POLICY
| APPLICABLE PRODUCTS
| NEW POLICY OVERVIEW OR UPDATED POLICY REVISIONS
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Delgocitinib (Anzupgo) (CP.PHAR.744)
| 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 Hand Eczema (CHE) (must meet all):
- Diagnosis of CHE;
- Member has hand eczema that has persisted for greater than 3 months or returned twice or more within the last 12 months;
- Provider attestation that member has moderate to severe hand;
- Prescribed by or in consultation with a dermatologist or allergist;
- Age at least 18 years;
- One of the following:
- For Illinois HIM requests only: Failure of one formulary topical corticosteroid, unless clinically significant adverse effects are experienced or all are contraindicated;
- For all other requests: Failure of both of the following (i and ii), unless clinically significant adverse effects are experienced or all are contraindicated;
- One formulary topical corticosteroid used for at least 2 weeks;
- One of the following:
- A second formulary topical corticosteroid used for at least 2 weeks;
- One topical calcineurin inhibitor used for at least 4 weeks;
- Anzupgo is not prescribed concurrently with biologic medications (e.g., Dupixent ®, Adbry®), biologic disease-modifying antirheumatic drugs (e.g., Humira®, Enbrel®, Taltz®, Stelara®), JAK inhibitors (e.g., Cibinqo®, Opzelura™, Xeljanz®, Rinvoq®, Olumiant®), or potent immunosuppressants (e.g., azathioprine, cyclosporine);
- Dose does not exceed both of the following:
- One 30-gram tube per 2 weeks;
- 60 grams per month.
- Approval duration: 6 months
- Continued Therapy
- Chronic Hand Eczema (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 as evidenced by, including but not limited to, reduction in itching and scratching, no signs of erythema, scaling, hyperkeratosis/lichenification, vesiculation, edema, or fissures;
- Anzupgo is not prescribed concurrently with biologic medications (e.g., Dupixent, Adbry), biologic disease-modifying antirheumatic drugs (e.g., Humira, Enbrel, Taltz, Stelara), JAK inhibitors (e.g., Cibinqo, Opzelura, Xeljanz, Rinvoq, Olumiant), or potent immunosuppressants (e.g., azathioprine, cyclosporine);
- If request is for a dose increase, new dose does not exceed both of the following:
- One 30-gram tube per 2 weeks;
- 60 grams per month.
- Approval duration: 12 months
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Pegcetacoplan (Empaveli, Syfovre) (CP.PHAR.524)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter
| Policy updates include:
- Added criteria for new Food and Drug Administration (FDA)-approved indication of C3 Glomerulopathy, Primary Immune-Complex Membranoproliferative Glomerulonephritis (C3G/primary IC-MPGN) for Empaveli
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Dordaviprone (Modeyso) (CP.PHAR.745)
| 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
- Diffuse Midline Glioma (must meet all):
- Diagnosis of diffuse midline glioma;
- Prescribed by or in consultation with an oncologist;
- Age at least 1 year;
- Disease has both of the following characteristics:
- Presence of H3 K27M mutation;
- Progressive following prior therapy (includes radiation therapy);
- For Modeyso requests, member must use dordaviprone, 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:
- Adults: 625 mg per week;
- Pediatrics:
- Weight 10 kg to less than 12.5 kg: 125 mg per week;
- Weight 12.5 kg to less than 27.5 kg: 250 mg per week;
- Weight 27.5 kg to less than 42.5 kg: 375 mg per week;
- Weight 42.5 kg to less than 52.5 kg: 500 mg per week;
- Weight at least 52.5 kg: 625 mg per week;
- 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
- Continued Therapy
- Diffuse Midline Glioma (must meet all):
- Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Modeyso for a covered indication and has received this medication for at least 30 days;
- Member is responding positively to therapy;
- For Modeyso requests, member must use dordaviprone, 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:
- Adults: 625 mg per week;
- Pediatrics:
- Weight 10 kg to less than 12.5 kg: 125 mg per week;
- Weight 12.5 kg to less than 27.5 kg: 250 mg per week;
- Weight 27.5 kg to less than 42.5 kg: 375 mg per week;
- Weight 42.5 kg to less than 52.5 kg: 500 mg per week;
- Weight at least 52.5 kg: 625 mg per week;
- 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
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Zongertinib (Hernexeos) (CP.PHAR.750)
| 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
- Non-Small Cell Lung Cancer(NSCLC) (must meet all):
- Diagnosis of unresectable, recurrent, advanced, or metastatic NSCLC;
- Prescribed by or in consultation with an oncologist;
- Age at least 18 years;
- Prescribed as single agent;
- Disease has activating HER2 (ERBB2) mutations;
- Failure of a prior systemic therapy;
- For Hernexeos requests, member must use zongertinib, 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:
- For body weight less than 90 kg: 120 mg (2 tablets) per day;
- For body weight at least 90 kg: 180 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). *Prescribed regimen must be FDA-approved or recommended by NCCN
- Approval duration: 12 months
- Continued Therapy
- Non-Small Cell Lung Cancer (must meet all):
- Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Hernexeos for a covered indication and has received this medication for at least 30 days;
- Member is responding positively to therapy;
- For Hernexeos requests, member must use zongertinib, 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:
- For body weight less than 90 kg: 120 mg (2 tablets) per day;
- For body weight at least 90 kg: 180 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). *Prescribed regimen must be FDA-approved or recommended by NCCN
- Approval duration: 12 months
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Rilzabrutinib (Wayrilz) (CP.PHAR.751)
| 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
- Immune Thrombocytopenia (must meet all):
- Diagnosis of persistent or chronic ITP;
- Prescribed by or in consultation with a hematologist;
- Age at least 18 years;
- One of the following:
- Current (within 30 days) platelet count less than 30,000/µL;
- Member has an active bleed;
- Member meets one of the following:
- Failure of a systemic corticosteroid;
- Member has intolerance or contraindication to systemic corticosteroids, and failure of an immune globulin, unless contraindicated or clinically significant adverse effects are experienced (see Appendix B);
- *Prior authorization may be required for immune globulins
- Wayrilz is not prescribed concurrently with rituximab, a thrombopoietin receptor agonist (e.g., Doptelet®, Promacta®, Mulpleta®, Nplate®), or spleen tyrosine kinase inhibitor (e.g., Tavalisse™);
- Dose does not exceed 800 mg (2 tablets) per day.
- Approval duration: 12 months
- Continued Therapy
- Immune Thrombocytopenia (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 (e.g., increase in platelet count from baseline, reduction in bleeding events);
- Wayrilz is not prescribed concurrently with rituximab, a thrombopoietin receptor agonist (e.g., Doptelet, Promacta, Mulpleta, Nplate), or spleen tyrosine kinase inhibitor (e.g., Tavalisse);
- If request is for a dose increase, new dose does not exceed 800 mg (2 tablets) per day.
- Approval duration: 12 months
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Aceclidine (Vizz) (CP.PMN.302)
| 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.
- Presbyopia (must meet all):
- Diagnosis of presbyopia;
- Prescribed by or in consultation with an optometrist or ophthalmologist;
- Age between 45 and 75 years at the time of therapy initiation;
- Failure of corrective eyeglasses or contact lenses to resolve the presbyopia symptoms, unless contraindicated or clinically significant adverse effects are experienced;
Vizz is not prescribed concurrently with Vuity® or Qlosi™; - Dose does not exceed 2 drops per eye per day
- Approval duration: 12 months
- Continued Therapy
- Presbyopia (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 2 drops per eye per day.
- Approval duration: 12 months
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Brensocatib (Brinsupri) (CP.PMN.303)
| 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
- Non-Cystic Fibrosis Bronchiectasis (must meet all):
- Diagnosis of non-cystic fibrosis bronchiectasis confirmed by chest computed tomography (CT) scan;
- Prescribed by or in consultation with a pulmonologist;
- Age at least 12 years;
- Provider attestation that member is currently receiving optimal supportive therapy (examples include but are not limited to: airway clearance techniques, pulmonary rehabilitation, mucoactives [e.g., nebulized hypertonic saline, mannitol, dornase alfa, acetylcysteine], antibiotics [e.g., oral – azithromycin, erythromycin; inhaled – tobramycin, aztreonam]);
- Documentation of one of the following despite at least 3 months of optimal supportive therapy:
- Adults (age at least 18 years): Member has had at least 2 pulmonary exacerbations requiring systemic antibiotics in the last 12 months;
- Pediatrics (age 12 to 17 years): Member has had at least 1 pulmonary exacerbation requiring systemic antibiotics in the last 12 months;
- Member is not an active smoker as evidenced by recent (within the last 30 days) negative nicotine metabolite (i.e., cotinine) test;
- Member does not have a primary* diagnosis of asthma or chronic obstructive pulmonary disease; *Secondary (comorbid) diagnoses of asthma or chronic obstructive pulmonary disease are allowable
- Dose does not exceed 25 mg (1 tablet) per day.
- Approval duration: 12 months
- Continued Therapy
- Non-Cystic Fibrosis Bronchiectasis (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 25 mg (1 tablet) per day.
- Approval duration: 12 months
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Gemcitabine Intravesical System (Inlexzo) (CP.PHAR.753)
| 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
- 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
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Imlunestrant (Inluriyo) (CP.PHAR.754)
| 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
- 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
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Paltusotide (Palsonify) (CP.PHAR.755)
| 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
- 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
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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
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Risperidone LA inj (Risperdal Consta, Perseris, Rykindo, Uzedy) (CP.PHAR.293)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter
| Policy updates include:
- Added new indication of bipolar 1 disorder for Uzedy
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Pemetrexed (Alimta, Pemfexy, Axtle) (CP.PHAR.368)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter
| Policy updates include:
- 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
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Lenacapavir (Sunlenca, Yeztugo) (CP.PHAR.622)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter
| Policy updates include:
- Removed failure of Fuzeon per manufacturer discontinuation
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Lidocaine transdermal (Bondlido, Lidoderm, ZTlido) (CP.PMN.08)
| Ambetter
| Policy updates include:
- Added Bondlido as a new drug and dosage strength
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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
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