POLICY

APPLICABLE PRODUCTS

NEW POLICY OVERVIEW OR UPDATED POLICY REVISIONS

Adrabetadex (VTS-270) (CP.PHAR.777)

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 HIM.PHAR.154 for Ambetter
• Initial Approval Criteria: Niemann-Pick Disease Type C (NPC)(must meet all): *

*Criteria will mirror the clinical information from the prescribing information once FDA-approved

• Diagnosis of NPC confirmed by one of the following:
  • Genetic analysis indicating mutation in both alleles of NPC1 or NPC2;
  • Genetic analysis indicating mutation in one allele of NPC1 or NPC2 along with one of the following:
    • Positive filipin staining test result;
    • Positive biomarker result (e.g., oxysterol, lyso-sphingolipid, bile acid);
  • Prescribed by or in consultation with a geneticist, neurologist, endocrinologist, or metabolic disease specialist;
  • Member presents with both of the following:*
    • At least one neurological sign or symptom of the disease;
    • Neurological sign/symptom onset less than 6 years of age (i.e., infantile-onset);
  • Adrabetadex is not prescribed concurrently with Aqneursa™ or Miplyffa™;*
  • Dose does not exceed 900 mg intrathecally every 2 weeks.*
  • Approval duration: 12 months
• Continued Therapy: Niemann-Pick Disease Type C (must meet all): *
• *Criteria will mirror the clinical information from the prescribing information once FDA-approved
  • 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 evidenced by an improvement, stabilization, or slowed disease progression in a domain affected by NPC (e.g., ambulation, fine motor skills, swallowing, sitting, speech);*
  • Adrabetadex is not prescribed concurrently with Aqneursa or Miplyffa;*
  • If request is for a dose increase, new dose does not exceed 900 mg intrathecally every 2 weeks.*
  • Approval duration: 12 months
  • Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations;

Garetosmab (REGN2477) (CP.PHAR.778)

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 HIM.PHAR.154 for Ambetter
• Initial Approval Criteria: Fibrodysplasia Ossificans Progressiva (FOP) (must meet all): *

*Criteria will mirror the clinical information from the prescribing information once FDA-approved

• Diagnosis of FOP;*
• Prescribed by or in consultation with an orthopedics, orthopedic surgery, rheumatology, endocrinology, or metabolic disease specialist;
• Age at least 18 years;*
• Presence of ACVR1 FOP-causing mutation;*
• Documentation of baseline heterotopic ossification (HO) volume assessed by low-dose whole body computed tomography (WBCT) scan, excluding the head;*
• Member has a cumulative analog joint involvement scale (CAJIS) score at most 19 prior to treatment with REGN2477 (see Appendix E);*
• Failure of both of the following at up to maximally indicated doses, unless clinically significant adverse effects are experienced or all are contraindicated:*
  • Prednisone used for flare-ups;
  • Two nonsteroidal anti-inflammatory drugs (NSAIDs) between flare-ups;
• REGN2477 is not prescribed concurrently with Sohonos™;
• Dose does not exceed FDA-labeled maximum dose.*
• Approval duration: 6 months
• Continued Therapy: Fibrodysplasia Ossificans Progressiva (must meet all): *

*Criteria will mirror the clinical information from the prescribing information once FDA-approved

• 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 evidenced by one of the following:*
  • Reduction in flare-ups from baseline;
  • Improvement in annualized new HO volume as assessed by low-dose WBCT scan;
  • Increased or stabilized mobility;
• REGN2477 is not prescribed concurrently with Sohonos;
• If request is for a dose increase, new dose does not exceed the FDA-labeled maximum dose.*
• Approval duration: 12 months

Imlifidase (IdeS) (CP.PHAR.779 )

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 HIM.PHAR.154 for Ambetter
• Initial Approval Criteria: Desensitization for Kidney Transplantation (must meet all): *

*Criteria will mirror the clinical information from the prescribing information once FDA-approved

• Diagnosis of chronic kidney disease stage 5;
• One of the following:*
  • Member is active on the Organ Procurement & Transplantation Network (OPTN) waiting list for a deceased donor kidney transplant;
  • Member is currently scheduled to receive a deceased donor kidney transplant;
• Prescribed by or in consultation with a transplant specialist;
• Age at least 18 years;*
• Member is highly sensitized as evidenced by calculated panel reactive antibody (cPRA) at least 99.9%;*
• Prescribed as a single agent for desensitization (i.e., IdeS will not be used concurrently with other desensitization therapies [e.g., plasma exchange, intravenous immunoglobulin, rituximab]) (note: induction and maintenance immunosuppression therapies are allowed);*
• Member has not previously received IdeS;*
• Request does not exceed both of the following:*
  • 0.25 mg/kg per dose;
  • A total of 2 doses.
  • Approval duration: 12 months (up to a total of 2 doses) 
• Member is active on the Organ Procurement & Transplantation Network (OPTN) waiting list for a deceased donor kidney transplant;
• Member is currently scheduled to receive a deceased donor kidney transplant;
• Continued Therapy: Desensitization for Kidney Transplantation *

*Criteria will mirror the clinical information from the prescribing information once FDA-approved

• Re-authorization is not permitted
• Approval duration: Not applicable

Isaralgagene Civaparvovec (ST-920) (CP.PHAR.780)

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 medical benefit 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: Fabry Disease (must meet all): *

*Criteria will mirror the clinical information from the prescribing information once FDA-approved

• Diagnosis of Fabry disease by genetic confirmation of a mutation in the GLA gene and one of the following:*
  • Presence of a GLA pathogenic variant;
  • Presence of a GLA variant of unknown significance, and one of the following:
    • Enzyme assay demonstrating a deficiency of alpha-galactosidase A activity;
    • Family history of Fabry disease;
• Prescribed by or in consultation with a clinical geneticist, cardiologist, nephrologist, neurologist, lysosomal disease specialist, or Fabry disease specialist;
• Age at least 18 years;*
• Member has at least 1 symptom characteristic of Fabry disease (e.g., cornea verticillata, acroparesthesia, anhidrosis, angiokeratoma);*
• Member does not have any the following:*
  • Significant liver disease (e.g., clinically significant steatosis, fibrosis, metabolic dysfunction-associated steatohepatitis [MASH], cirrhosis, biliary disease, active hepatitis);
  • Heart failure with New York Heart Association (NYHA) classification at least Class III;
  • Estimated glomerular filtration rate (eGFR) less than 40 ml/min/1.73 m2;
• Member has not received previous gene therapy;*
• Member does not have detectable neutralizing antibodies to AAV6;*
• Dose does not exceed a single infusion of 2.63 x 1013 vector genomes (vg) per kg.*
• Approval duration: 3 months (one time infusion per lifetime)
• Continued Therapy: Fabry Disease*
• *Criteria will mirror the clinical information from the prescribing information once FDA-approved
  • Continued therapy will not be authorized as ST-920 is indicated to be dosed one time only.
  • Approval duration: Not applicable

Difamilast (Adquey) (CP.PMN.308)

Ambetter

Policy includes:

• Requests for indications not approved by the FDA are reviewed with the off-label use policy HIM.PHAR.154 for Ambetter
• Initial Approval Criteria: Atopic Dermatitis (must meet all):
  • Diagnosis of atopic dermatitis;
  • Age at least 2 years;
  • Failure of a 2-week trial of two generic medium to very high potency topical corticosteroids of different molecular identities, unless contraindicated (e.g., areas involving the face, neck, or intertriginous areas) or clinically significant adverse effects are experienced;^
  • Failure of a 2-week trial of topical tacrolimus, unless contraindicated or clinically significant adverse effects are experienced;^*

*Prior authorization may be required for topical tacrolimus

• Dose does not exceed 60 grams per 30 days.
• Approval duration: 12 months
  
  
• Continued Therapy: Atopic Dermatitis (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;
• If request is for a dose increase, new dose does not exceed 60 grams per 30 days.
• Approval duration: 12 months

Insulin Icodec-abae (Awiqli) (HIM.PA.180)

Ambetter

Policy includes:

• Requests for indications not approved by the FDA are reviewed with the off-label use policy HIM.PHAR.154 for Ambetter
• Initial Approval Criteria: Type 2 Diabetes Mellitus (must meet all):
  • Diagnosis of type 2 diabetes mellitus;
  • Age at least 18 years;
  • Failure of both of the following, unless clinically significant adverse effects are experienced are both are contraindicated:*
    • Insulin glargine-ygfn (unbranded Semglee®);
    • Branded Tresiba® (insulin degludec).
  • Approval duration: 12 months
• Continued Therapy: Type 2 Diabetes Mellitus (must meet all):
  • o 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;
• Failure of both of the following, unless clinically significant adverse effects are experienced are both are contraindicated:*
  • Insulin glargine-ygfn (unbranded Semglee);
  • Branded Tresiba (insulin degludec).
• Approval duration: 12 months

Marnetegragene autotemcel (Kresladi) (CP.PHAR.599)

Ambetter

Policy updates include:

• Criteria updated per FDA labeling: removed minimum age requirement, removed option for those with an HLA-matched sibling donor, and updated dose requirement

Relacorilant (Lifyorli) (CP.PHAR.736)

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: Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (must meet all):
  • Diagnosis of epithelial ovarian, fallopian tube, or primary peritoneal cancer;
  • Prescribed by or in consultation with an oncologist;
  • Age at least 18 years;
  • Disease is platinum-resistant (i.e., disease progressed less than 6 months from completion of a platinum-containing therapy);
  • Member has received 1 to 3 prior systemic treatment regimens, at least one of which included bevacizumab (see Appendix B for examples);
  • Lifyorli is not prescribed concurrently with systemic glucocorticoids used for a lifesaving indication (e.g., immunosuppression after organ transplantation);
  • Prescribed in combination with nab-paclitaxel;
  • Request does not exceed any of the following:
    • 150 mg on the day before, the day of, and the day after each nab-paclitaxel infusion;
    • 3 capsules per dose;
    • 9 doses per 28 days;
  • Dose is at least 125 mg per dose.
  • Approval duration: 12 months
• Continued Therapy: Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (must meet all):
  • Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Lifyorli for a covered indication and has received this medication for at least 30 days;
  • Member is responding positively to therapy;
  • Prescribed in combination with nab-paclitaxel;
  • If request is for a dose increase, request does not exceed any of the following:
    • 150 mg on the day before, the day of, and the day after each nab-paclitaxel infusion;
    • 3 capsules per dose;
    • 9 doses per 28 days;
  • Dose is at least 125 mg per dose.
  • Approval duration: 12 months

Navepegritide (Yuviwel) (CP.PHAR.746)

Ambetter

Policy updates include:

• Criteria updated per prescribing information to include weight-based dosing and quantity limits
• Added to continued therapy requirement that Yuviwel is not prescribed concurrently with Voxzogo and any human growth hormone products

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

Ambetter

Policy updates include:

• Added newly approved autoinjector formulation for Pyzchiva
• Added newly approved single-dose vial for subcutaneous injection for Selarsdi
• Applied Idacio’s pediatric age extensions for hidradenitis suppurativa and uveitis
• For Sotyktu, added newly approved psoriatic arthritis indication
• Added Sotyktu to Appendix C for contraindications/boxed warnings section
• For Cosentyx, added newly approved hidradenitis suppurativa pediatric extension for ages at least 12 years.
• Added Otezla XR to description section and list of agents in “medically necessary when the following criteria are met” statement.

Diclofenac (Cambia, Flector, Licart, Pennsaid, Zipsor, Zorvolex) (CP.PCH.28)

Ambetter

Policy updates include:

• Updated Licart indication to include pediatric patients at least 6 years old

Pembrolizumab, Pembrolizumab Berahyaluronidase alfa-pmph (Keytruda, Keytruda Qlex) (CP.PHAR.322)

Ambetter

Policy updates include:

• Updated Food and Drug Administration (FDA) Approved Indication section with addition of Food and Drug Administration (FDA)-approved test for esophageal or GEJ cancer whose tumors express PD-L1 (combined positive score (CPS) at least 1)
• For Keytruda Qlex, added indication for usage in the neoadjuvant/adjuvant setting for locally advanced head and neck squamous cell carcinoma

Teplizumab-mzwv (Tzield) (CP.PHAR.492)

Ambetter

Policy updates include:

• Revised age requirement from at least 8 years to at least 1 year to reflect pediatric extension and added new boxed warning (viral reactivation)

Anifrolumab-fnia (Saphnelo) (CP.PHAR.551)

Ambetter

Policy updates include:

• Added new subcutaneous formulations of prefilled syringe and autoinjector

Faricimab (Vabysmo) (CP.PHAR.581)

Ambetter

Policy updates include:

• For retinal vein occlusion, removed the 6-month total treatment duration restriction and added continued therapy criteria allowing re-authorization

Tividenofusp Alfa (Avlayah) (CP.PHAR.748)

Ambetter

Policy includes:

• Requests for indications not approved by the FDA are reviewed with the off-label use policy HIM.PHAR.154 for Ambetter
• Initial Approval Criteria: Mucopolysaccharidosis (MPS) II: Hunter Syndrome (must meet all):
  • Diagnosis of MPS II (Hunter syndrome) confirmed by one of the following:
  • Enzyme assay demonstrating a deficiency of iduronate 2-sulfatase (IDS) activity;
  • Genetic confirmation of pathogenic or likely pathogenic mutation(s) in the IDS gene;
  • Age less than 18 years at initiation of Avlayah;
  • Member’s weight meets both of the following:
    • Documentation of current weight in kg;
    • Current weight ≥ 5 kg;
  • Member does not have advanced neurological impairment (e.g., severe cognitive decline, profound functional dependence);
  • Avlayah is not prescribed concurrently with Elaprase^®;
  • Dose does not exceed 15 mg/kg per week.
  • Approval duration: 12 months
• Continued Therapy: Mucopolysaccharidosis II: Hunter 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;
  • Member is responding positively to therapy as evidenced by improvement or stabilization in the individual member’s MPS II manifestation profile;
  • Member does not have advanced neurological impairment (e.g., severe cognitive decline, profound functional dependence);
  • Avlayah is not prescribed concurrently with Elaprase;
  • Documentation of member’s current weight in kg;
  • If request is for a dose increase, new dose does not exceed 15 mg/kg per week.
  • Approval duration: 12 months

Lunsotogene parvec-cwha (Otarmeni) (CP.PHAR.757)

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: Sensorineural Hearing Loss (must meet all):
  • Diagnosis of severe-to-profound sensorineural hearing loss as evidenced by both of the following:
    • Genetic testing confirms biallelic pathogenic or likely pathogenic OTOF variants;
    • Member meets all of the following in the requested treatment ear(s):
      • Severe-to-profound hearing loss defined by an average audiometric threshold of greater than 90 dB HL;
      • Absent auditory brainstem response (ABR);
      • Intact outer hair cell function as evidenced by one of the following:
        • Presence of otoacoustic emissions (OAE);
        • Presence of a cochlear microphonic;
• Prescribed by or in consultation with an otolaryngologist;
• Member does not have a history of a cochlear implant in the requested treatment ear(s);
• Member has not previously been treated with Otarmeni in the requested treatment ear(s);
• Member has not received prior gene therapy;
• Dose does not exceed a single intracochlear infusion of 7.2 x 10¹² vector genomes (vg) per ear.
• Approval duration: 3 months (one lifetime intracochlear infusion per ear)
  
  
• Continued Therapy: Sensorineural Hearing Loss
  • Re-authorization is not permitted. Members must meet the initial approval criteria.
  • Approval duration: Not applicable

Ruxolitinib (Jakafi, Jakafi XR, Opzelura) (CP.PHAR.98)

Ambetter

Policy updates include:

• Added new Jakafi XR formulation to policy
• Removed health plan-approved quantity limit criterion

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

Ambetter

Policy updates include:

• Added new indication for treatment of agitation associated with dementia due to Alzheimer’s disease
• Revised continued therapy criteria to allow continuity of care for major depressive disorder

Insulin Glargine (Basaglar, Langlara, Lantus/unbranded Lantus, Rezvoglar, Toujeo/unbranded Toujeo) (HIM.PA.09)

Ambetter

Policy updates include:

• Added Langlara to policy

Inhaled asthma and COPD agents (HIM.PA.153)

Ambetter

Policy updates include:

• For Symbicort Aerosphere, added new indication for asthma in patients 12 years of age and older and new strength of 80 mcg budesonide per updated prescribing information

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

Ambetter

Policy updates include:

• Revised “Rybelsus formulation R2” to “Ozempic tablets” per manufacturer rebranding and clarified Ozempic tablets vs injection where applicable
• Added new dosage form of single-dose prefilled syringes for Ozempic injection