Pharmacy Policies Updates

Amvuttra

Amvuttra moved to non-preferred for ATTR CM. Steps through one of three (Vyndamax, Vyndaqel, or Attruby)

Amvuttra moved to non-preferred for ATTR PN. Step through Wainua

Bendamustine

Administrative change to Length of Authorization section to delineate between authorization durations for initial and renewal periods. Per NCCN updates, made the following changes to criteria. To T-Cell Lymphomas, added use in T-Cell Prolymphocytic Leukemia. To Waldenström Macroglobulinemia/Lymphoplasmacytic Lymphoma, updated use as alternative therapy for previously treated disease to indicate patient must have persistent symptoms following primary therapy. To Adult Hodgkin Lymphoma use as palliative therapy for cHL, removed requirement that patient is >60 years of age or has poor PS/co-morbidities and updated use as subsequent therapy for Nodular Lymphocyte-Predominant Hodgkin Lymphoma to also allow for lack of response. Pediatric Hodgkin Lymphoma was extensively revised to include combination use with BV and nivolumab. To MM, updated to allow for use in CNS disease as part of multimodality therapy and added a footnote regarding use for relapsed/refractory disease indicating treatment is also allowed for POEMS, MIDD, and MGRS. Removed use for Primary Cutaneous Lymphoma. Renewal criteria revised as there are now no renewable indications. To dosing table, editorial change to remove note from WM/LPL as this is addressed in initial criteria. To NDCs, updated Vivimusta per PI updates/manufacturer change. Added Appendix A - Non-Quantitative Treatment Limitations (NQTL) Factor Checklist. To ICD-10 table, added C83.398 for DLBCL, C91.60 and C91.62 for Prolymphocytic leukemia, Z94.84 for HSCT, and updated codes for C86.10, C86.20, C86.50, C88.00 and C88.40 per NCCN. Updated ICD-10 crosswalk (for PCM) list. Editorial changes made to policy naming and throughout.

Beovu

Administrative changes to Length of Authorization section to delineate between authorization durations for initial and renewal periods and to Dosing Limits section to remove QL. To the Universal Criteria for non-use with other ophthalmic vascular endothelial growth factor (VEGF) inhibitors, added asterisk with a corresponding footnote stating that use as part of an alternating treatment regimen with other ophthalmic VEGF inhibitors is generally not permitted and will be reviewed on a case-by-case basis, and removed examples of ophthalmic VEGF inhibitors for conciseness. Editorial changes to Initial Criteria, Renewal Criteria, Dosage/Administration, and Billing Code section. Added Appendix A – Non-Quantitative Treatment Limitations (NQTL) Factor Checklist.

Bevacizumab Oncology

Administrative changes to Length of Authorization section to delineate between authorization durations for initial and renewal periods and to Initial and Renewal criteria to update ‘coverage’ to ‘prior authorization validity’. To CRC, added option for use for locally unresectable or medically inoperable rectal cancer. To Ovarian cancer, simplified use as single agent maintenance therapy for stage II-IV disease and BRCA1/2 wild-type or unknown. To pediatric central nervous system cancers added Optic Pathway Glioma and neurofibromatosis type 2 vestibular schwannomas and subsequent criteria based on KOL input and supportive literature. Dosing table was also updated to include supported dosing for both indications. To RCC, added a footnote to clarify use as FLT for stage IV disease is limited to M1 metastatic or unresectable T4, M0 disease. To renewal criteria, bullet requiring disease response/stable disease was modified to account for continues treatment for progression on bevacizumab for certain indications. Global change to add NQTL Factor Checklist (Appendix A) to policy. ICD10 table was updated with codes C72.30, C72.31, C72.32 for Optic Pathway Glioma. Updated ICD-10 crosswalk (for PCM) list. Editorial changes made to the policy title to put all drugs in alphabetical order.

Cyramza

Administrative changes to Length of Authorization section to delineate between authorization durations for initial and renewal periods and to Dosing Limits section to remove QL. To CRC and Appendiceal Adenocarcinoma, simplified criteria by removing pMMR/MSS, dMMR/MSI-H, and POLE/POLD1 criteria and adding a footnote regarding universal MMR or MSI testing. To Gastric, Esophageal, and Esophagogastric Junction Cancers heading, added Gastroesophageal Junction Cancer. Additionally, to Gastric, Esophageal, and Esophagogastric/Gastroesophageal Junction Cancers, removed unresectable locally from advanced disease to align with less restrictive PI indication. To HCC, simplified criteria to align with NCCN update. To NSCLC, added criteria for EGFR exon-19 deletion or exon 21 (L858R) substitution mutation positive disease to be detected by an FDA-approved or CLIA compliant test. Updated Pleural Mesothelioma heading by removing the word Malignant to align with NCCN. Added Thymic Carcinoma indication per NCCN 2A recommendations with corresponding updates made to Max Units and Dosage/Administration table. Editorial changes made throughout and to Renewal Criteria. Added Appendix A – Non-Quantitative Treatment Limitations (NQTL) Factor Checklist. To Appendix 1 ICD-10 codes, added C37, D15.0, D38.4, and Z85.238 (related to Thymic Carcinoma). Updated ICD-10 crosswalk (for PCM) list.

Elahere

Administrative changes to remove QL from Dosing Limits section and to update the renewal language. To Universal criteria, updated description of moderate to severe hepatic impairment to align with the PI. To Ovarian cancer, restructured criteria and added option for use for platinum-sensitive disease per updates in NCCN. To policy title, removed TM after Elahere and updated to R per the 7/2025 PI. Updated max units to more closely align with dosing regimen. Added Non-Quantitative Treatment Limitations (NQTL) Factor Checklist to appendix section. Minor editorial changes throughout.

Gemcitabine

Editorial change to policy naming. Administrative changes to Initial and Renewal criteria to update ‘coverage’ to ‘prior authorization validity’. To Bone cancer updated to indicate only supported 2A histologies and added note about other round cell tumors allowed to be treated like Ewing Sarcoma. To STS added Dedifferentiated Liposarcoma and Epithelioid hemangioendothelioma. To T-cell Lymphomas for extranodal NK/T0Cell lymphomas, removed “nasal type” requirement as NCCN allows use for extranasal disease. To Vulvar cancer added exclusion for use in vulva-confined recurrence as this is a 2B recommendation. To renewal criteria added severe cutaneous adverse reactions to list of unacceptable toxicities per PI update. To Billing/coding section extensively revised to add products and NDCs for gemcitabine approved through 505(b)(2) pathways from accord and Hospira and added BU descriptor to J9196. Global change to add NQTL Factor Checklist (Appendix A) to policy. To ICD-10 table added C79.89, D38.5, D38.6, modified C83.398, C86.00, C86.10, C86.20, C86.50, C86.60 and removed Z85.72.

Halaven

Administrative changes to Length of Authorization section to delineate between authorization durations for initial and renewal periods, to Dosing Limits section to remove QL, and to Initial and Renewal criteria to update ‘coverage’ to ‘prior authorization validity’. Per NCCN updates made to the following: Breast cancer for HER2 negative and HR positive disease added clarification of HER 2 status to first line therapy; STS removed “palliative therapy” from overarching and added it to the subtypes where applicable, added Dedifferentiated Liposarcoma with or without concurrent Well-differentiated Liposarcoma and Epithelioid Hemangioendothelioma as supported subtypes and clarified used for Retroperitoneal/Intra-Abdominal settings to the notes in STS updated to reflect naming convention changes. To Billing/Coding section added indication that product is available generically from various manufacturers. Additionally, global change to add NQTL Factor Checklist (Appendix A) to policy. To ICD-10 table added Z85.3 for Breast Cancer indication. Administrative change made to Appendix 2 to Palmetto GBA naming.

Infugem

To the Renewal Criteria, added severe cutaneous adverse reactions to the examples of unacceptable toxicity to align with the Warnings and Precautions section of the PI. Administrative changes to Length of Authorization section to delineate between authorization durations for initial and renewal periods, to remove QL from Dosing Limits section, and the addition of Appendix A – Non-Quantitative Treatment Limitations (NQTL) Factor Checklist to the policy as a part of the global changes being made across all policies. Administrative changes to Initial and Renewal criteria to update ‘coverage’ to ‘prior authorization validity’.

Ixempra

Administrative changes to Length of Authorization section to delineate between authorization durations for initial and renewal periods and to Dosing Limits section to remove QL. To breast cancer indication, updated options for use as first-line therapy for HR positive, HER2 negative disease to include no germline BCRA 1/2 mutation and/or IHC 0+, 1+, or 2+/ISH negative per updates in NCCN. Added Appendix A - Non-Quantitative Treatment Limitations (NQTL) Factor Checklist. Editorial changes throughout.

Lumoxiti

Policy is being retired due to the drug being removed from the market and no longer commercially available.

Nucala

Ad hoc review to add the FDA approved expanded indication for add-on maintenance treatment of adult patients with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype. Criteria was added to align with that of the Prime policy. Updated the references section to align with the references in the Prime policy. Administrative changes to Length of Authorization section to delineate between authorization durations for initial and renewal periods and addition of Appendix A – Non-Quantitative Treatment Limitations (NQTL) Factor Checklist to the policy as a part of the global changes being made across all policies. To ICD-10 section added J40, J41.0, J41.1, J41.8, J42, J44.0, J44.1, J44.89, and J44.9 (all related to COPD).

Onpattro

Onpattro moved to non-preferred for ATTR PN. Step through Wainua

Paclitaxel Albumin-Bound

Administrative changes to Length of Authorization section to delineate between authorization durations for initial and renewal periods as part of a global change being made across all policies. To Endometrial Carcinoma, made minor verbiage updates to align with NCCN updates. To Biliary Tract Cancers, removed resected from gross residual (R2) disease for use in combination with gemcitabine to align with NCCN update. Added Non-Quantitative Treatment Limitations (NQTL) Factor Checklist to appendix section. Other minor editorial changes made throughout.

Pemetrexed

Administrative change to Length of Authorization section to delineate between authorization durations for initial and renewal periods. To CNS Cancers, added primary vitreoretinal lymphoma/PCNSL ocular variant without other CNS involvement, added use in limited or extensive brain metastases from EGFR-sensitizing mutation positive NSCLC, and specified intra-cerebrospinal fluid should be used for leptomeningeal metastases from EGFR mutation-positive NSCLC which is to be determined by an FDA-approved or CLIA compliant test, all per NCCN. To Dosage/Administration table, added dosing for CNS Cancers - limited or extensive brain metastases per NCCN and updated max units in Dosing Limits section. Editorial changes made throughout. Added Appendix A – Non-Quantitative Treatment Limitations (NQTL) Factor Checklist. To Appendix 1 - Covered Diagnosis Codes, added C79.31 (related to CNS Cancers - extensive brain metastases). Updated ICD-10 crosswalk (for PCM) list.

Ranibizumab

Administrative changes to Length of Authorization section to delineate between authorization durations for initial and renewal periods and to Dosing Limits section to remove QL. To Universal Criteria for non-use with other ophthalmic vascular endothelial growth factor (VEGF) inhibitors, added asterisk with corresponding footnote stating that use as part of an alternating treatment regimen with other ophthalmic VEGF inhibitors is generally not permitted and will be reviewed on a case-by-case basis, and removed examples of ophthalmic VEGF inhibitors for conciseness. To Initial Criteria, updated current note on supplemental treatment to add DME and DR to list of applicable indications. To Renewal Criteria, added retinal vasculitis with or without occlusion to list of unacceptable toxicities to align with PIs. To Billing Code/Availability section added two new NDCs for Cimerli per IPD. Editorial changes throughout, including to the policy title to put all drugs in alphabetical order. Added Appendix A – Non-Quantitative Treatment Limitations (NQTL) Factor Checklist.

Susvimo

Administrative changes to Registered Trademark in policy title and to Length of Authorization section to delineate between authorization durations for initial and renewal periods. To Universal Criteria for non-use with other ophthalmic vascular endothelial growth factor (VEGF) inhibitors, added asterisk with corresponding footnote stating that use as part of an alternating treatment regimen with other ophthalmic VEGF inhibitors is generally not permitted and will be reviewed on a case-by-case basis. Added Appendix A – Non-Quantitative Treatment Limitations (NQTL) Factor Checklist. Editorial changes to Initial Criteria, Renewal Criteria, and Dosage/Administration sections. Updated ICD-10 crosswalk (for PCM) list.

Syfovre

Administrative changes to Registered Trademark in Policy Title, to Length of Authorization section to delineate between authorization durations for initial and renewal periods, and to Dosing Limits section to remove QL. Editorial change to Initial Criteria, Renewal Criteria, and Billing Code/Availability section. To Universal Criteria, removed examples of intravitreal complement inhibitors for conciseness. To GA, removed ‘central’ from definition of diagnosis of GA per updated AAO-PPP Guidelines. Added Appendix A – Non-Quantitative Treatment Limitations (NQTL) Factor Checklist.

Trastuzumab IV

To CNS Cancers, updated options for use in patients with brain metastases from breast cancer to align with the latest NCCN guidelines. Minor editorial changes throughout. Added Appendix A - Non-Quantitative Treatment Limitations (NQTL) Factor Checklist.

Ustekinumab

Ad hoc review to add the Ustekinumab-aekn 45 mg/0.5 mL vial for SC use in pediatric patients with Plaque Psoriasis and Psoriatic Arthritis who weigh less than 60 kg. Updated the NDC’s for all Otulfi products per the updated PI. Addition of Appendix A – Non-Quantitative Treatment Limitations (NQTL) Factor Checklist to the policy as a part of the global changes being made across all policies. Administrative changes to Initial and Renewal criteria to update ‘coverage’ to ‘prior authorization validity’ and editorial changes made to the policy title to put all drugs in alphabetical order.

Vyloy

Administrative changes to Length of Authorization section to delineate between authorization durations for initial and renewal periods. Added Esophageal Cancer and EGJ to the indication heading list (previously only Gastric and Gastro-Esophageal Junction from PI) to align with NCCN 2A recommended use. Also added additional uses in patients who are not surgical candidates and in patients with recurrent disease per NCCN. Added Appendix A - Non-Quantitative Treatment Limitations (NQTL) Factor Checklist. To Billing Code section, removed discontinued codes C9303 and J9999. Editorial changes made throughout.

Yondelis

Administrative changes to Length of Authorization section to delineate between authorization durations for initial and renewal periods, and to Dosing Limits section to remove QL. Added Appendix A - Non-Quantitative Treatment Limitations (NQTL) Factor Checklist. Per NCCN: to STS initial criteria for leiomyosarcoma in combination with doxorubicin as alternative systemic therapy removed use for stage IV disease and added recommendation for subsequent palliative therapy in retroperitoneal/intra-abdominal and extremity/body wall, head/neck. To use as single agent, added treatment settings of dedifferentiated liposarcoma with or without concurrent well-differentiated liposarcoma and epithelioid hemangioendothelioma. To neoadjuvant therapy, assess use for unfavorable tumor biology for retroperitoneal/intra-abdominal. To subsequent palliative therapy, updated to allow only for stage IV with disseminated metastasis. Updated footnote for well-differentiated liposarcoma to match NCCN verbiage. To Uterine Sarcoma, removed anthracycline therapy pre-requisite from subsequent therapy. To dosing/admin table added subsequent palliative therapy setting to combination use. Removed LLC from Palmetto GBA under Appendix 2. Editorial changes made throughout.

Zaltrap

Administrative changes to Length of Authorization section to delineate between authorization durations for initial and renewal periods and to Dosing Limits section to remove QL. To CRC and Appendiceal Adenocarcinoma, simplified criteria by removing pMMR/MSS, dMMR/MSI-H, and POLE/POLD1 criteria and adding a footnote regarding universal MMR or MSI testing. To Appendiceal Adenocarcinoma, updated criteria to allow use after previous treatment with oxaliplatin per NCCN Guidelines. Added Appendix A – Non-Quantitative Treatment Limitations (NQTL) Factor Checklist. Editorial changes made throughout.

Zepzelca

Administrative changes to Length of Authorization section to delineate between authorization durations for initial and renewal periods and to Dosing Limits section to remove QL. Minor editorial changes throughout.

Leuprolide depot

Ad hoc review to add the FDA approved product Vabrinty, an NDA authorized generic of Eligard (has the same GPI as Eligard), that will be kept at full parity with the Eligard criteria. Addition of Appendix A – Non-Quantitative Treatment Limitations (NQTL) Factor Checklist to the policy as a part of the global changes being made across all policies. Administrative changes to Initial and Renewal criteria to update ‘coverage’ to ‘prior authorization validity’ and editorial changes made to the policy title to put all drugs in alphabetical order.