POLICY
| APPLICABLE PRODUCTS
| NEW POLICY OVERVIEW OR UPDATED POLICY REVISIONS
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Glycerol Phenylbutyrate (Ravicti) (CP.PHAR.207)
| Ambetter
| Policy updates include:
- Revised stepwise redirection language per SDC request from an ‘or’ to ‘and’ statement
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Pegfilgrastim (Neulasta, Neulasta Onpro), Pegfilgrastim-jmdb (Fulphila), Pegfilgrastim-pbbk (Fylnetra), Pegfilgrastim-apgf (Nyvepria), Eflapegrastim-xnst (Rolvedon), Efbemalenograstim alfa-vuxw (Ryzneuta), Pegfilgrastim-fpgk (Stimufend), Pegfilgrastim-cbqv (Udenyca), Pegfilgrastim-bmez (Ziextenzo) (CP.PHAR.296)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter
| Policy updates include:
- For Stimufend, added new indication of hematopoietic subsyndrome of acute radiation syndrome to Food and Drug Administration approved indication section and section V
- Added newly Food and Drug Administration approved Ryzneuta
- For acute radiation syndrome, removed “request is not for Rolvedon” as off-label use is supported on National Comprehensive Cancer Network compendium and added standard off-label dosing language for Rolvedon and Ryzneuta
- Added Neulasta OnPro, Rolvedon, and Ryzneuta redirection to Udenyca where applicable
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Pembrolizumab (Keytruda) (CP.PHAR.322)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter
| Policy updates include:
- Updated Food and Drug Administration-approved indication for Merkel cell carcinoma to full Food and Drug Administration approval and added new indication of HER2-negative gastric/gastroesophageal junction
- For non-small cell lung cancer, criteria added for new Food and Drug Administration approved indication – “combination with platinum-containing chemotherapy as neoadjuvant therapy, then continued as single agent as adjuvant treatment after surgery for patients with tumors ≥ 4 cm or node positive” and option for disease to be resectable or resected
- Added criteria for newly approved Food and Drug Administration indication for biliary tract cancer and National Comprehensive Cancer Network
- For gastric/esophageal/gastroesophageal junction cancer, clarified specific uses per updated PI, including requirement that tumor must be HER2-positive and express PD-L1 (CPS ≥ 1) when prescribed in combination use with trastuzumab for gastric/gastroesophageal junction adenocarcinoma
for microsatellite instability-high/mismatch repair deficient, added gastric or gastroesophageal junction cancer as cancer type that can be prescribed as first line or subsequent therapy and added option to prescribe in combination with platinum- and fluoropyrimidine-based chemotherapy for gastric or gastroesophageal junction cancer per National Comprehensive Cancer Network - For urothelial cancer in combination with Padcev, updated Food and Drug Administration-approved indication to full approval and removed requirement for cisplatin ineligibility
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CP.PHAR.504 Voclosporin (Lupkynis)
| Ambetter
| Policy updates include:
- Added criteria for member’s treatment response and risk of worsening nephrotoxicity for requests exceeding > 12 months of Lupkynis therapy and revised continued approval duration to 6 months based on time to complete response with Lupkynis
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HIM.PA.SP60 Biologic and Non-biologic DMARDs
| Ambetter
| Policy updates include:
- Added Cyltezo with specific NDCs to list of preferred adalimumab products
- For Orencia, updated psoriatic arthritis criteria with pediatric extension to include ages 2 years and older
- For polyarticular juvenile idiopathic arthritis, added “for Orencia: members 2 to 17 years of age, prescribed route of administration is subcutaneous” to align with Medicaid criteria
- For Cosentyx, added newly approved hidradenitis suppurativa indication to criteria
- For Idacio, added newly approved uveitis indication to criteria
- For Idacio, added new dosage formulation [single-dose institutional use vial kit: 40 mg/0.8 mL]
- For Crohn’s disease and polyarticular juvenile idiopathic arthritis, updated Idacio pediatric dosing in section V
- Added newly approved biosimilar Wezlana to criteria
- Added Wezlana to section III.B
- For atopic dermatitis initial criteria, removed systemic immunosuppressant therapy step criterion per updated guideline and competitor analysis and in alignment with previously P&T approved approach
- For Appendix B, removed atopic dermatitis systemic immunosuppressant therapy therapeutic alternatives
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