Pharmacy Policy Updates

Bevacizumab Oncology

Adult CNS Cancers use for recurrent or progressive disease, added subtypes High-grade astrocytoma with piloid features (HGAP) and Pleomorphic Xanthoastrocytoma (PXA) WHO grade 3 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 Endometrial Carcinoma (Uterine Neoplasms), updated criteria to exclude use in clinical settings categorized as 2B recommendations in NCCN. To NSCLC, updated criteria to align with NCCN updates. Added indication of Respiratory Papillomatosis per literature review with corresponding updates made to Dosing table and Max Units. To Dosage/Administration, updated dosing for Appendiceal Neoplasms and Cancers per NCCN Guidelines, with a corresponding update made to Max Units. To Appendix 1 - Covered Diagnosis Codes, added D37.3 (related to Appendiceal Neoplasms and Cancers) per NCCN and D10.5, D10.6, D10.9, D14.0-D14.2, D14.30-D14.32, D14.4, D36.9, J38.7, and J39.2 (related to Respiratory Papillomatosis). Updated ICD-10 crosswalk (for PCM) list. Editorial changes throughout.

Briumvi

Administrative change to Length of Authorization section to delineate between authorization durations for initial and renewal periods. To Universal Criteria, added measurement of baseline LFTs per PI and softened hard vaccine requirement per global change. Extensively revised table on definitive diagnosis of relapsing-remitting disease to align with updated guidelines (2024 McDonald Criteria). To Renewal Criteria, added liver injury to examples of unacceptable toxicities based on updated PI, removed ‘brain/spinal’ from response to therapy to allow for any MRI, and removed note regarding patients with primary progressive MS. Added Appendix A – Non-Quantitative Treatment Limitations (NQTL) Factor Checklist. To Appendix 1 – Covered Diagnoses Codes removed G35 and added updated codes G35.A, G35.B0, G35.B1, G35.B2, G35.C0, G35.C1, G35.C2, G35.D (all related to multiple sclerosis). Editorial changes made throughout.

Columvi

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. Removed single agent use from Universal criteria and added back to specific indications, where applicable. To B-Cell Lymphomas, added option for use in combination with GemOx as subsequent therapy and added a footnote for single agent use to include patients with disease progression after transplant or CAR T-cell therapy per NCCN. Added indication of CLL/SLL histologic transformation (Richter) per 2A recommendation in NCCN. Corresponding update was made to Dosage/Administration table. Additionally, added a note to Dosage/Administration table regarding use via IV bag infusion or IV syringe infusion. Added Appendix A – Non-Quantitative Treatment Limitations (NQTL) Factor Checklist. To Appendix 1 – Covered Diagnosis Codes removed code Z85.72 (related to non-Hodgkin lymphomas) which is no longer supported per NCCN and added C83.00-C83.09 C91.10, C91.12 (related to CLL/SLL) and C83.398 (related to B-Cell Lymphomas) per NCCN. Editorial changes are made throughout and to Renewal Criteria.

Darzalex SQ

Ad hoc review to add the new FDA approved indication for the treatment of adult patients with high-risk smoldering multiple myeloma as monotherapy. Updates were made to all applicable sections throughout the policy to incorporate the new indication. Administrative changes were made 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. Appendix A – Non-Quantitative Treatment Limitations (NQTL) Factor Checklist was added to the policy as a part of the global changes being made across all policies. Other minor editorial changes were made throughout.

Epkinly

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. Removed single agent use from Universal criteria and added back to specific indications, where applicable. To B-Cell Lymphomas, added new FDA approved indication for the treatment of relapsed or refractory follicular lymphoma in combination with rituximab and lenalidomide. The dosing table and LOA were updated accordingly to note a maximum of 12 cycles. Also, to B-cell lymphomas, added option for use in combination with GemOx as subsequent therapy and added a footnote for single agent use to include patients with disease progression after transplant or CAR T-cell therapy per NCCN. Added indication of CLL/SLL histologic transformation (Richter) per 2A recommendation in NCCN. The corresponding update was made to the Dosage/Administration table. Editorial changes throughout policy. Added Appendix A – Non-Quantitative Treatment Limitations (NQTL) Factor Checklist. To Appendix 1 – Covered Diagnosis Codes, added C83.00-C83.09, C91.10, C91.12 (related to CLL/SLL) and C83.398 (related to B-cell Lymphomas) per NCCN.

Gazyva

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. Updated Max Units to one value per indication to account for all dosing regimens. To CLL/SLL, added new setting for use in histologic transformation (Ritcher) with pertinent criteria and dosing per NCCN. Updated options for use in first line and subsequent settings and updated verbiage throughout CLL/SLL indication to match changes in NCCN. To B-cell lymphomas, for FL, removed the requirement of Grade 1-2 disease to align with PI and NCCN. Added option for use as 3L and beyond treatment for Histologic transformation of Indolent to DLBCL as pretreatment prior to Glofitamab. Updated options for use in DLBCL, HGBL, HIV-related B-cell lymphoma, PTLD and MCL. Added option for use as induction therapy for MCL in combination with Zanubrutinib and Venetoclax with dosing per NCCN. Removed Castleman Disease from B-cell Lymphomas and created its own indication heading with pertinent criteria and dosing per NCCN. Added new indication of Waldenstrom Macroglobulinemia with criteria and dosing per NCCN. To Hairy Cell Leukemia, added option for use as a single agent for progression after therapy for R/R disease or in patients who are unable tolerate purine analogs. Added newly approved FDA indication for treatment of adult patients with active lupus nephritis who are receiving standard therapy. LOA, max units, dosing table, renewal criteria, and Appendix 1 were all updated to incorporate this new indication. Added Appendix A - Non-Quantitative Treatment Limitations (NQTL) Factor Checklist. To Appendix 1, added ICD-10 codes C83.398 related to DLBCL and C88.00 related to WG/LPL. Updated ICD-10 code C88.4 to C88.40 and removed Z85.72 as this ICD-10 code is no longer supported by NCCN. Added ICD-10 codes M32.14 & M32.15 related to Lupus Nephritis. Editorial changes throughout.

Infugem

The policy is being retired as the manufacturer has discontinued the product.

Kebilidi

Administrative changes to the Length of Authorization section to delineate between authorization durations for initial and renewal periods and to update verbiage in the HCT/MRR box. Editorial changes are made throughout and to Renewal Criteria. To HCPCS codes, added C9399 per IPD Analytics. Added Appendix A – Non-Quantitative Treatment Limitations (NQTL) Factor Checklist.

Lemtrada

Administrative change to Length of Authorization section to delineate between authorization durations for initial and renewal periods. REMS criterion deleted from Universal Criteria to eliminate redundancy with policy criteria, eliminate risk of inappropriate pend/denials, and to better align pharmacy/medical benefit criteria. Also, to Universal Criteria, softened hard vaccine requirement per global change. Extensively revised table on definitive diagnosis of relapsing-remitting disease to align with updated guidelines (2024 McDonald Criteria). From Renewal Criteria, removed ‘brain/spinal’ from response to therapy to allow for any MRI. To Covered Diagnosis Codes, removed G35 and added updated codes G35.A, G35.B0, G35.B1, G35.B2, G35.C0, G35.C1, G35.C2, and G35.D (all related to multiple sclerosis). Editorial changes throughout. Added Appendix A – Non-Quantitative Treatment Limitations (NQTL) Factor Checklist.

Monjuvi

Administrative changes to update ‘coverage’ to ‘prior authorization validity’ and add NQTL Factor Checklist (Appendix A) to policy. Removed examples of CD19 therapies in universal criteria for conciseness. To B-Cell Lymphomas, updated the following subtypes to align with updates in NCCN: DLBCL, Histologic transformation of Indolent lymphoma to DLBCL, HIV-related DLBCL, HGBL and PTLD. To Billing Code/Availability Information, added NDC for 73535-0208-xx 200mg single-dose vial.

Natalizumab

Administrative changes to the Length of Authorization section to delineate between authorization durations for initial and renewal periods, and to alphabetize drug names in policy title. REMS/TOUCH criterion deleted from Universal Criteria to eliminate redundancy with policy criteria, eliminate risk of inappropriate pend/denials, and to better align pharmacy/medical benefit criteria. Extensively revised table on definitive diagnosis of relapsing-remitting disease to align with updated guidelines (2024 McDonald Criteria). To Renewal Criteria, removed ‘brain/spinal’ from response to therapy to allow for any MRI, and updated unacceptable toxicities to include hematological abnormalities which align with current PI. To Covered Diagnosis Codes, removed G35 and added updated codes G35.A, G35.B0, G35.B1, G35.B2, G35.C0, G35.C1, G35.C2, and G35.D (all related to multiple sclerosis). Editorial changes throughout. Added Appendix A – Non-Quantitative Treatment Limitations (NQTL) Factor Checklist.

Ocrevus IV

Administrative change to Length of Authorization section to delineate between authorization durations for initial and renewal periods. To Universal Criteria, added measurement of baseline LFTs per PI and softened hard vaccine requirement per global change. Extensively revised and combined tables on definitive diagnosis of relapsing-remitting disease and primary progressive disease to align with updated guidelines (2024 McDonald Criteria). To Renewal Criteria, added liver injury to examples of unacceptable toxicities based on updated PI, removed ‘brain/spinal’ from response to therapy to allow for any MRI, and removed notes regarding patients with primary progressive MS. To Covered Diagnosis Codes, removed G35 and added updated codes G35.A, G35.B0, G35.B1, G35.B2, G35.C0, G35.C1, G35.C2, and G35.D (all related to multiple sclerosis). Editorial changes throughout. Added Appendix A – Non-Quantitative Treatment Limitations (NQTL) Factor Checklist.

Ocrevus SQ

Administrative change to Length of Authorization section to delineate between authorization durations for initial and renewal periods. To Universal Criteria, added measurement of baseline LFTs per PI and softened hard vaccine requirement per global change. Extensively revised and combined tables on definitive diagnosis of relapsing-remitting disease and primary progressive disease to align with updated guidelines (2024 McDonald Criteria). To Renewal Criteria, added liver injury to examples of unacceptable toxicities based on updated PI, removed ‘brain/spinal’ from response to therapy to allow for any MRI, and removed notes regarding patients with primary progressive MS. To Covered Diagnosis Codes, removed G35 and added updated codes G35.A, G35.B0, G35.B1, G35.B2, G35.C0, G35.C1, G35.C2, and G35.D (all related to multiple sclerosis). Editorial changes throughout. Added Appendix A – Non-Quantitative Treatment Limitations (NQTL) Factor Checklist.

Omvoh

Ad hoc review to add the newly FDA approved 200 mg/2 mL prefilled pen and 200 mg/2 mL prefilled syringe formulations as additional options for use in subcutaneous maintenance dosing for the treatment of moderately to severely active ulcerative colitis in adults (previously, each maintenance treatment for ulcerative colitis required the injection of two consecutive 100 mg/mL prefilled pens or prefilled syringes to obtain the full dose). The new products were added to the list of existing products within the Billing Code/Availability section. A corresponding update was made to the Dosage/Administration table. 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. Appendix A – Non-Quantitative Treatment Limitations (NQTL) Factor Checklist was added to the policy as a part of the global changes being made across all policies. Other minor editorial changes were made throughout.

Oncaspar

Administrative changes to the Length of Authorization section to delineate between authorization durations for initial and renewal period. To ALL, added option for use as maintenance therapy for AYA and adults <65 years of age with T-ALL. To T-Cell Lymphomas, clarified use for R/R extranodal NK/T-Cell lymphoma is supported after additional therapy with alternate combination chemotherapy regimen to align with NCCN. To Appendix 1, updated ICD-10 code C86.0 to C86.00 with corresponding change to descriptor. Added Appendix A - Non-Quantitative Treatment Limitations (NQTL) Factor Checklist. Editorial changes throughout.

Opdivo SQ

Ad hoc review to add the newly expanded FDA use as monotherapy for the treatment of adult patients with unresectable or metastatic MSI-H/dMMR CRC following treatment with intravenous nivolumab and ipilimumab combination therapy. Also, the newly added FDA expanded use as monotherapy for the first-line treatment of adult patients with unresectable or metastatic HCC following treatment with intravenous nivolumab and ipilimumab combination therapy. Criteria changes were also applied to incorporate the FDA conversion from accelerated approval to regular approval for unresectable or metastatic HCC who have been previously treated with sorafenib to now include criteria that Opdivo Qvantig will be used following treatment with intravenous nivolumab and ipilimumab combination therapy. Updated the post-notes under the Substitution/Switch-Therapy heading to also include the Opdivo IV-E policy Document Number: IC-0541, as applicable.

Paclitaxel Albumin-Bound

To NSCLC, simplified bullet for treatment of recurrent, advanced, or metastatic disease per changes in NCCN. Updated verbiage throughout. To Endometrial Carcinoma (Uterine Neoplasms), updated criteria to exclude use in clinical settings categorized as 2B recommendations in NCCN. To Kaposi Sarcoma, updated definition of advanced disease in the R/R setting and added new setting for use of KSHV-Associated Inflammatory Cytokine Syndrome with relevant criteria per NCCN. Dosing table and LOA updated to accommodate new settings for use. To Appendix 1 ICD-10 codes, added D89.89 and D89.9 related to KS/disorders involving immune mechanisms and updated ICD-10 crosswalk (for PCM).

Pemetrexed

To policy heading, updated route of administration section to include intrathecal use (this route of administration is already included within the criteria/dosing table, per NCCN guidelines). To Peritoneal and Pleural Mesothelioma indications, updated subsequent therapy single agents no longer require prior immunotherapy or rechallenge criteria per NCCN updates. To NS-NSCLC, updated criteria and verbiage in the footnote table to align with latest NCCN guideline changes. To Thymomas and Thymic Carcinomas, broadened use to subsequent therapy for unresectable or metastatic disease (previously allowed only as second line therapy) per NCCN. Other minor editorial changes were made throughout.

Rethymic

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. Updated verbiage in the MRR/HCT box as per Global Changes. Added Appendix A - Non-Quantitative Treatment Limitations (NQTL) Factor Checklist. Editorial changes throughout.

Rylaze

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 Renewal criteria, updated heading name of Acute Lymphoblastic Leukemia to say Acute Lymphoblastic Leukemia/Lymphoblastic lymphoma to mirror naming used in the initial criteria. Global change to add NQTL Factor Checklist (Appendix A) to policy. Updated CTCAE to version 6.0 and updated ICD-10 code C86.0 to C86.00 per CMS update.

Trastuzumab IV

Policy heading updated to add Intrathecal/Intraventricular routes of administration as the policy supports these compendia recognized routes of administration. To Max Units removed separate heading for Appendiceal Adenocarcinoma, now bundled under “All Other Indications” due to corresponding update in dosing box to reflect the dosing that is supported by the new NCCN guideline for Appendiceal Neoplasms and Cancers. To endometrial carcinoma per NCCN, 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. Appendiceal Cancer heading updated to reflect new NCCN naming convention for indication. The new naming convention was updated throughout the policy. Also, to Appendiceal Cancer, removed option for use in combination with lapatinib, and removed use as initial therapy, now only recommended as subsequent therapy for recurrent, progressive, peritoneal-only metastatic, or extraperitoneal disease. To ICD-10 table D37.3 was added related to appendiceal neoplasms.

Vyepti

Made administrative changes to the Length of Authorization section to delineate between authorization durations for initial and renewal periods and removed QL from the Dosing Limits section as part of the global changes being made across all policies. Also added Appendix A – Non-Quantitative Treatment Limitations (NQTL) Factor Checklist to the policy per global change. To Universal Criteria, removed examples of CGRP inhibitors for conciseness and added additional examples of prophylactic intervention modalities to be used in combination to align with latest guidelines/compendia recommendations. To Preventative Treatment of Chronic Migraines, removed step therapy through oral and botulinum toxin therapy per IHS and AHS guidelines support. To Preventative Treatment of Episodic Migraines, updated definition to 4-14 monthly headache days per month with at least 4 days per month with characteristics and symptoms consistent with migraine with and/or without aura (had previously been restricted to use if 5 attacks lasting 4-72 hours of migraine without aura only) based on AHS guidelines. Also, to Episodic Migraine, removed the medication overuse headache trial and failure of acute migraine treatments based on guideline/compendia support. Removed corresponding table regarding prophylactic oral medications and migraine features. To Renewal Criteria, added additional examples of unacceptable toxicity per latest PI updates and updated the disease response measure regarding monthly migraine days to align with latest IHS guidelines. To ICD10 codes, added G43.E01, G43.E09, G43.E11, G43.E19 (related to chronic migraine). Other minor editorial changes were made throughout.

Vyvgart IV

Ad hoc review to remove the following criteria from the footnote in the dosing table per the updated PI: The safety of initiating subsequent cycles sooner than 50 days from the start of the previous treatment cycle has not been established. The footnote was amended to state: Administer subsequent treatment cycles based on clinical evaluation, but no sooner than 28 days after the last administration of the previous treatment cycle. The Max Units within the Dosing Limits section was also updated to reflect this change.

Vyvgart SQ

Ad hoc review to remove the following criteria from the footnote in the dosing table for gMG per the updated PI: The safety of initiating subsequent cycles sooner than 50 days from the start of the previous treatment cycle has not been established. The footnote was amended to state: Administer subsequent treatment cycles based on clinical evaluation, but no sooner than 28 days from the last administration of the previous treatment cycle. The Max Units for gMG within the Dosing Limits section were also updated to reflect this change.

Zynlonta

Administrative changes to the Length of Authorization section to delineate between authorization durations for initial and renewal periods, updated ‘coverage’ to ‘prior authorization validity, and removed LLC from Palmetto GBA in Medicare table. To Universal criteria, removed examples of CD19 therapies and removed examples of clinically significant infections for conciseness. To B-Cell Lymphomas, for Histologic Transformation of Indolent Lymphomas, updated use to be allowable after 2 or more regimens for indolent disease prior to transformation per changes in NCCN. Global change to add NQTL Factor Checklist (Appendix A) to policy. Removed ICD 10 code C83.39 as this is no longer supported by NCCN and replaced it with C83.398 related to DLBCL.

Zynteglo

Administrative changes to Length of Authorization section to delineate between authorization durations for initial and renewal periods and to the Dosing Limits section to remove QL. Updated the HCT/MRR verbiage as part of a global change being made to all applicable policies. Added softened criteria on live vaccines based on PI and global update. Updated criteria on not receiving other gene therapies to clarify this applies to gene therapies used for beta-thalassemia. Aligned verbiage on HLA donor with other gene therapy policies. Editorial changes throughout policy. Removed discontinued codes from the Billing Code/Availability section. Added Appendix A – Non-Quantitative Treatment Limitations (NQTL) Factor Checklist.

Asparlas

Administrative change 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 to policy. Minor editorial changes made throughout.

Besponsa

Administrative changes to Length of Authorization section to delineate between authorization durations for initial and renewal periods. Updated ® symbol to ™ to align with PI. Updated Adult B-cell precursor ALL language to align with NCCN recommendations for relapsed/refractory disease and frontline therapy. Removed option for use as treatment for minimal residual disease as this is no longer supported by NCCN. Removed examples of TKI options and instead added footnote. Added NQTL Factor Checklist (Appendix A) to policy. Editorial changes are made throughout.

Botox

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’. Editorial change to Universal Criteria to group exclusions for use into a single policy point to limit inappropriate pends. Removed examples of Botulinum Toxins from Universal Criteria for conciseness. To spastic conditions reformatted to remove separate headings for spasticity due to multiple sclerosis or Schilder’s disease and acquired spasticity secondary to spinal cord or brain injuries as both will now be reviewed/fall under diagnosis of Upper/Lower limb spasticity and correspondingly removed examples of conditions causing spasticity to align with compendia and KOL support. To Primary Axillary Hyperhidrosis, added Sofpironium to list of pre-req topical agents based on UpToDate. To Prophylaxis for Chronic Migraine, section extensively revised including adding assessment of baseline disease severity to align with other first line recommended medications, adding examples of prophylactic intervention modalities to be used in combination (to renewal criteria as well), and requirement to rule out other causes of headaches, to align with guidelines/UTD recommendations. Removed step therapy through oral as the latest International Headache Society (IHS) and American Headache Society (AHS) guidelines all are in favor of first-line botulinum toxin therapy based on the efficacy, safety, and tolerability. Removed corresponding table regarding prophylactic oral medications and migraine features. To Esophageal Achalasia updated to allow use when patient is not a candidate for definitive therapy per UTD recommendation. Removed focal from upper/lower limb spasticity in renewal criteria to align with initial criteria indication. Global change to add NQTL Factor Checklist (Appendix A) to policy. To ICD-10 code table G35-multiple sclerosis replaced with more specific codes G35.A, G35.B0-G35.2, G35.C0-G35.C2 and G35.D. Minor editorial changes made throughout for clarity.

Daxxify

Administrative changes to Length of Authorization section to delineate between authorization durations for initial and renewal periods. Editorial change to Universal Criteria to group exclusions for use into a single policy point to limit inappropriate pends. Removed examples of Botulinum Toxins from Universal Criteria for conciseness. Added Appendix A – Non-Quantitative Treatment Limitations (NQTL) Factor Checklist. Editorial changes are made throughout.

Dysport

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’. Editorial change to Universal Criteria to group exclusions for use into a single policy point to limit inappropriate pends. Removed examples of Botulinum Toxins from Universal Criteria for conciseness. To spastic conditions reformatted to remove heading for spasticity of the lower limbs due to multiple sclerosis or Schilder’s disease this will now be reviewed/fall under diagnosis of Upper/Lower limb spasticity and removed examples of conditions causing spasticity to align with compendia and KOL support. To Prophylaxis for Chronic Migraine, section extensively revised including adding assessment of baseline disease severity to align with other first line recommended medications, adding examples of prophylactic intervention modalities to be used in combination (to renewal criteria as well), and requirement to rule out other causes of headaches, to align with guidelines/UTD recommendations. Removed step therapy through oral as the latest International Headache Society (IHS) and American Headache Society (AHS) guidelines all are in favor of first-line botulinum toxin therapy based on the efficacy, safety, and tolerability. Removed corresponding table regarding prophylactic oral medications and migraine features. To Primary Axillary Hyperhidrosis, added Sofpironium to list of pre-req topical agents based on UpToDate. Added compendia supported indication of Severe Palmar Hyperhidrosis including new start and renewal criteria. Additionally, updated MU, dosing box, and ICD10 table (added code L74.512) to reflect addition of Palmar indication. Global change to add NQTL Factor Checklist (Appendix A) to policy. To ICD-10 code table G35-multiple sclerosis replaced with more specific codes G35.A, G35.B0-G35.2, G35.C0-G35.C2 and G35.D. Additionally editorial changes to ICD10 table to place all codes in correct order. Minor editorial changes made throughout for clarity.

Myobloc

Added intraglandular to route of administration in title based on package insert. 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’. Converted Max Units section into a table format to align with other Botulinum Toxin policies. Editorial change to Universal Criteria to group exclusions for use into a single policy point to limit inappropriate pends. Removed examples of Botulinum Toxins from Universal Criteria for conciseness. To Prophylaxis for Chronic Migraine, section extensively revised including adding assessment of baseline disease severity to align with other first line recommended medications, adding examples of prophylactic intervention modalities to be used in combination (to renewal criteria as well), and requirement to rule out other causes of headaches, to align with guidelines/UTD recommendations. Removed step therapy through oral as the latest International Headache Society (IHS) and American Headache Society (AHS) guidelines all are in favor of first-line botulinum toxin therapy based on the efficacy, safety, and tolerability. Removed corresponding table regarding prophylactic oral medications and migraine features. To Primary Axillary Hyperhidrosis, added Sofpironium to list of pre-req topical agents based on UpToDate. Global change to add NQTL Factor Checklist (Appendix A) to policy. To ICD-10 code table G35-multiple sclerosis replaced with more specific codes G35.A, G35.B0-G35.2, G35.C0-G35.C2 and G35.D. G82.50-G82.52 for ULS added to align across other toxin policies. Minor editorial changes are made throughout for clarity.

Xeomin

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’. Editorial change to Universal Criteria to group exclusions for use into a single policy point to limit inappropriate pends. Removed examples of Botulinum Toxins from Universal Criteria for conciseness. To spastic conditions removed examples of conditions causing spasticity to align with compendia and KOL support. To Prophylaxis for Chronic Migraine, section extensively revised including adding assessment of baseline disease severity to align with other first line recommended medications, adding examples of prophylactic intervention modalities to be used in combination (to renewal criteria as well), and requirement to rule out other causes of headaches, to align with guidelines/UTD recommendations. Removed step therapy through oral as the latest International Headache Society (IHS) and American Headache Society (AHS) guidelines all are in favor of first-line botulinum toxin therapy based on the efficacy, safety, and tolerability. Removed corresponding table regarding prophylactic oral medications and migraine features. To Primary Axillary Hyperhidrosis, added Sofpironium to list of pre-req topical agents based on UpToDate. Global change to add NQTL Factor Checklist (Appendix A) to policy. To ICD-10 code table G35-multiple sclerosis replaced with more specific codes G35.A, G35.B0-G35.2, G35.C0-G35.C2 and G35.D. G82.50-G82.52 for ULS added to align across other toxin policies. Minor editorial changes are made throughout for clarity.