Pharmacy Policies Available Online

Amvuttra

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. Also added Appendix A – Non-Quantitative Treatment Limitations (NQTL) Factor Checklist per global update. To Universal Criteria updated examples of drugs not allowed in combination. To renewal criteria updated nomenclature for Cardiomyopathy to include Hereditary to match the rest of the policy. To Dosing table updated induction to “All Indications” for conciseness. To Appendix 1 added E85.4 for Organ-limited amyloidosis (related to ATTR-CM) per IPD. Editorial changes throughout.

Bavencio

No clinical changes. Editorial changes made throughout.

Cinqair

Ad hoc review to align with the updates made to the Prime Therapeutics IL-5 Inhibitor PAQL policy: to the severe eosinophilic asthma criteria, updated wording of exacerbation requirements to better define each type of exacerbation and to clarify the number of exacerbations required; added agents to the Contraindicated as Concomitant Therapy table. Other minor editorial changes throughout the criteria to align with Prime IL-5 verbiage updates.

Datroway

Ad hoc review to add the expanded indication for the treatment of adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy. To the Universal criteria pertaining to conducting an ophthalmic exam, updated the criteria to specify that visual acuity testing and slit lamp examination must be conducted every 3 cycles based on the updated PI. To the HER-2 negative expression table, updated language to align with NCCN updated verbiage by including ERBB2. Editorial changes made throughout.

Denosumab

To Prolia: Universal Criteria global change to remove specific contraindications in criteria and replace with general language indicating member does not have any FDA contraindications. To OP in Men and Women, added symbol with note regarding members with very high risk to reflect additional guideline supported treatment settings where members are not subject to prior trial and failure requirements with bisphosphonates. To Xgeva: Universal Criteria global change to remove specific contraindications in criteria and replace with general language indicating member does not have any FDA contraindications. To multiple myeloma, added footnote to indicate may also be used in combination with primary myeloma therapy for POEMS, MIDD, MGRS based on NCCN. Per update to NCCN, indication of Systemic Mastocytosis is now supported by NCCN for Prolia and biosimilar products and no longer supported for Xgeva; indication was moved to Prolia review portion of policy; corresponding updates made to MU, Renewal Criteria, dosing table, and Appendix 1 codes to reflect this change. To Appendix 1 – Covered Diagnosis Codes, added C50.A0-C50.A2 (related to breast cancer) and Z85.46 (related to prostate cancer) to both Prolia and Xgeva per NCCN. Editorial changes made throughout.

Evenity

Administrative changes to Length of Authorization section to include number of days allowed for authorization durations. To Universal Criteria, global change to remove specific contraindications in criteria and replace with general language indicating member does not have any FDA contraindications. To note regarding members with very high risk, updated to reflect additional guideline supported treatment settings where members are not subject to prior trial and failure requirements with bisphosphonates and/or denosumab. To NDCs, added new product, of single use glass PFS with automatic needle guard. Added Appendix A - Non-Quantitative Treatment Limitations (NQTL) Factor Checklist. Editorial changes made throughout.

Exdensur

Ad hoc review to remove references to the single-dose prefilled autoinjector presentation and to retain only the single-dose prefilled syringe presentation per the latest FDA decision. Made the following changes to align with the updates made to the Prime Therapeutics IL-5 Inhibitor class: to the severe eosinophilic asthma criteria, updated wording of exacerbation requirements to better define each type of exacerbation and to clarify the number of exacerbations required; added agents to the Contraindicated as Concomitant Therapy table. Other minor editorial changes throughout the criteria to align with Prime IL-5 verbiage updates.

Fasenra

Ad hoc review to add the newly approved FDA expanded indication for the treatment HES without an identifiable non-hematologic secondary cause. Also added dosing, dosing limits, and ICD-10 codes (D72.110, D72.111 and D72.119) for new HES indication. Additional updates were made align with the updates made to the Prime Therapeutics IL-5 Inhibitor PAQL policy: to the severe eosinophilic asthma criteria, updated wording of exacerbation requirements to better define each type of exacerbation and to clarify the number of exacerbations required; added agents to the Contraindicated as Concomitant Therapy table; updated references. Other minor editorial changes were made throughout the criteria to align with Prime IL-5 verbiage updates.

Golimumab IV

Ad hoc review to add the new approved biosimilar product, Immgolis INTRI, in anticipation of its launch into the marketplace. It will be kept at full parity with the reference product, Simponi Aria. The Max Units in the Dosing Limits section was also updated to reflect the addition of this new product. The policy was subsequently re-named Golimumab to encompass both Simponi ARIA and Immgolis INTRI. Additional editorial changes made throughout

Imfinzi

To NSCLC, added option for use in the subsequent setting for ERBB2 (HER2) mutation positive tumors and updated criteria for recurrent, advanced or metastatic disease to align with NCCN compendia and guideline recommendations. To Bladder Cancer, added new FDA approved indication for use in combination with BCG therapy for treatment of non-muscle invasive bladder cancer (NMIBC) with relevant criteria per the PI. Corresponding change was also made to the dosing table to incorporate dosing for NMIBC. Length of Authorization and Max Units sections were updated accordingly. Other minor editorial changes throughout.

Imjudo

To NSCLC, added option for use in the subsequent setting for ERBB2 (HER2) mutation positive tumors and updated criteria for recurrent, advanced or metastatic disease to align with NCCN compendia and guideline recommendations. Editorial changes made throughout.

Jemperli

To Length of Authorization, updated verbiage pertaining to renewals for anal carcinoma for clarity. To dMMR/MSI-H Tumors, updated setting of neoadjuvant treatment of gastric cancers to better align with NCCN. Also to dMMR/MSI-H tumors, updated setting of primary treatment of endometrial carcinoma to indicate use is for recurrent disease. Editorial changes made throughout.

Krystexxa

Administrative changes to Length of Authorization section and to include number of days allowed for authorization durations. To Universal Criteria, global change to remove any specific contraindications in criteria and replaced with general language indicating member does not have any FDA contraindications. Editorial changes made throughout.

Levoleucovorin

To Initial Criteria, removed Mantle Cell Lymphoma for use in combination with high-dose methotrexate and added Neuroendocrine Tumors of the Gastrointestinal Tract (Well-Differentiated Grade 1/2), Lung, and Thymus for use in combination with fluorouracil-based regimens as per NCCN. To Covered Diagnosis table, removed the following ICD-10 codes C83.10, C83.11, C83.12, C83.13, C83.14, C83.15, C83.16, C83.17, C83.18 (related to Mantle Cell Lymphoma) and added D37.3 (related to Appendiceal Adenocarcinoma) per NCCN. Added Appendix A - Non-Quantitative Treatment Limitations (NQTL) Factor Checklist. Editorial changes made throughout. Editorial changes made throughout.

Libtayo

To NSCLC, updated criteria to align with NCCN compendia and guideline recommendations. To Dosage/Administration table, updated single agent use duration for anal carcinoma to align with NCCN. Editorial changes made throughout.

Loqtorzi

To Length of Authorization, added table with maximum length of therapy, dose and dosing frequency to align with other policies in same class. To Head and Neck Cancers, for Very Advanced disease removed duplicative treatment settings that fall under unresectable disease. To Notes box, added an additional note to possible scenarios when previous therapy with a programmed death (PD-1/PD-L1)-directed therapy could be allowable. To Dosing Table, streamlined dose for Anal Carcinoma to align with other policies in same class for combination therapy. Editorial changes made throughout.

Nucala

Ad hoc review to align with the updates made to the Prime Therapeutics IL-5 Inhibitor PAQL policy: to the severe eosinophilic asthma criteria, updated wording of exacerbation requirements to better define each type of exacerbation and to clarify the number of exacerbations required; to COPD criteria, added examples of COPD inhaled maintenance therapy and also updated wording of exacerbation requirements to better define each type of exacerbation and to clarify the number of exacerbations required; to HES criteria, updated diagnostic criteria measures, simplified example listings of hypereosinophilia-related organ involvement and examples of non-hematologic secondary causes of HES, updated flare history criteria, updated HES conventional step therapy requirements, removed HES combo therapy requirements from Renewal criteria section; added agents to the Contraindicated as Concomitant Therapy table; updated references. Other minor editorial changes were made throughout the criteria to align with Prime IL-5 verbiage updates.

Onpattro

Administrative changes to Length of Authorization section to include number of days allowed for authorization durations. Also added Appendix A – Non-Quantitative Treatment Limitations (NQTL) Factor Checklist per global update. To Universal Criteria updated examples of drugs not allowed in combination. To Dosing Table updated naming of indication to correspond to the rest of the policy. Editorial changes throughout.

Opdualag

Administrative change to Length of Authorization section to include number of days allowed for authorization durations. Updated the footnote for metastatic disease to include oligometastatic disease and brain metastases per NCCN. To Appendix 1 - Covered Diagnosis Codes, added C43.10 (related to Cutaneous Melanoma). Editorial updates made to renewal section to better align with PI. Added Appendix A - Non-Quantitative Treatment Limitations (NQTL) Factor Checklist. Editorial changes made throughout.

Palonosetron

Administrative change to Length of Authorization section to include number of days allowed. To CINV in adults and pediatrics, removed repeat dosing in multi day emetogenic regimens preclusion based on NCCN guidelines allowing use up to every 2 days. Dosing table and Max Units were updated accordingly. Updated HEC, MEC, risk factors tables to align with current NCCN guidelines. To Billing Code section, updated verbiage on 505(b)(2) products with current links to NDC Directory and FDA Orange Book. Added Appendix A – Non-Quantitative Treatment Limitations (NQTL) Factor Checklist. Editorial changes made throughout. 

Penpulimab KCQX

To Head and Neck Cancers, for Very Advanced disease removed duplicative treatment settings that fall under unresectable disease and updated footnote verbiage. Additionally, for Head and Neck Cancers, updated criteria and Dosage/Administration table to clarify combination therapy is for 18 weeks then Penpulimab is continued as a single agent for the remainder of the treatment window. To Notes box, 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 made throughout.

Qalsody

Editorial change to Length of Authorization section to include number of days allowed. Other editorial changes throughout. Added Appendix A – Non-Quantitative Treatment Limitations (NQTL) Factor Checklist.

Radicava IV

Editorial change to Length of Authorization section to include number of days allowed. Other editorial changes throughout. Added Appendix A – Non-Quantitative Treatment Limitations (NQTL) Factor Checklist

Rituximab IV

To Adult ALL, added option for use in dose-adjusted EPOCH + TKI regimen for patients with PH+ disease. To CNS Cancers, added note regarding interchangeability of products for intrathecal or intraventricular administration. To primary CNS lymphoma, relapsed or refractory, added option to use Ibrutinib with lenalidomide. To Appendix 1, added ICD-10 code M05.A related to RA. Editorial changes made throughout.

Simponi Aria

Policy will be renamed to Golimumab IV with addition of Immgolis Intri biosimilar.

Sustol

Administrative change to Length of Authorization section to include number of days allowed. To CINV, updated statement on repeat dosing to clarify intent is not to use more frequently than once a week. Updated HEC, MEC, and risk factors tables to align with current NCCN guidelines. Added Appendix A – Non-Quantitative Treatment Limitations (NQTL) Factor Checklist. Editorial changes made throughout. 

Tecentriq IV

To NSCLC, expanded ERBB2 (HER2) mutation positive tumors from first-line only to first-line or subsequent therapy for single-agent use (PS 3) and non-squamous combination regimens (PS 0–2), per NCCN 2A recommendation. Added new indication for use as single agent adjuvant treatment for muscle invasive bladder cancer (MIBC) after cystectomy in patients who have circulating tumor DNA molecular residual disease (ctDNA MRD). Updates were also made to the Length of Authorization, Dosage/Administration, and ICD-10 coding sections to reflect the addition of this new indication. Editorial changes made throughout.

Tecentriq SQ

Ad hoc review to add the expanded indication for use as single agent adjuvant treatment for muscle invasive bladder cancer (MIBC) after cystectomy in patients who have circulating tumor DNA molecular residual disease (ctDNA MRD). Updates were also made to the Length of Authorization, Dosage/Administration, and ICD-10 coding sections to reflect the addition of this new indication. Editorial changes made throughout.

Tecvayli

Ad hoc review to Multiple Myeloma to add combination therapy with daratumumab IV with corresponding update to the dosing table per NCCN. Also, to the dosing table, added dosing for combination therapy with talquetamab per NCCN. Editorial changes made throughout.

Tevmibra

No clinical changes.

Tezspire

Ad hoc review to align with the updates made to the Prime Therapeutics Tezspire PAQL policy: to the severe asthma criteria, updated wording of exacerbation requirements to better define each type of exacerbation and to clarify the number of exacerbations required; added agents to the Contraindicated as Concomitant Therapy table. Other minor editorial changes throughout the criteria to align with Prime Tezspire PAQL policy verbiage updates.

Tzield

Ad hoc review to add the expanded indication to delay the decline in endogenous insulin production in pediatric patients age 8 to 17 recently diagnosed with Stage 3 type 1 diabetes. Updates were also made to the Length in Authorization, Dosing Limits, Renewal Criteria, dosing table, and ICD-10 codes to reflect the addition of this new indication for use. For Stage 2 T1D, updated the criteria to reflect separate diagnostic criteria for patients ≥ 1 year of age to < 18 years of age and ≥ 18 years of age to < 45 years of age based on updates made to the PI based on updated clinical trial information and limitations of use. Moved criteria for confirmation that Stage 2 T1D diagnosis is of autoimmune origin from under the Universal Criteria heading to under the criteria for Stage 2 T1D and also updated the verbiage in this criteria to align with the updated PI verbiage. To the Universal Criteria, added criteria confirming that the patient has no FDA labeled contraindications to align with new contraindications for use added to the PI and also added criteria confirming that therapy will not be used as a disease modifying therapy in non-autoimmune dysglycemic conditions per the new limitations of use in the updated PI. Added ICD-10 crosswalk (for PCM).

Unloxcyt

To Notes box, added an additional note to possible scenarios when previous therapy with a programmed death (PD-1/PD-L1)-directed therapy could be allowable.

Vyepti

Ad hoc review to add criteria to clarify the specific headache features that are consistent with migraines. To the Renewal Criteria, added severe constipation as an example of unacceptable toxicity based on the updated PI. 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. Additional editorial changes made throughout.

Vyjuvek

Administrative changes to Length of Authorization section to include number of days allowed for authorization durations. Added MRR/HCT embedded verbiage box. Made the following updates to more closely align with the Prime Therapeutics PBM Vyjuvek policy: Updated initial approval window to 12 months (previously 6 months); to Universal Criteria, removed skin graft exclusion criteria, added gene therapy product indicated for DEB in the agents not to be used concomitantly criterion, added exclusion for current/history of SCC in the area to be treated, and moved the active infection criteria up from the indication specific section; to DEB indication, simplified wound-specific criteria; to Renewal Criteria, updated beneficial response criteria to provide examples of clinical benefit that may be attained rather than specific benefit requirements. Other editorial changes were made throughout.

Vyvgart IV

Ad hoc review to include the treatment of gMG in adults who are anti-acetylcholine receptor antibody (AChR-Ab) seronegative based on the expanded FDA approval. Previously use was only approved for adults who were AChR antibody positive and use is now allowed in all adults with gMG irrespective of AChR antibody status. The footnote in the dosing table was amended to state, ‘Administer subsequent treatment cycles based on clinical evaluation, but no sooner than 7 days from the last administration of the previous treatment cycle,’ based on updated information provided in the Clinical Trials Experience section of the PI. The Max Units within the Dosing Limits section was also updated to reflect this change. 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 the quantity/dose requirements from initial/renewal criteria as this information was duplicative with the dosage/administration section. Additional editorial changes made throughout.

Vyvgart SQ

Ad hoc review to include the treatment of gMG in adults who are anti-acetylcholine receptor antibody (AChR-Ab) seronegative based on the expanded FDA approval. Previously use was only approved for adults who were AChR antibody positive and use is now allowed in all adults with gMG irrespective of AChR antibody status. The footnote in the dosing table was amended to state, ‘Administer subsequent treatment cycles based on clinical evaluation, but no sooner than 7 days from the last administration of the previous treatment cycle,’ based on updated information provided in the Clinical Trials Experience section of the PI. The Max Units within the Dosing Limits section was also updated to reflect this change. 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. To the Renewal Criteria section, clarified that non-use in combination with Rystiggo, Soliris, Bkemv, Epysqli, Ultomiris, Zilbrysq, or Imaavy only applies to gMG. Additional editorial changes made throughout.

Xolair

Ad hoc review to align with the updates made to the Prime Therapeutics Xolair PA policy: to the moderate to severe persistent asthma criteria, updated wording of exacerbation requirements to better define each type of exacerbation and to clarify the number of exacerbations required; to the CSU criteria, Removed "otherwise known as chronic idiopathic urticaria" and "CIU" acronym throughout; added agents to the Contraindicated as Concomitant Therapy table; updated references. Other minor editorial changes throughout the criteria to align with Prime Xolair PA policy verbiage updates.

Zevaskyn

Administrative change to Length of Authorization section to include number of days allowed for authorization durations. Updated trademark in policy title to align with package insert. To RDEB, added option of biallelic pathogenic (or likely pathogenic) variants in the collagen type VII alpha 1 chain (COL7A1) gene for confirming diagnosis. To Billing Code/Availability section, added HCPCS code J3389 and removed HCPCS code J3590 per IPD. Added Appendix A - Non-Quantitative Treatment Limitations (NQTL) Factor Checklist. Editorial changes made throughout.

Zynyz

No clinical changes. Editorial changes made throughout.

Botox

Administrative changes to Length of Authorization section to include number of days allowed for authorization durations. Global change was made to remove specific contraindications in criteria and replace with general language indicating member does not have any FDA labeled contraindications. To Prophylaxis for Chronic Migraines, clarified headache features that are consistent with migraines. To Temporomandibular disorders, removed requirement of unilateral painful symptoms as per updated literature Botox can be used bilaterally. Corresponding updates were made to Dosage/Administration table and Max Units. To Dosage/Administration table, updated dosing for Chronic Anal Fissures from ‘up to 25 units’ to ‘up to 100 units’ per review of updated literature. To Appendix 1 – Covered Diagnosis Codes, added G24.8 (related to Dystonias). To Appendix 2, replaced retired LCAs of A57474, A56472, A52848, and A56646 with updated LCAs A59809, A59726, A59707, and A59714, respectively. Editorial changes throughout.

Daxxify

Administrative changes to Length of Authorization section to include number of days allowed for authorization durations. Global change was made to remove specific contraindications in criteria and replace with general language indicating member does not have any FDA labeled contraindications. To Appendix 2, replaced retired LCA of A52848 with updated LCA A59707 and added LCAs A59726, A59714, and A59809. Editorial changes throughout.

Dysport

Administrative changes to Length of Authorization section to include number of days allowed for authorization durations. Global change was made to remove specific contraindications in criteria and replace with general language indicating member does not have any FDA labeled contraindications. To Prophylaxis for Chronic Migraines, clarified headache features that are consistent with migraines. To Appendix 2, replaced retired LCAs of A57474, A56472, A52848, and A56646 with updated LCAs A59809, A59726, A59707, and A59714, respectively. Editorial changes throughout.

Firmagon

Administrative change to Length of Authorization section to allow approval duration of 6 months initially with 6 month renewal to algin with other oncology policies. Also updated to include the number of days approved. Editorial change to update patient to member & coverage to prior authorization validity. Added Appendix A - Non-Quantitative Treatment Limitations (NQTL) Factor Checklist.

Leuprolide Depot

Editorial change to Length of Authorization Section to include number of days allowed. To Breast and Ovarian Cancer, added J1954 based on NCCN update now including code and corresponding product Lutrate Depot, To Uterine Sarcoma removed J9217 since NCCN no longer lists any products associated with J code and updated criteria to include stage II-IV and ER/PR+ disease as additional therapy following total hysterectomy based on NCCN update. To Head and Neck Cancer, added J1950 and J9003 and removed J1954 based on codes/brand products listed on NCCN codes. To Gender Dysphoria added all J codes to heading as criteria applies to all products based on requirement of GnRH policies to be compliant with state statues. Corresponding updates were made to the Dosing Table based on the previously noted criteria/dosing changes: moved Uterine Sarcoma to fall under 3.75mg monthly/11.25mg every 3 months dosing only, for Head & Neck Cancer, added Lupron Depot (J1950) and Camcevi ETM (J9003) dosing while removing Lutrate Depot & Leuprolide Acetate Depot (J9154) dosing, and to Gender Dysphoria which currently had dosing for Lupron Depot and Fensolvi, added dosing for all other products now that the indication applies to all products in policy as well as removed requirement to use in combination with transdermal estradiol for Lupron Depot only. Corresponding updates were made to the Max Units Section as well based on the previously noted: to J1950, added Head and Neck Cancer, Uterine Sarcoma was moved from 6 to 3 billable units every 84 days, Gender Dysphoria was moved from 3 billable units every 84 days to 24 units every 168 days, to J1952, added Gender Dysphoria, to J1954, added Breast/Ovarian Cancer and Gender Dysphoria and removed Head & Neck Cancer, to J9217, removed Uterine Sarcoma and added Gender Dysphoria with 12 billable units every 336 days, and to J9003, added Head & Neck Cancer and Gender Dysphoria. To Renewal Section, updated all absence of toxicity statements to align with current PIs for products which included adding severe cutaneous adverse reactions based on PI updates. To Billing Code Section, added 505b2 designation to Fensolvi, Camcevi and Camcevi ETM based on initial FDA approval letters and added new Camcevi ETM NDC 69448-0024-xx, removed its discontinued unclassified code J3490. Corresponding updates were made to Appendix 1 (ICD-10 codes) based on criteria updates previously noted: to J1950 added C06.9, C07, C08.0-1, C08.9, D37.031-2, D37.039 (related to Salivary Gland Tumors), C50.A0-2 (related to Inflammatory Breast Cancer), to J9217, added C50.A0-2 (related to Inflammatory Breast Cancer), removed C54.0-3, C54.8-9, C55, Z85.42 (related to Uterine Sarcoma), added D37.031-2, D37.039 (related to Salivary Gland Tumors), added F64.0-2, F64.8-9, F64.A (related to Gender Dysphoria), separated out J1954 into its own table from J1952. To J1952, added D37.031-2, D37.039 (related to Salivary Gland Tumors) and added F64.0-2, F64.8-9, F64.A (related to Gender Dysphoria). To J1954, added all codes related to Breast Cancer including new codes related to Inflammatory Breast Cancer, Ovarian Cancer, Prostate Cancer, and Gender Dysphoria, to J9003, added C06.9, C07, C08.0-1, C08.9, D37.031-2, D37.039 (related to Salivary Gland Tumors), added F64.0-2, F64.8-9, F64.A (related to Gender Dysphoria), and to all J codes, updated F64.9 to note discontinued 10/1/26 and F64.A effective 10/1/26 with corresponding code description based on ICD10 code update (related to Gender Dysphoria). Other editorial changes throughout policy.

Myobloc

Administrative changes to Length of Authorization section to include number of days allowed for authorization durations. Global change was made to remove specific contraindications in criteria and replace with general language indicating member does not have any FDA labeled contraindications. To Prophylaxis for Chronic Migraines, clarified headache features that are consistent with migraines. To Appendix 2, replaced retired LCAs of A57474, A56472, A52848, and A56646 with updated LCAs A59809, A59726, A59707, and A59714, respectively. Editorial changes throughout.

Short-Acting G-CSF

Ad hoc review to add the new approved biosimilar product, Filkri, in anticipation of its launch into the marketplace. It will be kept at full parity with the reference product, Neupogen. The Max Units in the Dosing Limits section was also updated to reflect the addition of this new product. 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. Additional editorial changes made throughout.

Supprelin LA

Editorial change to Length of Authorization section to include number of days allowed. Removed Universal Criteria and hypersensitivity preclusion (contraindication) to remain consistent across all policies in class. To Renewal Criteria, added severe cutaneous adverse reactions to unacceptable toxicities per PI update. Other editorial changes throughout. Added Appendix A – Non-Quantitative Treatment Limitations (NQTL) Factor Checklist. To Appendix 1, updated ICD-10 code F64.9 to note discontinuation on 10/1/26 and added F64.A effective 10/1/26 along with its corresponding code description.

Trelstar

Updated policy title to include ‘pamoate’ to differentiate from other salt forms of drug. Editorial change to Length of Authorization section to include number of days allowed. Editorial changes to MU section to include ‘billable’ units and ‘mg’. Added compendia symbol to Prostate Cancer indication. To Uterine Sarcoma, added stage II-IV and ER/PR+ disease requirements per NCCN update, as well as updated criteria to include use as additional therapy following total hysterectomy. To Renewal Criteria, added convulsions and severe cutaneous adverse reactions to unacceptable toxicities to align with PI. Also to CPP in renewal, added age criteria of <13 years to align with initial criteria and other GnRH policies with CPP indication. Updated Dosing Table and MU to group Breast cancer with Head and Neck Cancer, and added additional dosing options for Gender Dysphoria of 11.25mg every 12 weeks and 22.5 mg every 24 weeks per WPATH SOC 8 guidelines. Other editorial changes throughout. Added Appendix A – Non-Quantitative Treatment Limitations (NQTL) Factor Checklist. To Appendix 1 (ICD-10 codes), added C50.A0-A2 (related to inflammatory breast cancer) and D37.031-032, D37.039 (related to salivary gland tumors), and updated ICD-10 code F64.9 to note discontinuation on 10/1/26 and added F64.A effective 10/1/26 along with its corresponding code description.

Triptodur

Editorial change to Length of Authorization section to include number of days allowed. Removed Universal Criteria and hypersensitivity preclusion (contraindication) to remain consistent across all policies in class. To Renewal Criteria, added severe cutaneous adverse reactions to unacceptable toxicities per PI update. Other editorial changes throughout. Added Appendix A – Non-Quantitative Treatment Limitations (NQTL) Factor Checklist. To Appendix 1, updated ICD-10 code F64.9 to note discontinuation on 10/1/26 and added F64.A effective 10/1/26 along with its corresponding code description.

Xeomin

Administrative changes to Length of Authorization section to include number of days allowed for authorization durations. Global change was made to remove specific contraindications in criteria and replace with general language indicating member does not have any FDA labeled contraindications. To Prophylaxis for Chronic Migraines, clarified headache features that are consistent with migraines. To Appendix 2, replaced retired LCAs of A57474, A56472, A52848, and A56646 with updated LCAs A59809, A59726, A59707, and A59714, respectively. Editorial changes throughout.

Zoladex

Editorial change to Length of Authorization section to include number of days allowed. Removed Universal Criteria and pregnancy preclusion (contraindication) to remain consistent across all policies in class. Added Gender Dysphoria initial and renewal criteria and updated Max Units, Dosing Table, ICD-10 codes accordingly. Due to addition of this indication, updated Universal Criteria age 18 criteria to include ‘unless otherwise specified’. To Uterine Sarcoma, added stage II-IV and ER/PR+ disease requirements per NCCN update, as well as updated criteria to include use as additional therapy following total hysterectomy. To Renewal Criteria, added severe cutaneous adverse reactions to unacceptable toxicities per PI update. Other editorial changes throughout. Added Appendix A – Non-Quantitative Treatment Limitations (NQTL) Factor Checklist. To Appendix 1 (ICD-10 codes), added C50.A0-A2 (related to inflammatory breast cancer), D37.031-032, D37.039 (related to salivary gland tumors), and F64.0-2, F64.8-9, F64.A (noted F64.9 discontinued on 10/1/26 and F64.A effective 10/1/26) along with its corresponding code description (related to Gender Dysphoria).

Zoledronic Acid

Administrative changes to Length of Authorization section to include number of days allowed for authorization durations. To Initial Approval Criteria age requirement, expanded use of Zometa/zoledronic acid (branded) in Langerhans Cell Histiocytosis to pediatric population per NCCN. A corresponding update was made to the Dosage/Administration table for the LCH pediatric population. To Multiple Myeloma for Zometa/zoledronic acid (branded), added footnote to indicate may also be used in combination with primary myeloma therapy for POEMS, MIDD, MGRS based on NCCN. To Reclast Universal Criteria, global change to remove specific contraindications in criteria and replace with general language indicating member does not have any FDA contraindications. Added Appendix A - Non-Quantitative Treatment Limitations (NQTL) Factor Checklist. To Appendix 1 – Covered Diagnosis Codes for Zometa/Zoledronic acid (branded), added C50.A0-C50.A2 (related to Breast Cancer) per NCCN. Editorial changes made throughout.