Selpercatinib (Retevmo) (CP.PHAR.478)

Ambetter

• Updated to reflect pediatric expanded use down to 2 years of age (previously 12 years of age) for thyroid cancers and new pediatric use in solid tumors
• Added age restriction for histiocytic neoplasms per National Comprehensive Cancer Network (NCCN)
• Converted Food and Drug Administration (FDA) approved indication for thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate) from accelerated approval to full approval per PI

Derisomaltose (Monoferric) (CP.PHAR.480)

Ambetter

Policy update includes:

• For cancer- and chemotherapy-induced anemia, added redirection to preferred iron products

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

Ambetter

• For Omnipod DASH and Omnipod 5, moved device limit (1 per 4 years) from approval duration to criteria and revised approval duration to 30 days due to operational limitations for benefit programming
• Added NDC for Omnipod DASH PDM Kit per request

Tralokinumab-ldrm (Adbry) (CP.PHAR.577)

Ambetter

Policy update includes:

• Added new autoinjector 300 mg/2 mL dosage formulation and added maximum numbers of injections to approval criteria

Sodium Oxybate (Xyrem, Lumryz) and Calcium Magnesium Potassium Sodium Oxybate (Xywav) (CP.PMN.42)

Ambetter

• For narcolepsy with cataplexy and narcolepsy with excessive daytime sleepiness, added redirection to generic Xyrem for brand Xyrem requests and “for Xywav or Lumryz requests” modified failure of “Xyrem” to failure of “sodium oxybate (Xyrem)”
• Added generic Xyrem to criteria and Xyrem to Risk Evaluation and Mitigation Strategy (REMS) program information in Appendix C

Deutetrabenazine (Austedo, Austedo XR) (CP.PCH.42)

Ambetter

Policy Updates include:

• Added new strengths of Austedo XR extended-release tablets (18 mg, 30 mg, 36 mg, 42 mg, 48 mg)

Immune Globulins (CP.PHAR.103)

Ambetter

Policy Updates include:

• Added Yimmugo to policy

Ferumoxytol (Feraheme) (CP.PHAR.165)

Ambetter

Policy Updates include:

• Added criteria for National Comprehensive Cancer Network (NCCN)-supported indication of cancer- and chemotherapy-induced anemia with redirection to preferred iron products

Afilbercept (Eylea, Eylea HD, Opuviz, Yesafili, Ahzantive) (CP.PHAR.184)

Ambetter

• Added Eylea biosimilars Opuviz, Yesafili, and Ahzantive
• Separated macular edema following retinal vein occlusion into new section with specification that request is for Eylea, Opuviz, Yesafili, or Ahzantive

Factor VIIa Recombinant (NovoSeven RT, SevenFact) (CP.PHAR.220)

Ambetter

• Added new vial strength of 2 mg

Ferric Carboxymaltose (Injectafer) (CP.PHAR.234)

Ambetter

Policy Updates include:

• Added criteria for National Comprehensive Cancer Network (NCCN)-supported indication of cancer- and chemotherapy-induced anemia with redirection to preferred iron products

Durvalumab (Imfinzi) (CP.PHAR.339)

Ambetter

Policy Updates include:

• Added criteria for newly Food and Drug Administration (FDA)-approved indication of mismatch repair deficient   (dMMR) endometrial cancer

Adagrasib (Krazati) (CP.PHAR.605)

Ambetter

• Added new Food and Drug Administration (FDA)-approved indication for the treatment of colorectal cancer
• updated Appendix B 
• Added off-label criteria for ampullary adenocarcinoma and biliary tract cancers as subsequent therapy per National Comprehensive Cancer Network (NCCN) compendium

Repotrectinib (Augtyro) (CP.PHAR.667)

Ambetter

Policy Updates include:

• Added new solid tumor indication with criteria and new strength 160 mg capsule

Colchicine (Colcrys, Lodoco) (CP.PMN.123)

Ambetter

Policy Updates include:

• Removed product-specification for cardiovascular prophylaxis in continued therapy section

Bedaquiline (Sirturo) (CP.PMN.212)

Ambetter

• Updated FDA approved indications to reflect changes from accelerated to full approval per updated prescribing information.
• Removed increased mortality from boxed warnings.

Pitolisant (Wakix) (CP.PMN.221)

Ambetter

Policy Updates include:

• Added pediatric extension for excessive daytime sleepiness with narcolepsy

Bempedoic acid (Nexletol), bempedoic acid-ezetimibe (Nexlizet) (CP.PMN.237)

Ambetter

• Criteria updated to reflect the revised indication for primary hyperlipidemia which now includes forms other than heterozygous familial hypercholesterolemia  (HeFH) and the new indication for reducing the cardiovascular risk reduction in adults who are unable to take recommended statin therapy (including those not taking a statin) with established CVD or a high risk for a cardiovascular disease (CVD) event but without established cardiovascular disease (CVD)
• Reduced statin adherence duration from 4 months to 8 weeks, simplified statin trial and failure criteria for moderate- and low-intensity statin regimens to require insufficient therapeutic response to one high intensity statin for 8 weeks or reversible muscle-related symptoms associated with both rosuvastatin and atorvastatin
• Removed criteria restricting coadministration with Repatha or Praluent

Delandistrogene Moxeparvovec-rokl (Elevidys) (CP.PHAR.593)

Ambetter

• Updated Food and Drug Administration (FDA) approved indications with conversion from accelerated approval to full approval for patients with ≥ 4 years of age and ambulatory plus expansion to non-ambulatory patients (accelerated approval)
• revised age restrictions to ≥ 4 years (previously ≥ 4 and ≤ 5 years)
• added treatment of non-ambulatory duchenne muscular dystrophy patients to Section III Diagnosis/Indications not covered based on current available evidence.

Donanemab-azbt (Kisunla) (CP.PHAR.594)

Ambetter

• Drug is now Food and Drug Administration (FDA)-approved – criteria updated per Food and Drug Administration (FDA) labeling: clarified that the initial 3 month auth duration covers the first 3 monthly infusions instead of the first 4 monthly infusions
• For Continued Therapy updated the required follow-up MRI schedule, treatment discontinuation thresholds, and MRI-contingent reauth durations

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

Ambetter

• Modified Remicade stepwise redirection by adding if member has failed Inflectra, Renflexis, and Avsola, member must use unbranded Remicade
• For unbranded Remicade, member must use Inflectra and Renflexis, then if member has failed Inflectra and Renflexis, member must use Avsola
• For Crohn’s disease and ulcerative colitis, added additional requirement for Zymfentra requests requiring provider attestation that “member is unable to receive continued therapy with IV infliximab due to lack of caregiver or support system for assistance with administration and/or inadequate access to healthcare facility or home care interventions and/or lack of transportation to healthcare facility.”
• For Kevzara, added newly approved polyarticular juvenile idiopathic arthritis indication to criteria
• For Skyrizi, added newly approved Ulcerative Colitis indication to criteria
• For Crohn’s disease, ulcerative colitis, plaque psoriasis, psoriatic arthritis: added newly approved biosimilar Pyzchiva to criteria
• For psoriatic arthritis: added Rinvoq to list of agents for ages > 2 years and older
• For Orencia requests for ages 2 to 17 years and Selarsdi/Wezlana requests for ages 6 to 17 years, added Rinvoq to list of redirected agents.

Elafibranor (Iqirvo) (CP.PHAR.688)

Ambetter

Policy includes:

• Requests for indications not approved by the Food and Drug Administration (FDA) are reviewed with the off-label use policy for the relevant line of business: HIM.PHAR.154 for Ambetter
• Initial Approval Criteria: Primary Biliary Cholangitis (PBC) (must meet all):
  • Diagnosis of PBC;
  • Prescribed by or in consultation with a hepatologist or gastroenterologist;
  • Age ≥ 18 years;
  • Failure (as evidenced by sustained elevation in alkaline phosphatase (ALP) ≥ 1.67 times the upper limit of normal) of ≥ 12 month trial of ursodeoxycholic acid (UDCA) (ursodiol) at a dose of ≥ 13 mg/kg/day, unless contraindicated or clinically significant adverse effects are experienced;
  • Prescribed in combination with ursodeoxycholic acid (UDCA), unless contraindicated or clinically significant adverse effects are experienced;
  • Dose does not exceed 80 mg (1 tablet) per day.
  • Approval duration: 6 months

• Continued Therapy: Primary Biliary Cholangitis (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;
  • Member is responding positively to therapy as evidenced by one of the following (a or b):
    • Initial reauthorization: reduction in alkaline phosphatase (ALP) level from pretreatment level;
    • Subsequent reauthorization: continued reduction or maintenance of initial reduction in alkaline phosphatase (ALP) level;
  • If request is for a dose increase, new dose does not exceed 80 mg (1 tablet) per day.
  • Approval duration: 12 months

Imetelstat (Rytelo) (CP.PHAR.690)

Ambetter

Policy includes:

• Requests for indications not approved by the Food and Drug Administration (FDA) are reviewed with the off-label use policy HIM.PHAR.154 for Ambetter
• Initial Approval Criteria: Myelodysplastic Syndromes (MDS) (must meet all):
  • Diagnosis of MDS with transfusion-dependent anemia;
  • Prescribed by or in consultation with a hematologist or oncologist;
  • Age ≥ 18 years;
  • Member has low risk or intermediate-1 risk MDS disease as classified by International Prognostic Scoring System (IPSS);
  • Documentation of at least 4 red blood cell (RBC) units transfused over 8 weeks;
  • Member does not have del(5q) cytogenetic abnormality;
  • Member meets one of the following :
    • Inadequate response to or ineligible for ESA therapy;
    • One of the following:
      • Failure of Retacrit™, unless contraindicated or clinically significant adverse effects are experienced;
      • *Prior authorization may be required for Retacrit
      • If Retacrit is unavailable due to shortage, member must use Epogen®, unless contraindicated or clinically significant adverse effects are experienced;
      • *Prior authorization may be required for Epogen
  • Rytelo is not prescribed concurrently with Reblozyl®;
  • Request meets one of the following :*
    • Dose does not exceed 7.1 mg/kg every 4 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 Food and Drug Administration (FDA)-approved or recommended by National Comprehensive Cancer Network (NCCN)
  • Approval duration: 6 months
• Continued Therapy: Myelodysplastic Syndromes (must meet all):
  • Member meets one of the following:
    • Currently receiving medication via Centene benefit or member has previously met initial approval criteria;
    • Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations;
  • Member is responding positively to therapy as evidence by decrease of red blood cell (RBC) transfusions requirement;
  • Rytelo is not prescribed concurrently with Reblozyl;
  • If request is for a dose increase, request meets one of the following :
  • Dose does not exceed 7.1 mg/kg every 4 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 Food and Drug Administration (FDA)-approved or recommended by National Comprehensive Cancer Network (NCCN)
  • Approval duration: 6 months

Olezarsen (CP.PHAR.689)

Ambetter

Policy includes:

• Criteria will mirror the clinical information from the prescribing information once Food and Drug Administration (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 Food and Drug Administration (FDA) are reviewed with the off-label use policy HIM.PHAR.154 for Ambetter.
• Initial Approval Criteria:  Familial Chylomicronemia Syndrome (FCS) (must meet all):*
• *Criteria will mirror the clinical information from the prescribing information once Food and Drug Administration (FDA)-approved
  • Diagnosis of FCS;*
  • Genetic testing confirms the presence of one of the following loss-of-function
  • mutations in FCS-causing genes (e.g., lipoprotein lipase (LPL), apolipoprotein C-II (APOC2), apolipoprotein C-VI (APOA5),  glycosylphosphatidylinositol-anchored high-density lipoprotein1binding protein 1 (GPIHBP1), lipase maturation factor 1 (LMF1) (a, b, or c):
    • Homozygote;
    • Compound heterozygote;
    • Double heterozygote;
  • Prescribed by or in consultation with a cardiologist, endocrinologist, or lipid specialist;
  • Age ≥ 18 years;*
  • Fasting triglycerides ≥ 880 mg/dL or ≥ 10 mmol/L (lab must be dated within 90 days);
  • Failure of both of the following at up to maximally indicated doses, unless clinically significant adverse effects are experienced or all are contraindicated (a and b);
    • Fibrates (e.g., fenofibric acid, fenofibrate, fenofibrate micronized, gemfibrozil);
    • Omega-3 fatty acids (e.g., omega-3-acid ethyl esters, icosapent ethyl);
  • Dose does not exceed 80 mg every 4 weeks.*
  • Approval duration:  Medicaid/HIM – 6 months
• Continued Therapy: Familial Chylomicronemia Syndrome (must meet all):*
• *Criteria will mirror the clinical information from the prescribing information once Food and Drug Administration (FDA)-approved
  • 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;
  • Member is responding positively to therapy as evidenced by reduction in fasting triglycerides from baseline;
  • If request is for a dose increase, new dose does not exceed 80 mg every 4 weeks.*
  • Approval duration: Medicaid/HIM – 12 months

Carbetocin (CP.PHAR.546)

Ambetter

Policy update includes:

• No significant changes as drug is not yet Food and Drug Administration (FDA)-approved
• Expanded age ranges to reflect on-going phase 3 study eligibility

Ketamine (Ketalar) (CP.PMN.296)

Ambetter

Policy includes:

• Requests for indications not approved by the Food and Drug Administration (FDA) are reviewed with the off-label use policy HIM.PHAR.154 for Ambetter.
• Initial Approval Criteria: Requests for Ketamine (must meet all):
  • Diagnosis of one of the following:
    • An Food and Drug Administration (FDA) approved indication;
    • A use supported by one of the following:
• Micromedex DrugDex with strength of recommendation Class I or IIa;
• Evidence from at least two high-quality, published studies in reputable peer-reviewed journals or evidence-based clinical practice guidelines that provide all of the following:
  • Adequate representation of the member’s clinical characteristics, age, and diagnosis;
  • Adequate representation of the prescribed drug regimen;
  • Clinically meaningful outcomes as a result of the drug therapy in question;
  • Appropriate experimental design and method to address research questions;
    • One of the following off-label indications:
• Treatment-resistant depression (TRD);
• Major depressive disorder (MDD);
  • If request is for brand Ketalar, member must use generic ketamine, unless contraindicated or clinically significant adverse effects are experienced;
  • For TRD and MDD, all of the following:
    • Request is for intravenous (IV) ketamine;
    • Prescribed by or in consultation with a psychiatrist;
    • Age ≥ 18 years;
    • Member meets one of the following:
• Request is for the treatment of a member in a State with limitations on step therapy in certain mental health settings;
• For all other requests, both of the following:
  • Failure of TWO antidepressants from the following, each tried for ≥ 4 weeks at up to maximally indicated doses, unless clinically significant adverse effects are experienced or all are contraindicated: selective serotonin reuptake inhibitor (SSRI), serotonin norepinephrine reuptake inhibitor  (SNRI), bupropion, mirtazapine, vilazodone;
  • Failure of ONE of the following antidepressant augmentation therapies, each used for ≥ 4 weeks, unless clinically significant adverse effects are experienced or all are contraindicated: second-generation antipsychotic, lithium, thyroid hormone, buspirone;
    • Request meets one of the following:
• Dose does not exceed 0.5 mg/kg IV for up to 8 doses;
• Dose does not exceed 1 mg/kg IV as a single dose;
• Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).
  • Approval duration: 3 months
• Continued Therapy: All Indications in Section I
  • Re-authorization is not permitted. Members must meet the initial approval criteria.
  • Approval duration: Not applicable

Blinatumomab (Blincyto) (CP.PHAR.312)

Ambetter

Policy updates include:

• Added new Food and Drug Administration (FDA) approved indication for Philadelphia chromosome-negative (Ph-) B-cell precursor acute lymphoblastic leukemia (B-ALL) as consolidation therapy and added age restriction of at least 1 month per updated prescribing information
• Rearranged criteria into Philadelphia chromosome-positive (Ph+) vs Ph- disease, added pathway for use as induction therapy for Ph+ disease, removed requirement that relapsed or refractory Ph+ disease must be refractory to tyrosine kinase inhibitor (TKI), added pathway for use as maintenance therapy for Ph- disease, added pathway for use after consolidation therapy and for Ph-like disease for pediatric members, and specified how Blincyto should be prescribed for all uses per National Comprehensive Cancer Network (NCCN)

Pembrolizumab (Keytruda) (CP.PHAR.322)

Ambetter

Policy updates include:

• Added new Food and Drug Administration (FDA) approved indication for endometrial cancer in combination with carboplatin and paclitaxel followed by Keytruda as a single agent.

Epcoritamab-bysp (Epkinly) (CP.PHAR.634)

Ambetter

Policy updates include:

• Updated Food and Drug Administration (FDA) approved indications to include follicular lymphoma

Vigabatrin (Sabril) (CP.PHAR.169)

Ambetter

Policy updates include:

• Added newly Food and Drug Administration (FDA) -approved Vigafyde oral solution to the criteria.

Tadalafil BPH - ED (Cialis) (CP.PMN.132)

Ambetter

Policy updates include:

• Added Chewtadzy to policy

Peanut Allergen Powder-dnfp (Palforzia) (CP.PMN.220)

Ambetter

Policy updates include:

• Updated minimum age from 4 years to 1 year (along with corresponding dosing) per newly approved pediatric extension

Roflumilast (Daliresp, Zoryve) (CP.PMN.46)

Ambetter

Policy updates include:

• Added criteria for newly Food and Drug Administration (FDA)-approved dosage form (Zoryve 0.15% cream) and indication of atopic dermatitis; specified that only the 0.3% cream should be used for plaque psoriasis per updated FDA labeling

Eculizumab (Soliris), Eculizumab-aeeb (Bkemv)  (CP.PHAR.97)

Ambetter

Policy updates include:

• Added newly approved biosimilar, Epysqli

Filgrastim (Neupogen), Filgrastim-sndz (Zarxio), Tbo-filgrastim (Granix), Filgrastim-aafi (Nivestym), Filgrastim-ayow (Releuko) (CP.PHAR.297)

Ambetter

Policy updates include:

• Added Nypozi to policy

Crovalimab (PiaSky) (CP.PHAR.664)

Ambetter

Policy updates include:

• Drug is now FDA approved - criteria updated per FDA labeling: modified criteria to require age ≥ 13 years and body weight ≥ 40 kg, added documentation of member’s current body weight, added criterion that members switching therapy from another C5 must administer dose at the time of next scheduled C5 inhibitor dose, clarified dose maximum to include only SC maintenance doses in the continued therapy section; references reviewed and updated.