POLICY
| APPLICABLE PRODUCTS
| NEW POLICY OVERVIEW OR UPDATED POLICY REVISIONS
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Selpercatinib (Retevmo) (CP.PHAR.478)
| Ambetter
| Policy update includes:
- Updated to reflect pediatric expanded use down to 2 years of age (previously 12 years of age) for thyroid cancers and new pediatric use in solid tumors
- Added age restriction for histiocytic neoplasms per National Comprehensive Cancer Network (NCCN)
- Converted Food and Drug Administration (FDA) approved indication for thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate) from accelerated approval to full approval per PI
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Derisomaltose (Monoferric) (CP.PHAR.480)
| Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy update includes:
- For cancer- and chemotherapy-induced anemia, added redirection to preferred iron products
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Insulin Delivery Systems (V-Go, Omnipod, InPen) (CP.PHAR.534)
| Ambetter
| Policy update includes:
- For Omnipod DASH and Omnipod 5, moved device limit (1 per 4 years) from approval duration to criteria and revised approval duration to 30 days due to operational limitations for benefit programming
- Added NDC for Omnipod DASH PDM Kit per request
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Tralokinumab-ldrm (Adbry) (CP.PHAR.577)
| Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy update includes:
- Added new autoinjector 300 mg/2 mL dosage formulation and added maximum numbers of injections to approval criteria
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Sodium Oxybate (Xyrem, Lumryz) and Calcium Magnesium Potassium Sodium Oxybate (Xywav) (CP.PMN.42)
| Ambetter
| Policy update includes:
- For narcolepsy with cataplexy and narcolepsy with excessive daytime sleepiness, added redirection to generic Xyrem for brand Xyrem requests and “for Xywav or Lumryz requests” modified failure of “Xyrem” to failure of “sodium oxybate (Xyrem)”
- Added generic Xyrem to criteria and Xyrem to Risk Evaluation and Mitigation Strategy (REMS) program information in Appendix C
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Blinatumomab (Blincyto) (CP.PHAR.312)
| Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- Specified that infant acute lymphoblastic leukemia must have KMT2A status (11q23 rearranged) and added pathway for use as frontline consolidation therapy per National Comprehensive Cancer Network (NCCN)
- Revised boxed warning in Appendix C per updated prescribing information
- Added new Food and Drug Administration (FDA) approved indication for Philadelphia chromosome-negative (Ph-) B-cell precursor acute lymphoblastic leukemia (B-ALL) as consolidation therapy and added age restriction of at least 1 month per updated prescribing information
- Rearranged criteria into Philadelphia chromosome-positive (Ph+) vs Ph- disease, added pathway for use as induction therapy for Ph+ disease, removed requirement that relapsed or refractory Ph+ disease must be refractory to tyrosine kinase inhibitor (TKI), added pathway for use as maintenance therapy for Ph- disease, added pathway for use after consolidation therapy and for Ph-like disease for pediatric members, and specified how Blincyto should be prescribed for all uses per National Comprehensive Cancer Network (NCCN)
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Pembrolizumab (Keytruda) (CP.PHAR.322)
| Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- For classical Hodgkin lymphoma, added option to be prescribed with ICE and added pathway for palliative therapy (previously had after hematopoietic stem cell transplant, which falls under palliative therapy) per National Comprehensive Cancer Network (NCCN)
- For urothelial carcinoma, added pathway to be prescribed as single agent and member has previously received other chemotherapy (previously only allowed post-platinum chemotherapy)
- For hepatocellular carcinoma, removed disease is classified as Child-Pugh Class A
- For biliary tract cancer, added option for resected gross residual (R2) disease and removed combination with Lenvima per National Comprehensive Cancer Network (NCCN)
- For endometrial carcinoma, clarified continued as a single agent for maintenance therapy when prescribed in combination with carboplatin and paclitaxel
- For National Comprehensive Cancer Network (NCCN) recommended uses (off-label): expanded to stage IB for mycosis fungoides, for prescribed as first-line or subsequent therapy - added metastatic anaplastic carcinoma, anaplastic sarcoma, and vaginal cancer, for prescribed as single-agent subsequent therapy – added soft tissue sarcoma subtypes, added option for Keytruda to be prescribed in combination with cyclophosphamide and bevacizumab for platinum-resistant persistent ovarian cancer, fallopian tube cancer, and primary peritoneal cancer per National Comprehensive Cancer Network (NCCN)
- For continuation requests, added criterion for maximum duration of therapy (previously was included within requests for dose increase criterion)
- Updated appendix E
- Added new Food and Drug Administration (FDA) approved indication for endometrial cancer in combination with carboplatin and paclitaxel followed by Keytruda as a single agent
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