Pharmacy Policies Available Online

Adakveo

Administrative changes to Length of Authorization section to delineate between authorization durations for initial and renewal periods, and to Initial and Renewal criteria to update ‘coverage’ to ‘prior authorization validity’. To Universal Criteria, removed preclusion for use in combination with Oxbryta (voxelotor) as it was withdrawn from the market in 2024 and removed examples of gene therapy for conciseness. Added Appendix A - Non-Quantitative Treatment Limitations (NQTL) Factor Checklist.

Aflibercept

Ad hoc review to add the expanded indication for Eylea HD for the treatment of macular edema following retinal vein occlusion (MEfRVO) and to add an additional, more frequent dosing regimen for the previously approved indications of treatment of neovascular age-related macular degeneration, diabetic macular edema, and diabetic retinopathy. Updates were also made to the Dosing Limits section and the dosing table to reflect these changes. Editorial changes were made 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. Removed Aflibercept-yszy from the policy title, Billing Code/Availability, Max Units, the footnote in the Initial Criteria, and the dosing table as the manufacturer has not assigned an NDC for this product and has no plans to make it commercially available. Coding updates made to CMS reference A52451 (jurisdiction 6, K) along with adding Opuviz and Yesafili to the article title. Coding updates made to CMS reference A53387 (jurisdiction J, M).

Bavencio

Administrative changes to Length of Authorization section to delineate between authorization durations for initial and renewal periods and to include number of days allowed. To Universal Criteria, removed examples of PD-1/PD-L1 inhibitors for conciseness. To MCC, updated options for use to align with updates in NCCN. To Urothelial Carcinoma, condensed criteria to allow use in the PI settings only as NCCN no longer recommends anything as level 1 or 2A outside of what is covered within the PI. To Endometrial carcinomas, added option for use in combination with axitinib as subsequent treatment for recurrent pMMR tumors. Also updated criteria to exclude use in clinical settings categorized as 2B recommendations in NCCN. To Thymic Carcinomas, removed option for use as preoperative systemic therapy for surgically resectable disease if R0 resection is uncertain per update in NCCN. Added Appendix A - Non-Quantitative Treatment Limitations (NQTL) Factor Checklist. Editorial changes throughout.

Beqvez

To policy title, added ‘Hemophilia Products’ to align with naming of other hemophilia policies. 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, to Initial and Renewal criteria to update ‘coverage’ to ‘prior authorization validity’. To Billing Code/Availability section, removed inactive HCPCS code J3590 and C9172. Added Appendix A - Non-Quantitative Treatment Limitations (NQTL) Factor Checklist.

Breyanzi

Ad hoc review to add the expanded indication for treatment of adults with relapsed or refractory marginal zone lymphoma (MZL) who have received at least two prior lines of systemic therapy. Updates were made to the dosing table to reflect the addition of this new indication. Editorial changes were made to the footnote boxes under the dosing table to align more closely with the PI verbiage.

Casgevy

Softened hard vaccine requirement per global change. Updated criteria on not receiving other gene therapies to clarify this applies to gene therapies used for sickle cell disease or beta thalassemia and updated corresponding footnote. Removed discontinued unclassified codes from Billing Code/Availability section. Editorial changes throughout policy. Added Appendix A – Non-Quantitative Treatment Limitations (NQTL) Factor Checklist.

Danyelza

Administrative changes to Length of Authorization section to delineate between authorization durations for initial and renewal periods and to include number of days allowed. To Universal criteria, removed examples of GD2-binding monoclonal antibodies for conciseness. To High-Risk Neuroblastoma, added options for use in combination with temozolomide, irinotecan and sargramostim following induction therapy or following consolidation therapy for progressive disease per NCCN. Corresponding changes were made to the dosing table and max units section. Added Appendix A - Non-Quantitative Treatment Limitations (NQTL) Factor Checklist. To Appendix 1, added ICD-10 codes C72.0-C72.1, C72.20-C72.22, C72.30-C72.32, C72.40-C72.42, C72.50, C72.59, C72.9, C74.00-C74.02, C74.10-C74.12, C74.91-C74.92 all related to neuroblastoma.

Elevidys

Administrative change to Length of Authorization section to delineate between authorization durations for initial and renewal periods. To DMD, the following updates were made due to PI updates: update was made to active infection criteria to also exclude use if recent (within 4 weeks) infection, criteria was added to have provider confirm patient has not received a recent vaccination (within 4 weeks of treatment), examples of baseline liver function assessments were added, updates were made to the note surrounding preexisting liver impairment and hepatic viral infection, and update was made to the note regarding patients with DMD gene mutation at exon 59 or higher to align with new PI wording. Removed examples of DMD-directed antisense oligonucleotide therapy for conciseness. To Dosage/Administration table, a note was added to instruct patients to maintain proximity to a healthcare facility for at least 2 months following infusion. Added Appendix A – Non-Quantitative Treatment Limitations (NQTL) Factor Check. Editorial changes were made throughout.

Erwinaze

Policy is being discontinued. All active HCPCS will be retired by CMS in 2026, and manufacturer production of the medication has not occurred for many years due to long term backorder of product ingredients.

Gemcitabine

Added other routes of administration listed as 1/2A in NCCN (intrapelvic, intravesical, intraurethral, and subcutaneous) to policy title. Administrative change to Length of Authorization section to include number of days allowed for authorization durations. Added compendia symbol to FDA approved indications as they are also noted in NCCN compendia. To Pancreatic Adenocarcinoma, added a footnote indicating squamous and adenosquamous carcinomas can be treated the same way per NCCN. To Kaposi Sarcoma, added new indication of Kaposi-sarcoma associated herpesvirus (KSHV)-Associated Inflammatory Cytokine Syndrome (KICS) per NCCN. Updated heading to just Bladder Cancer and moved urothelial carcinoma to applicable indications under this heading. Additionally, added the specific non-urothelial subtype of pure adenocarcinoma including urachal per NCCN. To B-Cell Lymphomas, added option of indolent transformation to high-grade B-cell lymphoma with MYC and BCL6 rearrangements per NCCN. Removed “Primary” from Cutaneous Lymphomas heading per NCCN Guideline update. To Vulvar Cancer, removed the 2B exclusion from criteria to align with how other indications are noted in policy. Editorial changes throughout. To Covered Diagnosis (Appendix 1), added C31.0, C31.1, D37.031, D37.032, D37.039, and Z85.818 (related to Head and Neck Cancers), D89.89, D89.9 (related to Kaposi Sarcoma – KSHV-Associated Inflammatory Cytokine Syndrome), and Z85.12 (related to SCLC).

Givlaari

Administrative change 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. Added Appendix A-Non-Quantitative Treatment Limitations (NQTL) Factor Checklist to policy. Minor editorial changes were made throughout.

Hemgenix

Added ‘Hemophilia Products’ to the policy title. 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, to Initial and Renewal criteria to update ‘coverage’ to ‘prior authorization validity’. To Hemophilia B criteria, removed fidanacogene elaparvovec example from prior AAV-vector-based regimen criteria since it has been discontinued. Also to Hemophilia B criteria, updated baseline antibody titer to include value from the newer 9-point assay. Added Appendix A - Non-Quantitative Treatment Limitations (NQTL) Factor Checklist.

Imdelltra

Administrative changes to Policy Name to reflect registered trademark, to Length of Authorization section to delineate between authorization durations for initial and renewal periods, and to Initial and Renewal criteria to update ‘coverage’ to ‘prior authorization validity. To Universal Criteria, removed the bullet precluding use in patients with CNS metastases as NCCN now allows use in patients with brain metastases from SCLC. Added new indication of CNS Cancers with pertinent criteria per NCCN. To Billing Code/Availability, for J9026, removed "Effective 01/01/2025". Also removed discontinued code J9999 and C9170. Added Appendix A - Non-Quantitative Treatment Limitations (NQTL) Factor Checklist. Added ICD-10 codes Z85.118 & Z85.12 related to SCLC per NCCN.

Imfinzi

Administrative change to Length of Authorization section to include number of days allowed for authorization durations and editorial change to combine Gastric and Esophageal Cancer. To NSCLC, removed exon 21 mutation from criteria based on NCCN compendia and 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 newly approved FDA indication for use with FLOT chemotherapy as neoadjuvant and adjuvant treatment, followed by single agent therapy, for adults with resectable gastric or gastroesophageal junction adenocarcinoma (GC/GEJC). Both Gastric and Esophageal Cancer and Esophagogastric Junction Cancer headings were updated along with Dosing Table to align with PI for this new indication. To Endometrial Carcinoma (Uterine Neoplasms), aligned criteria for adjuvant and primary treatment for stage III-IV disease with NCCN recommendations. Also 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.

Imjudo

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 of disseminated disease since NCCN no longer lists as 2B. Also to NSCLC, updated biomarker footnoted text to align with latest NCCN recommendations/guideline.

Jemperli

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.

Lantidra

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. Added HCT/MRR box under initial criteria. Under initial and universal criteria, softened hard vaccine requirement per global update. Added FDA Orphan Drug Designation symbol to Diabetes Mellitus (Type 1) heading. Updated dosing table to allow for use up to 48 hours post product release time to align with PI. Added Appendix A-Non-Quantitative Treatment Limitations (NQTL) Factor Checklist to policy. To Appendix 1, added ICD 10 code E10.649 per IPD and removed E10.8, E10.9. Editorial changes were made throughout.

Libtayo

Administrative change to Length of Authorization section to include number of days allowed for authorization durations. To Cutaneous Squamous Cell Carcinoma (cSCC), added use as a single agent for unresectable or incompletely resected satellitosis/in-transit metastasis per NCCN and added to LOA/dosing table. 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. Also to NSCLC, updated biomarker footnoted text to align with latest NCCN recommendations/guidelines. Updated heading and dosing table for ‘Appendiceal Adenocarcinoma’ to ‘Appendiceal Neoplasms and Cancers’ based on new separated NCCN guideline from Colon Cancer guideline. To this indication added use as neoadjuvant therapy or use for recurrent, progressive, metastatic peritoneal-only or extraperitoneal disease. To Appendix 1 (Covered Diagnosis), added D37.3, Z85.038 (related to Appendiceal Neoplasms and Cancers). Editorial changes throughout.

Loqtorzi

Administrative change to Length of Authorization section to include number of days allowed for authorization durations. Updated Appendiceal Adenocarcinoma to Appendiceal Neoplasms and Cancers to align with new NCCN nomenclature and updated clinical settings within the criteria to align with NCCN updates. To Appendix 1 - Covered Diagnosis Codes, added D37.3 and Z85.038 (related to Appendiceal Neoplasms and Cancers), and C31.0, C31.1, and Z85.818 (related to Head and Neck Cancers) per NCCN. Editorial changes were made throughout.

Lunsumio

Updated the indication heading from Follicular Lymphoma to B-Cell Lymphomas and added use in DLBCL, HGBCL, HIV-Related B-Cell Lymphomas, and PTLD per NCCN 2A recommendations along with corresponding criteria and ICD-10 codes. To the Renewal Criteria, updated the examples of unacceptable toxicity to more closely align with the Warnings and Precautions section of the PI. 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 the Length of Authorization to delineate between authorization durations for initial and renewal periods and to include the number of days for approval.

Luxturna

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

Lyfgenia

Softened hard vaccine requirement per global change. Updated criteria on not receiving other gene therapies to clarify this applies to gene therapies used for sickle cell disease and updated corresponding footnote. Removed absence of G-CSF from mobilization criteria in Dosing Table notes due to duplicity. Editorial changes throughout policy. Added Appendix A – Non-Quantitative Treatment Limitations (NQTL) Factor Checklist.

Omisirge

Ad hoc review to add the newly approved expanded indication for the treatment of adults and pediatric patients six years and older with Severe Aplastic Anemia (SAA) following reduced intensity conditioning and for whom a compatible donor is not available. The Initial Criteria section was reformatted and updates were also made to the dosing table and ICD-10 coding to reflect the addition of this new indication. Added the HCT/MRR box to maintain parity with all other cell/gene therapy products. 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 the Length of Authorization and Initial Criteria sections to update ‘coverage’ to ‘prior authorization validity’.

Papzimeos

Editorial changes were made to the Initial Approval Criteria to align with the verbiage in the PI. No clinical updates.

Penpulimab-kcqx

Administrative change to Length of Authorization section to include number of days allowed for authorization durations. Added indication of Appendiceal Neoplasms and Cancers per 2A recommendation in NCCN. Corresponding update was made to Dosage/Administration table. To Appendix 1 – Covered Diagnosis Codes, added C18.1, D37.3, and Z85.038 (related to Appendiceal Neoplasms and Cancers). Editorial changes were made throughout.

Polivy

Administrative changes to Length of Authorization section to delineate between authorization durations for initial and renewal periods. To B-cell lymphomas, added option for use as first-line therapy in combination with R-CHP for stage I-II disease and IPI >1 per NCCN. Also added option for use as subsequent therapy in combination with mosunetuzumab for treatment of DLBCL, HGBL, HIV-related DLBCL, and PTLD. To PTLD, added option for use in combination with R-CHP for 1L or 2L for partial response, persistent or progressive disease. Added Appendix A - Non-Quantitative Treatment Limitations (NQTL) Factor Checklist. To ICD-10 table removed C83.39 as this code is no longer supported by NCCN. Editorial changes were made throughout.

Rituximab IV

To Policy heading updated to add Intrathecal/Intraventricular routes of administration as the policy supports these compendia recognized routes of administration. Administrative changes to Length of Authorization section to include number of days allowed. To Oncology Indications heading, added TA-TMA to be excluded from the requirement of CD20 antigen expression positive. To CLL/SLL, for use as FLT for disease without del(17p)/TP53 mutation, clarified used with bendamustine is only when BTK-I and BCL2-I are not available. To CNS Cancers for treatment of primary CNS lymphoma, simplified regimens for use as consolidation treatment. For CLL/SLL with del(17p)/TP53 mutation, added option for use in combination with venetoclax as subsequent therapy. To B-Cell Lymphomas, for low-grade/follicular, removed requirement for grade 1-2 disease to align with NCCN. To Castleman Disease, for treatment of unicentric disease, added option for use in disease that has been incompletely resected. To Pediatric Aggressive Mature B-Cell Lymphomas, for setting of PTLD, removed requirement of B-Cell type disease as NCCN currently allows use for all types. To Hairy Cell Leukemia, simplified options for use in combination with vemurafenib. Added new indication for use in KSHV-associated inflammatory cytokine syndrome. Dosing table, LOA and max units sections updated accordingly. Updated heading of Management of Immunotherapy Related toxicities to Management of Immune Checkpoint Inhibitor-Related toxicities to align with new verbiage in NCCN. Heading was updated throughout the policy including LOA, max units and dosing table. To MS, extensively revised table for definitive diagnosis of RRMS to align with updated 2024 McDonald Criteria. To renewal criteria for MS, loosened MRI requirements. To SLE renewal criteria, added requirement for continued use in combination with standard SLE therapies to mirror Prime Standard Lupus PA criteria. To IgG4-Related Disease, added sinonasal tract as a potential affected organ per literature support. Added new indication for use in Wiskott-Aldrich syndrome as pretreatment prior to etuvetidigene autotemcel infusion with corresponding dosing, max units and ICD-10 code. To Appendix 1, added ICD-10 codes C46.0-C46.4, C46.50-C46.52, C46.7, C46.9, D89.89, & D89.9 related to KSHV-associated inflammatory cytokine syndrome. Removed ICD-10 code G35 for MS and replaced with G35.A, G35.B0, G35.B1, G35.B2, G35.C0. G35.C1, G35.C2 & G35.D. Added ICD-10 code D82.0 for Wiskott-Aldrich syndrome. Editorial changes throughout.

Rituximab SQ

Administrative changes to 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 hard vaccine requirement per global changes. Also to Universal Criteria, to the bullet precluding use with IV chemotherapy, clarified that restriction applies to all IV administered agents. To CLL/SLL, added note allowing use for histologic transformation (Richter) per NCCN. Added new indication for use in KSHV-associated inflammatory cytokine syndrome. Dosing table, LOA and max units sections updated accordingly. Added Appendix A - Non-Quantitative Treatment Limitations (NQTL) Factor Checklist. To Appendix 1, added ICD-10 codes C46.0-C46.4, C46.50-C46.52, C46.7, C46.9, D89.89, & D89.9 related to KSHV-associated inflammatory cytokine syndrome. Editorial changes throughout.

Roctavian

Added ‘Hemophilia Products’ to the policy title. 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 vaccine requirement per global changes update, to Initial and Renewal criteria to update ‘coverage’ to ‘prior authorization validity’. Added Appendix A - Non-Quantitative Treatment Limitations (NQTL) Factor Checklist.

Spinraza

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. Under Initial criteria, global change to update verbiage in the HCT/MRR box. From Universal Criteria, removed requirement on not having received prior treatment with SMA gene therapy due to published results from RESPOND trial showing efficacy in patients that received Spinraza after Zolgensma. Added Appendix A-Non-Quantitative Treatment Limitations (NQTL) Factor Checklist to policy. To Appendix 2, removed LCD A58579 as it was retired on 10/02/2025 and combined Jurisdiction E and F as per active LCD. Editorial changes were made throughout.

Tecentriq IV

Administrative change to Length of Authorization section to include number of days allowed for authorization durations. To NSCLC, updated criteria to align with NCCN updates. Added indications of Thymic Carcinoma and Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma per NCCN 2A recommendations with corresponding updates made to Length of Authorization, Max Units, and Dosage/Administration sections. To Appendix 1 - Covered Diagnosis Codes, added C37, D15.0, D38.4, and Z85.238 (related to Thymic Carcinoma) and C83.00-C83.09, C83.30-C83.39, C91.10, and C91.12 (related to CLL/SLL). Updated ICD-10 crosswalk (for PCM) list. Editorial changes were made throughout.

Tecentriq SQ

Administrative changes to Policy Name to reflect registered trademark and to Length of Authorization section to include number of days allowed for authorization durations. To NSCLC, updated criteria to align with NCCN updates. To HCC, removed adjuvant therapy criteria and replaced with subsequent therapy per NCCN updates. To Cutaneous Melanoma, updated subsequent therapy criteria to align with NCCN updates. To Alveolar Soft Part Sarcoma (ASPS), updated criteria to include expanded indication for use in pediatric patients 12 years of age and older who weigh at least 40 kg. A corresponding update was made to Universal Criteria to add a note to indicate the requirement for patient to be at least 62 kg does not apply to ASPS. Added indications of Colon Cancer, Thymic Carcinoma, and Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma per NCCN 2A recommendations with corresponding updates made to Length of Authorization and Dosage/Administration sections. To Appendix 1 - Covered Diagnosis Codes, added C18.0, C18.2-C18.9, and Z85.038 (related to Colon Cancer), C37, D15.0, D38.4, and Z85.238 (related to Thymic Carcinoma) and C83.00-C83.09, C83.30-C83.39, C91.10, and C91.12 (related to CLL/SLL). Editorial changes were made throughout.

Tevimbra

Administrative change to Length of Authorization section to include number of days allowed for authorization durations. 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. Updated Appendiceal Adenocarcinoma to Appendiceal Neoplasms and Cancers to align with new NCCN nomenclature and updated clinical settings within the criteria to align with NCCN updates. Added indications of Adult Classic Hodgkin Lymphoma (CHL) and Endometrial Carcinoma per NCCN 2A recommendations. Dosing table, length of authorization, and max units sections were updated to accommodate new indication of CHL. To Dosage/Administration table, added additional option of 400 mg every 6 weeks to the All Other Indications row per updated PI. To Appendix 1 - Covered Diagnosis Codes, added C54.0-C54.3, C54.8, C54.9, C55, and Z85.42 (related to Endometrial Carcinoma), C81.10-C81.19, C81.20-C81.29, C81.30-C81.39, C81.40-C81.49, C81.70-C81.79, C81.90-C81.99, and Z85.71 (related to Adult Classic Hodgkin Lymphoma), and D37.3 and Z85.038 (related to Appendiceal Neoplasms and Cancers), and Z85.818 (related to Head and Neck Cancers) per NCCN. Editorial changes were made throughout.

Tzield

Updated trademark symbol to ®. Administrative changes to Length of Authorization section to delineate between authorization durations for initial and renewal periods. To Initial criteria, softened hard vaccine requirement per global update. To Diabetes Mellitus (Type 1) heading, added orphan drug symbol. Also to T1DM, updated criteria for dysglycemia to change fasting glucose value from 110mg/dL to 100mg/dL and to add A1C criteria as an option to align with the 2026 ADA guidelines. Added Appendix A-Non-Quantitative Treatment Limitations (NQTL) Factor Checklist to policy. Editorial changes were made throughout.

Unloxcyt

To cSCC, added use in patients with satellitosis/in-transit metastasis per NCCN. Administrative changes to Length of Authorization section to include the number of days for approval.

Zolgensma

Administrative change to Length of Authorization section to delineate between authorization durations for initial and renewal periods. To Initial Approval Criteria, updated verbiage HCT/MRR box. To SMA, updated liver function criteria to align with PI update. From Dosing Table, removed note on single-dose infusion only since noted earlier in table itself. Added Appendix A-Non-Quantitative Treatment Limitations (NQTL) Factor Checklist to policy. Editorial changes were made throughout.

Zynyz

Administrative change to Length of Authorization section to include number of days allowed for authorization durations. To Merkel Cell Carcinoma, clarified that in-transit regional disease is required to be N+ per NCCN. Updated Appendiceal Adenocarcinoma to Appendiceal Neoplasms and Cancers to align with new NCCN nomenclature and updated criteria to align with NCCN updates. To Appendix 1 ICD-10 codes, added D37.3 and Z85.038 (related to Appendiceal Neoplasms and Cancers). Editorial changes were made throughout.

Trogarzo

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