POLICY
| APPLICABLE PRODUCTS
| NEW POLICY OVERVIEW OR UPDATED POLICY REVISIONS
|
Omalizumab (Xolair) (CP.PCH.49)
| Ambetter
| Policy updates include:
- Added off-label indications and criteria for systemic mastocytosis and immunotherapy-related pruritus per National Comprehensive Cancer Network
- Updated formulations to include strengths of prefilled syringe and autoinjectors
|
Ramucirumab (Cyramza) (CP.PHAR.119)
| Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- Per National Comprehensive Cancer Network added off-label indication criteria for mesothelioma
|
Trabectedin (Yondelis) (CP.PHAR.204)
| Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- for uterine leiomyosarcoma, clarified Yondelis prescribed as single agent for those who has received a prior anthracycline-containing regimen and added option for usage of Yondelis in combination with doxorubicin
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Natalizumab (Tysabri) (CP.PHAR.259)
| Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- Added adalimumab-adbm to listed examples of preferred adalimumab products
- Added Tyruko, a biosimilar, to policy.
|
Bezlotoxumab (Zinplava) (CP.PHAR.300)
| Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- Updated Clostridium difficile infection age requirement from ≥18 years to ≥ 1 year per Food and Drug Administration pediatric expansion
|
Erwinia Asparaginase (Rylaze) (CP.PHAR.301)
| Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- For acute lymphoblastic leukemia, added Asparlas to criteria that member was developed hypersensitivity to
- Removed discontinued Erwinaze product from policy
|
Siltuximab (Sylvant) (CP.PHAR.329)
| Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- In cytokine release syndrome initial criteria, added Sylant may be used to replace the second dose of Actemra OR Tofidence per National Comprehensive Cancer Network
|
Avelumab (Bavencio) (CP.PHAR.333)
| Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- Per National Comprehensive Cancer Network guidelines added coverage criteria for salivary gland tumors (category 2B recommendation)
|
Dupilumab (Dupixent) (CP.PHAR.336)
| Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- For atopic dermatitis removed oral systemic therapy step criterion per updated guideline and competitor analysis
- Added off-label indication and criteria for immunotherapy-related pruritus per National Comprehensive Cancer Network
|
Letermovir (Prevymis) (CP.PHAR.367)
| Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- Per updated prescribing information for allogeneic hematopoietic stem cell transplant , added allowance for use through Day 200 post-transplantation if at risk for late cytomegalovirus infection and disease
- Added examples of risk factors for late cytomegalovirus infection and disease to Appendix D
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Pemetrexed (Alimta, Pemfexy) (CP.PHAR.368)
| Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- For central nervous system, added option for treatment of leptomeningeal metastases per National Comprehensive Cancer Network
- Added criteria for cervical cancer per National Comprehensive Cancer Network
- Removed HCPCS codes [J9321]
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Bortezomib (Velcade) (CP.PHAR.410)
| Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- Removed specification that 1 mg and 2.5 mg were speicially indicated after 1 prior therapy per package insert update
- Revised product availability for solutions from 2.5 mg/mL to 3.5 mg/3.5mL per package insert
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Fam-trastuzumab deruxtecan-nxki (Enhertu) (CP.PHAR.456)
| Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- Per National Comprehensive Cancer Network guidelines, clarified that off-label use for appendiceal adenocarcinoma is included as a colorectal cancer, added criteria for use as adjuvant therapy in rectal cancer, added criteria for off-label use for cervical cancer, salivary gland tumors, and endometrial carcinoma
|
Lumasiran (Oxlumo) (CP.PHAR.473)
| Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- For Commercial line of business changed approval duration to “6 months or duration of request, whichever is less;”, for reauthorization added decrease from baseline in plasma oxalate levels along with symptomatic improvement as a pathway for reauthorization
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Vosoritide (Voxzogo) (CP.PHAR.525)
| Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- Updated criteria with pediatric age extension
- Added appendix D general information on use in pediatric population
|
Allogeneic cultured keratinocytes and dermal fibroblasts (StrataGraft) (CP.PHAR.562)
| Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- Clarified that initial approval duration is for “one application only per thermal burn occurrence”
|
Zoledronic Acid (Reclast, Zometa) (CP.PHAR.59)
| Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- For osteoporosis, clarified failure of “generic” alendronate is preferred
- For Paget’s disease, removed initial criteria requiring failure of an oral bisphosphonate per guidelines
- Removed Paget’s disease indication for oral bisphosphonates from Appendix B
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Tremelimumab-actl (Imjudo) (CP.PHAR.612)
| Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- In initial approval criteria, added section C to include gastric, esophageal and esophagogastric junction cancer for off-label National Comprehensive Cancer Network recommended uses per National Comprehensive Cancer Network compendium
- Removed inactive HCPCS codes
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Cenegermin-bkbj (Oxervate) (CP.PMN.186)
| Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- Added optometrist as an additional prescriber option
|
Anakinra (Kineret) (CP.PHAR.244)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- Added adalimumab-adbm to listed examples of preferred adalimumab products
- For rheumatoid arthritis removed redirection to Kevzara and Olumiant.
|
Certolizumab (Cimzia) (CP.PHAR.247)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- Added adalimumab-adbm to listed examples of preferred adalimumab products
- For rheumatoid arthritis removed redirection to Kevzara and Olumiant.
|
Etanercept (Enbrel) (CP.PHAR.250)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- Added adalimumab-adbm to listed examples of preferred adalimumab products
- For rheumatoid arthritis removed redirection to Kevzara and Olumiant.
|
Golimumab (Simponi, Simponi Aria) (CP.PHAR.253)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- Added adalimumab-adbm to listed examples of preferred adalimumab products
- For rheumatoid arthritis removed redirection to Kevzara and Olumiant.
|
Human Growth Hormone (Somapacitan, Somatrogon, Somatropin) (CP.PHAR.517)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- For human immunodeficiency virus-associated wasting or cachexia, added options for member to meet criteria if weight < 90% of the lower limit of ideal body weight or body mass index ≤ 20 kg/m2
- Added HCPCS/CPT code [C9399, J3590]
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Ivosidenib (Tibsovo) (CP.PHAR.137)
| Ambetter
| Policy updates include:
- added newly approved myelodysplastic syndromes indication
- For Appendix B, added therapeutic alternative examples of initial systemic therapies for myelodysplastic syndromes
- Updated boxed warning as differentiation syndrome applies to acute myeloid leukemia and myelodysplastic syndromes per prescriber information.
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Olaparib (Lynparza) (CP.PHAR.360)
| Ambetter
| Policy updates include:
- For breast cancer, removed “HER2 negative” criteria as National Comprehensive Cancer Network compendium currently supports use in HER2 positive, BRCA 1/2-germline mutated disease with level 2A evidence
- Updated Appendix D with HER2-positive, BRCA 1/2-germline mutated disease information per National Comprehensive Cancer Network compendium
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Axicabtagene ciloleucel (Yescarta) (CP.PHAR.362)
| Ambetter
| Policy updates include:
- Added the following National Comprehensive Cancer Network compendium supported uses for large B-cell lymphoma: monomorphic post-transplant lymphoproliferative disorders (B-cell type), extranodal marginal zone lymphoma of the stomach, extranodal marginal zone lymphoma of nongastric sites (noncutaneous), nodal marginal zone lymphoma
- Revised reference from AIDS to human immunodeficiency virus consistent with National Comprehensive Cancer Network
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Teprotumumab (Tepezza) (CP.PHAR.465)
| Ambetter
| Policy updates include:
- For corticosteroid redirection added additional bypass for significant proptosis and diplopia consistent with 2022 American Thyroid Association recommendations
- For continuation of therapy reduced approval duration to 1 month
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Zanubrutinib (Brukinsa) (CP.PHAR.467)
| Ambetter
| Policy updates include:
- Added criteria for hairy cell leukemia per National Comprehensive Cancer Network; updated mantle cell lymphoma regimens in Appendix B
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Colchicine (Colcrys, Lodoco) (CP.PMN.123)
| Ambetter
| Policy updates include:
- For Gout Anti-Inflammatory Prophylaxis, updated “unless contraindicated” to “unless contraindicated or clinically significant adverse effects are experienced”
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Insulin glargine (Rezvoglar, Semglee, Toujeo) (HIM.PA.09)
| Ambetter
| Policy updates include:
- For Semglee, updated Food and Drug Administration approved indications section to align with prescriber information
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Human Growth Hormone (Somapacitan, Somatrogon, Somatropin) (HIM.PA.161)
| Ambetter
| Policy updates include:
- For human immunodeficiency virus-associated wasting or cachexia, added options for member to meet criteria if weight < 90% of the lower limit of ideal body weight or body mass index ≤ 20 kg/m2
- Added HCPCS/CPT code [C9399, J3590]
|
Propranolol (Hemangeol) (CP.PCH.51)
| Ambetter
| Policy created
- 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: Proliferating Infantile Hemangioma:
- Diagnosis of proliferating infantile hemangioma
- Age ≥ 5 weeks
- Weight ≥ 2 kg
- Approval duration: 6 months
- Continued Therapy: Proliferating Infantile Hemangioma:
- 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
- Member is responding positively to therapy;
- Member meets one of the following:
- Member has not received ≥ 12 months of consecutive therapy
- Documentation supports recurrence of hemangioma
- Approval duration: 6 months
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Mavacamten (Camzyos) (CP.PMN.272)
| Ambetter
| Policy updates include:
- Revised the requirement for a prior trial of all three of a beta-blocker, a calcium channel blocker, and disopyramide to require only two of those three alternatives.
|
Ulcer Therapy Products (CP.PMN.277)
| Ambetter
| Policy updates include:
- Added Voquezna with corresponding criteria set for erosive esophagitis
- Updated Appendix C with Voquezna Triple/Dual Pak contraindications
- Renamed policy from Ulcer Therapy Combinations to Ulcer Therapy Products.
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Dextromethorphan-Quinidine (Nuedexta) (CP.PMN.93)
| Ambetter
| Policy updates include:
- Added neuropsychologist and psychiatrist as optional specialist prescribers
- In Appendix C updated link to Baseline Center for Neurologic Study-Lability Scale (CNS-LS) questionnaire
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Vamorolone (Agamree) (CP.PHAR.659)
| 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: Duchenne Muscular Dystrophy(must meet all):
- Diagnosis of duchenne muscular dystrophy confirmed by one of the following:
- Genetic testing (e.g., dystrophin deletion or duplication mutation found);
- If genetic studies are negative (i.e., no mutation identified), positive muscle biopsy (e.g., absence of dystrophin protein);
- Prescribed by or in consultation with a neurologist;
- Age ≥ 2 years;
- Failure of a ≥ 6 month trial of prednisone, unless contraindicated or clinically significant adverse effects are experienced;
- Documentation of member’s current weight in kg;
- Dose does not exceed one of the following:
- 6 mg/kg (up to a maximum of 300 mg) per day;
- If member has mild (Child-Pugh A) to moderate (Child-Pugh B) hepatic impairment: 2 mg/kg (up to a maximum of 100 mg) per day;
- If co-administered with strong CYP3A4 inhibitors (e.g., itraconazole): 4 mg/kg (up to a maximum of 200 mg) per day.
- Approval duration: 6 months
- Continued Therapy: Duchenne Muscular Dystrophy:
- 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 (refer to state specific addendums for CC.PHARM.03A and CC.PHARM.03B);
- Member is responding positively to therapy;
- Documentation of member’s current weight in kg;
- If request is for a dose increase, new dose does not exceed one of the following:
- 6 mg/kg (up to a maximum of 300 mg) per day;
- If member has mild (Child-Pugh A) to moderate (Child-Pugh B) hepatic impairment: 2 mg/kg (up to a maximum of 100 mg) per day;
- If co-administered with strong CYP3A4 inhibitors (e.g., itraconazole): 4 mg/kg (up to a maximum of 200 mg) per day.
- Approval duration: 12 months
|
Bimekizumab-bkzx (Bimzelx) (CP.PHAR.660)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy includes:
- Requests for indications not approved by the FDA are reviewed with the off-label use policy for the relevant line of business: CP.PMN.53 for Medicaid and CHIP
- Criteria is only applicable for Medicaid and CHIP when the drug is added to the formulary for coverage
- Initial Approval Criteria: Plaque Psoriasis (must meet all):
- Diagnosis of moderate-to-severe plaque psoriasis as evidenced by involvement of one of the following:
- ≥ 3% of total body surface area;
- Hands, feet, scalp, face, or genital area;
- Prescribed by or in consultation with a dermatologist or rheumatologist;
- Age ≥ 18 years;
- Member meets one of the following:
- Failure of a ≥ 3 consecutive month trial of methotrexate (MTX) at up to maximally indicated doses;
- Member has intolerance or contraindication to MTX (see Appendix D), and failure of a ≥ 3 consecutive month trial of cyclosporine or acitretin at up to maximally indicated doses, unless clinically significant adverse effects are experienced or both are contraindicated;
- Member has intolerance or contraindication to MTX, cyclosporine, and acitretin, and failure of phototherapy, unless contraindicated or clinically significant adverse effects are experienced;
- Member meets ONE of the following, unless contraindicated or clinically significant adverse effects are experienced:
- Failure of a ≥ 3 consecutive month trial of one* adalimumab product (e.g. Hadlima™, Yusimry™, adalimumab-adaz, and adalimumab-fkjp are preferred);
- History of failure of two TNF blocker; *Prior authorization may be required for adalimumab product
- Failure of a ≥ 3 consecutive month trial of Taltz*, unless contraindicated or clinically significant adverse effects are experienced;
- *Prior authorization may be required for Taltz
- Dose does not exceed one of the following:
- 320 mg at weeks 0, 4, 8, 12, and 16, then every 8 weeks;
- Weight > 120 kg: 320 mg at weeks 0, 4, 8, 12, and 16, then every 4 weeks.
- Approval duration: 6 months
- Continued Therapy: Plaque Psoriasis (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 (refer to state specific addendums for CC.PHARM.03A and CC.PHARM.03B);
- Member is responding positively to therapy;
- If request is for a dose increase, new dose does not exceed one of the following:
- 320 mg every 8 weeks;
- Weight > 120 kg: 320 mg every 4 weeks.
- Approval duration: 12 months
|
Mirikizumab-mrkz (Omvoh) (CP.PHAR.662)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy includes:
- Requests for indications not approved by the FDA are reviewed with the off-label use policy for the relevant line of business: CP.PMN.53 for Medicaid and CHIP
- Criteria is only applicable for Medicaid and CHIP when the drug is added to the formulary for coverage
- Initial Approval Criteria: Ulcerative Colitis (must meet all):
- Diagnosis of ulcerative colitis;
- Prescribed by or in consultation with a gastroenterologist;
- Age ≥ 18 years;
- Documentation of a Mayo Score ≥ 6;
- Failure of an 8-week trial of systemic corticosteroids, unless contraindicated or clinically significant adverse effects are experienced;
- Member meets ONE* of the following, unless contraindicated or clinically significant adverse effects are experienced:
- Failure of a ≥ 3 consecutive month trial of one adalimumab product (e.g. Hadlima, Yusimry, adalimumab-adaz, and adalimumab-fkjp are preferred);
- History of failure of two TNF blockers; *Prior authorization may be required for adalimumab products
- If member has had a history of failure of two TNF blockers or one adalimumab product, then failure of Zeposia®;
- Member does not have combination use with biological disease-modifying antirheumatic drugs or Janus kinase inhibitors (see Section III: Diagnoses/Indications for which coverage is NOT authorized);
- Dose does not exceed both of the following (a and b):
- Initial (IV): 300 mg at Weeks 0, 4, and 8;
- Maintenance (SC): 200 mg at Week 12 and every 4 weeks.
- Approval duration: 6 months
- Continued Therapy: Ulcerative Colitis (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 (refer to state specific addendums for CC.PHARM.03A and CC.PHARM.03B);
- Member is responding positively to therapy;
- Member does not have combination use with biological disease-modifying antirheumatic drugs or Janus kinase inhibitors (see Section III: Diagnoses/Indications for which coverage is NOT authorized);
- If request is for a dose increase, new dose does not exceed 200 mg every 4 weeks.
- Approval duration: 12 months
|
Capivasertib (Truqap) (CP.PHAR.663)
| 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 ≥ 18 years;
- Disease has all of the following characteristics:
- HR-positive (i.e., estrogen or progesterone receptor [ER/PR]-positive);
- HER2-negative;
- Recurrent unresectable (local or regional) or metastatic;
- Positive for PIK3CA/AKT1/PTEN-alteration(s);
- Truqap is prescribed in combination with fulvestrant;
- Disease progression or recurrence after an endocrine-based regimen;
- If member is a premenopausal female, member has been treated with ovarian ablation or is receiving ovarian suppression;
- For Truqap requests, member must use generic capivasertib, if available, unless contraindicated or clinically significant adverse effects are experienced;
- Request meets one of the following:*
- Dose does not exceed both of the following for 4 days followed by 3 days off:
- 800 mg per day;
- 4 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: 6 months
- Continued Therapy: Breast Cancer (must meet all):
- Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Truqap for a covered indication and has received this medication for at least 30 days;
- Member is responding positively;
- For Truqap requests, member must use generic capivasertib, 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 both of the following for 4 days followed by 3 days off:
- 800 mg per day;
- 4 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
|
Crovalimab (CP.PHAR.664)
| 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
- Criteria will mirror the clinical information from the prescribing information once FDA-approved
- Initial Approval Criteria: Paroxysmal Nocturnal Hemoglobinuria (must meet all):
- Diagnosis of paroxysmal nocturnal hemoglobinuria;*
- Prescribed by or in consultation with a hematologist;
- Age ≥ 12 years;*
- Flow cytometry shows detectable glycosylphosphatidylinositol (GPI)-deficient hematopoietic clones or ≥ 10% paroxysmal nocturnal hemoglobinuria cells;*
- Failure of a ≥ 3-month trial of a C5 inhibitor* (e.g., Soliris®, Ultomiris®) up to maximally indicated doses, unless contraindicated or clinically significant adverse effects are experienced; *Prior authorization may be required for Soliris and Ultomiris
- Crovalimab is not prescribed concurrently with another FDA-approved product for paroxysmal nocturnal hemoglobinuria (e.g., Soliris, Ultomiris, Empaveli™);
- Dose does not exceed the following:*
- IV loading dose on Day 1:
- Weight ≥ 40 to < 100 kg: 1,000 mg;
- Weight ≥ 100 kg: 1,500 mg;
- SC loading doses starting Day 2: 340 mg every week;
- SC maintenance doses starting Week 5:
- Weight ≥ 40 to < 100 kg: 680 mg every 4 weeks;
- Weight ≥ 100 kg: 1,020 mg every 4 weeks.
- Approval duration: 6 months
- Continued Therapy: Paroxysmal Nocturnal Hemoglobinuria (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 (refer to state specific addendums for CC.PHARM.03A and CC.PHARM.03B);
- Member is responding positively to therapy as evidenced by, including but not limited to, improvement in any of the following parameters:
- Improved measures of intravascular hemolysis (e.g., normalization of LDH);
- Reduced need for red blood cell transfusions;
- Increased or stabilization of hemoglobin levels;
- Less fatigue;
- Improved health-related quality of life;
- Fewer thrombotic events;
- Crovalimab is not prescribed concurrently with another FDA-approved product for paroxysmal nocturnal hemoglobinuria (e.g., Soliris, Ultomiris, Empaveli);
- If request is for a dose increase, new dose does not exceed one of the following:*
- Weight ≥ 40 to < 100 kg: 680 mg SC every 4 weeks;
- Weight ≥ 100 kg: 1,020 mg SC every 4 weeks.
- Approval duration: 6 months
|
Danicopan (ALXN2040) (CP.PHAR.665)
| 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
- Criteria will mirror the clinical information from the prescribing information once FDA-approved
- Initial Approval Criteria: Paroxysmal Nocturnal Hemoglobinuria (must meet all):
- Diagnosis of paroxysmal nocturnal hemoglobinuria;
- Prescribed by or in consultation with an hematologist;
- Age ≥ 18 years;
- Member has clinically significant extravascular hemolysis while on a C5 inhibitor (e.g., Soliris®, Ultomiris®) as evidenced by both of the following:
- Documentation of hemoglobin ≤ 9.5 g/dL;
- Documentation of reticulocyte count ≥ 120 ×109/L;
- Member has been receiving a C5 inhibitor (e.g., Soliris, Ultomiris) for the last 6 months;
- ALXN2040 is prescribed concurrently with a C5 inhibitor (e.g., Soliris, Ultomiris);
- Dose does not exceed 600 mg per day.
- Approval duration: 6 months
- Continued Therapy: Paroxysmal Nocturnal Hemoglobinuria (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 (refer to state specific addendums for CC.PHARM.03A and CC.PHARM.03B);
- Member is responding positively to therapy as evidenced by, including but not limited to, improvement in any of the following parameters:
- Improved measures of intravascular or extravascular hemolysis (e.g., normalization of LDH, reduced absolute reticulocyte counts, reduced bilirubin);
- Reduced need for red blood cell transfusions;
- Increased or stabilization of hemoglobin levels;
- Less fatigue;
- Improved health-related quality of life;
- Fewer thrombotic events;
- ALXN2040 is prescribed concurrently with a C5 inhibitor (e.g., Soliris, Ultomiris);
- If request is for a dose increase, new dose does not exceed 600 mg per day.*
- Approval duration: 6 months
|
Fruquintinib (Fruzaqla) (CP.PHAR.666)
| 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: Colorectal Cancer (must meet all):
- Diagnosis of metastatic or advanced colorectal cancer (including appendiceal adenocarcinoma);
- Prescribed by or in consultation with an oncologist;
- Age ≥ 18 years;
- Documentation of RAS (KRAS or NRAS) wild-type gene status;
- Member has progressed through all available regimens for colorectal cancer that include all the following agents,* unless clinically significant adverse effects are experienced or all are contraindicated:
- 5-fluorouracil or capecitabine;
- Oxaliplatin and irinotecan;
- An anti-VEGF agent (e.g., bevacizumab, Stivarga®, Zaltrap®);
- If tumor expresses the RAS wild-type gene, an anti-EGFR agent: Erbitux® or Vectibix®; Prior authorization may be required
- Prescribed as a single agent;
- For Fruzaqla requests, member must use fruquintinib, if available, unless contraindicated or clinically significant adverse effects are experienced;
- Request meets one of the following:*
- Both of the following:
- Dose is at least 3 mg per day on days 1 to 21 of each 28-day cycle;
- Dose does not exceed 5 mg per day on days 1 to 21 of each 28-day cycle;
- 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
- Continued Therapy: Colorectal Cancer (must meet all):
- Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Fruzaqla for a covered indication and has received this medication for at least 30 days;
- Member is responding positively to therapy;
- Prescribed as a single agent;
- For Fruzaqla requests, member must use fruquintinib, if available, unless contraindicated or clinically significant adverse effects are experienced;
- If request is for a dose increase, request meets one of the following:*
- Both of the following:
- New dose is at least 3 mg per day on days 1 to 21 of each 28-day cycle;
- New dose does not exceed 5 mg per day on days 1 to 21 of each 28-day cycle;
- 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
|
Repotrectinib (Augtyro) (CP.PHAR.667)
| 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 (must meet all):
- Diagnosis of locally advanced or metastatic NSCLC;
- Prescribed by or in consultation with an oncologist;
- Age ≥ 18 years;
- Disease is ROS1 positive;
- For Augtyro requests, member must use repotrectinib, if available, unless contraindicated or clinically significant adverse effects are experienced;
- Request meets one of the following:
- Dose does not exceed both of the following:
- 320 mg per day;
- 8 capsules 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: 6 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 Augtyro for a covered indication and has received this medication for at least 30 days;
- Member is responding positively to therapy
- For Augtyro requests, member must use repotrectinib, if available, unless contraindicated or clinically significant adverse effects are experienced;
- If request is for a dose increase, request meets one of the following:
- Dose does not exceed both of the following:
- 320 mg per day;
- 8 capsules 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
|
Toripalimab (Loqtorzi) (CP.PHAR.668)
| Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| 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, and CP.PMN.53 for Medicaid and CHIP
- Criteria is only applicable for Medicaid and CHIP when the drug is added to the formulary for coverage
- Initial Approval Criteria: Advanced Nasopharyngeal Carcinoma (must meet all):
- Diagnosis of nasopharyngeal carcinoma
- Prescribed by or in consultation with an oncologist
- Age ≥18 years
- Disease is unresectable, recurrent, or metastatic
- Loqtorzi is prescribed in one of the following ways:
- In combination with cisplatin and gemcitabine
- As a single agent for disease that has progressed on or after platinum-containing chemotherapy
- Member has not received prior treatment with an anti-PD-(L)1 antibody
- Request meets one of the following:
- In combination with cisplatin and gemcitabine: 240 mg every three weeks
- As a single agent for disease that has progressed on or after platinum-containing chemotherapy: 3 mg/kg intravenously every two 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
- Continued Therapy: Advanced Nasopharyngeal Carcinoma (must meet all):
- Member is Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Loqtorzi for a covered indication and has received this medication for at least 30 days
- Member is responding positively to therapy
- Request meets one of the following:
- In combination with cisplatin and gemcitabine: 240 mg every three weeks for up to total maximum of 24 months
- As a single agent: 3 mg/kg every two 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: 12 months
|
Abrocitinib (Cibinqo) (CP.PHAR.578)
| Ambetter
| Policy updates include:
- For initial criteria, removed systemic immunosuppressant therapy step criterion per updated guideline and competitor analysis
- In Appendix B, removed systemic immunosuppressant therapy therapeutic alternatives
|
Birch Triterpenes (Filsuvez) (CP.PHAR.669)
| Ambetter
| Policy created.
- 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 Epidermolysis Bullosa (must meet all):
- Diagnosis of dystrophic epidermolysis bullosa or junctional epidermolysis bullosa confirmed by genetic testing
- Prescribed by or in consultation with a geneticist, dermatologist, or histopathologist
- Age ≥ 6 months
- Target wounds are partial-thickness and have been present for ≥ 21 days and < 9 months
- Documentation of size of target wounds at baseline
- Provider attestation that member is concomitantly receiving standard of care preventative or treatment therapies for wound care (e.g., polymeric membrane, superabsorbent dressings, soft-silicone foam, enzyme alginogel, protease
- Dose does not exceed 1 tube per target wound per day.
- Approval duration: 3 months
- Continued Therapy Epidermolysis Bullosa (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 (refer to state specific addendums for CC.PHARM.03A and CC.PHARM.03B)
- Filsuvez is not applied on target wounds that have completely healed
- Member is responding positively to therapy as evidenced by, including but not limited to, improvement in any of the following parameters:
- Decrease in wound size
- Decrease in pain or itch severity for target wound sites associated with dressing changes
- If request is for a dose increase, new dose does not exceed 1 tube per target wound per day.
- Approval duration: 6 months
|
Eflornithine (Iwilfin) (CP.PHAR.670)
| Ambetter
| Policy created.
- 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 Neuroblastoma (must meet all):
- Diagnosis of high-risk neuroblastoma
- Prescribed by or in consultation with an oncologist
- Age ≥ 1 year
- For Iwilfin requests, member must use eflornithine, if available, unless contraindicated or clinically significant adverse effects are experienced
- Member previously received multiagent, multimodality therapy including anti-GD2 immunotherapy (e.g., Unituxin)
- Provider attestation that neuroblastoma is currently in remission demonstrated by a partial response or better to prior therapy with no evidence of disease in the bone marrow
- Documentation of member’s current body surface area (BSA, in m2)
- Request meets one of the following:
- Dose does not exceed the FDA approved maximum recommended dose by BSA
- 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
- Continued Therapy Neuroblastoma (must meet all):
- Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Iwilfin for a covered indication and has received this medication for at least 30 days
- Member is responding positively to therapy
- Member has not received ≥ 2 years of Iwilfin therapy
- If request is for a dose increase, request meets one of the following (a or b):*
- New dose does not exceed the FDA approved maximum recommended dose by BSA
- 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 (up to 2 years of total therapy)
|
Elexacaftor/Ivacaftor/Tezacaftor; Ivacaftor (Trikafta) (CP.PHAR.440)
| Ambetter
| Policy updates include:
- Revised initial approval criteria: removed “for age 2 > years” and “ppFEV1 that is between 40 – 90%” in criteria stating documentation of member’s ppFEV1
- Revised “chart notes that indicate pulmonary function tests” to “documentation of one of the following pulmonary function tests”
- In continued therapy criteria: revised criteria from “stabilization in ppFEV1 if baseline was > 70%, or increase in ppFEV1 if baseline was <70%” to “stabilization or improvement in ppFEV1” and revised “stabilization in lung clearance index (LCI) if baseline was > 7.4” to “stabilization or decrease in lung clearance index from baseline”
- Revised Appendix D to remove information on advanced Cystic Fibrosis disease
|
Insulin Delivery Systems
(V-Go, Omnipod, InPen) (CP.PHAR.534)
| Ambetter
| Policy updates include:
- Added Omnipod GO and corresponding criteria
- Removed Omnipod as it will no longer be available in the US after 12/31/23 per the manufacturer
|
Ivacaftor (Kalydeco) (CP.PHAR.210)
| Ambetter
| Policy updates include:
- Revised initial approval criteria and removed “for age 2 > years” and “ppFEV1 that is between 40 – 90%” in criteria stating documentation of member’s ppFEV1
- Revised “chart notes that indicate pulmonary function tests” to “documentation of one of the following pulmonary function tests”
- In continued therapy criteria revised criteria from “stabilization in ppFEV1 if baseline was > 70%, or increase in ppFEV1 if baseline was <70%” to “stabilization or improvement in ppFEV1” and revised “stabilization in lung clearance index if baseline was > 7.4” to “stabilization or decrease in LCI from baseline”
- Revised Appendix D to remove information on advanced Cystic Fibrosis disease
|
Lisocabtagene maraleucel (Breyanzi) (CP.PHAR.483)
| Ambetter
| Policy created:
- Criteria will mirror the clinical information from the prescribing information once FDA-approved
- 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 Lymphocytic Leukemia, Small Lymphocytic Lymphoma * (must meet all): *Only for initial treatment dose subsequent doses will not be covered.
- Diagnosis of relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma
- Prescribed by or in consultation with an oncologist or hematologist
- Age ≥ 18 years
- One of the following :
- Member has measurable disease as evidenced by one of the following assessed within the last 30:
- Measurable lymph nodes ≥ 1.5 cm in the greatest transverse diameter
- Hepatomegaly
- Splenomegaly
- Demonstration of chronic lymphocytic leukemia cells in the peripheral blood by flow cytometry
- Member has received ≥ 2 prior lines of therapy (see Appendix B for examples) that include both of the following :
- One BTKi (e.g., Brukinsa®, Calquence®, Imbruvica®)
- One BCL2i (e.g., Venclexta®) *Prior authorization may be required.
- Member does not have active central nervous system (CNS) involvement by malignancy or history or presence of clinically relevant CNS pathology (e.g., epilepsy, generalized seizure disorder, aphasia, stroke with current neurologic sequelae, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, cerebral edema, or psychosis)*
- Member has not previously received treatment with CAR T-cell immunotherapy (e.g., Abecma®, Carvykti™, Kymriah™, Tecartus™, Yescarta™)
- Breyanzi is not prescribed concurrently with other CAR T-cell immunotherapy (e.g., Abecma, Carvykti, Kymriah, Tecartus, Yescarta)
- Dose does not exceed 100 x 106 CAR-positive T-cells.*
- Approval duration: 3 months (1 dose only, with 4 doses of tocilizumab (Actemra) if requested at up to 800 mg per dose)
- Continued Therapy: Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
- Continued therapy will not be authorized as Breyanzi is indicated to be dosed one time only.
- Approval duration: Not applicable
|
Lumacaftor-ivacaftor (Orkambi) (CP.PHAR.213)
| Ambetter
| Policy updates include:
- Revised initial approval criteria and removed “for age 2 > years” and “ppFEV1 that is between 40 – 90%” in criteria stating documentation of member’s ppFEV1
- Revised “chart notes that indicate pulmonary function tests” to “documentation of one of the following pulmonary function tests”
- In continued therapy criteria: revised criteria from “stabilization in ppFEV1 if baseline was > 70%, or increase in ppFEV1 if baseline was <70%” to “stabilization or improvement in ppFEV1” and revised “stabilization in lung clearance index if baseline was > 7.4” to “stabilization or decrease in lung clearance index from baseline”
- Revised Appendix D to remove information on advanced Cystic Fibrosis disease
|
Nirogacestat (Ogsiveo) (CP.PHAR.671)
| Ambetter
| Policy created.
- 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 Desmoid Tumor (must meet all):
- Diagnosis of a desmoid tumor (aggressive fibromatosis);
- Prescribed by or in consultation with an oncologist;
- Age ≥ 18 years;
- Documentation of a progressing desmoid tumor;
- For Ogsiveo requests, member must use nirogacestat, if available, unless contraindicated or clinically significant adverse effects are experienced;
- Request meets one of the following:
- Dose does not exceed 300 mg (6 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: 6 months
- Continued Therapy Desmoid Tumor (must meet all):
- Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Ogsiveo for a covered indication and has received this medication for at least 30 days;
- Member is responding positively to therapy;
- For Ogsiveo requests, member must use nirogacestat, if available, unless contraindicated or clinically significant adverse effects are experienced;
- If request is for a dose increase, request meets one of the following (a or b):*
- New dose does not exceed 300 mg (6 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
|
Roflumilast (Daliresp, Zoryve) (CP.PMN.46)
| Ambetter
| Policy updates include:
- Added criteria for newly FDA-approved dosage form (Zoryve topical foam) and indication of seborrheic dermatitis
|
Secukinumab (Cosentyx) (CP.PHAR.261)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- Added adalimumab-adbm to listed examples of preferred adalimumab products
- Added newly approved hidradenitis suppurativa indication to criteria
- Added Wezlana to section III.B
|
Tocilizumab (Actemra, Tofidence) (CP.PHAR.263)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- Added adalimumab-adbm to listed examples of preferred adalimumab products
- For rheumatoid arthritis removed redirection to Kevzara and Olumiant
|
Tezacaftor/Ivacaftor; Ivacaftor (Symdeko) (CP.PHAR.377)
| Ambetter
| Policy updates include:
- Revised initial approval criteria and removed “chart notes showing ppFEV1 that is between 40 – 90%” and revised criteria to “documentation of member’s baseline precent predicted forced expiratory volume in 1 second (ppFEV1)”
- In continued therapy: revised criteria from “stabilization in ppFEV1 if baseline was > 70%, or increase in ppFEV1 if baseline was <70%” to “stabilization or improvement in ppFEV1”
- Revised Appendix D to remove information on advanced Cystic Fibrosis disease
|
Tralokinumab-ldrm (Adbry) (CP.PHAR.577)
| Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- Updated criteria with pediatric extension to include ages 12 years and older
- In initial criteria, removed systemic immunosuppressant therapy step criterion
- In Appendix B, removed systemic immunosuppressant therapy therapeutic alternatives
|
Travoprost (iDose TR) (CP.PHAR.672)
| Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy created.
- 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 Open Angle Glaucoma and Ocular Hypertension (must meet all):
- Diagnosis of open-angle glaucoma or ocular hypertension;
- Prescribed by or in consultation with an ophthalmologist;
- Age ≥ 18 years;
- Medical justification supports inability to manage regular glaucoma eye drop use (e.g., due to age or comorbidities including visual impairment);
- The affected eye has not received prior treatment with iDose TR;
- At the time of request, member has none of the following contraindications:
- Active or suspected ocular or periocular infection;
- Diagnosis of corneal endothelial cell dystrophy (e.g., Fuchs’ Dystrophy, corneal guttatae);
- History of corneal transplantation or endothelial cell transplant (e.g., Descemet’s Stripping Automated Endothelial Keratoplasty [DSAEK]);
- Hypersensitivity to travoprost or to any other component of iDose TR;
- Dose does not exceed both of the following:
- 75 mcg per eye;
- One implant per eye.
- Approval duration: one implant per eye (lifetime total)
- Continued Therapy Open Angle Glaucoma and Ocular Hypertension
- Re-authorization is not permitted. Members must meet the initial approval criteria.
- Approval duration: Not applicable
|
