Pharmacy Policy Updates

Eculizumab

Administrative change to Length of Authorization 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 part of global changes being made across all policies. Replaced the verbiage and criteria in sections I, III, IV, and VII with that of the corresponding Prime Therapeutics Soliris (eculizumab) Bkemv (eculizumab-aeeb) Epysqli (eculizumab-aagh) and Ultomiris (ravulizumab-cwvz) Medical Drug Criteria Policy verbiage. Made editorial changes within the dosing table to align with PI. Administrative change to remove HCPCS codes that became obsolete on 04/01/2025. Coding updates made to CMS reference A54548 (jurisdiction 6, K).

Imaavy

Replaced the MPS criteria in sections III and IV with that of the applicable corresponding Prime sourced gMG criteria. Addition of Appendix A – Non-Quantitative Treatment Limitations (NQTL) Factor Checklist to the policy as a part of the global changes being made across all policies.

Piasky

Administrative change to Length of Authorization 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 part of global changes being made across all policies. Replaced the verbiage and criteria in sections I, III, IV, and VII with that of the corresponding Prime Therapeutics Piasky Medical Drug Criteria Policy verbiage.

Rystiggo

Replaced the MPS criteria in sections I, III, and IV with that of the corresponding Prime Therapeutics Rystiggo (rozanolixizumab) Medical Drug policy criteria. References to Section VII was also updated to replace the previous references with those from Prime policy. Administrative change 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 part of global changes being made across all policies

Ultomiris

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 addition of Appendix A – Non-Quantitative Treatment Limitations (NQTL) Factor Checklist to the policy as part of global changes being made across all policies. Also removed mention of the Subcutaneous product from all affected sections in the policy as it was never commercially launched and has been removed from the PI. Replaced the verbiage and criteria in sections I, III, IV, and VII with that of the corresponding Prime Therapeutics Soliris (eculizumab) Bkemv (eculizumab-aeeb) Epysqli (eculizumab-aagh) and Ultomiris (ravulizumab-cwvz) Medical Drug Criteria Policy verbiage. Made editorial changes within the dosing table to align with PI.

Vyvgart SQ

Replaced the MPS criteria in sections I, III, and IV with that of the corresponding Prime Efgartigimod policy criteria. References Section VII was also updated to replace the previous references with those from Prime policy. Added the newly approved 1,000 mg/10,000 units of single-dose prefilled syringe and updated the dosing table to reflect the new dosing for this product. Administrative change 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 part of global changes being made across all policies.

Aflibercept

Ad hoc review to add the newly approved unbranded biologic product Aflibercept-yszy (same cell-line as Opuviz), which will be kept at full parity with the reference product, Eylea. Addition of Appendix A – Non-Quantitative Treatment Limitations (NQTL) Factor Checklist to the policy as a part of the global changes being made across all policies. Administrative changes to Initial and Renewal criteria to update ‘coverage’ to ‘prior authorization validity’ and editorial changes made to the policy title to put all drugs in alphabetical order.

Amtagvi

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 Max Units replaced minimum dose with maximum dose (72 X 109 of viable cells). To Initial Criteria, update the HCT/MRR box to the current language. To Cutaneous Melanoma, added ‡ symbol to heading (since it is now in NCCN) and added footnote defining metastatic disease per NCCN. To Billing Code/Availability, added HCPCS code C9399 per IPD Analytics. Editorial changes to Initial and Renewal, and to Dosing Table. Added Appendix A – Non-Quantitative Treatment Limitations (NQTL) Factor Checklist.

Azedra

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

Bavencio

Administrative change to add NQTL Factor Checklist (Appendix A) to policy. Editorial changes were made throughout.

Emrelis

To NSCLC, updated criteria to allow for use in recurrent, advanced, or metastatic diseases to align with NCCN 2A recommendation. To Renewal Criteria, minor edit to align criteria on unacceptable toxicity with PI. To dosing table, added cap of 190 mg in patients weighing ≥100kg per PI. Added Appendix A – Non-Quantitative Treatment Limitations (NQTL) Factor Checklist.

Encelto

Administrative change to Length of Authorization section to delineate between authorization durations for initial and renewal periods. To Initial Criteria, updated HCT/MRR box to current language. Editorial changes were made throughout policy. Added Appendix A – Non-Quantitative Treatment Limitations (NQTL) Factor Checklist. Removed HCPCS Code J3590 as it was discontinued on 10/01/2025.

Fyarro

Updated ™ to ® per manufacturer website. 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, updated verbiage regarding hypersensitivity to rapamycin derivatives to mirror the PI. To PEComa criteria, updated verbiage from metastatic-to-metastatic malignant disease per the PI. To renewal criteria, updated list of unacceptable toxicities to better align with the PI. Added Non-Quantitative Treatment Limitations (NQTL) Factor Checklist to appendix section. Editorial changes throughout.

Imfinzi

To Endometrial Cancer, updated heading to “Uterine Neoplasms – Endometrial Carcinoma” to encompass verbiage in both NCCN and the PI. To NSCLC, removed staging under adjuvant treatment to align with PI indication. To SCLC, added use as subsequent treatment per NCCN with a corresponding update made to the Dosing Table. To Gastric Cancers, added option for use as perioperative systemic therapy in combination with FLOT per new NCCN recommendation. Dosing table, LOA and MU were updated to accommodate this new setting. To Esophageal and EGJ cancer, reformatted criteria and added option for use in combination with FLOT as induction therapy for relieving dysphagia or as perioperative/postoperative management. Dosing table, LOA and MU were updated. To Bladder Cancer, updated criteria to remove “radical” from cystectomy to align with NCCN. Added Appendix A - Non-Quantitative Treatment Limitations (NQTL) Factor Checklist. To Appendix 1 ICD-10 codes, added Z85.12 (related to SCLC). Editorial changes throughout.

Imjudo

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

Jemperli

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

Leqembi IV

Renamed the policy Leqembi IV to delineate from the newly created Leqembi SQ policy. To Universal Criteria, updated criteria about not using concurrently with other anti-amyloid immunotherapies by removing aducanumab as it is no longer available and adding lecanemab SQ with a caveat that it does not apply during switch therapy. Removed criteria for no stroke/TIA, seizures, psychiatric illnesses, and history of alcohol or substance abuse as they are not absolute contraindications for use in the PI. To the Renewal Criteria, updated the examples of unacceptable toxicity to align with the updates made to the Warnings and Precautions section of the PI. To the Renewal Criteria and dosing table, added criteria requiring the patient to have a pre- 3rd infusion MRI for monitoring of ARIA-E and ARIA-H microhemorrhages per the updated PI and also updated the footnotes in both sections to make reference to the new Leqembi IQLIK 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’ and to Length of Authorization to delineate between authorization durations for initial and renewal periods.

Libtayo

Administrative changes to add Appendix A – Non-Quantitative Treatment Limitations (NQTL) Factor Checklist to the policy as a part of the global changes being made across all policies. Other minor editorial changes were made throughout.

Loqtorzi

Added Appendix A - Non-Quantitative Treatment Limitations (NQTL) Factor Checklist. To Head and Neck Cancers, updated footnote defining Very Advanced Head and Neck Cancers to align with latest NCCN guidelines. Made editorial changes throughout.

Lutathera

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. Moved Ki67 requirement from Initial Approval Criteria to the applicable Neuroendocrine and Adrenal Tumors subtypes. Removed examples of long-acting and short-acting somatostatin analogues from Initial Criteria for conciseness. Updated criteria for well-differentiated grade 3 NET, gastrointestinal disease, pancreatic disease, and Pheochromocytoma/Paraganglioma to align with NCCN updates. Editorial changes were made throughout and to Renewal Criteria. Added Appendix A – Non-Quantitative Treatment Limitations (NQTL) Factor Checklist. To Covered Diagnosis Codes, updated E34.0 to E34.00 and added E34.01 and E34.09 (related to carcinoid syndrome) per NCCN.

Opdivo IV

Renamed the policy Opdivo IV to delineate from Opdivo SQ policy. Administrative changes to Initial and Renewal criteria to update ‘coverage’ to ‘prior authorization validity.’ To universal criteria added preclusion for use concomitantly with subcutaneous nivolumab to prevent duplicative therapy. Updates by NCCN recommendations: To Bone cancers updated to remove exclusion of mesenchymal chondrosarcoma as this is a distinct subtype. To Colorectal Cancer and Appendiceal Adenocarcinoma added option for specific use of combination with ipilimumab for advanced or metastatic disease for patients who previously received checkpoint inhibitor monotherapy. To Kaposi Sarcoma updated description of advanced disease to reflect T1, extensive T0 cutaneous, or nodal disease. To Cutaneous Melanoma removed examples of BRAF targeted therapy from initial criteria for conciseness. To Small Cell Lung Cancer, updated recommendation to subsequent systemic therapy as a single agent for relapsed or progressive disease, removed previous requirements. To Renal Cell Carcinoma, removed triangle note superscript from combination with cabozantinib as subsequent therapy in patients with relapsed or stage IV disease as if used following prior IO therapy this is now a 2B recommendation. To Merkel Cell Carcinoma added support for use as single agent or in combination with ipilimumab for in-transit N+ regional disease. Global change to add NQTL Factor Checklist (Appendix A) to policy. To ICD-10 table added Z85.12 related to SCLC. Updated ICD-10 crosswalk (for PCM) list.

Opdivo SQ

Administrative changes to Length of Authorization section to delineate between authorization durations for initial and renewal periods, to Initial and Renewal criteria to update ‘coverage’ to ‘prior authorization validity.’ Global change to add NQTL Factor Checklist (Appendix A) to policy. To universal criteria removed list of PD-1/PD-L1 therapies for conciseness and to add strategy that therapy will not be used concurrently with IV chemo agents with a notation allowing only where FDA approved combinations are allowed. New indication added to section III titled Substitution/Switch-Therapy for Intravenous Nivolumab section added to allow for patients starting combination therapy with nivolumab and either ipilimumab or IV chemotherapy to switch to subcutaneous form after combination therapy has been completed or to substitute directly when not used in combination with ipilimumab or IV chemotherapy as a new start and references the Opdivo IV policy to direct reviews to appropriate use cases from the IV policy. The indications that follow are all NCCN 2A supported to substitute the SQ form of the drug where the IV formulation is recommended. To Renewal criteria, editorial changes to refer duration of auth to section I. To note box, added use for patients with RCC and clear cell histology to be reviewed on case-by-case basis to align with Opdivo IV policy. To Dosing/Admin table, extensively revised to add newly supported indications and allow for supported single agent treatment settings and to support settings where switch therapy from IV nivolumab combination therapy will be supported and will need to be limited to 2 years of therapy. Indication where the IV form allows use every 2 or 4 weeks with no limitations on use will be allowed under the “all other indications” dosing. To Billing/Coding HCPCS updated to remove discontinued J and C codes. To ICD10 table added associated codes applicable for the following NCCN supported indications: Ampullary Adenocarcinoma, Anal Carcinoma, Adult CNS Cancer, Cervical cancer, Appendiceal Adenocarcinoma, Gestational Trophoblastic Neoplasia, Kaposi Sarcoma, Uveal Melanoma, Merkel Cell Carcinoma, Peritoneal and Pleural Mesothelioma, Small Bowel Adenocarcinoma, SCLC, STS, Endometrial Carcinoma, Vulvar Cancer, Vaginal Cancer, and Squamous Cell Skin Cancer.

Penpulimab-kcqx

Renamed Nasopharyngeal carcinoma (NPC) heading as Head and Neck Cancers to encompass recommendations from both the PI and NCCN. Added combination use with either cisplatin or carboplatin and gemcitabine as subsequent therapy for metastatic cancer of the nasopharynx AND added use for very advanced head and neck cancer per NCCN 2A recommendations. Added an additional note to possible scenarios when previous therapy with a programmed death (PD-1/PD-L1)-directed therapy could be allowable. Editorial changes were made throughout. Added Appendix A – Non-Quantitative Treatment Limitations (NQTL) Factor Checklist. To Covered Diagnosis Codes, added C79.89 (related to Very Advanced Head and Neck Cancer).

Pluvicto

Administrative changes to Length of Authorization section to delineate between authorization durations for initial and renewal periods. Editorial changes were made throughout. Added Appendix A – Non-Quantitative Treatment Limitations (NQTL) Factor Checklist.

Tecelra

Administrative changes to Length of Authorization section to delineate between authorization durations for initial and renewal periods, added Appendix A - Non-Quantitative Treatment Limitations (NQTL) Factor Checklist, removed obsolete HCPCS codes J9999 and C9399, and updated language in MRR box per global update. Removed requirement for prior treatment of ifosfamide and doxorubicin specifically and instead changed to use subsequent therapy and added use for advanced disease, all to encompass latest NCCN guideline recommendations. Updates made to ICD 10 table (added C47.0, C47.10, C47.11, C47.12, C47.20, C47.21, C47.22, C47.3, C47.4, C47.5, C47.6, C47.8, C47.9, C48.0, C48.1, C48.2, C48.8, and Z85.831 all related to Synovial Sarcoma). Editorial changes were made throughout.

Tecentriq IV

Added new indication for Colon Cancer as adjuvant therapy in combination with FOLFOX or CAPEOX followed by single agent maintenance based on NCCN 2A recommendations to all affected sections of the policy. To ICD10 code table, added C18.0, C18.2-C18.9, Z85.038 (all related to Colon Cancer). Administrative changes to add Appendix A – Non-Quantitative Treatment Limitations (NQTL) Factor Checklist to the policy as a part of the global changes being made across all policies. Other minor editorial changes were made throughout.

Tevimbra

To Gastric cancers, removed "and Gastroesophageal Junction" cancers from the heading, as this is already covered under the Esophageal/Esophagogastric Junction Cancers heading above with more liberal criteria, and added the GEJ verbiage to that heading. To both Gastric and Esophageal/EGJ/GEJ Cancers, removed “locally advanced” from settings to now allow use in unresectable, recurrent, or metastatic per the PI and NCCN. To Head and Neck cancers, updated footnote defining very advanced head and neck cancers per changes in NCCN. To the dosing table, updated dosing to allow for use of the 150mg q2w, 200mg q3w, or 300mg q4w dosing regimens for treatment of solid tumors based on a pharmacodynamic analysis that found no difference in safety or efficacy between dosing options, with a corresponding update made to MU. To the Notes box, added a bullet regarding use as palliative therapy for Gastric, Esophageal, and Esophagogastric/Gastroesophageal Junction Cancers as a possible scenario when previous therapy with a programmed death (PD-1/PD-L1)-directed therapy could be allowable, per NCCN. Added Appendix A - Non-Quantitative Treatment Limitations (NQTL) Factor Checklist. Editorial changes throughout. Updated ICD-10 crosswalk (for PCM) list.

Tivdak

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, aligned ophthalmic exam criteria with current PI and removed single agent therapy based on NCCN 2A recommendation to use in combination with pembrolizumab which was added to the Cervical Cancer indication. Added general footnote on using an FDA-approved assay since this indication is for patients with PDL1 positive disease. Added new indication of Vaginal Cancer based on NCCN. To Dosing Table, updated indication section to encompass all indications since the same dosing applies to both Cervical and Vaginal Cancer. Editorial changes to Initial and Renewal criteria, and to Appendix 2. Added Appendix A – Non-Quantitative Treatment Limitations (NQTL) Factor Checklist. To Coverage Diagnosis table, added C52 (related to Vaginal Cancer).

Unloxcyt

Editorial changes to Initial and Renewal criteria. Removed criteria on re-biopsy from Notes box in Renewal section since it does not apply to Unloxcyt. To Billing Code section, removed discontinued code J9999. Added Appendix A – Non-Quantitative Treatment Limitations (NQTL) Factor Checklist.

Veopoz

Administrative changes to Length of Authorization section to delineate between authorization durations for initial and renewal periods and to Dosing Limits section to remove QL. To the Universal Criteria, removed examples of complement inhibitors for conciseness. Editorial changes to Initial Criteria and Renewal Criteria. Added Appendix A – Non-Quantitative Treatment Limitations (NQTL) Factor Checklist.

Vyjuvek

Ad hoc review to remove the age requirement criteria for patients to be at least 6 months of age as use has now been FDA approved for adults and pediatric patients (0 to 16 years of age). Updated the dosing table to reflect the addition of treatment in this new patient population and also updated the footnote in the dosing table to indicate that application can be by a healthcare professional, patient, or caregiver either at a healthcare professional setting or at a home setting. Previously administration was only allowed by a healthcare provider. 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.’

Yervoy

Administrative changes to Initial and Renewal criteria to update ‘coverage’ to ‘prior authorization validity.’ Updates by NCCN recommendations: To Bone cancers updated to remove exclusion of mesenchymal chondrosarcoma as this is a distinct subtype. To Kaposi Sarcoma updated description of advanced disease to reflect T1, extensive T0 cutaneous, or nodal disease. To Cutaneous Melanoma removed examples of BRAF targeted therapy from initial criteria for conciseness. To Merkel Cell Carcinoma added support for use as single agent or in combination with nivolumab for in-transit N+ regional disease. Global change to add NQTL Factor Checklist (Appendix A) to policy.

Zilretta

Administrative changes to Length of Authorization section to delineate between authorization durations for initial and renewal periods, removed QL from Dosing Limits section and made 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. Other minor editorial changes were made throughout.

Zynyz

Administrative changes to Length of Authorization section to delineate between authorization durations for initial and renewal periods. To Universal Criteria, added ‘unless otherwise specified’ to criteria on prior PD-1/PDL-1 use since we refer to table at end of Renewal section which lists scenarios for re-initiating therapy. To SCAC indication, for use as subsequent therapy, removed if no prior immunotherapy received to align with other PD-1/PD-L1 policies. To MCC, added option for use for in-transit regional disease per updates in NCCN. Editorial changes to Initial Criteria and Renewal Criteria. Added Appendix A – Non-Quantitative Treatment Limitations (NQTL) Factor Checklist

Leuprolide depot

Ad hoc review to add the newly approved product Camcevi ETM for the treatment of prostate cancer. Updates were also made to the Dosing Limits, dosing table, and Diagnosis Codes sections to reflect the addition of this new product. To the Renewal Criteria for Lupron Depot Ped and Fensolvi, updated the examples of unacceptable toxicity to align with the Warnings and Precautions section of the updated PI’s.

Torisel

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 changes to Initial and Renewal criteria to update’ coverage’ to ‘prior authorization validity.’ Additionally, global change to add NQTL Factor Checklist (Appendix A) to policy.

Xofigo

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