Adalimumab (Humira), Adalimumab-atto (Amjevita), Adalimumab-adbm (Cyltezo), Adalimumab-bwwd (Hadlima), Adalimumab-adaz (Hyrimoz) (CP.PHAR.242)

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

Policy updates include:

• For PJIA, added redirection to Actemra
• For RA, added redirection to Olumiant
• For AS, added redirection to Xeljanx if failed prior TNF blocker
• For PsO, allowed phototherapy as alternative to systemic conventional DMARD if contraindicated or clinically significant adverse effects are experienced

Aducanumab-avwa (Aduhelm) (CP.PHAR.468)

Ambetter

Policy updates include:

• Revised policy to state Aduhelm is not medically necessary based on current available evidence

Alectinib (Alecensa) (CP.PHAR.369)

Ambetter

Policy updates include:

• Added criterion for use as single-agent therapy for NSCLC
• Added off-label indication criteria for ALCL per NCCN

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

Ambetter

Policy updates include:

• Added requirement that Lumizyme not be prescribed concurrently with Nexviazyme

Bamlanivimab-etesevimab (LY-CoV555-LY-CoV016) (CP.PHAR.532)

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

Policy updates include:

• Added requirement for documentation that this product is not being used for pre-exposure prophylaxis
• Criteria added to reflect new FDA limitation of use against use in regions where infection or exposure is likely due to a non-susceptible SARS-CoV-2 variant

Biologic DMARDs (HIM.PA.SP60)

Ambetter

Policy updates include:

• Added newly FDA-approved indications: AD and PsA for Rinvoq, aGVHD for IV Orencia, ERA for Cosentyx, PsA for Skyrizi, AS for Xeljanz/Xeljanz XR, FDA use extension to mild PsO for Otezla after failure of at least one topical therapy
• Pediatric use extension down to 2 years and older for PsA for Cosentyx
• Removed oral and topical steroid requirement for Behçet’s disease
• Added off-label use for Kawasaki disease for infliximab
• For moderate-to-severe PsO, allowed phototherapy as alternative to systemic conventional DMARD if contraindicated or clinically significant adverse effects are experienced
• For Olumiant, Rinvoq, and Xeljanz, updated place in therapy after TNFi per FDA labeling

Brigatinib (Alunbrig) (CP.PHAR.342)

Ambetter

Policy updates include:

• Added criterion for use as single-agent therapy for NSCLC and IMT indications per NCCN

Cabazitaxel (Jevtana) (CP.PHAR.316)

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

Policy updates include:

• Added requirement that “member will use a gonadotropin-releasing hormone (GnRH) analog concurrently or has had a bilateral orchiectomy” per NCCN
• Removed pregnancy from contraindications per prescribing information
• Added new 60 mg/3 mL strength to product availability

Caplacizumab-yhdp (Cablivi) (CP.PHAR.416)

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

Policy updates include:

• For treatment extension requests, added requirement that member continues to have signs of persistent underlying disease per PI
• Clarified that requirement for maximum 58 days of therapy per treatment cycle applies to treatment extension requests

Casirivimab and imdevimab (REGN-COV2) (CP.PHAR.520)

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

Policy updates include:

• For post-exposure prophylaxis, added a requirement for documentation that the member is at high risk for disease progression and that the member does not have any limitations against use, per the EUA label
• Criteria added to reflect new FDA limitation of use against use in regions where infection or exposure is likely due to a non-susceptible SARS-CoV-2 variant

Celecoxib (Celebrex, Elyxyb) (CP.PMN.122)

Ambetter

Policy updates include:

• Added redirection to generic celecoxib for brand Celebrex requests per formulary status
• Limited use of Elyxyb to its FDA labeled indication

Ceritinib (Zykadia) (CP.PHAR.349)

Ambetter

Policy updates include:

• Added criterion for Zykadia being prescribed as single-agent therapy for NSCLC and inflammatory myofibroblastic tumor indications per NCCN

Certolizumab (Cimzia) (CP.PHAR.247)

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

Policy updates include:

• For RA, added redirection to Olumiant
• For PsO, allowed phototherapy as alternative to systemic conventional DMARD if contraindicated or clinically significant adverse effects are experienced

Crizotinib (Xalkori) (CP.PHAR.90)

Ambetter

Policy updates include:

• For NSCLC, clarified criteria as MET as exon 14 skipping or high-level MET amplification positive per NCCN
• Added hematologist as specialist in ALCL
• Added criterion for Xalkori single-agent therapy for NSCLC, ALCL, and inflammatory myofibroblastic tumor per NCCN
• Added histiocytic neoplasms indications per NCCN category 2A

Dabrafenib (Tafinlar) (CP.PHAR.239)

Ambetter

Policy updates include:

• Per NCCN added “limited resectable” melanoma classification
• Added allowance for therapy without Tafinlar for NSCLC
• Clarified thyroid cancer should be advanced or metastatic
• Clarified specific BRAF V600E mutation is a criterion for only ATC of thyroid cancers
• Added radioactive iodine therapy criterion for follicular, papillary, and Hürthle cell carcinomas
• Added indications of central nervous system cancers, hepatobiliary cancers, and histiocytic neoplasms

Dasatinib (Sprycel) (CP.PHAR.72)

Ambetter

Policy updates include:

• Per NCCN for CML and ALL added exclusions for mutations that are contraindicated
• For GIST added Ayvakit and removed Sutent and Stivarga as prior therapy options
• For CML, AML, chordoma, and myeloid/lymphoid neoplasms added that member has contraindication, intolerance, or disease progression on imatinib or allowed by-passing of redirection if state regulations do not allow step therapy in certain oncology settings

Durvalumab (Imfinzi) (CP.PHAR.339)

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

Policy updates include:

• Per prescribing information, for continued therapy, added the following requirement to reemphasize the NSCLC approval duration: “For NSCLC requests, member has not received more than 12 months of Imfinzi therapy”

Eculizumab (Soliris) (CP.PHAR.97)

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

Policy updates include:

• For NMOSD added stepwise redirection requirement if member has failed rituximab, then member must use Enspryng

Entecavir (Baraclude) (HIM.PA.08)

Ambetter

Policy updates include:

• Added notation referring requests for brand Baraclude tablets to formulary exception policy per non-formulary status and availability of other formulary first-line HBV medications
• For oral solution requests, added documentation for inability to use tablets per formulary status

Erlotinib (Tarceva) (CP.PHAR.74)

Ambetter

Policy updates include:

• For bone cancer added single-agent therapy criterion per NCCN

Gefitinib (Iressa) (CP.PHAR.68)

Ambetter

Policy updates include:

• Added criterion for use as single-agent therapy for NSCLC

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

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

Policy updates include:

• For PJIA, added redirection to Actemra
• For RA, added redirection to Olumiant
• For AS, added redirection to Xeljanx if failed prior TNF blocker
• For PsA, clarified that redirection applies only to age 18 or older

Imatinib (Gleevec) (CP.PHAR.65)

Ambetter

Policy updates include:

• Per NCCN clarified off label use in chronic myelomonocytic leukemia is positive for either a t(5;12) translocation associated with the ETV6-PDGFRβ fusion gene or PDGFRβ gene rearrangements at 5q32
• For ASM added additional indications for well-differentiated systemic mastocytosis and when eosinophilia is present with FIP1L1-PDGFRA fusion gene
• For KS added allowance for non-AIDS-related KS
• For melanoma added requirement that disease is metastatic or unresectable
• For pigmented villonodular synovitis/tenosynovial giant cell tumor revised to only require use as single-agent therapy and removing previous requirements for morbidity and functional limtations
• For HES/CEL applied 18 years or older age requirement per prescribing information

Imiglucerase (Cerezyme) (CP.PHAR.154)

Ambetter

Policy updates include:

• Added max dosing recommendations per Prescribing Information

Inebilizumab-cdon (Uplizna) (CP.PHAR.458)

Ambetter

Policy updates include:

• Added stepwise redirection requirement if member has failed rituximab, then member must use Enspryng

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

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

Policy updates include:

• Clarified GVHD use as steroid-refractory
• Added NCCN-recommended off-label use for Rosai-Dofrman disease
• Updated existing off-label pediatric mature B-Cell NHL criteria to reflect FDA-approved status

Ipilimumab (Yervoy) (CP.PHAR.319)

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

Policy updates include:

• For melanoma, added pathway for use as a single agent or in combination with Keytruda or Imlygi
• For HCC, added additional optional for prior use of Tecentriq + bevacizumab
• For NSCLC, removed use in disease positive for tumor mutation burden biomarker, revised requirement for “progression on PD-1/PD-L1 inhibitors” to “no contraindications to PD-1/PD-L1 inhibitors”
• Clarified criteria regarding disease mutation status (unknown status is no longer allowed, and prior targeted therapy is now only required for ROS1 and EGFR S768I, L861Q, and/or G719X mutations)
• Removed requirement for PD-L1 ≥ 1% as it is not necessary given allowable compendial uses
• For uveal melanoma, added requirement that disease is metastatic

Isavuconazonium (Cresemba) (CP.PMN.154)

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

Policy updates include:

• Revised max quantity from 2 vials to 1 vial per FDA labeling

Itraconazole (Sporanox, Tolsura) (CP.PMN.124)

Ambetter

Policy updates include:

• Updated max dosing for coccidioidomycosis infection per compendia, including addition of HIV-specific dosing

Lenalidomide (Revlimid) (CP.PHAR.71)

Ambetter

Policy updates include:

• Per NCCN added additional use in combination with Monjuvi for MZL and FL
• For myelofibrosis-associated anemia corrected requirements for ≥ 500 vs < 500 (previously was > 500 vs ≤ 500)
• Added off-label use for Langerhans cell histiocytosis as a single agent therapy
• Modified KS requirements to allow use in non-AIDs related KS
• Revised CLL/SLL to remove options for first-line therapy
• Removed mycosis fungoides/Sezary syndrome off-label use
• Removed primary cutaneous CD30+ T-cell lymphoproliferative disorders off-label use
• Modified peripheral T-cell lymphoma to allow use as initial palliative intent therapy

Lorlatinib (Lorbrena) (CP.PHAR.406)

Ambetter

Policy updates include:

• Added criterion for use as single-agent therapy for NSCLC

Melphalan flufenamide (Pepaxto) (CP.PHAR.535)

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

Policy updates include:

• For consistency per label added requirement from initial authorization to continuation of therapy requiring that Pepaxto is prescribed in combination with dexamethasone

Mitoxantrone (Novantrone) (CP.PHAR.258)

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

Policy updates include:

• Removed mantle cell lymphoma as a coverable B-cell lymphoma and clarified coverable ALL types per NCCN

Naproxen/Esomeprazole (Vimovo) (CP.PMN.117)

Ambetter

Policy updates include:

• Added risk factors for developing NSAID-induced gastric ulcers to criteria

Nilotinib (Tasigna) (CP.PHAR.76)

Ambetter

Policy updates include:

• Per NCCN for CML and ALL added exclusions for mutations that are contraindicated
• For GIST added Quinlock and Sprycel as additional prior therapy options
• Added criteria set for off-label use in myeloid/lymphoid neoplasms
• For CML, AML, and myeloid/lymphoid neoplasms added that member has contraindication, intolerance, or disease progression on imatinib or allowed by-passing of redirection if state regulations do not allow step therapy in certain oncology settings

Ocrelizumab (Ocrevus) (CP.PHAR.335)

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

Policy updates include:

• Added rheumatoid arthritis and lupus nephritis/systemic lupus erythematosus as diagnoses not covered due to safety concerns resulting in termination of the respective clinical studies

Paclitaxel, Protein-Bound (Abraxane) (CP.PHAR.176)

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

Policy updates include:

• Removed criterion for Abraxane+Tecentriq combination therapy in triple-negative breast cancer as this indication was withdrawn in August 2021 and no longer supported by NCCN
• Per NCCN, added “unresponsive to preoperative systemic therapy” as a breast cancer status
• Added gallbladder cancer indication
• Added single-agent therapy criterion for cutaneous melanoma, uveal melanoma, and endometrial carcinoma indications
• Removed bladder cancer indication as this is no longer supported

Pomalidomide (Pomalyst) (CP.PHAR.116)

Ambetter

Policy updates include:

• Per NCCN for KS applied requirement for failure of liposomal doxorubicin and paclitaxel to non-AIDS-related KS
• For primary CNS lymphoma added additional use for induction therapy if unable to use high-dose methotrexate

Quinine Sulfate (Qualaquin) (CP.PMN.262)

Ambetter

Policy updates include:

• For babesiosis, added requirement for use in combination with clindamycin per IDSA and CDC

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

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

Policy updates include:

• Clarified GVHD use as steroid-refractory
• Added NCCN-recommended off-label use for Rosai-Dofrman disease
• Updated existing off-label pediatric mature B-Cell NHL criteria to reflect FDA-approved status

Sacituzumab govitecan-hziy (Trodelvy) (CP.PHAR.475)

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

Policy updates include:

• For TNBC: removed “locally advanced” requirement as disease can be local or regional per NCCN
• Added recurrent urothelial carcinoma indication per NCCN
• Added criterion for use as single-agent therapy for both TNBC and urothelial cancer per NCCN

Secukinumab (Cosentyx) (CP.PHAR.261)

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

Policy updates include:

• For AS, added redirection to Xeljanx if failed prior TNF blocker
• Applied FDA-approved pediatric use extension down to 2 years of age for active PsA
• For PsA, modified redirection to apply for age 18 or older
• Added newly approved indication for active ERA
• For PsO, allowed phototherapy as alternative to systemic conventional DMARD if contraindicated or clinically significant adverse effects are experienced

Selpercatinib (Retevmo) (CP.PHAR.478)

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

Policy updates include:

• Added criterion for use as single-agent therapy for NSCLC and thyroid cancers
• Added qualifier of recurrent thyroid cancer
• Removed radioactive iodine criteria for ATC
• Added indication criteria for histiocytic neoplasms

Sipuleucel-T (Provenge) (CP.PHAR.120)

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

Policy updates include:

• Added requirement that “member will use a gonadotropin-releasing hormone (GnRH) analog concurrently or has had a bilateral orchiectomy” per NCCN and alignment with other prostate cancer clinical policies
• Added clarification on approval duration for up to a total of 3 doses

Sunitinib (Sutent) (CP.PHAR.73)

Ambetter

Policy updates include:

• Per NCCN added additional off-label uses in GIST for combination therapy with everolimus and SDH mutation positive disease
• For GIST with disease progression or intolerance to imabinib clarified request is for single agent therapy
• For differentiated and medullary thyroid carcinoma revised requirement of failure of two FDA approved therapies to more closely align with NCCN Compendium which recommends Sutent if clinical trials or other systemic therapies are not available or appropriate
• For RCC initial authorization clarified in adjuvant therapy request is for up to nine cycles consistent with the current requirement for continuation of therapy

Taliglucerase Alfa (Elelyso) (HIM.PA.162)

Ambetter

Policy updates include:

• Added max dosing recommendations per Prescribing Information

Topotecan (Hycamtin) (CP.PHAR.64)

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

Policy updates include:

• For ovarian cancer, expanded coverable diagnoses to include additional types of ovarian cancer as well as fallopian tube and primary peritoneal cancer and added requirement for use as a single agent or in combination with bevacizumab or sorafenib
• For cervical cancer, added requirement for use in combination with cisplatin or paclitaxel, or as a single agent as second-line or subsequent therapy
• For off-label uses, removed primary CNS lymphoma and added specific requirements for use in Ewing sarcoma, osteosarcoma, endometrial sarcoma, and rhabdomyosarcoma