Gemcitabine Intravesical System (Inlexzo) (CP.PHAR.753)

Ambetter

Policy includes

• Requests for indications not approved by the FDA are reviewed with the off-label use policy HIM.PHAR.154 for Ambetter
• Initial Approval Criteria
  • Non-Muscle Invasive Bladder Cancer (NMIBC) (must meet all):
    • Diagnosis of NMIBC with carcinoma in-situ;
    • Prescribed by or in consultation with an oncologist or urologist;
    • Age at least 18 years;
    • Member is refractory to  bacillus Calmette-Guerin (BCG)* treatment; *Prior authorization may be required for BCG immunotherapy
    • Member is not a candidate for cystectomy;
    • Member has previously undergone transurethral resection of bladder tumor (TURBT);
    • Request meets one of the following:
      • Dose does not exceed 225 mg once every 3 weeks for 8 instillations, followed by once every 12 weeks for 6 instillations;
      • Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).
    • Approval duration: 12 months
• Continued Therapy
  • Non-Muscle Invasive Bladder Cancer (must meet all):
    • Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Inlexzo for a covered indication and has received this medication for at least 30 days;
    • Member is responding positively to therapy as evidenced by lack of disease recurrence or progression;
    • Member has not received at least 14 instillations;
    • If request is for a dose increase, request meets one of the following:
      • If member has received < 8 instillations: New dose does not exceed 225 mg once every 3 weeks for up to 8 total instillations, followed by once every 12 weeks for 6 instillations;
      • If member has received at least 8 instillations: New dose does not exceed 225 mg once every 12 weeks for up to 6 total instillations;
      • New dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).
    • Approval duration: 12 months

Imlunestrant (Inluriyo) (CP.PHAR.754)

Ambetter

Policy includes:

• Requests for indications not approved by the FDA are reviewed with the off-label use policy HIM.PHAR.154 for Ambetter
• Initial Approval Criteria
  • Breast Cancer (must meet all):
    • Diagnosis of breast cancer;
    • Prescribed by or in consultation with an oncologist;
    • Age at least 18 years;
    • Disease has all of the following characteristics:
      • estrogen receptor (ER)-positive;
      • human epidermal growth factor receptor 2 (HER2) -negative;
      • estrogen receptor-1 (ESR1) -mutated;
      • Advanced (including locally advanced) or metastatic;
    • Disease has progressed following at least one line of endocrine therapy;
    • If member is a premenopausal or perimenopausal biological female, member has been treated with ovarian ablation or is receiving ovarian suppression;
    • If member is a biological male, member is receiving an agent that suppresses testicular steroidogenesis (e.g., gonadotropin-releasing hormone agonists);
    • For brand Inluriyo requests, member must use generic imlunestrant, if available, unless contraindicated or clinically significant adverse effects are experienced;
    • Request meets one of the following:
      • Dose does not exceed one of the following:
        • 400 mg (2 tablets) per day;
        • If member is receiving a concomitant strong CYP3A inducer (e.g., carbamazepine, fosphenytoin, phenytoin, rifampin): 600 mg (3 tablets) per day;
      • Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).
    • Approval duration: 12 months
• Continued Therapy
  • Breast Cancer (must meet all):
    • Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Inluriyo for breast cancer and has received this medication for at least 30 days;
    • Member is responding positively to therapy;
    • Dose is at least 200 mg per day;
    • For brand Inluriyo requests, member must use generic imlunestrant, if available, unless contraindicated or clinically significant adverse effects are experienced;
    • If request is for a dose increase, request meets one of the following:
      • New dose does not exceed one of the following:
        • 400 mg (2 tablets) per day;
        • If member is receiving a concomitant strong CYP3A inducer (e.g., carbamazepine, fosphenytoin, phenytoin, rifampin): 600 mg (3 tablets) per day;
      • New dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).
    • Approval duration: 12 months

Paltusotide (Palsonify) (CP.PHAR.755)

Ambetter

Policy includes:

• Requests for indications not approved by the FDA are reviewed with the off-label use policy HIM.PHAR.154 for Ambetter
• Initial Approval Criteria
  • Acromegaly (must meet all):
    • Diagnosis of acromegaly as evidenced by one of the following:
      • Pre-treatment insulin-like growth factor-I (IGF-I) level above the upper limit of normal based on age and gender for the reporting laboratory;
      • Serum growth hormone (GH) level at least 1 µg/L after a 2-hour oral glucose tolerance test;
    • Prescribed by or in consultation with an endocrinologist;
    • Age at least 18 years;
    • Inadequate response to surgical resection or pituitary irradiation, or member is not a candidate for such treatment;
    • Failure of Sandostatin® LAR Depot, unless contraindicated or clinically adverse effects are experienced;

*Prior authorization may be required for Sandostatin LAR Depot

• Dose does not exceed both of the following:
  • 60 mg per day;
  • 2 tablets per day.
• Approval duration: 12 months
• Continued Therapy
  • Acromegaly (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;
      • Member is responding positively to therapy;
      • If request is for a dose increase, new dose does not exceed both of the following (a and b):
        • 60 mg per day;
        • 2 tablets per day.
      • Approval duration: 12 months

Remibrutinib (Rhapsido) (CP.PHAR.756)

Ambetter

Policy includes:

• 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
• Initial Approval Criteria
  • Chronic Spontaneous Urticaria (CSU) (must meet all):
    • Diagnosis of CSU;
    • Prescribed by or in consultation with a dermatologist, immunologist, or allergist;
    • Age at least 18 years;
    • One of the following:
      • For Illinois HIM requests only: Failure of one antihistamine at maximum indicated doses used for at least 2 weeks, unless clinically significant adverse effects are experienced or all are contraindicated;
      • For all other requests: Failure of both of the following, unless clinically significant adverse effects are experienced or all are contraindicated (i and ii):
        • Two antihistamines (including one second generation antihistamine – e.g., cetirizine, levocetirizine, fexofenadine, loratadine, desloratadine) at maximum indicated doses, each used for at least 2 weeks;
        • A leukotriene modifier (LTRA) in combination with an antihistamine at maximum indicated doses for at least 2 weeks;
    • Rhapsido is not prescribed concurrently with Dupixent® or Xolair®;
    • Dose does not exceed 50 mg (2 tablets) per day.
    • Approval duration: 12 months
• Continued Therapy
  • Chronic Spontaneous Urticaria (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;
    • Member is responding positively to therapy;
    • Rhapsido is not prescribed concurrently with Dupixent or Xolair;
    • If request is for a dose increase, new dose does not exceed 50 mg (2 tablets) per day.
    • Approval duration: 12 months

Risperidone LA inj (Risperdal Consta, Perseris, Rykindo, Uzedy) (CP.PHAR.293)

Ambetter

Policy updates include:

• Added new indication of bipolar 1 disorder for Uzedy

Pemetrexed (Alimta, Pemfexy, Axtle) (CP.PHAR.368)

Ambetter

• Updated indication for Axtle to include combination with Keytruda and a platinum for non-small cell lung cancer
• added off-label indication of thyroid carcinoma per National Comprehensive Cancer Network (NCCN) Compendium
• updated HCPCS code description for J9292

Lenacapavir (Sunlenca, Yeztugo) (CP.PHAR.622)

Ambetter

Policy updates include:

• Removed failure of Fuzeon per manufacturer discontinuation

Lidocaine transdermal (Bondlido, Lidoderm, ZTlido) (CP.PMN.08)

Ambetter

Policy updates include:

• Added Bondlido as a new drug and dosage strength

Roflumilast (Daliresp, Zoryve) (CP.PMN.46)

Ambetter

Policy updates include:

• Added Zoryve 0.05% cream to criteria with pediatric extension down to 2 years of age for atopic dermatitis