Pharmacy Policy Updates

Adcetris

Administrative change to Length of Authorization (LOA) section to delineate between authorization durations for initial and renewal periods. Extensively revised pediatric cHL in accordance with the latest NCCN guidelines. Dosing table and LOA sections updated to reflect changes. To Primary cutaneous Lymphomas for MF/SS, added option for use in combination with systemic therapy for generalized cutaneous or extracutaneous lesions. Minor editorial changes throughout.

Berinert

Administrative changes to Length of Authorization section to delineate between authorization durations for initial and renewal periods and to Dosing Limits section to remove QL. To Universal Criteria, added preclusion of use with other agents indicated for the treatment of acute attacks with a note that combo duplicate therapy will be reviewed on a case-by-case basis. To the clinical presentations table for HAE with normal C1INH, removed requirement of lack of efficacy of corticosteroids with or without omalizumab in patients with a family history of HAE, to align with guidelines.

Blincyto

Administrative changes to Length of Authorization section to delineate between authorization durations for initial and renewal periods and to Dosing Limits section to remove QL. Updated Max Units to one value that encompasses induction, consolidation, and continued therapy. To the Adult ALL, added additional use as frontline induction therapy with a TKI for Ph+ disease per NCCN 2A recommendation. Additionally, updated criteria for consolidation therapy, maintenance therapy, and therapy for relapsed or refractory disease to align with the latest NCCN updates. To Pediatric ALL, restructured criteria and updated to align with latest NCCN recommendations. Additionally, updated criteria to include BCR:ABL1 nomenclature throughout. Editorial changes were made throughout and to the Renewal Criteria. To Dosage/Administration table, added dosing for Adult ALL use as frontline induction therapy with a TKI and updated dosing for maintenance therapy. Also, simplified dosing for consolidation therapy. Corresponding updates were made to LOA.

Cinryze

Administrative changes to Length of Authorization section to delineate between authorization durations for initial and renewal periods and to Dosing Limits section to remove QL. To Universal Criteria, added garadacimab (Andembry) to list of prophylactic agents for which combination use is prohibited. To Prophylaxis Against HAE Attacks, softened criteria to align with guideline recommendations. Editorial changes were made throughout. Added single-dose carton kit to NDC section per PI.

Cosela

Updated the policy heading to reflect the registered trademark for Cosela. Administrative changes to Length of Authorization section to delineate between authorization durations for initial and renewal periods and to Dosing Limits section to remove QL. Removed examples of colony stimulating factors from Universal Criteria for conciseness.

Darzalex IV

Administrative change to Length of Authorization section to delineate between authorization durations for initial and renewal periods. To Multiple Myeloma, added use in combination with bortezomib, lenalidomide, dexamethasone for newly diagnosed patients who are ineligible for transplant, use as a single agent for maintenance therapy for symptomatic disease in transplant candidates, and use as primary treatment for high-risk smoldering myeloma based on NCCN recommendations. Removed induction therapy for transplant patients from POEMS indication due to NCCN allowing in transplant ineligible patients as well. Added footnote to those regimens in Multiple Myeloma that may also be used for POEMS, MIDD, MGRS based on NCCN. To Systemic Light Chain Amyloidosis, added use in combination with venetoclax for relapsed or refractory disease. Added new indications to Dosing Table and LOA sections. To Covered Diagnosis table, added C90.11, C90.21 and C90.31 (related to Multiple Myeloma).

Datroway

Ad hoc review to add the newly approved indication for the treatment of adult patients with locally advanced or metastatic EGFR-mutated NSCLC who have received prior EGFR-directed therapy and platinum-based chemotherapy. Additional criteria for use in patients with EGFR exon 19 deletion or L858R mutation and nonsquamous cell histology was also added to the NSCLC indication to include the NCCN recommendations for use. Updates were also made to the dosing table and ICD-10 coding to reflect the addition of this new indication. Criteria for single agent use was moved from under the Breast Cancer indication and to under the Universal Criteria heading as it applies to both indications for use. Removed criteria for ECOG PS of 0-1 to align with the less restrictive NCCN recommendations. Administrative changes to Length of Authorization section to delineate between authorization durations for initial and renewal periods as part of the global changes being made across all policies.

Elrexfio

Ad hoc review to add the newly approved four-week dosing regimen for patients who have received at least 24 weeks of treatment at the every two-week dosing schedule and have maintained the response. Administrative change to Length of Authorization section to delineate between authorization durations for initial and renewal periods as part of the global changes being made across all policies.

Erbitux

Administrative change to Length of Authorization section to delineate between authorization durations for initial and renewal periods. To CRC, updated options for use to align with the latest NCCN Colon and Rectal guidelines. To Head and Neck Cancers, updated footnotes defining very advanced head and neck cancers and ethmoid sinus tumors. Editorial changes were made to NSCLC.

Evkeeza

Administrative changes to Policy Title to update registered trademark, to Length of Authorization section to delineate between authorization durations for initial and renewal periods, to Dosing Limits section to remove QL. Also to LOA, updated initial approval period from 3 to 6 months per global changes for non-oncology drugs with set/fixed doses. From the Covered Diagnosis Codes, removed E78.00 for pure hypercholesterolemia, unspecified.

Gamifant

Ad hoc review to add the expanded indication for adult and pediatric patients with HLH/MAS in known or suspected Still’s disease, including systemic sJIA, with an inadequate response or intolerance to glucocorticoids, or with recurrent MAS. Updates were also made to the Renewal Criteria, Dosing table, and ICD-10 codes to reflect the addition of this new indication. Updated the treatment heading for Hemophagocytic Lymphohistiocytosis (HLH) to now state Primary Hemophagocytic Lymphohistiocytosis (HLH) to delineate from the new expanded indication for use. Moved criteria for no HSCT from under Universal Criteria to under Primary HLH as it only applies to this indication. From the Universal Criteria for screening for the presence of latent TB, removed criteria for monitoring every 2 weeks and as clinically indicated to align with the updates made to the PI. Updated the Universal Criteria verbiage for prophylaxis in patients for Herpes Zoster, Pneumocystis Jirovecii, and fungal infections to align with the PI recommendations. From the Renewal Criteria for ongoing monitoring for adenovirus, EBV, and CMV viruses, removed criteria for monitoring every 2 weeks to align with the updates made to the PI. Updated the dosing table and max units for Primary HLH for dose titration to reflect the updates in the PI that allow for dose escalation on day 4, day 7, and day 10 if clinically appropriate. Other editorial changes were made to the dosing table to align with PI to provide more clarity. Administrative change to Length of Authorization section to delineate between authorization durations for initial and renewal periods as part of the global changes being made across all policies. Updated the Max Units in the Dosing Limits section to indicate the max units allowed over a 30-day period.

Hyaluronic Acid Derivatives

Administrative changes to Length of Authorization section to delineate between authorization durations for initial and renewal periods, to Dosing Limits section to remove QL, and to policy title to update registered trademarks. Updated max units for VISCO-3 to align with max units for Hyalgan, Supartz, & Supartz FX since all share the same HCPCS, J7321. Editorial changes throughout to update drug names.

IV Immune Globulins

To Policy name added newly approved product Gammagard Liquid ERC. Administrative changes to Length of Authorization section to delineate between authorization durations for initial and renewal periods and to Dosing Limits section to remove QL. To Max units added indication of Cancer-Associated Venous Thromboembolic Disease. To Dermatomyositis/Polymyositis initial criteria, split criteria into 2 different headings, kept Polymyositis criteria static, and made updates to Dermatomyositis diagnostic criteria per recent KOL recommendations to allow use without requiring muscle biopsy in select patients (proximal weakness with classic skin manifestations or clinically amyopathic dermatomyositis). To Acquired Immune Deficiency Secondary to ALL/MM updated to reflect NCCN and KOL supported indication for use when pt has recurrent, life-threatening infections. Note added to use in prevention of infection and IgG level to indicate special use case for patients with IgG myeloma. To Management of Immune Checkpoint Inhibitor-Related Toxicities removed examples of checkpoint inhibitors and added use in hemolytic anemia, aplastic anemia, and thrombocytopenia. To CAR T-Cell-Related Toxicities added use if patient has AIDP-type picture for both anti-CD-19 and BCMA therapies. Added indication of Cancer-Associated Venous Thromboembolic Disease and associated dosing per NCCN. To reference table added new Gammagard ERC product and made other minor updates according to the Immune Deficiency Foundation product table and product package inserts as needed. To Renewal criteria, global change was made to add criteria to refer to section I for authorization limits. To Dosing table added supported dosing for Cancer associated Venous Thromboembolic Disease, CAR T-Cell-Related toxicity AIDP type. To Billing and coding table added new Gammagard ERC product and updated NDC codes for Panzyga per recent PI update. To ICD-10 table added C91.00-91.02 for ALL, D59.0, D59.2 and D61.1 for Immune Checkpoint Inhibitor-Related Toxicities and D75.821, D75.822, D75.828, and D75.829 related to Cancer-Associated Venous Thromboembolic Disease. Other editorial changes were made throughout for clarity. Updated ICD-10 crosswalk (for PCM) list.

Kalbitor

Administrative changes to Length of Authorization section to delineate between authorization durations for initial and renewal periods and to Dosing Limits section to remove QL. To Universal Criteria, added preclusion of use with other agents indicated for the treatment of acute attacks with a note that combo duplicate therapy will be reviewed on a case-by-case basis. To the clinical presentations table for HAE with normal C1INH, removed requirement of lack of efficacy of corticosteroids with or without omalizumab in patients with a family history of HAE, to align with guidelines

Kisunla

Ad hoc review to add the newly approved dosing titration schedule to reduce the incidence of ARIA-E. Also, updated corresponding max units. Administrative changes to Length of Authorization section to delineate between authorization durations for initial and renewal periods and to the Dosing Limits section to remove the Quantity Limit as part of the global changes being made across all policies.

Leqvio

Administrative changes to Length of Authorization section to delineate between authorization durations for initial and renewal periods and to Dosing Limits section to remove QL. Made updates to criteria based on newly amended indication as adjunct to diet and exercise to reduce LDL in adults with hypercholesterolemia. Replaced Primary Hyperlipidemia with Primary Hypercholesterolemia throughout policy including indication heading. To Universal criteria, removed use with other lipid-lowering therapies to now say use in conjunction with diet and exercise. From Primary Hypercholesterolemia removed Simvastatin 80mg daily as an example of high-intensity statin. To Dosing Table, removed reference to combination use with statins due to amended indication. To Renewal Criteria, added severe hypersensitivity reactions based on PI update. To Covered Diagnosis table, added E75.5 and E78.49 which are additional primary codes and removed I21, I21.0, I21.1, I21.2, I21.9, I21.A9 which are secondary codes.

Monjuvi

Ad hoc review to add the new indication for use in combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory follicular lymphoma. Updates were also made to the Length of Authorization, Dosing Limits, and dosing table to reflect the addition of this new indication. To the Renewal Criteria, updated the examples of unacceptable toxicity to align with the Warnings and Precautions section of the PI and also made editorial changes to indicate referral to Section I for the max duration of authorization for each indication. Administrative changes to Length of Authorization section to delineate between authorization durations for initial and renewal periods and to the Dosing Limits section to remove the Quantity Limit as part of the global changes being made across all policies. To the ICD-10 table, updated C83.39 to C83.398 and deleted Z85.72 to align with NCCN. Added ICD-10 crosswalk (for PCM) list to Appendix 3.

Rituximab IV 

Administrative changes to Length of Authorization section to delineate between authorization durations for initial and renewal periods for oncology and non-oncology indications. Made updates to the Dosing Limits section to align with LOA and Dosing Table. To ALL, removed combination with TKI-based regimen as this is no longer recommended by NCCN. To CNS Cancers, made extensive updates to align with latest NCCN recommendations, added primary vitreoretinal lymphoma/PCNSL ocular variant without other CNS involvement and specified when intra-cerebrospinal fluid vs intravenous therapy should be used. To Adult B-Cell lymphomas, made Burkitt lymphoma indication only to align with all other similar subtypes. Added Transplant Associated-Thrombotic Microangiopathy in Adult and Pediatric Patients new indication to all affected sections of the policy as result of the 2024 Onco Ad Board Meeting and in line with the latest EBMT guidelines. To Pediatric Idiopathic Nephrotic Syndrome, made updates to the diagnostic criteria for frequently relapsing nephrotic syndrome, steroid dependent nephrotic syndrome, and steroid resistant nephrotic syndrome in line with KDIGO 2025 Nephrotic Syndrome in Children Guidelines. To the Dosing Table for Management of Immunotherapy-Related Toxicities, aligned dosing for Bullous Pemphigoid and Bullous Dermatitis together, as per NCCN guideline recommendations, which also aligns with existing LOA requirements. Made other editorial changes to the dosing table for clarity. Added ICD10 Z94.84 (related to HCT) based on NCCN updates and added M31.11 (related to Transplant-Associated Thrombotic Microangiopathy) based on addition of this new indication.

Ruconest

Administrative changes to Length of Authorization section to delineate between authorization durations for initial and renewal periods and to Dosing Limits section to remove QL. To Universal Criteria, added preclusion of use with other agents indicated for the treatment of acute attacks with a note that combo duplicate therapy will be reviewed on a case-by-case basis. To the clinical presentations table for HAE with normal C1INH, removed requirement of lack of efficacy of corticosteroids with or without omalizumab in patients with a family history of HAE, to align with guidelines. Editorial changes were made throughout.

Rybrevant

Administrative change to Length of Authorization section to delineate between authorization durations for initial and renewal periods and to Dosing Limits section to remove QL. Removed requirement for patients to not have untreated brain metastases and deleted the Universal criteria heading. To NSCLC, removed option for use as subsequent therapy in combination with carboplatin and pemetrexed for patients with EGFR S768I, L861Q, and/or G719X mutations per update in NCCN. Added footnote defining limited progression. Added new indication for use in CNS cancers arising from EGFR exon 19 or exon 21 L858R mutation positive NSCLC with pertinent criteria and dosing per NCCN. To NSCLC in Dosing Table, added ‘unless otherwise specified’ to statement on treatment until progression or toxicity to account for use in combination with lazertinib following disease progression. Removed note regarding premedication in Dosing Table. Editorial changes to renewal criteria. To Appendix 1, added ICD-10 codes C79.31 for Secondary malignant neoplasm of brain.

SC Immune Globulins

To Policy name added newly approved product Gammagard Liquid ERC. Administrative changes to Length of Authorization section to delineate between authorization durations for initial and renewal periods and to Dosing Limits section to remove QL. To Max units added Gammagard Liquid ERC. Editorial change to CIDP reference note. To Billing/coding and dosing table added Gammagard Liquid ERC. Also made updates to 90284 coding per IPD. Other minor editorial changes were made throughout.

Synagis

Administrative change to Length of Authorization section to delineate between authorization durations for initial and renewal periods and to Dosing Limits section to remove QL. To Prevention of RSV indication, removed footnote on additional dose in indication section since noted in the Dosing Table. Editorial change to renewal criteria on duration of authorization.

Tepezza

Administrative changes to Length of Authorization section to delineate between authorization durations for initial and renewal periods and to Dosing Limits section to remove QL. Updates to Initial Criteria for TED based off of KOL review recommendations. Additionally, criteria enriched to allow for Tepezza as first line therapy without prior glucocorticoids and to define use for inactive disease. CAS scoring table added to policy to correspond with added criteria. Editorial change to renewal criteria and to specify that re-treatment can be considered on case-by-case basis.

Ustekinumab

Ad hoc review to add the newly approved Steqeyma 45 mg/0.5 mL vial for SC use in pediatric patients with Plaque Psoriasis and Psoriatic Arthritis who weigh less than 60 kg.

Vectibix

Administrative change to Length of Authorization section to delineate between authorization durations for initial and renewal periods. To CRC, updated criteria to align with latest NCCN 2A recommendations, simplified criteria by removing pMMR/MSS, dMMR/MSI-H, and POLE/POLD1 criteria and added a footnote regarding universal MMR or MSI testing. Added new indication of Appendiceal Adenocarcinoma with pertinent criteria and dosing per NCCN. To Appendix 1, added ICD-10 code C18.1 for Malignant neoplasm of appendix.

Portrazza

Administrative changes to Length of Authorization section to delineate between authorization durations for initial and renewal periods and to Dosing Limits section to remove QL. Updated Max Units to total dose to be received over a 21-day period and not individual dosages on specific days. Other minor editorial changes made.