Adagrasib (Krazati) (CP.PHAR.605)

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 recurrent, locally advanced, or metastatic NSCLC;
  • Prescribed by or in consultation with an oncologist;
  • Age ≥ 18 years;
  • Disease is positive for KRAS G12C mutation;
  • Member has received at least one systemic therapy;
  • Member has not received prior treatment with Lumakras™;
  • Request meets one of the following (a or b):
    • Dose does not exceed 1,200 mg (6 tablets) per day;
    • Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use
  • Approval duration: 6 months
• Continuation Approval Criteria: Non-Small Cell Lung Cancer (must meet all):
  • Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Krazati 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 (a or b):
    • New dose does not exceed 1,200 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).
  • Approval duration: 12 months

Alectinib (Alecensa) (CP.PHAR.369)

Ambe

tter

Po

licy updates include:

• Added off-label NCCN-supported indications of diffuse large B-cell lymphoma, Erdheim-Chester disease, and uterine sarcoma

Anakinra (Kineret) (CP.PHAR.244) (PDF)

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

Policy updates include:

• For RA, added TNFi criteria to allow bypass if member has had history of failure of two TNF blockers

Binimetinib (Mektovi) (CP.PHAR.50)

Ambetter

Policy updates include:

• For melanoma added limited resectable melanoma and added off-label criteria for histiocytic neoplasms per NCCN category 2A recommendation 

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

Ambetter

Policy updates include:

• For Actemra, revised criteria for COVID-19 emergency authorized use to FDA-approved indication
• For AS, pJIA, PsO, PsA, RA, CD, and UC, added TNFi criteria to allow bypass if member has had history of failure of two TNF blockers

Brexanolone (Zulresso) (CP.PHAR.417)

Ambetter

Policy updates include:

• Shortened the trial durations of antidepressant agent from 8 weeks to 4 weeks

Brigatinib (Alunbrig) (CP.PHAR.342)

Ambetter

Policy updates include:

• Added off-label NCCN-supported indications of Erdheim-Chester disease and uterine sarcoma

Bupropion-naltrexone (Contrave) (CP.PCH.12)

Ambetter

Policy updates include:

• Removed continued therapy criterion of BMI ≥ 25 kg/m2

Capecitabeine (Xeloda) (CP.PHAR.60)

Ambetter

Policy updates include:

• Collapsed off-label criteria for anal carcinoma and added to NCCN recommended (off-label) criteria set;
• Added ampullary adenocarcinoma and extrapulmonary neuroendocrine carcinoma to NCCN recommended (off-label) list;

Ceritinib (Zykadia) (CP.PHAR.349)

Ambetter

Policy updates include:

• Added off-label NCCN-supported indications of Erdheim-Chester disease and uterine sarcoma
• Removed capsule formulation as this was discontinued

Certolizumab (Cimzia) (CP.PHAR.247)

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

Policy updates include:

• For PsA and RA, added TNFi criteria to allow bypass if member has had history of failure of two TNF blockers

Ciltacabtagene Autoleucel (Carvykti) (CP.PHAR.533)

Ambetter

Policy updates include:

• Added additional option to currently required measurable disease requirement to allow for progressive disease as defined by IMWG
• Clarified requirement for diagnosis of relapsed or refractory multiple myeloma

Corticosteroids for Ophthalmic Injection (Iluvien, Ozurdex, Retisert, Xipere, Yutiq) (CP.PHAR.385)

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

Policy updates include:

• Added Dextenza to policy;
• Revised dosing frequency for Ozurdex from q4 months to q3 months 

Crizotinib (Xalkori) (CP.PHAR.90)

Ambetter

Policy updates include:

• Added off-label NCCN-supported indications of cutaneous melanoma and uterine sarcoma

Dasatinib (Sprycel) (CP.PHAR.72)

Ambetter

Policy updates include:

• For MLNE added NCCN supported use in the blast phase;
• Added off-label use in melanoma;
• Modified continued approval duration for Medicaid and HIM lines of business from 6 to 12 months

Dupilumab (Dupixent) (CP.PHAR.336)

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

Policy updates include:

• For CRSwNP modified requirement from three intranasal steroids to require only two

Durvalumab (Imfinzi) (CP.PHAR.339)

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

Policy updates include:

• For NSCLC per NCCN Compendium added recurrent or advanced disease and additional actionable molecular biomarkers that could be negative for use in combination with Imjudo and platinum therapy
• Added off-label continuation maintenance therapy
• Added off-label use for cervical cancer
• Clarified maximum 12 month continued approval duration applies only to stage II-III NSCLC

Elacestrant (Orserdu) (CP.PHAR.623)

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):
  • Member meets one of the following (a or b):
    • Diagnosis of advanced, recurrent unresectable, or stage IV (M1) metastatic breast cancer;
    • Diagnosis of inflammatory breast cancer with no response to preoperative systemic therapy;
  • Prescribed by or in consultation with an oncologist;
  • Age ≥ 18 years;
  • For Orserdu requests, member must use elacestrant, if available, unless contraindicated or clinically significant adverse effects are experienced;
  • Disease has all of the following characteristics (a, b, and c):
    • Estrogen receptor (ER) positive;
    • Human epidermal growth factor receptor 2 (HER2)-negative;
    • Estrogen receptor 1 (ERS1)-mutated;
  • Member meets one of the following (a or b):
    • Disease has progressed following at least one line of endocrine therapy (e.g., exemestane, fulvestrant, anastrozole, letrozole, tamoxifen);
    • Member has visceral crisis, defined as severe organ dysfunction, as assessed by signs and symptoms, laboratory studies, and rapid progression of disease;
  • Member has received prior treatment with a CDK4/6 inhibitor (e.g., Ibrance®, Verzenio®, Kisqali®);
  • If member is a biological female, member is postmenopausal (see Appendix D);
  • Used as a single agent therapy;
  • Request meets one of the following (a or b):
    • Dose does not exceed 345 mg (1 tablet) 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
• Continuation Approval Criteria: Breast Cancer (must meet all):
  • Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Orserdu for a covered indication and has received this medication for at least 30 days;
  • Member is responding positively to therapy;
  • For Orserdu requests, member must use elacestrant, 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 345 mg (1 tablet¥) 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

Elapegademase-lvlr (Revcovi) (CP.PHAR.419)

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

Policy updates include:

• Added hematologist specialty option to criteria

Encorafenib (Braftovi) (CP.PHAR.127)

Ambetter

Policy updates include:

• For melanoma criteria added limited resectable melanoma,
• For colon and rectal cancer added appendiceal adenocarcinoma per NCCN category 2A recommendation

Enfortumab Vedotin-ejfv (Padcev) (CP.PHAR.455)

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

Policy updates include:

• Added additional urothelial cancer indication in combination with pembrolizumab for patients ineligible for cisplatin-containing chemotherapy
• Added urologist prescriber for urological cancers

Erlotinib (Tarceva) (CP.PHAR.74)

Ambetter

Policy updates include:

• Corrected maximum dose quantity to 3 tablets, which corresponds with 450 mg;
• For kidney cancer, added criterion for Tarceva monotherapy or in combination with bevacizumab per NCCN Compendium

Fecal microbiota, live-jslm (Rebyota) (CP.PHAR.613)

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: Prevention of Clostridioides difficile Infection (must meet all):
  • Diagnosis of CDI confirmed by documentation of positive Clostridioides difficile test;
  • Age ≥ 18 years;
  • Member has recurrent CDI as evidenced by one of the following (a or b):
    • At least 2 episodes of CDI recurrence after a primary episode (i.e., total 3 episodes);
    • At least 2 episodes of severe CDI resulting in hospitalization within the last year;
  • Member has received at least 10 consecutive days of antibiotic therapy for the current CDI (e.g., metronidazole, vancomycin, fidaxomicin);
  • The current CDI is controlled (< 3 unformed/loose stools/day for 2 consecutive days [i.e., diarrhea, or Bristol Stool Scale type 6-7]);
  • Member has not previously received Rebyota treatment or prior fecal microbiota transplant;
  • Dose does not exceed a single dose of 150 mL.
  • Approval duration: 3 months (1 dose only)
• Continuation Approval Criteria: Prevention of Clostridioides difficile Infection
  • Re-authorization is not permitted as the efficacy of repeat courses of Rebyota has not been sufficiently established

Ferric Pyrophosphate Citrate (Triferic) (CP.PHAR.624)

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: Iron Replacement Therapy with Hemodialysis-Dependent Chronic Kidney Disease (must meet all):
  • Diagnosis of iron replacement therapy with HDD-CKD;
  • Transferrin saturation (TSAT) ≤ 30%;
  • Serum ferritin ≤ 500 ng/mL;
  • Documentation that Triferic is not used for peritoneal dialysis or home hemodialysis;
  • Failure of Ferrlecit® and Venofer®, unless clinically significant adverse effects are experienced or both are contraindicated;
  • Dose does not exceed 6.75 mg elemental iron per infusion/injection
  • Approval duration: 3 months
• Continuation Approval Criteria: Iron Replacement Therapy with Hemodialysis-Dependent Chronic Kidney Disease  (must meet all):
  • Member meets one of the following (a or b):
    • 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 (a, b, or c):
    • Hgb;
    • TSAT;
    • Serum ferritin;
  • If request is for a dose increase, new dose does not exceed 6.75 mg elemental iron per infusion/injection.
  • Approval duration: 3 months

Fluticasone Propionate (Xhance) (CP.PMN.95)

Ambetter

Policy updates include:

• Modified requirement from two formulary intranasal steroids to require only one

Golimumab (Simponi, Simponi Aria) (CP.PHAR.253)

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

Policy updates include:

• For AS, pJIA, PsA, and RA, added TNFi criteria to allow bypass if member has had history of failure of two TNF blockers

Guselkumab (Tremfya) (CP.PHAR.364)

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

Policy updates include:

• For PsA, added TNFi criteria to allow bypass if member has had history of failure of two TNF blockers

Histrelin Acetate (Vantas, Supprelin LA) (CP.PHAR.172)

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

Policy updates include:

• Added off-label use criteria for gender dysphoria or gender transition

Human Growth Hormone (Somapacitan, Somatropin)(HIM.PA.161)

Ambetter

Policy updates include:

• Added additional stepwise redirection to Omnitrope vial if Norditropin and Humatrope are not available (e.g. due to drug shortages).

Idecabtagene Vicleucel (Abecma) (CP.PHAR.481)

Ambetter

Policy updates include:

• Added additional option to currently required measurable disease requirement to allow for progressive disease as defined by IMWG;
• Clarified requirement for diagnosis of relapsed or refractory multiple myeloma

Insulin Delivery Systems (V-Go, Omnipod, InPen) (CP.PHAR.534)

Ambetter

Policy updates include:

• For V-Go, revised minimum age requirement from 21 years to 18 years per user guide

Itraconazole (Sporanox, Tolsura) (CP.PMN.124)

Ambetter

Policy updates include:

• Per IDSA dosing recommendations reduced trial duration of fluconazole for oropharyngeal candidiasis from 14 to 7 days,
• For esophageal candidiasis from 21 to 14 days, for oropharyngeal candidiasis reduced nystatin suspension or clotrimazole troches/lozenges trial duration from 14 to 7 days

Lasmiditan (Reyvow) (CP.PMN.218)

Ambetter

Policy updates include:

• Removed 200 mg strength per updated PI and revised maximum tablets allowed from 1 to 2 tablets

Lenacapavir (Sunlenca) (CP.PHAR.622)

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: HIV-1 Infection (must meet all):
  • Diagnosis of multidrug resistant HIV-1 infection;
  • Prescribed by or in consultation with an infectious disease or HIV specialist;
  • Age ≥ 18 years;
  • Documentation of resistance to at least 2 antiretroviral medications from at least 3 of the 4 main classes (NRTI, NNRTI, PI, INSTI), unless clinically significant adverse effects are experienced or all are contraindicated;
  • Failure of one of the following, unless clinically significant adverse effects are experienced, both are contraindicated, or member is resistant to both: Fuzeon®, Selzentry® if CCR5 tropic;
  • Current (within the past 30 days) HIV ribonucleic acid viral load of ≥ 200 copies/mL;
  • Prescribed concurrently with additional antiretroviral agents to which member is susceptible, if available;
  • Dose does not exceed one of the following (a, b, or c):
    • Initiation Option 1 (i and ii):
      • Day 1: 927 mg by subcutaneous injection (2 x 1.5 mL injections) and 600 mg orally (2 x 300 mg tablets);
      • Day 2: 600 mg orally (2 x 300 mg tablets);
    • Initiation Option 2 (i-iv):
      • Day 1: 600 mg orally (2 x 300 mg tablets);
      • Day 2: 600 mg orally (2 x 300 mg tablets);
      • Day 8: 300 mg orally (1 x 300 mg tablet);
      • Day 15: 927 mg by subcutaneous injection (2 x 1.5 mL injections);
    • Maintenance:
      • 927 mg by subcutaneous injection (2 x 1.5 mL injections) every 6 months (26 weeks) from the date of the last injection ± 2 weeks.
  • Approval duration: 7 months
• Continuation Approval Criteria: HIV-1 Infection (must meet all):
  • Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Sunlenca for multidrug resistant HIV-1 infection and has received this medication for at least 30 days;
  • Member is responding positively to therapy;
  • If request is for a dose increase, new dose does not exceed one of the following (a, b, or c):
    • Initiation Option 1 (i and ii):
      • Day 1: 927 mg by subcutaneous injection (2 x 1.5 mL injections) and 600 mg orally (2 x 300 mg tablets);
      • Day 2: 600 mg orally (2 x 300 mg tablets);
    • Initiation Option 2 (i-iv):
      • Day 1: 600 mg orally (2 x 300 mg tablets);
      • Day 2: 600 mg orally (2 x 300 mg tablets);
      • Day 8: 300 mg orally (1 x 300 mg tablet);
      • Day 15: 927 mg by subcutaneous injection (2 x 1.5 mL injections);
    • Maintenance:
      • 927 mg by subcutaneous injection (2 x 1.5 mL injections) every 6 months (26 weeks) from the date of the last injection ± 2 weeks                         
  • Approval duration: 12 months

Lorlatinib (Lorbrena) (CP.PHAR.406)

Ambetter

Policy updates include:

• Added off-label NCCN-supported indications of diffuse large B-cell lymphoma, Erdheim-Chester disease, IMT, and uterine sarcoma

Mepolizumab (Nucala) (CP.PHAR.200)

Ambetter

Policy updates include:

• Per February SDC, for CRSwNP modified requirement from three intranasal steroids to require only two

Mercaptopurine (Purixan) (CP.PHAR.447)

Ambetter

Policy updates include:

• Added by-passing of redirection if state regulations do not allow step therapy in certain oncology settings

Methotrexate (Otrexup, Rasuvo, Xatmep, Reditrex, Jylamvo) (CP.PHAR.134)

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

Policy updates include:

• Added new dosage formulation Jylamvo and criteria for MF and NHL indications
• Updated RA maximum dosing to 30 mg/week.

Milnacipran (Savella) (CP.PMN.125)

Ambetter

Policy updates include:

·        Shortened the trial durations of antidepressant agents from 8 weeks to 4 weeks

Mirvetuximab soravtansine-gynx (Elahere) (CP.PHAR.617)

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

Policy includes:

• Criteria is only applicable for Medicaid and CHIP when the drug is added to the formulary for coverage
• Requests for indications not approved by the FDA are reviewed with the off-label use policy for the relevant line of business: HIM.PHAR.154 for Ambetter, and CP.PMN.53 for Medicaid and CHIP
• Initial Approval Criteria: Ovarian Cancer (must meet all):
  • Diagnosis of epithelial ovarian, fallopian tube, or primary peritoneal cancer;
  • Prescribed by or in consultation with an oncologist;
  • Age ≥ 18 years;
  • Member meets all of the following parameters (a, b, and c) (see Appendix D):
  • FRα positive ovarian cancer determined by the Ventana FOLR1 (Folate Receptor 1/Folate Receptor Alpha) Assay;
  • Platinum resistant ovarian cancer;
  • Received at least 1 but no more than 3 prior systemic lines of anticancer therapy, including at least 1 line of therapy containing bevacizumab;
  • Documentation of current actual body weight in kg and height in cm;
  • Request meets one of the following (a or b):
  • Dose does not exceed 6mg/kg dosed based on adjusted ideal body weight (see Appendix D) on day 1 of every 3-week cycle ;
  • 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
• Continuation Approval Criteria: Ovarian Cancer (must meet all):
  • Currently receiving medication via Centene benefit or documentation supports that member is currently receiving Elahere for a covered indication and has received this medication for at least 30 days.
  • Member is responding positively to therapy.
  • Documentation of current actual body weight in kg;
  • If request is for a dose increase, request meets one of the following (a or b):
    • New dose does not exceed 6 mg/kg dosed based on adjusted ideal body weight (see Appendix D) on day 1 of every 3-week 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

Mosunetuzumab-axgb (Lunsumio) (CP.PHAR.618)

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

Policy includes:

• Criteria is only applicable for Medicaid and CHIP when the drug is added to the formulary for coverage
• Requests for indications not approved by the FDA are reviewed with the off-label use policy for the relevant line of business: HIM.PHAR.154 for Ambetter, and CP.PMN.53 for Medicaid and CHIP
• Initial Approval Criteria: Follicular Lymphoma (must meet all):
  • Diagnosis of relapsed or refractory follicular lymphoma characterized as both of the following (a and b):
    • Grade 1, 2 or 3a (low grade or slow growing);
    • Presence of at least one bi-dimensionally measurable lesion (≥ 1.5 cm in its largest dimension for nodal lesions, or ≥1.0 cm in its largest dimension for extranodal lesions;
  • Prescribed by or in consultation with an oncologist or a hematologist;
  • Age ≥ 18 years;
  • Member has received at least two prior lines of systemic therapy including all of the following (a and b);
    • One anti-CD20-directed therapy (e.g., rituximab, Arzerra®, Gazyva®);
    • One alkylating agent (e.g., bendamustine, cyclophosphamide);
  • Member does not have a known current or past central nervous system (CNS) lymphoma, or a history of CNS disease (e.g., stroke/transient ischemic attack with residual neurologic deficits; epilepsy with seizures in the past 2 years; CNS vasculitis or neurodegenerative disease);
  • Dose does not exceed one of the following (a or b):
    • All of the following (i, ii and iii):
      • Cycle 1:
        • Day 1: 1 mg;
        • Day 8: 2 mg;
        • Day 15: 60 mg;
      • Cycle 2: Day 1: 60 mg;
      • Cycles 3+: Day 1: 30 mg;
    • Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).
  • Approval duration: 9 months (8 treatment cycles of 21 days each)
• Continuation Approval Criteria: Follicular Lymphoma (must meet all):
  • Currently receiving medication via Centene benefit or documentation supports that member is currently receiving Lunsumio for a covered indication and has received this medication for at least 30 days;
  • Member meets one of the following (a or b):
    • Received 8 initial treatment cycles and needs further therapy due to incomplete or partial response;
    • Did not receive 8 initial treatment cycles, and wishes to resume therapy;
  • Member is responding positively to therapy;
  • If request is for a dose increase, request meets one of the following (a or b):
    • All of the following (i, ii and iii):
      • Cycle 1:
        • Day 1: 1 mg;
        • Day 8: 2 mg;
        • Day 15: 60 mg;
      • Cycle 2: Day 1: 60 mg;
      • Cycles 3+: Day 1: 30 mg;
    • 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 (see comments below)
    • For members who received 8 initial treatment cycles, 9 additional continued therapy cycles will be approved for the total of 17 cycles between the initial and continued therapy.
    • For members who did not receive 8 initial treatment cycles, but wish to resume therapy, approval will be granted to complete the 8 initial treatment cycles after which re-authorization for continued therapy will be required.

Nabumatone Double-Strength (Relafen DS) (CP.PMN.287)

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: Osteoarthritis or Rheumatoid Arthritis (must meet all):
  • Diagnosis of OA or RA;
  • Age ≥ 18 years;
  • Member must use generic nabumetone 500 mg or 750 mg tablet, unless contraindicated or clinically significant adverse effects are experienced;
  • Documentation supports inability to use multiple generic nabumetone 500 mg tablets to achieve the requested Relafen DS dose;
  • Dose does not exceed both of the following (a and b):
    • 2,000 mg per day;
    • 2 tablets per day.
  • Approval duration: 12 months
• Continuation Approval Criteria: Osteoarthritis or Rheumatoid (must meet all):
  • Member meets one of the following (a or b):
    • 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 both of the following (a and b):
    • 2,000 mg per day;
    • 2 tablets per day.
• Approval duration: 12 months

Naloxegol (Movantik) (HIM.PA.167)

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: Opioid-Induced Constipation (must meet all):
  • Diagnosis of OIC;
  • Age ≥ 18 years;
  • Member has been taking opioid(s) for ≥ 4 weeks due to chronic pain not caused by active cancer;
  • Dose does not exceed both of the following (a and b):
    • 25 mg per day;
    • 1 tablet per day.
  • Approval duration: 6 months
• Continuation Approval Criteria: Opioid-Induced Constipation (must meet all):
  • Member meets one of the following (a or b):
    • 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 continues to receive opioid therapy;
  • Member is responding positively to therapy;
  • If request is for a dose increase, new dose does not exceed both of the following (a and b):
    • 25 mg per day
    • 1 tablet per day
  • Approval duration: 12 months

Natalizumab (Tysabri) (CP.PHAR.259)

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

Policy updates include:

• For CD, added TNFi criteria to allow bypass if member has had history of failure of two TNF blockers;
• For MS, to be inclusive of members continuing therapy from a different benefit, revised Medicaid/HIM continued approval duration to reference the duration of total treatment received rather than the number of re-authorizations

Nedosiran (DCR-PHXC) (CP.PHAR.619)

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: Primary Hyperoxaluria Type 1 (must meet all):
• Diagnosis of PH1 confirmed by one of the following (a or b):
  • Genetic testing confirming presence of mutations in the AGXT gene;
  • Liver biopsy confirming alanine glyoxylate aminotransferase (AGT) enzyme deficiency;
• Prescribed by or in consultation with an endocrinologist, hepatologist, or nephrologist;
• Age ≥ 6 years;
• Documentation of estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73 m²;
• Documentation of one of the following (a or b):
  • Urinary oxalate (UOx) excretion > 0.70 mmol/1.73 m²/24 h, confirmed on repeat testing;
  • Spot urinary oxalate-to-creatinine (UOx:Cr) molar ratio greater than normal for age, confirmed on repeat testing;
• Failure to achieve normalization of UOx excretion levels after at least three months of pyridoxine (vitamin B6) at up to maximally indicated doses, unless contraindicated or clinically significant adverse effects are experienced;
• Member has not had a liver transplant;
• Documentation of member’s current body weight (in kg);
• Dose does not exceed FDA-labeled maximum dosing.
• Approval duration: 6 months
• Continued Approval Criteria: Primary Hyperoxaluria Type 1 (must meet all):
  • Member meets one of the following (a or b):
    • 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 either of the following parameters (a or b):
    • Decrease from baseline in UOx excretion of > 30%;
    • Improvement in PH1 symptoms (e.g., nephrolithiasis, nephrocalcinosis, kidney function, ischemic skin ulcers, metabolic bone disease, refractory anemia, cardiomyopathy, abnormalities in cardiac conduction) and one of the following (i or ii):
• Decrease from baseline in UOx excretion;
• Improvement in spot UOx:Cr molar ratio;
  • Member has not had a liver transplant;
  • Documentation of member’s current body weight (in kg);
  • If request is for a dose increase, new dose does not exceed FDA-labeled maximum dosing.
  • Approval duration: 12 months

Nilotinib (Tasigna) (CP.PHAR.76) (PDF)

Ambetter

Policy updates include:

• Added NCCN Compendium supported off-label uses for pigmented villonodular synovitis/tenosynovial giant cell tumor and melanoma;
• Modified continued approval duration for Medicaid and HIM lines of business from 6 to 12 months

Nirsevimab (Beyfortus) (CP.PHAR.614)

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
• 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: Preterm, Late Preterm or Term Infant (must meet all):
  • Member was born with a GA of ≥ 29 weeks 0 days;
  • Age at onset of RSV season ≤ 12 months;
  • Request is for RSV prophylaxis;
  • Medical justification supports requests for RSV prophylaxis beyond the identified season duration for Florida or beyond September through May for the remainder of the U.S.
  • Member has not previously received Beyfortus, Synagis, or other RSV monoclonal antibody or any RSV vaccine, including maternal RSV vaccination;
  • Member has not been hospitalized or previously infected with RSV disease during the current RSV season;
  • Dose does not exceed a single dose of one of the following (a or b):
    • Body weight < 5 kg: 50 mg;
    • Body weight ≥ 5 kg: 100 mg.
  • Approval duration: 4 weeks (1 dose per lifetime)
• Initial Approval Criteria: Chronic Lung Disease of Prematurity (must meet all):
  • Diagnosis of CLD of prematurity (i.e., BPD) defined as GA < 32 weeks and a requirement for > 21% oxygen for ≥ 28 days after birth;
  • Medical management (i.e., supplemental oxygen, bronchodilators, or diuretics) of CLD was required within the previous 6 months;
  • Age at onset of RSV season ≤ 12 months;
  • Request is for RSV prophylaxis;
  • Medical justification supports requests for RSV prophylaxis extending beyond the identified season duration for Florida or beyond September through May for the remainder of the U.S.
  • Member has not previously received Beyfortus, Synagis, or other RSV monoclonal antibody or any RSV vaccine, including maternal RSV vaccination;
  • Member has not been hospitalized or previously infected with RSV disease during the current RSV season;
  • Dose does not exceed a single dose of one of the following (a or b):
    • Weight < 5 kg: 50 mg;
    • Weight ≥ 5 kg: 100 mg.
  • Approval duration: 4 weeks (1 dose per lifetime)
• Initial Approval Criteria: Congenital Heart Disease (must meet all):
  • Diagnosis of hemodynamically significant CHD and one of the following (a or b):
    • CHD is unoperated or partially corrected;
    • Presence of acyanotic cardiac lesions and one of the following (i or ii):
• Pulmonary hypertension with ≥ 40 mmHg measured pressure in the pulmonary artery;
• Requirement of daily medication therapy to manage CHD;
  • Age at onset of RSV season ≤ 12 months;
  • Request is for RSV prophylaxis;
  • Medical justification supports requests for RSV prophylaxis extending beyond the identified season duration for Florida or beyond September through May for the remainder of the U.S. (see Appendix D);
  • Member has not previously received Synagis or other RSV monoclonal antibody or any RSV vaccine, including maternal RSV vaccination;
  • Member has not been hospitalized or previously infected with RSV disease during the current RSV season;
  • Dose does not exceed a single dose of one of the following (a or b):
    • Weight < 5 kg: 50 mg;
    • Weight ≥ 5 kg: 100 mg.
  • Approval duration: 6 months (1 dose per lifetime, unless member is undergoing cardiopulmonary bypass surgery in which case an additional dose may be administered [2 doses total per lifetime]
• Continuation Approval Criteria: All Indications in Section I
  • Continued therapy will not be authorized as Beyfortus is indicated to be dosed once prior to commencement of the RSV season during the first year of life, unless member is undergoing cardiopulmonary bypass surgery, in which case an additional dose may be administered (2 doses total per lifetime)

Olutasidenib (Rezlidhia) (CP.PHAR.615)

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: Acute Myeloid Leukemia (must meet all):
  • Diagnosis AML;
  • Prescribed by or in consultation with an oncologist or hematologist;
  • Age ≥ 18 years;
  • Disease is relapsed or refractory;
  • Presence of an IDH1 mutation;
  • For Rezlidhia requests, member must use generic olutasidenib if available, unless contraindicated or clinically significant adverse effects are experienced;
  • Request meets one of the following (a or b):
    • Dose does not exceed 300 mg (2 capsules) 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
• Continuation Approval Criteria: Acute Myeloid Leukemia (must meet all):
  • Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Rezlidhia for a covered indication and has received this medication for at least 30 days;
  • Member is responding positively to therapy;
  • For Rezlidhia requests, member must use olutasidenib, 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 (2 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).
• Approval duration: 12 months

Osimertinib (Tagrisso) (CP.PHAR.294)

Ambetter

Policy updates include:

• For NSCLC adjuvant treatment updated allowable stages from stage IB–IIIA to stage IB–IIIB per NCCN off-label support

Ozanimod (Zeposia) (CP.PHAR.462)

Ambetter

Policy updates include:

• For UC, added TNFi criteria to allow bypass if member has had history of failure of two TNF blockers;
• For MS, to be inclusive of members continuing therapy from a different benefit, revised continued approval duration to reference the duration of total treatment received rather than the number of re-authorizations

Pacritinib (Vonjo) (CP.PHAR.583)

Ambetter

Policy updates include:

• For MF added criteria for lower-risk disease per NCCN 2A recommendation and added criteria for higher-risk disease with platelets ≥ 50 x 109/L per NCCN 1 recommendation
• For continued therapy section updated FDA maximum dosing to mirror PI

Palivizumab (Synagis) (CP.PHAR.16)

Ambetter

Policy updates include:

• For CLD added bronchodilator therapy as an additional option to confirm appropriateness of therapy in the second year of life per AAP guidance

Pegfilgrastim (Neulasta, Neulasta Onpro), Pegfilgrastim-jmdb (Fulphila), Pegfilgrastim-pbbk (Fylnetra), Pegfilgrastim-apgf (Nyvepria), Eflapegrastim-xnst (Rolvedon), Pegfilgrastim-fpgk (Stimufend), Pegfilgrastim-cbqv (Udenyca), Pegfilgrastim-bmez (Ziextenzo) (CP.PHAR.296)

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

Policy updates include:

• Added Udenyca as step through requirement to co-prefer with Ziextenzo

Pembrolizumab (Keytruda) (CP.PHAR.322)

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

Policy updates include:

• Added additional urothelial cancer indication in combination with enfortumab vedotin for patients ineligible for cisplatin-containing chemotherapy
• Updated FDA approved indication for MSI-H/dMMR (Microsatellite Instability-High/Mismatch Repair Deficient Cancer) solid tumors to reflect full FDA approval per package insert

Pertuzumab (Perjeta) (CP.PHAR.227)

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

Policy updates include:

• For breast cancer, added option for Perjeta without taxanes and chemotherapy for members previously treated with chemotherapy and trastuzumab without pertuzumab and revised docetaxel to taxane-containing chemotherapy per NCCN 2A recommendation;
• For colorectal cancer, removed requirement for no previous use of a HER2 inhibitor therapy
• Added unresectable or metastatic HER2-positive gallbladder cancer and cholangiocarcinoma to NCCN recommended uses (off-label)

Phentermine (Adipex-P, Lomaira) (CP.PCH.13)

Ambetter

Policy updates include:

• Changed age requirement to ≥ 17 years instead of > 16 years;
• For age 17 years, added obesity defined as BMI ≥ 95th percentile standardized for age and sex;
• Removed continued therapy criterion of BMI ≥ 25 kg/m2;  

Pirtobrutinib (Jaypirca) (CP.PHAR.620)

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: Mantle Cell Lymphoma (must meet all):
  • Diagnosis of MCL;
  • Prescribed by or in consultation with an oncologist or hematologist;
  • Age ≥ 18 years;
  • For Jaypirca requests, member must use pirtobrutinib, if available, unless contraindicated or clinically significant adverse effects are experienced;
  • Member has received ≥ 2 prior lines of therapy
  • Member has received prior treatment with a BTK inhibitor (e.g., Imbruvica®, Brukinsa®, Calquence®);
  • Request meets one of the following (a or b):
    • Dose does not exceed (i and ii):
      • 200 mg per day;
      • 2 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
• Continuation Approval Criteria: Mantle Cell Lymphoma (must meet all):
  • Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Jaypirca for a covered indication and has received this medication for at least 30 days;
  • Member is responding positively to therapy;
  • For Jaypirca requests, member must use pirtobrutinib, 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 (i and ii):
      • 200 mg per day;
      • 2 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

Relugolix (Orgovyx), Relugolix-Estradiol-Norethindrone (Myfembree) (CP.PHAR.529)

Ambetter

Policy updates include:

• For prostate cancer, removed specific diagnosis characteristic requirements to align with current approach for the other GnRH agents (all are recommended for use in the same place in therapy per NCCN

Remestemcel-L (Ryoncil) (CP.PHAR.474)

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
• 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: Acute Graft-Versus-Host Disease (must meet all):
  • Diagnosis of steroid-refractory acute GVHD (grades II to IV), post hematopoietic cell transplantation, as evidenced by any of the following (a, b, or c):
    • Progression of acute GVHD within 3 to 5 days of therapy onset with ≥ 2 mg/kg per day of prednisone or dose equivalent corticosteroid (see Appendix D and E);
    • Failure to improve within 5 to 7 days of treatment initiation with ≥ 2 mg/kg per day of prednisone or dose equivalent corticosteroid (see Appendix D and  E );
    • Partial response after > 28 days of immunosuppressive treatment including ≥ 2 mg/kg per day of prednisone or dose equivalent corticosteroid (see Appendix B, D, and E);
  • Prescribed by or in consultation with an oncologist, hematologist, or bone marrow transplant specialist;
  • Age 2 months to ≤ 17 years;
  • Request meets one of the following (a or b):
    • Dose does not exceed 2 x 106 MSC/kg (1 dose) two times per week;
    • Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).
  • Approval duration: 1 month (8 doses total)
• Continuation Approval Criteria: Acute Graft-Versus-Host Disease (must meet all):
  • Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Ryoncil for a covered indication and has received this medication for at least 30 days;
  • For requests extending beyond 28 days, member has demonstrated evidence of a “partial” or “mixed” response but not yet a “complete” response (see Appendix E);
  • Member has not received more than 12 doses;
  • Request meets one of the following (a or b):
    • Dose does not exceed 2 x 106 MSC/kg (1 dose) per week;
    • Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence)
  • Approval duration: 1 month (4 additional doses, up to a total of 12 doses)

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

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

Policy updates include:

• For PsA and CD, added TNFi criteria to allow bypass if member has had history of failure of two TNF blockers

Sacituzumab govitecan-hziy (Trodelvy) (CP.PHAR.475)

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

Policy updates include:

• Updated commercial LOB approval language to standard language with addition of “whichever is longer
• Added new indication for treatment of HR-positive, HER2-negative breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting

Secukinumab (Cosentyx) (CP.PHAR.261)

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

Policy updates include:

• For AS and PsA, added TNFi criteria to allow bypass if member has had history of failure of two TNF blockers

Sorafenib (Nexavar) (CP.PHAR.69)

Ambetter

Policy updates include:

• For generic redirection removed “if available” as generic is now available;
• Per NCCN Compendium added additional ovarian cancer subtypes

Sunitinib (Sutent) (CP.PHAR.73)

Ambetter

Policy updates include:

• For RCC adjuvant therapy added clarification that clear cell histology is required per NCCN and prescribing information;
• For pNET added additional options for recurrent and advanced disease per NCCN;
• Added pheochromocytoma/paraganglioma as NCCN supported off-label uses

Sutimlimab-jome (Enjaymo) (CP.PHAR.503)

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

Policy updates include:

• Removed requirement for history of at least one documented blood transfusion within 6 months (initial criteria)
• Revised required increase in hemoglobin level from 2 to 1.5 g/dL (continued criteria), and modified evidence of positive response from being both of the following to just one of the following per revised FDA indication and new data from the CADENZA study
• Corrected hemoglobin-related continued criteria from > to ≥ per pivotal trial design

Tildrakizumab-asmn (Ilumya) (CP.PHAR.386)

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

Policy updates include:

• For PsO, added TNFi criteria to allow bypass if member has had history of failure of two TNF blockers

Tiopronin Delayed-Release (Thiola EC) (CP.PCH.50)

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: Severe Homozygous Cystinuria (must meet all):
  • Diagnosis of severe homozygous cystinuria;
  • Prescribed for the prevention of cystine stone formation;
  • Body weight ≥ 20 kg;
  • Provider attestation that Thiola EC is prescribed in combination with all the following preventative measures (a, b, and c):
    • High fluid intake;
    • Urinary alkalization (e.g., potassium citrate, citric acid);
    • Dietary modification;
  • Provider attestation that member has had prior failure or inadequate response to preventative measures alone (e.g., high fluid intake, urinary alkalization, and dietary modification);
  • Dose does not exceed any of the following (a or b):
    • Adult: 3,000 mg per day;
    • Pediatric: 50 mg/kg per day.
  • Approval duration: 12 months
• Continued Approval Criteria: Severe Homozygous Cystinuria (must meet all):
  • Member meets one of the following (a or b):
    • 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 any of the following (a or b):
    • Adult: 3,000 mg/day;
    • Pediatric 50 mg/kg per day.
  • Approval duration: 12 months

Trastuzumab, Biosimilars, Trastuzumab-Hyaluronidase (CP.PHAR.228)

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

Policy updates include:

• Added gallbladder cancer and cholangiocarcinoma as NCCN supported off-label indication

Ublituximab-xiiy (Briumvi) (CP.PHAR.621)

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 Sclerosis (must meet all):
  • Diagnosis of one of the following (a, b, or c):
    • Clinically isolated syndrome, and member is contraindicated to both, or has experienced clinically significant adverse effects to one, of the following at up to maximally indicated doses: an interferon-beta agent (Avonex®, Betaseron®/Extavia®†, Rebif®, or Plegridy®), glatiramer (Copaxone®, Glatopa®);
    • Relapsing-remitting MS, and failure of all of the following at up to maximally indicated doses, unless clinically significant adverse effects are experienced or all are contraindicated (i, ii, iii, and iv):
      • Dimethyl fumarate (generic Tecfidera®);
      • Aubagio®;
      • Gilenya®;
      • An interferon-beta agent (Avonex, Betaseron/Extavia†, Rebif, or Plegridy) or glatiramer (Copaxone, Glatopa);
    • Secondary progressive MS
  • Prescribed by or in consultation with a neurologist;
  • Age ≥ 18 years;
  • Briumvi is not prescribed concurrently with other disease modifying therapies for MS
  • Documentation of both baseline number of relapses per year and expanded disability status scale (EDSS) score;
  • At the time of request, member does not have active hepatitis B infection (positive results for hepatitis B surface antigen and anti-hepatitis B virus tests);
  • Dose does not exceed the following:
    • Initial dose: 150 mg, followed by a second 450 mg dose 2 weeks later;
    • Maintenance dose: 450 mg every 24 weeks.
  • Approval duration: 6 months
• Continuation Approval Criteria: Multiple Sclerosis (must meet all):
  • Member meets one of the following (a or b):
    • 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 meets one of the following (a or b):
    • If member has received < 1 year of total treatment: Member is responding positively to therapy;
    • If member has received ≥ 1 year of total treatment: Member meets one of the following (i, ii, iii, or iv):
      • Member has not had an increase in the number of relapses per year compared to baseline;
      • Member has not had ≥ 2 new MRI-detected lesions;
      • Member has not had an increase in EDSS score from baseline;
      • Medical justification supports that member is responding positively to therapy;
  • Briumvi is not prescribed concurrently with other disease modifying therapies for MS
  • If request is for a dose increase, new dose does not exceed 450 mg every 24 weeks.
  • Approval duration:
    • If member has received < 1 year of total treatment – up to a total of 12 months of treatment
    • If member has received ≥ 1 year of total treatment – 12 months

Ustekinumab (Stelara) (CP.PHAR.264)

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

Policy updates include:

• For CD, PsO, PsA, and UC, added TNFi criteria to allow bypass if member has had history of failure of two TNF blockers

Vedolizumab (Entyvio) (CP.PHAR.265)

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

Policy updates include:

• For UC and CD, added TNFi criteria to allow bypass if member has had history of failure of two TNF blockers

Zilucoplan (RA101495) (CP.PHAR.616)

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: Generalized Myasthenia Gravis (must meet all):
  • Diagnosis of gMG;
  • Prescribed by or in consultation with a neurologist;
  • Age ≥ 18 years;
  • Myasthenia Gravis-Activities of Daily Living (MG-ADL) score ≥ 6 at baseline;
  • Myasthenia Gravis Foundation of America (MGFA) clinical classification of Class II to IV;
  • Member has positive serologic test for anti-AChR antibodies;
  • Failure of a corticosteroid (see Appendix B), unless contraindicated or clinically significant adverse effects are experienced;
  • Failure of a cholinesterase inhibitor, unless contraindicated or clinically significant adverse effects are experienced;
  • Failure of at least one immunosuppressive therapy, unless clinically significant adverse effects are experienced or all are contraindicated;
  • RA101495 is not prescribed concurrently with Soliris®, Ultomiris®, or Vyvgart®;
  • Documentation of member’s current weight (in kg);
  • Dose does not exceed 0.3 mg/kg per day.
  • Approval duration: 6 months
• Continuation Approval Criteria: Generalized Myasthenia Gravis (must meet all):
  • Member meets one of the following (a or b):
    • 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 a ≥ 2-point reduction from baseline in the MG-ADL total score;
  • RA101495 is not prescribed concurrently with Soliris, Ultomiris, or Vyvgart;
  • Documentation of member’s current weight (in kg);
  • If request is for a dose increase, new dose does not exceed 0.3 mg/kg per day.
  • Approval duration: 6 months