Nivolumab (Opdivo) (CP.PHAR.121)

Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP

Policy updates include:

• For urothelial carcinoma, updated indication and criteria for the first-line treatment of urothelial carcinoma in combination with cisplatin and gemcitabine
• Converted advanced/metastatic urothelial carcinoma from accelerated approval to full FDA-approval. for non-small cell lung cancer, revised dose limit for use in combination with Yervoy from 3 mg/kg every 2 weeks to 360 mg every 3 weeks, removed criteria for use in tumors positive for tumor mutation burden biomarkers per National Comprehensive Cancer Network No Longer Recommended Uses
• For colorectal cancer, clarified weight-based dose limit for pediatric members
• Added off-label criteria per National Comprehensive Cancer Network compendium: for malignant pleural mesothelioma as subsequent therapy, classic Hodgkin lymphoma as palliative therapy, squamous cell carcinoma of the head and neck in combination with Erbitux or with cisplatin and gemcitabine, colorectal cancer characterized with POLE/POLED1 mutation, esophageal cancer or esophagogastric junction cancer characterized with microsatellite instability-high (MSI-H) or mismatch repair deficient (Dmmr) mutations, gastric cancer characterized with MSI-H or dMMR mutations, adult relapsed or refractory primary mediastinal large B-cell lymphoma, MSI-H or dMMR mutational cancers (e.g., ampullary adenocarcinoma, small bowel adenocarcinoma, endometrial carcinoma), biliary tract cancers, classic Kaposi sarcoma in combination with Yervoy, soft tissue sarcomas, anaplastic thyroid carcinoma as a single agent, anal carcinoma prior to resection, and merkel cell carcinoma
• Removed off-label criteria per National Comprehensive Cancer Network compendium: failure of induction therapy/initial treatment for primary mediastinal large B-cell lymphoma, and bone cancer as a single agent

Alirocumab (Praluent) (CP.PHAR.124)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP

Policy updates include:

• Updated criteria per pediatric age expansion for heterozygous familial hypercholesterolemia
• For heterozygous familial hypercholesterolemia and atherosclerotic cardiovascular disease, clarified statin and ezetimibe step therapy criteria apply to members ≥ 18 years old.

Ravulizumab-cwvz (Ultomiris) (CP.PHAR.415)

Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP

Policy updates include:

• Criteria added for new FDA indication: neuromyelitis optica spectrum disorder
• Updated contraindications per revised FDA labeling.

Zanubrutinib (Brukinsa) (CP.PHAR.467)

Ambetter

Policy updates include:

• Added new FDA-approved indication for follicular lymphoma
• For mantle cell lymphoma, added option to be prescribed in combination with ritixumab or as a component of TRIANGLE regimen per National Comprehensive Cancer Network
• For marginal zone lymphoma, added criterion that disease is releapsed, refractory, or progressive

Ciltacabtagene Autoleucel (Carvykti) (CP.PHAR.533)

Ambetter

Policy updates include:

• Updated boxed warnings to include secondary hematological malignancies per prescribing information
• Updated criteria to reflect expanded indication for use after at least one prior line of therapy

Maralixibat (Livmarli) (CP.PHAR.543)

Ambetter

Policy updates include:

• Criteria updated with newly approved indication for progressive familial intrahepatic cholestasis: modified age restriction, removed minimum body weight restriction, and updated limitation of use and contraindications per FDA labeling

Omalizumab (Xolair) (CP.PCH.49)

Ambetter

Policy updates include:

• Added new FDA-labeled indication of IgE-mediated food allergy
• Corrected continued therapy section for NCCN Compendium indications to allow for continued therapy for an approval duration of 6 months
• Moved immunotherapy-related pruritus appendix information to Appendix I.

Lumasiran (Oxlumo) (CP.PHAR.473)

Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP

Policy updates include:

• Added exclusion for concomitant use of Oxlumo with Rivfloza
• Clarified the intent of the dialysis criteria to reflect that the member should not be on peritoneal dialysis and if they are on hemodialysis then they have been on a stable hemodialysis regimen for at least 4 weeks, per the ILLUMINATE-C trial inclusion criteria
• Added urologists to the list of specialist prescribers
• Updated Commercial authorization duration language to match current standard language

Sodium Phenylbutyrate-Taurursodiol (Relyvrio) (CP.PHAR.584)

Ambetter

Policy updates include:

• Updated Appendix D table of revised El Escorial criteria
• References reviewed and updated
• Removed initial approval criteria and limited continued authorization to 1 month due to manufacturer withdrawal
• Added Appendix F with details of market withdrawal

Spesolimab-sbzo (Spevigo) (CP.PHAR.606)

Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP

Policy updates include:

• Added Bimzelx, Zymfentra, Omvoh, Wezlana, Sotyktu, and Velsipity to section III.B
• References reviewed and updated
• Added criteria for newly approved pediatric extension for patients 12 years of age and older weighing at least 40 kg
• Added newly approved subcutaneous formulation.

Nedosiran (Rivfloza) (CP.PHAR.619)

Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP

Policy updates include:

• For Commercial line of business changed approval duration to “6 months or to the member’s renewal date, whichever is longer”
• Added exclusion for concomitant use of Rivfloza with Oxlumo
• For Continued Therapy clarified that one of the listed criteria would need to be met, to align with Oxlumo criteria
• Added urologists to the list of specialist prescribers

Resmetirom (Rezdiffra) (CP.PHAR.647)

Ambetter

Policy updates include:

• Drug is now FDA-approved – criteria updated per FDA labeling: added new metabolic dysfunction-associated steatohepatitis (MASH) terminology
• Added metabolic dysfunction-associated steatohepatitis (MASH) fibrosis diagnostic test options and timeframe from within the last 6 months
• Updated criterion for body mass index (BMI) lower limit requiring documentation of adherence to lifestyle modification from 27 kg/m2 to 25 kg/m2 per overweight range of body mass index (BMI) index
• Added prescriber attestation that member is currently receiving standard of care management for concomitant related conditions
• Updated maximum FDA-labeled dosing
• For positive response criteria, added option of metabolic dysfunction-associated steatohepatitis (MASH) resolution with no worsening of fibrosis