Blue Cross Blue Shield of North Dakota (BCBSND) continually develops and revises pharmacy policies in response to rapidly changing pharmaceutical requirements. Our commitment is to update the provider community as pharmacy policies are adopted and/or revised.
Commercial Updates
The following Commercial prior authorization medical drug policies have revisions effective July 14, 2026:
*see www.gatewaypa.com/policydisplay/52
| To Universal Criteria, removed preclusion for use in combination with bleomycin and replaced it with statement indicating the member must not have any FDA contraindications to the drug. To Adult CHL, for primary treatment in combination with nivolumab or dacarbazine, updated criteria to allow use with or without involved-site radiation per NCCN. Editorial changes are made throughout. |
Adstiladrin | Ad hoc review to update the policy to include use in patients with NMIBC that have high-grade papillary Ta/T1 tumors without CIS per NCCN 2A recommendation. Updated the Length of Authorization section to now allow a 6-month initial authorization. To simplify the Renewal Criteria, the 3-month timeframe to confirm CR for the initial renewal and the footnote stating that providers should consider cystectomy in patients with CIS do not have a complete response to treatment after 3 months or if CIS recurs was removed. Updated the footnote box in the dosing table to include information pertaining to thawing Adstiladrin in a water bater per the updated PI. Additional editorial changes are made throughout. |
Aflibercept | Ad hoc review to include up to every 20 weeks dosing for the treatment of neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular edema (DME) in patients who have one year of successful response based on visual and anatomic outcomes. Coding updates made to CMS reference A52451 (jurisdiction 6, K). Administrative change to update HCPCS for Eydenzelt. Q5170 will be effective on 07/01/2026. J3590 will be discontinued on 07/01/2026. |
Amondys45 | Administrative changes to the Length of Authorization section to delineate between authorization durations for initial and renewal periods and to include the number of days for approval. Added Appendix A – Non-Quantitative Treatment Limitations (NQTL) Factor Checklist. Made other minor editorial changes throughout. |
Briumvi | 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 tables containing specific diagnostic criteria for RRMS, SPMS, and CIS in order to streamline and simplify the policy. Additional editorial changes are made throughout. |
Cosentyx | Ad hoc review to now allow use for the treatment of ankylosing spondylitis in patients 12 years of age and older. This indication was previously only approved for use in adult patients. Updates were also made to the renewal criteria section and dosing table to reflect the addition of this new indication. |
Darzalex IV | To MM, added footnote to Multiple Myeloma heading that regimens may also be used for POEMS, MIDD, MGRS based on NCCN. Editorial changes are made throughout. |
Darzalex SQ | To Multiple Myeloma, added footnote to Multiple Myeloma heading that regimens may also be used for POEMS, MIDD, MGRS based on NCCN. Also, to Multiple Myeloma, added use in combination with teclistamab as an option for patients who have had prior therapy with lenalidomide and a proteasome inhibitor, based on update to NCCN guidelines. To Systemic Light Chain Amyloidosis, reworded overarching criteria for Mayo stage IIIb cardiac disease and added use in combination with venetoclax for relapsed or refractory disease based on NCCN update. A corresponding update was made to Dosage/Administration table. Editorial changes are made throughout. |
Denosumab | Ad hoc review to add the Prolia biosimilars, Boncresa and Osvyrti, and Xgeva biosimilars, Oziltus and Jubereq, in anticipation of their launch into the marketplace and to add their new classified HCPCS codes effective 07.01.2026. Q5171 for Boncresa, Q5165 for Oziltus, Q5166 for Osvyrti and Jubereq, and Q5167 for Enoby and Xtrenbo will all be effective 07.01.2026. J3590 will be discontinued for Boncresa, Oziltus, Osvyrti, Jubereq, Enoby, and Xtrenbo on 07.01.2026. Removed HCPCS J3590 for Aukelso, Bosaya, Bildyos, and Bilprevda as it was discontinued on 04.01.2026. 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. Coding updates made to CMS reference A52399 (jurisdiction 6, K). Additional editorial changes are made throughout. |
Elrexfio | Administrative changes to the Length of Authorization section to include number of days allowed for authorization durations. To Multiple Myeloma per NCCN update added asterisk and statement noting allowable for use in the treatment of Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal protein, Skin changes (POEMS), Monoclonal Immunoglobulin Deposition Disease (MIDD), and plasma cell-related Monoclonal Gammopathy of Renal Significance (MGRS). Added Appendix A - Non-Quantitative Treatment Limitations (NQTL) Factor Checklist. Editorial changes throughout. |
Elzonris | 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. Added Appendix A – Non-Quantitative Treatment Limitations (NQTL) Factor Checklist. Editorial changes are made throughout. |
Enjaymo | Administrative change to Length of Authorization section to delineate between authorization durations for initial and renewal periods and to include number of days allowed. Under Universal Criteria, softened vaccine language per global changes. To Billing/Coding updated NDC per new manufacturer PI. Added Appendix A - Non-Quantitative Treatment Limitations (NQTL) Factor Checklist. Editorial changes are made throughout. |
Epkinly | Ad hoc review to update the dosing table to remove the recommendation for 24-hour hospitalization following administration of the first full 48 mg dose on Cycle 1 Day 15 in patients with relapsed/refractory diffuse large-B cell lymphoma or high-grade B-cell lymphoma based on the updated PI. Added a footnote to the dosing table stating to assess whether hospitalization or outpatient monitoring is appropriate based on comorbidities or other situational factors for the first 48 mg dosage of Epkinly per the 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 are made throughout. |
Erbitux | To CRC, extensively revised criteria to align with changes in NCCN Colon and Rectal guidelines. Added new indication of Small Bowel Adenocarcinoma with relevant criteria and dosing per NCCN. To NSCLC, updated “exon 21 L858R positive” verbiage to now say “L858R mutation” to align with NCCN verbiage. To Appendix 1 - Covered Diagnosis Codes, removed ICD-10 codes C00.0, C00.1 & C00.2 related to Head & Neck Cancers, and added C17.0, C17.1, C17.2, C17.3, C17.8, C17.9, and Z85.068 related to Small Bowel Adenocarcinoma per NCCN. Editorial changes are made throughout. |
Exondys51 | Administrative changes to the Length of Authorization section to delineate between authorization durations for initial and renewal periods and to include the number of days for approval. Added Appendix A – Non-Quantitative Treatment Limitations (NQTL) Factor Checklist. Made other minor editorial changes throughout. |
Feraheme | Administrative change to Length of Authorization section to delineate between authorization durations for initial and renewal periods. Global change to remove any specific contraindications in criteria and replace them with general language indicating member does not have any FDA contraindications. To Iron Deficiency Anemia due to Chronic Kidney Disease, re-aligned ferritin, TSAT, and hemoglobin criteria based on new KDIGO guidelines for 2026. To Iron Deficiency Anemia in members intolerant to or who have had an unsatisfactory response to oral iron, allowed use for conditions where iron is unlikely to be absorbed due to AGA 2024 guidelines. Added Appendix A – Non-Quantitative Treatment Limitations (NQTL) Factor Checklist. Editorial changes are made throughout. |
Long-Acting G-CSF | Ad hoc review to add the Neulasta 4 mg/0.4 mL single-dose vial formulation that is now available in the marketplace. Added the Neulasta biosimilar, Armlupeg, in anticipation of its launch into the marketplace and added its new classified HCPCS code Q5169 that will effective 7.1.26 and J3590 will be discontinued on 7.1.26. 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. |
Injectafer | Administrative change to Length of Authorization section to delineate between authorization durations for initial and renewal periods. Global change to remove any specific contraindications in criteria and replace with general language indicating member does not have any FDA contraindications. To Iron Deficiency Anemia in Non-Dialysis-Dependent Chronic Kidney Disease, re-aligned ferritin, TSAT, and hemoglobin criteria based on new KDIGO guidelines for 2026. To Iron Deficiency Anemia in members intolerant to or who have had an unsatisfactory response to oral iron, allowed use for conditions where iron is unlikely to be absorbed due to AGA 2024 guidelines. Also, updated hemoglobin value to align with current WHO guidelines. Added Appendix A – Non-Quantitative Treatment Limitations (NQTL) Factor Checklist. Editorial changes are made throughout. |
Izervay | Updated trademark in policy title to align with package insert. 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. Global change to remove any specific contraindications in criteria and replaced with general language indicating member does not have any FDA contraindications. Editorial changes throughout. Added Appendix A – Non-Quantitative Treatment Limitations (NQTL) Factor Checklist. |
Keytruda IV | Per updates to NCCN, to initial criteria for Anal Carcinoma added combination with paclitaxel and carboplatin, then continued as a single agent for inguinal node recurrence or first line therapy of metastatic disease; corresponding updates made to dosing and LoA sections to reflect this addition. To Biliary Tract Cancers, added option to use carboplatin if ineligible for cisplatin, added additional options for incidental finding on pathologic review, and added allowance as neoadjuvant therapy for members that have jaundice. To Urothelial Carcinoma, removed exclusion for recurrence of stage T3-4 disease or palpable inguinal lymph nodes, added first-line use in recurrent primary carcinoma of the urethra, and added use as adjuvant therapy for members who did not have platinum based neoadjuvant therapy and have pT3, pT4, or pN+ disease. To Triple Negative Breast Cancer added use in combination with sacituzumab govitecan as first line therapy for recurrent unresectable or metastatic disease OR inflammatory disease. To Adult CNS Cancers, streamlined criteria to prevent inappropriate pends. To Cervical Cancer, added option to continue pembrolizumab as maintenance therapy after combination with CRT for FIGO 2014 Stage III-IVA disease. To Head and Neck Cancers, for Very Advanced disease removed duplicative treatment settings that fall under unresectable disease. To Kaposi Sarcoma, removed exclusion for patients with multicentric Castleman disease (MCD) or KSHV–associated inflammatory cytokine syndrome (KICS) as this is up to provider discretion. To Cutaneous Melanoma, for use in combination with lenvatinib removed requirement for disease progression following treatment with anti PD1/PDL1-based therapy, updated adjuvant treatment clinical settings, and updated footnote for metastatic disease. To NSCLC as subsequent therapy for recurrent, advanced or metastatic disease, removed requirement for PD-L1 expressing tumors and added use for ERBB2 (HER2) positive disease. To Ovarian Cancer, removed exclusion for treatment of biochemical relapse and added use for small cell carcinoma of the ovary, hypercalcemic type as a single agent for progressive or recurrent disease; corresponding update was made to dosing table to reflect this addition. To Soft Tissue Sarcoma, added new recommendation for use in combination with radiation therapy as neoadjuvant, followed by single agent adjuvant therapy with all corresponding criteria,; the dosing section and LoA section were updated accordingly to reflect this addition. To MSI-H/dMMR Cancers, added use as neoadjuvant therapy for Small Bowel Adenocarcinoma and removed exclusion for Biliary tract cancers. To TMB-H cancer, added use as initial therapy for Small Bowel Adenocarcinoma when member has pMMR/MSS disease with previous FOLFOX/CAPEOX. To ICD10 Table, added C43.10 related to Cutaneous Melanoma, C50.A0, A1, and A2 related to inflammatory breast cancer, and D48.60-D48.62 related to STS - Borderline/Malignant Phyllodes Tumor of the Breast. Editorial changes throughout. |
Keytruda SQ | To initial criteria for Esophageal cancer aligned verbiage with PI. To Dosing table for SCCHN aligned verbiage to PI dosing. To Billing/Coding section, removed discontinued J9999 which was discontinued on 04.01.2026. To ICD10 Table, added C43.10 related to Cutaneous Melanoma, C50.A0, A1, and A2 related to inflammatory breast cancer, and D48.60-D48.62 related to STS - Borderline/Malignant Phyllodes Tumor of the Breast. Editorial changes throughout. |
Kyprolis | Administrative changes to the 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 MM, added footnote to Multiple Myeloma heading that regimens may also be used for POEMS, MIDD, MGRS based on NCCN. Added Appendix A - Non-Quantitative Treatment Limitations (NQTL) Factor Checklist. Added ICD-10 codes C90.11, C90.21, and C90.31 (related to Multiple Myeloma). Editorial changes made throughout. |
Lemtrada | 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. Global change to remove specific contraindications in the Universal Criteria (specifically criteria for no HIV and no active infections) and replaced with general language indicating members does not have any FDA labeled contraindications. To the Universal Criteria, added criteria requiring AST, ALT, alkaline phosphatase, and bilirubin levels to be measured at baseline and periodically throughout therapy based on the PI. Moved the criteria for single agent use from under the Multiple Sclerosis heading to under the Universal Criteria heading as it needs to be confirmed upon each renewal. Removed tables containing specific diagnostic criteria for RRMS and SPMS in order to streamline and simplify the policy. To the Renewal Criteria, updated the examples of unacceptable toxicity to more closely align with the Warnings and Precautions section of the PI. Additional editorial changes are made throughout. |
Lynozyfic | Administrative changes to the Length of Authorization section to include number of days allowed for authorization durations. To MM, added footnote to Multiple Myeloma heading that regimens may also be used for POEMS, MIDD, MGRS based on NCCN. Added orphan drug designation for Multiple Myeloma. To Billing Code/Availability section, added HCPCS code J9601 and removed HCPCS codes C9307 and J9999 per IPD. Added Appendix A - Non-Quantitative Treatment Limitations (NQTL) Factor Checklist. Editorial changes are made throughout. |
Monoferric | Administrative change to Length of Authorization section to delineate between authorization durations for initial and renewal periods. Global change to remove any specific contraindications in criteria and replace with general language indicating member does not have any FDA contraindications. To Iron Deficiency Anemia in Non-Dialysis-Dependent Chronic Kidney Disease, re-aligned ferritin, TSAT, and hemoglobin criteria based on new KDIGO guidelines for 2026. To Iron Deficiency Anemia in members intolerant to or who have had an unsatisfactory response to oral iron, allowed use for conditions where iron is unlikely to be absorbed due to AGA 2024 guidelines. Also, updated hemoglobin value to align with current WHO guidelines. Added Appendix A – Non-Quantitative Treatment Limitations (NQTL) Factor Checklist. Editorial changes are made throughout. |
Natalizumab | 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 tables containing specific diagnostic criteria for RRMS, SPMS, and CIS in order to streamline and simplify the policy. Additional editorial changes are made throughout. |
Ocrevus IV | 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. Global change to remove specific contraindications in the general Initial Criteria (specifically criteria for no history of life-threatening administration reactions to ocrelizumab) and replaced with general language in the Universal Criteria section indicating member does not have any FDA labeled contraindications. Removed tables containing specific diagnostic criteria for RRMS, PPMS, SPMS, and CIS in order to streamline and simplify the policy. Additional editorial changes are made throughout. |
Ocrevus SQ | 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. Global change to remove specific contraindications in the general Initial Criteria (specifically criteria for no history of life-threatening administration reactions to ocrelizumab) and replaced with general language in the Universal Criteria section indicating member does not have any FDA labeled contraindications. Removed tables containing specific diagnostic criteria for RRMS, PPMS, SPMS, and CIS in order to streamline and simplify the policy. Additional editorial changes are made throughout. |
Omisirge | Updated LoA section to delineate initial and renewal approval timeframes. Global change to remove any specific contraindications in criteria and replace with general language indicating members does not have any FDA contraindications. Removed footnote “Do NOT open the metal cassettes until time of thaw” from dosing table to align with update to PI. Editorial changes are made throughout. |
Opdivo IV | To Ampullary Adenocarcinoma, added ECOG status to combination with ipilimumab and added criteria for single agent use per NCCN updates. A corresponding update was made to Dosage/Administration section for single agent use and to MU. To Anal Carcinoma, added combination use with paclitaxel and carboplatin, then continuation as a single agent for inguinal node recurrence or first line treatment of metastatic disease. Corresponding updates were made to the LOA and Dosage/Administration sections. To Biliary Tract Cancers, added use in T1b or greater and/or T1a with positive margins as findings on pathologic review for neoadjuvant use and added use as neoadjuvant therapy for gallbladder cancer with jaundice per NCCN updates. To Urothelial Carcinoma (Bladder Cancer), removed exclusion of recurrence of stage T3-4 disease or palpable inguinal lymph nodes for primary carcinoma of the urethra per NCCN update. To Adult CNS Cancers, simplified criteria for use for brain metastases from melanoma and NSCLC. To SCCHN very advanced disease, removed duplicative treatment settings that fall under unresectable disease. To Adult CHL, updated unfavorable disease description for use in combination with AVD per NCCN. To Cutaneous Melanoma use as single agent adjuvant therapy, added use in NED after initial treatment with local or regional therapy for clinical satellite/in-transit metastases AND local satellite/in-transit recurrence and removed the requirement of TLND for resectable disease limited to nodal recurrence following excision of recurrence per NCCN updates. Additionally, updated the footnote for metastatic disease to include oligometastatic disease and brain metastases per NCCN. To NSCLC, added use as subsequent therapy for disease positive for ERBB2 (HER2) per NCCN update. To Small Bowel Adenocarcinoma, added option for combination use with ipilimumab as subsequent therapy for advanced or metastatic disease if checkpoint inhibitor monotherapy was previously received. To Soft Tissue Sarcoma, added use as subsequent therapy for unresectable or metastatic TMB-H Borderline/Malignant Phyllodes Tumor of the Breast per NCCN. Added indication of Ovarian, Fallopian Tube, and Primary Peritoneal Cancer - clear cell carcinoma of the ovary and small cell carcinoma of the ovary (hypercalcemic type) with corresponding updates made to LOA, MU, and Dosing/Administration sections per NCCN 2A recommendation. To Dosage/Administration section, an additional dosing option was added for CRC, Appendiceal Neoplasms and Cancers, and Small Bowel Adenocarcinoma per NCCN. Additionally, an update was made to age and weight for Pediatric cHL to reflect new FDA-approval for this indication. To Appendix 1 - Covered Diagnosis Codes, added C43.10 (related to Cutaneous Melanoma), C56.1-C56.3, C56.9, C57.00-C57.02, C57.10-C57.12, C57.20-C57.22, C57.3, C57.4, C57.7-C57.9, Z85.43 (related to Ovarian Cancer/Fallopian Tube Cancer/Primary Peritoneal Cancer), and D48.60-D48.62 (related to Soft Tissue Sarcoma). Editorial changes are made throughout. |
Opdivo SQ | To Universal Criteria, removed steerage to IV formulation if required 900 mg/15,000 units dose. Corresponding updates were made to MU. To Squamous Cell Carcinoma of the Head and Neck, added setting of recurrent disease to align with the PI. To Dosage/Administration table, added pediatric dosing to cutaneous melanoma and CRC per PI and added corresponding footnote indicating steerage to IV formulation for members weighing < 80 kg still applies. To Billing Code/Availability Information, added new 300 mg/5,000 units SDV formulation. To Appendix 1 - Covered Diagnosis Codes, added C43.10 (related to Cutaneous Melanoma), C56.1-C56.3, C56.9, C57.00-C57.02, C57.10-C57.12, C57.20-C57.22, C57.3, C57.4, C57.7-C57.9, Z85.43 (related to Ovarian Cancer/Fallopian Tube Cancer/Primary Peritoneal Cancer), and D48.60-D48.62 (related to Soft Tissue Sarcoma) to align with the Opdivo IV policy. Editorial changes are made throughout. Added ICD-10 crosswalk for PCM. |
Qutenza | 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. Editorial changes are made throughout. |
Ryplazim | 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. Also to LOA, updated language around complete/less than complete response to correspond to lesions in order to align with Dosing Table and Renewal section verbiage. Editorial changes throughout. Added Appendix A – Non-Quantitative Treatment Limitations (NQTL) Factor Checklist. |
Sarclisa | 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 MM, added footnote to Multiple Myeloma heading that regimens may also be used for POEMS, MIDD, MGRS based on NCCN. Also to MM, added option for use as primary treatment in combination with lenalidomide and dexamethasone for non-transplant candidates or if transplant is deferred. Dosing table was updated to include this new regimen. To the dosing table, updated dosing regimen for combination therapy with carfilzomib, lenalidomide and dexamethasone in transplant candidates to allow up to 8 induction cycles (previously only 6 induction cycles) per changes in NCCN. Length of authorization was updated to reflect this change. Added Appendix A - Non-Quantitative Treatment Limitations (NQTL) Factor Checklist. Editorial changes throughout. |
Scenesse | 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. Editorial changes throughout. Added Appendix A – Non-Quantitative Treatment Limitations (NQTL) Factor Checklist. |
Spinraza | Ad hoc review to add the new high dose regimen along with the new 28 mg/5 mL and 50 mg/5 mL single dose vial formulations. The renewal criteria were also updated to include criteria for transitioning to the high dose regimen. Updated Max Units to align with dosing table. From Appendix 2, removed CMS Article A58578 (jurisdiction E and F) as it was retired on 01.02.2025. Additional editorial changes are made throughout. |
Talvey | Administrative changes to the 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 Initial Criteria, updated to include use in patients who are scheduled for and awaiting to receive step up doses. To Multiple Myeloma, added footnote to Multiple Myeloma heading that regimens may also be used for POEMS, MIDD, MGRS based on NCCN. Also, to Multiple Myeloma, added use as bridging option for BCMA CAR-T therapy in relapse and/or refractory myeloma per NCCN 2A recommendation. Added Appendix A - Non-Quantitative Treatment Limitations (NQTL) Factor Checklist. Editorial changes are made throughout. |
Tecvayli | Administrative changes to the 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 Initial Criteria, updated to include use in patients who are scheduled for and awaiting to receive step up doses. To Multiple Myeloma, added footnote to Multiple Myeloma heading that regimens may also be used for POEMS, MIDD, MGRS based on NCCN. Also, to Multiple Myeloma, updated to allow use in combination with daratumumab per NCCN update. Corresponding update was made to Dosage/Administration table. Added Appendix A - Non-Quantitative Treatment Limitations (NQTL) Factor Checklist. Editorial changes are made throughout. |
Tzield | Ad hoc review to expand the indication for use to delay the onset of Stage 3 type 1 diabetes (T1D) to pediatric patients between 1 to 8 years of age with Stage 2 T1D. This was preciously only approved for use in patients at least 8 years of age. Updated the criteria for absence of active EBV or CMV to now also include criteria for confirmation of an undetectable viral load per the updated PI. Updated the criteria for non-use in patients with Type 2 DM to now state that it will be confirmed that diagnosis is of autoimmune origin and does not suggest Type 2 Diabetes Mellitus or other forms of diabetes per the updated PI. Updates were also made to the dosing table to reflect use in this new patient population. Updated the Non-Quantitative Treatment Limitations (NQTL) Factor Checklist table in Appendix A to change the Safety and efficacy factor from ‘No: PA not a priority’ to ‘Yes: Consider for PA’ as a Boxed Warning has now been added to the PI. Additional editorial changes are made throughout. |
Ustekinumab | Ad hoc review to add the expanded indication for Stelara for the treatment of pediatric patients 2 years and older with moderately to severely active Crohn’s disease. This was previously only approved for use in adult patients. Updates were made to the Initial and Renewal Criteria sections along with the dosing table to reflect the addition of this new indication. Updated Crohn’s disease indication to add “Adult” throughout the policy to distinguish between Adult and Pediatric indications. Added indication for use as supportive therapy in combination with marnetegragene autotemcel (Kresladi™). Updates were made to the Initial Criteria, Length of Authorization, Max Units, and dosing table to reflect the addition of this new indication. Administrative change to update HCPCS for Starjemza. Q5164 will be effective on 07/01/2026. C9399 and J3590 will be discontinued on 07/01/2026. |
Vabysmo | Ad hoc review to remove the 6-month duration specified for monthly dosing for the treatment of macular edema following retinal vein occlusion (RVO) based on the updated PI. Updates were made to the Length of Authorization, Dosing Limits, Renewal Criteria, and dosing table 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. 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 Initial and Renewal Criteria sections to update ‘coverage’ to ‘prior authorization validity’. Coding updates made to CMS reference A52451 (jurisdiction 6, K). Additional editorial changes are made throughout. |
Viltepso | Administrative changes to the Length of Authorization section to delineate between authorization durations for initial and renewal periods and to include the number of days for approval. Added Appendix A – Non-Quantitative Treatment Limitations (NQTL) Factor Checklist. Made other minor editorial changes throughout. |
Vyondys53 | Administrative changes to the Length of Authorization section to delineate between authorization durations for initial and renewal periods and to include the number of days for approval. Added Appendix A – Non-Quantitative Treatment Limitations (NQTL) Factor Checklist. Made other minor editorial changes throughout. |
Yervoy | To Ampullary Adenocarcinoma, added ECOG status to criteria per NCCN. To Biliary Tract Cancers, added use in T1b or greater and/or T1a with positive margins as findings on pathologic review for neoadjuvant use and added use as neoadjuvant therapy for gallbladder cancer with jaundice per NCCN updates. To CNS Cancer, simplified criteria for use for brain metastases from melanoma. To Cutaneous Melanoma use as single agent adjuvant therapy, added use in NED after initial treatment with local or regional therapy for local satellite/in-transit recurrence and removed the requirement of TLND for resectable disease limited to nodal recurrence following excision of recurrence per NCCN updates. Additionally, updated the footnote for metastatic disease to include oligometastatic disease and brain metastases per NCCN. To NSCLC, added use as subsequent therapy of disease positive for ERBB2 (HER2) per NCCN update. To Soft Tissue Sarcoma, added use as subsequent therapy for unresectable or metastatic TMB-H Borderline/Malignant Phyllodes Tumor of the Breast per NCCN. Added indication of Ovarian, Fallopian Tube, and Primary Peritoneal Cancer - clear cell carcinoma of the ovary and small cell carcinoma of the ovary (hypercalcemic type) with corresponding updates made to LOA, MU, and Dosing/Administration sections per NCCN 2A recommendation. To Appendix 1 - Covered Diagnosis Codes, added C43.10 (related to Cutaneous Melanoma), C56.1, C56.2, C56.3, C56.9, C57.00-C57.02, C57.10-C57.12, C57.20-C57.22, C57.3, C57.4, C57.7-C57.9, Z85.43 (related to Ovarian Cancer/Fallopian Tube Cancer/Primary Peritoneal Cancer), and D48.60-D48.62 (related to Soft Tissue Sarcoma). Editorial changes are made throughout. |
Zynyz | Ad hoc review to add a new dosing regimen of 375 mg every 3 weeks for squamous cell carcinoma of the anal canal (SCAC) when used as monotherapy or combination therapy. |
The following Commercial post service claim edits medical drug policies have revisions effective June 1, 2026:
*see www.gatewaypa.com/policydisplay/52
Bortezomib | 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. Global change to remove any specific contraindications in criteria and replaced with general language indicating member does not have any FDA contraindications. To Multiple Myeloma heading, added footnote that MM regimens may also be used for POEMS, MIDD, MGRS based on NCCN. To WM/LPL, added to the criteria that dosing in combination with rituximab and dexamethasone may also be used with or without cyclophosphamide, per NCCN recommendations. Removed Adult T-Cell Leukemia/Lymphoma indication and criteria as per NCCN T-Cell Lymphomas guideline update which removes bortezomib regimen. To Pediatric ALL, updated criteria to include BCR::ABL1 nomenclature throughout, per 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. To Pediatric Hodgkin Lymphoma, streamlined criteria for relapsed or refractory disease. To Dosing Table and Dosing Limits sections, updated cycle length from 35 days to 21 days for MM/SLCA indications to be most encompassing of available dosing patterns based on literature/PI support. To Billing Code section, per IPD, DrugIQ, and RxFlex updated NDC for Dr. Reddy’s, added NDC for Fresenius Kabi, and added Fosun Pharma USA along with its NDCs to the Maia Pharmaceuticals row. Added Appendix A – Non-Quantitative Treatment Limitations (NQTL) Factor Checklist. To ICD-10 table, added C90.11, C90.21, C90.31 (related to Multiple Myeloma), D89.89 and D89.9 (related to KSHV Inflammatory Cytokine Syndrome) and removed C91.50, C91.52 (related to T-Cell Leukemia/Lymphoma). Editorial changes throughout. |
Empliciti | 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 Multiple Myeloma heading, added asterisk and corresponding footnote indicating that regimens may also be used for POEMS, MIDD, MGRS based on NCCN. Added Appendix A - Non-Quantitative Treatment Limitations (NQTL) Factor Checklist. Editorial changes throughout. |
The following Commercial medical drug policies have coding updates effective July 1, 2026:
New Code | Brand Name (Generic Name) |
J1577 | Qivigy (immune globulin) |
J3405 | Itvisma (onasemnogene abeparvovec-brve) |
J3386 | Waskyra (etuvetidigene autotemcel) |
J1289 | Yartemlea (narsoplimab-wuug) |
J2361 | Exdensur (depemokimab-ulaa) |
J9037 | Blenrep (belantamab mafodontin-blmf) |
J9062 | Rybrevant Faspro (amivantamab & hyaluronidase-lpuj) |
Q5168 | Nufymco (ranibizumab-leyk) |
Q5171 | Boncresa (denosumab-mobz)* |
Q5165 | Oziltus (denosumab-mobz)^ |
Q5170 | Eydenzelt (aflibercept-boav) |
Q5166 | Osvyrti (denosumab-desu)* |
Q5166 | Jubereq (denosumab-desu)^ |
Q5167 | Enoby (denosumab-qbde)* |
Q5167 | Xtrenbo (denosumab-qbde)^ |
Q5169 | Armlupeg (pegfilgrastim-unne) |
Q5164 | Starjemza (ustekinumab-hmny) |
J9232 | Docetaxel [Hospira] (docetaxel) |
*Prolia biosimilar | |
