Cinacalcet (Sensipar) (CP.PHAR.61)

Ambetter

Policy updates include:

• For all indications, added criteria to use generic cinacalcet over brand Sensipar

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

Ambetter

• Added newly approved biosimilar, Bkemv
• Updated the list of therapies that Soliris/Bkemv should not be prescribed concurrently with to include Rystiggo, Vyvgart, Hytrulo, and Zilbrysq for generalized myasthenia gravis, Fabhalta for paroxysmal nocturnal hemoglobinuria, and Ultomiris for neuromyelitis optica spectrum disorder
• Revised contraindications in Appendix C per updated Soliris prescribing information

Tesamorelin (Egrifta SV) (CP.PHAR.109)

Ambetter

Policy updates include:

• Revised clinical indicators for abdominal lipodystrophy criteria to require waist circumference and waist-hip ratio thresholds that reflect efficacy studies
• Revised Food and Drug Administration (FDA) Approved Indications and contraindications, removed criteria allowing pediatric use in members with closed epiphyses

Mecasermin (Increlex) (CP.PHAR.150)

Ambetter

Policy updates include:

• Revised verbiage that Increlex is not prescribed concurrently with growth hormone (previously only Somatropin was included)

Risperidone Long-Acting Injection (Perseris, Risperdal Consta, Rykindo, Uzedy) (CP.PHAR.293)

Ambetter

• Added generic redirection to brand Risperdal Consta requests
• Revised approval duration for whichever is longer
• Added HCPCs code [J3590, C9399] for Risvan

Sargramostim (Leukine) (CP.PHAR.295)

Ambetter

• Per National Comprehensive Cancer Network (NCCN) Compendium for high-risk neuroblastoma added additional supported combination therapies
• Added National Comprehensive Cancer Network (NCCN) Compendium supported off-label use in the treatment of chemotherapy-induced febrile neutropenia
• Revised dosing requirements to allow guideline or National Comprehensive Cancer Network (NCCN) supported off-label dosing
• For acute radiation syndrome to confirm weight-based dosing added requirement for documentation of member’s current weight (in kg)

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

Ambetter

• Per National Comprehensive Cancer Network (NCCN) Compendium for MDS added requirement that member previously has no response to either an erythropoiesis-stimulating agent (e.g., epoetin alfa, darbepoetin) or Reblozyl
• For bone marrow transplantation removed subcutaneous route of administration per prescribing information
• To confirm weight-based dosing added requirement for documentation of member’s current weight (in kg)

Brentuximab Vedotin (Adcetris) (CP.PHAR.303)

Ambetter

• Per National Comprehensive Cancer Network (NCCN) – for classical Hodgkin lymphoma, added pathway for use as a component of BrECADD for stage III-IV disease for members aged 18-61 years
• For T-cell lymphomas, removed requirement for 2 prior therapies for hepatosplenic T-cell lymphoma and added pathway for combination use with bendamustine for peripheral T-cell lymphoma, breast implant-associated anaplastic large cell lymphoma, and hepatosplenic T-cell lymphoma
• For mycosis fungoides and Sezary syndrome, added that Adcetris must be prescribed as a single agent, in combination with skin-directed therapy, or in combination with bendamustine
• For B-cell lymphomas, removed T-cell type monomorphic post-transplant lymphoproliferative disorder (PTLD)

Blinatumomab (Blincyto) (CP.PHAR.312)

Ambetter

• Specified that infant acute lymphoblastic leukemia must have KMT2A status (11q23 rearranged) and added pathway for use as frontline consolidation therapy per National Comprehensive Cancer Network (NCCN)
• Revised boxed warning in Appendix C per updated prescribing information

Pembrolizumab (Keytruda) (CP.PHAR.322)

Ambetter

• For classical Hodgkin lymphoma, added option to be prescribed with ICE and added pathway for palliative therapy (previously had after hematopoietic stem cell transplant, which falls under palliative therapy) per National Comprehensive Cancer Network (NCCN)
• For urothelial carcinoma, added pathway to be prescribed as single agent and member has previously received other chemotherapy (previously only allowed post-platinum chemotherapy)
• For hepatocellular carcinoma, removed disease is classified as Child-Pugh Class A
• For biliary tract cancer, added option for resected gross residual (R2) disease and removed combination with Lenvima per National Comprehensive Cancer Network (NCCN)
• For endometrial carcinoma, clarified continued as a single agent for maintenance therapy when prescribed in combination with carboplatin and paclitaxel
• For National Comprehensive Cancer Network (NCCN) recommended uses (off-label): expanded to stage IB for mycosis fungoides, for prescribed as first-line or subsequent therapy - added metastatic anaplastic carcinoma, anaplastic sarcoma, and vaginal cancer, for prescribed as single-agent subsequent therapy – added soft tissue sarcoma subtypes, added option for Keytruda to be prescribed in combination with cyclophosphamide and bevacizumab for platinum-resistant persistent ovarian cancer, fallopian tube cancer, and primary peritoneal cancer per National Comprehensive Cancer Network (NCCN)
• For continuation requests, added criterion for maximum duration of therapy (previously was included within requests for dose increase criterion)
• Updated appendix E

Plerixafor (Mozobil) (CP.PHAR.323)

Ambetter

Policy updates include:

• To confirm weight-based dosing added requirement for documentation of member’s current weight (in kg)

Fulvestrant (Faslodex Injection) (CP.PHAR.424)

Ambetter

• Revised policy/criteria section to also include generic fulvestrant
• Added redirection to generic fulvestrant for all indications
• Removed stage II and IIIA disease references from endometrial carcinoma criteria per National Comprehensive Cancer Network (NCCN)
• Removed adjuvant therapy for stage IV disease from endometrial carcinoma criteria for consolidation as this may be captured by metastatic disease option
• Added additional criteria options for recurrent and extrauterine disease for uterine carcinoma criteria per National Comprehensive Cancer Network (NCCN)

Tucatinib (Tukysa) (CP.PHAR.497)

Ambetter

• Added POLE/POLD1 mutation option if member is ineligible for, or disease has progressed on, checkpoint inhibitor immunotherapy in colorectal cancers
• Added off-label criteria for National Comprehensive Cancer Network (NCCN)-supported biliary tract cancers
• Added note that prior authorization may be required for combination therapy for all indications

Pegcetacoplan (Empaveli, Syfovre) (CP.PHAR.524)

Ambetter

• For paroxysmal nocturnal hemoglobinuria, added Fabhalta, Voydeya, and Bkemv to the list of therapies that Empaveli should not be prescribed concurrently with
• For geographic atrophy, clarified that diagnostic characteristics must be confirmed on fundus autofluorescence imaging per health plan request and in alignment with pivotal study design
• Revised Empaveli contraindications in Appendix C per updated prescribing information

Maralixibat (Livmarli) (CP.PHAR.543)

Ambetter

• For initial criteria, added exclusions for portal hypertension and history of a hepatic decompensation event for both progressive familial intrahepatic
• Cholestasis and Alagille syndrome per competitor analysis and to align with other progressive familial intrahepatic
• Cholestasis and Alagille syndrome criteria

Betibeglogene Autotemcel (Zynteglo) (CP.PHAR.545)

Ambetter

• Revised lower age limit to age ≥ 4 years and removed accompanying age < 5 criteria
• Removed age qualifier of ≥ 12 years for receipt of ≥ 8 transfusions of packed red blood cells per year
• Added clarification for time component and documentation within the last 6 months for negative human immunodeficiency virus (HIV) test
• Approval duration extended from 3 months to 6 months to allow for member preparation and adequate time for gene therapy manufacture
• Added clarification of a one-time dose only for continued authorization
• Corrected template language for continued therapy

Fidanacogene Elaparvovec-dzkt (Beqvez) (CP.PHAR.643)

Ambetter

• Drug is now Food and Drug Administration (FDA) approved – criteria updated per Food and Drug Administration (FDA) labeling: clarified documentation of negative test for neutralizing antibodies to AAVRh74var
• Added medical director review
• Removed criterion for subsequent negative factor IX inhibitor test if member has an initial positive test result
• Added criteria for documentation of HIV test with minimum CD4+ cell count or maximum viral load for positive HIV test
• Added criterion that member does not have current liver-related conditions
• Added criterion for hepatologist attestation of Beqvez eligibility if sustained liver enzymes or radiological liver abnormalities present
• Added criterion for documentation of member’s body weight to allow verification of weight based dose
• Added information in Appendix E on dose calculation for weight based doses

Givinostat (Duvyzat) (CP.PHAR.644)

Ambetter

• Duvyzat is now Food and Drug Administration (FDA) approved – criteria updated per Food and Drug Administration (FDA) labeling: added option for positive muscle biopsy for diagnosis of duchenne muscular dystrophy (DMD) if genetic studies negative per DMD Care Considerations Working Group
• Removed age restriction of < 18 years at therapy initiation
• Revised ambulatory criteria with removal of 4SC ≤ 8 seconds requirement
• Removed Corrected QT Interval (QTcF), triglycerides and Left ventricular ejection fraction (LVEF) contraindications from criteria
• Added documentation of member’s baseline ambulatory function as evidenced by motor function tests
• For continued therapy, added improvement or stabilization in member’s ambulatory function from baseline as example of responding positively to therapy

Lidocaine Transdermal (Lidoderm, ZTlido) (CP.PMN.08)

Ambetter

• For diabetic neuropathy, added desvenlafaxine as an example serotonin-norepinephrine reuptake inhibitor (SNRI) per American Academy of Neurology (AAN) and American Diabetes Association (ADA) guidelines
• Revised Lidoderm/ZTlido to generic transdermal lidocaine in Policy/Criteria
• For continued therapy, added requirement of a trial of generic lidocaine patches
• In Appendix B, removed commercially unavailable brand alternatives.

Linezolid (Zyvox) (CP.PMN.27)

Ambetter

Policy updates include:

• Added requirement if request is for orally administered brand Zyvox, member must use generic linezolid

Quetiapine Extended-Release (Seroquel XR) (CP.PMN.64)

Ambetter

Policy updates include:

• Revised continued therapy criteria to allow continuity of care for all indications

Vortioxetine (Trintellix) (CP.PMN.65)

Ambetter

Policy updates include:

• Revised continued therapy to allow continuity of care for antidepressants
• In Appendix B, added Wellbutrin SR to therapeutic alternatives and clarified that fluvoxamine used in depression is off-label

Milnacipran (Savella) (CP.PMN.125)

Ambetter

Policy updates include:

• Revised continued therapy criteria to allow continuity of care in antidepressants for all indications

Esketamine (Spravato) (CP.PMN.199)

Ambetter

Policy updates include:

• Revised continued therapy section to allow continuity of care for treatment-resistant depression

Amisulpride (Barhemsys) (CP.PMN.236)

Ambetter

• Added age requirement per prescribing information
• Revised approval duration from one time “approval” to “dose”

Ivermectin (Stromectol, Sklice) (CP.PMN.269)

Ambetter

• For Appendix C, updated contraindications section for Stromectol to align with prescriber information
• For Appendix D, updated supplemental information for ivermectin’s use in COVID-19
• For table V, updated dosing regimen for Sklice

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

Ambetter

Policy updates include:

• Revised continued therapy section to allow continuity of care.

Gepirone (Exxua) (CP.PMN.292)

Ambetter

Policy updates include:

• Revised continued therapy to allow continuity of care for antidepressants

Levomilnacipran (Fetzima) (HIM.PA.125)

Ambetter

Policy updates include:

• Revised continued therapy to allow continuity of care for antidepressants
• In Appendix B, added Wellbutrin SR to therapeutic alternatives and clarified that fluvoxamine used in depression is off-label

Tolvaptan (Jynarque, Samsca) (CP.PHAR.27)

Ambetter

Policy updates include:

• Revised policy/ criteria section to also include generic tolvaptan

Ravulizumab-cwvz (Ultomiris) (CP.PHAR.415)

Ambetter

Policy updates include:

• Updated the list of therapies that Ultomiris should not be prescribed concurrently with to include Bkemv for all indications, Fabhalta for paroxysmal nocturnal hemoglobinuria, and Rystiggo, Vyvgart Hytrulo, and Zilbrysq for generalized myasthenia gravis

Inebilizumab-cdon (Uplizna) (CP.PHAR.458)

Ambetter

Policy updates include:

• Added Bkemv and Ultomiris to the list of therapies that Uplizna should not be prescribed concurrently with

Satralizumab-mwge (Enspryng) (CP.PHAR.463)

Ambetter

Policy updates include:

• Added Bkemv and Ultomiris to the list of therapies that Enspryng should not be prescribed concurrently with

Iptacopan (Fabhalta) (CP.PHAR.656)

Ambetter

Policy updates include:

• Added Voydeya and Bkemv to the list of therapies that Fabhalta should not be prescribed concurrently with

Cariprazine (Vraylar) (CP.PMN.91)

Ambetter

Policy updates include:

• Revised continued therapy criteria to allow continuity of care for all indications

Topiramate Extended-Release (Qudexy XR, Trokendi XR) (CP.PMN.281)

Ambetter

Policy updates include:

• Revised “Failure of a trial” language to template “Member must use” language

Mometasone (Nasonex) (HIM.PA.93)

Ambetter

• Revised policy/criteria section to also include generic mometasone
• Added redirection to generic mometasone for brand Nasonex requests

Pegfilgrastim (Neulasta and biosimilars) (CP.PHAR.296)

Ambetter

• For bone marrow transplantation consolidated required drug redirections into a single sub-bullet for added clarity
• For all indications, removed redirection to Zarxio and Ziextenzo, added redirection to Nyvepria to co-prefer Udenyca and Nyvepria.

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 intravenous 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.”

Elamipretide (MTP-131) (CP.PHAR.680)

Ambetter

Policy includes:

• Criteria will mirror the clinical information from the prescribing information once Food and Drug Administration (FDA)-approved.
• 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:  Barth Syndrome (must meet all):
  • Diagnosis of Barth syndrome confirmed by DNA testing for the presence of a mutation in the tafazzin (TAZ) gene;
  • Prescribed by or in consultation with a clinical geneticist, metabolic disease specialist, endocrinologist, cardiologist, hematologist, or neurologist;
  • Age ≥ 12 years;
  • Dose does not exceed 40 mg per day.
  • Approval duration: 6 months
• Continued Therapy: Barth Syndrome (must meet all):
  • Member meets one of the following:
    • Currently receiving medication via Centene benefit or member has previously met initial approval criteria;
    • Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state specific  addendums of CC.PHARM.03A and CC.PHARM.03B);
  • Member is responding positively to therapy as evidenced by improvement in the individual member’s Barth syndrome manifestation profile;
  • If request is for a dose increase, new dose does not exceed 40 mg per day.
  • Approval duration: 12 months

Govorestat (AT-007) (CP.PHAR.681)

Ambetter

Policy includes:

• Criteria will mirror the clinical information from the prescribing information once Food and Drug Administration (FDA)-approved
• 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: Classic Galactosemia (must meet all):
  • Diagnosis of classic galactosemia confirmed by reduced (≤ 3% of normal) galactose-1-phosphate uridyltransferase (GALT)
  • activity;
  • Prescribed by or in consultation with a geneticist or metabolic specialist;
  • Age ≥ 2 years;
  • Dose does not exceed the Food and Drug Administration (FDA) approved maximum.
  • Approval duration: 6 months
• Continued Therapy: Classic Galactosemia (must meet all):
  • Member meets one of the following:
    • Currently receiving medication via Centene benefit or member has previously met initial approval criteria;
    • Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state specific addendums for CC.PHARM.03A and CC.PHARM.03B);
  • Member is responding positively to therapy;
  • If request is for a dose increase, new dose does not exceed the Food and Drug Administration (FDA) approved
  • maximum.
  • Approval duration: 12 months

N-Acetyl-L-Leucine (IB1001) (CP.PHAR.682)

Ambetter

Policy includes:

• Criteria will mirror the clinical information from the prescribing information once Food and Drug Administration (FDA)-approved
• 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: Niemann-Pick Disease Type C (NPC) (must meet all):
  • Diagnosis of NPC confirmed by one of the following:
    • Genetic analysis indicating mutation in both alleles of NPC1 or NPC2;
    • Genetic analysis indicates mutation in one allele of NPC1 or NPC2, along with one of the followin:
• Positive filipin staining test result;
• Positive biomarker result (e.g., oxysterol, lyso-sphingolipid, bile acid);
  • Prescribed by or in consultation with an endocrinologist or metabolic disease specialist;
  • Age ≥ 4 years;
  • Documentation of member’s current body weight in kg and weight is ≥ 15 kg;
  • Member presents with ≥ 2 neurological signs or symptoms of the disease (e.g., hearing loss, vertical supranuclear gaze palsy, ataxia, dementia, dystonia, seizures, dysarthria, dysphagia);
  • Scale for the Assessment and Rating of Ataxia (SARA) baseline score ≥ 7 and ≤ 34;
  • Dose does not exceed 4 g per day.
  • Approval duration: 12 weeks
• Continued Therapy: Niemann-Pick Disease Type C (must meet all):
  • Member meets one of the following:
    • Currently receiving medication via Centene benefit or member has previously met initial approval criteria;
    • Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state specific addendums for CC.PHARM.03A and CC.PHARM.03B);
  • Member is responding positively to therapy as evidenced by a decrease or stabilization in the SARA score from baseline;
  • If request is for a dose increase, new dose does not exceed 4 g per day.
  • Approval duration: 6 months

Acoramidis (AG10) (CP.PHAR.683)

Ambetter

Policy includes:

• Criteria will mirror the clinical information from the prescribing information once Food and Drug Administration (FDA)-approved
• 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: Transthyretin Amyloid Cardiomyopathy (must meet all):
  • Diagnosis of transthyretin amyloidosis
  • Cardiomyopathy (ATTR-CM) as supported by one of the following
    • Tissue biopsy amyloid protein is identified as transthyretin via mass spectrometry or immunohistochemistry, and:
  • Tissue biopsy is of endomyocardial origin;
    • Member meets all of the following:
• Echocardiography (Echo), cardiac magnetic resonance imaging (CMR), or positron emission tomography (PET) findings are consistent with cardiac amyloidosis;
• Cardiac uptake is Grade 2 or 3 on a radionuclide scan utilizing one of the following radiotracers (1, 2, or 3):
  • 99m technetium (Tc)-labeled 3,3-diphosphono-1,2-propanodicarboxylicacid (DPD);
  • 99mTc-labeled pyrophosphate (PYP);
  • 99mTc-labeled hydroxymethylene diphosphonate (HMDP);
• Each of the following laboratory tests is negative for monoclonal protein:
  • Serum kappa/lambda free light chain ratio analysis;
  • Serum protein immunofixation;
  • Urine protein immunofixation;
  • Prescribed by or in consultation with a cardiologist;
  • Age ≥ 18 years;
  • Member has heart failure of New York Heart Association (NHYA) Class I, II, or III;
  • Member has one of the following
    • At least 1 prior hospitalization for heart failure;
    • Current (within the last 30 days) clinical evidence of heart failure (i.e., signs and symptoms,;
  • AG10 is not prescribed concurrently with Vyndaqel®/Vyndamax™, Onpattro®, Amvuttra®, or Wainua™;
  • Dose does not exceed 1,600 mg (2 tablets) per day
  • Approval duration: 6 months
• Continued Therapy: Transthyretin Amyloid Cardiomyopathy (must meet all):
  • Member meets one of the following:
    • Currently receiving medication via Centene benefit or member has previously met initial approval criteria;
    • Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state specific addendums for CC.PHARM.03A and CC.PHARM.03B);
  • Member is responding positively to therapy as evidenced by, including but not limited to improvement or stabilization in any of the following parameters:
    • Walking ability;
    • Cardiac related hospitalization;
    • Cardiac procedures or laboratory tests (e.g., Holter monitoring, echocardiography, electrocardiogram, plasma BNP or NT-proBNP, serum troponin);
  • AG10 is not prescribed concurrently with Vyndaqel/Vyndamax, Onpattro, Amvuttra, or Wainua;
  • If request is for a dose increase, new dose does not exceed 1,600 mg (2 tablets) per day
  • Approval duration: 12 months

Sacubitril/Valsartan (Entresto) (CP.PCH.52)

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: Heart Failure (must meet all):
  • Diagnosis of chronic heart failure of New York Heart Association (NYHA) Class II, III, or IV;
  • Prescribed by or in consultation with a cardiologist;
  • Age ≥ 1 year;
  • At the time of request, member has none of the following contraindications:
    • Concomitant use with angiotensin-converting enzyme (ACE) inhibitors;
    • If member has a diagnosis of diabetes, concomitant use with aliskiren;
  • For members with left ventricular ejection fraction (LVEF) ≥ 41% (i.e., heart failure with mildly reduced or preserved ejection fraction), failure of Jardiance® or dapagliflozin (Farxiga®), unless  contraindicated or clinically significant adverse effects are experienced;
  • Dose does not exceed both of the following:
    • Sacubitril 194 mg/valsartan 206 mg per day;
    • 2 tablets for adults per day
  • Approval duration: 12 months
• Continued Therapy: Heart Failure (must meet all):
  • Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Entresto for heart failure 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 both of the following:
    • Sacubitril 194 mg/valsartan 206 mg per day;
    • 2 tablets for adults per day.
  • Approval duration: 12 months

Nogapendekin alfa inbakicept-pmln (Anktiva) (CP.PHAR.684)

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: Non-muscle Invasive Bladder Cancer (must meet all):
  • Diagnosis of NIMBC characterized as one of the following:
    • carcinoma in situ (CIS) only;
    • Ta/T1 high-grade disease with concomitant CIS;
  • Prescribed by or in consultation with an oncologist;
  • Age ≥ 18 years;
  • Member is refractory to Bacillus Calmette-Guérin (BCG) treatment;
  • Anktiva is prescribed in combination with BCG;
  • Request meets one of the following:
  • Dose does not exceed 400 mcg (1 vial) administered per week for up to 12 doses;
  • 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 (up to 12 doses)
• Continued Therapy: Non-muscle Invasive Bladder Cancer must meet all):
  • Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Anktiva for a covered indication and has received this medication for at least 30 days;
  • Member is responding positively to therapy as evidenced by lack of disease recurrence or progression;
  • Total treatment duration does not exceed 37 months;
  • If request is for a dose increase, request meets one of the following:
  • New dose does not exceed 400 mcg (1 vial) per week for up to 24 doses;
  • New dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).
  • *Prescribed regimen must be Food and Drug Administration (FDA)-approved or recommended by National Comprehensive Cancer Network (NCCN)
  • Approval duration: 12 months (up to 24 doses)

Tarlatamab-dlle (Imdelltra) (CP.PHAR.685)

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: Small Cell Lung Cancer (must meet all):
  • Diagnosis of extensive stage small cell lung cancer (ES-SCLC);
  • Prescribed by or in consultation with an oncologist;
  • Age ≥ 18 years;
  • Disease has progressed on or after receiving platinum based therapy;
  • Request meets one of the following:
    • Dose does not exceed:
      • Cycle 1, step-up dose: 1 mg on Day 1, and 10 mg on Day 8 and Day 15;
      • Cycle 2 and beyond: 10 mg on Day 1 and Day 15 of each cycle;
    • Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).
    • *Prescribed regimen must be Food and Drug Administration (FDA)-approved or recommended by National Comprehensive Cancer Network (NCCN)
  • Approval duration: 6 months
• Continued Therapy: Small Cell Lung Cancer (must meet all):
  • Currently receiving medication via Centene benefit, or documentation supports that
  • member is currently receiving Imdelltra 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 10 mg on Days 1 and 15 of each cycle;
    • New dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).
    • *Prescribed regimen must be Food and Drug Administration (FDA)-approved or recommended by National Comprehensive Cancer Network (NCCN)
  • Approval duration: 12 months

Tislelizumab-jsgr (Tevimbra) (CP.PHAR.686)

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: Esophageal Cancer (must meet all):
  • Diagnosis of unresectable, locally advanced, recurrent, or metastatic esophageal squamous cell
  • Carcinoma (ESCC);
  • Prescribed by or in consultation with an oncologist;
  • Age ≥18 years;
  • For ESCC, both of the following:
    • Member has had previous treatment with a fluoropyrimidine-based (e.g., 5-fluorouracil, capecitabine) and platinum-based (e.g., carboplatin, cisplatin, oxaliplatin) chemotherapy;
    • Prior systemic chemotherapy did NOT include a PD-1 or PD-(L)1 inhibitor (e.g.,nivolumab, ipilimumab, pembrolizumab);
  • Tevimbra is used as a single-agent;
  • Request meets one of the following:
  • Dose does not exceed 200 mg IV every 3 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 Esophageal cancer (must meet all):
• Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Tevimbra 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 200 mg IV every 3 weeks;
  • New dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).
  • *Prescribed regimen must be Food and Drug Administration (FDA)-approved or recommended by National Comprehensive Cancer Network (NCCN)
• Approval duration: 12 months

Tovorafenib (Ojemda) (CP.PHAR.687)

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: Pediatric Low-Grade Glioma (LGG)(must meet all):
  • Diagnosis of relapsed or refractory LGG;
  • Prescribed by or in consultation with an oncologist;
  • Age ≥ 6 months;
  • Disease is positive for one of the following:
    • BRAF fusion or rearrangement;
    • BRAF V600 mutation;
  • Failure of at least one line of prior systemic therapy;
  • Documentation of the member’s current body surface area (BSA)(m2);
  • Request meets one of the following:
    • Dose does not exceed both of the following:
      • 380 mg per m2 of BSA;
      • 600 mg once weekly;
    • 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: 12 months
• Continued Therapy: Pediatric Low-Grade Glioma (must meet all):
  • Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Ojemda 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:*
    • Both of the following:
    • Documentation of the member’s current body surface area (BSA)(m2);
    • Dose does not exceed both of the following:
      • 380 mg per m2 of BSA;
      • 600 mg once weekly;
    • 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: 12 months

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 for the relevant line of business: 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;
      • 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 (SSRI), serotonin norepinephrine reuptake inhibitor (SNRI), bupropion, mirtazapine, vilazodone;
    • 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

Aripiprazole Orally Disintegrating Tablet (CP.PCH.37)

Ambetter

Policy updates include:

• Revised continued therapy criteria to allow continuity of care for all indications

Burosumab-twza (Crysvita) (CP.PHAR.11)

Ambetter

Policy updates include:

• For all indications, added requirement to Continued Therapy section that Crysvita not be used concomitantly with oral phosphate or vitamin D replacement therapy

Pazopanib (Votrient) (CP.PHAR.81)

Ambetter

• Revised policy/criteria section to also include generic pazopanib
• For soft tissue sarcoma, added bypass of prior therapy or ineligibility for extraskeletal myxoid chondrosarcoma and epithelioid hemangioendothelioma per National Comprehensive Cancer Network (NCCN)

Peginterferon Alfa-2a (Pegasys) (CP.PHAR.89)

Ambetter

Policy updates include:

• Updated definition of significant fibrosis from stage 3-4 to stage 2-4 per 2024 World Health Organization (WHO) chronic hepatitis B guidelines

Aztreonam (Cayston) (CP.PHAR.209)

Ambetter

Policy updates include:

• For initial criteria, added Kitabis Pak to list of preferred tobramycin inhalation agents

Ivacaftor (Kalydeco) (CP.PHAR.210)

Ambetter

• For continued therapy, clarified positive response as an “improvement” (e.g., decrease) of LCL and improvement of percent predicted forced expiratory volume in 1 second (ppFEV1) as an "increase from baseline”
• For Appendix D, updated lung clearance index (LCI) supplemental information

Lumacaftor/Ivacaftor (Orkambi) (CP.PHAR.213)

Ambetter

• For initial therapy, removed criterion “percent predicted forced expiratory volume in 1 second (ppFEV1) that is between 40 – 90%” from documentation of member’s percent predicted forced expiratory volume in 1 second (ppFEV1)” to align with other cystic fibrosis transmembrane (CFTR) modulator criteria
• For continued therapy, clarified positive response as an “improvement” (e.g., decrease) of lung clearance index (LCI) and improvement of percent predicted forced expiratory volume in 1 second (ppFEV1) as an "increase from baseline”
• For Appendix D, updated lung clearance index (LCI) supplemental information and removed supplemental pediatric extension clinical trial information for patients ages 12 months to < 24 months.

Ixazomib (Ninlaro) (CP.PHAR.302)

Ambetter

Policy updates include:

• Per National Comprehensive Cancer Network (NCCN) Compendium for multiple myeloma added additional use in combination with Venclexta and dexamethasone for patients with t(11:14)
• For systemic light chain amyloidosis added additional use in combination with cyclophosphamide and dexamethasone

Daratumumab (Darzalex), Daratumumab/Hyaluronidase-fihj (Darzalex Faspro) (CP.PHAR.310)

Ambetter

• Per National Comprehensive Cancer Network (NCCN) Compendium for systemic light chain amyloidosis added off-label use as a single agent for newly diagnosed disease if member has significant neuropathy or has Mayo stage IIIb disease
• Added off-label use for T-cell acute lymphoblastic leukemia
• For multiple myeloma as subsequent therapy added combination use with dexamethasone and Venclexta
• For multiple myeloma maintenance therapy added combination use with lenalidomide

Tezacaftor/Ivacaftor; Ivacaftor (Symdeko)  (CP.PHAR.377)

Ambetter

• For initial approval criteria, removed “chart notes showing percent predicted forced expiratory volume in 1 second (ppFEV1) that is between 40 – 90%” and revised criteria to “documentation of member’s baseline precent predicted forced expiratory volume in 1 second (ppFEV1)” to align with other cystic fibrosis transmembrane (CFTR) modulator criteria
• For continued therapy, revised criteria from “stabilization in percent predicted forced expiratory volume in 1 second (ppFEV1) if baseline was > 70%, or increase in percent predicted forced expiratory volume in 1 second (ppFEV1) if baseline was <70%” to “stabilization or improvement (e.g., increase) in percent predicted forced expiratory volume in 1 second (ppFEV1) from baseline” to align with other cystic fibrosis transmembrane (CFTR) modulator criteria
• Revised Appendix D to remove information on advanced Cystic Fibrosis disease

Lutetium Lu 177 Dotatate (Lutathera) (CP.PHAR.384)

Ambetter

Policy updates include:

• Updated neuroendocrine tumor criteria to reflect newly approved pediatric expansion

Erdafitinib (Balversa) (CP.PHAR.423)

Ambetter

• Updated “gemcitabine chemotherapy” to “other chemotherapy” for previous therapies to align with National Comprehensive Cancer Network (NCCN) Compendium
• Revised Commercial approval durations to align with Ambetter for this oral oncology agent

Selinexor (Xpovio) (CP.PHAR.431)

Ambetter

Policy updates include:

• For diffuse large B-cell lymphoma, revised header to the umbrella diagnosis of B-cell lymphoma and added monomorphic post-transplant lymphoproliferative disorder (B-cell type) per National Comprehensive Cancer Network (NCCN)

Polatuzumab Vedotin-piiq (Polivy) (CP.PHAR.433)

Ambetter

• Consolidated Food and Drug Administration (FDA) and National Comprehensive Cancer Network (NCCN) recommended uses into one criteria set under the umbrella diagnosis of B-cell lymphoma
• For first-line use, added stage modified International Prognostic Index (IPI) score as an alternate pathway per National Comprehensive Cancer Network (NCCN)
• Allowed first-line use in histologic transformation of indolent lymphoma to diffuse large B-cell lymphoma per National Comprehensive Cancer Network (NCCN)
• Removed follicular lymphoma as a coverable off-label use as it is no longer supported by National Comprehensive Cancer Network (NCCN)

Elexacaftor/Ivacaftor/Tezacaftor; Ivacaftor (Trikafta) (CP.PHAR.440)

Ambetter

• For continued therapy, clarified positive response as an “improvement” (e.g., decrease) of lung clearance index (LCI) and improvement of percent predicted forced expiratory volume in 1 second (ppFEV1) as an "increase from baseline”
• For Appendix D, updated lung clearance index (LCI) supplemental information

Capmatinib (Tabrecta) (CP.PHAR.494)

Ambetter

• For initial criteria: added option for “if epidermal growth factor receptor (EGFR) mutant with high-level mesenchymal-epithelial transition amplifications, Tabrecta is used with Tagrisso” per National Comprehensive Cancer Network (NCCN)
• Removed “member does not have symptomatic CNS metastases” as Tabrecta may be used in CNS brain metastases per National Comprehensive Cancer Network (NCCN)

Loncastuximab Tesirine-lpyl (Zynlonta) (CP.PHAR.539)

Ambetter

• Revised language from “AIDS-related diffuse large B-cell lymphoma” to “HIV-related diffuse large B-cell lymphoma” to align with National Comprehensive Cancer Network (NCCN)
• Added post-transplant lymphoproliferative disorders (PTLD) and histologic transformation of indolent lymphomas related to diffuse large B-cell lymphoma as additional examples of large B-cell lymphoma

Dostarlimab-gxly (Jemperli) (CP.PHAR.540)

Ambetter

Policy updates include:

• Revised solid tumors criteria per National Comprehensive Cancer Network (NCCN) – added additional disease qualifiers of early stage or unresectable for gastric cancer and locally unresectable or medically inoperable for colon and rectal cancers, added pathway to allow members who are not surgical candidates for gastric and esophageal/esophagogastric junction cancers, added POLE/POLD1 mutation for colon and rectal cancers, and added bypass of prior therapies for colon cancer, esophageal/esophagogastric junction cancer with planned esophagectomy or if request is for palliative therapy, gastric cancer that is early stage or surgically unresectable or if request is for palliative therapy, and rectal cancer

Talimogene laherepvec (Imlygic) (CP.PHAR.542)

Ambetter

• Added criteria for metastatic melanoma and off label criteria for combination use with Yervoy per National Comprehensive Cancer Network (NCCN) compendium
• In continued therapy, clarified criteria to require documentation of the type, quantity, and size of new or remaining lesions

Sotorasib (Lumakras) (CP.PHAR.549)

Ambetter

• Added disclaimer that indication is approved under accelerated approval to Food and Drug Administration (FDA) Approved Indications section
• Added National Comprehensive Cancer Network (NCCN) recommended off-label use criteria for ampullary adenocarcinoma, pancreatic adenocarcinoma, rectal cancer, appendiceal adenocarcinoma, and colon cancer

Budesonide (Tarpeyo) (CP.PHAR.572)

Ambetter

Policy updates include:

• Revise redirection to require one alternative systemic corticosteroid.

Nivolumab and Relatlimab-rmbw (Opdualag) (CP.PHAR.588)

Ambetter

• Added off label indication for resectable or limited resectable melanoma per National Comprehensive Cancer Network (NCCN) 2A recommendation
• Revised weight criteria to apply only to pediatric patients

Atidarsagene autotemcel (Lenmeldy) (CP.PHAR.602)

Ambetter

• Drug is now Food and Drug Administration (FDA) approved – criteria updated per Food and Drug Administration (FDA) labeling: clarified diagnostic criteria to only require 24-hour urine collection if novel alleles are identified, added coverage for children between 7 to 17 years of age as long as onset of symptoms began before age 7, revised metachromatic leukodystrophy forms to align with terminology used in the package insert, clarified that walking independently means without support and modified intelligence quotient (IQ) requirement from 70 to 85, updated dosing to include minimum and maximum recommendations
• Added physician specialized in bone marrow transplantation as a prescriber option per specialist feedback
• Added allowance for prior receipt of allogeneic hematopoietic stem cell transplant in alignment with study protocol

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

Ambetter

Policy updates include:

• Added National Comprehensive Cancer Network (NCCN) Compendium supported off-label use for classic follicular lymphoma

Glofitamab-gxbm (Columvi) (CP.PHAR.636)

Ambetter

• Added National Comprehensive Cancer Network (NCCN) Compendium supported off-label use in histologic transformation of follicular or marginal zone lymphoma to diffuse large B-cell lymphoma
• Added allowances for partial response, no response, or progressive disease after prior therapy

Brexpiprazole (Rexulti) (CP.PMN.68)

Ambetter

• For Schizophrenia, changed to “failure of one of the following generic atypical antipsychotics…” (previously was failure of two) to align with other atypical antipsychotics
• Revised continued therapy criteria to allow continuity of care for MDD
• For Appendix C, updated boxed warnings language to align with prescriber information

Isotretinoin (Absorica, Absorica LD, Amnesteem, Claravis, Myorisan, Zenatane) (CP.PMN.143)

Ambetter

Policy updates include:

• Added off-label criteria for hidradenitis suppurativa per local market request.

Lumateperone (Caplyta) (CP.PMN.232)

Ambetter

Policy updates include:

• For Schizophrenia, changed to “failure of one of the following generic atypical antipsychotics…” (previously was failure of two) to align with other atypical antipsychotics

Progesterone (Crinone, Endometrin, Milprosa) (CP.PMN.243)

Ambetter

• Removed Milprosa from policy due to product discontinuation
• Evidence of coverage for infertility/fertility preservation language added for Ambetter line of business (AR, CA, Il, LA, NV, NJ, NC, and all other states)

Step Therapy (HIM.PA.109)

Ambetter

Policy updates include:

• Revised continued therapy criteria to allow continuity of care for any medication treating heart failure, seizures, HIV infection, psychiatric conditions, depression, cancer, and organ transplant. Revised Section V to remove zolpidem tartrate ER and ramelteon, revised fenoprofen calcium to reference brand Nalfon.

Sofosbuvir/Velpatasvir (Epclusa) (HIM.PA.SP1)

Ambetter

• Revised policy/criteria section to also include generic sofosbuvir/velpatasvir
• Removed qualifier of “chronic” from hepatitis C virus (HCV) criteria as American Association for the Study of Liver Diseases - Infectious Diseases Society of America (AASLD-IDSA) recommends treatment of both acute and chronic hepatitis C virus (HCV)
• Added prescriber exception for Ambetter Georgia per plan request
• Added Appendix G for guidance on incomplete adherence and American Association for the Study of Liver Diseases - Infectious Diseases Society of America (AASLD-IDSA) recommended management of treatment interruptions

Sofosbuvir (Sovaldi) (HIM.PA.SP2)

Ambetter

• Removed qualifier of “chronic” from hepatitis C virus (HCV) criteria as American Association for the Study of Liver Diseases - Infectious Diseases Society of America (AASLD-IDSA) recommends treatment of both acute and chronic hepatitis C virus (HCV)
• Added prescriber exception for HIM Georgia per plan request
• Added “if applicable for the requested indication” to the Epclusa authorized generic redirection in the other diagnoses/indications section
• Added Appendix G for guidance on incomplete adherence and American Association for the Study of Liver Diseases - Infectious Diseases Society of America (AASLD-IDSA) recommended management of treatment interruptions

Ledipasvir/Sofosbuvir (Harvoni) (HIM.PA.SP3)

Ambetter

• Revised policy/criteria section to also include generic ledipasvir/sofosbuvir
• Removed qualifier of “chronic” from hepatitis C virus (HCV) criteria as American Association for the Study of Liver Diseases - Infectious Diseases Society of America (AASLD-IDSA) recommends treatment of both acute and chronic hepatitis C virus (HCV)
• Added prescriber exception for HIM Georgia per plan request
• Added “if applicable for the requested indication” to the Epclusa authorized generic redirection in the other diagnoses/indications section
• Added Appendix G for guidance on incomplete adherence and American Association for the Study of Liver Diseases - Infectious Diseases Society of America (AASLD-IDSA) recommended management of treatment interruptions

Glecaprevir/Pibrentasvir (Mavyret) (HIM.PA.SP36)

Ambetter

• Removed qualifier of “chronic” from hepatitis C virus (HCV) criteria as American Association for the Study of Liver Diseases - Infectious Diseases Society of America (AASLD-IDSA) recommends treatment of both acute and chronic hepatitis C virus (HCV)
• Added prescriber exception for HIM Georgia per plan request
• Added “if applicable for the requested indication” to the Epclusa authorized generic redirection in the other diagnoses/indications section
• Added Appendix G for guidance on incomplete adherence and American Association for the Study of Liver Diseases - Infectious Diseases Society of America (AASLD-IDSA) recommended management of treatment interruptions

Dasabuvir/Ombitasvir/Paritaprevir/Ritonavir (Viekira Pak) (HIM.PA.SP61)

Ambetter

• Removed qualifier of “chronic” from hepatitis C virus (HCV) criteria as American Association for the Study of Liver Diseases - Infectious Diseases Society of America (AASLD-IDSA) recommends treatment of both acute and chronic hepatitis C virus (HCV)
• Added prescriber exception for HIM Georgia per plan request
• Added “if applicable for the requested indication” to Epclusa authorized generic redirection in the Other diagnoses/indications section
• Added Appendix G for guidance on incomplete adherence and American Association for the Study of Liver Diseases - Infectious Diseases Society of America (AASLD-IDSA) recommended management of treatment interruptions

Elbasvir/Grazoprevir (Zepatier) (HIM.PA.SP62)

Ambetter

• Removed qualifier of “chronic” from hepatitis C virus (HCV) criteria as American Association for the Study of Liver Diseases - Infectious Diseases Society of America (AASLD-IDSA) recommends treatment of both acute and chronic hepatitis C virus (HCV)
• Added prescriber exception for HIM Georgia per plan request
• Added “if applicable for the requested indication” to Epclusa authorized generic redirection in the Other diagnoses/indications section
• Added Appendix G for guidance on incomplete adherence and American Association for the Study of Liver Diseases - Infectious Diseases Society of America (AASLD-IDSA) recommended management of treatment interruptions

Sofosbuvir/Velpatasvir/Voxilaprevir (Vosevi) (HIM.PA.SP63)

Ambetter

• Removed qualifier of “chronic” from hepatitis C virus (HCV) criteria as American Association for the Study of Liver Diseases - Infectious Diseases Society of America (AASLD-IDSA) recommends treatment of both acute and chronic hepatitis C virus (HCV)
• Added prescriber exception for HIM Georgia per plan request
• Added Epclusa authorized generic redirection to other diagnoses/indications section
• Added Appendix G for guidance on incomplete adherence and American Association for the Study of Liver Diseases - Infectious Diseases Society of America (AASLD-IDSA) recommended management of treatment interruptions

Alpelisib (Piqray, Vijoice) (CP.PHAR.430)

Ambetter

Policy updates include:

• Added oral granules dosage form per updated prescribing information

Danicopan (Voydeya) (CP.PHAR.665)

Ambetter

Policy updates include:

• Added Bkemv (Soliris biosimilar) as another C5 inhibitor option

Mavacamten (Camzyos) (CP.PMN.272)

Ambetter

• Removed upper limit for left ventricular thickness for familial disease or positive genetic test as thickness above 15 mm is diagnostic regardless of familial status/genetic testing
• Added Appendix D with examples of genes that can cause familial hypertrophic cardiomyopathy

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

Ambetter

• Added criteria for chronic rhinosinusitis without nasal polyps (CRSsNP) and requiring trial of two intranasal corticosteroids and one intranasal saline agent
• Updated Appendix B with therapeutic alternatives for chronic rhinosinusitis without nasal polyps (CRSsNP) and intranasal saline agents.

Human Growth Hormone (Somapacitan, Somatrogon, Somatropin, Lonapegsomatropin-tcgd)  (HIM.PA.161)

Ambetter

• Added Skytrofa to policy and updated policy references to the relevant line of business
• Added Genotropin/Genotropin Miniquick as co-preferred drugs with Norditropin and Humatrope, added redirection to Zomacton if preferred drugs are not available (i.e., due to drug shortages).