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
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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)
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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
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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
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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”
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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
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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]
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Propranolol (Hemangeol) (CP.PCH.51)
| Ambetter
| Policy created.
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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.
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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
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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 blockers;
- *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
|
