Effective January 1, 2024: Pharmacy and Biopharmacy Policies

Dichlorphenamide (Keveyis) (CP.PMN.261)

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

Policy updates include:

• Added requirement for use of generic for brand Keveyis requests

Step Therapy (HIM.PA.109)

Ambetter

Policy updates include:

• For Ubrelvy, added clarification that Ubrelvy should not be prescribed concurrently with other calcitonin gene-related peptide receptor inhibitors

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

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

Policy updates include:

• Added criteria requiring use of preferred Humira biosimilars Yusimry, Hadlima, unbranded adalimumab-fkjp, and unbranded adalimumab-adaz to policy
• Added Appendix K for preferred adalimumab product national drug code(NDC) reference
• Removed criteria requiring use of preferred Amjevita NDCs and Appendix with Amjevita NDC references
• For Amjevita, Cyltezo, Hadlima, updated FDA approved indications, approval criteria, and dosing in section V to reflect new uveitis indication
• For Hadlima and Hulio, updated FDA approved indications, approval criteria, and dosing in section V to reflect new hidradenitis suppurativa (HS) indication

Ustekinumab (Stelara) (CP.PHAR.264)

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

Policy updates include:

• Added criteria requiring use one adalimumab product and stating Yusimry, Hadlima, unbranded adalimumab-fkjp, and unbranded adalimumab-adaz as preferred
• For psoriatic arthritis and Plaque psoriasis, removed criteria requiring use of Enbrel
• For ulcerative colitis, removed criteria requiring use of Simponi, Humira, and Amjevita
• Updated Appendix B with relevant therapeutic alternatives

Etanercept (Enbrel) (CP.PHAR.250)

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

Policy updates include:

• For all indications, added criteria requiring use of one adalimumab product and stating Yusimry, Hadlima, unbranded adalimumab-fkjp, and unbranded adalimumab-adaz as preferred
• For ankylosing spondylitis, added criteria requiring use of preferred agents Taltz and Xeljanz/Xeljanz XR for plaque psoriasis, added criteria requiring use of preferred agent Taltz
• For polyarticular juvenile idiopathic arthritis, added criteria requiring use of preferred agents Actemra and Xeljanz/ Xeljanz XR
• For psoriatic arthritis, added criteria requiring use of preferred agents Otezla, Taltz, Xeljanz/ Xeljanx XR
• For rheumatoid arthritis, added criteria requiring use of preferred agents Actemra, Kevzara, Xeljanz/Xeljanz XR, and Olumiant
• Updated Appendix B with relevant therapeutic alternatives

Golimumab (Simponi, Simponi Aria) (CP.PHAR.253)

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

Policy updates include:

• For ankylosing spondylitis, removed criteria requiring use of Cimzia and Enbrel
• For psoriatic arthritis, polyarticular juvenile idiopathic arthritis, rheumatoid arthritis, removed criteria requiring use of Enbrel
• Added criteria requiring use of one adalimumab product and stating Yusimry, Hadlima, unbranded adalimumab-fkjp, and unbranded adalimumab-adaz as preferred
• For ulcerative colitis, added requirement of Zeposia use after failure of one adalimumab product or history of failure of two tumor necrosis factor blockers
• Updated Appendix B with relevant therapeutic alternatives

Secukinumab (Cosentyx) (CP.PHAR.261)

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

Policy updates include:

• For ankylosing spondylitis, removed criteria requiring use of Enbrel and Cimzia
• For psoriatic arthritis and enthesitis-related arthritis, removed criteria requiring use of Enbrel
• For ankylosing spondylitis, plaque psoriasis, psoriatic arthritis, added criteria requiring use of one adalimumab product and stating Yusimry, Hadlima, unbranded adalimumab-fkjp, and unbranded adalimumab-adaz as preferred
• For non-radiographic axial, removed redirection to Cimzia
• Updated Appendix B with relevant therapeutic alternatives

Natalizumab (Tysabri) (CP.PHAR.259)

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

Policy updates include:

• For Crohn’s disease removed criteria requiring use of Humira and Amjevita, added criteria requiring use of one adalimumab product and stating Yusimry, Hadlima, unbranded adalimumab-fkjp, and unbranded adalimumab-adaz as preferred
• Updated Appendix B with relevant therapeutic alternatives

Certolizumab (Cimzia) (CP.PHAR.247)

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

Policy updates include:

• For psoriatic arthritis and rheumatoid arthritis, removed criteria requiring use of Enbrel
• For ankylosing spondylitis, Crohn’s disease, plaque psoriasis, psoriatic arthritis, rheumatoid arthritis, added criteria requiring use of one adalimumab product and stating Yusimry, Hadlima, unbranded adalimumab-fkjp, and unbranded adalimumab-adaz as preferred
• For ankylosing spondylitis, added criteria requiring use of preferred Taltz and Xeljanz/Xeljanz XR
• For non-radiographic axial, added criteria requiring use of preferred Taltz
• Udated Appendix B with relevant therapeutic alternatives

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

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

Policy updates include:

• For psoriatic arthritis, removed criteria requiring use of Enbrel
• For Crohn’s disease, removed criteria requiring use of Humira and Amjevita
• Added criteria requiring use of one adalimumab product and stating Yusimry, Hadlima, unbranded adalimumab-fkjp, and unbranded adalimumab-adaz as preferred
• Updated Appendix B with relevant therapeutic alternatives

Guselkumab (Tremfya) (CP.PHAR.364)

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

Policy updates include:

• For psoriatic arthritis, removed criteria requiring use of Enbrel
• For plaque psoriasis and psoriatic arthritis, added criteria requiring use of one adalimumab product and stating Yusimry, Hadlima, unbranded adalimumab-fkjp, and unbranded adalimumab-adaz as preferred
• Updated Appendix B with relevant therapeutic alternatives

Anakinra (Kineret) (CP.PHAR.244)

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

Policy updates include:

• For rheumatoid arthritis, removed criteria requiring use of Enbrel and replaced with requirement for use of one adalimumab product and stating Yusimry, Hadlima, unbranded adalimumab-fkjp, and unbranded adalimumab-adaz as preferred
• Updated Appendix B with relevant therapeutic alternatives

Vedolizumab (Entyvio) (CP.PHAR.265)

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

Policy updates include:

• For ulcerative colitis, removed criteria requiring use of Simponi, Humira, and Amjevita
• For Crohn’s disease, removed criteria requiring use of Humira and Amjevita
• Added criteria requiring use of one adalimumab product and stating Yusimry, Hadlima, unbranded adalimumab-fkjp, and unbranded adalimumab-adaz as preferred
• Updated Appendix B with relevant therapeutic alternatives

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

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

Policy updates include:

• Removed criteria requiring use of Enbrel
• Added criteria requiring use of of one adalimumab product and stating Yusimry, Hadlima, unbranded adalimumab-fkjp, and unbranded adalimumab-adaz as preferred
• Updated Appendix B with relevant therapeutic alternatives

Olaparib (Lynparza) (CP.PHAR.360)

Ambetter

Policy updates include:

• Updated indication for maintenance treatment of recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer to clarify use with deleterious or suspected deleterious mutations in the germline BRCA genes or mutations in the somatic BRCA genes disease

Temozolomide (Temodar) (CP.PHAR.77)

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

Policy updates include:

• For anaplastic astrocytoma removed criteria for refractory disease to reflect revised indications for newly diagnosed anaplastic astrocytoma and refractory anaplastic astrocytoma
• Added off-label criteria for pediatric diffuse midline gliomas

Donanemab (LY300281) (CP.PHAR.594)

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

Policy updates include:

• For Initial Approval Criteria:
  • Removed the requirement for enrollment in an National Institutes of Health-sponsored trial since that does not apply to drugs in this class that have obtained full Food and Drug Administration approval
  • Added specialist prescriber requirement
  • Added an exclusion against concomitant use with other anti-amyloid monoclonal antibodies
  • Added an exclusion against concomitant use with anticoagulants/antiplatelet therapies, an attestation requirement re: discussing ApoE4 status with the member, and an exclusion if pre-existing stroke, TIA, or seizures
• For Continued Therapy:
  • Removed the requirement for enrollment in an National Institutes of Health-sponsored trial
  • Added a requirement for follow-up MRI results to identify new-onset amyloid-related imaging abnormalities
  • Added requirement for cognitive and functional testing results to confirm that the member has not progressed beyond the mild stage of Alzheimer’s disease
  • Added an exclusion for use with concomitant anticoagulant or antiplatelet therapy
  • Added an exclusion against concomitant use with other anti-amyloid monoclonal antibodies added max dosing limits and Approval Durations

Budesonide (Uceris) (CP.PCH.11)

Ambetter

Policy updates include:

• Added criterion that member must use generic budesonide tablet or rectal foam
• For Health insurance marketplace line of business changed approval duration from 6 months to 12 months

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

Ambetter

Policy updates include:

• For brand Pennsaid added requirement to use generic formulation

Lapatinib (Tykerb) (CP.PHAR.79)

Ambetter

Policy updates include:

• per National Comprehensive Cancer Network, for breast cancer, updated lapatinib is prescribed in combination with “trastuzumab, and member has received at least 3 prior therapies” from previous criteria “trastuzumab, and member has received at least 2 prior therapies” to align with National Comprehensive Cancer Network compendium and current invasive breast cancer guideline version 4.2023 as combination regimen is considered fourth-line currently
• For initial approval criteria, added “advanced” to “disease is recurrent, advanced, or metastatic (stage IV)” to align with Food and Drug Administration approved indication language

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

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

Policy updates include:

• Per National Comprehensive Cancer Network – for colorectal cancer added that disease is advanced, metastatic, or unresectable
• For cervical cancer added option for single-agent therapy
• For renal cell carcinoma removed combination therapy option with interferon alfa
• For ovarian cancers simplified bevacizumab combination therapy criterion when used with a platinum and chemotherapy along with corresponding staging update to IB-IV disease,
• Added combination therapy option with gemcitabine for platinum-resistant disease, and removed combination therapy with Zejula
• For hepatocellular carcinoma added Child-Pugh class B option
• Clarified off-label indication of primary central nervous system cancer is specifically for lymphoma
• Modified low-grade (WHO Grade I) glioma to circumscribed glioma
• Revised mesotheliomas to remove “malignant” per terminology change

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 health insurance marketplace line of business (AZ, CA, KS, MI, NE, NJ, NM, NC, SC, and all other states)
• For prepubertal cryptorchidism, added criterion “member has not received more than 3 months of therapy” to continued therapy
• Removed references to Bravelle due to product discontinuation

Lenvatinib (Lenvima) (CP.PHAR.138)

Ambetter

Policy updates include:

• For hepatocellular carcinoma, added prescribed as a single agent per National Comprehensive Cancer Network
• Added off-label criteria for cutaneous melanoma per National Comprehensive Cancer Network category 2A recommendation

Clinical Policy: Leuprolide Acetate (Eligard, Fensolvi, Lupaneta Pack, Lupron Depot, Lupron Depot-Ped), Leuprolide mesylate (Camcevi) (CP.PHAR.173)

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

Policy updates include:

• For uterine fibroids added requirement that Lupron Depot is prescribed concurrently with iron therapy per Food and Drug Administration indication and revised Commercial approval duration to 3 months as treatment per label is limited to three months
• For gender dysphoria continuation of therapy added example of positive response to therapy
• Updated Eligard Food and Drug Administration-approved indication per prescribing information for use in the treatment of advanced prostate cancer

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

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

Policy updates include:

• Removed combination use with Arzerra for chronic lymphocytic leukemia from initial criteria as use is no longer supported by National Comprehensive Cancer Network chronic lymphocytic leukemia/small lymphocytic lymphoma guideline
• Renamed AIDS-related B-cell lymphoma to HIV-related per National Comprehensive Cancer Network naming changes

Carfilzomib (Kyprolis) (CP.PHAR.309)

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

Policy updates include:

• Updated multiple myeloma initial approval criteria to include “for maintenance therapy, Kyprolis is prescribed  in combination with lenalidomide” and “in combination with bendamustine and dexamethasone for patients with late relapse or progressive disease who have failed at least three prior therapies” to align with current National Comprehensive Cancer Network compendium and multiple myeloma guidelines
• For Appendix B, updated section with current multiple myeloma primary therapies and previously treated for relapsed or refractory therapies per current multiple myeloma guidelines version 3.2023 and removed Panobinostat regimens as agent was withdrawn from market

Vincristine Sulfate Liposome Injection (Marqibo) (CP.PHAR.315)

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

Policy updates include:

• Removed initial approval criteria for acute lymphoblastic leukemia as use is not supported by the Food and Drug Administration and National Comprehensive Cancer Network
• Removed Appendix B table
• Updated Appendix D with National Comprehensive Cancer Network reference

Cetuximab (Erbitux) (CP.PHAR.317)

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

Policy updates include:

• For head and neck squamous cell carcinoma added combination therapy with Opdivo per National Comprehensive Cancer Network
• For colorectal cancer added CapeOX as a possible combination therapy per National Comprehensive Cancer Network
• For colon cancer that is KRAS/NRAS/BRAF wild-type added criterion that disease is left-sided only per National Comprehensive Cancer Network, along with rationale in Appendix E
• For squamous cell skin cancer, removed “locally” from locally advanced disease qualifier as disease can be regional per National Comprehensive Cancer Network

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

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

Policy updates include:

• For breast cancer, revised trastuzumab and Margenza combination therapy options with Halaven to be fourth-line therapy or beyond per National Comprehensive Cancer Network update
• Simplified soft tissue sarcoma criteria to create separate criterion that disease is advanced, metastatic, recurrent, or unresectable

Panitumumab (Vectibix) (CP.PHAR.321)

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

Policy updates include:

• Removed reference to formulary exception policy Ambetter.PA.103 for Vectibix 400 mg/20 mL formulation under health insurance marketplace to allow application of this policy for all Vectibix formulations under health insurance marketplace
• Simplified criteria by removing criterion qualifier “first-line treatment” as it overlaps with subsequent-line treatment regimens and to align with New Century Health criteria
• added CapeOx as potential combination regimen per National Comprehensive Cancer Network
• Added criterion that disease is left-sided only for colon cancer that is KRAS/NRAS/BRAF wild-type per National Comprehensive Cancer Network & NCH, along with rationale in Appendix D

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

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

Policy updates include:

• For basal cell carcinoma and cutaneous squamous cell carcinoma, added prescribed as a single agent per National Comprehensive Cancer Network and added total treatment duration up to 24 months
• For non-small cell lung cancer updated verbiage from wild-type to negative
• References reviews and updated
• Food and Drug Administration approved indication for metastatic basal cell carcinoma converted from accelerated approval to traditional approval
• Section V updated per package insert

Duvelisib (Copiktra) (CP.PHAR.400)

Ambetter

Policy updates include:

• For off-label T-cell lymphoma indication added criterion for use as a single agent per National Comprehensive Cancer Network

Brexanolone (Zulresso) (CP.PHAR.417)

Ambetter

Policy updates include:

• Revised criterion for diagnosis of major depressive episode that began no later than the first 4 weeks following delivery per updated American College of Obstetricians and Gynecologists guidance
• Added requirement that member has not received prior treatment with Zulresso or Zurzuvae for the current pregnancy
• Corrected MADRS score to ≥ 35 for severe depression added additional approval pathway if member does not have severe depression as demonstrated by at least one of the depression scores, documentation of severe depression as evidenced by a psychiarist clinical interview

Thioguanine (Tabloid) (CP.PHAR.437)

Ambetter

Policy updates include:

• For off-label acute lymphoblastic leukemia indication, revised age criterion to < 65 years, removed relapsed/refractory requirement, and clarified the Philadelphia chromosome-positive acute lymphoblastic leukemia criteria applies to members < 18 years per National Comprehensive Cancer Network

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

Ambetter

Policy updates include:

• Added redirection requirement of generic trientine hydrochloride to initial approval criteria

Antithymocyte Globulin (Atgam, Thymoglobulin) (CP.PHAR.506)

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

Policy updates include:

• For transplant rejection added criterion prescribed in combination with conventional therapy per package insert with examples added in Appendix D
• Continuation of care applied to transplant-related indications in continued therapy section
• Clarified total duration and doses of Thymoglobulin and Atgam therapy in continued therapy section (7days/doses for Thymoglobulin for prophylaxis of acute rejection, 14 days/doses for Thymoglobulin for treatment of acute treatment, and 42 days/21 doses for Atgam)

anifrolumab-fnia (Saphnelo) (CP.PHAR.551)

Ambetter

Policy updates include:

• Added exclusion for concurrent biologic per Warning in the Prescribing Information

Belzutifan (Welireg) (CP.PHAR.553)

Ambetter

Policy updates include:

• Added criterion for monotherapy per National Comprehensive Cancer Network and NCH criteria
• Added maximum number of tablets corresponding to dose in initial and continued criteria

Halcinonide (Halog) (Ambetter.PA.20)

Ambetter

Policy updates include:

• Added redirection to generic halcinonide cream for brand Halog requests in continued therapy section
• Added “prior authorization may be required for generic halcinonide cream” in criteria
• Removed brand Elocon from Appendix B as it is currently off-market

Testosterone (Androderm) (Ambetter.PA.87)

Ambetter

Policy updates include:

•   For gender dysphoria added requirement for age ≥ 18 years

Naproxen oral suspension (Naprosyn) (Ambetter.PA.130)

Ambetter

Policy updates include:

• Added requirement for use of generic formulation for brand Naprosyn 

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

Ambetter

Policy updates include:

• No significant changes
• Added exclusion against concomitant use of multiple different nitisinone products
• Added generic redirection for 2 mg, 5 mg, 10 mg strengths (generic nitisinone 20 mg strength is either NF or same tier level as brand Orfadin 20 mg)

Migalastat (Galafold) (CP.PHAR.394)

Ambetter

Policy updates include:

• Added exclusion against concomitant use of Galafold with Elfabrio to the Initial Approval Criteria section, since Elfabrio is now Food and Drug Administration-approved
• Added exclusion against concomitant use with either Fabrazyme or Elfabrio to the Continued Therapy section

Rimegepant (Nurtec ODT) (CP.PHAR.490)

Ambetter

Policy updates include:

• For migraine prophylaxis added clarification that prior authorization may be required for alternative calcitonin gene-related peptide redirections
• Clarified for acute migraine failure of two formulary “generic” 5HT1-agonist migraine medications

Glycerol phenylbutyrate (Ravicti) (CP.PHAR.207)

Ambetter

Policy updates include:

• Modified redirection to be stepwise, first requiring generic sodium phenylbutyrate, then if member has intolerance or contraindication to generic sodium phenylbutyrate member must use Pheburane

Sodium phenylbutyrate (Buphenyl, Pheburane, Olpruva) (CP.PHAR.208)

Ambetter

Policy updates include:

• Added redirection to generic sodium phenylbutyrate in initial approval criteria and continued approval section

Aprepitant (Aponvie Cinvanti Emend), fosaprepitant (Emend Injection, Focinvez) (CP.PMN.19)

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

Policy updates include:

• Focinvez added to policy
• Added Emend for injection to section V