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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 Dec. 10, 2026:
*see www.gatewaypa.com/policydisplay/52 on or after Dec. 1, 2026.
Adzynma | Ad hoc review to add Universal Criteria to require that all members will have ADAMTS13 activity and ADAMTS13 neutralizing antibodies assessed prior to initiation and periodically during the course of treatment based on the new Boxed Warning in the PI. Added specific examples to the criteria for FDA labeled contraindications to provide better clarity and to more closely align with the PI. Added neutralizing antibodies to the examples of unacceptable toxicity in the Renewal Criteria section to align with the updates made to the PI. To Appendix A, updated the Safety and efficacy factor in the table to ‘Yes: Consider for PA’ to reflect the addition of the Boxed Warning to the PI. To Appendix 2, updated contractor name from National Government Services, Inc. to Wellpoint Federal. |
Amtagvi | To Cutaneous Melanoma, removed footnote detailing alternate settings which could be considered as metastatic disease per changes in NCCN. To Appendix 1, added ICD-10 code C43.10 related to cutaneous melanoma. To Appendix 2, updated contractor name from National Government Services, Inc. to Wellpoint Federal for jurisdictions 6 and K (13 & 14). Editorial changes made throughout. |
Azedra | Administrative changes to Length of Authorization section to include number of days allowed for authorization durations. To dose/admin table removed note regarding safety/handling of the medication for conciseness. To Appendix 2, updated contractor name from National Government Services, Inc. to Wellpoint Federal. Editorial changes made throughout. |
Bavencio | To Appendix 2, updated contractor name from National Government Services, Inc. to Wellpoint Federal. Removed ICD-10 crosswalk for PCM due to one single value in Max Units section. Editorial changes made throughout. |
Benlysta IV | Reverted Benlysta cross benefit policy back into 2 separate IV and SQ policies, per business decision. 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 to the policy, updated contractor name from National Government Services, Inc. to Wellpoint Federal in Appendix 2, and made other minor editorial changes throughout the criteria, per global updates. Updated dosing table to more clearly indicate age of pediatric members must be at least 5 years old and also updated the note regarding transition from IV to SQ use guidance, all per PI. Made the following revisions to align with the updates made to the Prime Therapeutics Lupus PAQL policy: updated reference section, removed quantity/dose requirements from initial/renewal criteria as this information was duplicative with the dosage/administration 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 Criteria for conciseness and to streamline the criteria review; condensed the concomitant immunomodulatory therapy criteria for conciseness while maintaining the same intent; streamlined language surrounding prerequisite and combination therapy while keeping intent at parity with the Prime Therapeutics Lupus PAQL policy; removed other FDA labeled or compendia supported diagnosis criteria and criteria noting ‘medical records required’ to shift to MPS standard procedures for review of those requests; streamlined renewal criteria to follow MPS standard language formatting with reference to section III for all repeatable criteria required; removed steerage requirements. Other minor editorial changes were made throughout. |
Berinert | To universal criteria, updated exclusionary combination therapy statement to remove noted specific targets of treatment. Removal of specific possible triggers for HAE attacks per KOL in favor of statement with confirmation that the provider has counseled to avoid triggers for attacks. Per updates in the 2025 World Allergy Organization guideline, Hereditary Angioedema with Normal C1 Inhibitor Updated International Consensus statement from HAE International (HAEi) and the US HAE Association (HAEA), and The International/Canadian Hereditary Angioedema 2026 Guideline the following was updated: To Treatment of Acute HAE Attacks, the indication heading was previously derived from PI and specified acute treatment being specifically allowed for abdominal, facial, or laryngeal attacks of HAE, however, this will be updated instead to “Treatment of acute attacks of Hereditary Angioedema (HAE)” based on latest guideline recommendations for use for all acute HAE attacks. Also, extensively revised this section to align with current classification of disease, diagnosis, and treatment guidelines. Renewal criteria revised beneficial response criteria per KOL. Added Appendix A - Non-Quantitative Treatment Limitations (NQTL) Factor Checklist. To Appendix 2, updated contractor name from National Government Services, Inc. to Wellpoint Federal. Editorial changes made throughout. |
Cinryze | Administrative changes to Length of Authorization section to include number of days allowed for authorization durations. To universal criteria updated exclusionary combination therapy statement to remove noted specific targets of treatment and instead exclude any therapy indicated for the long-term prophylaxis of HAE, per KOL note added allowing use in combination with other prophylactic therapies when Cinryze is used as short-term prophylaxis only. Removal of specific possible triggers for HAE attacks per KOL in favor of statement with confirmation that the provider has counseled to avoid triggers for attacks. Per updates in the 2025 World Allergy Organization guideline, Hereditary Angioedema with Normal C1 Inhibitor Updated International Consensus statement from HAE International (HAEi) and the US HAE Association (HAEA), and The International/Canadian Hereditary Angioedema 2026 Guideline and KOL input the following was updated: To Prophylaxis for HAE Attacks indication, extensively revised section to align with current classification of disease, diagnosis, and treatment guidelines. Renewal criteria revised beneficial response criteria per KOL. Added Appendix A - Non-Quantitative Treatment Limitations (NQTL) Factor Checklist. To Appendix 2, updated contractor name from National Government Services, Inc. to Wellpoint Federal. Editorial changes made throughout. |
Emrelis | Administrative changes to Length of Authorization section to include the number of days allowed. To Billing Code/Availability info, removed discontinued HCPCS codes C9306 and J9999. To Appendix 2, updated contractor name from National Government Services, Inc. to Wellpoint Federal for jurisdictions 6 and K (13 & 14). Editorial changes throughout. |
Fyarro | Update to Length of Authorization section to include days. 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 the Universal criteria, also added criteria for non-use in members with severe hepatic impairment per the updated PI. To Appendix 2, updated contractor name from National Government Services, Inc. to Wellpoint Federal. Editorial changes made throughout. |
Imfinzi | To BTC, updated criteria on incidental findings on pathologic review for neoadjuvant therapy in gallbladder cancer to align with NCCN. To Appendix 2, updated contractor name from National Government Services, Inc. to Wellpoint Federal. Updated ICD-10 PCM Crosswalk. Editorial changes made throughout. |
Imjudo | To Appendix 2, updated contractor name from National Government Services, Inc. to Wellpoint Federal. No clinical changes |
Injectafer | Ad hoc review to add universal criteria to check serum phosphate levels at baseline and as clinically indicated AND to correct any pre-existing hypophosphatemia prior to administering treatment based on the new Boxed Warning added to the PI. Added specific examples to the criteria for FDA labeled contraindications to provide better clarity and to more closely align with the PI. To Appendix A, updated the Safety and efficacy factor in the table to ‘Yes: Consider for PA’ to reflect the addition of the Boxed Warning to the PI. To Appendix 2, updated contractor name from National Government Services, Inc. to Wellpoint Federal. |
IVIG | Ad hoc review to remove HCPCS changes that would have been effective Jan. 1, 2027, as per CMS these changes will no longer be made for Jan. 1, 2027. To the Refences section and Appendix 2, updated contractor name from National Government Services, Inc. to Wellpoint Federal. |
Jemperli | No clinical changes. To Appendix 2, updated contractor name from National Government Services, Inc. to Wellpoint Federal. Editorial changes made throughout. |
Kalbitor | To universal criteria updated exclusionary combination therapy statement to remove noted specific targets of treatment. Removal of specific possible triggers for HAE attacks per KOL in favor of statement with confirmation that the provider has counseled to avoid triggers for attacks. Per updates in the 2025 World Allergy Organization guideline, Hereditary Angioedema with Normal C1 Inhibitor Updated International Consensus statement from HAE International (HAEi) and the US HAE Association (HAEA), and The International/Canadian Hereditary Angioedema 2026 Guideline and KOL input the following was updated: To Treatment of Acute HAE Attacks indication, extensively revised section to align with current classification of disease, diagnosis, and treatment guidelines. To renewal criteria, revised beneficial response criteria per KOL. Added Appendix A - Non-Quantitative Treatment Limitations (NQTL) Factor Checklist. To Appendix 2, updated contractor name from National Government Services, Inc. to Wellpoint Federal. Editorial changes made throughout. |
Libtayo | To Appendix 2, updated contractor name from National Government Services, Inc. to Wellpoint Federal. No clinical changes. |
Loqtorzi | To Appendix 2, updated contractor name from National Government Services, Inc. to Wellpoint Federal. No clinical changes. |
Lutetium dotatate | Added newly approved product Bexlutry, approved via the 505(b)(2) pathway indicated for treatment of adults with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors. Additionally, added newly approved product Bravnetsa, indicated for treatment of adults with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors, this product is bioequivalent and therapeutically equivalent to Lutathera and will be kept at full parity with Lutathera with the exception of pediatric members due to exclusion in FDA PI for this population. Due to these newly approved products, policy was renamed to Lutetium dotatate. Criteria section for Neuroendocrine and Adrenal Tumors was split to identify criteria specific to Bexlutry and Lutathera/Bravnetsa. To initial criteria for all products, updated requirement that member’s disease be somatostatin receptor-positive in all measurable tumor lesions by either SSTR-PET/CT or SSTR-PET/MRI in addition to OctreoScan per NCCN guideline. Added new indication of Thyroid Carcinoma for Lutathera and Bravnetsa only with subsequent criteria for Medullary Carcinoma per update to NCCN compendia which is now a 2A recommendation. To dose/admin table removed note regarding safety/handling of the medication for conciseness. To Appendix 1 split ICD 10 table to indicate codes billable for Bexlutry only and codes for Lutathera/Bravnetsa only. To Lutathera/Bravnetsa section of coding added ICD10 codes C73 and Z85.850 related to Thyroid Carcinoma. To Appendix 2, updated contractor name from National Government Services, Inc. to Wellpoint Federal. Editorial changes made throughout. |
Penpulimab | To Head and Neck Cancers, updated footnote defining very advanced disease to align with NCCN. To Appendix 2, updated contractor name from National Government Services, Inc. to Wellpoint Federal for jurisdictions 6 and K (13 & 14). Editorial changes made throughout. |
Rituximab IV | To SLE and LN, removed exclusion of use for severe active CNS lupus per updated guidelines. To Appendix 1, removed ICD-10 codes C83.50-C83.58 (related to ALL) as it’s no longer supported in NCCN. Added ICD-10 codes E85.3, E85.4, E85.81, E85.89, E85.9 (related to Waldenström Macroglobulinemia/Lymphoplasmacytic Lymphoma), T86.01, and T86.02 (related to Hematopoietic Cell Transplantation). To Appendix 2, updated contractor name from National Government Services, Inc. to Wellpoint Federal. Editorial changes made throughout. |
Ruconest | To Universal criteria, applied global change to remove specific contraindications in criteria and replace with general language indicating member does not have any FDA contraindications and updated exclusionary combination therapy statement to remove noted specific targets of treatment. Removal of specific possible triggers for HAE attacks per KOL in favor of statement with confirmation that the provider has counseled to avoid triggers for attacks. Per updates in the 2025 World Allergy Organization guideline, Hereditary Angioedema with Normal C1 Inhibitor Updated International Consensus statement from HAE International (HAEi) and the US HAE Association (HAEA), and The International/Canadian Hereditary Angioedema 2026 Guideline and KOL input the following was updated: To Treatment of Acute HAE Attacks indication, extensively revised section to align with current classification of disease, diagnosis, and treatment guidelines. Renewal criteria revised beneficial response criteria per KOL. Added Appendix A - Non-Quantitative Treatment Limitations (NQTL) Factor Checklist. To Appendix 2, updated contractor name from National Government Services, Inc. to Wellpoint Federal. Editorial changes made throughout. |
Saphnelo IV | 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 to the policy, updated contractor name from National Government Services, Inc. to Wellpoint Federal in Appendix 2, 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 Lupus PAQL policy: updated reference section, removed quantity/dose requirements from criteria within the initial/renewal for indication-specific criteria as this information was duplicative with the dosage/administration 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 Criteria for conciseness and to streamline the criteria review; condensed the concomitant immunomodulatory therapy criteria for conciseness while maintaining the same intent; aligned Indication Specific Criteria more closely with the Package insert while maintaining prerequisite and combination therapy intent at parity with the other agents within the Prime Therapeutics Lupus PAQL policy, where applicable; removed other FDA labeled or compendia supported diagnosis criteria to shift to MPS standard procedures for review of those requests; streamlined renewal criteria to follow MPS standard language formatting with reference to section III for all repeatable criteria required; removed steerage requirements. Other minor editorial changes were made throughout. |
SCIG | Ad hoc review to remove HCPCS changes that would have been effective Jan. 1, 2027, as per CMS these changes will no longer be made for Jan. 1, 2027. To Appendix 2, updated contractor name from National Government Services, Inc. to Wellpoint Federal. |
Tecelra | To Appendix 2, updated contractor name from National Government Services, Inc. to Wellpoint Federal for jurisdictions 6 and K (13 & 14). Editorial changes made throughout. |
Tecentriq IV | To NSCLC, updated criteria to align with NCCN compendia and guideline recommendations. To Dosage/Administration table, combined rows for Colon Cancer and Small Bowel Adenocarcinoma for conciseness. To Appendix 1 - Covered Diagnosis Codes, removed ICD-10 code Z85.51 as this is not supported in NCCN. To Appendix 2, updated contractor name from National Government Services, Inc. to Wellpoint Federal for jurisdictions 6 and K (13 & 14). Editorial changes made throughout. |
Tevimbra | To both Gastric and Esophageal/Esophagogastric/Gastroesophageal Junction Cancers, added newly approved FDA indication for use in combination with zanidatamab and fluoropyrimidine- and platinum containing chemotherapy as first line treatment of HER2- positive (IHC 3+ or IHC 2+/ISH+) unresectable locally advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma. To Head and Neck Cancers, for Very Advanced disease removed duplicative treatment settings that fall under unresectable disease. To Appendix 2, updated contractor name from National Government Services, Inc. to Wellpoint Federal for jurisdictions 6 and K (13 & 14). Editorial changes throughout. |
Tivdak | Administrative changes to Length of Authorization section to include number of days allowed for authorization durations and to Appendix 2 to update contractor name from National Government Services, Inc. to Wellpoint Federal. Editorial changes throughout. |
Unloxcyt | Administrative change to Policy Name to reflect registered trademark. To Appendix 2, updated contractor name from National Government Services, Inc. to Wellpoint Federal for jurisdictions 6 and K (13 & 14). Editorial changes made throughout. |
Veopoz | Administrative changes to Length of Authorization section to include the number of days allowed. Global change to remove any specific contraindications in criteria and replace with general language indicating member does not have any FDA labeled contraindications. To Appendix 2, updated contractor name from National Government Services, Inc. to Wellpoint Federal for jurisdictions 6 and K (13 & 14). |
Yartemlea | To Billing Code/Availability section, removed obsolete J3590 HCPCS as it was discontinued on July 1, 2026. To Appendix 1, removed ICD-10 code M31.10 based on IPD and manufacturer billing guide. To Appendix 2, updated contractor name from National Government Services, Inc. to Wellpoint Federal. Editorial changes made throughout. |
Ziihera | Ad hoc review to add the FDA approved expanded indication for use in combination with fluoropyrimidine- and platinum-containing chemotherapy with or without tislelizumab for the first-line treatment of adults with HER2-positive unresectable locally advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma. Universal Criteria was updated with criteria for monitoring and managing severe diarrhea as per black box warning update to the PI. The Dosing Limits section, dosing table, and ICD-10 codes were updated to reflect the addition of this new indication. To Appendix 2, updated contractor name from National Government Services, Inc. to Wellpoint Federal for jurisdictions 6 and K (13 & 14). |
Zilretta | To Appendix 2, updated contractor name from National Government Services, Inc. to Wellpoint Federal for jurisdictions 6 and K (13 & 14). Editorial changes made throughout. |
Zynyz | To Appendix 2, updated contractor name from National Government Services, Inc. to Wellpoint Federal. Editorial changes made throughout. |
The following Commercial post service claim edit medical drug policies have revisions effective Nov. 1, 2026:
*see www.gatewaypa.com/policydisplay/52
Torisel | Administrative change to Length of Authorization section to include number of days allowed for authorization durations. To Initial criteria softened language for hard vaccine requirement and removed single agent requirement as NCCN allows for use in combination therapy for some indications. Also, added global change to remove any specific contraindications in criteria and replace with general language indicating member does not have any FDA contraindications. Updated Renal Cell Carcinoma heading to Advanced Renal Cell Carcinoma to simplify criteria. Added Pediatric Rhabdomyosarcoma as a new indication, per NCCN recommendation; reflected this update in dosing table and LOA. To Appendix 2, updated contractor name from National Government Services, Inc. to Wellpoint Federal. Editorial changes made throughout. |
Xofigo | Administrative changes to Length of Authorization section to include the number of days allowed. Global change to remove any specific contraindications in criteria and replace with general language indicating member does not have any FDA labeled contraindications. To Appendix 2, updated contractor name from National Government Services, Inc. to Wellpoint Federal for jurisdictions 6 and K (13 & 14). |