Respiratory

Cinqair^® (Reslizumab) Approval Criteria:

• An FDA approved indication of add-on maintenance treatment of patients with severe asthma with an eosinophilic phenotype; AND
• Member must be 18 years of age or older; AND
• Member must have a blood eosinophil count of at least 400/mcL (within three to four weeks of dosing); AND
• Member must have had at least two asthma exacerbations requiring systemic corticosteroids within the last 12 months or require daily systemic corticosteroids despite compliant use of high-dose inhaled corticosteroid (ICS) plus at least one additional controller medication; AND
• Member must have failed a high-dose ICS used compliantly within the last 3-6 consecutive months (for ICS/LABA combination medications, the highest approved dose meets this criteria); AND
• Member must have failed at least one other asthma controller medication used in addition to the high-dose ICS compliantly for at least the past three months; AND
• Cinqair® must be administered in a healthcare setting by a healthcare professional prepared to manage anaphylaxis; AND
• Cinqair® must be prescribed by an allergist, pulmonologist, or pulmonary specialist or the member must have been evaluated by an allergist, pulmonologist, or pulmonary specialist within the last twelve months (or be an advanced care practitioner with a supervising physician who is an allergist, pulmonologist, or pulmonary specialist); AND
• Initial approvals will be for the duration of six months after which time compliance will be evaluated for continued approval. 
• Member’s weight should be provided on prior authorization requests. Weights should have been taken within the last four weeks to provide accurate weight-based dosing. 

Prior Authorization form

ivacaftor (Kalydeco®) Approval Criteria:

• An FDA approved indication of cystic fibrosis(CF) with a mutation in the CFTR gene detected by genetic testing that is responsive to ivacaftor based on clinical and/or in vitro assay data; AND
• Documentation must be submitted with results of CFTR genetic testing; AND
• Member must be 1 month of age or older; AND
• Members using Kalydeco^® must be supervised by a pulmonary disease specialist; and
• Prescriber must verify the member has been counseled on proper administration of Kalydeco^® including taking with a fat-containing food; and
• Prescriber must verify that ALT, AST, and bilirubin will be assessed prior to initiating Kalydeco^®, every 3 months during the first year of treatment, and annually thereafter; and
• Prescriber must verify that pediatric members will receive baseline and follow-up ophthalmological examinations as recommended in the package labeling; and
• Member must not be taking any of the following medications concomitantly with Kalydeco^®: rifampin, rifabutin, phenobarbital, carbamazepine, phenytoin, or St. John’s wort; and
• For members 1 month to younger than 6 months of age:
  • Member must not have any level of hepatic impairment; and
  • Member must not be taking concomitant moderate or strong CYP3A inhibitors (e.g., ketoconazole, itraconazole, clarithromycin); and 
• A quantity limit of two tablets or 2 granule packets per day, (56 per 28 days) will apply; AND
• An age restriction of 1 month to less than 6 years of age will apply to Kalydeco® oral granule packets. Members 6 years of age or older will require a patient-specific, clinically significant reason why the member cannot use the oral tablet formulation.
• Approvals will be based on the recommended dosing per package labeling based on the member’s age and recent weight, if applicable. For members who require weight-based dosing, the member’s recent weight must be provided on the prior authorization request; AND
• Initial approval will be for the duration of 6 months. After 6 months of utilization, compliance and information regarding efficacy, such as improvement in forced expiratory volume in 1 second (FEV₁), will be required for continued approval; AND
• Subsequent approvals will be for the duration of 1 year.  

lumacaftor/ivacaftor (Orkambi™) Approval Criteria:

• An FDA approved diagnosis of cystic fibrosis (CF) in patients who are homozygous for the F508del mutation in the CFTR gene detected by genetic testing; AND
• If the patient’s genotype is unknown, an FDA-cleared CF mutation test should be used to detect the presence of the F508del mutation on both alleles of the CFTR gene; AND  
• Orkambi™ will not be approved for patients with CF other than those homozygous for the F508del mutation; AND
• Member must be 12 months of age or older; AND
• Members using Orkambi™ must be supervised by a pulmonary specialist; AND
• Prescriber must verify the member has been counseled on proper administration of Orkambi^® including taking with a fat-containing food; AND
• The prescriber must verify that ALT, AST, and bilirubin will be assessed prior to initiating Orkambi™, every three months during the first year of treatment, and annually thereafter; AND
• Prescriber must verify that pediatric members will receive baseline and follow-up ophthalmological examinations as recommended in the package labeling; AND
• Members must not be taking any of the following medications concomitantly with Orkambi™: rifampin, rifabutin, phenobarbital, carbamazepine, phenytoin, and St. John’s wort; AND
• A quantity limit of four tablets per day or 112 tablets per 28 days will apply or a quantity limit of two packets per day or 56 packets per 28 days will apply.
• An age restriction of 12 months to 6 years of age will apply to Orkambi® oral granule packets. Members 6 years of age or older will require a patient-specific, clinically significant reason why the member cannot use the oral tablet formulation.
• Approvals will be based on the recommended dosing per package labeling based on the member’s age and recent weight, if applicable. For members who require weight-based dosing, the member’s recent weight must be provided on the prior authorization request; AND
• Initial approval will be for the duration of 6 months. After 6 months of utilization, compliance and information regarding efficacy, such as improvement in FEV1, will be required for continued approval; AND
  
• Subsequent approvals will be for the duration of 1 year. 

Inhaled Tobramycin Products (Bethkis®, Tobi®, Tobi® Podhaler™, and Kitabis™ Pak), Pulmozyme® (Dornase Alfa), & Cayston® (Aztreonam) Approval Criteria:

• Use of inhaled tobramycin products, Pulmozyme® (dornase alfa), and Cayston® (aztreonam) is reserved for members who have a diagnosis of cystic fibrosis.
  • Kitabis^® Pak and generic tobramycin 300mg/5mL nebulized solution are the preferred inhaled tobramycin products. Authorization of Bethkis^® or Tobi® Podhaler™ a patient-specific, clinically significant reason why the preferred inhaled tobramycin products (Kitabis^® Pak and generic tobramycin 300mg/5mL nebulized solution is not appropriate for the member.
  • Preferred inhaled tobramycin products (Kitabis™ Pak, and tobramycin 300mg/5mL nebulized solution), dornase alfa, and aztreonam inhalation will not require a prior authorization and claims will pay at the point of sale if member has a reported diagnosis of cystic fibrosis within the past 12 months of claims history.
  • If the member does not have a reported diagnosis, a manual prior authorization will be required for coverage consideration. 
• Use of inhaled tobramycin products and Cayston® (aztreonam) is restricted to 28 days of therapy per every 56 days to ensure cycles of 28 days on therapy followed by 28 days off therapy. 
  • Use outside of this recommended regimen may be considered for coverage via a manual prior authorization submission with a patient-specific, clinically significant reason why the member would need treatment outside of the FDA approved dosing. 
  • Pharmacies should process the prescription claim with a 56 day supply. 

tezacaftor/ivacaftor (Symdeko®) Approval Criteria:

• An FDA approved diagnosis of cystic fibrosis (CF) in patients who are homozygous for the F508del mutation or who have at least 1 mutation in the CF transmembrane conductance regulator (CFTR) gene detected by genetic testing that is responsive to tezacaftor/ivacaftor based on in vitro data and/or clinical evidence; AND
• If the patient’s genotype is unknown, an FDA-cleared CF mutation test should be used to detect the presence of a CFTR mutation followed by verification with bi-directional sequencing, when recommended by the mutation test instructions for use; AND
• Member must be 6 years of age or older; AND
• Members using Symdeko® must be supervised by a pulmonary specialist; AND
• If the member is currently stabilized on Orkambi® (lumacaftor/ivacaftor) and experiencing adverse effects associated with Orkambi® use, the prescriber must indicate that information on the prior authorization request; AND
• The prescriber must verify that the member has been counseled on proper administration of Symdeko® including taking with a fat-containing food; AND
• The prescriber must verify that ALT, AST, and bilirubin will be assessed prior to initiating Symdeko®, every 3 months during the first year of treatment, and annually thereafter; AND
• Prescriber must verify that pediatric members will receive baseline and follow-up ophthalmological examinations as recommended in the package labeling; AND
• Members must not be taking any of the following medications concomitantly with Symdeko®: rifampin, rifabutin, phenobarbital, carbamazepine, phenytoin, and St. John’s wort; AND
• A quantity limit of 2 tablets per day or 56 tablets per 28 days will apply.
• Approvals will be based on the recommended dosing per package labeling based on the member’s age and recent weight, if applicable. For members who require weight-based dosing, the member’s recent weight must be provided on the prior authorization request; AND
• Initial approvals will be for the duration of 6 months. After 6 months of utilization, compliance and information regarding efficacy, such as improvement in FEV1, will be required for continued approval. Additionally after 6 months of utilization, information regarding efficacy as previously mentioned or fewer adverse events must be provided for members who switched from Orkambi® to Symdeko®; AND
• Subsequent approvals will be for the duration of 1 year. 

• An FDA approved diagnosis of cystic fibrosis (CF) in members who have at least 1 F508del mutation in the CF transmembrane conductance regulator (CFTR) gene or a mutation in the CFTR gene that is responsive based on vitro data; AND
• If the member’s genotype is unknown, an FDA-cleared CF mutation test should be used to detect the presence of a CFTR mutation followed by verification with bi-directional sequencing when recommended by the mutation test’s instructions for use; AND
• Member must be 2 years of age or older; AND
• Members using Trikafta^® must be supervised by a pulmonary specialist; AND
• If member is currently stabilized on Orkambi^® (lumacaftor/ivacaftor) or Symdeko^® (tezacaftor/ivacaftor and ivacaftor) and experiencing adverse effects associated with Orkambi^® or Symdeko^® use, the prescriber must indicate that information on the prior authorization request; AND
• Prescriber must verify that member has been counseled on proper administration of Trikafta^® including taking with a fat-containing food; AND
• Prescriber must verify that ALT, AST, and bilirubin will be assessed prior to initiating Trikafta^®, every 3 months during the first year of treatment, and annually thereafter; AND
• Prescriber must verify that the member does not have severe hepatic impairment; AND
• Prescriber must verify that pediatric members will receive baseline and follow-up ophthalmological examinations as recommended in the Trikafta^® Prescribing Information; AND
• Member must not be taking any of the following medications concomitantly with Trikafta^®: rifampin, rifabutin, phenobarbital, carbamazepine, phenytoin, and St. John’s wort; AND
• The following quantity limits will apply:
  • Oral tablets: A quantity limit of 3 tablets per day or 84 tablets per 28 days; OR
  • Oral granules: A quantity limit of 2 packets per day or 56 packets per 28 days; AND
• For Trikafta^® oral granules, an age restriction of 2 years to 5 years of age will apply. Members 6 years of age or older will require a patient-specific, clinically significant reason why the Trikafta^® tablets cannot be used; and 
• Approvals will be based on the recommended dosing per package labeling based on the member’s age and recent weight, if applicable. For members who require weight-based dosing, the member’s recent weight must be provided on the prior authorization request; AND
• Initial approval will be for the duration of 6 months. After 6 months of utilization, compliance and information regarding efficacy, such as improvement in forced expiratory volume in 1 second (FEV₁), will be required for continued approval. Additionally after 6 months of utilization, information regarding efficacy as previously mentioned or fewer adverse events than with a previous CFTR therapy must be provided for members who switched from Orkambi^® (lumacaftor/ ivacaftor) or Symdeko^® (tezacaftor/ivacaftor and ivacaftor); AND
• Subsequent approvals will be for the duration of 1 year. 

Prior Authorization form

Dupixent^® (Dupilumab Injection) Approval Criteria [Eosinophilic Phenotype Asthma Diagnosis]:

• An FDA approved indication for add-on maintenance treatment of patients with moderate-to-severe eosinophilic phenotype asthma or oral corticosteroid-dependent asthma; AND
• Member must be 6 years of age or older; AND
• Member must have a baseline blood eosinophil count of ≥150cell/mcL (can apply to either a recent level or in history prior to oral corticosteroid use); AND
• Member must have had at least 2 asthma exacerbations requiring systemic corticosteroids within the last 12 months or require daily systemic corticosteroids despite compliant use of high-dose inhaled corticosteroid (ICS) plus at least 1 additional controller medication; AND
• Member must have failed a medium-to-high-dose ICS used compliantly within the last 3-6 consecutive months (for ICS/LABA combination products, the highest FDA approved dose meets this criteria); AND
• Member must have failed at least 1 other asthma controller medication used in addition to the medium-to-high-dose ICS compliantly for at least the past 3 months; AND
• The prescriber must verify the member has been counseled on proper administration and storage of Dupixent®; AND
• Dupixent® must be prescribed by an allergist, pulmonologist, or pulmonary specialist or the member must have been evaluated by an allergist, pulmonologist, or pulmonary specialist within the last 12 months (or be an advanced care practitioner with a supervising physician who is an allergist, pulmonologist, or pulmonary specialist); AND
• Initial approvals will be for the duration of 6 months after which time compliance will be evaluated for continued approval; AND
• Quantities approved must not exceed FDA recommended dosing requirements.   

Dupixent (dupilumab injection) Approval Criteria [Atopic Dermatitis]:

• An FDA approved diagnosis of moderate-to-severe atopic dermatitis not adequately controlled with topical prescription therapies; AND
• Member must be 6 months of age or older; AND
• Member must have documented trials within the last six months for a minimum of two weeks that resulted in failure with both of the following therapies (or have a contraindication or documented intolerance):
  • One medium potency to very-high potency Tier-1 topical corticosteroid; AND
  • One topical calcineurin inhibitor [e.g., Elidel (pimecrolimus), Protopic (tacrolimus)]; AND
• Dupixent must be prescribed by a dermatologist, allergist, or immunologist or the member must have been evaluated by a dermatologist, allergist, or immunologist within the last twelve months (or be an advanced care practitioner with a supervising physician who is a dermatologist, allergist, or immunologist); AND
• Requests for concurrent use of Dupixent with other biologic medications will be reviewed on a case-by-case basis and will require patient-specific information to support the concurrent use. (Dupixent has not been studied in combination with other biologic therapies.)
• Initial approvals will be for the duration of 16 weeks. Reauthorization may be granted if the prescriber documents the member is responding well to treatment. Additionally, compliance will be evaluated for continued approval. 

Dupixent® (Dupilumab Injection) Approval Criteria [Chronic Rhinosinusitis with Nasal Polyposis (CRSwNP) Diagnosis]:

• An FDA approved indication for add-on maintenance treatment in adult patients with inadequately controlled CRSwNP; AND
• Member must be 18 years of age or older; AND
• Member must have a documented trial with an intranasal corticosteroid that resulted in failure (or have a contraindication or documented intolerance); AND
• Member must meet 1 of the following:
  • Member has required prior sino-nasal surgery; OR
  • Member has previously been treated with systemic corticosteroids in the past 2 years (or has a contraindication or documented intolerance); AND 
• Dupixent® must be prescribed by an otolaryngologist, allergist, immunologist, OR pulmonologist or the member must have been evaluated by an otolaryngologist, allergist, immunologist, or pulmonologist within the last 12 months (or be an advanced care practitioner with a supervising physician who is an otolaryngologist, allergist, immunologist, or pulmonologist); AND
• Member has symptoms of chronic rhinosinusitis (e.g., facial pain/pressure, reduction or loss of smell, nasal blockade/obstruction/congestion, nasal discharge) for 12 weeks or longer despite attempts at medical management; AND
• Member has evidence of nasal polyposis by direct examination, sinus CT scan, or endoscopy; AND  
• Member will continue to receive intranasal corticosteroid therapy, unless contraindicated; AND
• Prescriber must verify the member has been counseled on proper administration and storage of Dupixent®; AND
• Requests for concurrent use of Dupixent® with other biologic medications will be reviewed on a case-by-case basis and will require patient-specific information to support the concurrent use; AND
• Initial approvals will be for the duration of 6 months. Reauthorization may be granted if the prescriber documents the member is responding well to treatment. Additionally, compliance will be evaluated for continued approval; AND
• A quantity limit of 2 syringes every 28 days will apply.

Dupixent^® (Dupilumab) Approval Criteria [Eosinophilic Esophagitis (EoE) Diagnosis]:

• An FDA approved diagnosis of EoE; AND
• Member must be 12 years of age or older and weigh ≥40kg; AND
• Dupixent^® must be prescribed by a gastroenterologist, allergist, or immunologist, or the member must have been evaluated by a gastroenterologist, allergist, or immunologist within the last 12 months (or be an advanced care practitioner with a supervising physician who is a gastroenterologist, allergist, or immunologist); AND
• Member must have 2 or more episodes of dysphagia per week; AND
• Member must have ≥15 intraepithelial eosinophils per high-power field (eos/hpf); AND
• Member must have documented trials for a minimum of 8 weeks that resulted in failure with both of the following therapies (or have a contraindication or documented intolerance):
  • 1 high-dose proton pump inhibitor; AND
  • 1 swallowed inhaled respiratory corticosteroid (e.g., budesonide); AND
• Requests for concurrent use of Dupixent^® with other biologic medications will be reviewed on a case-by-case basis and will require patient-specific information to support the concurrent use (Dupixent^® has not been studied in combination with other biologic therapies); AND
• Initial approvals will be for the duration of 6 months. Reauthorization may be granted if the prescriber documents the member is responding well to treatment. Additionally, compliance will be evaluated for continued approval; AND
• A quantity limit of 8mL (4 syringes) every 28 days will apply.

Dupixent^® (Dupilumab) Approval Criteria [Prurigo Nodularis (PN) Diagnosis]:

• An FDA approved diagnosis of PN for at least 3 months; AND
• Member must have a Worst-Itch Numeric Rating Scale (WI-NRS) score of ≥7; AND
• Member must have ≥20 PN lesions; AND
• Member must be 18 years of age or older; AND
• Dupixent^® must be prescribed by a dermatologist, allergist, or immunologist or the member must have been evaluated by a dermatologist, allergist, or immunologist within the last 12 months (or an advanced care practitioner with a supervising physician who is a dermatologist, allergist, or immunologist); AND
• Prescriber must verify that all other causes of pruritis have been ruled out; AND
• Member must have documented trials within the last 6 months for a minimum of 2 weeks that resulted in failure with both of the following therapies (or have a contraindication or documented intolerance):
  • 1 medium potency to very-high potency Tier-1 topical corticosteroid; AND
  • 1 topical calcineurin inhibitor [e.g., Elidel^® (pimecrolimus), Protopic^® (tacrolimus)]; AND
• Requests for concurrent use of Dupixent^® with other biologic medications will be reviewed on a case-by-case basis and will require patient-specific information to support the concurrent use (Dupixent^® has not been studied in combination with other biologic therapies); AND
• Initial approvals will be for the duration of 6 months. Reauthorization may be granted if the prescriber documents the member is responding well to treatment. Additionally, compliance will be evaluated for continued approval.

Dupixent® (Dupilumab Injection) Prior Authorization Form

Fasenra^® (Benralizumab Injection) Approval Criteria: 

• An FDA approved indication for add-on maintenance treatment of patients with severe eosinophilic phenotype asthma; AND
• Member must be age 12 years or older; AND
• Member must have history of a baseline blood eosinophil count of ≥150cell/mcL (can apply to either a recent level or in history prior to oral corticosteroid use); AND
• Member must have had at least two asthma exacerbations requiring systemic corticosteroids within the last 12 months or require daily systemic corticosteroids despite compliant use of high-dose inhaled corticosteroid (ICS) plus at least one additional controller medication; AND
• Member must have failed a medium-to-high dose ICS used compliantly within the last 3-6 consecutive months (for ICS/LABA combination products, the ICS component would meet criteria at an equivalent medium-to-high dose); AND
• Member must have failed at least one other asthma controller medication used in addition to the high-dose ICS compliantly for at least the past 3 months; AND
• For authorization of Fasenra® prefilled syringe, prescriber must verify the injection will be administered in a health care setting by a health care professional prepared to manage anaphylaxis; OR
• For authorization of Fasenra® prefilled autoinjector pen, prescriber must verify the member or caregiver has been trained by a health care professional on subcutaneous administration, monitoring for any allergic reactions, and storage of Fasenra®; AND
• Prescriber must verify member or caregiver has been properly trained on administration and storage of Fasenra®; AND
• Fasenra® must be prescribed by an allergist, pulmonologist, or pulmonary specialist or the member must have been evaluated by an allergist, pulmonologist, or pulmonary specialist within the last twelve months (or be an advanced care practitioner with a supervising physician who is an allergist, pulmonologist, or pulmonary specialist); AND
• Initial approvals will be for the duration of six months after which time compliance will be evaluated for continued approval.
• A quantity limit of 1 prefilled syringe or prefilled autoinjector pen per 56 days will apply.   

Prior Authorization form   

montelukast granules (Singulair®)

PA criteria:

• Montelukast granules require prior authorization for all ages.  Authorization requires patient-specific clinically significant reason why member cannot use montelukast tablets or chewable tablets. Age-appropriate trials of asthma and/or allergic rhinitis medications are required.  

zileuton (Zyflo®, Zyflo CR®)  

• Children age 12 and older with:
  • Diagnosis of mild or moderate persistent asthma, AND
  • Trial of inhaled corticosteroid AND corticosteroid/LAB2A therapy within the previous 6 months, and reason for trial failure, AND
  • Recent trial with at least one other available leukotriene modifier that did not yield adequate response.  

Prior Authorization form  

mepolizumab injection (Nucala® ) Approval Criteria [Eosinophilic Granulomatosis with Polyangiitis (EGPA) Diagnosis]:

• An FDA approved indication for the treatment of eosinophilic granulomatosis with polyangiitis (EGPA); AND
• Member meets one of the following:
  • Member must have a past history of at least one confirmed EGPA relapse [requiring increase in oral corticosteroid (OCS) dose, initiation/increased dose of immunosuppressive therapy, or hospitalization] with in the past twelve months; OR
  • Member must have refractory disease within the last six months following induction of standard treatment regimen administered compliantly for at least three months; AND 
• Diagnosis of granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA) will not be approved; AND
• Failure to achieve remission despite glucocorticoid therapy (oral prednisone equivalent equal to or greater than 7.5mg/day) for a minimum of 4 weeks duration; AND
• Nucala® must be prescribed by an allergist, pulmonologist, pulmonary specialist, or rheumatologist or the member must have been evaluated by an allergist, pulmonologist, pulmonary specialist, or rheumatologist within the last twelve months (or be an advanced care practitioner with a supervising physician who is an allergist, pulmonologist, pulmonary specialist, or rheumatologist); AND
• For authorization of Nucala® vial, prescriber must verify the injection will be administered in a healthcare setting by a healthcare professional prepared to manage anaphylaxis; AND
• For authorization of Nucala® prefilled autoinjector or prefilled syringe, prescriber must verify the member or caregiver has been trained by a health care professional on subcutaneous administration, monitoring for any allergic reactions, and storage of Nucala®; AND
• A quantity limit of 3 vials, prefilled autoinjectors, or prefilled syringes per 28 days will apply.
• Initial approvals will be for the duration of six months after which time compliance will be evaluated for continued approval. For continued approval, member must be compliant and prescriber must verify the member is responding to Nucala® as demonstrated by a Birmingham Vasculitis Activity Score (BVAS) of zero, fewer EGPA relapses from baseline, or a decrease in daily OCS dose regimen from baseline.

mepolizumab injection (Nucala® ) Approval Criteria [Severe Eosinophilic Phenotype Asthma Diagnosis]:

• An FDA approved indication for add-on maintenance treatment of patients with severe eosinophilic phenotype asthma; AND
• Member must be age 6 years or older; AND
• Member must have a baseline blood eosinophil count of 150 cell/mcL or greater within the last six weeks of initiation of dosing; AND
• Member must have had at least two asthma exacerbations requiring systemic corticosteroids within the last twelve months or require daily systemic corticosteroids despite compliant use of high-dose inhaled corticosteroid (ICS) plus at least one additional controller medication; AND
• Member must have failed a medium-to-high dose ICS used compliantly within the last 3-6 consecutive months (for ICS/LABA combination products, the ICS component would meet criteria at an equivalent medium-to-high dose); AND
• Member must have failed at least one other asthma controller medication used in addition to the high-dose ICS compliantly for at least the past three months; AND
• For authorization of Nucala® vial, prescriber must verify the injection will be administered in a healthcare setting by a healthcare professional prepared to manage anaphylaxis; OR
• For authorization of Nucala® prefilled autoinjector or prefilled syringe, prescriber must verify the member or caregiver has been trained by a health care professional on subcutaneous administration, monitoring for any allergic reactions, and storage of Nucala®; AND
• Nucala® must be prescribed by an allergist, pulmonologist, or pulmonary specialist or the member must have been evaluated by an allergist, pulmonologist, or pulmonary specialist within the last twelve months (or be an advanced care practitioner with a supervising physician who is an allergist, pulmonologist, or pulmonary specialist); AND
• Initial approvals will be for the duration of six months after which time compliance will be evaluated for continued approval; AND
• A quantity limit of 1 vial, prefilled autoinjector, or prefilled syringe per 28 days will apply.   

• An FDA approved diagnosis of hypereosinophilic syndrome (HES) for ≥6 months without an identifiable non-hematologic secondary cause; and
• Member must be 12 years of age or older; and
• Member must have a past history of at least 2 confirmed HES flares [requiring increase in oral corticosteroid (OCS) dose, initiation/incrased dose of cytotoxic or immunosuppressive therapy, or hospitalization] within the past 12 months; and 
• Member must have a baseline blood eosinophil count of ≥1,000 cells/mcL in the last 4 weeks prior to initiating Nucala^®; and
• A diagnosis of FIP1L1-PDGFRα kinase-positive HES will not be approved; and
• Failure to achieve remission despite corticosteroid therapy (oral prednisone equivalent ≥10mg/day) for a minimum of 4 weeks duration or member is unable to tolerate corticosteroid therapy due to significant side effects from corticosteroid therapy; and
• Nucala^® must be prescribed by a hematologist or a specialist with expertise in treatment of HES (or an advanced care practitioner with a supervising physician who is a hematologist or a specialist with expertise in treatment of HES); and
• For authorization of Nucala^® vial, prescriber must verify the injection will be administered in a health care setting by a health care professional prepared to manage anaphylaxis; or
• For authorization of Nucala^® prefilled autoinjector or prefilled syringe, prescriber must verify the member or caregiver has been trained by a health care professional on subcutaneous administration, monitoring for any allergic reactions, and storage of Nucala^®; and
• A quantity limit of 3 vials, prefilled autoinjectors, or prefilled syringes per 28 days will apply; and 
• Initial approvals will be for the duration of 6 months after which time compliance will be evaluated for continued approval. For continued approval, member must be compliant and prescriber must verify the member is responding to Nucala^® as demonstrated by fewer HES flares from baseline or by a decrease in daily OCS dosing from baseline.

Palforzia™ (Peanut Allergen Powder-dnfp) Approval Criteria:  

• Member must be 4 to 17 years of age to initiate initial dose escalation (maintenance dosing may be continued for members 4 years of age and older); AND  
• Member must have a diagnosis of peanut allergy confirmed by a positive skin test, positive in vitro test for peanut-specific IgE, or positive clinician-supervised oral food challenge; AND
• Prescriber must confirm member will use Palforzia™ with a peanut-avoidant diet; AND  
• Member must not have severe uncontrolled asthma; AND
• Member must not have a history of eosinophilic esophagitis or other eosinophilic gastrointestinal disease; AND
• Member must not have had severe or life-threatening anaphylaxis within the previous 60 days; AND
• Member or caregiver must be trained in the use of an auto-injectable epinephrine device and have such a device available for immediate use at all times; AND
• Prescriber must be an allergist, immunologist, or be an advanced care practitioner with a supervising physician that is an allergist or immunologist; AND
• Prescriber, health care setting, and pharmacy must be certified in the Palforzia™ Risk Evaluation and Mitigation Strategy (REMS) program; AND
• Member must be enrolled in the Palforzia™ REMS program; AND
• Palforzia™ must be administered under the direct observation of a health care provider in a REMS certified health care setting with an observation duration in accordance with the prescribing information; AND
• After successful completion of initial dose escalation and all levels of up-dosing as documented by the prescriber, initial approvals of maintenance dosing will be for 6 months. For continued approval, the member must be compliant and prescriber must verify the member is responding well to treatment. 

Prior Authorization form

Oralair® (Sweet Vernal, Orchard, Perennial Rye, Timothy, & Kentucky Blue Grass Mixed Pollens Allergen Extract) Approval Criteria:   

• Member must be between 5 and 65 years of age; AND
• Member must have a positive skin test or in vitro testing for pollen specific IgE antibodies to one of the five grass pollens contained in Oralair®; AND
• Member must not have severe uncontrolled asthma; AND
• Member must have failed conservative attempts to control allergic rhinitis; AND
• Member must have failed pharmacological agents used to control allergies including the following (dates and duration of trials must be indicated on the prior authorization request):
  • Antihistamines: Trials of two different products for 14 days each during a previous season; AND
  • Montelukast: One 14-day trial during a previous season in combination with an antihistamine; AND
  • Nasal steroids: Trials of two different products for 21 days each during a previous season; AND 
• Treatment must begin greater than or equal to 16 weeks prior to the start of the grass pollen season (October 15th) and continue throughout the season; AND
• The first dose must be given in the physician’s office, and the member must be observed for at least 30 minutes post dose; AND
• A quantity limit of one tablet daily will apply; AND
• Initial approvals will be for the duration of six months of therapy to include 16 weeks prior to the season and continue throughout the season; AND
• Member must not be allergic to other allergens for which they are receiving treatment via subcutaneous immunotherapy also known as “allergy shots”; AND
• Member or family member must be trained in the use of an auto-injectable epinephrine device and have such a device available for use at home; AND
• Prescriber must be an allergist, immunologist, or be an advanced care practitioner with a supervising physician that is an allergist or immunologist.

Prior Authorization form

Grastek® (Timothy Grass Pollen Allergen Extract) Approval Criteria:

• Member must be 5 to 65 years of age; and
• Member must have a positive skin test (labs required) or in vitro testing for pollen specific immunoglobulin E (IgE) antibodies for Timothy grass or cross-reactive grass pollen (cool season grasses); and
• Member must not have severe uncontrolled asthma; and
• Member must have failed conservative attempts to control allergic rhinitis; and
• Member must have failed pharmacological agents used to control allergies including the following (dates and duration of trials must be indicated on the prior authorization request):
  • Antihistamines: Trials of 2 different products for 14 days each during a previous season; and
  • Intranasal corticosteroids: Trials of 2 different products for 21 days each during a previous season; and
• Treatment must begin ≥12 weeks prior to the start of the grass pollen season (November 15^th) and continue throughout the season; and
• The first dose must be given in the physician’s office, and the member must be observed for at least 30 minutes post dose; and
• A quantity limit of 1 tablet daily will apply; and
• Initial approvals will be for the duration of 6 months of therapy to include 12 weeks prior to the season and continue throughout the season; and
• Member must not be allergic to other allergens for which they are receiving treatment via subcutaneous immunotherapy also known as “allergy shots”; and
• Member or family member must be trained in the use of an auto-injectable epinephrine device and have such a device available for use at home; and
• Prescriber must be an allergist, immunologist, or be an advanced care practitioner with a supervising physician that is an allergist or immunologist.

Odactra® (House Dust Mite Allergen Extract) Approval Criteria:

• Member must be 12 to 65 years of age; and
• Member must have a positive skin test (labs required) to licensed house dust mite allergen extracts or in vitro testing for immunoglobulin E (IgE) antibodies to Dermatophagoides farinae or Dermatophagoides pteronyssinus house dust mites; and
• Member must not have severe uncontrolled asthma; and
• Member must have failed conservative attempts to control allergic rhinitis; and
• Member must have failed pharmacological agents used to control allergies including the following (dates and duration of trials must be indicated on the prior authorization request):
  • Antihistamines: Trials of 2 different products for 14 days each; and
  • Intranasal corticosteroids: Trials of 2 different products for 21 days each; and
• The first dose must be given in the physician’s office, and the member must be observed for at least 30 minutes post dose; and
• Member must not be allergic to other allergens for which they are receiving treatment via subcutaneous immunotherapy also known as “allergy shots”; and
• Member or family member must be trained in the use of an auto-injectable epinephrine device and have such a device available for use at home; and
• Prescriber must be an allergist, immunologist, or be an advanced care practitioner with a supervising physician that is an allergist or immunologist; and
• A quantity limit of 1 tablet daily will apply; and
• Initial approvals will be for the duration of six months of therapy, at which time the prescriber must verify the patient is responding well to Odactra® therapy. Additionally, compliance will be evaluated for continued approval.

Ragwitek® (Short Ragweed Pollen Allergen Extract) Approval Criteria:

• Member must be 5 to 65 years of age; and
• Member must have a positive skin test or in vitro testing for pollen specific immunoglobulin E (IgE) antibodies to short ragweed pollen; and
• Member must not have severe uncontrolled asthma; and
• Member must have failed conservative attempts to control allergic rhinitis symptoms; and
• Member must have failed pharmacological agents used to control allergies including the following (dates and duration of trials must be indicated on the prior authorization request):
  • Antihistamines: Trials of 2 different products for 14 days each during a previous season; and
  • Intranasal corticosteroids: Trials of 2 different products for 21 days each during a previous season; and
• Treatment must begin ≥12 weeks prior to the start of ragweed pollen season (May 15^th) and continue throughout the season; and
• The first dose must be given in the physician’s office, and the member must be observed for at least 30 minutes post dose; and
• A quantity limit of 1 tablet daily will apply; and
• Initial approvals will be for the duration of 6 months of therapy to include 12 weeks prior to the season and continue throughout the season; and
• Member must not be allergic to other allergens for which they are receiving treatment via subcutaneous immunotherapy also known as “allergy shots”; and
• Member or family member must be trained in the use of an auto-injectable epinephrine device and have such a device available for use at home; and
• Prescriber must be an allergist, immunologist, or be an advanced care practitioner with a supervising physician that is an allergist or immunologist.

• An FDA approved diagnosis of pulmonary arterial hypertension; and
• Medical supervision by a pulmonary specialist or cardiologist; and
• A patient-specific, clinically significant reason why the member cannot use generic sildenafil oral tablets must be provided; or
• A clinical exception for use as initial combination therapy with Letairis^® (ambrisentan) applies; and
• A quantity limit of 60 tablets per 30 days will apply.

• An FDA approved diagnosis of pulmonary arterial hypertension or chronic thromboembolic pulmonary hypertension (CTEPH); and
  • Members with a diagnosis of pulmonary arterial hypertension must have previous failed trials of at least 1 medication in each of the following categories:
    • Revatio^® (sildenafil) or Adcirca^® (tadalafil); and
    • Letairis^® (ambrisentan) or Tracleer^® (bosentan); and
  • Members with a diagnosis of CTEPH must currently be on anticoagulation therapy; and
• Medical supervision by a pulmonary specialist or cardiologist; and
• Member must not be on any concurrent phosphodiesterase (PDE) inhibitor therapy; and
• Member must not have a diagnosis of pulmonary hypertension associated with idiopathic interstitial pneumonias (PH-IIP); and
• Female members and all health care professionals (prescribers and dispensing pharmacies) must be enrolled in the Adempas^® REMS program; and
• A quantity limit of 90 tablets per 30 days will apply.

• An FDA approved diagnosis of pulmonary arterial hypertension; and
• Member must have previous failed trials of at least 1 medication in each of the following categories:
  • Revatio^® (sildenafil) or Adcirca^® (tadalafil); and
  • Letairis^® (ambrisentan) or Tracleer^® (bosentan); and
• Medical supervision by a pulmonary specialist or cardiologist; and
• Female members and all health care professionals (prescribers and dispensing pharmacies) must be enrolled in the Opsumit^® REMS program; and
• A quantity limit of 30 tablets per 30 days will apply.

• An FDA approved diagnosis of pulmonary arterial hypertension; and
• Member must have previous failed trials of at least 1 medication in each of the following categories:
  • Revatio^® (sildenafil) or Adcirca^® (tadalafil); and
  • Letairis^® (ambrisentan) or Tracleer^® (bosentan); and
• Medical supervision by a pulmonary specialist or cardiologist; and
• A quantity limit of 180 tablets per 30 days will apply.

• An FDA approved diagnosis of pulmonary arterial hypertension; and
• Medical supervision by a pulmonary specialist or cardiologist; and
• A quantity limit of 180 tablets per 30 days will apply.

• An FDA approved diagnosis of pulmonary arterial hypertension; and
• Medical supervision by a pulmonary specialist or cardiologist; and
• An age restriction will apply. The oral suspension formulation may be approvable for members 6 years of age and younger. Members 7 years of age and older must have a patient-specific, clinically significant reason why the member is not able to use the oral tablet formulation; and
• A quantity limit of 224mL per 30 days (2 bottles) will apply.

Tadliq^® (Tadalafil Oral Suspension) Approval Criteria:

• An FDA approved diagnosis of pulmonary arterial hypertension; AND
• Medical supervision by a pulmonary specialist or cardiologist; AND
• A patient-specific, clinically significant reason why the member cannot use generic sildenafil oral suspension must be provided; AND
• An age restriction will apply. Members 7 years of age and older must have a patient-specific, clinically significant reason why the member cannot use generic tadalafil 20mg oral tablets, even when the tablets are crushed; AND
• A quantity limit of 300mL per 30 days (2 bottles) will apply. 

Tyvaso DPI^® (Treprostinil Powder for Inhalation) Approval Criteria:

• An FDA approved diagnosis of 1 of the following:
  • Pulmonary arterial hypertension (PAH); OR
  • Pulmonary hypertension associated with interstitial lung disease (PH-ILD); AND
    • Diagnosis of PH-ILD must be confirmed by right-sided heart catheterization; AND
• Medical supervision by a pulmonary specialist or cardiologist; AND
• For a diagnosis of PAH:
  • Member must have previous failed trials of at least 1 of each of the following categories:
    • Revatio^® (sildenafil) or Adcirca^® (tadalafil); AND
    • Letairis^® (ambrisentan) or Tracleer^® (bosentan); AND
  • A patient-specific, clinically significant reason why Tyvaso^® (treprostinil inhalation solution) and Remodulin^® (treprostinil injection), which are available without a prior authorization, are not appropriate for the member must be provided; AND
• For a diagnosis of PH-ILD, a patient-specific, clinically significant reason why Tyvaso^® (treprostinil inhalation solution), which is available without a prior authorization, is not appropriate for the member must be provided. 

• An FDA approved diagnosis of pulmonary arterial hypertension; and
• Member must be 18 years of age or older; and
• Member must have previous failed trials of at least 1 medication in each of the following categories (alone or in combination):
  • Revatio^® (sildenafil), Adcirca^® (tadalafil), or Adempas^® (riociguat); and
  • Letairis^® (ambrisentan) or Tracleer^® (bosentan); and
  • Orenitram^® (treprostinil); and
• Medical supervision by a pulmonary specialist and/or cardiologist; and
• A quantity limit of 2 tablets daily will apply for all strengths with an upper dose limit of 1,600mcg twice daily.

nintedanib (Ofev® ) Approval Criteria:

• An FDA approved diagnosis of one of the following:
  • Treatment of idiopathic pulmonary fibrosis (IPF); OR
  • Treatment of chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype; OR
    Slowing the rate of decline in pulmonary function in patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD); AND
• Member must be 18 years of age or older; AND
• Prescriber must verify liver function tests (LFTs) (e.g., ALT, AST, bilirubin) will be monitored prior to initiation of Ofev® treatment, at regular intervals during the first 3 months of treatment, and periodically thereafter or as clinically indicated; AND
• Female members must not be pregnant and must have a negative pregnancy test immediately prior to therapy initiation. Female members of reproductive potential must be willing to use effective contraception while on therapy and for at least 3 months after therapy completion; AND
• Medication must be prescribed by, or in consulatation with, a pulmonologist or pulmonary specialist (or an advanced care practitioner with a supervising physician who is a pulmonologist or pulmonary specialist); AND
• A quantity limit of 60 capsules per 30 days will apply.

pirfenidone (Esbriet®) Approval Criteria:

• An FDA approved diagnosis of idiopathic pulmonary fibrosis (IPF); AND  
• Member must be 18 years of age or older; AND
• Prescriber must verify liver function tests (LFTs) (e.g., ALT, AST, bilirubin) will be monitored prior to the initiation of Esbriet®, monthly for the first 6 months of treatment, and every 3 months thereafter, and as clinically indicated; AND
• Medication must be prescribed by a pulmonologist or pulmonary specialist (or an advanced care practitioner with a supervising physician who is a pulmonologist or pulmonary specialist); AND
• A quantity limit of 270 capsules or tablets per 30 days will apply for the 267mg strength capsules and tablets, and a quantity limit of 90 tablets per 30 days will apply for the 801mg strength tablets.

PA Criteria:

Member Selection: 

• Infants younger than 12 months of age at the start of RSV season:
  • Born before 29 weeks, 0 days gestation; or
  • Born before 32 weeks, 0 days gestation and develop chronic lung disease (CLD) of prematurity (require >21% oxygen supplementation for ≥28 days after birth); or
  • Have hemodynamically significant congenital heart disease [acyanotic heart disease and receiving medication to control congestive heart failure (CHF) and will require surgical procedures, or have moderate-to-severe pulmonary hypertension]; or
  • May be considered for:
    • Infants with neuromuscular disease or a congenital anomaly that impairs the ability to clear secretions from the upper airway because of ineffective cough; or
    • Infants who undergo cardiac transplantation during RSV season; or
    • Infants who are profoundly immunocompromised during RSV season; or
    • Infants with cystic fibrosis with clinical evidence of CLD and/or are nutritionally compromised; or
   
• Infants 12 to 24 months of age at the start of RSV season: 
  • Born before 32 weeks, 0 days gestation and have CLD of prematurity (required ≥28 days of oxygen after birth) and continue to require medical support (chronic corticosteroid therapy, diuretic therapy, or supplemental oxygen) during the 6 months before the start of the RSV season; or
  • May be considered for:
    • Infants who undergo cardiac transplantation during RSV season; or
    • Infants who are profoundly immunocompromised during RSV season; or
    • Infants with cystic fibrosis with manifestations of severe lung disease or weight for length less than the 10^th percentile.

Product Selection: A patient-specific, clinically significant reason why the member cannot receive Beyfortus™ (nirsevimab-alip), as recommended by the CDC, must be provided. Additionally, the prescriber must confirm the member has not already received Beyfortus™ for the current RSV season. Concomitant use with Beyfortus™ will not be approved.

Length of treatment:  Palivizumab is approved for use only during RSV season in Oklahoma as determined by the Oklahoma State Department of Health (OSDH) Viral Respiratory Illness Sentinel Surveillance System or other credible statewide monitoring system. The threshold for determining RSV seasonality is 10% of positive tests. RSV is determined to be in season once the percentage of positive tests is >10%; however, due to a potential lag in reporting data, palivizumab coverage will begin when the percentage of positive tests is consistently increasing and approaching the 10% threshold. RSV season is determined to be at an end when the percentage of positive tests is consistently <10%. Initial and subsequent approvals will be for the duration of 1 month until RSV season end. A separate prior authorization request will be required for consideration of initial approval and for each subsequent approval. Members initially approved for palivizumab will require a patient-specific, clinically significant reason why the member still cannot receive Beyfortus™ (nirsevimab-alip). 

Units authorized: The member’s current weight (taken within the last 3 weeks) must be provided on the prior authorization request in order to authorize the appropriate amount of drug required according to package labeling. Doses are to be administered no more often than every 30 days. Members given doses more frequently than every 30 days will not be authorized for additional doses. Doses administered prior to the member’s discharge from a hospital will be counted as one of the approved total. 

Dose-pooling: To avoid unnecessary risk to the patient, multiple patients are not to be treated from a single vial. Failure to follow this recommendation will result in referral of the provider to the Quality Assurance Committee of the Oklahoma Health Care Authority.  

Prior Authorization Initiation Form - Synagis

Prior Authorization Continuation Form - Synagis

Tezspire^® (Tezepelumab-ekko) Approval Criteria:

• An FDA approved diagnosis of add-on maintenance treatment for severe asthma; AND
• Member must be 12 years of age or older; AND
• Member must have experienced ≥2 asthma exacerbations requiring oral or injectable corticosteroids or that resulted in hospitalization in the last 12 months; AND
• Member must have failed a medium-to-high dose inhaled corticosteroid (ICS) used compliantly within the last 3-6 consecutive months (for ICS/LABA combination products, the ICS component would meet criteria at an equivalent medium-to-high dose); AND
• Member must have failed at least 1 other asthma controller medication used in addition to the medium to high dose ICS compliantly for at least the past 3 months; AND
• For authorization of Tezspire^® vial or pre-filled syringe, prescriber must verify that the injection will be administered by a health care provider prepared to manage anaphylaxis; AND
• For authorization of Tezspire^® pre-filled pen, prescriber must verify that the injection will be administered by a health care provider prepared to manage anaphylaxis or the member or caregiver has been trained by a health care professional on subcutaneous administration, monitoring for any allergic reactions, and storage of Tezspire^®; and 
• Tezspire^® must be prescribed by an allergist, pulmonologist, or pulmonary specialist, or the member must have been evaluated by an allergist, pulmonologist, or pulmonary specialist within the last 12 months (or an advanced care practitioner with a supervising physician who is an allergist, pulmonologist, or pulmonary specialist); AND
• Initial approvals will be for the duration of 6 months after which time compliance will be evaluated for continued approval; AND
• A quantity limit of 1.91mL (1 single-dose glass vial or single-dose pre-filled syringe) per 28 days will apply. 
  
  Tezspire PA Form

omalizumab injection (Xolair®) Approval Criteria [Asthma Diagnosis]:

• Member must be between 6-75 years of age; AND
• Member must have a diagnosis of severe persistent asthma (as per NAEPP guidelines); AND
• Member must have a positive skin test to at least one perennial aeroallergen. Positive perennial allergens must be listed on the prior authorization request; AND
• Member must have a pretreatment serum IgE level between 30-1300 IU/ml (depending on member age); AND
• Member weight must be between 20-150kg; AND
• Member must have been on for medium-to-high dose inhaled corticosteroids (ICS) (for ICS/LABA combination products, the ICS component would meet criteria at an equivalent medium-to-high dose) within the last 3-6 consecutive months; AND
• Prescribed Xolair® dose must be an FDA approved regimen per Xolair® prescribing information; AND
• For authorization of Xolair® vial, prescriber must verify the injection will be administered in a healthcare setting by a healthcare professional prepared to manage anaphylaxis; AND
• For authorization of Xolair^® prefilled autoinjector or prefilled syringe, prescriber must verify the following:
  • Member has no prior history of anaphylaxis; and
  • Member must have had at least 3 doses of Xolair^® under the guidance of a health care provider with no hypersensitivity reactions; and
  • Member has been trained by a health care professional on subcutaneous administration, monitoring for any allergic reactions, and storage of Xolair^®; and
• Xolair® must be prescribed by an allergist, pulmonologist, or pulmonary specialist or the member must have been evaluated by an allergist, pulmonologist, or pulmonary specialist within the last twelve months (or be an advanced care practitioner with a supervising physician who is an allergist, pulmonologist, or pulmonary specialist); AND
• Member must have been in the ER or hospitalized, due to an asthma exacerbation, twice in the past twelve months (date of visits must be listed on the prior authorization request), or have been determined to be dependent on systemic steroids to prevent serious exacerbations; AND
• Both the prior authorization request form and statement of medical necessity form must be submitted for processing.
  
  

Xolair^® (Omalizumab) Approval Criteria [Nasal Polyps Diagnosis]:

• An FDA approved indication for add-on maintenance treatment of nasal polyps in adult members with inadequate response to nasal corticosteroids; and
• Member must be 18 years of age or older; and
• Member must have a trial of intranasal corticosteroids for at minimum the past 4 weeks; and
• Prescriber must verify member will continue to receive intranasal corticosteroid therapy, unless contraindicated; and
• Member has symptoms of chronic rhinosinusitis (e.g., facial pain/pressure, reduction or loss of smell, nasal blockade/obstruction/congestion, nasal discharge) for 12 weeks or longer despite attempts at medical management; and
• Member has evidence of nasal polyposis by direct examination, sinus CT scan, or endoscopy; and
• Member must have a pretreatment serum IgE level between 30 and 1,500 IU/mL; and
• Member’s weight must be between 31kg and 150kg; and
• Prescribed Xolair^® dose must be an FDA approved regimen per Xolair^® Prescribing Information; and
• For authorization of Xolair^® vial, prescriber must verify the injection will be administered in a health care setting by a health care professional prepared to manage anaphylaxis; and
• For authorization of Xolair^® prefilled autoinjector or prefilled syringe, prescriber must verify the following:
  • Member has no prior history of anaphylaxis; and
  • Member must have had at least 3 doses of Xolair^® under the guidance of a health care provider with no hypersensitivity reactions; and
  • Member has been trained by a health care professional on subcutaneous administration, monitoring for any allergic reactions, and storage of Xolair^®; and
• Xolair^® must be prescribed by an otolaryngologist, allergist, immunologist, or pulmonologist or the member must have been evaluated by an otolaryngologist, allergist, immunologist, or pulmonologist within the last 12 months (or an advanced care practitioner with a supervising physician who is an otolaryngologist, allergist, immunologist, or pulmonologist); and
• Initial approvals will be for the duration of 6 months. Reauthorization may be granted if the prescriber documents the member is responding well to treatment. Additionally, compliance will be evaluated for continued approval. 

Xolair^® (Omalizumab Injection) Approval Criteria [Chronic Idiopathic Urticaria (CIU) Diagnosis]:

• Member must be > 12 years of age; AND
• Other forms of urticaria must be ruled out; AND
• Other potential causes of urticaria must be ruled out; AND
• Member must have an Urticaria Activity Score (UAS) >16; AND
• For authorization of Xolair^® vial, prescriber must verify the injection will be administered in a health care setting by a health care professional prepared to manage anaphylaxis; and
• For authorization of Xolair^® prefilled autoinjector or prefilled syringe, prescriber must verify the following:
  • Member has no prior history of anaphylaxis; and
  • Member must have had at least 3 doses of Xolair^® under the guidance of a health care provider with no hypersensitivity reactions; and
  • Member has been trained by a health care professional on subcutaneous administration, monitoring for any allergic reactions, and storage of Xolair^®; and
• Prescriber must be an allergist, immunologist, dermatologist, or be an advanced care practitioner with a supervising physician that is an allergist, immunologist, or dermatologist; AND
• A trial of a second generation H1antihistamine dosed four times the maximum FDA dose within the last three months for at least four weeks (or less if symptoms are intolerable); AND   
• Initial dosing will only be approved at 150mg every 4 weeks.  If inadequate results at this dose, then the dose may be increased to 300mg every 4 weeks: AND
• Initial approvals will be for the duration of 3 months. 

For Xolair requests, please submit these forms together:

• Xolair Statement of Medical Necessity for Asthma
• Xolair Statement of Medical Necessity for Chronic Idiopathic Urticaria 
• Xolair PA Form