Pharmacy Policies Updates

Abecma

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 criteria to update verbiage in the HCT/MRR box and ‘coverage’ to ‘prior authorization validity’. REM criterion removed per updated FDA PI. To MM, added asterisk and note per NCCN that regimen may also be used for the treatment of Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal protein, Skin changes (POEMS), Monoclonal Immunoglobulin Deposition Disease (MIDD), and plasma cell-related Monoclonal Gammopathy of Renal Significance (MGRS). Editorial change to renewal criteria. To note section in the dosing table, updated to reflect changes to PI including instructions for patient monitoring after infusion. Global change to add NQTL Factor Checklist (Appendix A) to policy. Other minor editorial changes were made throughout.

Adcetris

To Mycosis Fungoides/Sezary Syndrome, updates to primary therapy and subsequent therapy to include cutaneous or extracutaneous lesions with LCT. Also, removed in combination with systemic therapy to align with NCCN guideline recommendations. Updates made to Dosing table and Length of Authorization to differentiate between MF/SS and Primary Cutaneous CD30+ T-Cell Lymphoproliferative Disorders. Added Appendix A-Non-Quantitative Treatment Limitations (NQTL) Factor Checklist policy. Editorial changes are made throughout.

Aflibercept

Ad hoc review to add the newly approved biosimilar product, Eydenzelt, which will be kept at full parity with the reference product, Eylea.

Aphexda

Administrative changes to the 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, removed examples of CXCR4-antagonist for conciseness. To the Billing code section, updated NCD for Aphexda per 5/2025 PI. Added Appendix A - Non-Quantitative Treatment Limitations (NQTL) Factor Checklist. Editorial changes throughout.

Aucatzyl

Administrative changes to the Length of Authorization section to delineate between authorization durations for initial and renewal periods and to Initial criteria to update verbiage in the HCT/MRR box and ‘coverage’ to ‘prior authorization validity’. To ALL, added compendia symbol to indication heading, updated to include diagnosis of refractory disease per PI, and change to list of TKI made to clarify which are acceptable as previous therapy. Additionally, ALL added footnotes regarding use may be applicable in adolescents and AYA patients 15 to 39 years of age per NCCN guidelines. Editorial change to renewal criteria. Note section in dosing table updated to reflect changes to PI including instructions for patient monitoring after infusion and storage information for infusion bags. To billing/coding, removed C9301 and J9999 as these were discontinued on 07/01/2025 and updated to Q2058 to reflect full verbiage. Global change to add NQTL Factor Checklist (Appendix A) to policy. ICD10 codes removed C91.01 as this code is not supported by NCCN.

Breyanzi

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 criteria to update verbiage in the HCT/MRR box and ‘coverage’ to ‘prior authorization validity’. REM criterion removed by updated FDA PI. Per NCCN updates, the following changes to B-cell Lymphomas: added support for HIV-related plasmablastic lymphoma, editorialized PTLD, updated Richters transformation and transformation of indolent lymphoma to require two prior lines of therapy for indolent disease prior to transformation and made other minor verbiage changes to align with NCCN changes. To Pediatric Aggressive Mature B-cell Lymphoma, added footnote regarding use may be applicable in adolescent and AYA patients > 18 to < 39 years of age if treated in a pediatric oncology setting per NCCN guidelines. Editorial change to renewal criteria. To notes section in dosing table updated to reflect changes to PI including instructions for patient monitoring after infusion. Global change to add NQTL Factor Checklist (Appendix A) to policy. Minor editorial changes are made throughout for clarity.

Carvykti

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 criteria to update verbiage in the HCT/MRR box and ‘coverage’ to ‘prior authorization validity’. REM criterion removed per updated FDA PI. To MM, added asterisk and note per NCCN that regimen may also be used for the treatment of Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal protein, Skin changes (POEMS), Monoclonal Immunoglobulin Deposition Disease (MIDD), and plasma cell-related Monoclonal Gammopathy of Renal Significance (MGRS). Editorial change to renewal criteria. To notes section in dosing table, updated to reflect changes to PI including instructions for patient monitoring after infusion. Global change to add NQTL Factor Checklist (Appendix A) to policy. Other minor editorial changes were made throughout.

Darzalex IV

Added Appendix A – Non-Quantitative Treatment Limitations (NQTL) Factor Checklist. Editorial changes made throughout.

Denosumab

Ad hoc review to add the newly approved Prolia biosimilars: Bildyos, Bosaya, Enoby, and Denosumab-bmwo and Xgeva biosimilars: Aukelso, Bilprevda, Denosumab-bmwo, and Xtrenbo to the policy at full parity with each reference product. Added these new products to all applicable sections (initial, renewal, dosing, billing code/availability). Removed HCPCS code J3590 for Osenvelt, Stoboclo, Bomyntra, Conexxence, Denosumab-bnht, Denosumab-dssb, Ospomyv, and Xbryk as it was discontinued as of 10.01.25. 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’ along with editorial changes made to the policy title to put all drugs in alphabetical order. 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.

Erbitux

Added Appendix A-Non-Quantitative Treatment Limitations (NQTL) Factor Checklist to policy. Editorial changes are made throughout.

Evkeeza

Added the FDA approved expanded indication to now allow use for treatment of HoFH in pediatric patients at least 1 year of age; previously only approved for use in patients at least 5 years of age. To Universal Criteria, removed the exclusion for use in combination with lomitapide per KOL review and ACC guidance. To HoFH indication, added back lomitapide to agents that might be used in combination (in the initial and renewal sections). Also added additional options for tried/failed criteria with at least a 6-month trial of lomitapide. Broadened the verbiage from “despite pharmacologic treatment, unless contraindicated, with PCSK9/ezetimibe/statin” to instead be “despite receiving LDL-lowering therapy, unless contraindicated” within the LDL-C level criterion to encompass the updates made to the t/f criteria. Added Appendix A – Non-Quantitative Treatment Limitations (NQTL) Factor Checklist to the policy per global change. Covered Diagnosis Code section was updated to remove outdated code E78.01 and replace with E78.010 (related to HoFH). Other minor editorial changes were made throughout.

GCSF LA

Made administrative changes to alphabetize policy naming and made changes to the Length of Authorization section to delineate between authorization durations for initial and renewal periods, all as part of the global changes being made across all policies. Also added Appendix A – Non-Quantitative Treatment Limitations (NQTL) Factor Checklist to the policy per global change. Added indication of Pediatric Aggressive Mature B-Cell Lymphomas for all the pegfilgrastim products based on NCCN now allowing use in this setting. Made updates to the risk factors for febrile neutropenia table to align with NCCN. Made editorial changes to the dosing table. Updated NDC codes for Ryzneuta, Fulphila, and Udenyca as applicable based on PI, IPD and/or DrugIQ availability. Added ICD10 codes C65.1, C65.2, C65.9 (related to Wilms Tumor), C83.30-C83.39, C83.70-C83.79, C85.20-C85.29, and D47.Z1 (related to Pediatric Aggressive Mature B-cell Lymphomas) per latest NCCN recommendations. Made other minor editorial changes throughout.

IVIG

Ad hoc review to add the newly approved product Qivigy, which is kept at full parity to all of the other IVIG products within the policy. 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.’

Keytruda IV

Reformatted Length of Authorization section to separate out approval durations for neoadjuvant and adjuvant treatment settings to better align with Dosing Table. To Bladder Cancer/Urothelial carcinoma, made editorial changes to use as single agent first-line treatment in platinum-ineligible patients for better readability. To Cervical Cancer, updated option for use in combination with tisotumab vedotin-tftv to now require patient to be immuno-oncology therapy naïve per NCCN. To Esophageal and EGJ cancer, updated first-line treatment to require PD-L1 CPS ≥1 regardless of HER2 status or histology per NCCN. To Head and Neck Cancer, updated options for use in resectable locally advanced disease to incorporate both the PI and new NCCN recommendations. To Kaposi Sarcoma, added option for use with antiretroviral therapy (ART) and updated types of advanced disease. To RCC, updated subsequent therapy for clear cell histology to apply only to patients who are immune-oncology therapy naïve when used in combination with axitinib or lenvatinib and removed footnote that allowed on a case-by-case basis as per NCCN now noting prior IO use as 2B. Also, to adjuvant therapy added SBRT in addition to nephrectomy to apply to patients with stage II and III disease. To MCC, added in-transit N+ regional disease to use as a single agent. To SCLC, removed requirement for chemotherapy free interval of ≤6 months and simplified options for use to allow as subsequent treatment for progressive or relapsed diseases per new NCCN guidelines. To Dosing Table, added until disease progression or unacceptable toxicity to Extranodal NK/T-Cell Lymphomas. Editorial changes throughout criteria. Added Appendix A – Non-Quantitative Treatment Limitations (NQTL) Factor Checklist.

Kimmtrak

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’. To Uveal Melanoma, removed requirement that patients have no prior systemic treatment in the advanced or metastatic setting to align with the PI indication and NCCN recommendations. Added Non-Quantitative Treatment Limitations (NQTL) Factor Checklist to appendix section.

Kisunla

To Universal Criteria, removed aducanumab since no longer available and added IV/SQ to lecanemab to list of other anti-amyloid immunotherapies to not use concurrently. Also removed criteria on psychiatric illness and history of alcohol or substance abuse as they are not contraindications in the PI. To Renewal Criteria, updated examples of unacceptable toxicities to align with updates made to the Warnings and Precautions section of the PI. Also updated response of therapy statement to include slowing of progression of disease to clarify the disease is progressive. Aligned the tables on ARIA with current PI language and reformatted table cells. Editorial changes throughout policy. Added Appendix A – Non-Quantitative Treatment Limitations (NQTL) Factor Checklist.

Krystexxa

Ad hoc review to add the new Ready-to-Use 8 mg/50 mL (0.16 mg/mL) single-dose vial product and updated the description for the 8 mg/mL product to clarify that it is ‘To-be-Diluted.’ 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’.

Kymriah

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 criteria to update verbiage in the HCT/MRR box and ‘coverage’ to ‘prior authorization validity’. REM criterion removed per updated FDA PI. Per NCCN updates, to transformation of indolent lymphoma update to require two prior lines of therapy for indolent disease prior to transformation. Added support for HIV-related plasmablastic lymphoma. Editorial change to renewal criteria. To notes section in dosing table updated to reflect changes to PI including instructions for patient monitoring after infusion. Global change to add NQTL Factor Checklist (Appendix A) to policy. Minor editorial changes are made throughout for clarity.

Libtayo

Ad hoc review to add the FDA approved expanded indication for the adjuvant treatment of patients with cutaneous squamous cell carcinoma (cSCC) at high risk of recurrence after surgery and radiation. The Length of Authorization, dosing table, and dosing limits sections were also updated to reflect the addition of this new indication. Also to cSCC, reformatted and updated criteria for neoadjuvant therapy to reflect that use in patients with regional or satellitosis/in-transit metastatic disease, very high-risk disease, and locally advanced disease and updated the footnote for very high-risk features to align with NCCN.

Mozobil

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, removed examples of CXCR4-antagonists for conciseness. To Peripheral mobilization of stem cells for transplantation, added options for use in combination with filgrastim (or biosimilars) or tbo-filgrastim AND cyclophosphamide OR other disease-specific chemotherapy, per NCCN. To Renewal Criteria, bullet referring providers back to section I for duration of authorization limits. Added Appendix A - Non-Quantitative Treatment Limitations (NQTL) Factor Checklist. Editorial changes throughout.

Niktimvo

Administrative change to Length of Authorization section to delineate between authorization durations for initial and renewal periods. Added compendia symbol to aGVHD indication since it is now listed in NCCN. Updated current step through belumosudil to note this applies to ages 12 years and older based on the FDA approved age of belumosudil. To Billing Code/Availability, removed discontinued HCPCS code J3590. Editorial changes to Initial and Renewal sections. Added Appendix A – Non-Quantitative Treatment Limitations (NQTL) Factor Checklist.

Ryoncil

Administrative change to Length of Authorization section to delineate between authorization durations for initial and renewal periods. Also, to the LOA, added note referring back to section IV & V for recurrence therapy criteria. To Initial Criteria, updated HCT/MRR box to current language. To Renewal Criteria, replaced ‘flare’ with ‘recurrence’ to better align with PI. To Billing Code/Availability, removed discontinued HCPCS codes C9399 and J3590 per IPD and added table listing all available product NDCs noted in PI. Editorial changes throughout policy. Added Appendix A – Non-Quantitative Treatment Limitations (NQTL) Factor Checklist.

Rytelo

Ad hoc review to update an ‘AND’ to ‘OR’ in between criteria for patients who has del(5q) mutation or patient does not have del(5q) mutation. Administrative changes to Length of Authorization section to delineate between authorization durations for initial and renewal periods. Editorial changes throughout policy. Added Appendix A – Non-Quantitative Treatment Limitations (NQTL) Factor Checklist.

Tecartus

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 criteria to update verbiage in the HCT/MRR box and ‘coverage’ to ‘prior authorization validity’. REM criterion removed per updated FDA PI. To ALL change to list of TKI made to clarify which are acceptable as previous therapy. Editorial change to renewal criteria. To notes section in dosing table, updated to reflect changes to PI including instructions for patient monitoring after infusion. Global change to add NQTL Factor Checklist (Appendix A) to policy. Editorial changes are made throughout.

Tecentriq IV

Ad hoc review to add the new FDA approved use in combination with lurbinectedin for the maintenance treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) whose disease has not progressed after first-line induction therapy with atezolizumab (IV/SC), carboplatin, and etoposide. New NCCN 2A recommendations were also incorporated for subsequent therapy for ES-SCLC disease progression/relapses after a prolonged disease-free interval for use in combination with carboplatin and etoposide followed by maintenance therapy as a single agent or in combination with lurbinectedin. Per NCCN, added ICD-10 code Z85.12 (related to SCLC).

Tecentriq SQ

Ad hoc review to add the new FDA approved use in combination with lurbinectedin for the maintenance treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) whose disease has not progressed after first-line induction therapy with atezolizumab (IV/SC), carboplatin, and etoposide. New NCCN 2A recommendations were also incorporated for subsequent therapy for ES-SCLC disease progression/relapses after a prolonged disease-free interval for use in combination with carboplatin and etoposide followed by maintenance therapy as a single agent or in combination with lurbinectedin. Per NCCN, added ICD-10 code Z85.12 (related to SCLC). 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. Administrative changes to Initial and Renewal criteria to update ‘coverage’ to ‘prior authorization validity. Editorial changes are made to the Billing Code/Availability section to remove obsolete HCPCS codes. Other minor editorial changes were made throughout.

Tremfya

Ad hoc review to now allow treatment of moderate-to-severe plaque psoriasis and active psoriatic arthritis in pediatric patients 6 years and older who also weigh at least 40 kg; previously only approved for use in adult patients. Also, updated the policy to allow the newly approved option of SQ induction dosing for the treatment of adult patients with moderately to severely active ulcerative colitis; previously only approved for IV induction dosing. The Length of Authorization, Dosing Limits, Renewal Criteria, dosing, and ICD-10 code sections were also updated to reflect the new approvals. 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 to Length of Authorization to delineate between authorization durations for initial and renewal periods.

Ustekinumab

Ad hoc review to add the newly approved unbranded biologic product Ustekinumab-auub (same cell-line as Wezlana). This product will be kept at full parity with the reference product, Stelara.

Xiaflex

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 Peyronie's Disease, REM criterion was deleted to eliminate redundancy with policy criteria, eliminate risk of inappropriate pend/denials, and to better align pharmacy/medical benefit criteria. Added Appendix A – Non-Quantitative Treatment Limitations (NQTL) Factor Checklist. Editorial changes are made throughout.

Yescarta

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 criteria to update verbiage in the HCT/MRR box and ‘coverage’ to ‘prior authorization validity’. REM criterion removed by updated FDA PI. Per NCCN updates, to transformation of follicular lymphoma and indolent lymphoma update to require two prior lines of therapy for indolent disease prior to transformation. Added support for HIV-related plasmablastic lymphoma. To Pediatric Aggressive Mature B-cell Lymphoma, added footnote regarding use may be applicable in adolescent and AYA patients > 18 to < 39 years of age if treated in a pediatric oncology setting per NCCN guidelines. Editorial change to renewal criteria. To notes section in dosing table updated to reflect changes to PI including instructions for patient monitoring after infusion. Global change to add NQTL Factor Checklist (Appendix A) to policy. Minor editorial changes made throughout for clarity. To ICD10 codes removed C88.4 as this code is not supported by NCCN.

Zepzelca

Ad hoc review to add the new FDA approved indication for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) whose disease has not progressed after first-line induction therapy with atezolizumab (IV/SC), carboplatin, and etoposide to be used as maintenance therapy in combination with atezolizumab (IV/SC). New NCCN 2A recommendations were also incorporated for disease progression/relapse after a prolonged disease-free interval as maintenance therapy with atezolizumab (IV/SC) following at least stable disease on carboplatin, etoposide and atezolizumab (IV/SC) and updates were made to single agent use to allow use as subsequent systemic therapy if not previously used for progression or relapse. Universal Criteria was removed from the policy as it only contained criteria for single agent use requirement which is no longer overarching with the addition of the new treatment regimens. To the Dosing/Administration table, added new PI administration guidance on use of lurbinectedin in cases of atezolizumab IV/SC immune-related severe adverse events. Per NCCN, added the following ICD-10: Z85.118, Z85.12 (related to SCLC). Other minor editorial changes were made throughout.

GCSF SA

Made administrative changes to the Policy Naming to alphabetize/editorialize product names, to the Length of Authorization section to delineate between authorization durations for initial and renewal periods, to the Dosing Limits section to remove the Quantity Limit, as part of the global changes being made across all policies. Also added Appendix A – Non-Quantitative Treatment Limitations (NQTL) Factor Checklist to the policy per global change. To AML, updated criteria to remove re-induction therapy as this is no longer supported in NCCN. To the MDS section, added that short acting G-CSFs may also be used following relapse after prior therapy based on NCCN in addition of this use setting. To Management of CAR-T Related Toxicity, removed examples of CAR-T therapy for conciseness. Added indication of Pediatric Aggressive Mature B-Cell Lymphomas based on NCCN now allowing broad use in this setting. Made updates to the risk factors for febrile neutropenia table to align with NCCN. Removed obsolete HCPCs codes J3590 and C9173 (related to Nypozi). Added ICD10 codes C65.1, C65.2, C65.9 (related to Wilms Tumor), C83.30-C83.39, C83.70-C83.79, C85.20-C85.29, and D47.Z1 (related to Pediatric Aggressive Mature B-cell Lymphomas) per latest NCCN recommendations. Made other minor editorial changes throughout.

Lanreotide

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. Removed examples of long-acting somatostatin analog therapy from Universal Criteria for conciseness. To Neuroendocrine and Adrenal Tumors, updated criteria for lung/thymic disease, DIPNECH, disease of the pancreas, and pheochromocytoma/paraganglioma to align with NCCN updates. To Renewal Criteria, added examples of unacceptable toxicity to align with PI. Added Appendix A – Non-Quantitative Treatment Limitations (NQTL) Factor Checklist. To Appendix 1 - Covered Diagnosis Codes, removed code E24.8 (related to Cushing's syndrome) which is no longer supported and E34.0 (related to carcinoid syndrome) which is now captured under E34.00 per NCCN. Editorial changes are made throughout.

Leukine

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. From Length of Authorization and Dosing Table removed specific regimens noted under neuroblastoma since we do not specify each regimen in the initial criteria and instead listed the max dose and duration for any neuroblastoma regimen. Updated Max Units to total dose to be received over a 14- or 28-day period and not individual dosages on specific days, and to include the new max dose for neuroblastoma. Editorial changes throughout policy. Reformatted Renewal Criteria to apply to all indications and updated list of unacceptable toxicities to align with PI and GCSF-SA policy. Added Appendix A – Non-Quantitative Treatment Limitations (NQTL) Factor Checklist.

Sandostatin LAR

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. Updated Carcinoid Tumors/Neuroendocrine Tumors heading to Carcinoid Tumors/Neuroendocrine and Adrenal Tumors and removed the examples from the heading. Additionally, updated criteria for lung/thymic disease, DIPNECH, GI disease, disease of pancreas, and pheochromocytoma/paraganglioma to align with NCCN updates. Added Merkel Cell Carcinoma indication per NCCN 2A recommendation with corresponding updates made to Dosage/Administration and Max Units sections. To Renewal Criteria, updated examples of unacceptable toxicity to align with PI. To Dosage/Administration table, updated dosing for Thymomas from 20 mg every 14 days to 30 mg every 14 days per updated literature, with a corresponding update made to MU. To NDCs, added a footnote that these products are available generically. Added Appendix A – Non-Quantitative Treatment Limitations (NQTL) Factor Checklist. To Appendix 1 - Covered Diagnosis Codes, added C4A.0, C4A.10, C4A.111, C4A.112, C4A.121, C4A.122, C4A.20-C4A.22, C4A.30, C4A.31, C4A.39, C4A.4, C4A.51, C4A.52, C4A.59-C4A.62, C4A.70-C4A.72, C4A.8, C4A.9, C7B.1, Z85.821 (related to Merkel Cell Carcinoma) and updated E34.0 to E34.00 and added E34.01 and E34.09 (related to Carcinoid Syndrome). Editorial changes are made throughout. Updated ICD-10 crosswalk (for PCM) list.

Signifor LAR

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. Removed examples of long-acting somatostatin analog therapy from Universal Criteria for conciseness. Added Appendix A – Non-Quantitative Treatment Limitations (NQTL) Factor Checklist. Editorial changes are made throughout.