Pharmacy Policy Updates

Adcetris

Administrative changes to the Length of Authorization section to include number of days allowed for authorization durations. Universal criteria added exception statement to CD30+ disease to allow for CD30 negative disease specified. Removed ‘Primary’ from Cutaneous Lymphomas throughout policy based on NCCN. To Adult cHL, for use in combination with BrECADD, removed age range based on removal from NCCN rec. To T-cell Lymphomas, added orphan drug designation symbol to Adult T-Cell Leukemia/Lymphomas and Extranodal NK/T-Cell Lymphomas. To Peripheral T-cell Lymphoma added updated NCCN recommendations for use as single agent for relapsed or refractory disease as subsequent therapy OR as initial palliative intent therapy for Enteropathy-Associated T-cell Lymphoma, Monomorphic Epitheliotropic Intestinal T-cell Lymphoma, Nodal Peripheral T-cell Lymphoma with TFH phenotype, and Follicular T-cell Lymphoma. Also, to PTCL added cyclophosphamide, doxorubicin, etoposide, prednisone regimen for use as initial therapy for previously untreated disease. Additionally, this new combination regimen was added to the dosing box and LoA section. To B-Cell lymphomas, it was updated to allow use for disease to be CD30 negative for DLBCL, HIV-related B-Cell Lymphomas and PTLD based on 2026 Oncology ad board recommendations as well as NCCN updates.

Adstiladrin

Added HCT/MRR box since this drug is a gene therapy. Administrative changes to Length of Authorization section to delineate between authorization durations for initial and renewal periods and include the number of days allowable, and to Initial and Renewal criteria to update ‘coverage’ to ‘prior authorization validity’. Added Non-Quantitative Treatment Limitations (NQTL) Factor Checklist to appendix section.

Anktiva

Administrative changes to Length of Authorization section to delineate between authorization durations for initial and renewal periods and to include number of days allowable, and to Initial and Renewal criteria to update ‘coverage’ to ‘prior authorization validity’. Added Non-Quantitative Treatment Limitations (NQTL) Factor Checklist to appendix section.

Cerezyme

Ad hoc review to add the FDA approved expanded indication for the treatment of non- CNS manifestations of Type 1 or Type 3 Gaucher disease in adults and pediatric patients; previously only approved for patients at least 2 years of age with Type 1 Gaucher disease that results in one or more of the following conditions: anemia, thrombocytopenia, bone disease, or hepatomegaly/splenomegaly. Removed the age requirement criteria as the updated indication for use no longer places a limitation on patient age and made editorial changes to the dosing table to align with the updated PI. Updated 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 and to include the number of days for approval 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’.

Darzalex IV

Administrative change to Length of Authorization section to include number of days allowed for authorization durations. To MM, added use in combination with teclistamab as an option for patients who have had prior therapy with lenalidomide and a proteasome inhibitor, based on update to NCCN guidelines. A corresponding update was made to the Dosage/Administration table. Added indication of HIV-Related B-Cell Lymphoma – plasmablastic lymphoma per NCCN 2A recommendation. Corresponding updates were made to LOA, Dosing Limits, Dosage/Administration, and ICD 10 code table (C83.30-C83.38, C83.398). Editorial changes made throughout. 

Datroway

Administrative changes to the Length of Authorization section to include number of days allowed for authorization durations. To Breast cancer updated criteria for prior endocrine-based therapy to align more closely with PI and NCCN. To NSCLC, per NCCN updates removed exclusion for locoregional recurrence or symptomatic local disease without evidence of disseminated disease and added EGFR mutations: S768I, L861Q, G719X, or exon 20 insertion. Removed HCPCS Code C9174 and J9999 as these were discontinued 10/01/2025. Added Appendix A – Non-Quantitative Treatment Limitations (NQTL) Factor Checklist. Editorial changes made throughout.

Enhertu

Ad hoc review to add the FDA approved expanded indication for use in combination with pertuzumab for the first-line treatment of adult patients with unresectable or metastatic HER2-positive (IHC 3+ or ISH+) breast cancer as determined by an FDA-approved test. Administrative changes to Length of Authorization section to delineate between authorization durations for initial and renewal periods and to include the number of days for approval 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’.

Erbitux

Administrative changes to the Length of Authorization section to include number of days allowed for authorization durations. Updated section heading to reflect new NCCN guidelines for Appendiceal Neoplasms and Cancers. Additionally, to this section included recurrent, progressive metastatic peritoneal-only and extraperitoneal disease throughout, added neoadjuvant therapy to BRAF V600 E disease, and added additional treatment setting and regimens for KRAS/NRAS and BRAF V600E wild type disease. Footnote for MMR/MSI testing removed per NCCN. To Head and Neck Cancers added Cancer of the Glottic Larynx, Supraglottic Larynx, and Occult primary cancers (non-HPV-positive) for use as sequential systemic therapy/radiation. Also to H&N Cancer, removed performance status requirements from first line and subsequent therapy, and removed staging requirements to streamline criteria and align indication with guideline and other policies for H&N Cancer. To NSCLC removed verbiage on mediastinal lymph node recurrence with prior radiation therapy and excluding use in patients with locoregional recurrence or symptomatic local disease without evidence and disseminated disease since NCCN no longer lists as 2B and to initial and subsequent therapy with lazertinib updated to allow with or without amivantamab. To the ICD10 table, remove C44.0, C44.09, C77.0, C79.89, D37.01 and added D37.3 (related to Appendiceal Neoplasms and Cancers), C05.2, D37.04, Z85.810, Z85.22, and Z85.818 (related to Head and Neck Cancer) per NCCN. Updated ICD-10 crosswalk (for PCM) list. Editorial changes made throughout.

Ilaris

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. Under Initial and Universal Criteria, softened hard vaccine requirements per global changes update. Additionally, under Universal Criteria, removed examples of biologic therapy for conciseness. Added Appendix A – Non-Quantitative Treatment Limitations (NQTL) Factor Checklist. Editorial changes made throughout.

Inlexzo

To Bladder Cancer, added compendia symbol since Inlexzo is now noted in NCCN. To Billing Code section, added for hospital use only to C9399 per IPD. To Appendix 1, removed Z85.51 as it is no longer listed in NCCN. Minor editorial changes throughout.

Jelmyto

Administrative change to Length of Authorization section to delineate between authorization durations for initial and renewal periods and include number of days allowed, and to update Prior Authorization validity verbiage. Added Appendix A - Non-Quantitative Treatment Limitations (NQTL) Factor Checklist.

Keytruda IV

Administrative change to Length of Authorization section to include number of days allowed for authorization durations. To Urothelial Carcinoma (Bladder Cancer), added the newly FDA approved neoadjuvant/adjuvant use in combination with enfortumab vedotin followed by single agent pembrolizumab in the adjuvant setting for the treatment of muscle invasive bladder cancer in cisplatin ineligible patients to all affected sections within the policy. Updates were also made to this indication include a footnote to allow use in combination with enfortumab vedotin as second line therapy despite previous treatment with immunotherapy or chemotherapy (no prior enfortumab vedotin use) and to clarify use for primary carcinoma of the urethra as first-line metastatic or as second-line setting for recurrent or metastatic disease, all to align with NCCN recommendations. Added a footnote to the Gastric, Esophageal, and Esophagogastric/Gastroesophageal Junction Cancer sections as well as the MSI-H/dMMR and TMB-H sections to allow previous therapy with a programmed death (PD-1/PD-L1)-directed therapy if no disease progression in certain settings, per NCCN. To Head and Neck Cancers, made extensive update of criteria for use per new NCCN guidelines. To CLL/SLL, updated criteria to align with NCCN updates and added a footnote indicating prior treatment could have included PD-1/PD-L1-directed therapy when used as additional therapy. To adult cHL, added criteria for single agent use post-allogeneic cell transplant, added to criteria regarding relapsed or refractory disease to allow use with or without prior checkpoint inhibitor exposure, and added that use in primary therapy is allowable as single agent therapy with or without ISRT, all to align with NCCN. To NSCLC, removed verbiage on mediastinal lymph node recurrence with prior radiation therapy and excluding use in patients with locoregional recurrence or symptomatic local disease without evidence and disseminated disease since NCCN no longer lists as 2B. Editorial change made to bullet for neoadjuvant treatment to now clarify neoadjuvant treatment will be followed by adjuvant treatment. Updated definition of stage IIIB disease and updated biomarker footnoted text and biomarker language within the criteria to align with latest NCCN recommendations/guidelines. To Primary Cutaneous Lymphomas heading, removed “Primary” to align with NCCN guideline naming update. To cSCC, added use for satellitosis/in-transit metastatic disease that is unresectable or incompletely resected, per NCCN. To Thymic Carcinoma, removed criteria for use in preoperative setting and updated criteria for second line setting to now be allowable for subsequent use instead, based on NCCN updates. To Endometrial Carcinoma (Uterine Neoplasms), removed exclusion for in the first line setting for presence of isolated metastasis as this is no longer 2B NCCN recommendation. Added new indication of Bone Cancer to align with NCCN new recommendations. Updated use for Appendiceal Adenocarcinoma to now be named Appendiceal Neoplasms and Cancers to align with new NCCN nomenclature and updated clinical use settings within the criteria for POLE/POLD1 Mutation Cancers to align with NCCN updates. To initial therapy for Thyroid Cancers under the TMB-H Cancer heading, made updates to the verbiage regarding radioactive iodine refractory disease to mirror NCCN recommendations. Other minor editorial changes were made throughout the policy. Aligned the ICD-10 table with the latest NCCN recommended codes: Added C05.2, D37.031, D37.032, D37.039, D37.04, Z85.12, Z85.22, Z85.810, Z85.818 (related to Head and Neck Cancers), D37.3, Z85.038 (related to Appendiceal Neoplasms and Cancers); Removed C00.0-C00.2, C44.00, C44.09, C77.0, C79.89, D37.01 (related to Head and Neck Cancers), C62 series of codes and Z85.47 (related to Testicular Cancer).

Keytruda SQ

Made changes throughout the policy to eliminate specific compendia-only supported criteria to instead align all indication-specific criteria with the FDA package insert supported information while also allowing any requests for Substitution/Switch-Therapy for Intravenous Pembrolizumab to be reviewed via criteria within the intravenous pembrolizumab policy, per business decision. Additionally, added the Substitution/Switch-Therapy for Intravenous Pembrolizumab setting to the Length of Authorization and Dosage/Administration section which will route to the intravenous pembrolizumab policy for all applicable non-package insert supported criteria, per business decision. Administrative change to Length of Authorization section to include number of days allowed for authorization durations. To Urothelial Carcinoma, added the newly FDA approved neoadjuvant/adjuvant use in combination with enfortumab vedotin followed by single agent pembrolizumab in the adjuvant setting for the treatment of muscle invasive bladder cancer in cisplatin ineligible patients to all affected sections within the policy. Made corrections to NDC descriptions for both vial formulations. To Appendix 1, aligned ICD-10 codes with the intravenous pembrolizumab policy, per business decision.

Lunsumio IV

Ad hoc review to add criteria stating that therapy will not be used concomitantly with subcutaneous mosunetuzumab to align with the newly created Lunsumio Velo (SQ) policy. Clarified that use for the treatment of Follicular Lymphoma is as a single agent to align with the PI and NCCN. Editorial changes made to the Renewal Criteria and dosing table to provide better clarity.

Nplate

Administrative changes to the 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 universal criteria editorial change to statement regarding use of romiplostim not be used to normalize platelet count to help eliminate inappropriate pends. Added new indication of Immune Checkpoint Inhibitor-Related Toxicities with pertinent criteria per 2A recommendation in NCCN. Corresponding updates were made to Length of Auth section, Dosing Limits section, and Dosage/Administration table. Added Appendix A - Non-Quantitative Treatment Limitations (NQTL) Factor Checklist. Removed CMS reference A57160 (Jurisdiction 15) as it is not applicable to Nplate.

Onivyde

Administrative change to Length of Authorization section to include number of days allowed for authorization durations. Added dMMR/MSI-H Cancer to Max Units Section to account for Gastric, Esophageal and Esophagogastric Junction Cancers neoadjuvant dosing. To Endometrial Carcinoma (Uterine Neoplasms) and under dMMR/MSI-H Endometrial Carcinoma, updated to allow for recurrent disease and any line of therapy with exclusions for NCCN 2B recommendations of use for locoregional recurrence in patients with no prior radiation therapy to site of recurrence, or previous vaginal brachytherapy only and after surgical exploration for locoregional recurrence in patients with disease confined to the vagina or paravaginal soft tissue. Also updated for use as maintenance therapy in stage III-IV tumors. To dMMR/MSI-H and POLE/POLD1 Cancers, updated Appendiceal Adenocarcinoma to Appendiceal Neoplasms and Cancers to align with new NCCN nomenclature and updated criteria to align with current NCCN appendiceal recommendations. Also added Gastric, Esophageal or Esophagogastric Junction Cancer to neoadjuvant therapy based on new NCCN rec and added new regimen to LOA and Dosing Table accordingly. To Appendix 1 - Covered Diagnosis Codes, added D37.3 and Z85.038 (related to Appendiceal Neoplasms and Cancers) per NCCN. Editorial changes were made throughout. Updated ICD 10 crosswalk.

Opdivo IV

Administrative change to Length of Authorization section to include number of days allowed for authorization durations. To Bone Cancers, updated options for use based on cell histology and added option for use as a single agent or in combination with sunitinib for dedifferentiated chondrosarcoma. The length of authorization section was updated accordingly. To Cervical cancer, added option for use in combination with ipilimumab for recurrent or metastatic adenocarcinoma, adenosquamous carcinoma, or squamous cell carcinoma. Added new setting for use in persistent, recurrent/metastatic small cell NECC per NCCN recs. Updated Indication heading of Appendiceal Adenocarcinoma to Appendiceal Neoplasms and Cancers per changes in NCCN. Criteria was updated to allow treatment as a single agent or in combination with ipilimumab for recurrent, progressive, peritoneal-only or extraperitoneal disease. To Esophageal, Esophagogastric & Gastric cancers, added allowance for use in patients with either no prior checkpoint inhibitor or no tumor progression while on checkpoint inhibitor therapy when used in the first- or subsequent-line settings. To SCCHN, added new option for use in combination with cetuximab for unresectable, recurrent, persistent, or metastatic disease. To Adult CHL, made multiple changes to incorporate recommendations from the latest NCCN guideline updates for all regimens. To RCC, made editorial change to move RCC note from triangle footnote box up to the criteria, for clarity. To NSCLC, removed verbiage on mediastinal lymph node recurrence with prior radiation therapy and excluding use in patients with locoregional recurrence or symptomatic local disease without evidence and disseminated disease since NCCN no longer lists as 2B. To neoadjuvant treatment, added option for use in combination with platinum and docetaxel per changes in NCCN. Updated biomarker footnoted text to align with latest NCCN recommendations/guidelines. Updated heading of Endometrial Carcinomas to Uterine Neoplasms as NCCN now allows use for treatment of uterine sarcomas as well as endometrial carcinomas. Criteria was updated to align with latest version of NCCN guidelines. To Vulvar and Vaginal cancers, added option for use in combination with ipilimumab as subsequent treatment of recurrent or metastatic disease. To CLL/SLL, updated criteria to align with NCCN updates and added a footnote indicating prior treatment could have included PD-1/PD-L1-directed therapy when used as additional therapy. To the dosing table, added dosing for treatment of Bone Cancer in combination with sunitinib. Added option for use in combination with ipilimumab for treatment of vaginal, vulvar or cervical cancers. Streamlined dosing options for treatment of appendiceal neoplasms & cancers. To Appendix 1, removed ICD-10 codes C00.0-C00.2, C44.00, C44.09, C77.0 , C79.89, D37.01. Added ICD-10 codes C05.2, D37.04, Z85.810, Z85.818 & Z85.22 (related to H&N Cancers), D37.3 & Z85.038 (related to Appendiceal Neoplasms). Updated ICD-10 crosswalk (for PCM) list. Editorial changes made throughout.

Opdivo SQ

Made changes throughout the policy to eliminate specific compendia-only supported criteria to instead align all indication-specific criteria with the FDA package insert. Added the Substitution/Switch-Therapy for Intravenous Nivolumab setting to the Length of Authorization and Dosage/Administration section which will route to the intravenous nivolumab policy for all applicable non-package insert supported criteria, per business decision. Administrative change to Length of Authorization section to include number of days allowed for authorization durations. To Substitution/Switch therapy, removed list of indications supported by NCCN as these were not all inclusive anyway, per business decision. Added FDA expanded indication for use in pediatric patients at least 12 years of age for treatment of melanoma or MSI-H/dMMR colorectal cancer. To Renewal criteria, updated list of unacceptable toxicities to better align with the PI. To Appendix 1, aligned ICD-10 codes with the Opdivo IV policy. Editorial changes made throughout.

Oxlumo

Administrative changes to Length of Authorization section to include the number of days allowed and delineate between authorization durations for initial and renewal periods. To MU, updated months to days to streamline billing. Removed example of urinary oxalate reducing agents from Universal Criteria for conciseness. Added Appendix A - Non-Quantitative Treatment Limitations (NQTL) Factor Checklist. To Appendix 1 - Covered Diagnosis Codes, updated to add codes E72.530, E72.538, and E72.539 to replace previous code of E72.53. Editorial changes throughout. Added disclaimer note to Max Units section denoting that max units do not reflect the max dosing limits in the PI.

Padcev

Administrative change to Length of Authorization section to delineate between authorization durations for initial and renewal periods as well as to include number of days allowed. To Bladder Cancer, removed line of therapy for use in combination with pembrolizumab to better streamline criteria since NCCN now allows in both first and second line, and added new FDA indication for use in combination with pembrolizumab as neoadjuvant treatment and then continued after cystectomy as adjuvant treatment for the treatment of MIBC in cisplatin ineligible patients. The dosing for the new indication was added to the dosing table and LOA was also updated to include. Also to bladder cancer but for use as a single agent, added option to use in second-line therapy since NCCN now allows and added footnote per NCCN regarding use in second line therapy which applies to both single agent and combination use. Editorial changes throughout. Added Appendix A – Non-Quantitative Treatment Limitations (NQTL) Factor Checklist.

Rybrevant IV

Ad hoc review to add criteria stating that therapy will not be used concomitantly with subcutaneous amivantamab to align with the newly created Rybrevant Faspro (SQ) policy. Administrative changes to Length of Authorization section to include the number of days for approval 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’. Other minor editorial changes made throughout to align this policy with the Rybrevant Faspro (SQ) policy.

Skysona

Administrative changes to Length of Authorization section to delineate between authorization durations for initial and renewal periods, to Initial criteria to update verbiage in the HCT/MRR box and softened hard vaccine requirement per global changes update, and to Initial and Renewal criteria to update ‘coverage’ to ‘prior authorization validity’. Updated max units section per new HCPCS code. Removed inactive HCPCS code J3590 – Unclassified biologics and J9399 - Unclassified drugs or biologicals and added new HCPCS code J3387 – Injection, elivaldogene autotemcel, per treatment, per IPD Analytics. Added Appendix A - Non-Quantitative Treatment Limitations (NQTL) Factor Checklist.

Trodelvy

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. To Initial Approval Criteria added primary prophylaxis with an G-CSF starting in first cycle of treatment in all patients at increased risk of febrile neutropenia to align with PI update. To Urothelial Cancer per NCCN, update made to allow use for subsequent therapy in patients previously treated with platinum chemotherapy and PD-1/PD-L1 therapy. Added Appendix A – Non-Quantitative Treatment Limitations (NQTL) Factor Checklist. Editorial changes made throughout.

Uplizna

Ad hoc review to add the expanded indication for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) or anti-muscle specific tyrosine kinase (MuSK) antibody positive. Updates were also made to the Length of Authorization section to reflect the addition of this new indication. Added ICD-10 codes G70.00 and G70.01 for gMG. Administrative change to the Length of Authorization section to include the number of days for approval as part of the global change being made across all policies.

Yervoy

Administrative change to Length of Authorization section to include number of days allowed for authorization durations. To Bone Cancers, updated options for use to be sorted by cell histology. Updated Indication heading of Appendiceal Adenocarcinoma to Appendiceal Neoplasms and Cancers per changes in NCCN. Criteria was updated to allow use in combination with nivolumab for recurrent, progressive, peritoneal-only or extraperitoneal disease and to define use based on history with or without checkpoint inhibitors. To Esophageal, Esophagogastric & Gastric cancers, added allowance for use in patients with either no prior checkpoint inhibitor or no tumor progression while on checkpoint inhibitor therapy when used in the first- or second-line settings. To RCC, made editorial change to move RCC note from triangle footnote box up to the criteria, for clarity. To NSCLC, removed verbiage on mediastinal lymph node recurrence with prior radiation therapy and excluding use in patients with locoregional recurrence or symptomatic local disease without evidence and disseminated disease since NCCN no longer lists as 2B. Updated biomarker footnoted text to align with latest NCCN recommendations/guidelines. Added new indications of vulvar cancer, vaginal cancer, cervical cancer and uterine neoplasms with corresponding criteria, dosing and ICD-10 codes per NCCN. Length of authorization and max units sections were updated to accommodate new indications. To Appendix 1, added ICD-10 codes C51.0-C51.2, C51.8, C51.9 (related to vulvar cancer), C52 (related to vaginal cancer), C53.0, C53.1, C53.8, C53.9 (related to cervical cancer), C54.0-C54.3, C54.8, C54.9, C55, Z85.42 (related to endometrial cancer), and D37.3, Z85.038 (related to Appendiceal Neoplasms). Updated ICD-10 crosswalk (for PCM) list. Editorial changes made throughout.

Zolgensma

Ad hoc review to add criteria for the patient to be clinically stable, have no active infections, be up to date on vaccines, considered for cardiac evaluation, and have platelet counts drawn to align with the PI and to keep at parity with the Itvisma policy.

Zusduri

To Initial Criteria, removed criteria on concurrent use with Jelmyto since criteria already notes use as a single agent. Editorial changes throughout policy including to Renewal Criteria on duration of authorization. From Billing Code Section, removed discontinued unclassified code J9999. Added Appendix A – Non-Quantitative Treatment Limitations (NQTL) Factor Checklist

Aranesp

Updated Non-Dialysis to Non-ESRD throughout policy to align with HCPCS code description. Administrative changes to Length of Authorization section to delineate between authorization durations for initial and renewal period and to include number of days allowed for authorization durations. To Universal Criteria, added option for patient to bypass adequate iron stores levels if on intravenous iron concurrently and removed footnote regarding this scenario. To Anemia Due to Myeloproliferative Neoplasms - Myelofibrosis, updated wording to align with NCCN and updated criteria for patients with splenomegaly and constitutional symptoms currently controlled on a JAK inhibitor from use in combination with ruxolitinib to in combination with a JAK inhibitor per NCCN update. To Renewal Criteria, updated list of unacceptable toxicities to better align with the PI and other ESA policies. Added Appendix A – Non-Quantitative Treatment Limitations (NQTL) Factor Checklist. Editorial changes made throughout.

Epoetin alfa

Updated Non-Dialysis to Non-ESRD throughout policy to align with HCPCS code description. Administrative changes to Length of Authorization section to delineate between authorization durations for initial and renewal period and to include number of days allowed for authorization durations. To Universal Criteria, added option for patient to bypass adequate iron stores levels if on intravenous iron concurrently and removed footnote regarding this scenario. To Anemia Due to Myeloproliferative Neoplasms - Myelofibrosis, updated wording to align with NCCN and updated criteria for patients with splenomegaly and constitutional symptoms currently controlled on a JAK inhibitor from use in combination with ruxolitinib to in combination with a JAK inhibitor per NCCN update. To Renewal Criteria, updated list of unacceptable toxicities to better align with the PI and other ESA policies. Added Appendix A – Non-Quantitative Treatment Limitations (NQTL) Factor Checklist. Editorial changes made throughout.

Fulvestrant

Removed symbol related to ANDA generics from policy title and updated verbiage related to this in Billing Code section. 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. To Dosing Limits updated to delineate allowable MU for ‘Ovarian Cancer’ and ‘All other indications’ due to update for Endometrial Cancer. Due to multisource generic status policy indications were heavily redacted. To Breast Cancer redactions to allow for use in any line of therapy and as single agent or combination use for recurrent unresectable (local or regional), advanced, or metastatic disease that is either HER-positive or HER2-negative. To stage IV (m1) HER2-negative disease with activating HER2 mutation allowed when used with trastuzumab and neratinib or tucatinib as third line and beyond without additional restrictions. Updated Ovarian Cancer heading to align with NCCN. To Endometrial carcinoma added use in combination with abemaciclib for ER-positive tumors only and added restriction for 2B recommendation for locoregional recurrence in patients with no prior radiation therapy to site of recurrence, or previous vaginal brachytherapy only, therapy after surgical exploration for locoregional recurrence in patients with disease confined to the vagina or paravaginal soft tissue, and disease that is not suitable for primary surgery in patients with suspected or gross cervical involvement. To Uterine Sarcoma redactions made to allow for use when single agent and confirmation of histology only. To dosing table for Endometrial Carcinoma added use in combination with abemaciclib with accompanying loading and maintenance dosing. Global change to add NQTL Factor Checklist (Appendix A) to policy. Editorial changes made throughout.

Mircera

Updated Non-Dialysis to Non-ESRD throughout policy to align with HCPCS code description. Administrative changes to Length of Authorization section to delineate between authorization durations for initial and renewal period and to include number of days allowed for authorization durations. To Universal Criteria, added option for patient to bypass adequate iron stores levels if on intravenous iron concurrently and removed footnote regarding this scenario. Added Appendix A – Non-Quantitative Treatment Limitations (NQTL) Factor Checklist. Editorial changes made throughout.

New Code
April 1, 2026

Brand Name (Generic Name)

J9183

Inlexzo (gemcitabine)

J9277

Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph)

Q5161

Aukelso (denosumab-kyqq)

Q5161

Bosaya (denosumab-kyqq)

Q5162

Bilprevda (denosumab-nxxp)

Q5162

Bildyos (denosumab-nxxp)

J3404

Papzimeos (zopapogene imadenovec-drba)

J9601

Lynozyfic (linvoseltamab-gcpt)

J9278

Kyxata (carboplatin)

J1553

Yimmugo (intravenous immune globulin)

J9003

Camcevi ETM (leuprolide mesylate