Effective March 1, 2026: Pharmacy and Biopharmacy Policies

POLICY

APPLICABLE PRODUCTS

NEW POLICY OVERVIEW OR UPDATED POLICY REVISIONS

Diclofenac (Cambia, Flector, Licart, Pennsaid, Solaraze, Zipsor, Zorvolex) (CP.PCH.28)

Ambetter

Policy updates include:

• Added must use generic formulation language for brand Flector, Licart, Zipsor and Pennsaid in continued therapy
• Added must use generic formulation language for Cambia requests

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

Ambetter

Policy updates include:

• Per National Comprehensive Cancer Network (NCCN) for ovarian cancer added supported uses in malignant sex cord-stromal tumors, carcinosarcoma (malignant mixed Müllerian tumors), low-grade serous carcinoma, endometrioid carcinoma, mucinous neoplasms of the ovary
• Added Eligard as a product that can be used for breast cancer
• Added Camcevi as a product that can be used for salivary gland tumors
• Added criteria set for uterine sarcoma
• For endometriosis and uterine leiomyomata (fibroids), added allowance for age less than 18 years when member is postpubertal per prescribing information
• Added new strength, Camcevi ETM (21 mg)

Abrocitinib (Cibinqo) (CP.PCH.57)

Ambetter

Policy updates include:

• Policy created, adapted from CP.PHAR.578 with the following revisions: for atopic dermatitis initial approval criteria, added redirection to preferred agents Dupixent and Rinvoq.

Lebrikizumab (Ebglyss) (CP.PCH.58)

Ambetter

Policy updates include:

• Policy created, adapted from CP.PHAR.704 with the following revisions: for atopic dermatitis initial approval criteria, added redirection to preferred agents Dupixent or Rinvoq.

Nemolizumab-ilto (Nemluvio) (CP.PCH.59)

Ambetter

Policy updates include:

• Policy created,adapted from CP.PHAR.703 with the following revisions: for atopic dermatitis initial approval criteria, added redirection to preferred agents Dupixent or Rinvoq.

Tralokinumab-ldrm (Adbry) (CP.PCH.60)

Ambetter

Policy updates include:

• Policy created, adapted from CP.PHAR.577 with the following revisions: for atopic dermatitis initial approval criteria, added redirection to preferred agents Dupixent or Rinvoq

Pomalidomide (Pomalyst) (CP.PHAR.116)

Ambetter

Policy updates include:

• Removed redirection to generic

Venetoclax (Venclexta) (CP.PHAR.129)

Ambetter

Policy updates include:

• Revised Medicaid and Ambetter initial approval durations to 12 months for all indications
• For chronic lymphocytic leukemia/small lymphocytic lymphoma, removed the requirement for “relapse if previously used as first-line therapy” when used in combination with Gazyva per National Comprehensive Cancer Network (NCCN), removed requirement for “for relapsed/refractory disease” when used as subsequent therapy per National Comprehensive Cancer Network (NCCN), added combination therapies recommended per National Comprehensive Cancer Network (NCCN)
• For acute myeloid leukemia, removed the age at least 60 years pathway and added the Food and Drug Administration (Food and Drug Administration (FDA))-labeled option for age at least 75 years, replaced “disease is newly diagnosed” with “induction, post-induction, or consolidation therapy” per National Comprehensive Cancer Network (NCCN), and simplified criteria for relapsed/refractory disease
• For multiple myeloma, added option for central nervous system per National Comprehensive Cancer Network (NCCN)
• For additional National Comprehensive Cancer Network (NCCN) recommended uses section, added adult acute lymphoblastic leukemia supported uses and myelodysplastic syndromes use per National Comprehensive Cancer Network (NCCN)

Avatrombopag (Doptelet) (CP.PHAR.130)

Ambetter

Policy updates include:

• Updated pediatric extension for immune thrombocytopenia and added new formulation Doptelet Sprinkle (oral granules) to policy
• For immune thrombocytopenia diagnosis criterion, added option that immune thrombocytopenia could be persistent
• Approval duration for immune thrombocytopenia revised from 6 months to 12 months
• Added redirection to eltrombopag (generic Promacta) for immune thrombocytopenia
• Removed redirection to immune globulin if intolerant or contraindicated to systemic corticosteroid

Infertility and Fertility Preservation (CP.PHAR.131)

Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP

Policy updates include:

• Evidence of coverage for infertility/fertility preservation language added for Ambetter line of business (DE, GA, IN, KS, KY, MI, MO, NE, NY, NH, OH, OK, PA, SC, TN, TX)

Methotrexate (Otrexup, Rasuvo, Xatmep, Reditrex, Jylamvo) (CP.PHAR.134)

Ambetter

Policy updates include:

• For mycosis fungoides, clarified disease is stage IA-III per National Comprehensive Cancer Network (NCCN)
• For Jylamvo, added off-label indication for Sezary syndrome stage IV, primary cutaneous CD30+ T-cell lymphoproliferative disorders – subtype cutaneous anaplastic large cell lymphoma(ACLC) and lyp, subcutaneous panniculitis-like T-cell lymphoma and management of immunotherapy-related toxicities as supported by National Comprehensive Cancer Network (NCCN) 2A
• Updated initial approval duration for all indications from 6 to 12 months for Medicaid/Ambetter lines of business

Ivosidenib (Tibsovo) (CP.PHAR.137)

Ambetter

Policy updates include:

• Revised Medicaid and Ambetter initial approval durations to 12 months
• For acute myeloid leukemia, removed the age at least 60 years pathway, removed requirement that disease is newly diagnosed, added requirement for monotherapy use in relapsed/refractory disease, and replaced medical justification requirement for inability to use intensive induction chemotherapy with option to either be unsuitable candidate or decline per National Comprehensive Cancer Network (NCCN)
• For myelodysplastic syndromes, added option for higher-risk disease per National Comprehensive Cancer Network (NCCN)
• For glioma indication, added requirement for lack of Voranigo tolerability per National Comprehensive Cancer Network (NCCN)

Lenvatinib (Lenvima) (CP.PHAR.138)

Ambetter

Policy updates include:

• For all indications, extended initial approval duration from 6 months to 12 months for this maintenance medication for a chronic condition
• For differentiated thyroid cancer, added Lenvima use in oncocytic carcinoma that is not RAI-refractory per National Comprehensive Cancer Network (NCCN) and added off-label use in combination with pembrolizumab per National Comprehensive Cancer Network (NCCN)
• For medullary thyroid cancer, added Retevmo as an option for treatment failure
• For endometrial carcinoma, clarified that endometrial carcinoma should be advanced or recurrent and added option for off label use as a single agent per National Comprehensive Cancer Network (NCCN)

Pegvaliase-pqpz (Palynziq) (CP.PHAR.140)

Ambetter

Policy updates include:

• Added Sephience (newly Food and Drug Administration (FDA)-approved for PKU) as an agent that should not be used concomitantly with Palynziq

Baclofen (Fleqsuvy, Gablofen, Lioresal, Lyvispah, Ozobax/Ozobax DS) (CP.PHAR.149)

Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP

Policy updates include:

• Added member must use generic baclofen vial or ampule language for Gablofen vial or Lioresal requests
• For Gablofen and Lioresal updated approval duration for initial and continued therapy to 12 months

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

Ambetter

Policy updates include:

• Added National Comprehensive Cancer Network (NCCN) compendium supported off-label uses in ovarian cancer, salivary gland tumors, and uterine sarcoma

Adalimumab (Humira), Adalimumab-afzb (Abrilada), Adalimumab-atto (Amjevita), Adalimumab-adbm (Cyltezo), Adalimumab-bwwd (Hadlima), Adalimumab-fkjp (Hulio), Adalimumab-adaz (Hyrimoz), Adalimumab-aacf (Idacio), Adalimumab-ryvk (Simlandi), Adalimumab-aaty (Yuflyma), Adalimumab-aqvh (Yusimry) (CP.PHAR.242)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS) and CHIP

Policy updates include:

• For ulcerative colitis, added option for MAYO Endoscopic Score greater than 2 to define moderate-to-severe ulcerative colitis
• For ankylosing spondylitis, Crohn’s disease, hidradenitis suppurativa, plaque psoriasis, polyarticular juvenile idiopathic, rheumatoid arthritis, ulcerative colitis, and uveitis, added bypass of conventional therapies if a member has failed a biologic agent to clarify intention of not stepping back from biologic agent to conventional therapy

Anakinra (Kineret) (CP.PHAR.244)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS) and CHIP

Policy updates include:

• For rheumatoid arthritis, added bypass of conventional therapies if a member has failed a biologic agent to clarify intention of not stepping back from biologic agent to conventional therapy
• Extended initial approval durations to 12 months for chronic conditions

Canakinumab (Ilaris) (CP.PHAR.246)

Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP

Policy updates include:

• For systemic juvenile idiopathic, added bypass of conventional therapies if a member has failed a biologic agent to clarify intention of not stepping back from biologic agent to conventional therapy
• Extended initial approval durations to 12 months for chronic conditions

Certolizumab (Cimzia) (CP.PHAR.247)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS) and CHIP

Policy updates include:

• For ankylosing spondylitis, Crohn’s disease, plaque psoriasis, rheumatoid arthritis, polyarticular juvenile idiopathic, added bypass of conventional therapies if a member has failed a biologic agent to clarify intention of not stepping back from biologic agent to conventional therapy
• Extended initial approval durations to 12 months for chronic conditions

Etanercept (Enbrel) (CP.PHAR.250)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS) and CHIP

Policy updates include:

• For psoriatic arthritis, applied step therapy to Otezla for pediatric age redirection as Otezla has a newly approved pediatric extension for 6 years and older
• For ankylosing spondylitis, plaque psoriasis, polyarticular juvenile idiopathic, and rheumatoid arthritis, added bypass of conventional therapies if a member has failed a biologic agent to clarify intention of not stepping back from biologic agent to conventional therapy
• Extended initial approval durations to 12 months for chronic conditions

Infliximab (Remicade), Infliximab-axxq (Avsola), Infliximab-dyyb (Inflectra, Zymfentra), and Infliximab-abda (Renflexis) (CP.PHAR.254)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS) and CHIP

Policy updates include:

• For ulcerative colitis, added option for MAYO Endoscopic Score greater than 2 to define moderate-to-severe ulcerative colitis
• For ankylosing spondylitis, Crohn’s disease, plaque psoriasis, rheumatoid arthritis, and ulcerative colitis, added bypass of conventional therapies if a member has failed a biologic agent to clarify intention of not stepping back from biologic agent to conventional therapy
• Extended initial approval durations to 12 months for chronic conditions

Ixekizumab (Taltz) (CP.PHAR.257)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS) and CHIP

Policy updates include:

• For ankylosing spondylitis, nr-axspa, and plaque psoriasis, added bypass of conventional therapies if a member has failed a biologic agent to clarify intention of not stepping back from biologic agent to conventional therapy
• Extended initial approval durations to 12 months for chronic conditions

Natalizumab (Tysabri), Natalizumab-sztn (Tyruko) (CP.PHAR.259)

Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP

Policy updates include:

• For Crohn’s disease, added bypass of conventional therapies if a member has failed a biologic agent to clarify intention of not stepping back from biologic agent to conventional therapy
• Extended initial approval durations to 12 months for Crohn’s disease

Rituximab (Rituxan), Rituximab-arrx (Riabni), Rituximab-pvvr (Ruxience), Rituximab-abbs (Truxima), Rituximab/Hyaluronidase (Rituxan Hycela) (CP.PHAR.260)

Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP

Policy updates include:

• Added off-label criteria for bullous pemphigoid
• For rheumatoid arthritis, added bypass of conventional therapies if a member has failed a biologic agent to clarify intention of not stepping back from biologic agent to conventional therapy
• Removed castleman disease from b-cell lymphoma initial approval criteria as castleman disease is not categorized as b-cell lymphoma per National Comprehensive Cancer Network (NCCN) and added castleman disease to National Comprehensive Cancer Network (NCCN) compendium indications (off-label) initial approval criteria
• Extended initial approval durations to 12 months for chronic conditions

Secukinumab (Cosentyx) (CP.PHAR.261)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS) and CHIP

Policy updates include:

• For psoriatic arthritis, applied step therapy to Otezla for pediatric age redirection as Otezla has a newly approved pediatric extension for 6 years and older
• For ankylosing spondylitis, nr-axspa, plaque psoriasis, and hidradenitis suppurativa, added bypass of conventional therapies if a member has failed a biologic agent to clarify intention of not stepping back from biologic agent to conventional therapy
• Extended initial approval durations to 12 months for chronic conditions

Tocilizumab (Actemra), Tocilizumab-anoh (Avtozma), Tocilizumab-bavi (Tofidence), Tocilizumab-aazg (Tyenne) (CP.PHAR.263)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS) and CHIP

Policy updates include:

• For Avtozma, added newly approved cytokine release syndrome indication to criteria
• For Actemra, updated indication for COVID-19 to include pediatric extension
• For cytokine release syndrome, giant cell arteritis, systemic juvenile idiopathic, and Castleman’s disease, added redirection from biosimilars to preferred agent Actemra
• For giant cell arteritis, polyarticular juvenile idiopathic, rheumatoid arthritis, and systemic juvenile idiopathic, added bypass of conventional therapies if a member has failed a biologic agent to clarify intention of not stepping back from biologic agent to conventional therapy
• Added HCPCS code [Q5156] for Avtozma
• Extended initial approval duration to 12 months for chronic condition indications

Ustekinumab (Stelara), Ustekinumab-aauz, Ustekinumab-srlf (Imuldosa), (Otulfi), Ustekinumab-ttwe (Pyzchiva), Ustekinumab-aekn (Selarsdi), Ustekinumab-hmny (Starjemza), Ustekinumab-stba (Steqeyma), Ustekinumab-auub (Wezlana), Ustekinumab-kfce (Yesintek) (CP.PHAR.264)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS) and CHIP

Policy updates include:

• For ulcerative colitis, added option for MAYO Endoscopic Score greater than 2 to define moderate-to-severe ulcerative colitis
• For Crohn’s disease, plaque psoriasis, ulcerative colitis, added bypass of conventional therapies if a member has failed a biologic agent to clarify intention of not stepping back from biologic agent to conventional therapy
• Extended initial approval durations to 12 months for chronic conditions

Vedolizumab (Entyvio) (CP.PHAR.265)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS) and CHIP

Policy updates include:

• For ulcerative colitis, added option for MAYO Endoscopic Score greater than 2 to define moderate-to-severe ulcerative colitis
• Added bypass of conventional therapies if a member has failed a biologic agent to clarify intention of not stepping back from biologic agent to conventional therapy
• Extended initial approval durations to 12 months for chronic conditions

Irinotecan Liposome (Onivyde) (CP.PHAR.304)

Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP

Policy updates include:

• For ampullary adenocarcinoma, added option for prescribed in combination with NALIRIFOX (fluorouracil, leucovorin, liposomal irinotecan, and oxaliplatin) regimen as first-line therapy for metastatic disease per National Comprehensive Cancer Network (NCCN)
• For initial approval criteria, extended approval duration from 6 months to 12 months

Obinutuzumab (Gazyva) (CP.PHAR.305)

Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP

Policy updates include:

• For chronic lymphocytic leukemia/small lymphocytic lymphoma indication and combination therapy with Venclexta, removed requirement for previous combination use as first-line therapy per National Comprehensive Cancer Network (NCCN)
• For section header “Follicular and Other B-Cell Lymphomas,” revised to “B-Cell Lymphomas and Tumors with B-Cell Predominance” to capture indication for Castleman disease
• For indication of histologic transformation of marginal zone lymphoma to diffuse large B-cell lymphoma, revised indication language from marginal zone lymphoma to indolent lymphomas per National Comprehensive Cancer Network (NCCN)
• For certain B-cell neoplasms where Gazyva is prescribed prior to Columvi administration, removed monotherapy requirement, revised third-line to for second-line therapy, and added mantle cell lymphoma indication per National Comprehensive Cancer Network (NCCN)
• For follicular lymphoma and marginal zone lymphomas, add combination therapy with Revlimid option per National Comprehensive Cancer Network (NCCN)
• For mantle cell lymphoma, added option for in combination with Venclexta and Brukinsa per National Comprehensive Cancer Network (NCCN)
• Added monotherapy option for hairy cell leukemia per National Comprehensive Cancer Network (NCCN)
• Revised all initial approval durations for Medicaid and Ambetter lines of business to 12 months

Bendamustine (Belrapzo, Bendeka, Treanda, Vivimusta) (CP.PHAR.307)

Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP

Policy updates include:

• For all indications, extended initial approval duration for Medicaid and Ambetter from 6 months to 12 months for this maintenance medication for a chronic condition
• For off-label National Comprehensive Cancer Network (NCCN) uses per National Comprehensive Cancer Network (NCCN), added off-label indications of T-cell prolymphocytic leukemia (T-PLL) and Follicular helper T-cell (TFH) lymphoma and removed mycosis fungoides/Sezary syndrome

Carfilzomib (Kyprolis) (CP.PHAR.309)

Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP

Policy updates include:

• For multiple myeloma primary treatment, added option to be prescribed in combination with Sarclisa per National Comprehensive Cancer Network (NCCN)
• Initial approval durations changed from 6 to 12 months for Medicaid/Ambetter

Pralatrexate (Folotyn) (CP.PHAR.313)

Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP

Policy updates include:

• Added National Comprehensive Cancer Network (NCCN) off-label use for subcutaneous panniculitis-like T-cell lymphoma
• For brand requests, added redirection to generic
• Extended initial approval duration for Ambetter/Medicaid from 6 to 12 months

Cetuximab (Erbitux) (CP.PHAR.317)

Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP

Policy updates include:

• Per National Comprehensive Cancer Network (NCCN) – for HNSCC, added option for use if member is receiving reirradiation with concurrent radiotherapy
• For colorectal cancer, replaced “unresectable” with “recurrent”, specified that POLE/POLD1mutation positive disease must have ultra-hypermutated phenotype, removed prior therapy requirement when prescribed for BRAF V600E mutation positive in combination with Braftovi and added clarification that regimen may be “with or without fluorouracil, leucovorin, oxaliplatin (FOLFOX)”, and modified requirement for left-sided colon cancer to also apply to unresectable metachronous metastases
• For Non-Small Cell Lung Cancer, simplified criterion requiring disease progression on prior therapy to no longer call out T790M positive disease
• Extended initial approval duration for Ambetter/Medicaid from 6 to 12 months
• Revised approval durations for Commercial from 6/12 months to standard injectable authorization of “6 months or to the member’s renewal date, whichever is longer”

Eribulin Mesylate (Halaven) (CP.PHAR.318)

Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP

Policy updates include:

• For soft tissue sarcoma, added liposarcoma and epithelioid hemangioendothelioma subtypes per National Comprehensive Cancer Network (NCCN) compendium and guidelines
• For initial approval criteria, extended approval duration from 6 months to 12 months for Ambetter and Medicaid

Panitumumab (Vectibix) (CP.PHAR.321)

Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP

Policy updates include:

• Specified that POLE/POLD1 mutation positive disease must have ultra-hypermutated phenotype and specified that unresectable synchronous metastases are in the liver and/or lung per National Comprehensive Cancer Network (NCCN)
• Extended initial approval duration for Ambetter/Medicaid from 6 to 12 months
• Revised approval durations for Commercial from 6/12 months to standard injectable authorization of “6 months or to the member’s renewal date, whichever is longer”

Sarilumab (Kevzara) (CP.PHAR.346)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS) and CHIP

Policy updates include:

• For rheumatoid arthritis and polyarticular juvenile idiopathic, added bypass of conventional therapies if a member has failed a biologic agent to clarify intention of not stepping back from biologic agent to conventional therapy
• Extended initial approval durations to 12 months for chronic conditions

Daunorubicin/Cytarabine (Vyxeos) (CP.PHAR.352)

Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP

Policy updates include:

• Added diagnosis option of acute myeloid leukemia that is poor risk without TP53 mutation or del(17)p abnormality per National Comprehensive Cancer Network (NCCN)
• Updated National Comprehensive Cancer Network (NCCN) nomenclature for AML-MRC
• Revised Medicaid and Ambetter initial and continued approval durations to 12 months

Abemaciclib (Verzenio) (CP.PHAR.355)

Ambetter

Policy updates include:

• Added criteria for soft tissue sarcoma as off-label indication is supported by National Comprehensive Cancer Network (NCCN) compendium and guidelines
• For initial approval criteria, extended approval duration from 6 months to 12 months for Ambetter and Medicaid
• For endometrial carcinoma initial therapy, added “12 months or duration of request, whichever is less” for commercial

Guselkumab (Tremfya) (CP.PHAR.364)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS) and CHIP

Policy updates include:

• For ulcerative colitis, added option for MAYO Endoscopic Score greater than 2 to define moderate-to-severe ulcerative colitis
• For plaque psoriasis, ulcerative colitis, and Crohn’s disease, added bypass of conventional therapies if a member has failed a biologic agent to clarify intention of not stepping back from biologic agent to conventional therapy

Neratinib (Nerlynx) (CP.PHAR.365)

Ambetter

Policy updates include:

• For breast cancer, added prescribed in combination with Kadcyla for central nervous system brain metastases per National Comprehensive Cancer Network (NCCN)
• Extended approval duration from 6 months to 12 months for Ambetter and Medicaid
• Added criteria for cervical cancer as off-label indication is supported by National Comprehensive Cancer Network (NCCN) compendium and guidelines

Brodalumab (Siliq) (CP.PHAR.375)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS) and CHIP

Policy updates include:

• Added bypass of conventional therapies if a member has failed a biologic agent to clarify intention of not stepping back from biologic agent to conventional therapy

Tildrakizumab-asmn (Ilumya) (CP.PHAR.386)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS) and CHIP

Policy updates include:

• Added bypass of conventional therapies if a member has failed a biologic agent to clarify intention of not stepping back from biologic agent to conventional therapy

Azacitidine (Onureg, Vidaza) (CP.PHAR.387)

Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP

Policy updates include:

• For acute myeloid leukemia, added that use with Nexavar must be for relapsed or refractory disease per National Comprehensive Cancer Network (NCCN)
• Extended initial approval durations from 6 to 12 months for Ambetter/Medicaid and for Onureg requests for Commercial
• Updated Appendix E with revised language and exception for Tennessee

Leucovorin Injection (CP.PHAR.393)

Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP

Policy updates include:

• Revised initial approval durations for high-dose methotrexate therapy rescue and combination chemotherapy with 5-fluorouracil (5-FU) to 12 months for Medicaid line of business
• For continued therapy section, added continuation of care pathway for high-dose MTX rescue as part of chemotherapy or combination chemotherapy with 5-fluorouracil (5-FU)

Cemiplimab-rwlc (Libtayo) (CP.PHAR.397)

Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP

Policy updates include:

• For cutaneous squamous cell carcinoma, added option for disease that is satellitosis/in-transit metastasis that is unresectable or incompletely resected per National Comprehensive Cancer Network (NCCN)
• For cervical, vaginal cancer and vulvar cancer, clarified usage as second-line or subsequent therapy per National Comprehensive Cancer Network (NCCN)
• Added off-label indications for anal carcinoma and deficient mismatch repair (dMMR)/microsatellite instability-high (MSI-H) or POLE/POLD1mutation with tumor cancers for: small bowel adenocarcinoma, and rectal and colon cancer per National Comprehensive Cancer Network (NCCN)
• Initial approval durations changed from 6 to 12 months for Medicaid/Ambetter

Dacomitinib (Vizimpro) (CP.PHAR.399)

Ambetter

Policy updates include:

• Added criterion for use as single-agent therapy for non-small cell lung cancer
• Extended initial approval duration for Medicaid and Ambetter from 6 months to 12 months for this maintenance medication for a chronic condition

Duvelisib (Copiktra) (CP.PHAR.400)

Ambetter

Policy updates include:

• For all indications, extended initial approval duration for Medicaid and Ambetter from 6 months to 12 months for this maintenance medication for a chronic condition
• For off-label T-cell lymphomas, added option for use in combination with romidepsin per National Comprehensive Cancer Network (NCCN)

Fremanezumab-vfrm (Ajovy) (CP.PHAR.403)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS) and CHIP

Policy updates include:

• Added pediatric extension for episodic migraine requiring redirection to topiramate
• Modified initial and continuation of therapy approval duration to 12 months

Risankizumab-rzaa (Skyrizi) (CP.PHAR.426)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS) and CHIP

Policy updates include:

• For ulcerative colitis, added option for MAYO Endoscopic Score greater than 2 to define moderate-to-severe ulcerative colitis
• For plaque psoriasis, Crohn’s disease, and ulcerative colitis, added bypass of conventional therapies if a member has failed a biologic agent to clarify intention of not stepping back from biologic agent to conventional therapy
• Added new 180 mg/1.2 ml single-dose prefilled syringe dosage form and strength
• For Crohn’s disease and ulcerative colitis criteria, added “if request is for vials/cartridges” to clarify quantity limit applies to vial/cartridge requests only.

Sapropterin Dihydrochloride (Kuvan, Javygtor) (CP.PHAR.43)

Ambetter

Policy updates include:

• Added Sephience (newly Food and Drug Administration (FDA)-approved for PKU) as an agent that should not be used concomitantly with sapropterin
• Extended initial approval duration to 12 months

Thioguanine (Tabloid) (CP.PHAR.437)

Ambetter

Policy updates include:

• Removed hematologist specialty from glioma indication

Trientine (Cuvrior, Syprine) (CP.PHAR.438)

Ambetter

Policy updates include:

• Added trientine hydrocholoride to medically necessary statement as generic trientine hydrocholoride also requires prior authorization
• For initial therapy, extended approval duration from 6 months to 12 months for Medicaid and Ambetter

Valrubicin (Valstar) (CP.PHAR.439)

Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP

Policy updates include:

• Added option of urologist to fulfill specialist requirement
• Removed specification of recurrent or persistent disease and added option for use as initial intravesical chemotherapy for non-muscle-invasive bladder cancer per National Comprehensive Cancer Network (NCCN)
• Clarified failure of bacillus Calmette-Guerin (BCG) to member is refractory to bacillus Calmette-Guerin (BCG) treatment and added criterion that member is not a candidate for cystectomy per Food and Drug Administration (FDA) labeling

Entrectinib (Rozlytrek) (CP.PHAR.441)

Ambetter

Policy updates include:

• 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 criteria for histiocytic neoplasms per National Comprehensive Cancer Network (NCCN) 2A recommendation with allowance for hematology specialty, added option for advanced disease for solid tumors, and revised maximum capsules for pediatrics
• For all indications, extended initial approval duration for Medicaid and Ambetter from 6 months to 12 months for this maintenance medication for a chronic condition

Fedratinib (Inrebic) (CP.PHAR.442)

Ambetter

Policy updates include:

• Added off-label criteria for myeloproliferative neoplasms per National Comprehensive Cancer Network (NCCN) category 2A
• Initial approval durations changed from 6 to 12 months for Medicaid/Ambetter

Ozanimod (Zeposia) (CP.PHAR.462)

Ambetter

Policy updates include:

• For ulcerative colitis, added option for MAYO Endoscopic Score greater than 2 to define moderate-to-severe ulcerative colitis
• For ulcerative colitis, added bypass of conventional therapies if a member has failed a biologic agent to clarify intention of not stepping back from biologic agent to conventional therapy

Arimoclomol (Miplyffa) (CP.PHAR.510)

Ambetter

Policy updates include:

• Added requirement that for members weighing at least 15 kg, failure of a at least 3-month trial of Aqneursa
• Revised initial approval duration from 6 months to 12 months
• For continued therapy, added positive response option of slowed disease progression in a domain affected by Niemann-Pick disease type C

Belumosudil (Rezurock) (CP.PHAR.552)

Ambetter

Policy updates include:

• Added exclusion for concomitant use with Niktimvo

Chlorambucil (Leukeran) (CP.PHAR.554)

Ambetter

Policy updates include:

• Added use in Hodgkin’s disease (removed from Section III)
• For all indications, extended initial approval duration from 6 months to 12 months for this maintenance medication for a chronic condition

Tisotumab Vedotin-tftv (Tivdak) (CP.PHAR.561)

Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP

Policy updates include:

• Added allowance for combination use with Keytruda for PD-L1 positive cervical cancer per National Comprehensive Cancer Network (NCCN)
• Extended initial approval duration for Ambetter/Medicaid from 6 to 12 months

Denosumab (Prolia, Xgeva and biosimilars) (CP.PHAR.58)

Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP

Policy updates include:

• For multiple myeloma or solid tumor, giant cell tumor of bone, hypercalcemia of malignancy, systemic mastocytosis, added redirection to Osenvelt and Wyost for if request is for a product other than Osenvelt and wyost/xgeva requests for initial and continuation of therapy requests
• Added new biosimilars Bildyos and Bilprevda to criteria
• Added new HCPCS codes Q5157, Q5158, Q5159
• Added new biosimilars Bosaya, Aukelso, Enoby, and Xtrenbo to criteria

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

Ambetter

Policy updates include:

• For Trelstar added National Comprehensive Cancer Network (NCCN) compendium supported off-label uses in breast cancer, salivary gland tumors, and uterine sarcoma

Quizartinib (Vanflyta) (CP.PHAR.646)

Ambetter

Policy updates include:

• Revised acute myeloid leukemia initial approval duration to 12 months
• For acute myeloid leukemia added option for relapsed/refractory disease treatment and for maintenance therapy as a single agent, added options of post-allogeneic hematopoietic cell transplantation and previous receipt a FLT3 inhibitor per National Comprehensive Cancer Network (NCCN)
• Added off-label criteria for lymphoid, myeloid or mixed phenotype neoplasms with eosinophilia per National Comprehensive Cancer Network (NCCN)

Resmetirom (Rezdiffra) (CP.PHAR.647)

Ambetter

Policy updates include:

• Revised biopsy lookback period from 6 months to 3 years per American Association for the Study of Liver Diseases (AASLD) guidance
• For imaging-based biomarker examples, replaced fibroscan with vibration-controlled transient elastography (VCTE) as fibroscan is an example of vibration-controlled transient elastography (VCTE)
• Moved Michigan Alcohol Screening Test (MAST), FibroScan-AST (FAST), and MRE combined with FIB-4 (MEFIB) examples of non-invasive diagnostic scores to Appendix E
• For diet and exercise criterion, removed the body mass index at least 25 kg/m2 , revised “lifestyle modification” to “physician-directed weight loss program that involves a reduced calorie diet, increased physical activity, and behavioral modification,” and clarified that member continues these strategies with Rezdiffra use
• Revised initial approval duration to 12 months
• For continued therapy, added requirements for prescriber attestation of continued standard of care management and documentation of adherence to physician-directed weight loss program
• Added redirection to Wegovy and exclusion for concurrent Wegovy use.

Rozanolixizumab-noli (Rystiggo) (CP.PHAR.648)

Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP

Policy updates include:

• For generalized myasthenia gravis, clarified that the required immunosuppressive therapy should be non-steroidal
• For Medicaid and Ambetter, extended approval durations from 6 to 12 months as gmg is a chronic condition

Talquetamab-tgvs (Talvey) (CP.PHAR.649)

Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP

Policy updates include:

• Added option to be prescribed in combination with Tecvayli with at least 3 prior lines of therapy per National Comprehensive Cancer Network (NCCN)
• Initial approval duration changed from 6 to 12 months for Medicaid/Ambetter

Elranatamab-bcmm (Elrexfio) (CP.PHAR.652)

Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP

Policy updates include:

• Added new 4-week dosing regimen to criteria
• Initial approval duration changed from 6 to 12 months for Medicaid/Ambetter

Motixafortide (Aphexda) (CP.PHAR.655)

Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP

Policy updates include:

• Added transplant specialist as a prescriber option

Bimekizumab-bkzx (Bimzelx) (CP.PHAR.660)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS) and CHIP

Policy updates include:

• For plaque psoriasis, ankylosing spondylitis, and hidradenitis suppurativa, added bypass of conventional therapies if a member has failed a biologic agent to clarify intention of not stepping back from biologic agent to conventional therapy

Mirikizumab-mrkz (Omvoh) (CP.PHAR.662)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS) and CHIP

Policy updates include:

• For ulcerative colitis, added option for MAYO Endoscopic Score greater than 2 to define moderate-to-severe ulcerative colitis
• For Crohn’s disease and ulcerative colitis, added bypass of conventional therapies if a member has failed a biologic agent to clarify intention of not stepping back from biologic agent to conventional therapy

Garadacimab (Andembry) (CP.PHAR.673)

Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP

Policy updates include:

• Added redirection to one of the following: Haegarda, Takhzyro, or Orladeyo.

Levacetylleucine (Aqneursa) (CP.PHAR.682)

Ambetter

Policy updates include:

• Revised initial approval duration from 6 months to 12 months
• For continued therapy, added positive response option of slowed disease progression in a domain affected by Niemann-Pick disease Type C

Inotuzumab Ozogamicin (Besponsa) (CP.PHAR.359)

Ambetter

Policy updates include:

• Removed criteria option for age at least 15 years for Philadelphia chromosome-negative per National Comprehensive Cancer Network (NCCN) Compendium
• Added criteria option to relapsed or refractory disease when prescribed as frontline therapy and age at least 18 years per National Comprehensive Cancer Network (NCCN) Compendium

Vorasidenib (Voranigo) (CP.PHAR.699)

Ambetter

Policy updates include:

• Added indication of other high-grade glioma per National Comprehensive Cancer Network (NCCN)
• For World Health Organization (WHO) grade 3 and 4 disease, removed criterion for poor Karnofsky Performance Status (KPS) and added option for use as adjuvant therapy per National Comprehensive Cancer Network (NCCN)
• Revised initial approval duration to 12 months

Inavolisib (Itovebi) (CP.PHAR.702)

Ambetter

Policy updates include:

• Added option for regionally advanced disease or recurrent disease per National Comprehensive Cancer Network (NCCN)
• Clarified ovarian ablation or ovarian suppression is required if members are premenopausal or perimenopausal
• Added requirement to be prescribed in combination with an agent that suppresses testicular steroidogenesis if members are male
• Extended initial approval duration from 6 months to 12 months for this maintenance medication for a chronic condition

Zolbetuximab-clzb (Vyloy) (CP.PHAR.705)

Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP

Policy updates include:

• Added options for use in recurrent disease and as palliative therapy in members who are not surgical candidates per National Comprehensive Cancer Network (NCCN)
• Extended initial approval duration for Ambetter/Medicaid from 6 to 12 months
• Revised approval durations for Commercial from 6/12 months to standard injectable authorization of “6 months or to the member’s renewal date, whichever is longer”

Delgocitinib (Anzupgo) (CP.PHAR.744)

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
  • Chronic Hand Eczema (CHE) (must meet all):
    • Diagnosis of CHE;
    • Member has hand eczema that has persisted for greater than 3 months or returned twice or more within the last 12 months;
    • Provider attestation that member has moderate to severe hand;
    • Prescribed by or in consultation with a dermatologist or allergist;
    • Age at least 18 years;
    • One of the following:
      • For Illinois HIM requests only: Failure of one formulary topical corticosteroid, unless clinically significant adverse effects are experienced or all are contraindicated;
      • For all other requests:  Failure of both of the following (i and ii), unless clinically significant adverse effects are experienced or all are contraindicated;
        • One formulary topical corticosteroid used for at least 2 weeks;
        • One of the following:
          • A second formulary topical corticosteroid used for at least 2 weeks;
          • One topical calcineurin inhibitor used for at least 4 weeks;      
    • Anzupgo is not prescribed concurrently with biologic medications (e.g., Dupixent ^®, Adbry^®), biologic disease-modifying antirheumatic drugs (e.g., Humira^®, Enbrel^®, Taltz^®, Stelara^®), JAK inhibitors (e.g., Cibinqo^®, Opzelura^™, Xeljanz^®, Rinvoq^®, Olumiant^®), or potent immunosuppressants (e.g., azathioprine, cyclosporine);
    • Dose does not exceed both of the following:
      • One 30-gram tube per 2 weeks;
      • 60 grams per month.
    • Approval duration: 6 months
• Continued Therapy
  • Chronic Hand Eczema (must meet all):
    • Member meets one of the following:
      • Currently receiving medication via Centene benefit or member has previously met initial approval criteria;
      • Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations;
    • Member is responding positively to therapy as evidenced by, including but not limited to, reduction in itching and scratching, no signs of erythema, scaling, hyperkeratosis/lichenification, vesiculation, edema, or fissures;
    • Anzupgo is not prescribed concurrently with biologic medications (e.g., Dupixent, Adbry), biologic disease-modifying antirheumatic drugs (e.g., Humira, Enbrel, Taltz, Stelara), JAK inhibitors (e.g., Cibinqo, Opzelura, Xeljanz, Rinvoq, Olumiant), or potent immunosuppressants (e.g., azathioprine, cyclosporine);
    • If request is for a dose increase, new dose does not exceed both of the following:
      • One 30-gram tube per 2 weeks;
      • 60 grams per month.
    • Approval duration: 12 months

Dordaviprone (Modeyso) (CP.PHAR.745)

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
  • Diffuse Midline Glioma (must meet all):
    • Diagnosis of diffuse midline glioma;
    • Prescribed by or in consultation with an oncologist;
    • Age at least 1 year;
    • Disease has both of the following characteristics:
      • Presence of H3 K27M mutation;
      • Progressive following prior therapy (includes radiation therapy);
    • For Modeyso requests, member must use dordaviprone, 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:
        • Adults: 625 mg per week;
        • Pediatrics:
          • Weight 10 kg to less than 12.5 kg: 125 mg per week;
          • Weight 12.5 kg to less than 27.5 kg: 250 mg per week;
          • Weight 27.5 kg to less than 42.5 kg: 375 mg per week;
          • Weight 42.5 kg to less than 52.5 kg: 500 mg per week;
          • Weight at least 52.5 kg: 625 mg per week;
    • Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence). *Prescribed regimen must be FDA-approved or recommended by NCCN
    • Approval duration: 12 months

• Continued Therapy
  • Diffuse Midline Glioma (must meet all):
    • Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Modeyso for a covered indication and has received this medication for at least 30 days;
    • Member is responding positively to therapy;
    • For Modeyso requests, member must use dordaviprone, 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 one of the following:
        • Adults: 625 mg per week;
        • Pediatrics:
          • Weight 10 kg to less than 12.5 kg: 125 mg per week;
          • Weight 12.5 kg to less than 27.5 kg: 250 mg per week;
          • Weight 27.5 kg to less than 42.5 kg: 375 mg per week;
          • Weight 42.5 kg to less than 52.5 kg: 500 mg per week;
          • Weight at least 52.5 kg: 625 mg per week;
      • 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

Zongertinib (Hernexeos) (CP.PHAR.750)

Ambetter

Policy includes:

• Requests for indications not approved by the FDA are reviewed with the off-label use policy for the relevant line of business: HIM.PHAR.154 for Ambetter
• Initial Approval Criteria
  • Non-Small Cell Lung Cancer(NSCLC) (must meet all):
    • Diagnosis of unresectable, recurrent, advanced, or metastatic NSCLC;
    • Prescribed by or in consultation with an oncologist;
    • Age at least 18 years;
    • Prescribed as single agent;
    • Disease has activating HER2 (ERBB2) mutations;
    • Failure of a prior systemic therapy;
    • For Hernexeos requests, member must use zongertinib, 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:
        • For body weight less than 90 kg: 120 mg (2 tablets) per day;
        • For body weight at least 90 kg: 180 mg (3 tablets) per day;
      • Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence). *Prescribed regimen must be FDA-approved or recommended by NCCN
    • Approval duration: 12 months
• Continued Therapy
  • Non-Small Cell Lung Cancer (must meet all):
    • Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Hernexeos for a covered indication and has received this medication for at least 30 days;
    • Member is responding positively to therapy;
    • For Hernexeos requests, member must use zongertinib, 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 one of the following:
        • For body weight less than 90 kg: 120 mg (2 tablets) per day;
        • For body weight at least 90 kg: 180 mg (3 tablets) per day;
          • New dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence). *Prescribed regimen must be FDA-approved or recommended by NCCN
    • Approval duration: 12 months

Rilzabrutinib (Wayrilz) (CP.PHAR.751)

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
  • Immune Thrombocytopenia (must meet all):
    • Diagnosis of persistent or chronic ITP;
    • Prescribed by or in consultation with a hematologist;
    • Age at least 18 years;
    • One of the following:
      • Current (within 30 days) platelet count less than 30,000/µL;
      • Member has an active bleed;
    • Member meets one of the following:
      • Failure of a systemic corticosteroid;
      • Member has intolerance or contraindication to systemic corticosteroids, and failure of an immune globulin, unless contraindicated or clinically significant adverse effects are experienced (see Appendix B); *Prior authorization may be required for immune globulins
    • Wayrilz is not prescribed concurrently with rituximab, a thrombopoietin receptor agonist (e.g., Doptelet^®, Promacta^®, Mulpleta^®, Nplate^®), or spleen tyrosine kinase inhibitor (e.g., Tavalisse^™);
    • Dose does not exceed 800 mg (2 tablets) per day.
    • Approval duration: 12 months

• Continued Therapy
  • Immune Thrombocytopenia (must meet all):
    • Member meets one of the following:
      • Currently receiving medication via Centene benefit or member has previously met initial approval criteria;
      • Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations;
    • Member is responding positively to therapy (e.g., increase in platelet count from baseline, reduction in bleeding events);
    • Wayrilz is not prescribed concurrently with rituximab, a thrombopoietin receptor agonist (e.g., Doptelet, Promacta, Mulpleta, Nplate), or spleen tyrosine kinase inhibitor (e.g., Tavalisse);
    • If request is for a dose increase, new dose does not exceed 800 mg (2 tablets) per day.
    • Approval duration: 12 months

Lapatinib (Tykerb) (CP.PHAR.79)

Ambetter

Policy updates include:

• For breast cancer, removed extensive from brain metastases as National Comprehensive Cancer Network (NCCN) supports use in limited and extensive brain metastases
• Added “perimenopausal” to member is a premenopausal female to align with other breast cancer criteria
• For initial approval criteria, extended approval duration from 6 months to 12 months for Ambetter and Medicaid
• For colorectal cancer, removed criteria for “no previous use of a HER2 inhibitor therapy (e.g., trastuzumab, Kadcyla, Tykerb, Perjeta)” as National Comprehensive Cancer Network (NCCN) supports use for Tykerb without this requirement, updated HER2-positive to HER2-amplified per National Comprehensive Cancer Network (NCCN)

Bevacizumab (Alymsys, Avastin, Avzivi, Jobevne, Mvasi, Vegzelma, Zirabev) (CP.PHAR.93)

Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP

Policy updates include:

• For all indications, extended initial approval duration for Medicaid and Ambetter from 6 months to 12 months for this maintenance medication for a chronic condition
• For the following oncology indications, revised the following per National Comprehensive Cancer Network (NCCN): for epithelial ovarian, fallopian tube, and primary peritoneal cancer, added option for combination use in platinum-resistant persistent disease with carboplatin and paclitaxel, carboplatin and gemcitabine, or carboplatin and liposomal doxorubicin
• Added additional off-label use in primary spinal cord tumors
• For ophthalmology uses, revised diabetic retinopathy to allow any cause and stage

Elivaldogene Autotemcel (Skysona) (CP.PHAR.556)

Ambetter

Policy updates include:

• Updated Food and Drug Administration (FDA)-approved indication to include lack of an available HLA-matched donor for allogeneic hematopoietic stem cell transplantation
• Removed criterion option for having an human leukocyte antigen (HLA)-matched donor and its accompanying criteria

Lubiprostone (Amitiza) (CP.PMN.142)

Ambetter

Policy updates include:

• For opioid-induced constipation, updated initial approval duration from 6 to 12 months
• For continued therapy, added criterion for opioid-induced constipation, member continues to receive opioid therapy

Tofersen (Qalsody) (CP.PHAR.591)

Ambetter

Policy updates include:

• For continued therapy, added requirement for no tracheostomy or permanent ventilation and a positive response example of slowing of ALSFRS-R slope decline compared to baseline

Donanemab (Kisunla) (CP.PHAR.594)

Ambetter

Policy updates include:

• Updated recommended dosing regimen per the Prescribing Information
• For Continued Therapy criteria, clarified that the neurocognitive testing results used for coverage redetermination should be “recent (within the last month)” to ensure that Kisunla continues to be used only for those who remain in the mild stage of disease
• Updated the requirement for follow-up pre-infusion MRIs to be done within the prior week instead of within the prior month, to align with the approach for Leqembi

Lecanemab-irmb (Leqembi) (CP.PHAR.596)

Ambetter

Policy updates include:

• For Continued Therapy criteria, clarified that the neurocognitive testing results used for coverage redetermination should be “recent (within the last month)” to ensure that Leqembi continues to be used only for those who remain in the mild stage of disease
• Updated the requirement for follow-up pre-infusion MRIs to be done within the prior week instead of within the prior month per the updated Leqembi Prescribing Information
• Added dosing and auth limits for newly Food and Drug Administration (FDA)-approved subcutaneous Leqembi Iqlik to the criteria

Axatilimab-csfr (Niktimvo) (CP.PHAR.691)

Ambetter

Policy updates include:

• Clarified systemic immunosuppressant as non-steroidal
• Extended initial approval duration for Medicaid and Ambetter from 6 months to 12 months for this maintenance medication for a chronic condition

Zopapogene Imadenovec (Papzimeos) (CP.PHAR.730)

Ambetter

Policy includes:

• Criteria is only applicable for Medicaid and CHIP when the drug is added to the formulary for coverage
• 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
  • Respiratory Papillomatosis (RPR) (must meet all):
    • Diagnosis of RRP;
    • Diagnosis is confirmed by tissue biopsy;
    • Prescribed by or in consultation with an otolaryngologist or pulmonologist;
    • Age at least 18 years;
    • In the previous 12 months, member has had at least 3 interventions (surgical resection or laser ablation) aimed at reducing voice and airway symptoms caused by the papilloma;
    • If age at most 45 years, member has previously completed the HPV vaccination series, unless contraindicated or clinically significant adverse effects are experienced;
    • Prior to initiation of Papzimeos treatment, member is scheduled to undergo an endoscopic surgical debulking procedure to remove laryngotracheal papilloma;
    • Dose does not exceed four total doses of 5 × 10¹¹ particle units (PU)
    • Approval duration: 6 months
• Continued Therapy
  • Respiratory Papillomatosis
    • Continued therapy will not be authorized as Papzimeos is indicated to be dosed as a single treatment course (four doses lifetime) only
    • Approval duration: Not applicable

Ciprofloxacin/Fluocinolone (Otovel) (CP.PMN.249)

Ambetter

Policy updates include:

• For otitis media with tympanostomy tubes, revised systemic antibiotic requirement to otic antibiotic

Continuous Glucose Monitors (CP.PMN.214)

Ambetter

Policy updates include:

• Removed option for management with oral agents for type 2 diabetes
• Added options for gestational diabetes and history of problematic hypoglycemia
• Updated freestyle Libre redirection to apply to age at least 2 years

Finerenone (Kerendia) (CP.PMN.266)

Ambetter

Policy updates include:

• Added new heart failure indication and accompanying 40 mg dosage strength
• For chronic kidney disease, added criterion requiring serum potassium at most 5.0 meq/L
• Removed requirement for age at least 18 years for type 2 diabetes

Levodopa Inhalation Powder (Inbrija) (CP.PMN.267)

Ambetter

Policy updates include:

• Removed the exclusion qualifier of “early morning” from “off” time requirement

Pilocarpine (Qlosi, Vuity) (CP.PMN.270)

Ambetter

Policy updates include:

• Removed requirement that member does not have glaucoma or ocular hypertension and current literature
• Extended initial approval duration from 6 months to 12 months for this maintenance medication for a chronic condition
• Added requirement that pilocarpine is not prescribed concurrently with Vizz

Lotilaner (Xdemvy) (CP.PMN.291)

Ambetter

Policy updates include:

• Added optometrist or ophthalmologist prescriber requirement

Semaglutide (Wegovy) (CP.PMN.295)

Ambetter

Policy updates include:

• Wegovy is now Food and Drug Administration (FDA) approved for MASH – criteria updated per Food and Drug Administration (FDA) labeling: revised biopsy lookback period from 6 months to 3 years per American Association for the Study of Liver Diseases (AASLD) guidance
• For imaging-based biomarker examples, replaced Fibroscan with vibration-controlled transient elastography (VCTE) as fibroscan is an example of vibration-controlled transient elastography (VCTE)
• Moved Michigan Alcohol Screening Test (MAST), FibroScan-AST (FAST), and MRE combined with FIB-4 (MEFIB) examples of non-invasive diagnostic scores to Appendix E
• For members with concurrent Type 2 diabetes mellitus, added trial of Rybelsus, Trulicity and Victoza
• For diet and exercise criterion, clarified that member continues diet and exercise with concomitant Wegovy
• For continued therapy, moved location of criterion regarding tolerance to maintenance dose of at least 1.7 mg once weekly after at least 17 weeks of Wegovy therapy
• Revised language from “if this is a second or subsequent renewal request” to “after at least 12 months of therapy” to determine positive response

Tirzepatide (Zepbound) (CP.PMN.298)

Ambetter

Policy updates include:

• For obstructive sleep apnea, updated positive airway pressure criterion to require continued symptoms of obstructive sleep apnea despite adherence to positive airway pressure therapy, unless a member is not a candidate for positive airway pressure therapy

Aceclidine (Vizz) (CP.PMN.302)

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.
  • Presbyopia (must meet all):
    • Diagnosis of presbyopia;
    • Prescribed by or in consultation with an optometrist or ophthalmologist;
    • Age between 45 and 75 years at the time of therapy initiation;
    • Failure of corrective eyeglasses or contact lenses to resolve the presbyopia symptoms, unless contraindicated or clinically significant adverse effects are experienced;
      Vizz is not prescribed concurrently with Vuity^® or Qlosi^™;
    • Dose does not exceed 2 drops per eye per day
    • Approval duration: 12 months
• Continued Therapy
  • Presbyopia (must meet all):
    • Member meets one of the following:
      • Currently receiving medication via Centene benefit or member has previously met initial approval criteria;
      • Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations;
    • Member is responding positively to therapy;
    • If request is for a dose increase, new dose does not exceed 2 drops per eye per day.
    • Approval duration: 12 months

Brensocatib (Brinsupri) (CP.PMN.303)

Ambetter

Policy includes:

• Requests for indications not approved by the FDA are reviewed with the off-label use policy for the relevant line of business: HIM.PHAR.154 for Ambetter
• Initial Approval Criteria
  • Non-Cystic Fibrosis Bronchiectasis (must meet all):
    • Diagnosis of non-cystic fibrosis bronchiectasis confirmed by chest computed tomography (CT) scan;
    • Prescribed by or in consultation with a pulmonologist;
    • Age at least 12 years;
    • Provider attestation that member is currently receiving optimal supportive therapy (examples include but are not limited to: airway clearance techniques, pulmonary rehabilitation, mucoactives [e.g., nebulized hypertonic saline, mannitol, dornase alfa, acetylcysteine], antibiotics [e.g., oral – azithromycin, erythromycin; inhaled – tobramycin, aztreonam]);
    • Documentation of one of the following despite at least 3 months of optimal supportive therapy:
      • Adults (age at least 18 years): Member has had at least 2 pulmonary exacerbations requiring systemic antibiotics in the last 12 months;
      • Pediatrics (age 12 to 17 years): Member has had at least 1 pulmonary exacerbation requiring systemic antibiotics in the last 12 months;
    • Member is not an active smoker as evidenced by recent (within the last 30 days) negative nicotine metabolite (i.e., cotinine) test;
    • Member does not have a primary* diagnosis of asthma or chronic obstructive pulmonary disease; *Secondary (comorbid) diagnoses of asthma or chronic obstructive pulmonary disease are allowable
    • Dose does not exceed 25 mg (1 tablet) per day.
    • Approval duration: 12 months
• Continued Therapy
  • Non-Cystic Fibrosis Bronchiectasis (must meet all):
    • Member meets one of the following:
      • Currently receiving medication via Centene benefit or member has previously met initial approval criteria;
      • Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations;
    • Member is responding positively to therapy;
    • If request is for a dose increase, new dose does not exceed 25 mg (1 tablet) per day.
    • Approval duration: 12 months

Off-Label Use (CP.PMN.53)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS) and CHIP

Policy updates include:

• Added requirements if request is for experimental or investigational use with resources to the attestation form per Centers for Medicare & Medicaid Services (CMS) requirements

Quantity Limit Override and Dose Optimization (CP.PMN.59)

Ambetter

Policy updates include:

• Added quantity limit exception criteria specific to acute therapies, with requirements for epinephrine (adopted from CP.PMN.144 that will be retired) and other acute therapies
• Removed criteria set for opioid QL exceptions as section I.A. will be applied

Ophthalmic Corticosteroids (HIM.PA.03)

Ambetter

Policy updates include:

• Removed FML suspension as it is discontinued
• Clarified at least 18 age requirement applies to Lotemax suspension and ointment

Adefovir (Hepsera) (CP.PHAR.142)

Ambetter

Policy updates include:

• Removed brand Hepsera from policy as it is no longer available
• Added generic adefovir to policy for review
• Removed criteria redirecting brand Hepsera to generic adefovir
• Revised initial approval duration from 6 months to 12 months

Doxepin (Silenor, Prudoxin, Zonalon) (HIM.PA.147)

Ambetter

Policy updates include:

• For insomnia, extended initial approval duration from 6 to 12 months
• For pruritis, added existing quantity limit (1 tube per 6 months) directly into criteria

Methoxsalen (Uvadex) (HIM.PA.17)

Ambetter

Policy updates include:

• Per National Comprehensive Cancer Network (NCCN), added Lymphir as an alternative prior therapy option
• Revised initial approval duration from 7 to up to 20 cycles to reflect the maximum number of cycles allowed per Food and Drug Administration (FDA) labeling

Palbociclib (Ibrance) (HIM.PA.173)

Ambetter

Policy updates include:

• For soft tissue sarcoma, removed “retroperitoneal” and added criteria “request is for capsule formulation” per National Comprehensive Cancer Network (NCCN)
• For initial approval criteria, extended approval duration from 6 months to 12 months

Tezepelumab (Tezspire) (HIM.PA.176)

Ambetter

Policy updates include:

• Removed continued therapy redirection to Dupixent, Fasenra, and Nucala
• Removed redirection to Nucala

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

Ambetter

Policy updates include:

• For Otezla, added newly approved pediatric extension to 6 years and older for psoriatic arthritis and applied redirection to Otezla for pediatric agents indicated for psoriatic arthritis
• For Avtozma, added newly approved cytokine release syndrome indication to criteria
• For ulcerative colitis, added option for MAYO Endoscopic Score greater than 2 to define moderate-to-severe ulcerative colitis
• Added bypass of conventional therapies if a member has failed a biologic agent to clarify intention of not stepping back from biologic agent to conventional therapy
• For Skyrizi, added new 180 mg/1.2 ml single-dose prefilled syringe dosage form and strength
• For Skyrizi Crohn’s disease and ulcerative colitis criteria, added “if request is for vials/cartridges” to clarify quantity limit applies to vial/cartridge requests only
• Added HCPCS code [Q5156] for Avtozma
• For plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis initial approval criteria, added redirection to additional preferred ustekinumab products (Pyzchiva, Steqeyma, and Yesintek) and applied to continuation of therapy requests, and for members initiating therapy with Stelara added a single step through preferred agents
• For rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa, uveitis initial therapy, added redirection to preferred adalimumab products (adalimumab-aaty, adalimumab-adaz, adalimumab-adbm, Simlandi) and removed redirection to Cyltezo
• For members initiating therapy with Humira initial approval criteria, added single step through preferred agents

Glaucoma Agents (CP.PMN.286)

Ambetter

Policy updates include:

• Added Simbrinza (adopted from HIM.PA.15, policy to retire) to this policy

Lebrikizumab (Ebglyss) (CP.PHAR.704)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS) and CHIP

Policy updates includes:

• Extended initial approval duration from 6 months to 12 months
• For continued therapy, added “including but not limited to” to allow additional options for positive response
• Removed commercial and ambetter line of business