Pharmacy Policy Updates

Aflibercept

Administrative changes to the Length of Authorization section to update verbiage and include number of days allowed. To the Dosing table, added voluntary dose reduction and/or interval extension recommendations. To Billing Code/Availability, added the newly approved Yesafili 2 mg/0.05 mL single-dose pre-filled syringe product. Added the Ahzantive 2 mg/0.05 mL single dose pre-filled syringe product and added the NDC for the Ahzantive 2 mg/0.05 mL single-dose vial per the updates made to the PI. Removed Aflibercept-yszy from the References section as the manufacturer has not assigned an NDC for this product and has no plans to make it commercially available. Editorial changes throughout.

Bevacizumab ONCO

Administrative changes to the Length of Authorization section to include number of days allowed for authorization durations. Small Bowel Adenocarcinoma per NCCN added combination use with irinotecan as subsequent therapy. Ovarian cancer added combination use with pembrolizumab and paclitaxel for PDL CPS >1 platinum-resistant disease after one or more prior lines of therapy based on FDA approved indication and use for pembrolizumab. HCPCS updated to remove Jobevne from J9999 and removal of effective and discontinued dates. Editorial changes made throughout.

Cabazitaxel

Removed symbols related to ANDA generics from policy title and updated verbiage related to this in the Billing Code section. Administrative changes to the Length of Authorization section to delineate between authorization durations for initial and renewal periods and to include number of days allowed for authorization durations. Also, to length of authorization added a new dosing option of 16 mg/m2 every 2 weeks in patients 65 and over. To prostate cancer in combination with carboplatin removed support for use when disease has progressed on prior docetaxel and has not received prior novel hormone therapy, additionally section was updated to reflect changes in nomenclature per NCCN. To Renewal criteria, updated bullet requiring disease response/no disease progression to use our standard verbiage. To dosing box added NCCN supports alternate dosing for patients 65 and over. Global change to add NQTL Factor Checklist (Appendix A) to policy. Editorial changes made throughout.

Cinqair

Administrative changes to the Length of Authorization section to delineate between authorization durations for initial and renewal periods and to include number of days allowed for authorization durations. Also added Appendix A – Non-Quantitative Treatment Limitations (NQTL) Factor Checklist to the policy and made other minor editorial changes throughout the criteria, per global updates. Added the following to align with the updates made to the Prime Therapeutics IL-5 Inhibitor PAQL policy: updated the length of authorization windows to 12 months initial and 12 months renewal; to the severe eosinophilic asthma criteria, added examples of asthma control therapy, added criteria for patients that have had prior biologic immunomodulator use for the treatment of asthma in the past 12 months, removed additional step requiring baseline blood eosinophil count of 400 cells/microliter or higher to now align with all other IL-5 inhibitor policies; defined types of specialists which Cinqair must be prescribed by or in consult with; removed quantity/dose requirements from initial/renewal criteria as this information was duplicative with the dosage/administration section; slimmed clinical benefit criteria within the renewal section; added agents to the Contraindicated as Concomitant Therapy table. Made other minor editorial changes throughout the criteria to align with Prime verbiage updates. Steerage toward preferred provider-administered and self-administered products was maintained within the policy, per business decision, with formatting updates made for clarity. The references in Section VII were also updated to reflect the Prime IL-5 policy references. Updated the ICD10 description for J82.81.

Darzalex SQ

Ad hoc review to add the new FDA approved indication for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for ASCT in combination with bortezomib, lenalidomide, and dexamethasone. Updates were made to all applicable sections throughout the policy to incorporate the new indication. Added footnote to those regimens in Multiple Myeloma that may also be used for POEMS, MIDD, and MGRS based on NCCN. Administrative changes were made to Initial and Renewal criteria to include number of days allowed for authorization durations. Editorial changes made throughout.

Entyvio IV

Administrative changes to Length of Authorization section to delineate between authorization durations for initial and renewal periods and to include number of days allowed for authorization durations, and to Initial and Renewal criteria to update ‘coverage’ to ‘prior authorization validity’. To Initial criteria softened hard vaccine requirement per global changes update. To Ulcerative Colitis and Crohn’s Disease, added asterisk to 3-month trial criteria to note 3 months of corticosteroids are not required if early non-response is confirmed based on guidelines and KOL. To Management of Immune Checkpoint Inhibitor-Related Toxicities, updated to allow use in G2-G4 colitis if member shows microscopic colitis on histology to align with NCCN recommendation. Added new indications of Management of CAR T-cell and Lymphocyte Engager-Related Toxicities per NCCN 2A recommendation along with corresponding initial criteria and dosing. Also updated the Dosing Limits section to reflect the addition of this new indication. Added Appendix A - Non-Quantitative Treatment Limitations (NQTL) Factor Checklist. To Appendix 1, added ICD-10 codes T80.82XA, T80.82XS, T80.89XA, T80.89XS (related to Management of CAR T-Cell and Lymphocyte Engager-Related Toxicities). Editorial changes made throughout.

Gamifant

Administrative change to Length of Authorization section to include number of days allowed for authorization durations. To Universal Criteria, softened hard vaccine requirement per global changes update. Added indication of Management of Immune Checkpoint Inhibitor-Related Toxicities to allow for use as additional immunosuppression for immunotherapy-related HLH-like syndrome if no response to corticosteroids after 5 days per NCCN; corresponding updates made to Renewal Criteria and Dosage/Administration table. Added Appendix A - Non-Quantitative Treatment Limitations (NQTL) Factor Checklist. Editorial changes made throughout.

HA Derivatives

Administrative changes to the Length of Authorization section to include number of days allowed for authorization durations. Added newly approved device, Hymovis One to apply to criteria by adding to policy title, Max units, Dosing, and Billing Code sections. Added Appendix A – Non-Quantitative Treatment Limitations (NQTL) Factor Checklist. Editorial changes made throughout.

Ilumya

Administrative change to Length of Authorization section to delineate between authorization durations for initial and renewal periods as well as include number of days allowed. Softened hard vaccine requirements in Initial and Universal sections. Editorial changes throughout. Added Appendix A – Non-Quantitative Treatment Limitations (NQTL) Factor Checklist.

Infliximab

Administrative changes to Length of Authorization to delineate between authorization durations for initial and renewal periods and to include number of days allowed. Softened vaccine language as per global change. Updates made to Pediatric UC, Crohn’s Disease, and Pediatric CD: added asterisk to 3-month trial criteria to note 3 months of corticosteroids are not required if early non-response is confirmed based on guidelines and KOL. Under Management of Immune Checkpoint Inhibitor-Related Toxicities made updates to align with NCCN recommendations to allow for use in G2-G4 colitis if member shows microscopic colitis on histology and removed G4 hemolytic anemia along with corresponding ICD 10 codes D59.0 and D59.2. Also for this indication, updated dosing and MU under dosing limits. Added indication of, Management of CAR T-Cell and Lymphocyte Engager-Related Toxicities to align with NCCN 2A recommendations and related LOA, dosing, ICD10 codes, and max units. Added voluntary dose reduction and/or interval extension criteria to dosing table. Appendix A – Non-Quantitative Treatment Limitations (NQTL) Factor Checklist was added to the policy per global change. To Appendix 1, added ICD-10 codes T80.82XA, T80.82XS, T80.89XA, T80.89XS (related to management of immune checkpoint inhibitor-related toxicities). Editorial changes made throughout.

Keytruda IV

Ad hoc review to add the newly FDA approved use in combination with paclitaxel, with or without bevacizumab, for the treatment of adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma whose tumors express PD-L1 and who have received one or two prior systemic treatment regimens. Updates were made to all affected sections of the policy to include this new use. Made other global and editorial changes throughout.

Keytruda SQ

Ad hoc review to add the newly FDA approved use in combination with paclitaxel, with or without bevacizumab, for the treatment of adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma whose tumors express PD-L1 and who have received one or two prior systemic treatment regimens. Updates were made to all affected sections of the policy to include this new use. Made other global and editorial changes throughout.

Leqvio

Ad hoc review to add the newly approved indication for use in pediatric patients at least 12 years of age for HoFH and to add the expanded use in HeFH pediatric patients age 12 years and older (was previously only approved for adult patients for the HeFH indication). The indication heading was also updated for Hyperlipidemia to match the FDA approved labeling. Exclusion for use in combination with other therapies was also modified. To the diagnostic tables, made updates to incorporate previously omitted pediatric-related criteria and made other updates for clarity. Absence of unacceptable toxicity was updated in the Renewal Criteria section to align with the latest PI. Administrative changes were made to the Length of Authorization section to update verbiage and include number of days allowed. Also added Appendix A – Non-Quantitative Treatment Limitations (NQTL) Factor Checklist to the policy per global change. The ICD-10 chart was updated to remove obsolete codes E78.4 and E78.01 and to add E78.010 (related to HoFH), E78.011 (related to HeFH) and E78.019 (related to HoFH and HeFH). Other minor editorial changes were made throughout.

Lymphir

Administrative changes to the Length of Authorization section to delineate between authorization durations for initial and renewal periods and to include number of days allowed. To Initial Approval Criteria removed exclusion for use in members with cardiac disease or those with significant infections as these conditions are not limited by NCCN. To Billing Code/Administration, remove discontinued HCPCS code J9999. Added Appendix A - Non-Quantitative Treatment Limitations (NQTL) Factor Checklist. Editorial changes throughout.

Paclitaxel Albumin-Bound

Administrative changes to the Length of Authorization section to include number of days allowed for authorization durations. To Breast Cancer, updated verbiage from BRCA 1/2 mutation to BRCA 1/2 pathogenic variant to align with NCCN updated verbiage. To NSCLC, updated molecular mutations verbiage to biomarkers per NCCN. To Pancreatic Adenocarcinoma, updated heading to “Pancreatic Cancer” and added histologies of adenocarcinoma, adenosquamous carcinoma, or squamous carcinoma to criteria per NCCN guidance; changes were made throughout the policy for this indication. To Appendix 1 - Covered Diagnosis Codes, added C50.A0-C50.A2 (related to Breast Cancer) per NCCN. Editorial changes made throughout.

Pemetrexed

Administrative changes to the Length of Authorization section to include number of days allowed for authorization durations. To CNS Cancers, simplified criteria for use for brain metastases from NSCLC. To Ovarian Cancer, updated verbiage prohibits immediate treatment for a biochemical relapse. Editorial changes throughout.

Provenge

Administrative change to Length of Authorization section to delineate between authorization durations for initial and renewal periods and to update prior authorization validity language. Added Appendix A - Non-Quantitative Treatment Limitations (NQTL) Factor Checklist. To the CMS appendix, remove the row for article A52926 as this has been retired. Updated jurisdiction for A55719 to include both jurisdictions E & F.

Roctavian

Added a Max Unit section disclaimer stating that the max units don’t necessarily reflect the prescribing information max dosing limitations. Updated verbiage from “Patient” to “Member” as part of global changes for 2026.

Rybrevant SQ

Ad hoc review to add newly approved dosing of every 4 weeks as a single agent or in combination with lazertinib for members with locally advanced or metastatic NSCLC. Updated Dosing Table to separate from every 2-week dosing, added NDCs related to the new dosing to the Billing Code section, and updated Max Units section accordingly. Editorial changes throughout.

Simponi ARIA

Administrative changes to the Length of Authorization section to delineate between authorization durations for initial and renewal periods and to include number of days allowed. Softened hard vaccine requirements in Universal Criteria. Added Appendix A – Non-Quantitative Treatment Limitations (NQTL) Factor Checklist. Editorial changes made throughout.

Skyrizi IV

Administrative change to Length of Authorization section to delineate between authorization durations for initial and renewal periods. Softened hard vaccine requirement in Universal Criteria. To Ulcerative Colitis and Crohn’s Disease, added asterisk to 3-month trial criteria to note 3 months of corticosteroids are not required if early non-response is confirmed based on guidelines and KOL. Added Appendix A – Non-Quantitative Treatment Limitations (NQTL) Factor Checklist. Editorial changes made throughout.

Sylvant

Administrative changes to the Length of Authorization section to delineate between authorization durations for initial and renewal periods and to include number of days allowed. To universal criteria, softened language surrounding use of live vaccines as per global changes. Also updated bullet requiring single agent use to say "unless otherwise specified" to accommodate new indication added. Added footnote indicating the HIV-negative and HHV-8 negative disease only applies to Castleman Disease indications (MCD/UCD). To Unicentric Castleman Disease, added first-line or alternate first-line therapy for unresectable or incompletely resected disease as per NCCN update. To Management of CAR T-cell related toxicities, updated indication heading to allow management of lymphocyte engager related toxicities. Per NCCN updates, criteria were updated to include CRS from either CAR T-cell or T-cell engaging bispecific agents and added option for use in addition tocilizumab as alternative cytokine blockade. The dosing table and LOA were updated to allow a maximum of 2 doses for management of CAR T or lymphocyte engager related toxicity. Added new indication of KSHV-Associated Inflammatory Cytokine Syndrome with corresponding updates to criteria, dosing, LOA and max units. Added ICD 10 codes related to this new indication (C46.0-C46.4, C46.50-C46.52, C46.7, C46.9, D89.89, D89.9) as per NCCN. Added Appendix A - Non-Quantitative Treatment Limitations (NQTL) Factor Checklist. Editorial changes throughout.

Tocilizumab IV

Administrative changes to alphabetize all agents in policy name, To Length of Authorization section to include number of days allowed for authorization durations. Softened hard vaccine requirements in Universal Criteria. To Giant Cell Arteritis, added MRA, CT, and FDG/PET as examples of diagnostic imaging per UTD and renewal criteria for GCA. To Castleman Disease, updated criteria to include first-line or alternate first-line therapy for both UCD and MCD to align with NCCN updates. To Cytokine Release Syndrome, separated criteria based on CRS due to CART or T-cell engaging bispecific agents to better align with NCCN updates. For CRS due to CART removed specific criteria and now allowing use in any grade based on NCCN and for CRS due to bispecific agents added additional agents of talquetamab, elranatamb, or linovseltamab based on NCCN multiple myeloma guidelines. To Management of Immune Checkpoint Inhibitor Related Toxicities, minor updates to criteria to align with NCCN updates specifically for G3-G4 pneumonitis, G3 or G4 elevated ALT/AST and G3 or G4 elevated alkaline phosphatase. Per NCCN, added new 2A indication of KSHV-Associated Inflammatory Cytokine Syndrome with corresponding updates to criteria, LOA, Max Units, and Dosing sections. To the Billing Code section, remove discontinued unclassified code J3590 for Avtozma and unbranded biologic tocilizumab-anoh IV which was replaced by Q5156. Added Appendix A – Non-Quantitative Treatment Limitations (NQTL) Factor Checklist. To Appendix 1 ICD-10 codes, added C46.0-C46.4, C46.50, C46.51, C46.52, C46.7 C46.9, D89.89, D89.9 (related to Kaposi Sarcoma), C90.00, C90.02, C90.10, C90.12, C90.20, C90.22, C90.30, C90.32, Z29.89, Z85.79 (related to Multiple Myeloma). Updated ICD-10 crosswalk (for PCM) list. Editorial changes made throughout.

Trastuzumab IV

Administrative changes to the Length of Authorization section to include number of days allowed for authorization durations. To Breast Cancer added combination use with aromatase inhibition with palbociclib and pertuzumab and combination use with tucatinib (with or without fulvestrant) per NCCN updates. To CNS Cancers, simplified criteria for use for brain metastases from breast cancer. To Appendiceal Neoplasms and Cancers, removed preclusion that patient has not previously received HER2 targeted therapy and indicated that patient has not previously received trastuzumab per NCCN update. Added Small Bowel Adenocarcinoma per NCCN 2A recommendation with a corresponding update made to the HER2-positive overexpression criteria table. Additionally, to the HER2-positive overexpression criteria table, updated language to align with NCCN updated verbiage. To Appendix 1 - Covered Diagnosis Codes, added C17.0-C17.3, C17.8, C17.9, Z85.068 (related to Small Bowel Adenocarcinoma), C50.A0-C50.A2 (related to Breast Cancer), and D37.031, D37.032, D37.039 (related to Head and Neck Cancers). Editorial changes made throughout.

Yescarta

Ad hoc review to remove exclusion of primary CNS lymphoma per updated PI, which no longer limits use in this setting. Softened vaccine language per global update. Editorial changes made throughout.