POLICY
| APPLICABLE PRODUCTS
| NEW POLICY OVERVIEW OR UPDATED POLICY REVISIONS
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Dapsone (Aczone Gel) (CP.PCH.32)
| Ambetter
| Policy update includes:
- Clarified criteria applies to generic dapsone gel
- Added member must use generic dapsone gel
- In initial approval criteria, clarified failure of two preferred topical anti-acne agents from different listed classes, clarified that adapalene and combination products may require prior authorization updated Appendix B
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Lapatinib (Tykerb) (CP.PHAR.79)
| Ambetter
| Policy update includes:
- For bone cancer, added “conventional or chondroid” to criterion “diagnosis of recurrent conventional or chondroid chordoma”
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Bevacizumab (Alymsys, Avastin, Avzivi, Mvasi, Vegzelma, Zirabev) (CP.PHAR.93)
| Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy update includes:
- Re-organized Food and Drug Administration (FDA)-approved indications for improved clarity
- For the following oncology indications, revised the following per National Comprehensive Cancer Network (NCCN): for non-small cell lung cancer, added qualifier of unresectable, specified sensitizing EGFR mutation for combination use with erlotinib, added additional agents with which pemetrexed and Tecentriq can be prescribed, removed requirement that the combination of carboplatin and paclitaxel is reserved for first-line treatment
- For renal cell carcinoma, added qualifier of relapsed
- For ovarian cancer, removed requirement that use with platinum agent + chemotherapy followed by single agent bevacizumab be limited to Stage IB-IV disease, added that combination with Zejula may be used for maintenance therapy if intolerant to Lynparza, added additional combination regimens for platinum-resistant disease (cyclophosphamide and Keytruda, Ixempra, Elahere), added combination with Elhere for platinum-sensitive disease
- For hepatocellular carcinoma, removed requirement that disease is Child-Pugh class A or B and added pathway for adjuvant therapy in members at high risk of recurrence following resection or ablation
- Added additional off-label uses (pleomorphic xanthroastrocytoma, gliosarcoma, H3-mutated high-grade glioma, high-grade astrocytoma with piloid features, neurofibromatosis type 2 vestibular schwannomas with hearing loss, vaginal cancer)
- Added requirement for combination use for ampullary adenocarcinoma, peritoneal mesothelioma, pleural mesothelioma, small bowel adenocarcinoma, or vulvar cancer
- For ophthalmology uses: revised choroidal neovascularization to allow any cause and added additional examples, added radiation retinopathy and retinopathy of prematurity as supported by literature, added requirement for ophthalmologist prescriber, removed age restriction as some covered diagnoses may affect pediatric populations
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Erenumab-aooe (Aimovig) (CP.PHAR.128)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy update includes:
- Added Zavzpret to list of calcitonin gene-related peptide (CGRP) inhibitors that should not be prescribed concurrently with Aimovig, removed references to “injectable or oral calcitonin gene-related peptide (CGRP)” as Zavzpret is a nasal product
- Updated HCPCS code J3490 to J3590 for unclassified biologics
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Avatrombopag (Doptelet) (CP.PHAR.130)
| Ambetter
| Policy update includes:
- Added concurrent thrombopoietin receptor agonists and spleen tyrosine kinase inhibitor exclusions to all Food and Drug Administration (FDA)-labeled indications per competitor criteria
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Infertility and Fertility Preservation (CP.PHAR.131)
| Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy update includes:
- Evidence of coverage for infertility/fertility preservation language for HIM line of business updated for the following states: add AR, IL, LA, NV and removed KS, MI, NE, NM, SC
- Added HCPC code [J3490, J3590]
- Added for brand Cetrotide requests redirection to generic cetrorelix
- Removed references to brand Novarel due to product discontinuation
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Idelalisib (Zydelig) (CP.PHAR.133)
| Ambetter
| Policy update includes:
- For chronic lymphocytic leukemia/small lymphocytic lymphoma, revised prior therapy requirement from at least one prior therapy to prior therapy with Bruton tyrosine kinase (BTK) inhibitor and Venclexta-based regimens per National Comprehensive Cancer Network (NCCN)
- Updated Appendix B per National Comprehensive Cancer Network (NCCN)
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Elagolix (Orilissa), Elagolix/Estradiol/Norethinedrone (Oriahnn) (CP.PHAR.136)
| Ambetter
| Policy update includes:
- For Oriahnn, added Ambetter non-formulary disclaimer and reference to formulary exception policy HIM.PA.103
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Lenvatinib (Lenvima) (CP.PHAR.138)
| Ambetter
| Policy update includes:
- For differentiated thyroid cancer, clarified Hurthle cell carcinoma as oncocytic carcinoma and added criteria requiring prescription as monotherapy
- For medullary carcinoma, revised section title to include anaplastic carcinoma and added off-label criteria for anaplastic thyroid carcinoma per National Comprehensive Cancer Network (NCCN) category 2A recommendation
- Clarified Afinitor as everolimus due to generic availability
- For renal cell carcinoma, simplified criteria requiring failure of a prior renal cell carcinoma therapy to “as subsequent therapy”
- For endometrial carcinoma, clarified systemic therapy as platinum-based systemic therapy
- For thymic carcinoma, removed requirement for disease type due to National Comprehensive Cancer Network (NCCN) 2A recommended use in all disease types, simplified criteria requiring members who “have not tolerated or responded to National Comprehensive Cancer Network (NCCN) recommended agents” to “as subsequent therapy”
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Mogamulizumab-kpkc (Poteligeo) (CP.PHAR.139)
| Ambetter
| Policy update includes:
- For adult T-cell leukemia/lymphoma initial criteria, added “prescribed as a single-agent” to align with National Comprehensive Cancer Network (NCCN) compendium and guideline
- For Appendix B, added another therapeutic option “Zidovudine and interferon” for adult T-cell leukemia/lymphoma first line therapy
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Bendamustine (Belrapzo, Bendeka, Treanda, Vivimusta) (CP.PHAR.307)
| Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy update includes:
- Removed reference to HIM.PA.103 formulary exception policy for generic bendamustine due to formulary status on at least one Ambetter state formulary
- Clarified that policy applies to generic bendamustine
- For all indications, revised commercial approval duration to “6 months or to the member’s renewal date, whichever is longer”
- For non-Hodgkin lymphoma per National Comprehensive Cancer Network (NCCN), clarified follicular lymphoma is classic, updated formatting for Marginal zone lymphoma to clarify types
- Specified DLBL is with no intention to preceed to transplant, revised high-grade B-cell lymphoma criteria to lymphoma with no intention to proceed to transplant, added requirements for combination use for classic follicular lymphoma, Marginal zone lymphoma, indolent non-Hodgkin lymphoma, diffuse large B-cell lymphoma, human immunodeficiency virus (HIV)-related B-cell lymphoma, post-transplant lymphoproliferative disorder not otherwise specified, and high-grade B-cell lymphoma per National Comprehensive Cancer Network (NCCN)
- For off-label National Comprehensive Cancer Network (NCCN) uses per National Comprehensive Cancer Network (NCCN), added relapsed or refractory requirements to Hodgkin lymphoma, multiple myeloma, and systemic light chain amyloidosis, added as subsequent therapy requirement to multiple myeloma and Pthymic carcinomaL, added initial therapy requirement to peripheral T-cell lymphoma
- Added off-label indications of mycosis fungoides / Sezary syndrome, enteropathy-associated T-cell lymphoma, and anaplastic large cell lymphoma, clarified peripheral T-cell lymphoma subtypes, clarified Waldenstrom’s macroglobulinemia includes Bing-Neel syndrome, added requirements for combination use for T-cell lymphomas, mycosis fungoides / Sezary syndrome, and Waldenstrom’s macroglobulinemia
- Updated Appendix B per National Comprehensive Cancer Network (NCCN)
- Removed bendamustine 45mg and 180mg vials per product discontinuation
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Elotuzumab (Empliciti) (CP.PHAR.308)
| Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy update includes:
- Added hematologist as prescriber option
- Added criterion disease is relapsed or refractory per National Comprehensive Cancer Network (NCCN)
- Added International Myeloma Working Group (IMWG) criterion defining progressive multiple myeloma disease as multiple myeloma class alignment
- For Commercial line of business, revised approval duration to standard language of “6 months or to the member’s renewal date, whichever is longer”
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Carfilzomib (Kyprolis) (CP.PHAR.309)
| Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy update includes:
- For relapse or refractory multiple myeloma prescribing regimens: added hematologist as prescriber option, added International Myeloma Working Group (IMWG) criterion defining progressive multiple myeloma disease as multiple myeloma class alignment, revised verbiage from “one or three lines of therapy” to “one to three lines of therapy”, added verbiage “in patients who have received one to three lines of therapy” when used in combination with Xpovio, cyclophosphamide, or pomalidomide
- Added regimen option in combination with venetoclax and dexamethasone in patients with t(11:14) translocations
- For systemic light chain amyloidosis, added option for treatment for newly diagnosed disease or relapsed/refractory disease as a repeat of initial therapy if relapse-free for several years per National Comprehensive Cancer Network (NCCN)
- For Commercial line of business, revised approval duration to standard language of “6 months or to the member’s renewal date, whichever is longer”
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Belinostat (Beleodaq) (CP.PHAR.311)
| Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy update includes:
- Per National Comprehensive Cancer Network (NCCN), added that Beleodaq must be prescribed as a single agent and added requirements regarding prior therapies (with bypass allowed if prescribed as palliative therapy for peripheral T-cell lymphoma)
- Removed primary cutaneous anaplastic large cell lymphoma as a coverable off-label use as it is no longer recommended by National Comprehensive Cancer Network (NCCN)
- Removed “gamma delta” qualifier from hepatosplenic T-cell lymphoma as National Comprehensive Cancer Network (NCCN) does not specify this
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Pralatrexate (Folotyn) (CP.PHAR.313)
| Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy update includes:
- Updated notation regarding Ambetter non-formulary status for 40 mg/2 ml vials to exclude Ambetter FL and AZ per current formulary status
- Revised policy/criteria section to also include generic pralatrexate
- For non-cutaneous T-cell lymphomas, added requirement that Folotyn be prescribed as a single agent per National Comprehensive Cancer Network (NCCN)
- Removed “gamma delta” qualifier from hepatosplenic T-cell lymphoma as National Comprehensive Cancer Network (NCCN) does not specify this
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Cetuximab (Erbitux) (CP.PHAR.317)
| Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy update includes:
- Per National Comprehensive Cancer Network (NCCN) – for HNSCC, added qualifier of unresectable disease and added alternative combinations with Keytruda, paclitaxel, or docetaxel
- For colorectal cancer, added pathways for Kirsten rat sarcoma 2 viral oncogene homologue (KRAS) G12C, deficient mismatch repair/microsatellite instability-high (dMMR/MSI-H), and polymerase epsilon/delta (POLE/POLD1) mutations with corresponding requirements related to combination use and/or prior therapy, limited combination use with irinotecan for after prior therapy only, and modified requirement for left-sided colon cancer to only apply to unresectable synchronous liver/lung metastases
- For non-small cell lung cancer, specified sensitizing EGFR mutations (EGFR exon 19 deletion or exon 21 L858R, EGFR S768I, L861Q, and/or G719X mutation positive)
- For penile cancer, added qualifier of recurrent disease
- For squamous cell skin cancer, added qualifiers of unresectable and recurrent disease, removed qualifier of very high risk, and added pathway for combination use with carboplatin and paclitaxel
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Panitumumab (Vectibix) (CP.PHAR.321)
| Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy update includes:
- Per National Comprehensive Cancer Network (NCCN) – added pathways for Kirsten rat sarcoma 2 viral oncogene homologue (KRAS) G12C, deficient mismatch repair/microsatellite instability-high (dMMR/MSI-H), and polymerase epsilon/delta (POLE/POLD1) mutations with corresponding requirements related to combination use and/or prior therapy
- Removed prior therapy requirement when requested for use as a single agent
- Modified requirement for left-sided colon cancer to only apply to unresectable synchronous metastases
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Ribociclib (Kisqali), Ribociclib/Letrozole (Kisqali Femara) (CP.PHAR.334)
| Ambetter
| Policy update includes:
- For Kisqali, updated the Food and Drug Administration (FDA) approved indication for use in combination with fulvestrant to reflect the population expansion from “in postmenopausal women or in men” to “adults”
- For initial therapy, added “perimenopausal female” to the requirement for ovarian ablation/suppression
- Added criteria for endometrial carcinoma as off-label indication is supported by National Comprehensive Cancer Network (NCCN) compendium and guidelines
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Pegaspargase (Oncaspar), Calaspargase Pegol-mknl (Asparlas) (CP.PHAR.353)
| Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy update includes:
- For T-cell lymphoma removed hepatosplenic T-cell lymphoma indication and added GELAD (gemcitabine, etoposide, pegaspargase, dexamethasone)
- regimen option per National Comprehensive Cancer Network (NCCN)
- Revised Commercial approval durations to “6 months or to the member’s renewal date, whichever is longer;” references reviewed and updated.
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Copanlisib (Aliqopa) (CP.PHAR.357)
| Ambetter
| Policy update includes:
- Removed initial approval criteria due to manufacturer withdrawal
- Added information regarding the market withdrawal to Appendix D
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Azacitidine (Onureg, Vidaza) (CP.PHAR.387)
| Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy update includes:
- Revised policy/criteria section to also include generic azacitidine
- For all indications where applicable, updated generic redirection to include Vidaza
- For acute myelogenous leukemia, removed requirement for Onureg that member is not able to or declines to complete intensive consolidation therapy and added requirements regarding usage of Vidaza (single agent and combination) per National Comprehensive Cancer Network (NCCN)
- Updated off-label criteria for “myelofibrosis” to instead refer to “myeloproliferative neoplasms” and added specific requirements around recommended uses (bridging therapy prior to transplant and use as a single agent or in various combinations) per National Comprehensive Cancer Network (NCCN)
- Added off-label criteria for peripheral T-cell lymphomas per National Comprehensive Cancer Network (NCCN)
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Duvelisib (Copiktra) (CP.PHAR.400)
| Ambetter
| Policy update includes:
- Added limitation of use per package insert
- For chronic lymphocytic leukemia/small lymphocytic lymphoma, revised prior therapy requirement from at least one prior therapy to prior therapy with Bruton tyrosine kinase (BTK) inhibitor and Venclexta-based regimens per National Comprehensive Cancer Network (NCCN) and package insert
- Updated Appendix B per National Comprehensive Cancer Network (NCCN)
- Clarified boxed warning language per package insert
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Fremanezumab-vfrm (Ajovy) (CP.PHAR.403)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy update includes:
- Added Zavzpret to list of calcitonin gene-related peptide (calcitonin gene-related peptide (CGRP)) inhibitors that should not be prescribed concurrently with Ajovy, removed references to “injectable or oral calcitonin gene-related peptide (calcitonin gene-related peptide (CGRP))” as Zavzpret is a nasal product
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Galcanezumab-gnlm (Emgality) (CP.PHAR.404)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy update includes:
- Added Zavzpret to list of calcitonin gene-related peptide (calcitonin gene-related peptide (CGRP)) inhibitors that should not be prescribed concurrently with Emgality, removed references to “injectable or oral calcitonin gene-related peptide (calcitonin gene-related peptide (CGRP))” as Zavzpret is a nasal product
- Updated HCPCS code J3490 to J3590 for unclassified biologics
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Pexidartinib (Turalio) (CP.PHAR.436)
| Ambetter
| Policy update includes:
- For tenosynovial giant cell tumor and histiocytic neoplasms, added requirement to be prescribed as a single agent per National Comprehensive Cancer Network (NCCN) compendium
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Thioguanine (Tabloid) (CP.PHAR.437)
| Ambetter
| Policy update includes:
- Added generic redirection per oral oncology template language
- For acute lymphoblastic leukemia revised criterion for combination with Sprycel® or imatinib to a tyrosine kinase inhibitor and removed age < 65 criterion and removed requirement for age < 18 years in Philadelphia chromosome-positive acute lymphoblastic leukemia per National Comprehensive Cancer Network (NCCN) Compendium
- For glioma removed requirement for prior fractionated external beam radiation therapy per National Comprehensive Cancer Network (NCCN) Compendium
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Valrubicin (Valstar) (CP.PHAR.439)
| Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy update includes:
- Clarified that policy applies to generic valrubicin
- Added criterion for brand Valstar requests, that member must use generic valrubicin
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Entrectinib (Rozlytrek) (CP.PHAR.441)
| Ambetter
| Policy update includes:
- For non-small cell lung cancer, added requirement for use as a single agent
- For neurotrophic tyrosine receptor kinase solid tumors, added requirement for recurrent or unresectable disease and use as a single agent per National Comprehensive Cancer Network (NCCN)
- Added off-label criteria for ROS1 positive melanoma per National Comprehensive Cancer Network (NCCN) 2A recommendation
- In continued therapy, added requirement that member must use generic if available
- Clarified solid tumors examples Appendix D per National Comprehensive Cancer Network (NCCN) compendium
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Nadofaragene Firadenovec-vncg (Adstiladrin) (CP.PHAR.461)
| Ambetter
| Policy update includes:
- Added option for prescribed by or in consultation with an urologist
- Added off-label indication for Ta/T1 high-grade disease without CIS per National Comprehensive Cancer Network (NCCN)
- Removed requirement for intravesical chemotherapy per National Comprehensive Cancer Network (NCCN)
- Added requirement that member is not a candidate for cystectomy
- Increased approval duration from 3 months to 6 months
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Ubrogepant (Ubrelvy) (CP.PHAR.476)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy update includes:
- Added Zavzpret to list of calcitonin gene-related peptide (calcitonin gene-related peptide (CGRP)) inhibitors that should not be prescribed concurrently with Ubrelvy
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Eptinezumab-jjmr (Vyepti) (CP.PHAR.489)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy update includes:
- Added Zavzpret to list of calcitonin gene-related peptide (calcitonin gene-related peptide (CGRP)) inhibitors that should not be prescribed concurrently with Vyepti, removed references to “injectable or oral calcitonin gene-related peptide (calcitonin gene-related peptide (CGRP))” as Zavzpret is a nasal product
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Rimegepant (Nurtec ODT) (CP.PHAR.490)
| Ambetter
| Policy update includes:
- For migraine prophylaxis redirection to injectable calcitonin gene-related peptide (calcitonin gene-related peptide (CGRP)), added requirement for a 3-month trial and clarified they should be used for migraine prophylaxis
- Added Zavzpret to list of calcitonin gene-related peptide (calcitonin gene-related peptide (CGRP)) inhibitors that should not be prescribed concurrently with Nurtec ODT
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Tafasitamab-cxix (Monjuvi) (CP.PHAR.508)
| Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy update includes:
- For additional National Comprehensive Cancer Network (NCCN) recommended uses (off-label) criteria, removed follicular lymphoma (grade 1-2) as not currently supported by National Comprehensive Cancer Network (NCCN) compendium
- For Appendix B, updated first-line therapy options for B-cell lymphoma subtypes
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Anifrolumab-fnia (Saphnelo) (CP.PHAR.551)
| Ambetter
| Policy update includes:
- Added exclusions for concurrent treatment with Lupkynis and diagnoses of severe active central nervous system lupus or severe active lupus nephritis
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Chlorambucil (Leukeran) (CP.PHAR.554)
| Ambetter
| Policy update includes:
- Clarified follicular lymphoma is classic
- For mycosis fungoides / Sezary syndrome, added requirement for use as a single agent and as subsequent treatment per National Comprehensive Cancer Network (NCCN)
- For chronic lymphocytic leukemia/small lymphocytic lymphoma, added requirement for combination use per National Comprehensive Cancer Network (NCCN)
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Atogepant (Qulipta) (CP.PHAR.566)
| Ambetter
| Policy update includes:
- Added Zavzpret to list of calcitonin gene-related peptide (calcitonin gene-related peptide (CGRP)) inhibitors that should not be prescribed concurrently with Qulipta
- Clarified redirection to injectable calcitonin gene-related peptide (calcitonin gene-related peptide (CGRP)) therapy that is ‘used for migraine prophylaxis’ and added requirement for a 3-month trial
- Added clarification in continuation of therapy to indicate requirement for concurrent use with other calcitonin gene-related peptide (calcitonin gene-related peptide (CGRP)) inhibitors does not apply to CA if member was previously approved via Centene benefit and is currently stable on therapy with both oral and injectable calcitonin gene-related peptide (calcitonin gene-related peptide (CGRP)) inhibitors
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Etranacogene Dezaparvovec-drlb (Hemgenix) (CP.PHAR.580)
| Ambetter
| Policy update includes:
- Revised baseline severity and treatment history criteria from use of a factor IX product for ≥ 12 months with ≥ 1 serious spontaneous bleed to current use of a factor IX product with timeframe removal, added option of current or historical life-threatening hemorrhage, and modified option of repeated, serious spontaneous bleeding episodes to align with Food and Drug Administration (FDA)
- Revised criterion for AAV5 neutralizing antibody titer of ≤ 1:678 to instead require a neutralizing anti-AAV5 antibody test and that member is deemed a suitable candidate for treatment due to the evolving nature of the anti-AAV5 neutralizing antibody test
- Added requirement for documentation of member’s body weight for dose determination.
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Donanemab-azbt (Kisunla) (CP.PHAR.594)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter
| Policy update includes:
- For members with ≥ 7 total infusions – shortened the perpetual reauth duration from 12 infusions per PA approval to 6 infusions per PA approval to align with the approach for Leqembi which is to provide 6 months of perpetual reauthorization at a time
- Removed the exclusion against concomitant use with Aduhelm since Aduhelm will be completely removed from the market by the time of the posting of these revised criteria
- Removed the age limit of 60-85 years of age
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Avacincaptad pegol (Izervay) (CP.PHAR.641)
| Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy update includes:
- Clarified that diagnostic characteristics must be confirmed on fundus autofluorescence imaging per health plan request in alignment with Syfovre geographic atrophy criteria and per pivotal study design
- Added exclusions for geographic atrophy that is secondary to a condition other than AMD and for combination use with other intravitreal complement inhibitor therapies per competitor analysis
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Niraparib and Abiraterone Acetate (Akeega) (CP.PHAR.645)
| Ambetter
| Policy update includes:
- Removed off-label use in those with “documentation of disease progression despite bilateral orchiectomy or other androgen deprivation therapy (ADT)” per National Comprehensive Cancer Network (NCCN)
|
Rozanolixizumab-noli (Rystiggo) (CP.PHAR.648)
| Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy update includes:
- Added new 420 mg/3 ml, 560 mg/4 ml, and 840/6 ml volume formulations and updated all quantity limits to 1 vial
- Added Bkemv, Epysqli, and Zilbrysq to the list of therapies that Rystiggo should not be prescribed concurrently with
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Talquetamab-tgvs (Talvey) (CP.PHAR.649)
| Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy update includes:
- Added International Myeloma Working Group (IMWG) criterion defining progressive multiple myeloma disease as multiple myeloma class alignment
|
Off-Label Use (CP.PMN.53)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy update includes:
- Added requirement that alternative drugs be used for at least 30 days
- Added bypass to all redirections for States with regulations against redirections in certain settings
- Added depression and transplant to list of continuity of care programs per current Centene standard approach
|
L-glutamine (Endari) (CP.PMN.116)
| Ambetter
| Policy update includes:
- Revised policy/criteria section to also include generic L-glutamine
- Added redirection to L-glutamine
|
Tazarotene (Arazlo, Fabior, Tazorac) (CP.PMN.244)
| Ambetter
| Policy update includes:
- For plaque psoriasis, added member must use generic formulation
- For acne vulgaris, clarified request is for Tazorac 0.1% cream or gel, Arazlo, or Fabior, added Tazorac age limit per package insert
- Added “unless clinically significant adverse effects are experienced or all are contraindicated” to generic formulary topical tazarotene redirection, added clarification stating prior authorization may be required for tretinoin and adapalene
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Metoclopramide (Gimoti) (CP.PMN.252)
| Ambetter
| Policy update includes:
- Added maximum quantity limit of 4 sprays daily to criteria
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Nifurtimox (Lampit) (CP.PMN.256)
| Ambetter
| Policy update includes:
- Added minimum weight per package insert
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Varenicline (Tyrvaya) (CP.PMN.273)
| Ambetter
| Policy update includes:
- Added Commercial line of business (CP.CPA.354 retired)
- Added redirection to generic Restasis
|
Ketorolac Nasal Spray (Sprix) (CP.PMN.282)
| Ambetter
| Policy update includes:
- Added age ≥ 65 years, renally impaired and patients < 50 kg quantity limit criterion and updated Section V
|
Nitazoxanide (Alinia) (HIM.PA.152)
| Ambetter
| Policy update includes:
- For all indications, clarified that member must use generic formulation if age ≥ 12 years
- For cryptosporidiosis, revised requirement for members with human immunodeficiency virus (HIV) infection to currently use antiretroviral therapy per human immunodeficiency virus (HIV) guidelines
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Palbociclib (Ibrance) (HIM.PA.173)
| Ambetter
| Policy update includes:
- For initial therapy, updated wording from “failure of Kisqali and Verzenio” to “must use Kisqali and Verzenio’
- Added criteria for step therapy bypass for state with regulations against redirections in cancer
- Updated Food and Drug Administration (FDA) approved indication section to align with prescriber information
- Added Appendix E “states with regulations against redirections in cancer”
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Eptinezumab-jjmr (Vyepti) (HIM.PA.SP64)
| Ambetter
| Policy update includes:
- Added Zavzpret to list of calcitonin gene-related peptide (calcitonin gene-related peptide (CGRP)) inhibitors that should not be prescribed concurrently with Vyepti, removed references to “injectable or oral calcitonin gene-related peptide (calcitonin gene-related peptide (CGRP))” as Zavzpret is a nasal product
|
Erenumab-aooe (Aimovig) (HIM.PA.SP65)
| Ambetter
| Policy update includes:
- Added Zavzpret to list of calcitonin gene-related peptide (calcitonin gene-related peptide (CGRP)) inhibitors that should not be prescribed concurrently with Aimovig, removed references to “injectable or oral calcitonin gene-related peptide (calcitonin gene-related peptide (CGRP))” as Zavzpret is a nasal product
|
Fremanezumab-vfrm (Ajovy) (HIM.PA.SP66)
| Ambetter
| Policy update includes:
- Added Zavzpret to list of calcitonin gene-related peptide (calcitonin gene-related peptide (CGRP)) inhibitors that should not be prescribed concurrently with Ajovy, removed references to “injectable or oral calcitonin gene-related peptide (calcitonin gene-related peptide (CGRP))” as Zavzpret is a nasal product
|
Galcanezumab-gnlm (Emgality) (HIM.PA.SP67)
| Ambetter
| Policy update includes:
- Added Zavzpret to list of calcitonin gene-related peptide (calcitonin gene-related peptide (CGRP)) inhibitors that should not be prescribed concurrently with Emgality, removed references to “injectable or oral calcitonin gene-related peptide (calcitonin gene-related peptide (CGRP))” as Zavzpret is a nasal product
|
Pegvaliase-pqpz (Palynziq) (CP.PHAR.140)
| Ambetter
| Policy update includes:
- Added exclusion against concomitant use with sapropterin (Kuvan) for Continued Therapy to mirror Initial Approval Criteria
|
Betaine (Cystadane) (CP.PHAR.143)
| Ambetter
| Policy update includes:
- For Cystadane requests, added redirection to generic
|
Tisotumab Vedotin-tftv (Tivdak) (CP.PHAR.561)
| Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy update includes:
- Added Section III, Diagnoses/Indications for which coverage is NOT authorized per current template
|
Lecanemab-irmb (Leqembi) (CP.PHAR.596)
| Ambetter
| Policy update includes:
- Clarified the covered indication as “mild cognitive impairment due to Alzheimer’s disease” to align with the Kisunla criteria
- Added exclusion against concomitant use with Kisunla
- Clarified for the reauth duration that infusions up to the 13th total infusion will be authorized for members with < 14 total infusions but ≥ 7 total infusions (instead of > 7 total infusions) to encompass those who have had a total of exactly 7 infusions by that point in time
- Removed the age limit of 50-90 years of age
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Zavegepant (Zavzpret) (CP.PHAR.630)
| Ambetter
| Policy update includes:
- Clarified redirection is to formulary “generic” 5HT1B/1D-agonist migraine medications
|
Tapinarof (Vtama) (CP.PMN.283)
| Ambetter
| Policy update includes:
- For continued therapy other diagnosis/indications section, corrected template changes
|
Bimekizumab-bkzx (Bimzelx) (CP.PHAR.660)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- Added criteria for newly approved indications for psoriatic arthritis, ankylosing spondylitis, and non-radiographic axial spondyloarthritis
- For plaque psoriasis and continued therapy section, added criteria “member does not have combination use with biological disease-modifying antirheumatic drugs or janus kinase inhibitors”
- Added new strength [320 mg/2 ml] for single-dose prefilled syringe and single-dose prefilled autoinjector
|
Benralizumab (Fasenra) (HIM.PA.SP70)
| Ambetter
| Policy updates include:
- For initial approval criteria, modified criteria requiring history of two exacerbations to instead require one exacerbation, added allowance for emergency room visit, removed intubation option, modified requirement of “leukotriene modifier” to “one additional asthma controller medication”)
- Added criteria for newly approved indication of eosinophilic granulomatosis with polyangiitis
|
Isotretinoin (Claravis Absorica Absorica LD Myorisan Zenatane Amnesteem) (CP.PMN.143)
| Ambetter
| Policy updates include:
- In initial approval criteria, clarified that combination products may require prior authorization, removed redirection to specific concentrations for benzoyl peroxide and tretinoin, removed redirection to trimethoprim-sulfamethoxazole per acne guideline
- Updated appendix b per clinical pharmacology
|
Ribociclib (Kisqali, Kisqali Femara) (CP.PHAR.334)
| Ambetter
| Policy updates include:
- For Kisqali, updated the Food and Drug Administration (FDA) approved indication for use in combination with fulvestrant to reflect the population expansion from “in postmenopausal women or in men” to “adults”
- For initial therapy, added “perimenopausal female” to the requirement for ovarian ablation/suppression
- Added criteria for endometrial carcinoma as off-label indication is supported by National Comprehensive Cancer Network (NCCN) compendium and guidelines
- References reviewed and updated. For Kisqali and Kisqali Femara, added criteria for newly approved indication for adjuvant treatment of adults with HR-positive, HER2-negative stage II and III early breast cancer at high risk of recurrence
|
Nivolumab (Opdivo) (CP.PHAR.121)
| Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- Added new Food and Drug Administration (FDA)-approved indication for neoadjuvant treatment followed by single-agent Opdivo as adjuvant treatment after surgery for non-small cell lung cancer
- Increased maximum duration allowed for neoadjuvant therapy from 3 cycles/9 weeks to 4 cycles/12 weeks
- For continued therapy: added criterion for maximum duration of therapy limit of 13 cycles for adjuvant non-small cell lung cancer, up to 1 year for all other adjuvant treatment, and up to 2 years for metastatic or recurrent non-small cell lung cancer, malignant pleural mesothelioma, advanced renal cell carcinoma in combination with cabozatinib, unresectable or metastatic urothelial carcinoma, esophageal squamous cell carcinoma, gastric cancer, esophagogastric junction, and esophageal adenocarcinoma
- Revised dose limit for non-small cell lung cancer in combination with Yervoy to 360 mg every 3 weeks
- Added additional dose limit option of 240 mg every 2 weeks for gastric cancer, esophagogastric junction cancer, and esophageal adenocarcinoma
|
Pancrelipase (Creon, Pancreaze, Pertzye, Viokace, Zenpep) (CP.PCH.44)
| Ambetter
| Policy updates include:
- Removed redirection to Pancreaze
- Apply redirection to Creon and Zenpep for Pancreaze requests
|
Glycerol Phenylbutyrate (Ravicti) (CP.PHAR.207)
| Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- Added redirection to generic sodium phenylbutyrate followed by redirection to Pheburane for requests for continuation of therapy
|
Dupilumab (Dupixent) (CP.PHAR.336)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS) and CHIP
| Policy updates include:
- Added newly approved chronic obstructive pulmonary disease indication to criteria. For prurigo nodularis initial approval criteria, updated diagnosis criteria from “Worst Itch-Numeric Rating Scale (WI-NRS) ≥ 7 on a scale of 0 to 10” to “Numeric rating scale > 7 on a scale of 0 (“no itch”) to 10 (“worst imaginable itch”) (e.g., Peak Pruritus Numeric Rating Scale, Worst Itch-Numeric Rating Scale)” to align with Nemluvio criteria
|
Glucagon-Like Peptide-1 (GLP-1) Receptor Agonists (CP.PMN.183)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS) and CHIP
| Policy updates include:
- Removed redirection to Bydureon bcise and Byetta
- Removed redirection to brand Victoza and added redirection to liraglutide (Victoza authorized generic)
- Revised redirection of preferred agents in a stepwise fashion, first requiring liraglutide (Victoza authorized generic), then if member has failed liraglutide, member must fail Trulicity
- Removed redirection criterion for Ozempic in members with established cardiovascular disease or multiple cardiovascular risk factors as redirection through liraglutide and Trulicity now align with all non-preferred products
- Added disclaimer that manufacturer astrazeneca has discontinued Bydureon bcise and Byetta products
|
Fezolinetant (Veozah) (CP.PMN.289)
| Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- For initial approval criteria, clarified number of failed agents from hormonal therapy products to two formulary estrogen products
|
Tenapanor (Ibsrela, Xphozah) (Ambetter.PA.174)
| Ambetter
| Policy updates include:
- For irritable bowel syndrome with constipation added step-wise redirection to Trulance
|
Dupilumab (Dupixent) (HIM.PA.SP69)
| Ambetter
| Policy updates include:
- Added newly approved chronic obstructive pulmonary disease indication to criteria. For prurigo nodularis initial approval criteria, updated diagnosis criteria from “Worst Itch-Numeric Rating Scale (WI-NRS) ≥ 7 on a scale of 0 to 10” to “Numeric rating scale > 7 on a scale of 0 (“no itch”) to 10 (“worst imaginable itch”) (e.g., Peak Pruritus Numeric Rating Scale, Worst Itch-Numeric Rating Scale)” to align with Nemluvio criteria
|
Nilotinib (Tasigna, Danziten) (CP.PHAR.76)
| Ambetter
| Policy updates include:
- Added newly approved Danziten to policy for chronic myeloid leukemia only
- For chronic myeloid leukemia, added age requirement ≥ 1 year for Tasigma
- For acute lymphoblastic leukemia, added age requirement ≥ 15 years per National Comprehensive Cancer Network (NCCN)
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