Effective March 1, 2023: Pharmacy and Biopharmacy Policies

Abiraterone (Zytiga, Yonsa) (CP.PHAR.84)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter

Policy updates include:

• Added NCCN off-label use for non-metastatic prostate cancer with prostate-specific antigen (PSA) persistence or recurrence after radical prostatectomy and life expectancy > 5 years
• Added per NCCN compendium allowance for Yonsa use in combination with dexamethasone

Acalabrutinib (Calquence) (CP.PHAR.366)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter

Policy updates include:

• Added HIM to the policy since it is now Tier 4 with PA on the Ambetter formulary
• Added NCCN-recommended off-label use for nodal marginal zone lymphoma

Adalimumab (Humira) Biosimilars (CP.PHAR.242)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP

Policy updates include:

• Removed step therapy requiring redirection to branded biologics for all indications in initial and continued therapy section
• For HS, removed redirection to oral retinoids and hormonal treatment

Aflibercept (Eylea) (CP.PHAR.184)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter

Policy updates include:

• Clarified initial criteria from “worse than” to state BCVA 20/50 “or worse

Alirocumab (Praluent) (CP.PHAR.124)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP

Policy updates include:

• Added bypass of ezetimibe trial if member requires > 25% additional lowering of LDL, and lowered minimum LDL requirement to 55 mg/dL for members with ASCVD at very high risk  

Aprepitant (Aponvie, Cinvanti, Emend) (CP.PMN.19)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter

Policy updates include:

• Updated FDA approved indications section to align with prescribing information for their respective products
• For the prevention of chemotherapy-induced nausea/vomiting added requirement that request is for generic aprepitant capsules, Emend, or Cinvanti as these are the only products FDA-approved for this indication

Atezolizumab (Tecentriq) (CP.PHAR.235)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter

Policy updates include:

• Added criterion for malignant peritoneal mesothelioma per NCCN
• Adjusted dose to not exceed 1,680 mg every 4 weeks for all indications per PI

Atidarsagene autotemcel (OTL-200) (CP.PHAR.602)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter

Policy includes:

• Criteria will mirror the clinical information from the prescribing information once FDA-approved
• 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: Metachromatic Leukodystrophy (must meet all):
  • Diagnosis of MLD confirmed by all of the following:
    • ARSA activity below the normal range in peripheral blood mononuclear cells or fibroblasts;
    • Presence of two disease-causing mutations of either known or novel alleles;
    • Presence of sulfatides in a 24-hour urine collection;
  • Prescribed by or in consultation with a medical geneticist or neurologist;
  • Age < 7 years;
  • Member has one of the following forms of MLD
    • Late infantile, and member does not have clinical manifestations of the disease;
    • Early juvenile, and one of the following :
      • Member does not have clinical manifestations of the disease;
      • Member has early clinical manifestations of the disease, but can still walk independently (≥ 10 steps) and does not have cognitive decline (intelligence quotient [IQ] ≥ 70);
  • Member has not previously received hematopoietic stem cell gene therapy or allogeneic transplant;
  • Dose does not exceed the FDA-approved maximum dose
  • Approval duration: 3 months (one time infusion per lifetime)
• Continued Approval Criteria: Metachromatic Leukodystrophy
  • Re-authorization is not permitted

Beremagene Geperpavec (Vyjuvek) (CP.PHAR.592)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter

Policy updates include:

• For initial criteria, clarified “member is not positive for anti-COL7 antibodies at baseline” with addition of “no evidence of immune response to COL7 as evidenced by immunofluorescence”     

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

Ambetter

Policy updates include:

• Added Amjevita as an alternative option to Humira for applicable indications

Budesonide (Tarpeyo) (CP.PHAR.572)

Ambetter

Policy updates include:

• Per clinical trial inclusion criteria added the following requirement: Recent (within the last 30 days) eGFR ≥ 35 mL/min/1.73 m2

Dextromethorphan-bupropion (Auvelity) (CP.PMN.284)

Ambetter

Policy updates include:

• Updated initial criteria to include trial of individual components

Eltrombopag (Promacta) (CP.PHAR.180)

Ambetter

Policy updates include:

• Per NCCN Compendium, for MDS added off-label indication of symptomatic anemia and its qualifiers

Evinacumab-dgnb (Evkeeza) (HIM.PA.166)

Ambetter

Policy updates include:

• Per 2022 ACC expert consensus decision pathway, lowered minimum LDL requirement to 55 mg/dL for members with ASCVD at very high risk

Evolocumab (Repatha) (CP.PHAR.123)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP

Policy updates include:

• Added bypass of ezetimibe trial if member requires > 25% additional lowering of LDL, and lowered minimum LDL requirement to 55 mg/dL for members with ASCVD at very high risk  

Exagamglogene Autotemcel (Exa-Cel) (CP.PHAR.603)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter

Policy includes:

• Criteria will mirror the clinical information from the prescribing information once FDA-approved
• 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: Transfusion-Dependent β-Thalassemia (must meet all):
  • Diagnosis of TDT with genetic confirmation
  • Prescribed by or in consultation with a hematologist and transplant specialist;
  • Age ≥ 12 years;
  • Documentation of receipt of ≥ 100 mL/kg or 10 units of packed red blood cells (pRBC) per year during the previous two years;
  • Attestation from transplant specialist for both the following (a and b):
    • Member understands the risk and benefits of alternative therapeutic options such as allogenic hematopoietic stem cell transplantation (HSCT);
    • Member is clinically stable and eligible to undergo myeloablative conditioning and HSCT;
  • Member has not received prior allogenic HSCT or gene therapy;
  • Dose does not exceed the FDA-labeled maximum dose.
  • Approval duration: 3 months (one time infusion per lifetime)
• Initial Approval Criteria: Sickle Cell Disease (must meet all):
  • Diagnosis of SCD with one of the following genotypes:
    • βS/βS;
    • βS/β0;
  • Prescribed by or in consultation with a hematologist and transplant specialist;
  • Age ≥ 12 years;
  • Documentation of ≥ two severe vaso-occlusive episodes per year during the previous two years;
  • Attestation from transplant specialist for both the following:
    • Member understands the risk and benefits of alternative therapeutic options such as allogenic HSCT;
    • Member is clinically stable and eligible to undergo myeloablative conditioning and HSCT;
  • Member has not received prior allogenic HSCT or gene therapy;
  • Dose does not exceed the FDA-labeled maximum dose.
  • Approval duration: 3 months (one time infusion per lifetime)
• Continued Approval Criteria: All Indications above:
  • Continued therapy will not be authorized as Exa-Cel is indicated to be dosed one time only.

Fam-trastuzumab deruxtecan-nxki (Enhertu) (CP.PHAR.456)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter

Policy updates include:

• Added off-label use for advanced or metastatic colon and rectal cancers per NCCN
• For NSCLC removed the criterion to require treatment of non-HER2 mutations first, to align with NCCN recommendations; added recurrent gastric or GEJ cancer as a covered indication  

Furosemide (Furoscix) (CP.PHAR.608)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and 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, 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: Heart Failure (must meet all):
  • Diagnosis of chronic heart failure (CHF) of NYHA Class II or Class III;
  • Prescribed by or in consultation with a cardiologist;
  • Age ≥ 18 years;
  • Provider attestation that member is showing signs of extracellular volume expansion due to CHF;
  • Documentation that member is a candidate for parenteral diuresis outside of the hospital, as defined by all of the following (a, b, c, and d):
    • Oxygen saturation ≥ 90% on exertion;
    • Respiratory rate < 24 breaths per  minute;
    • Resting heart rate < 100 beats per minute;
    • Systolic blood pressure > 100 mmHg;
  • Provider attestation that member will use Furoscix for short-term use only and will be transitioned to oral diuretics as soon as practical;
  • Member has been stable and is refractory to at least one of the following loop diuretics, at up to maximally indicated doses:
    • Furosemide oral tablets;
    • Torsemide oral tablets;
    • Bumetanide oral tablets;
  • Dose does not exceed both of the following:
    • 80 mg (1 cartridge) per day;
    • Total of 8 kits over 30 days.
  • Approval duration: 4 weeks (up to 8 kits total)
• Continued Approval Criteria: Heart Failure (must meet all):
  • Re-authorization is not permitted. Members must meet the initial approval criteria for each request.

Futibatinib (Lytgobi) (CP.PHAR.604)

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: Cholangiocarcinoma (must meet all):
  • Diagnosis of unresectable locally advanced or metastatic intrahepatic cholangiocarcinoma;
  • Prescribed by or in consultation with an oncologist;
  • Age ≥ 18 years;
  • Documentation of FGFR2 fusion or rearrangement;
  • Member has not previously received a selective FGFR inhibitor (e.g., Truseltiq™, Pemazyre™)
  • Failure of at least one previous systemic cancer therapy;
  • Prescribed as a single agent;
  • For Lytgobi requests, member must use futibatinib, if available, unless contraindicated or clinically significant adverse effects are experienced;
  • Request meets one of the following (a or b):
    • Dose does not exceed 20 mg (5 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 Approval Criteria: Cholangiocarcinoma (must meet all):
  • Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Lytgobi for a covered indication and has received this medication for at least 30 days;
  • Member is responding positively to therapy;
  • For Lytgobi requests, member must use futibatinib, 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 20 mg (5 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

Givosiran (Givlaari) (CP.PHAR.457)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter

Policy updates include:

• Added hepatologist as specialty able to prescribe or be in consultation with

GLP-1 receptor agonists (HIM.PA.53)

Ambetter

Policy updates include:

• Added bypass of metformin for members with ASCVD, indicators of high ASCVD risk, or chronic kidney disease per ADA guidelines
• Added new dosage strength (2 mg/3 mL pen) for Ozempic
• Added pediatric expansion for age ≥ 10 years for Trulicity

Icosapent ethyl (Vascepa) (CP.PMN.187)

Ambetter

Policy updates include:

• Removed redirection to generic icosapent ethyl for brand Vascepa requests for CVD risk reduction indication

Inclisiran (Leqvio) (CP.PHAR.568)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter

Policy updates include:

• Per 2022 ACC expert consensus decision pathway, lowered minimum LDL requirement to 55 mg/dL for members with ASCVD at very high risk  

Luspatercept-aamt (Reblozyl) (CP.PHAR.450)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter

Policy updates include:

• For TDT continued therapy, clarified criterion that positive response to therapy as evidenced by at least a 33% reduction in transfusion burden from baseline is required after 9 weeks of treatment (3 doses) at the maximum dose unless the request is for a dose increase prior to 9 weeks of treatment
• Per NCCN Compendium, removed requirement for combination w/G-CSF for MDS indication

Natalizumab (Tysabri) (CP.PHAR.259)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter

Policy updates include:

• Added Amjevita as an alternative option to Humira for CD

Nivolumab (Opdivo) (CP.PHAR.121)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter

Policy updates include:

• Added off-label criteria for bone cancer, central nervous system cancers, pediatric primary mediastinal large B-cell lymphoma, pediatric diffuse high-grade gliomas
• Removed age restriction from off-label criteria

OnabotulinumtoxinA (Botox) (CP.PHAR.232)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter

Policy updates include:

• Max dose for chronic anal fissures updated from 25 units to 100 units per treatment session  

Opioid Analgesics (HIM.PA.139)

Ambetter

Policy updates include:

• Added sickle cell disease
• For Continued Therapy for short-acting agents changed approval duration from 7 days to 1 month

Ozanimod (Zeposia) (CP.PHAR.462)

Ambetter

Policy updates include:

·        Added Amjevita as an alternative option to Humira for UC

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

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter

Policy updates include:

• For thymomas/thymic carcinomas added option for members who cannot tolerate first-line combination regimens per NCCN

Prademagene Zamikeracel (EB-101) (CP.PHAR.609)

Ambetter

Policy includes:

• 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: Recessive Dystrophic Epidermolysis Bullosa (must meet all):
  • Diagnosis of RDEB as evidenced by two copies of positive COL7A1 gene mutation by one of the following:
    • Immunofluorescence mapping;
    • Transmission electron microscopy;
    • Antigenic mapping;
  • Prescribed by or in consultation with a geneticist, dermatologist, or histopathologist;
  • Age ≥ 6 years;
  • Provider attestation that member is concomitantly receiving standard of care preventative or treatment therapies for wound care (e.g., polymeric membrane, super-absorbent dressings, soft-silicone foam, enzyme alginogel, protease)
  • Wound site must be a stage 2 chronic wound with an area of at least 20 cm2 and present for at least 6 months;
  • Member has no evidence of immune response to COL7 as evidenced by immunofluorescence (e.g., member is not positive for anti-COL7 antibodies at baseline);
  • Member does not have a history of squamous cell carcinoma in the area that will undergo treatment;
  • Dose does not exceed 6 sheets.
  • Approval duration: 3 months (1 application only)
• Continued Approval Criteria: Recessive Dystrophic Epidermolysis Bullosa:
  • Continued therapy will not be authorized as EB-101 is indicated to be a one-time surgical application.

Risankizumab-rzaa (Skyrizi) (CP.PHAR.426)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP

Policy updates include:

• Added Amjevita as an alternative option to Humira for CD

RP-L201 (CP.PHAR.599)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter

Policy includes:

• Criteria will mirror the clinical information from the prescribing information once FDA-approved
• 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: Leukocyte Adhesion Deficiency Type 1 (must meet all):
  • Confirmed diagnosis of LAD-I as demonstrated by flow cytometry indicating one of the following:
    • CD18 expression on < 2% neutrophils (polymorphonuclear neutrophils [PMNs]);
    • CD18 expression on ≥ 2% PMNs concurrently with all of the following (i, ii, and iii):
• CD11a or CD11b expression on < 2% PMNs;
• Genetic testing showing ITGB2 gene mutation;
• Clinical history consistent with LAD-I or a known family history
  • Prescribed by or in consultation with both of the following:
    • Transplant specialist;
    • One of the following (i-iv):
• Hematologist;
• Oncologist;
• Immunologist;
• Infectious disease specialist;
  • Age ≥ 3 months;
  • For members without documented family history of LAD-I: ≥ 1 prior significant bacterial or fungal infection;*
  • One of the following:
    • Member has no available human leukocyte antigen (HLA)-matched sibling donors;
    • Member has an available HLA-matched sibling donor, and both of the following (i and ii):
• Provider submits medical rationale that stem cell collection is not feasible (e.g., donor is in utero, is a newborn from whom cord blood was not collected, or is unable to undergo donation procedure because of medical impairments);
• Member/caregiver understands the risks and benefits of alternative therapeutic options such as allogeneic hematopoietic stem cell transplantation (HSCT);
  • Transplant specialist attestation that member is clinically stable and eligible to undergo myeloablative conditioning and HSCT;
  • Dose is at least 2 x 106 total CD34+ cells/kg.
  • Approval duration: 3 months (one time infusion per lifetime)
• Continued Approval Criteria: Leukocyte Adhesion Deficiency Type 1
  • Continued therapy will not be authorized as RP-L201 is indicated to be dosed one time only.

SGLT2 inhibitors (HIM.PA.91)

Ambetter

Policy updates include:

• Added bypass of metformin for members with ASCVD, indicators of high ASCVD risk, HF, or CKD per ADA guidelines

Sodium thiosulfate (Pedmark) (CP.PHAR.610)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and 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, 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: Ototoxicity Prophylaxis (must meet all):
  • Diagnosis of localized, non-metastatic solid tumor(s);
  • Member will be treated with cisplatin chemotherapy;
  • Prescribed by or in consultation with an oncologist;
  • Age > 1 month and ≤ 18 years;
  • Documentation of member’s body surface area in m2;
  • Documentation of member’s actual weight in kg;
  • Dose does not exceed one of the following (a, b, or c):
    • For body weight < 5 kg: 10 g/m2;
    • For body weight ≥ 5 kg: 15 g/ m2;
    • For body weight >10 kg: 20 g/m2 per cisplatin dose.
  • Approval duration: 6 months
• Continued Approval Criteria: Ototoxicity Prophylaxis (must meet all):
• Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Pedmark for a covered indication and has received this medication for at least 30 days;
  • Member is responding positively to therapy;
  • Documentation of member’s body surface area in m2;
  • Documentation of member’s actual weight in kg;
  • Dose does not exceed one of the following (a, b, or c):
    • For body weight < 5 kg: 10 g/m2;
    • For body weight ≥ 5 kg: 15 g/ m2;
    • For body weight >10 kg: 20 g/m2 per cisplatin dose.
• Approval duration: 12 months

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

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and 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, 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: Generalized Pustular Psoriasis (must meet all):
  • Diagnosis of GPP;
  • Documentation of GPP flares of moderate-to-severe intensity;
  • Prescribed by or in consultation with a dermatologist;
  • Age ≥ 18 years;
  • Failure of a ≥ 3 consecutive month trial of one of the following at up to maximally indicated doses, unless clinically significant adverse effects are experienced or all are contraindicated: methotrexate, cyclosporine, acitretin;
  • Spevigo is not prescribed concurrently with biological disease-modifying antirheumatic drug or Janus kinase inhibitors
  • Dose does not exceed 900 mg (2 vials) one time, followed by an optional second 900 mg (2 vials) dose 1 week later if flare symptoms persist.
  • Approval duration: 1 month
• Continued Approval Criteria: Generalized Pustular Psoriasis
  • Re-authorization is not permitted. Members must meet the initial approval criteria.

Teclistamab-cqyv (Tecvayli) (CP.PHAR.611)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and 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, 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: Multiple Myeloma (must meet all):
  • Diagnosis of relapsed or refractory multiple myeloma (RRMM);
  • Prescribed by or in consultation with a hematologist or an oncologist;
  • Age ≥ 18 years;
  • Tecvayli is prescribed as monotherapy;
  • Member has measurable disease as evidenced by one of the following assessed within the last 28 days (a, b, or c):
    • Serum M-protein ≥ 1 g/dL;
    • Urine M-protein ≥ 200 mg/24 h;
    • Serum free light chain (FLC) assay: involved FLC level ≥ 10 mg/dL (100 mg/L) provided serum kappa lambda FLC ratio is abnormal;
  • Member has received or has documented intolerance to ≥ 4 prior lines of therapy (see Appendix B for examples) that include all of the following (a, b, and c):
    • One proteasome inhibitor (e.g., bortezomib, Kyprolis®, Ninlaro®);
    • One immunomodulatory agent (e.g., Revlimid®, pomalidomide, Thalomid®);
    • One anti-CD38 antibody (e.g., Darzalex®/Darzalex Faspro™, Sarclisa®);
  • Member does not have a known active central nervous system (CNS) involvement (e.g., seizure, cerebrovascular ischemia) or exhibits clinical signs of meningeal involvement of multiple myeloma;
  • Member has not previously received treatment with anti-BCMA targeted therapy (e.g., Blenrep™, Abecma®, or Carvykti™);
  • Dose does not exceed all of the following:
    • Day 1: 0.06 mg/kg;
    • Day 4: 0.3 mg/kg;
    • Day 7: 1.5 mg/kg;
    • Day 8 and thereafter: 1.5 mg/kg per week;
    • Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label dose use (prescriber must submit supporting evidence).
  • Approval duration: 6 months
• Continued Approval Criteria:  Multiple Myeloma (must meet all):
  • Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Tecvayli for a covered indication and has received this medication for at least 30 days;
  • Member is responding positively to therapy;
  • If request is for a dose increase, request meets one of the following:
    • New dose does not exceed 1.5 mg/kg per week;
    • New dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label dose use (prescriber must submit supporting evidence).
  • Approval duration: 12 months

Teduglutide (Gattex) (CP.PHAR.114)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter

Policy updates include:

• Removed required somatropin trial for adults per AGA guidelines

Teprotumumab (Tepezza) (CP.PHAR.465)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter

Policy updates include:

• Added dosing requirements for vial quantity using the online dose calculator or dose rounding recommendations based on newly added Appendix E
• Per prescribing information added the following option for thyroid lab assessment: “Member has a recent (within the last 30 days) free thyroxine (FT4) and total triiodothyronine (T3) or free T3 (FT3) levels less than 50% above or below the laboratory defined reference range and is undergoing treatment to correct the mild hypo- or hyperthyroidism to maintain a euthyroid state”

Tisagenlecleucel (Kymriah) (CP.PHAR.361)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter

Policy updates include:

• For LBCL added NCCN supported use in AIDS-related DLBCL, primary effusion lymphoma, and HHV8-positive DLBCL

Tixagevimab-Cilgavimab (Evusheld) (CP.PHAR.571)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter

Policy updates include:

• Updated initial criteria’s dosing regimen from tixagevimab 150 mg (1 vial) and cilgavimab 150 mg to tixagevimab 300 mg (2 vials) and cilgavimab 300 mg (2 vials) and provided further clarification for continued therapy dosing: if prior dose was administered ≤ 3 months then repeat dose of tixagevimab 150 mg (1 vial) and cilgavimab 150 mg (1 vial) vs if prior dose was administered > 3 months then repeat dose of tixagevimab 300 mg (2 vials) and cilgavimab 300 mg (2 vials)

Tremelimumab-actl (Imjudo) (CP.PHAR.612)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and 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, 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: Non-Small Cell Lung Cancer (must meet all):
  • Diagnosis of NSCLC;
  • Prescribed by or in consultation with an oncologist;
  • Age ≥ 18 years;
  • Prescribed in combination with durvalumab and platinum-based therapy (see Appendix D);
  • Request meets one of the following (a, b, or c):
    • For body weight < 30 kg, dose does not exceed Imjudo 1 mg/kg every 3 weeks in combination with durvalumab 20 mg/kg and platinum-based chemotherapy for 4 cycles, and then durvalumab 20 mg/kg every 4 weeks as a single agent with histology-based pemetrexed therapy every 4 weeks, and a fifth dose of Imjudo 1 mg/kg in combination with durvalumab dose 6 at week 16;
    • For body weight ≥ 30 kg, dose does not exceed Imjudo 75 mg every 3 weeks in combination with durvalumab 1,500 mg and platinum-based chemotherapy for 4 cycles, and then durvalumab 1,500 mg every 4 weeks as a single agent with histology-based pemetrexed therapy every 4 weeks, and a fifth dose of Imjudo 75 mg in combination with durvalumab dose 6 at week 16
    • 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
• Initial Approval Criteria: Hepatocellular Carcinoma (must meet all):
  • Diagnosis of unresectable, liver-confined, or metastatic hepatocellular carcinoma;
  • Prescribed by or in consultation with an oncologist;
  • Age ≥ 18 years;
  • Prescribed in combination with durvalumab;
  • Request meets one of the following:
    • For body weight < 30 kg, new dose does not exceed 4 mg/kg as a single dose in combination with durvalumab 20 mg/kg at Cycle 1/Day 1, followed by durvalumab as a single agent every 4 weeks;
    • For body weight ≥ 30 kg, new dose does not exceed, 300 mg as a single dose in combination with durvalumab 1,500 mg at Cycle 1/Day 1, followed by durvalumab as a single agent every 4 weeks;
    • Dose supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence)
  • Approval duration: 6 months
• Continued Approval Criteria:  All Indications Above (must meet all):
  • Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Imjudo for a covered indication and has received this medication for at least 30 days;
  • Member is responding positively to therapy;
  • If request is for a dose increase, request meets one of the following:
    • For metastatic NSCLC:
      • For body weight < 30 kg, dose does not exceed 1 mg/kg every 3 weeks in combination with durvalumab 20 mg/kg and platinum-based chemotherapy for 4 cycles and a fifth dose of Imjudo 1 mg/kg in combination with durvalumab dose 6 at week 16;
      • For body weight ≥ 30 kg, dose does not exceed 75 mg every 3 weeks in combination with durvalumab 1,500 mg and platinum-based chemotherapy for 4 cycles, and a fifth dose of Imjudo 75 mg in combination with durvalumab dose 6 at week 16
    • For uHCC:
      • For body weight < 30 kg, new dose does not exceed Imjudo 4 mg/kg as a single dose in combination with durvalumab 20 mg/kg at Cycle 1/Day 1, followed by durvalumab as a single agent every 4 weeks;
      • For body weight ≥ 30 kg, new dose does not exceed, Imjudo 300 mg as a single dose in combination with durvalumab 1,500 mg at Cycle 1/Day 1, followed by durvalumab as a single agent every 4 weeks;
    • 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

Ustekinumab (Stelara) (CP.PHAR.264)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP

Policy updates include:

• Added Amjevita as an alternative option to Humira for CD and UC

Vedolizumab (Entyvio) (CP.PHAR.265)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP

Policy updates include:

• Added Amjevita as an alternative option to Humira for CD and UC

Voxelotor (Oxbryta) (CP.PHAR.451)

Ambetter

Policy updates include:

• Updated maximum dosing requirements to allow dose adjustments for CYPA3A4 inducers

Zoledronic Acid (Reclast, Zometa) (CP.PHAR.59)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter

Policy updates include:

• As a result of Zometa branded product being obsolete, removed distinction between Zometa and Reclast, removed requirements that ensured both products are not used in combination