Pharmacy Policy Updates

Adzynma

Administrative changes to the Length of Authorization section to delineate between authorization durations for initial and renewal period and to include number of days allowed for authorization durations. Global change to remove any specific contraindications in criteria and replace them with general language indicating members do not have any FDA contraindications. Added Appendix A – Non-Quantitative Treatment Limitations (NQTL) Factor Checklist. Editorial changes are made throughout the process.

Aliqopa

Policy is being retired because the manufacturer has withdrawn the product from the market as the confirmatory trial did not meet its primary endpoint of progression-free survival benefit versus the standard immunochemotherapy.

Akynzeo IV

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 Prevention of chemotherapy-induced nausea and vomiting (CINV), added use of a 4-drug combo for patients receiving MEC regimen with additional risk factors to align with NCCN update. Updated HEC, MEC and risk factor table to match NCCN. Added Appendix A – Non-Quantitative Treatment Limitations (NQTL) Factor Checklist. Editorial changes are made throughout the process.

Aldurazyme

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 MPS I added options of likely pathogenic variants in the IDUA gene for confirming diagnosis. Editorial changes throughout the world. Added Appendix A – Non-Quantitative Treatment Limitations (NQTL) Factor Checklist.

Bavencio

Added new indications for use in Colon Cancer, Rectal Cancer, and Small Bowel Adenocarcinoma with applicable criteria and dosing supported by NCCN. To ICD 10 table added the following per NCCN: C18.0, C18.2-C18.9, and C78.6 (related to Colon Cancer), C19, C20, C21.8 (related to rectal cancer), C78.00, C78.01, C78.02 and C78.7 (related to both Colon and Rectal Cancers) and C17.0, C17.1, C17.2, C17.3, C17.8, C17.9, and Z85.068 (related to Small Bowel Adenocarcinoma). Editorial changes are made throughout the process.

Braftovi

Updated the policy to add the newly FDA expanded indication for use in combination with cetuximab and fluorouracil-based chemotherapy for the treatment of adult patients with metastatic CRC with a BRAF V600E mutation. This was previously approved for use in combination with cetuximab and mFOLFOX6.

Cosentyx

Updated the policy ad hoc to now allow use for the treatment of moderate-to-severe hidradenitis suppurativa in patients 12 years of age and older. This indication was previously only approved for use in adult patients.

Doptelet

Updated the policy to add the new FDA expanded indication for for use in pediatric members 1 year and older with persistent or chronic ITP (previously only approved in Adults with chronic ITP) based on Prime Therapeutics Thrombopoietin Receptor Antagonists (TPO-RA), Tavalisse and Wayrilz PAQL policy criteria updates. Also added the new formulation of Doptelet Sprinkle 10 mg oral granule capsules for members age 1 to less than 6 years old to all affected sections.

Elaprase

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 MPS II, added option of likely pathogenic variants in the IDS gene for confirming diagnosis. Editorial changes throughout the process. Added Appendix A – Non-Quantitative Treatment Limitations (NQTL) Factor Checklist.

Elelyso

Administrative changes to Length of Authorization section to delineate between authorization durations for initial and renewal period 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 the process.

Elfabrio

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 Fabry Disease, added option of likely pathogenic variants in the GLA gene for confirming diagnosis. Editorial changes throughout the process. Added Appendix A – Non-Quantitative Treatment Limitations (NQTL) Factor Checklist.

Fabrazyme

Administrative change to Length of Authorization section to delineate between authorization durations for initial and renewal periods and to include number of days allowed. To Fabry Disease, added options of likely pathogenic variants in the GLA gene for confirming diagnosis. Added Appendix A - Non-Quantitative Treatment Limitations (NQTL) Factor Checklist. Editorial changes are made throughout the process.

Hernexeos

Updated the policy to now allow use for the treatment of adults with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC), whose tumors have HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations. This was previously only approved for use in patients who had received prior to systemic therapy.

Imfinzi

To Ampullary Adenocarcinoma, updated to include intermediate performance status (ECOG PS 2) per NCCN update. To Esophageal/EGJ Cancers, updated criteria for use as neoadjuvant therapy in combination with tremelimumab to better align with NCCN and the Imjudo policy. Added new indications for use in Colon Cancer, Rectal Cancer, and Small Bowel Adenocarcinoma with applicable criteria and dosing supported by NCCN. To the dosing table, for neoadjuvant treatment of Esophageal/Gastric indications, added “including induction therapy” in combination with FLOT to clarify that the dosing for induction therapy in combo with FLOT for relieving dysphagia falls under neoadjuvant therapy. The verbiage in the Length of Authorization section was updated to mirror changes made to the dosing table. To ICD 10 table added the following per NCCN: C18.0, C18.2-C18.9, and C78.6 (related to Colon Cancer), C19, C20, C21.8 (related to rectal cancer), C78.00, C78.01, C78.02 and C78.7 (related to both Colon and Rectal Cancers), and C17.0, C17.1, C17.2, C17.3, C17.8, C17.9, and Z85.068 (related to Small Bowel Adenocarcinoma). Editorial changes are made throughout the process.

Imjudo

Editorial changes are made throughout the process.

Jemperli

To dMMR/MSI-H Cancer initial therapy for Esophageal, Esophagogastric Junction, and Gastric cancers, added allowance for use in patients with either no prior checkpoint inhibitor therapy or no tumor progression while on checkpoint inhibitor therapy when used in the first-line setting. Additionally, to dMMR/MSI-H Cancer, added use as neoadjuvant therapy for advanced or metastatic Small Bowel Adenocarcinoma per NCCN. To Anal Carcinoma, added option for use in combination with paclitaxel and carboplatin for treatment of inguinal node recurrence or as first-line treatment of metastatic disease per NCCN. To Dosage/Administration table added dosing for combination therapy for Anal Carcinoma. Corresponding updates were made to Length of Authorization section. To Appendix 1 - Covered Diagnosis Codes, added ICD-10 codes C50.A0-C50.A2 (related to Breast Cancer) per NCCN. Editorial changes are made throughout the process.

Kanuma

Administrative change to Length of Authorization section to delineate between authorization durations for initial and renewal periods and to include number of days allowed. To LAL Deficiency, it added options of likely pathogenic variants in the LIPA gene for confirming diagnosis. Added Appendix A - Non-Quantitative Treatment Limitations (NQTL) Factor Checklist. Editorial changes are made throughout the process.

Lamzede

Administrative changes to the Length of Authorization section to delineate between authorization durations for initial and renewal period and to include number of days allowed for authorization durations. To Alpha Mannosidosis, added option of likely pathogenic variants in the MAN2B1 gene for confirming diagnosis. Added Appendix A – Non-Quantitative Treatment Limitations (NQTL) Factor Checklist. Editorial changes are made throughout the process.

Lenmeldy

Administrative changes to the Length of Authorization section to delineate between authorization durations for initial and renewal periods. To Initial criteria softened language for the pre-labwork and hard vaccine requirement. To Initial and Renewal criteria to update ‘coverage’ to ‘prior authorization validity.’ Removed inactive HCPCS code J3590 – Unclassified biologics and J9399 - Unclassified drugs or biologicals, per IPD Analytics. Added Appendix A - Non-Quantitative Treatment Limitations (NQTL) Factor Checklist. Editorial changes are made throughout the process.

Libatyo

To Anal Carcinoma, added combination use with paclitaxel and carboplatin for use as treatment of inguinal node recurrence or as first line therapy for metastatic disease per updates in NCCN. The Length of Authorization section and Dosing/Administration table were also updated to reflect this new addition. To NSCLC as subsequent therapy in combination added use for members with ERBB2 (HER2) mutations per NCCN. To Appendiceal removed specific use in neoadjuvant therapy as per NCCN this use falls under recurrent or metastatic disease. To Rectal Cancer, added option for use in locally unresectable or medically inoperable diseases per changes in NCCN. Editorial changes are made throughout the process.

Loqtorzi

Anal Carcinoma added use in combination with paclitaxel and carboplatin for use as treatment of inguinal node recurrence or as first line therapy for metastatic disease. Corresponding updates were made to the dosing box and length of authorization section to align with NCCN recommendations for this indication. To Rectal Cancer, added option for use in locally unresectable or medically inoperable diseases per changes in NCCN. Editorial changes are made throughout the process.

Lumizyme

Administrative changes to the Length of Authorization section to delineate between authorization durations for initial and renewal period and to include number of days allowed for authorization durations. To Pompe Disease, added option of likely pathogenic variants in the GAA gene for confirming diagnosis. Added Appendix A – Non-Quantitative Treatment Limitations (NQTL) Factor Checklist. Editorial changes are made throughout the process.

Mepsevii

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 MPS VI, added option of likely pathogenic variants in the GUSB gene for confirming diagnosis. Editorial changes throughout the process. Added Appendix A – Non-Quantitative Treatment Limitations (NQTL) Factor Checklist.

Naglazyme

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 MPS VI, added option of likely pathogenic variants in the ARSB gene for confirming diagnosis. Editorial changes throughout the process. Added Appendix A – Non-Quantitative Treatment Limitations (NQTL) Factor Checklist.

Nexviazyme

Administrative change to Length of Authorization section to delineate between authorization durations for initial and renewal periods and to include number of days allowed. To Pompe Disease, added option of likely pathogenic variants in the GAA gene for confirming diagnosis. Added Appendix A - Non-Quantitative Treatment Limitations (NQTL) Factor Checklist. Editorial changes are made throughout the process.

Penpulimab-kcqx

To Head and Neck cancers added use for oligometastatic disease in combination with cisplatin or carboplatin and gemcitabine as subsequent therapy. To Appendiceal removed specific use in neoadjuvant therapy as per NCCN this use falls under recurrent or metastatic disease. Per NCCN updates added indications of Colon Cancer, Rectal Cancer, Anal Carcinoma, and Small Bowel Adenocarcinoma per 2A recommendations. Corresponding updates made to Dosage/Administration table and Length of Authorization for the addition of the new indications. To Appendix 1 – Covered Diagnosis Codes, added C17.0-C17.3, C17.8, C17.9, and Z85.068 (related to Small Bowel Adenocarcinoma), C18.0, C18.2-C18.9, C78.00-C78.02, C78.6, C78.7 and C19, C20 (Colon/Rectal Cancer), C21.0-C21.2, and C21.8(related to Anal Carcinoma), C30.0, C31.0, and Z85.818(related to Very Advanced Head and Neck Cancer). Removed ICD-10 code C79.89 (related to Very Advanced Head and Neck Cancer). Editorial changes are made throughout the process.

Pombiliti

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 members does not have any FDA contraindications. To Pompe Disease, added option of likely pathogenic variants in the GAA gene for confirming diagnosis. Editorial changes throughout the process. Added Appendix A – Non-Quantitative Treatment Limitations (NQTL) Factor Checklist.

Poteligeo

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, and to Initial and Renewal criteria to update’ coverage’ to ‘prior authorization validity.’ Added Non-Quantitative Treatment Limitations (NQTL) Factor Checklist to appendix section. Updated Mycosis Fungoides/Sezary Syndrome indication heading to Cutaneous Lymphomas (Mycosis Fungoides/Sezary Syndrome) to align with NCCN. To Adult T-Cell Leukemia/Lymphoma, added use in combination with CHOP as first-line therapy, continued treatment, or additional therapy per NCCN. Corresponding updates were made to Length of Authorization, Max Units, and Dosage/Administration sections. Moved single agent use from Universal Criteria to under indication specific headings in order to incorporate the new recommendation allowing for combination use. Editorial changes throughout the process.

Reblozyl

Ad hoc review to update the up-titration dosing rules for Anemia Due to Myelodysplastic Syndromes based on the updates made to the PI to have different titration rules for ESA-naïve members and ESA-refractory or intolerant members. Updates were made to the dosing table and renewal criteria sections to reflect this update. Editorial and formatting changes were also made to the dosing table for both Beta Thalassemia and Anemia Due to Myelodysplastic Syndromes to more closely align with the changes made to the PI. 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. Administrative changes to Initial and Renewal criteria to update ‘coverage’ to ‘prior authorization validity.’ Other editorial changes were made throughout the process.

Rituximab IV

Administrative change to alphabetize agents in policy title. Oncology indications added statement to allow KSHV-Associated Inflammatory Cytokine Syndrome to be excluded from CD20 positive requirement. To Adult B-Cell Lymphomas - PTLD and Pediatric Aggressive B-Cell Lymphomas PTLD, added option for prevention of EBV PTLD when a member has EBV reactivation, indication was also added to length of the auth section. To Unicentric Castleman Disease, alternate first-line therapy for unresectable or incompletely resected disease per NCCN update. To Management of Immune Checkpoint Inhibitor Related Toxicities, updated criteria on myositis to align with NCCN. Split GPA/MPA criteria to allow for approvals as induction therapy in combination with steroids and maintenance therapy allowable with or without steroids to reflect guideline support for combination with steroid to induce remission and allow tapering or discontinuation of steroids when receiving maintenance therapy. To Multiple Sclerosis, removed tables required for definitive diagnosis for RRMS, SPMS, and CIS. To SLE/LN, removed criteria requiring confirmation of FDA labeled or compendia supported indication for use since rituximab is compendia supported for this use. To the Dosing table, added voluntary dose reduction and/or interval extension recommendations. Added ICD-10 codes D89.89, & D89.9 related to KSHV-associated inflammatory cytokine syndrome. Editorial changes are made throughout the process.

Rituximab SQ

To universal criteria added statement to allow for KSHV-Associated Inflammatory Cytokine Syndrome to be excluded from CD20 positive requirement. Editorial changes are made throughout the process.

Romidepsin

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, and to Initial and Renewal criteria to update’ coverage’ to ‘prior authorization validity.’ To Primary cutaneous Lymphomas for MF/SS, updated the indication to include generalized cutaneous or extracutaneous lesions with large cell transformation (LCT) to align with NCCN guidelines. To PTCL, add use as subsequent therapy for progressive disease per NCCN. Global change to add NQTL Factor Checklist (Appendix A) to policy. Editorial changes are made throughout the process.

Tecentriq IV

To Length of Authorization, streamlined duration of use for adjuvant treatment of Colon Cancer. To NSCLC, streamlined options for use in the adjuvant setting to align with NCCN. To Colon Cancer, remove the requirement for stage III disease for use in the adjuvant setting and instead allowed for treatment of stage IIC, III or metastatic disease. Also added option for use as a single agent for locally unresectable, medically inoperable, advanced, or metastatic disease per updated NCCN guidelines, along with dosing. Added new indications of Small Bowel Adenocarcinoma and Rectal Cancer with corresponding criteria and dosing per NCCN. LOA was updated to accommodate new SBA indication. To Appendix 1, added ICD-10 codes C43.10 (related to Cutaneous Melanoma), C17.0, C17.1, C17.2, C17.3, C17.8, C17.9, Z85.068 (related to Small Bowel Adenocarcinoma), C78.6 (related to Colon Cancer), C19, C20, C21.8 (related to Rectal Cancer), C78.00-C78.02, C78.7 (related to Colon and Rectal Cancer). Editorial changes throughout the process.

Tevimbra

To Esophageal, Esophagogastric & Gastric cancers, removed symbol leading to notes box from the indication heading and added allowance for use in patients with either no prior checkpoint inhibitor therapy or no tumor progression while on checkpoint inhibitor therapy when used in the first-line setting for gastric cancer or in the first or subsequent-line setting for esophageal/GEJ cancer. To Anal Carcinoma, added option for use in combination with paclitaxel and carboplatin as treatment of inguinal node recurrence or first-line treatment of metastatic disease. The dosing table and LOA were updated to accommodate this new regimen. To Appendiceal Neoplasms and Cancers, streamlined criteria to mirror other PD1/PD-L1 policies. To Rectal Cancer, added option for use in locally unresectable or medically inoperable per changes in NCCN. Editorial changes throughout the process.

Unloxcyt

Added Colon Cancer, Rectal Cancer, and Small Bowel Adenocarcinoma indication headings and criteria to Initial Approval Criteria section per NCCN. Updated Dosing table to indicate that the dosing pattern listed applies to all indications. Added additional active NDC to the Billing Code/Availability section, per DrugIQ review. To ICD10 table, added C18.0, C18.2-C18.9, C78.6 (related to Colon Cancer), C19, C20, C21.8 (related to Rectal Cancer), C78.00-C78.02, and C78.7 (related to both Colon and Rectal Cancer), C17.0, C17.1, C17.2, C17.3, C17.8, C17.9, and Z85.068 (related to Small Bowel Adenocarcinoma). Other editorial changes were made throughout the process.

Vimizim

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 MPS VI, add option of likely pathogenic variants in the GALNS gene for confirming diagnosis. Editorial changes throughout the process. Added Appendix A – Non-Quantitative Treatment Limitations (NQTL) Factor Checklist.

VPRIV

Administrative changes to the Length of Authorization section to delineate between authorization durations for initial and renewal period 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 the process.

Xenpozyme

Administrative changes to the Length of Authorization section to delineate between authorization durations for initial and renewal period and to include number of days allowed for authorization durations. To ASMD, added option of likely pathogenic variants in the SMPD1 gene for confirming diagnosis. To Renewal Criteria, an added option of skeletal maturation assessment is added to align with baseline measures in Initial Criteria. Added Appendix A – Non-Quantitative Treatment Limitations (NQTL) Factor Checklist. Editorial changes are made throughout the process.

Zynyz

Updated section heading for Anal Carcinoma, editorial changes to use with paclitaxel and carboplatin to add use as treatment of inguinal node recurrence per updates in NCCN. The Length of Authorization section and Dosing/Administration table were also updated to reflect changes to this indication. To Appendiceal removed specific use in neoadjuvant therapy as per NCCN this use falls under recurrent or metastatic disease. To Rectal Cancer, added option for use in locally unresectable or medically inoperable disease per changes in NCCN. Editorial changes are made throughout the process.

Alpha-1 Proteinase Inhibitors

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. Global change to remove any specific contraindications in criteria and replace them with general language indicating members do not have any FDA contraindications. To Emphysema due to AAT deficiency, added option for pharmacologic therapies as an example of optimal medical therapy per guideline support and client request. To the Billing Section, remove Prolastin-C powder as its NDCS are no longer active per IPD. Added Appendix A - Non-Quantitative Treatment Limitations (NQTL) Factor Checklist. Editorial changes are made throughout the process.

Beleodaq

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. PTCL added use as subsequent therapy for progressive disease per NCCN. Global change to add NQTL Factor Checklist (Appendix A) to policy. Editorial changes are made throughout the process.

Brineura

Administrative change to Length of Authorization section to delineate between authorization durations for initial and renewal periods and to include number of days allowed. Global change to remove any specific contraindications in criteria and replace them with general language indicating members do not have any FDA contraindications. Added Appendix A - Non-Quantitative Treatment Limitations (NQTL) Factor Checklist. Editorial changes are made throughout the process.

Civanti

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 Prevention of chemotherapy-induced nausea and vomiting (CINV), reformatted criteria and added use as 4-drug combo for members with additional risk factors receiving moderately emetogenic chemotherapy know to be higher risk to align with NCCN update. Updated HEC/MEC table and added the risk factor table to match NCCN. Added Appendix A – Non-Quantitative Treatment Limitations (NQTL) Factor Checklist. Editorial changes are made throughout the process.

Fosaprepitant IV

Administrative changes to alphabetize all agents in policy name. 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 Prevention of chemotherapy-induced nausea and vomiting (CINV), reformatted criteria and added use as 4-drug combo for members with additional risk factors receiving moderately emetogenic chemotherapy know to be higher risk to align with NCCN update. Updated HEC/MEC table and added the risk factor table to match NCCN. Added new NDC for Focinvez per IPD. Added Appendix A – Non-Quantitative Treatment Limitations (NQTL) Factor Checklist. Editorial changes are made throughout the process.

Mylotarg

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, and to Initial and Renewal criteria to update’ coverage’ to ‘prior authorization validity.’ Global change to add NQTL Factor Checklist (Appendix A) to policy. Editorial changes are made throughout the process.