Important Updates to Pharmacy Policies – Please Review

HIM.PA.SP60 

Biologic and Nonbiologic DMARDs 

2Q 2025 annual review: for UC initial criteria, added option for documentation of modified Mayo Score ≥ 5; removed redirection to preferred adalimumab products as adalimumab is not recommended due to low efficacy per 2024 AGA guidelines; for Appendix F, added supplemental information on modified Mayo Score; RT4: for Omvoh, added criteria for newly approved indication for CD and added new dosage forms [single-dose prefilled pen 200 mg/2 mL and single-dose syringe 200 mg/2 mL]; RT4: added newly approved biosimilar Avtozma to criteria; RT4: for Simlandi, added new single-dose autoinjector strength [80 mg/0.8 mL]; for sJIA, added redirection to NSAID as an option per clinical practice guidelines and competitor analysis; for CD, allowed redirection to preferred agent Rinvoq after TNF blocker per FDA labeling; for CRS, revised criteria from “member has developed refractory CRS related to blinatumomab therapy” to “used as supportive care in severe CRS related to blinatumomab therapy” and added criteria “used as prophylaxis to reduce the risk of CRS when administering teclistamab-cqyv” per NCCN compendium; added HCPCS code [Q9999]; for Appendix D, removed supplemental information on Enbrel in HS; updated section III.B with Spevigo and biosimilar verbiage; for Kawasaki disease, updated dose in section V from 5 mg/kg given over 2 hours to 10 mg/kg given over 2 hours; for Appendix M, removed supplemental information on COVID-19 therapeutic alternatives; references reviewed and updated. 

RT4: for Tyenne, added newly approved CRS and COVID-19 indications to criteria; for Appendix D, removed PsA and PsO supplemental information on Otezla; RT4: for Tremfya, added criteria for newly approved indication for CD; RT: for Tremfya, added new strength [100 mg/mL] for single-dose prefilled pen (Tremfya Pen); RT4: for Otulfi, added new dosage formulation [single-dose vial for SC injection: 45 mg/0.5 mL]; added Otulfi to “weight < 60 kg: 0.75 mg/kg per dose” pediatric dosing in section V for PsA and PsO; per SDC: for UC, revised redirection to include adalimumab product in criteria for “three of the following: Stelara, Skyrizi, Tremfya, adalimumab product [Humira/Cyltezo/Yuflyma]”; added step therapy bypass for IL HIM per IL HB 5395. 

9/1/2025 

HIM.PA.103 

Brand Name Override and Non-Formulary Medications 

Clarified for brand name drug requests, member must use generic or all preferred biosimilar(s), if available. 

9/1/2025 

CP.PHAR.103 

Immune Globulins 

2Q 2025 annual review: for CIDP, revised diagnostic criteria from “atypical CIDP” to “CIPD variants” aligning with 2021 EAN/PNS CIDP guidelines; applied redirection language to other diagnoses/indications section; for Section III, clarified usage for “maintenance or chronic” treatment of secondary immunodeficiencies induced by biologic therapies; for Arkansas, added reference to state-specific PANS/PANDAS AR.CP.PHAR.103 policy; references reviewed and updated. 

9/1/2025 

CP.PHAR.108 

Omacetaxine (Synribo) 

2Q 2025 annual review: removed off-label use in T315I mutation as this is no longer supported by NCCN Compendium; references reviewed and updated. 

9/1/2025 

CP.PHAR.155 

Cysteamine oral (Cystagon, Procysbi) 

2Q 2025 annual review: added prescriber requirement for nephrologist or a metabolic disease specialist experienced in management of nephropathic cystinosis (e.g., endocrinologist or urologist); references reviewed and updated. 

9/1/2025 

CP.PHAR.158 

Agalsidase Beta (Fabrazyme) 

2Q 2025 annual review: no significant changes; added requirement for documentation of member’s weight for dose calculation purposes; references reviewed and updated. 

9/1/2025 

CP.PHAR.164 

Miglustat (Zavesca) 

2Q 2025 annual review: no significant changes; added generic redirection; added HCPCS code for miglustat; references reviewed and updated. 

9/1/2025 

CP.PHAR.266 

Rilonacept (Arcalyst) 

2Q 2025 annual review: no significant changes; updated section III.B with Spevigo and biosimilar verbiage; references reviewed and updated. 

9/1/2025 

CP.PHAR.43 

Sapropterin Dihydrochloride (Kuvan, Javygtor) 

2Q 2025 annual review: no significant changes; added requirement for a redirection from Javygtor (branded generic) to unbranded generic sapropterin per an SDC recommendation; added a requirement for documentation of member’s current weight for dose calculation purposes; references reviewed and updated. 

9/1/2025 

CP.PHAR.512 

Pegunigalsidase alfa-iwxj (Elfabrio) 

2Q 2025 annual review: no significant changes; added concomitant use exclusion to the Continued Therapy section to echo the exclusion which currently exists in the Initial Approval Criteria; added requirement for documentation of member’s weight for dose calculation purposes; references reviewed and updated. 

9/1/2025 

CP.PHAR.606 

Spesolimab-sbzo (Spevigo) 

2Q 2025 annual review: no significant changes; updated section III.B with Spevigo and biosimilar verbiage; references reviewed and updated. 

9/1/2025 

HIM.PA.168 

Repository Corticotropin Injection (H.P. Acthar Gel, Purified Cortrophin Gel) 

2Q 2025 annual review: no significant changes; for infantile spasm added requirement for documentation of member’s current body surface area (BSA) in m2; references reviewed and updated.  

RT4: for Purified Cortrophin Gel, added new single-dose pre-filled syringe formulation to Section VI; updated quantity limit for MS to include prefilled syringes. 

9/1/2025 

CP.PHAR.121 

Nivolumab, Nivolumab Hyaluronidase-nvhy (Opdivo, Opdivo Qvantig) 

Per March SDC, for SCCHN, added redirection for nasopharyngeal carcinoma to Loqtorzi; added Appendix F to include states with regulations against redirections in cancer. 

9/1/2025 

CP.PHAR.236 

Darbepoetin Alfa (Aranesp) 

2Q 2025 annual review: extended continuation of therapy approval duration from 6 to 12 months for Medicaid/HIM for anemia due to CKD; removed 300 mg vial from product availability per updated prescribing information; references reviewed and updated. Per March SDC, for all indications, revised Retacrit and Epogen redirection language from “failure of” to “member must use” and revised criteria from “member meets one of the following” to “member must meet both of the following,” clarified members must use Epogen if member is unable to use Retacrit. 

9/1/2025 

CP.PHAR.238 

Methoxy Polyethylene Glycol-Epoetin Beta (Mircera) 

2Q 2025 annual review: extended continuation of therapy approval duration from 6 to 12 months for Medicaid/HIM; references reviewed and updated. Per March SDC, for all indications, revised Retacrit and Epogen redirection language from “failure of” to “member must use” and revised criteria from “member meets one of the following” to “member must meet both of the following,” clarified members must use Epogen if member is unable to use Retacrit. 

9/1/2025 

CP.PHAR.322 

Pembrolizumab (Keytruda) 

Per March SDC, for HNSCC, added redirection for nasopharyngeal carcinoma to Loqtorzi; added Appendix G to include states with regulations against redirections in cancer. 

9/1/2025 

CP.PHAR.677 

Vadadustat (Vafseo) 

2Q 2025 annual review: added requirement that Vafseo is not prescribed concurrently with Jesduvroq; extended continuation of therapy approval duration from 6 to 12 months for Medicaid/HIM; references reviewed and updated. Per March SDC, modified to require redirection to both Retacrit and Epogen (if member is unable to use Retacrit). 

9/1/2025 

CP.PMN.224 

Tenapanor (Ibsrela, Xphozah) 

Per March SDC, removed Commercial and added HIM line of business; for IBS-C added redirection to Linzess and Trulance (adapted from HIM.PA.174 that will be retired to align Medicaid with the existing HIM strategy), applied similar redirections from initial to continuation of therapy requests. 

9/1/2025 

HIM.PA.159 

Prucalopride (Motegrity) 

Per March SDC, added redirection to generic prucalopride for initial approval criteria and continued therapy. 

9/1/2025

CP.PHAR.227

Pertuzumab (Perjeta) 

2Q 2025 annual review: for continued therapy, added criterion for maximum duration for neoadjuvant or adjuvant breast cancer treatment, does not exceed a total of 1 year treatment (up to 18 cycles) per PI; updated standard approval language for commercial line of business to continued therapy of “6 months or to the member’s renewal date, whichever is longer”; references reviewed and updated. 

9/1/2025

CP.PHAR.246 

Canakinumab (Ilaris) 

2Q 2025 annual review: for sJIA, added redirection to NSAID as an option per clinical practice guidelines and competitor analysis; updated section III.B with Spevigo and biosimilar verbiage; references reviewed and updated. 

9/1/2025

CP.PHAR.260

Rituximab (Rituxan), Rituximab-arrx (Riabni), Rituximab-pvvr (Ruxience), Rituximab-abbs (Truxima), Rituximab-Hyaluronidase (Rituxan Hycela) 

2Q 2025 annual review: for B-cell lymphomas initial criteria, added extranodal marginal zone (stomach or nongastric sites), histologic transformation of indolent lymphomas to DLBCL, primary mediastinal large B-cell lymphoma and removed low-grade B-cell lymphoma for non-Hodgkin’s lymphoma subtypes per NCCN compendium; for NCCN compendium indications, removed “in patients who are CD20 positive” for acute lymphoblastic leukemia per NCCN compendium; for NMOSD initial criteria, added Bkemv, Epysqli, and Ultomiris to list of drugs not prescribed concurrently with Rituxan/Riabni/Ruxience/Truxima; for GPA and MPA, updated age to allow option for Riabni, Ruxience, Truxima: age ≥ 18 years; for continued therapy section, updated approval duration from 6 months to 12 months; updated section III.B with Spevigo and biosimilar verbiage; references reviewed and updated. 

9/1/2025

CP.PHAR.306 

Ofatumumab (Arzerra, Kesimpta) 

2Q 2025 annual review: for Arzerra, removed Waldenstrom’s macroglobulinemia/lymphoplasmacytic lymphoma criteria as this off-label use is no longer supported by NCCN and removed primary therapeutic examples for Appendix B; for Kesimpta (MS), removed requirements for documentation of baseline relapses/ expanded disability status score and specific measures of positive response per competitor analysis and removed notation that Extavia is the preferred interferon beta-1b product for the Medicaid line of business as it is no longer available on market per SDC; updated Appendix C to include Kesimpta’s new hypersensitivity contraindication; for MS continued therapy, modified HIM and Medicaid approval duration from “if member has received < 1 year of total treatment – up to a total of 12 months of treatment and if member has received > 1 year of total treatment – 12 months” to “12 months”; references reviewed and updated. 

9/1/2025 

CP.PHAR.319

Ipilimumab (Yervoy) 

2Q 2025 annual review: updated FDA indication for RCC and HCC to mirror PI; for melanoma, clarified combination use with Keytruda is off-label use per NCCN and revised adjuvant treatment maximum dosage per PI; for NSCLC per NCCN, added criteria for NRG1 gene fusion positive; removed criteria for the following mutations: RET rearrangement, EGFR exon 19 deletion, exon 21 L858R, ALK rearrangement, ROS1 rearrangement; for ESCC per NCCN, added off-label indication for prescribed as induction systemic therapy; for off-label NCCN compendium indications, consolidated MSI-H/dMMR cancers, revised biliary tract cancer criteria to allow primary treatment; in Appendix B, removed entries that are not redirections (Opdivo and Keytruda); in Appendix D, added no longer recommended indications; in Section V, clarified dosing regimen wording per PI; references reviewed and updated. 

9/1/2025 

CP.PHAR.339 

Durvalumab (Imfinzi) 

2Q 2025 annual review: per NCCN, for NSCLC, added that Imfinzi must be prescribed as a single agent and that disease does not have EGFR exon 19 deletion or exon 21 L858R mutation if stage II-III; added use as first-line therapy for NRG1 gene fusion positive tumors; removed use as subsequent therapy for EGFR exon 19 deletion, exon 21 deletion, exon 21 L858R tumors, ALK1 rearrangement, and ROS1 rearrangement positive tumors; for HCC; added additional qualifier of extrahepatic; for endometrial cancer, added additional qualifiers of metastatic, stage III, and stage IV; for cervical cancer, added that Imfinzi can be used as a single agent for maintenance therapy following combination use; for ampullary adenocarcinoma, removed qualifiers of unresectable localized and stage IV resected; for BTC, added “with curative intent” for recurrent definition to align with NCCN compendium wording; RT4: updated FDA approved indication for dMMR endometrial cancer to include FDA approved testing language; references reviewed and updated. 

9/1/2025

CP.PHAR.343 

Edaravone (Radicava, Radivaca ORS) 

2Q 2025 annual review: added edaravone to the Policy/Criteria applicability section; added generic redirection for IV Radicava request to initial and continued criteria; in initial criteria and Appendix D, clarified that “El Escorial” refers to revised El Escorial or Airlie House; references reviewed and updated. 

9/1/2025 

CP.PHAR.349 

Ceritinib (Zykadia) 

2Q 2025 annual review: removed criteria option for ROS1-positive NSCLC per NCCN update; references reviewed and updated. 

9/1/2025 

CP.PHAR.406 

Lorlatinib (Lorbrena)

2Q 2025 annual review: removed Zykadia from list of ROS1-positive NSCLC failure agents per NCCN update; added pediatric diffuse high-grade glioma to NCCN-supported off-label indications; references reviewed and updated.

9/1/2025

CP.PHAR.418 

Dexrazoxane (Totect) 

2Q 2025 annual review: removed brand Totect from criteria as product has been discontinued and obsolete; for doxorubicin-induced cardiomyopathy, clarified anthracycline-induced extravasation is an off-label use now that Totect has been discontinued; removed Hodgkin lymphoma in adults age > 60 years per NCCN; removed redirections to generic dexrazoxane now that product is only available as generic; references reviewed and updated. 

9/1/2025 

CP.PHAR.528 

Odevixibat (Bylvay) 

2Q 2025 annual review: for initial and continued therapy, added exclusion for concurrent use with other IBAT inhibitors; for exclusion of pathologic variations of the ABCB11 gene that predict complete absence of the BSEP protein, clarified this is specific to PFIC type 2; references reviewed and updated. 

9/1/2025 

CP.PHAR.623 

Elacestrant (Orserdu) 

2Q 2025 annual review: in continued therapy, added minimum dose of 172 mg per prescribing information; in Appendix B, updated therapeutic alternative dosing regimens per Clinical Pharmacology; references reviewed and updated. 

9/1/2025 

CP.PHAR.625 

Concizumab-tci (Alhemo) 

2Q 2025 annual review: added Hemlibra redirection for hemophilia A with inhibitors indication; moved Appendix D examples of positive response to therapy into continued therapy criteria section; references reviewed and updated. 

9/1/2025 

CP.PHAR.626 

Pozelimab-bbfg (Veopoz) 

2Q 2025 annual review: added criterion to prevent duplicative therapy with other complement inhibitors; references reviewed and updated. 

9/1/2025 

CP.PHAR.631 

Sparsentan (Filspari) 

2Q 2025 annual review: added to continuation of therapy requirement that Filspari is not prescribed concurrently with RAAS inhibitors, endothelin receptor antagonists (ERAs), or aliskiren; references reviewed and updated. 

9/1/2025 

CP.PHAR.69 

Sorafenib (Nexavar) 

2Q 2025 annual review: revised policy/criteria section to also include generic sorafenib; revised the following per NCCN – for HCC, removed requirement for confirmation of Child-Pugh class A or B7 status and added requirement for use as a single agent; for RCC, removed qualifiers of “relapsed” and “stage IV”; for DTC, added coverage for symptomatic disease; for MTC, specified that disease must be metastatic; for acute myeloid leukemia, restricted combination use to relapsed/refractory disease and removed allowance for single agent use for induction/consolidation therapy; references reviewed and updated. 

9/1/2025 

CP.PHAR.71 

Lenalidomide (Revlimid) 

2Q 2025 annual review: revised policy/criteria section to also include generic lenalidomide; per NCCN, for MM, added use as primary therapy for high-risk smoldering MM and symptomatic MM; for MDS, clarified recommended uses for no deletion 5q abnormality depending on ring sideroblasts (including addition of trial of Reblozyl or Rytelo for ring sideroblasts ≥ 15% [or ≥ 5% if SF3B1 mutation]), added that member has poor probability to respond to immunosuppressive therapy for serum erythropoietin > 500 mU/mL, and removed allowance for MDS/myeloproliferative overlap neoplasms that are wild-type for SF3B1 mutation; for MZL, added use as first-line therapy in combination with rituximab and removed use in combination with Monjuvi; for FL, added use as first-line in combination with Gazyva, specified use as a single agent or combination therapy for second-line or subsequent therapy, and removed specific requirements surrounding combination use with Monjuvi in non-transplant candidates; for classic Hodgkin lymphoma, removed requirement for use as fourth-line or later therapy and added use as single agent palliative subsequent therapy;  for adult T-cell leukemia/lymphoma and hepatosplenic gamma-delta T-cell lymphoma, specified use must be as a single agent; for CLL/SLL, specified use must be as a single agent or in combination with rituximab and specified prior therapies that must be tried; for B-cell lymphomas, clarified that Monjuvi can also be used in non-CAR T-cell therapy candidates and added additional pathways for use; references reviewed and updated. 

9/1/2025 

CP.PHAR.73 

Sunitinib (Sutent) 

2Q 2025 annual review: revised policy/criteria section to also include generic sunitinib; per NCCN, revised the following – for GIST, added tumor rupture as an acceptable qualifier; for pNET, added that tumor must be well-differentiated and removed requirement for use as a single agent; for off-label indications, added extraskeletal myxoid chondrosarcoma as a covered use and updated myeloid/lymphoid neoplasms to include mixed phenotype; modified Medicaid/HIM continued approval duration from 6 months to 12 months per standard oncology approach; references reviewed and updated. 

9/1/2025 

CP.PHAR.77 

Temozolomide (Temodar) 

2Q 2025 annual review: for off-label NCCN Compendium, added criteria for well-differentiated grade 3 neuroendocrine tumors, added criteria for pediatric medulloblastoma, revised the following off-label indications to align with NCCN recommended category 1 or 2A ratings: cutaneous melanoma, pediatric diffuse high-grade gliomas, intracranial and spinal ependymoma, and medulloblastoma; references reviewed and updated. 

9/1/2025 

CP.PHAR.78 

Thalidomide (Thalomid) 

2Q 2025 annual review: consolidated criteria for MCD, Kaposi sarcoma, and histiocytic neoplasms into one section of off-label NCCN Compendium Indications; in off-label NCCN compendium indications, added criteria for pediatric medulloblastoma per NCCN 2A recommendation; in continued therapy, clarified continuity of care does not apply to ENL, aphthous stomatitis, or aphthous ulcers and only applies to oncological indications; updated Appendix B per Clinical Pharmacology; references reviewed and updated. 

9/1/2025 

CP.PMN.125 

Milnacipran (Savella) 

2Q 2025 annual review: added gabapentin redirection option to 

fibromyalgia criteria; references reviewed and updated. 

9/1/2025 

CP.PMN.198 

Overactive Bladder Agents 

2Q 2025 annual review: for brand Myrbetriq, added redirection to generic mirabegron; references reviewed and updated. 

9/1/2025 

CP.PMN.209 

Solriamfetol (Sunosi) 

2Q 2025 annual review: for narcolepsy, updated indication in initial approval criteria to FDA-approved indication of “Narcolepsy with EDS” to align with prescriber information and competitor analysis; added criteria for documentation of MSLT with mean sleep latency ≤ 8 minutes with evidence of two or more SOREMPs or at least one SOREMP on MSLT and a SOREMP (less than 15 minutes) on the preceding overnight PSG and daily periods of irrepressible need to sleep or daytime lapses into sleep occurring for at least 3 months to align with other narcolepsy with EDS criteria; references reviewed and updated. 

9/1/2025 

CP.PMN.277 

Ulcer Therapy Products 

2Q 2025 annual review: for H. pylori infection, removed required redirection to generic Prevpac for all agents except for Omeclamox-Pak; for Talicia, added redirection to bismuth quadruple therapy; for Voquezna and Voquezna Triple/Dual Pak if request is for a clarithromycin-containing regimens, added requirement that H. pylori is clarithromycin-sensitive; for Voquezna, added requirement that it is prescribed in combination with amoxicillin or amoxicillin and clarithromycin; references reviewed and updated. 

9/1/2025 

CP.PMN.298 

Tirzepatide (Zepbound) 

2Q 2025 annual review: added Rybelsus as option for step therapy; for documentation of weight loss program, added member has been actively enrolled for at least 6 months and continues to be actively enrolled while concomitantly prescribed Zepbound; for continued therapy, modified approval duration for first reauthorization as 6 months and subsequent reauthorization as 12 months; references reviewed and updated. 

9/1/2025