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter
| Policy updates include:
- Removed requirement for gene sequencing per consensus guidelines as not required for primary diagnosis and recommended as follow-up tests
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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
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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
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Avapritinib (Ayvakit) (CP.PHAR.454)
| Ambetter
| Policy updates include:
- Added oncology bypass language to existing redirections
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Fam-Trastuzumab Deruxtecan-nxki (Enhertu) (CP.PHAR.456)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and 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
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Lumasiran (Oxlumo) (CP.PHAR.473)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter
| Policy updates include:
- For initial criteria, added medical geneticist
- References reviewd and updated.
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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
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Evinacumab-dgnb (Evkeeza) (CP.PHAR.511)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS) and CHIP
| 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 Praluent to apply only to age ≥ 18 years old per Praluent Food and Drug Administration (FDA)-approved indication for homozygous familial hypercholesterolemia
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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
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Interferon Gamma- 1b (Actimmune) (CP.PHAR.52)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and 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
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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)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and 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
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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
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Faricimab-svoa (Vabysmo) (CP.PHAR.581)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and 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
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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
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Teclistamab-cqyv (Tecvayli) (CP.PHAR.611)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and 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
- Revised all Commercial approval durations to “6 months or to the member’s renewal date, whichever is longer” per template for this injectable agent
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Mirvetuximab Soravatansine-gynx (Elahere) (CP.PHAR.617)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and 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)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and 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)
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Sotatercept (Winrevair) (CP.PHAR.657)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and 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
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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)
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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
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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
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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
|
Cosibelimab-Ipdl (Unloxcyt) (CP.PHAR.711)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and 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, and CP.PMN.53 for Medicaid and CHIP
- Criteria is only applicable for Medicaid and CHIP when the drug is added to the formulary for coverage
- 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
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Zenocutuzumab-zbco (Bizengri) (CP.PHAR.713)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and 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, and CP.PMN.53 for Medicaid and CHIP
- Criteria is only applicable for Medicaid and CHIP when the drug is added to the formulary for coverage
- 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
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Bimekizumab-bkzx (Bimzelx) (CP.PHAR.660)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS) and CHIP
| Policy updates include:
- Added newly approved indication for hidradenitis suppurativa
|
Aripiprazole Orally Disintegrating Tablet, Oral Film (Opipza) (CP.PMN.300)
| Ambetter
| Policy updates include:
- Adapted from previously approved policy CP.PCH.37 (retired)
- Added Medicaid line of business
- Added new formulation Opipza to policy with step therapy requirement for generic aripiprazole tablet, oral solution, and oral disintegrating tablet
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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
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Cabotegravir (Apretude), Cabotegravir/Rilpivirine (Cabenuva) (CP.PHAR.573)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and 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
|
Tocilizumab (Actemra), Tocilizumab-bavi (Tofidence),Tocilizumab-aazg (Tyenne) (CP.PHAR.263)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS) and CHIP
| Policy updates include:
- 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 clinical juvenile arthritis disease activity score (cJADAS)-10 from baseline” in continued therapy
- For Appendix I, added polyarticular juvenile idiopathic arthritis disease activity information per 2019 American College of Rheumatology (ACR) guidelines
|
Eladocagene Exuparvovec-tneq (Kebilidi) (CP.PHAR.595)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and 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.”
|
Fondaparinux (Arixtra) (CP.PHAR.226)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter
| Policy updates include:
- Updated appendix D with current National Comprehensive Cancer Network (NCCN)compendium language
- Added newly approved indication for treatment of venous thromboembolism in pediatric patients to criteria.
|
Setmelanotide (Imcivree) (CP.PHAR.491)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter
| Policy updates include:
- For Bardet-Biedl syndrome initial criteria, added standard approval language for Commercial line of business of “6 months or to the member’s renewal date, whichever is longer”
- Updated contraindications section to include hypersensitivity to setmelanotide or any of its excipients
- Updated criteria to reflect pediatric extension for age at least 2 years
|
Naltrexone (Vivitrol) (CP.PHAR.96)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter
| Policy updates include:
- Expanded treatment settings to include outpatient facility (e.g., physician’s office, outpatient clinic) with chart note documentation submitted demonstrating daily treatment with oral naltrexone, added standard approval language to Commercial line of business to continued therapy
|
SGLT2 inhibitors (HIM.PA.91)
| Ambetter
| Policy updates include:
- Updated type 2 diabetes mellitus criteria for Invokana, Invokamet, and Invokamet XR to reflect pediatric extensions for age at least 10 years
|
Compounded Medications (CP.PMN.280)
| Ambetter
| Policy updates include:
- For initial therapy, added criteria option that compounded drug is prescribed in the place of an Food and Drug Administration (FDA)-approved product that is in shortage per the FDA or American Society of Health-System Pharmacists (ASHP) Drug Shortages list and respective approval duration as “up to anticipated resolution date or 3 months for unknown resolution date;”
- For continued therapy for FDA-approved product in shortage, added requirement that product is still in shortage and approval duration as “up to anticipated resolution date or 6 months for unknown resolution date.”
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