Pharmacy Policy Updates

Bevacizumab Oncology

To Adult CNS Cancer, added criteria for use as single agent for progressive or symptomatic Neurofibromatosis type 2 related Schwannomatosis. To Colorectal Cancer, updated parenthetical information regarding use in combination with trifluridine and tipiracil can occur following oxaliplatin-based and irinotecan-based therapy or beyond second-line treatment, based on NCCN guideline update. To NSCLC, added ERBB2 (HER2) mutation positive tumors to the list of actionable biomarkers in the subsequent line of therapy setting based on NCCN updates. To Ovarian Cancer, added criteria for use for progressive or recurrent small cell carcinoma of the ovary, hypercalcemic type in combo with paclitaxel, and updated criteria for epithelial, ovarian, fallopian tube, or primary peritoneal type for use in combination with paclitaxel and pembrolizumab for PD-L1 positive disease to now align with NCCN recommendations which expand to use to persistent or recurrent setting, without restriction to previous lines of therapy. To Billing/Availability section, added additional NDC listings for Alymsys products per PI review. Made other minor editorial changes through the policy for clarity.

Bizengri

Administrative change to Length of Authorization section to delineate between authorization durations for initial and renewal periods as well as include number of days allowed. To NSCLC, added use for unresectable disease to more closely align with PI allowance. Added new indication to all applicable sections of the policy for Biliary Tract Cancers (Intra/Extra-hepatic Cholangiocarcinoma) based on both the newly added NCCN recommendations and the new FDA approval for use in adults with advanced unresectable or metastatic cholangiocarcinoma harboring a NRG1 gene fusion with disease progression on or after prior systemic therapy. To Billing Code, removed obsolete HCPCS code. Added Appendix A – Non-Quantitative Treatment Limitations (NQTL) Factor Checklist. To Covered Diagnosis Codes, added C22.1, C24.0, C 24.8, and C24.9 (all related to Biliary Tract Cancers). Editorial changes were made throughout.

Crysvita

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 criteria requiring Crysvita to be prescribed by, or in consultation with, a nephrologist or endocrinologist as this is a global change being made across all policies. Added Universal Criteria for members at high risk for hypercalcemia to have serum calcium and parathyroid hormone levels assessed prior to starting and during therapy based on the updated PI. To the Renewal Criteria, added moderate to severe hypercalcemia as an example of unacceptable toxicity per the Warnings and Precautions section in the updated PI. To the dosing table, added an optional dose increase regimen for adult patients with XLH who have an inadequate response to the currently approved 1.0 mg/kg every four weeks dosing regimen based on the newly FDA approved dosing. Also added dosing criteria for adult and pediatric patients with XLH that have serum phosphorus is within the normal range per the PI. To the dosing tablet for TIO, added criteria to assess fasting serum phosphorus level 2 weeks after dose adjustment and to refer to prescribing information for stepwise dose increase and decrease schedule. Administrative changes to the Initial and Renewal Criteria sections to update ‘coverage’ to ‘prior authorization validity’. 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. Additional editorial changes made throughout.

Enhertu

To Breast Cancer, updated recs for HER2+ disease to include recurrent disease as well as inflammatory breast cancer with no response to preoperative therapy as per NCCN. Also added two new FDA approved indications in adults with HER2-positive early-stage breast cancer. The first indication is for the neoadjuvant treatment of Stage II or III breast cancer, followed by taxane, trastuzumab, and pertuzumab (THP). The second indication is for the treatment of adults who have residual invasive disease after neoadjuvant HER2-targeted treatment. Dosing Table and LOA sections were updated accordingly. To CNS Cancer, simplified criteria to align with NCCN guidelines and to prevent inappropriate pends. Also added HER-low disease and leptomeningeal metastases from breast cancer as per NCCN updates. To CRC, updated with current NCCN recs which allow use for progression of advanced or metastatic disease without designation of line of therapy. Updated Appendiceal Adenocarcinoma to Appendiceal Neoplasms and Cancers throughout policy and updated with current NCCN which includes removing footnote related to dMMR/MSI-H or POLE/POLD1 disease as it no longer applies to the rec. To Ampullary Adenocarcinoma, added option for use in intermediate ECOG PS 2 as per NCCN. To Cervical Cancer, removed unresectable disease to align with NCCN. Updated recs for Occult Primary to align with latest NCCN 2A recs. To Pancreatic Adenocarcinoma, simplified recs to align with current NCCN recs to allow use as subsequent therapy for locally advanced/metastatic/recurrent disease and removed rec for alternative systemic therapy as this can now be reviewed under subsequent therapy heading. To Endometrial Carcinoma, removed unresectable and metastatic from subsequent therapy criteria leaving recurrent only to align with current NCCN rec. Also updated criteria to exclude use in certain clinical settings (for locoregional recurrence and surgical exploration for locoregional recurrence) categorized as 2B recommendations in NCCN guidelines. To Vulvar Cancer, removed unresectable disease to align with NCCN. To the HER2-positive overexpression criteria table, updated language to align with NCCN updated verbiage and separated out Endometrial Carcinoma under the Solid Tumors section. Additionally, to HER2-negative expression criteria table, updated language to align with NCCN updated verbiage and added CNS to the HER2-low expression criteria table. To Appendix 1 (Covered Diagnosis Codes), added C50.A0-A2 (related to Breast Cancer), C79.32 (related to CNS Cancer), D37.031, D37.032, D37.039 (related to Head and Neck Cancer) and D37.3 (related to Appendiceal Neoplasms and Cancers).

Folotyn

Administrative change to Length of Authorization section to delineate between authorization durations for initial and renewal periods as well as include number of days allowed. To PTCL, added additional use scenario for subsequent therapy for progressive disease to align with NCCN updates. To billing section, added asterisks with footnote to indicate that both vial sizes are available as an ANDA generic. Added Appendix A – Non-Quantitative Treatment Limitations (NQTL) Factor Checklist. Editorial changes made throughout.

Kadcyla

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. To Universal Criteria, added unless otherwise specified to single agent therapy criteria based on new NCCN CNS rec allowing combination use. To Breast cancer added clarification for local or regional unresectable disease per NCCN. To CNS cancers added use in combination with neratinib per NCCN and streamlined criteria to prevent inappropriate pends. To the HER2-positive overexpression criteria table, updated language to align with NCCN updated verbiage by including ERBB2 (also added to CNS criteria based on NCCN). Added Appendix A - Non-Quantitative Treatment Limitations (NQTL) Factor Checklist. To ICD10 Table, added C50.A0, A1, and A2 (related to inflammatory breast cancer) and D37.031, D37.032, D37.039 (related to Head and Neck Cancer - Salivary Gland Tumors). Editorial changes throughout.

Margenza

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. Also added ICD-10 codes C50.A0-C50.A2 (related to Breast Cancer) per NCCN. Editorial changes made throughout.

Ocrevus IV

Ad hoc review to add the expanded indication for the treatment of relapsing-remitting multiple sclerosis in pediatric patients 10 years of age and older who weigh 25 kilograms or more. The criteria was reformatted and the dosing table was updated to accommodate the addition of this new indication. Added specific examples in parentheses after the general criteria for no FDA labeled contraindications for clarity in accordance with global change being made across all policies.

Paclitaxel Albumin-Bound

To all oncology indications (where it was not previously noted already), added criteria for use as substitution for paclitaxel or docetaxel if the member has experienced hypersensitivity reactions despite premedication or member has contraindications to standard hypersensitivity premedication per KOL review. To NSCLC, for use as subsequent therapy updated biomarker to ERBB2 (HER2) based on NCCN update. To Ovarian, Fallopian Tube, and Primary Peritoneal Cancer, added new rec for platinum-resistant persistent disease or recurrence in combination with relacorilant to all types of disease and updated Dosing Table accordingly. To Pancreatic Cancer, made extensive revisions to criteria to align with NCCN which include adding new regimen for use as a component of PAXG, use as alternate neoadjuvant therapy following progression, and simplifying criteria for use as subsequent therapy. For the new rec as a component of PAXG, updated Dosing Table and LOA accordingly. To Cutaneous Melanoma, added symptomatic disease and eligibility criteria to align with updated NCCN verbiage. To BTC, added additional incidental findings to criteria based on NCCN update. To Appendix 1 – Covered Diagnosis Codes, added C43.10 (related to Cutaneous Melanoma).

Pemetrexed

To CNS Cancers, added note regarding interchangeability of products for intrathecal administration per updates to NCCN. To Thyroid Cancer, added option for use in locoregional invasive disease and unresectable gross residual disease after thyroidectomy for follicular, papillary and oncocytic carcinoma. Editorial changes made throughout.

Perjeta

To Breast Cancer, added use as first-line maintenance therapy in combination with aromatase inhibitor and trastuzumab with or without palbociclib in members with hormone receptor-positive disease per NCCN update and additional editorial changes to section criteria to simplify readability. To Central Nervous System (CNS) Cancers, reformatted criteria to align with NCCN and simplified criteria for use for brain metastases from breast cancer. To Colorectal Cancer (CRC), allowed use as subsequent therapy in any disease setting per NCCN update. To Appendiceal Cancer, heading updated to reflect new NCCN naming convention for indication. The new naming convention was updated throughout the policy. Added indication of Small Bowel Adenocarcinoma per NCCN. Corresponding addition to HER2-positive overexpression criteria chart was made. To Dosage/Administration table, reformatted breast cancer to call out initial and maintenance dosing for easier readability. Added the following ICD-10 codes per NCCN: C17.0-C17.3, C17.8, and C17.9. Z85.068 (related to Small Bowel Adenocarcinoma), C50.A0-C50.A2 (related to Breast Cancer), D37.031, D37.032, D37.039 (related to Head and Neck Cancers), D37.3 (related to Appendiceal Neoplasms and Cancers). Editorial changes made throughout.

Phesgo

Administrative changes to Length of Authorization section to delineate between authorization durations for initial and renewal periods and to include the number of days for approval and 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. To Breast Cancer, updated neoadjuvant/preoperative therapy and adjuvant therapy uses to be more inclusive of the pertuzumab/trastuzumab combination therapy settings within NCCN. Also added use as first-line maintenance therapy in combination with aromatase inhibitor with or without palbociclib in members with hormone receptor-positive disease following chemotherapy combo therapy to align with latest NCCN updates. To Dosage/Administration table, reformatted verbiage within the breast cancer maintenance dosing section for clarity. Added the following ICD-10 codes per NCCN: C50.A0-C50.A2 (related to Breast Cancer). Other editorial changes were made throughout.

Portrazza

The policy is being retired as the drug has been phased out due to shifting treatment standards and is no longer addressed in NCCN.

Ranibizumab

Ad hoc review to add the FDA approved biosimilar product, Nufymco, along with its corresponding HCPCS code Q5168 that will be effective 7.1.2026. Global change was made to remove specific contraindications in criteria and replace with general language indicating member does not have any FDA labeled contraindications. Editorial changes were made to the Length of Authorization section to include the number of days for approval as part of the global changes being made across all policies. Additional editorial changes made throughout.

Spevigo IV

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 to the policy and made other minor editorial changes throughout the criteria, per global updates. Made the following revisions to align with the updates made to the Prime Therapeutics Spevigo PAQL policy: Added weight required of greater than or equal to 40 kg for use in GPP, updated criterion regarding providing support for concomitant therapy with immunomodulators, removed quantity/dose requirements from initial/renewal criteria as this information was duplicative with the dosage/administration section, and updated reference section. Made the following changes to align criteria with MPS standard language formatting: Created criteria blocks within the Initial criteria to separate Universal and Indication specific relevant criteria in order to streamline the criteria review; edited concomitant immunomodulatory therapy criteria for conciseness while maintaining the same intent. Also made revisions to the indication specific criteria for GPP flare to more closely align with the FDA labeling and latest NPF/AAD recommendations. Other minor editorial changes were made throughout.

Trabectedin

Ad hoc review to add the newly approved product, Evdi, that was approved via the 505(b)(2) pathway and will be kept at parity with the reference product, Yondelis. Updates were also made to the Dosing Limits section to reflect the addition of this new product. The policy was subsequently re-named Trabectedin to encompass both Yondelis and Evdi. 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. 

Trastuzumab IV

Per updates to NCCN: To Breast Cancer to recurrent unresectable metastatic/inflammatory disease separated out use in combination with pertuzumab, aromatase inhibition and with or without palbociclib as first line maintenance therapy and added use for inflammatory disease for members with no response to preoperative systemic therapy. To CNS Cancers added note regarding interchangeability of products for intrathecal or intraventricular administration. To CRC removed combination use with lapatinib and removed requirement of “if intensive therapy is not recommended”. Also, to CRC allowed for use as subsequent therapy in any disease setting. To Billing Code section, added NDC for Ontruzant based on DrugIQ. Editorial changes throughout.

Trastuzumab 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 for authorization durations. To the HER2-positive overexpression criteria table, updated language to align with NCCN updated verbiage by including ERBB2. Added Appendix A - Non-Quantitative Treatment Limitations (NQTL) Factor Checklist. To ICD10 Table, added C50.A0, A1, and A2 (related to Inflammatory Breast Cancer). Editorial changes made throughout.

Ziihera

Administrative changes to Length of Authorization section to delineate between authorization durations for initial and renewal periods and to include the number of days allowed. To Universal Criteria, removed preclusion for use in members with untreated or symptomatic CNS metastases as NCCN does not restrict use in this population. To Billing Code/Availability, removed expired HCPCS code J9999 and C9302. Added Appendix A - Non-Quantitative Treatment Limitations (NQTL) Factor Checklist. Editorial changes made throughout.

Dextenza

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. Under universal criteria, global change to remove any 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. Added ICD 10 codes H25.11 and H25.12 related to age-related nuclear cataract. Editorial changes made throughout.

Iluvien

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. Under universal criteria, global change to remove any 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. Editorial changes made throughout.

Ozurdex

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. Under universal criteria, global change to remove any specific contraindications in criteria and replace with general language indicating member does not have any FDA contraindications. 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.

Retisert

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. Under universal criteria, global change to remove any specific contraindications in criteria and replace with general language indicating member does not have any FDA contraindications. Appendix A - Non-Quantitative Treatment Limitations (NQTL) Factor Checklist. Editorial changes made throughout.

Yutiq

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. Under universal criteria, global change to remove any 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. Editorial changes made throughout.