Policy
| Applicable Products
| New Policy Overview or Updated Policy Revisions
|
Pembrolizumab, Pembrolizumab Berahyaluronidase alfa-pmph (Keytruda, Keytruda Qlex) (CP.PHAR.322)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter
| Policy updates include:
- New indication for muscle invasive bladder cancer added
- Extended initial approval duration from 6 to 12 months for this maintenance medication for a chronic condition
- HCPCS code [J3590] removed and HCPCS code [J9999] added
|
Inebilizumab-cdon (Uplizna) (CP.PHAR.458)
| Ambetter
| Policy updates include:
- Added criteria for the newly approved indication of gmg
- For neuromyelitis optica spectrum disorder and immunoglobulin G4-related disease (IGG4-RD), extended initial approval durations for Medicaid and Ambetter from 6 to 12 months and revised all approval durations for Commercial to “6 months or to the member’s renewal date, whichever is longer”
|
Berotralstat (Orladeyo) (CP.PHAR.485)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS) and CHIP
| Policy updates include:
- Updated to reflect pediatric extension down to 2 years of age and added new oral pellet dosage form
|
Fibrinogen concentrate (human) (Fibryga, RiaSTAP), Fibrinogen Human-chmt (Fesility) (CP.PHAR.526)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter
| Policy updates include:
- Added newly approved Fesilty
|
Mitapivat (Pyrukynd, Aqvesme) (CP.PHAR.558)
| Ambetter
| Policy updates include:
- Added Aqvesme for treatment of anemia in adults with thalassemia to policy
|
Trofinetide (Daybue, Daybue Stix) (CP.PHAR.600)
| Ambetter
| Policy updates include:
- Added new Daybue Stix formulation
- Revised approval durations to 12 months
|
Pirtobrutinib (Jaypirca) (CP.PHAR.620)
| Ambetter
| Policy updates include:
- For chronic lymphocytic leukemia/small lymphocytic lymphoma, updated Food and Drug Administration (FDA) Approved Indications (s) section to reflect conversion from accelerated approval to full approval
- For chronic lymphocytic leukemia/small lymphocytic lymphoma, simplified prior therapy requirements to “Member has received prior treatment with a covalent BTK inhibitor” and simplified Richter’s transformation requirement per National Comprehensive Cancer Network (NCCN) compendium
- For all indications, extended initial approval duration from 6 to 12 months
|
Retifanlimab-dlwr (Zynyz) (CP.PHAR.629)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter
| Policy updates include:
- Updated Food and Drug Administration (FDA) Approved Indication(s) section for MCC from accelerated approval to full approval
- Extended Medicaid and Ambetter initial approval durations from 6 months to 12 months for this maintenance medication for a chronic condition
- For Merkel cell carcinoma, added pathway for in-transit regional disease and primary regional disease per National Comprehensive Cancer Network (NCCN) compendium and removed requirement of “Disease is not amenable to surgery or radiation therapy” for metastatic or recurrent locally advanced disease
|
Epcoritamab-bysp (Epkinly) (CP.PHAR.634)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter
| Policy updates include:
- Updated with newly approved indication of combination with lenalidomide and rituximab for relapsed or refractory follicular lymphoma and updated accelerated approved to traditional approval for follicular lymphoma indications
- Expanded monotherapy option for B-cell lymphoma subtypes per National Comprehensive Cancer Network (NCCN)
- Summarized National Comprehensive Cancer Network (NCCN) and Food and Drug Administration (FDA)-approved uses for improved clarity
- Extended initial approval duration for Medicaid/Ambetter from 6 months to 12 months
|
Nerandomilast (Jascayd) (CP.PHAR.759)
| Ambetter
| Policy updates include:
- Added newly Food and Drug Administration (FDA) approved indication for progressive pulmonary fibrosis
|
Cariprazine (Vraylar) (CP.PMN.91)
| Ambetter
| Policy updates include:
- Updated criteria with pediatric extension to include age 10 years and older for bipolar disorder and age 13 years and older for schizophrenia (both previously approved only in adults)
- Added new 0.5 mg and 0.75 mg capsule strengths
|
Berotralstat (Orladeyo) (HIM.PA.169)
| Ambetter
| Policy updates include:
- Updated to reflect pediatric extension down to 2 years of age and added new oral pellet dosage form
|
