Effective October 1, 2025: Pharmacy and Biopharmacy Policies

POLICY

APPLICABLE PRODUCTS

NEW POLICY OVERVIEW OR UPDATED POLICY REVISIONS

Nivolumab (Opdivo), Nivolumab/Hyaluronidase-nvhy (Opdivo Qvantig) (CP.PHAR.121)

Medicaid and CHIP

Policy updates include:

·         For colorectal cancer: updated Food and Drug Administration (FDA) Approved Indication(s) section to include combination use with Yervoy for unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer and to reflect conversion from accelerated approval to full approval for microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer that has progressed following treatment with fluropyrimidine, oxaliplatin, and irinotecan, clarified criteria for Opdivo Qvantig requests is prescribed as subsequent-line systemic therapy, updated Section V for adult and pediatric patients weighing at least 40 kg from "3 mg/kg” to “240 mg” IV followed by ipilimumab on the same day and added option for 6 mg/kg every 4 weeks after combination with ipilimumab for pediatric patients weighing <40 kg

·         For hepatocellular carcinoma: updated Food and Drug Administration (FDA) Approved Indication(s) section with addition of first-line treatment in combination with ipilimumab and conversion from accelerated approval to full approval for those who has progressed following treatment with fluoropyrimidine, oxaliplatin and irinotecan and updated criteria with the following: added disease is unresectable or metastatic, added criteria for usage in first-line systemic therapy setting and additional criteria for subsequent-line systemic therapy setting per National Comprehensive Cancer Network (NCCN).

·         Food and Drug Administration (FDA) Approved Indication(s) section and criteria to reflect revised indication that limits use to tumors expressing programmed death-ligand 1 (PD-L1) (1 or higher) in combination with chemotherapy for unresectable advanced or metastatic esophageal squamous cell carcinoma in first-line setting and gastric cancer, gastroesophageal junction cancer and esophageal adenocarcinoma (previously approved regardless of programmed death-ligand 1 (PD-L1) status)

·         For microsatellite instability-high (MSI-H) or mismatch repair deficient (dmmr) esophageal cancers, specified usage as perioperative therapy when prescribed as a single age, as induction or palliative therapy when prescribed combination with fluoropyrimidine-containing chemotherapy, and as induction, neoadjuvant, perioperative, or palliative when prescribed in combination with Yervoy.

Tocilizumabctemra Actemra (CP.PHAR.263)

Medicaid and CHIP

Policy updates include:

·         For Tyenne, added newly approved cytokine release syndrome and COVID-19 indications to criteria.

Ipilimumab (Yervoy) (CP.PHAR.319)

Medicaid and CHIP

Policy updates include:

·         For colorectal cancer, updated Food and Drug Administration (FDA) Approved Indication(s) section to earlier line of therapy with removal of language “that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan” and conversion from accelerated approval to full approval and updated dosing in Section V to reflect a maximum of 4 doses

·         For hepatocellular carcinoma, updated Food and Drug Administration (FDA) Approved Indication(s) section with addition of first-line treatment in combination with nivolumab and conversion from accelerated approval to full approval for those who have been previously treated with sorafenib, and updated criteria with the following: added disease is unresectable, metastatic or advanced

·         Removed documentation of Child-Pugh Class A status and member has previously received Nexavar, Lenvima, or Tecentriq + bevacizumab

·         Added criteria for usage in first-line and subsequent-line systemic therapy setting per National Comprehensive Cancer Network (NCCN).

·         Updated Food and Drug Administration (FDA) Approved Indication(s) section and criteria to reflect revised indication that limits use to tumors expressing programmed death-ligand 1 (PD-L1) (1 or higher) for unresectable advanced or metastatic esophageal squamous cell carcinoma in combination with Yervoy per updated PI (previously approved regardless of programmed death-ligand 1 (PD-L1) status)

·         Also for esophageal squamous cell carcinoma, added option to be prescribed as palliative therapy and clarified when prescribed as induction, neoadjuvant, perioperative, or palliative therapy that tumor is characterized as microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR).

Pembrolizumab (Keytruda) (CP.PHAR.322)

Medicaid and CHIP

Policy updates include:

·         Updated Food and Drug Administration (FDA) Approved Indication(s) section for first-line treatment of adults with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy whose tumors express PD-L1 (CPS at least 1) from accelerated approval to full approval

·         For gastric cancer, esophageal cancer, or gastroesophageal junction cancer, added option to bypass disease is unresectable, locally advanced, recurrent, or metastatic if member is planned for esophagectomy per National Comprehensive Cancer Network (NCCN)

Durvalumab (Imfinzi) (CP.PHAR.339)

Medicaid and CHIP

Policy updates include:

·         Added criteria for newly Food and Drug Administration (Food and Drug Administration (FDA))-approved indication of muscle invasive bladder cancer

·         Under continued approval duration, revised maximum number of cycles for resectable non-small cell lung cancer from 12 to 16 to include neoadjuvant treatment.

Ranibizumab (Lucentis, Susvimo), Lucentis Biosimilars (CP.PHAR.186)

Medicaid and CHIP

Policy updates include:

·         For Susvimo, updated Food and Drug Administration (FDA) indication to include diabetic retinopathy

Treprostinil (Orenitram, Remodulin, Tyvaso, Yutrepia) (CP.PHAR.199)

Medicaid and CHIP

Policy updates include:

·         Added new dosage form, Yutrepia

Mepolizumab (Nucala) (CP.PHAR.200)

Medicaid and CHIP

Policy updates include:

·         Added criteria for new Food and Drug Administration (FDA) approved indication of chronic obstructive pulmonary disease

Factor VIII (CP.PHAR.215)

Medicaid and CHIP

Policy updates include:

·         Updated age from at least 12 years of age to at least 7 years of age for Jivi per age extension

Dupilumab (Dupixent) (CP.PHAR.336)

Medicaid and CHIP

Policy updates include:

·         Added new indication for chronic spontaneous urticaria per updated prescribing information.

·         For chronic obstructive pulmonary disease, revised postbronchodilator forced expiratory volume in 1 second (FEV1) requirement from 30-70% to 20-80% to align with Nucala

Retifanlimab-dlwr (Zynyz) (CP.PHAR.629)

Medicaid and CHIP

Policy updates include:

·         Added new Food and Drug Administration (FDA)-approved indication for squamous cell carcinoma of the anal canal

Nipocalimab-aahu (Imaavy) (CP.PHAR.720)

Medicaid and CHIP

Policy includes:

·         Criteria is only applicable for Medicaid and CHIP when the drug is added to the fee schedule for coverage

·         Requests for indications not approved by the FDA are reviewed with the off-label use policy MS.PMN.53 for Medicaid and CHIP

·         Initial Approval Criteria: Generalized Myasthenia Gravis (gMG) (must meet all):

o   Diagnosis of gMG;

o   Prescribed by or in consultation with a neurologist;

o   Age at least 12 years;

o   Myasthenia Gravis-Activities of Daily Living (MG-ADL) score at least 6 at baseline;

o   Myasthenia Gravis Foundation of America (MGFA) clinical classification of Class II to IV;

o   Member has positive serologic test for one of the following:

§  Anti-AChR antibodies;

§  Anti-MuSK antibodies;

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  • If member has positive serologic test for anti-AChR antibodies: Failure of a cholinesterase inhibitor, unless contraindicated or clinically significant adverse effects are experienced;
  • Failure of a corticosteroid, unless contraindicated or clinically significant adverse effects are experienced;
  • Failure of at least one immunosuppressive therapy, unless clinically significant adverse effects are experienced or all are contraindicated;

o   Imaavy is not prescribed concurrently with Bkemv™/Epysqli®/Soliris®, Rystiggo®, Ultomiris®, Vyvgart®, Vyvgart® Hytrulo, or Zilbrysq®;

o   Documentation of member’s current weight (in kg);

o   Dose does not exceed both of the following:

§  Loading dose: 30 mg/kg once;

§  Maintenance dose: 15 mg/kg 2 weeks after the loading dose and every 2 weeks thereafter.

o   Approval duration: 6 months

·         Continued Therapy: Generalized Myasthenia Gravis (must meet all):

o   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;

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  • Member is responding positively to therapy as evidenced by a 2-point reduction in MG-ADL total score from baseline;
  • Imaavy is not prescribed concurrently with Bkemv/Epysqli/Soliris, Rystiggo, Ultomiris, Vyvgart, Vyvgart Hytrulo, or Zilbrysq;
  • Documentation of member’s current weight (in kg);

o   If request is for a dose increase, new dose does not exceed 15 mg/kg every 2 weeks.

o   Approval duration: 6 months