POLICY
| APPLICABLE PRODUCTS
| NEW POLICY OVERVIEW OR UPDATED POLICY REVISIONS
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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, Udenyca Onbody), Pegfilgrastim-bmez (Ziextenzo) (CP.PHAR.296)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter
| Policy updates include:
- Added new formulation for Udenyca prefilled syringe for use with the on-body injector
- For Acute Radiation Syndrome, added “Request is not for Udenyca Onbody”
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Pancrelipase (Creon, Pancreaze, Pertyze, Viokace, Zenpep) (CP.PCH.44)
| Ambetter
| Policy updates include:
- Updated the Food and Drug Administration (FDA) Approved Indication(s) section to reflect generalization of the approved indication language for Creon, Pancreaze, Pertzye, and Zenpep
- Revised maximum dose criterion to include 10,000 lipase units/kg per day
- Updated maximum dosing in Section V per revised Food and Drug Administration (FDA) labels for all products
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Nivolumab (Opdivo) (CP.PHAR.121)
| Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- Hepatocellular carcinoma, removed repeated criteria for documentation of Child-Pugh Class A and prescribed in combination with Yervoy
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Ferric Carboxymaltose (Injectafer) (CP.PHAR.234)
| Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- Corrected New York Heart Association (NYHA) class for heart failure indication
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Irinotecan Liposome (Onivyde) (CP.PHAR.304)
| Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- Added newly Food and Drug Administration (FDA)-approved use as first-line use when prescribed in combination with oxaliplatin, fluorouracil, and leucovorin for metastatic disease
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Pembrolizumab (Keytruda) (CP.PHAR.322)
| Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- Updated Food and Drug Administration (FDA)-approved indication section for hepatocellular carcinoma to full approval with update from those “who have previously been treated with sorafenib” to “secondary to hepatitis B who have received prior systemic therapy other than a PD-1/PD-L1-containing regimen”
- For hepatocellular carcinoma, added option for prior use of Cabometyx and added option to be prescribed as first-line treatment per National Comprehensive Cancer Network (NCCN)
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Avacincaptad pegol (Izervay) (CP.PHAR.641)
| Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy includes:
- Requests for indications not approved by the Food and Drug Administration (FDA) are reviewed with the off-label use policy for the relevant line of business: HIM.PHAR.154 for Ambetter, and CP.PMN.53 for Medicaid and CHIP
- Initial Approval Criteria: Geographic Atrophy (must meet all):
- Diagnosis of geographic atrophy with all of the following characteristics:
- Geographic atrophy is secondary to age-related macular degeneration;
- Total geographic atrophy area ≥ 2.5 and ≤ 17.5 mm2 (1 and 7 disk areas [DA], respectively);
- If geographic atrophy is multifocal, at least one focal lesion ≥ 1.25 mm2 (0.5 DA);
- Presence of hyperautofluorescence in the junctional zone of geographic atrophy ;
- Geographic atrophy is not centered in the fovea;
- Prescribed by or in consultation with an ophthalmologist;
- Age ≥ 50 years;
- Best corrected visual acuity (BCVA) between 20/25 and 20/320;
- Member does not have either of the following:
- Signs of diabetic retinopathy in either eye;
- Evidence of choroidal neovascularization in the eye(s) affected by geographic atrophy ;
- Dose does not exceed 2 mg (0.1 mL of 20 mg/mL solution) in each affected eye every 21 days.
- Approval duration: Medicaid/HIM – 6 months
- Continued Therapy: Geographic Atrophy (must meet all):
- Member meets one of the following:
- Currently receiving medication via Centene benefit or member has previously met initial approval criteria;
- Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state specific addendums for CC.PHARM.03A and CC.PHARM.03B);
- Member is responding positively to therapy;
- Treatment has not exceeded 12 months in the affected eye;
- If request is for a dose increase, new dose does exceed 2 mg (0.1 mL of 20 mg/mL solution) in each affected eye every 21 days.
- Approval duration: Medicaid/HIM – 6 months (up to 12 months of treatment per eye)
Policy updates include:
- Removed HCPCS codes [C9399, J3490] and added HCPCS code [J2782]
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Baloxavir Marboxil (Xofluza) (CP.PMN.185)
| Ambetter
| Policy updates include:
- Updated to reflect new pediatric expansion from at least 12 years of age to age at least 5 years for those who are high risk of developing influenza-related complications
- Updated Tamiflu pediatric dosages in Appendix B as recommended by the CDC and the American Academy of Pediatrics
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Compounded Medications (CP.PMN.280)
| Ambetter
| Policy updates include:
- Clarified that active ingredient(s) in compound are Food and Drug Administration (FDA)-approved.
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Repository Corticotropin Injection (Acthar Gel, Purified Cortrophin Gel) (CP.PHAR.168)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- For Acthar Gel updated product availability to include pre-filled injector
- Revised references to “H.P. Acthar Gel ” to instead reference “Acthar Gel” per prescribing information
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Pembrolizumab (Keytruda) (CP.PHAR.322)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter
| Policy updates include:
- For cervical cancer, criteria added for new Food and Drug Administration (FDA) indication for usage in combination with chemoradiotherapy with FIGO 2014 Stage III-IVA cancer.
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