POLICY

APPLICABLE PRODUCTS

NEW POLICY OVERVIEW OR UPDATED POLICY REVISIONS

Belimumab (Benlysta) (CP.PHAR.88)

Ambetter

Policy updates include:

• Updated lupus nephritis criteria and section V dosage/administration to reflect newly approved subcutaneous autoinjector dosing for pediatric patients
• Revised Food and Drug Administration (FDA) Approved Indication(s) section to remove “autoantibody positive” from SLE indication per updated Food and Drug Administration (FDA) labeling (no change to criteria)
• Modified initial approval duration for Medicaid/Ambetter from 6 months to 12 months as this is a maintenance medication for a chronic condition.

Immune Globulins (CP.PHAR.103)

Ambetter,

Policy updates include:

• Added new formulation Gammagard liquid ERC.

Rituximab (Rituxan, Riabni, Ruxience, Truxima, Rituxan Hycela) (CP.PHAR.260)

Ambetter

Policy updates include:

• For Riabni, Ruxience, and Truxima, added newly approved pemphigus vulgaris indication to criteria
• For granulomatosis with polyangiitis/microscopic polyangiitis, added criterion “dose is supported by compendium, practice guidelines, or peer-reviewed literature for the relevant off-label use” to initial approval and continued therapy per local market request

Buprenorphine (Sublocade, Brixadi) (CP.PHAR.289)

Ambetter

Policy updates include:

• For Sublocade, updated criteria to include option for second initiation dose between Day 8 to 1 Month

Larotrectinib (Vitrakvi) (CP.PHAR.414)

Ambetter

Policy updates include:

• Updated indication from accelerated approval to traditional full approval

Darolutamide (Nubeqa) (CP.PHAR.435)

Ambetter

Policy updates include:

• Added updated indication of metastatic castration-sensitive prostate cancer
• Removed criterion for combination with docetaxel
• Revised nomenclature of metastatic hormone-sensitive prostate cancer to metastatic castration-sensitive prostate cancer

Zanubrutinib (Brukinsa) (CP.PHAR.467)

Ambetter

Policy updates include:

• Added new tablet formulation

Tafasitamab-cxix (Monjuvi) (CP.PHAR.508)

Ambetter

Policy updates include:

• Added updated indication of follicular lymphoma and revised section I.A. header from diffuse large B-cell lymphoma to “B-cell Lymphoma”
• Moved additional National Comprehensive Cancer Network (NCCN) recommended off-label indications from section I.B. to fall under section I.A. B-cell lymphomas
• Replaced examples of diffuse large B-cell lymphoma with complete National Comprehensive Cancer Network (NCCN) subtype list in Appendix D
• Added National Comprehensive Cancer Network (NCCN) Compendium supported off-label use in B-cell lymphomas other than follicular lymphoma and histologic transformation of indolent lymphomas to diffuse large B-cell lymphoma
• Revised wording for “Member is not eligible for autologous stem cell transplant” to “no intention to proceed to transplant” per National Comprehensive Cancer Network (NCCN) Compendium
• Added relapsed or refractory marginal zone lymphoma to Section III diagnoses/indications for which coverage is not authorized due to lack of efficacy in this patient population observed in the INMIND trial.

Spesolimab-sbzo (Spevigo) (CP.PHAR.606)

Ambetter

Policy updates include:

• Added new dosage form [300 mg/2 ml (150 mg/ml) single-dose prefilled syringe] to criteria

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

Ambetter

Policy updates include:

• Added newly approved brand Yeztugo and corresponding human immunodeficiency virus (HIV)-1 prep criteria
• For human immunodeficiency virus (HIV)-1 treatment, revised continued approval duration for Commercial from “12 months” to “6 months or to the member’s renewal date, whichever is longer” per standard injectable agent approach

Garadacimab (Andembry) (CP.PHAR.673)

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: Hereditary Angioedema (HAE) (must meet all):

o Diagnosis of HAE confirmed by both of the following:

§ History of recurrent angioedema;

§ Low C4 level and low C1-INH antigenic or functional level;

o Prescribed by or in consultation with a hematologist, allergist, or immunologist;

o Age ≥ 12 years;

o Prescribed for long-term prophylaxis of HAE attacks, and request meets one of the following;

§ Member experiences more than one severe event per month;

§ Member is disabled more than five days per month;

§ Member has a history of previous airway compromise;

o Member is not using Andembry in combination with another FDA-approved product for long-term prophylaxis of HAE attacks (e.g., Cinryze®, Haegarda®, Takhzyro®, Orladeyo®);

o Dose does not exceed both of the following:

§ Loading dose: 400 mg;

§ Maintenance dose: 200 mg every month.

o Approval duration: 12 months

· Continued Therapy: Hereditary Angioedema (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;

•  
  • Member is responding positively to therapy as evidenced by a reduction in attacks from baseline;

o Member is not using Andembry in combination with another FDA-approved product for long-term prophylaxis of HAE attacks (e.g., Cinryze, Haegarda, Takhzyro, Orladeyo);

o If request is for a dose increase, new dose does not exceed 200 mg every month.

o Approval duration: 12 months

Datopotamab deruxtecan-dlnk (Datroway) (CP.PHAR.715)

Ambetter

Policy updates include:

• Added newly approved indication for non-small cell lung cancer

Sebetralstat (Ekterly) (CP.PHAR.723)

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: Hereditary Angioedema (HAE) (must meet all):

o Diagnosis of HAE confirmed by both of the following:

§ History of recurrent angioedema;

§ Low C4 level and low C1-INH antigenic or functional level;

o Prescribed by or in consultation with a hematologist, allergist, or immunologist;

o Age ≥ 12 years;

o Prescribed for treatment of acute HAE attacks;

o For members age ≥ 18 years: Failure of icatibant^ (generic Firazyr®), unless contraindicated or clinically significant adverse effects are experienced;

o Member is not using Ekterly in combination with another FDA-approved product for treatment of acute HAE attacks (e.g., Kalbitor®, Berinert®, Ruconest®, Firazyr);

o Dose does not exceed both of the following:

§ 600 mg (2 tablets) per dose;

§ Up to 2 doses (4 tablets) administered in a 24-hour period.

o Approval duration: 6 months

· Continued Therapy: Hereditary Angioedema (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);

•  
  • Member is responding positively to therapy;
  • Member is not using Ekterly in combination with another FDA-approved product for treatment of acute HAE attacks (e.g., Kalbitor, Berinert, Ruconest, Firazyr);

o If request is for a dose increase, new dose does not exceed both of the following:

§ 600 mg (2 tablets) per dose;

§ Up to 2 doses (4 tablets) administered in a 24-hour period.

o Approval duration: 12 months

Biologic and Non-biologic DMARDs (HIM.PA.SP60)

Ambetter

Policy updates include:

• Added newly approved biosimilar Starjemza to criteria
• For Steqeyma, added new dosage formulation [single-dose vial for subcutaneous injection: 45 mg/0.5 ml] and updated pediatric dosing for plaque psoriasis and psoriatic arthritis in section V

Insulin Glargine (Basaglar, Lantus/unbranded Lantus, Rezvoglar, Toujeo/unbranded Toujeo) (HIM.PA.09)

Ambetter

Policy updates include:

• Removed unbranded Semglee from policy
• Added redirection to unbranded Semglee if branded Semglee is unavailable due to shortage

Niraparib (Zejula) (CP.PHAR.408)

Ambetter

Policy updates include:

• Updated indication for maintenance treatment of adult patients with advanced ovarian cancer in the first-line setting with restriction to those with homologous recombination deficiency -positive tumors only
• For ovarian cancer, added criteria for members with platinum-sensitive persistent or recurrent disease per National Comprehensive Cancer Network (NCCN) and revised tablet quantity limit from 3 tablets to 1 tablet

Mercaptopurine (Purixan) (CP.PHAR.447)

Ambetter

Policy updates include:

• Added redirection to generic oral suspension
• For redirection to mercaptopurine tablets revised verbiage from “member must use” to “failure of.”