Pharmacy Policies Available Online

Adcetris

To Universal Criteria, added concomitant use with bleomycin due to pulmonary toxicity as an example of a contraindication to therapy for ease of review. To Pediatric Classic Hodgkin Lymphoma, to the notes box, added adequate response to less than 4 cycles of chemotherapy in those with relapse between 3 and 12 months as a highly favorable disease trait. Editorial changes made throughout. 

Amvuttra

Ad hoc review to clarify that the member must have ‘baseline’ NYHA Class I or II heart failure OR Class III heart failure to more closely align with the pivotal trial inclusion criteria. 

Casgevy

Ad hoc review to expand the current indication to include treatment of sickle cell disease (SCD) with recurrent vaso-occlusive crises and transfusion dependent thalassemia (TDT) in members at least 2 years of age. These indications were previously only approved for use in members at least 12 years of age. Added criteria for a patient with sickle cell disease to weigh at least 12 kg as prior to start of mobilization as per the PI. Updated the footnotes in the dosing table to more closely align with the PI verbiage. Editorial changes throughout. 

Cosela

Administrative changes to Length of Authorization section to include number of days allowed for authorization durations. To Billing Code/Availability Information, updated NDC per updated PI. Added Appendix A – Non-Quantitative Treatment Limitations (NQTL) Factor Checklist. Editorial changes made throughout. 

Darzalex IV

To Renewal criteria, updated the list of unacceptable toxicities to include serious infection per the latest PI. Editorial changes throughout. 

Erbitux

To CRC, updated combination with encorafenib and fluorouracil-based chemotherapy to encorafenib and fluoropyrimidine-based chemotherapy to encompass combination with CapeOX and simplified criteria throughout per review of NCCN. To NSCLC, updated criteria to align with NCCN Compendia and Guideline recommendations. Editorial changes made throughout. 

Evkeeza

Administrative changes to Length of Authorization section to include number of days allowed for authorization durations. To HoFH added LDLRAP1 and ARH as allowable alleles for DNA testing per 2026 ACC/AHA/Multisociety guideline on the Management of Dyslipidemia. To untreated LDL level updated to reflect allowance for confirmation when member has untreated LDL >400 mg/dL (previous recommendations required >500 mg/dL) per 2023 European Atherosclerosis Society Consensus Statement on Homozygous Familial Hypercholesterolemia. Retained treated LDL level criterion per KOL review. Added bempedoic acid to the list of LDL lowering therapy examples which may be used in conjunction. Made updates to prior treatment history requirements: updated to consolidate 3-month trial and failure from two step to a single option and will now be approvable when member meets either 6 month trial and failure of lomitapide or a 3 month trial and failure of a 3 drug combination and also updated the LDL goals criterion based on latest guidelines. Other minor editorial changes were made throughout. 

IVIG

Administrative changes to Length of Authorization section to include number of days allowed for authorization durations. To Primary Immunodeficiency, added use as supportive care during treatment with etuvetidigene autotemcel for Wiskott-Aldrich syndrome with a corresponding update to Renewal Criteria confirming continued treatment is necessary in members without adequate immune recovery. To Dermatomyositis and Polymyositis, added option to bypass double-step if disease remains severe, refractory, or has the potential to have serious sequelae with use of steroids plus immunosuppressants alone. To Management of Immune Checkpoint Inhibitor-Related Toxicities, updated use in myositis to align with NCCN update. To Management of CAR T-Cell-Related Toxicities, added Lymphocyte Engager to heading, updated anti-CD19 and BCMA-targeted CAR T-cell therapy toxicities to include bilateral facial palsy, and added use for hypogammaglobulinemia in B-Cell Lymphoma with use of BiTE therapy per NCCN updates. Added use in Histiocytic Neoplasms - Pediatric Langerhans Cell Histiocytosis per NCCN 2A recommendation. Corresponding updates were made to MU, Renewal Criteria, and Dosage/Administration sections for the new indications. Removed product reference use only table for simplicity. To Billing Code/Availability Information, updated HCPCS codes for all products, except Qivigy and Yimmugo, which will be effective 01/01/2027. Corresponding updates were made to the Dosing Limits section. To Appendix 1 - Covered Diagnosis Codes, added C96.0, C96.5, C96.6, C96.9, C96.Z (related to Langerhans-cell histiocytosis) and G92.00-G92.04, Z29.89 (related to CAR T-Cell and Lymphocyte Engager-Related Toxicities). To Appendix 2, removed the retired LCAs A54662 and A57194 as Jurisdictions E and F were combined under A54660 and A57194. Editorial changes made throughout. 

Keytruda IV

To Biliary Tract Cancers, removed use for jaundice as neoadjuvant therapy per NCCN guidelines. To Urothelial Carcinoma, removed criteria requiring member is ineligible for cisplatin-containing chemotherapy due to new FDA approval which extends approval of this regimen in neoadjuvant and adjuvant settings from patients who are cisplatin-ineligible to now also include cisplatin-eligible patients with MIBC who are candidates for cystectomy. Corresponding updates were made to the Length of Authorization and Dosage/Administration to reflect expanded indication and provide details regarding different dosing schedules for neoadjuvant/adjuvant use in cisplatin-eligible vs. cisplatin-ineligible patients. Also to Urothelial Carcinoma, added exclusion for recurrence of stage T3-4 disease or palpable inguinal lymph nodes for recurrent/metastatic primary carcinoma of the urethra based on NCCN guidelines. Updated criteria for Triple Negative Breast Cancer based on NCCN updates for the new FDA approved indication for use in combination with sacituzumab govitecan-hziy, for the first-line treatment of adult patients with unresectable locally advanced or metastatic disease. Minor updates were also made to the LOA and Dosage/Administration section to reflect the addition of this new regimen. To Renal Cell Carcinoma, added new FDA indication (along with incorporating NCCN support into criteria) for adjuvant treatment in combination with belzutifan in adults with renal cell carcinoma with a clear cell component (ccRCC) at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions. Also to RCC, removed prior SBRT from criteria which is category 2B or 3 in guidelines and removed with or without sarcomatoid features for stage II disease as well as removed within 1 year of nephrectomy for relapsed or stage IV disease to better align with Welireg policy. To NSCLC, added back NCCN 2B criteria 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 based on guidelines. To Ovarian, Fallopian Tube, and Primary Peritoneal Cancer, added back NCCN 2B exclusion for treatment of biochemical relapse per NCCN guidelines. To SCLC, added note on avoiding immune checkpoint inhibitor in transformed SCLC based on NCCN update To Thyroid Carcinoma and TMB-H Cancer, reformatted criteria to better align with new NCCN recs now including gross residual disease in neck after thyroidectomy. Added new indication of Malignant Histiocytic Neoplasms per NCCN 2A recommendation and corresponding updates were made to the MU and Dosing Table sections. To Dosing Table for Soft Tissue Sarcoma, added option for 400 mg every 6 weeks for single agent [excluding adjuvant treatment] per NCCN Dosing Templates. Updated Max Units section accordingly to now group STS under ‘all under indications’. To Appendix 1, added the following ICD-10 codes C96.20, C96.29, C96.9, and C96.Z (related to Malignant Histiocytic Neoplasms). Updated ICD-10 crosswalk (for PCM) list. Other editorial changes throughout. 

Keytruda SQ

Removed any reference to the Keytruda IV-E policy throughout the various sections in policy as EOV now has a Keytruda SQ-E policy therefore it will be referenced in the EOV policy. To Urothelial Carcinoma, removed criteria requiring member is ineligible for cisplatin-containing chemotherapy due to new FDA approval which extends approval of this regimen in neoadjuvant and adjuvant settings from patients who are cisplatin-ineligible to now include cisplatin-eligible patients with MIBC, who are candidates for cystectomy. Corresponding updates were made to the Length of Authorization and Dosage/Administration to reflect expanded indication and provide details regarding different dosing schedules for neoadjuvant/adjuvant use in cisplatin-eligible vs. cisplatin-ineligible patients. Updated criteria for Triple Negative Breast Cancer based on new FDA approved indication of use in combination with sacituzumab govitecan-hziy, for the first-line treatment of adult patients with unresectable locally advanced or metastatic disease. Updates were also made to the Dosage/Administration section to reflect the addition of this new regimen. To Renal Cell Carcinoma, added new FDA indication for adjuvant treatment in combination with belzutifan in adults with renal cell carcinoma with a clear cell component (ccRCC) at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions. To Appendix 1, added the following ICD-10 codes C96.20, C96.29, C96.9, and C96.Z (related to Malignant Histiocytic Neoplasms). Other editorial changes throughout. 

Leqembi IV

Ad hoc review to align the dosing in IV policy with that of the SQ policy based on the FDA approval of a new starting dosage regimen for the SQ formulation of Leqembi. Previously approved only as an IV starting dosage, with the option for transitioning to IV or SQ maintenance dosage after 18 months of treatment. Updates were made to the footnotes in the Renewal Criteria section and to the dosing table to reflect this new dosing option. Updates were also made to the Renewal Criteria pertaining to the frequency of MRI monitoring to align with the updates made to the PI. Updated the existing HCPCS code description for J0174, "Injection, lecanemab-irmb, 1 mg" to instead read "Lecanemab-irmb, for intravenous injection, 1 mg” to clarify the difference between SQ and IV formulations. Administrative changes to Length of Authorization section to include the number of days for approval. Other editorial changes made throughout. 

Leqvio

To Hypercholesterolemia, extensive revisions made to reflect updates per 2026 ACC/AHA/Multisociety Guidelines on the Management of Dyslipidemia including updates to clarify diagnosis of ASCVD and to remove ASCVD risk ranges and to allow use for any member with treated LDL-C ≥ 100 or ≥ 70 with subclinical atherosclerosis or additional ASCVD risk factors. To HoFH, added ARH as allowable allele for DNA testing per 2026 ACC/AHA/Multisociety guideline. To untreated LDL level, updated to reflect allowance for confirmation when member has untreated LDL >400 mg/dL (previous recommendations required >500 mg/dL) per 2023 European Atherosclerosis Society Consensus Statement on Homozygous Familial Hypercholesterolemia. Retained treated LDL level criterion per KOL review. Bempedoic acid added to list of options of LDL therapies to use in combination. Other minor editorial changes were made throughout. 

Opdivo IV

To Biliary Tract Cancers, removed use for jaundice as neoadjuvant therapy per NCCN guidelines. To Urothelial Carcinoma (Bladder Cancer), added exclusion of recurrence of stage T3-4 disease or palpable inguinal lymph nodes for primary carcinoma of the urethra per NCCN guidelines. To Pediatric CHL, added response to < 4 cycles of chemo to highly favorable member criteria for re-induction therapy as per NCCN update. To RCC, added use for relapsed or stage IV disease with non-clear cell histology in combination with ipilimumab which is now a 2A NCCN rec and updated rec for subsequent therapy in combination with cabozantinib to include without prior immune-oncology therapy. To NSCLC, added back 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 guidelines list as 2B. To SCLC, added note on avoiding immune checkpoint inhibitor in transformed SCLC based on NCCN update. To Thyroid Carcinoma, added new NCCN 2A rec for use in combination with ipilimumab for oncocytic and anaplastic carcinoma. LOA, Max Units, and Dosing Table were updated accordingly. To Ovarian, Fallopian Tube, Primary Peritoneal Cancer, added 2B exclusion on immediate treatment of biochemical relapse based on NCCN guidelines. Added new indication of Malignant Histiocytic Neoplasms to criteria and updated Dosing Table and Max Units, accordingly. To Appendix 1, added C96.20, C96.29, C96.9, C96.Z (related to Malignant Histiocytic Neoplasms), and Z85.850 (related to Thyroid Carcinoma). Updated ICD-10 crosswalk (for PCM) list. Editorial changes made throughout policy. 

Opdivo SQ

Removed any reference to the Opdivo IV-E policy throughout the various sections in policy as EOV now has an Opdivo SQ-E policy therefore it will be referenced in the EOV policy. To Dosing Table, added 900mg/15,000 units every 3 week dosing to the substitution/switch-therapy for IV nivolumab row due to PI/compendia support for Opdivo SQ max dosing to include every 3 week dosing. Corresponding updates were made to MU section to re-group indications. To Appendix 1, added C96.20, C96.29, C96.9, C96.Z (related to Malignant Histiocytic Neoplasms), and Z85.840 (related to Thyroid Carcinoma) to align with Opdivo IV policy. Updated ICD-10 crosswalk (for PCM) list. Editorial changes made throughout. 

Padcev

Ad hoc update to add the expanded FDA indication for use in combination with pembrolizumab as neoadjuvant treatment and then continued after cystectomy as adjuvant treatment, for the treatment of adults with MIBC (no longer a requirement to be cisplatin-ineligible for this setting). Updated LOA and dosing table to reflect expanded indication and provide details regarding the different dosing schedules for neoadjuvant/adjuvant use in cisplatin-eligible vs. cisplatin-ineligible members. Editorial changes throughout. 

Perjeta

Ad hoc update to breast cancer indication when used as first-line maintenance as part of combination therapy trastuzumab, endocrine therapy, with or without pertuzumab, and with or without palbociclib, to incorporate new FDA approved indication for Ibrance with existing NCCN supported indication. 

Rybrevant IV

To NSCLC, updated “exon 21 L858R mutation positive” verbiage to now say “L858R mutation” to align with NCCN verbiage. Additionally, added option for subsequent therapy in combination with lazertinib for disease progression on carboplatin or cisplatin/osimertinib/pemetrexed for nonsquamous histology or progression on osimertinib for symptomatic systemic disease with multiple lesions. To CNS Cancers, simplified criteria for use in brain metastases from NSCLC and added new NCCN recommended indication for leptomeningeal metastases from EGFR exon 19 deletion or L858R mutation positive NSCLC in combination with lazertinib. To Appendix 1, added ICD-10 code C79.32 (related to Leptomeningeal Metastases). Editorial changes made throughout. 

Rybrevant SQ

Per NCCN, Rybrevant SQ may be substituted in place of Rybrevant IV; aligned with Rybrevant IV policy. To NSCLC, updated “exon 21 L858R mutation positive” verbiage to now say “L858R mutation” to align with NCCN verbiage. Additionally, updated criteria to align with NCCN and Rybrevant IV policy. Added new indication for use in CNS cancers arising from EGFR exon 19 or exon 21 L858R mutation positive NSCLC with pertinent criteria and dosing per NCCN. To Appendix 1, added ICD-10 codes C79.31 and C79.32 related to CNS Cancers. Editorial changes made throughout. 

Sarclisa IV

Ad hoc review to add criteria stating that therapy will not be used concomitantly with subcutaneous isatuximab to align with the newly created Sarclisa Escena (SQ) policy. To Renewal Criteria, added anaphylactic reactions to the list of unacceptable toxicities to align with PI update 

SCIG

Administrative changes to Length of Authorization section to include number of days allowed for authorization durations. To PID, added use as supportive care during treatment with etuvetidigene autotemcel for Wiskott-Aldrich syndrome with a corresponding update to Renewal Criteria confirming continued treatment is necessary in members without adequate immune recovery. Added use in the Management of CAR T-Cell and Lymphocyte Engager-Related Toxicities per NCCN 2A recommendation. Corresponding updates were made to Max Units, Renewal Criteria, and Dosage/Administration sections. To HCPCS Codes, update was made to descriptor for J1569. Additionally, administrative changes were made to update HCPCS for Gammaked, Gamunex-C, Gammagard Liquid, and Gammagard Liquid ERC. J1583 will be effective on 01/01/2027 for Gammaked and Gamunex-C. J1586 will be effective on 01/01/2027 for Gammagard Liquid and Gammagard Liquid ERC. J1561 will be discontinued for Gammaked and Gamunex-C on 01/01/2027 and J1569 will be discontinued for Gammagard Liquid and Gammagard Liquid ERC on 01/01/2027. Added Appendix A – Non-Quantitative Treatment Limitations (NQTL) Factor Checklist. To Appendix 1 - Covered Diagnosis Codes, added T80.82XA, T80.82XS, T80.89XA, and T80.89XS (related to CAR T-Cell and Lymphocyte Engager-Related Toxicities). Editorial changes made throughout. 

Synagis

Added note box to policy to direct members and providers to AAP clinical practice guidelines for recommended agents for prevention of RSV disease. Added Appendix A - Non-Quantitative Treatment Limitations (NQTL) Factor Checklist. Editorial changes made throughout. 

Tecelra

Ad hoc update to expand the Synovial Sarcoma indication to include pediatric patients 12 years of age and older. The Dosing table and NDC were updated to reflect the change in recommended dosing range to 1.62 x 109 to 10 x 109 MAGE-A4 T cell receptor (TCR) positive T cells. Editorial changes made throughout.

Tevimbra

Ad hoc review to add the newly approved 150 mg/15 mL single-dose vial product and .made corresponding changes to Max Units section. 

Trastuzumab IV

Ad hoc update to breast cancer indication when used as first-line maintenance as part of combination therapy trastuzumab, endocrine therapy, with or without pertuzumab, and with or without palbociclib, to incorporate new FDA approved indication for Ibrance with existing NCCN supported indication. 

Trodelvy

Ad hoc review to add the expanded indication for use in combination with pembrolizumab for the first-line treatment of adult patients with unresectable or metastatic TNBC whose tumors express PD-L1 (CPS ≥10). Also added the expanded indication for use as a single agent as first-line treatment of adult patients with unresectable or metastatic TNBC who are not candidates for PD-1 or PD-L1 inhibitor based therapy. Additionally, expanded coverage for TNBC to include inflammatory breast cancer per NCCN. To HR+ HER2 negative disease, consolidated treatment options to include both the PI and NCCN. Updated the HER2-negative expression criteria table to align with current NCCN verbiage. 

Vectibix

Administrative changes to Length of Authorization section to include number of days allowed for authorization durations. To CRC, extensively revised criteria to align with changes in NCCN Colon and Rectal guidelines. Updated section heading to reflect new NCCN guideline for Appendiceal Neoplasms and Cancers. Additionally, included recurrent, progressive, metastatic peritoneal-only, and extraperitoneal disease throughout; added neoadjuvant therapy to BRAF V600 E disease; added additional treatment settings and regimens for KRAS/NRAS and BRAF V600E wild type disease; and removed footnote for MMR/MSI testing per NCCN updates. Added new indication of Small Bowel Adenocarcinoma with relevant criteria and dosing per NCCN. Added Appendix A-Non-Quantitative Treatment Limitations (NQTL) Factor Checklist to policy. To Appendix 1 - Covered Diagnosis Codes, added C17.0, C17.1, C17.2, C17.3, C17.8, C17.9, and Z85.068 (related to Small Bowel Adenocarcinoma) and D37.3 (related to Appendiceal Neoplasms and Cancers) per NCCN. Editorial changes made throughout. 

Yervoy

To Max Units Section, added Pericardial Mesothelioma, Tunica Vaginalis Testis Mesothelioma to align with Opdivo IV policy. To Biliary Tract Cancers, removed use for jaundice as neoadjuvant therapy per NCCN guidelines. To RCC, added use for relapsed or stage IV disease with non-clear cell histology in combination with nivolumab which is now a 2A NCCN rec. To NSCLC, added back 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 guidelines list as 2B. To SBA, added note on allowing subsequent therapy if checkpoint inhibitor monotherapy was previously received to align with Opdivo IV policy and NCCN compendia. To Ovarian, Fallopian Tube, Primary Peritoneal Cancer, added 2B exclusion on immediate treatment of biochemical relapse based on NCCN guidelines. To Thyroid Carcinoma, added new NCCN 2A rec for use in combination with nivolumab for oncocytic and anaplastic carcinoma. LOA, Max Units, and Dosing Table were updated accordingly. To Appendix 1, added C73 and Z85.850 (related to Thyroid Carcinoma). Updated ICD-10 crosswalk (for PCM) list. Editorial changes made throughout policy. 

Fosaprepitant IV

Ad hoc review to add the newly FDA approved product, Navitrux, which was approved via the 505(b)(2) pathway and will be kept at full parity with the reference product, Emend. The Dosing Limits section was also update to reflect the addition of this new product. 

Fulvestrant

Ad hoc review to add the FDA approved product Cligavyx, approved via the 505(b)(2) pathway. This product will be kept at full parity with the reference product, Faslodex. The Dosing Limits section was also update to reflect the addition of this new product. Editorial changes made throughout. 

Xeomin

Ad hoc review to remove the exclusion criterion of spasticity caused by cerebral palsy from the indication for pediatric upper limb spasticity based on the recent FDA approval to remove this limitation to treatment. As a result the indication heading was changed from Spastic Conditions to Upper Limb Spasticity as there is no longer any exclusionary criteria for patients 2 to 17 years of age.