Effective September 1, 2022: Pharmacy and Biopharmacy Policies

Adalimumab (Humira), Adalimumab-afzb (Abrilada), Adalimumab-atto (Amjevita), Adalimumab-adbm (Cyltezo), Adalimumab-bwwd (Hadlima), Adalimumab-fkjp (Hulio), Adalimumab-adaz (Hyrimoz) (CP.PHAR.242)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP

Policy updates include:

• Added biosimilars Abrilada and Hulio to policy.

Amivantamab-vmjw (Rybrevant) (CP.PHAR.544)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter

Policy updates include:

• Per NCCN compendium added additional option for recurrent NSCLC

Bebtelovimab (LY-CoV1404) (CP.PHAR.579)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter

Policy updates include:

• Added criteria to ensure that the member is not located in a geographic area where infection is likely to have been caused by a non-susceptible SARS-CoV-2 variant, per the EUA Limitations of Authorized Use.

Brexanolone (Zulresso) (CP.PHAR.417)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter

Policy updates include:

• Updated indication and age requirements from adults (18 years) to 15 years of age or older.

Bulevirtide (Hepcludex) (CP.PHAR.589)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter

Policy includes:

• Criteria will mirror the clinical information from the prescribing information once FDA-approved
• Criteria is only applicable for Medicaid and CHIP when the drug is added to the formulary for coverage
• Requests for indications not approved by the 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: Chronic Hepatitis D Infection (must meet all):
  • Diagnosis of chronic HDV infection as evidenced by detectable serum HDV RNA levels by quantitative assay in the last 6 months
  • Prescribed by or in consultation with a gastroenterologist, hepatologist, or infectious disease specialist
  • Age ≥ 18 years
  • Two elevated alanine transaminase (ALT) lab values within the past 12 months (≥ 70 IU/L for men, ≥ 50 IU/L for women)
  • Child-Pugh hepatic insufficiency score < 7 (Child-Pugh Class A)
  • No previous (within the last 2 years) or current decompensated liver disease, including coagulopathy, hepatic encephalopathy, and esophageal varices hemorrhage
  • Dose does not exceed 2 mg (1 vial) per day
  • Approval duration: 6 months
• Continuation Approval Criteria: Chronic Hepatitis D Infection (must meet all):
  • Currently receiving medication via Centene benefit or member has met initial approval criteria
  • Member is responding positively to therapy as evidenced by both of the following:
    • A reduction in HDV RNA levels or undetectable HDV RNA levels by quantitative assay
    • A reduction or normalization (≤ 35 IU/L for men, ≤ 25 IU/L for women) of ALT lab values
  • If request is for a dose increase, new dose does not exceed 2 mg (1 vial) per day
  • Approval duration: 12 months

Caplacizumab-yhdp (Cablivi) (CP.PHAR.416)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter

Policy updates include:

• Added alternate pathway for confirmation of diagnosis with ADAMTS13 level

Capmatinib (Tabrecta) (CP.PHAR.494)

Ambetter

Policy updates include:

• Added option for recurrent disease per NCCN

CNS Stimulants (CP.PMN.92)

Ambetter

Policy updates include:

• Updated criteria to reflect FDA approved pediatric extension to age ≥ 12 years.
• For indicators of increased cardiovascular risk, removed coronary artery/heart disease and clarified hypertension should be “controlled”.

Crizotinib (Xalkori) (CP.PHAR.90)

Ambetter

Policy updates include:

• Added new indication for Inflammatory Myofibroblastic Tumor.

Deutetrabenazine (Austedo) (CP.PCH.42)

Ambetter

Policy updates include:

• Per May SDC and prior clinical guidance, for TD removed requirement for AIMS score for initial authorizations.

Esketamine (Spravato) (CP.PMN.199)

Ambetter

Policy updates include:

• Reduced trial duration of antidepressants for TRD from at least 8 weeks to 4 weeks

Fenfluramine (Fintepla) (CP.PMN.246)

Ambetter

Policy updates include:

• Added criteria for newly FDA-approved indication of LGS.

Fulvestrant (Faslodex Injection) (CP.PHAR.424)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter

Policy updates include:

• Added “adenosarcoma without sarcomatous overgrowth” to disease classification for the indication of uterine sarcoma per NCCN guideline (2A category)

Lisocabtagene maraleucel (Breyanzi) (CP.PHAR.483)

Ambetter

Policy updates include:

• Pre-emptive criteria converted for new FDA approved indication: Large B-Cell Lymphoma

Loncastuximab tesirine-lpyl (Zynlonta) (CP.PHAR.539)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter

Policy updates include:

• Per NCCN compendium, added use in AIDS-related DLBCL, primary effusion lymphoma, and HHV8-positive DLBCL not otherwise specified
• Added additional off-label use in member that is not a candidate for transplant and request is for second-line therapy for partial response, no response, or progressive disease following chemoimmunotherapy in patients with histologic transformation to DLBCL

Mechlorethamine (Valchlor) (CP.PHAR.381)

Ambetter

Policy updates include:

• Added Langerhans cell histiocytosis to section B as NCCN recommended use (off label)

Nivolumab and Relatlimab (Opdualag) (CP.PHAR.588)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter

Policy includes:

• Criteria is only applicable for Medicaid and CHIP when the drug is added to the formulary for coverage
• Requests for indications not approved by the 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: Melanoma (must meet all):
  • Diagnosis of unresectable or metastatic melanoma
  • Prescribed by or in consultation with an oncologist
  • Age ≥ 12 years
  • Weight ≥ 40 kg
  • Request meets one of the following*:
    • Dose does not exceed 480 mg of nivolumab and 160 mg of relatlimab every 4 weeks
    • Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence)
    • *Prescribed regimen must be FDA-approved or recommended by NCCN
  • Approval duration: 6 months
• Continuation Approval Criteria: Melanoma (must meet all):
  • Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Opdualag for a covered indication and has received this medication for at least 30 days
  • Member is responding positively to therapy
  • If request is for a dose increase, request meets one of the following:*
    • New dose does not exceed 480 mg of nivolumab and 160 mg of relatlimab every 4 weeks;
    • New dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).
    • *Prescribed regimen must be FDA-approved or recommended by NCCN
• Approval duration: 12 months

Omaveloxolone (RTA-408) (CP.PHAR.590)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter

Policy includes:

• Criteria will mirror the clinical information from the prescribing information once FDA-approved
• Criteria is only applicable for Medicaid and CHIP when the drug is added to the formulary for coverage
• Requests for indications not approved by the 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: Friedreich’s Ataxia (must meet all):
  • Diagnosis of FA confirmed by FXN gene mutation on genetic testing
  • Prescribed by or in consultation with a neurologist
  • Age ≥ 16 years
  • Documentation of recent (within the last 30 days) baseline Modified Functional Assessment Rating Scale (mFARS) score between 20 and 80 (see Appendix D)
  • Member has the ability to swallow capsules
  • Dose does not exceed 150 mg (1 capsule) per day
  • Approval duration: 6 months
• Continuation Approval Criteria: Friedreich’s Ataxia (must meet all):
  • Currently receiving medication via Centene benefit or member has previously met initial approval criteria
  • Member is responding positively to therapy as evidenced by, including but not limited to, improvement in any of the following parameters: FA symptoms, maximal exercise testing, or mFARS score
  • If request is for a dose increase, new dose does not exceed 150 mg per day.
  • Approval duration: 6 months

Pegzilarginase (AEB1102) (CP.PHAR.587)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter

Policy includes:

• Criteria will mirror the clinical information from the prescribing information once FDA-approved
• Criteria is only applicable for Medicaid and CHIP when the drug is added to the formulary for coverage
• Requests for indications not approved by the 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: Arginase 1 Deficiency (must meet all):
  • Diagnosis of ARG1-D confirmed by one of the following:
    • Genetic confirmation of an ARG1 pathogenic variant
    • Documentation of reduced arginase enzyme activity in red blood cells
  • Prescribed by or in consultation with a physician experienced in treating metabolic disorders
  • Age ≥ 2 years
  • Provider attestation that member is currently on a protein-restricted diet and will continue this diet during treatment with pegzilarginase
  • Documentation of plasma arginine level from within the last 3 months
  • Dose does not exceed the FDA-approved maximum recommended dose
  • Approval duration: 6 months
• Continuation Approval Criteria: Arginase 1 Deficiency (must meet all):
  • Currently receiving medication via Centene benefit or member has previously met initial approval criteria
  • Member is responding positively to therapy as evidenced by a reduction in plasma arginine levels since initiation of therapy
  • Provider attestation that member is currently on a protein-restricted diet and will continue this diet during treatment with pegzilarginase
  •  If request is for a dose increase, new dose does not exceed the FDA-approved maximum recommended dose
  • Approval duration: 12 months

Polatuzumab Vedotin-piiq (Polivy) (CP.PHAR.433)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter

Policy updates include:

• For DLBCL per NCCN modified to only require one prior therapy and allow use as a single agent, updated Appendix D with DLBCL subtypes to align with NCCN
• For Section I,B Other NCCN Recommended Uses criteria set, removed HGBL as this is considered a DLBCL subtype
• Per NCCN modified to only require at least one prior therapy for all requests and require member is not a transplant candidate for all requests other than FL

Ripretinib (Qinlock) (CP.PHAR.502)

Ambetter

Policy updates include:

• Added additional option for progressive GIST
• Clarified criteria should require either that the request is following failure of 3 kinase inhibitors or member has a PDGFRA exon 18 mutation, not both
• For continued therapy added dose escalation option to 300 mg per day if member experienced disease progression on 150 mg/day per NCCN

Sacubitril-Valsartan (Entresto) (CP.PMN.67)

Ambetter

Policy updates include:

• Per May SDC and prior clinical guidance, added redirection to Jardiance for LVEF ≥ 41%, removed prior requirement restricting use to LVEF ≤ 40%.

Selinexor (Xpovio) (CP.PHAR.431)

Ambetter

Policy updates include:

• For MM added option for combination use with Darzalex Faspro, as well as carfilzomib and dexamethasone per NCCN
• For DLBCL added additional DLBCL subtypes (e.g., histological transformation from indolent lymphomas, AIDS-related DLBCL, primary effusion lymphoma, HHV8-positive DLBCL NOS), added additional descriptors for progressive disease and clarified refractory includes no or partial response to align with verbiage from NCCN compendium

Setmelanotide (Imcivree) (CP.PHAR.491)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter

Policy updates include:

• Updated criteria to include new FDA approved indication of obesity due to BBS
• Revised creatinine clearance and positive response requirements per prescribing information for POMC, PCSK1, or LEPR deficiency, removed initial maintenance approval duration of 6 months as weight loss should be evaluated after 4 months per prescribing information (requests for continued maintenance therapy may be approved using the continued approval criteria)

SGLT2 inhibitors (HIM.PA.91)

Ambetter

Policy updates include:

• For HFrEF, removed requirement for prior use of standard HF therapy as SGLT2 inhibitors are now a recommended first line therapy per 2022 AHA/ACC/HFSA guidelines.

Step Therapy (HIM.PA.109)

Ambetter

Policy updates include:

• Per May SDC and prior clinical guidance, removed zolpidem tartrate ER and ramelteon from criteria.

Tisagenlecleucel (Kymriah) (CP.PHAR.361)

Ambetter

Policy updates include:

• Pre-emptive criteria converted for new FDA approved indication: Follicular Lymphoma

Trientine (Syprine, Cuvrior) (CP.PHAR.438)

Ambetter

Policy updates include:

• added new dose form Cuvrior;  

Tucatinib (Tukysa) (CP.PHAR.497)

Ambetter

Policy updates include:

• Revised redirection language to failure of one or more anti-HER2 based regimens

Ulcer Therapy Combinations (Omeclamox Pak, Pylera, Talicia, Voquezna)(CP.PMN.277)

Ambetter

Policy updates include:

• Added Voquezna Triple/Dual Pak to criteria with specific redirection based on H. pylori clarithromycin- and amoxicillin-sensitivity.