Respiratory 2019

PA Criteria:

Tier 1 products for pediatric members are covered with no authorization necessary. OTC products are only covered for pediatric members.

For members 21 years and older, Tier 1 products are available with prior authorization.

Tier 2 authorization requires a documented 14 day trial of all Tier 1 products within the last 30 days.

Tier 3 authorization requires a 14 day trial with all Tier 2 products within the last 60 days (unless no age-appropriate Tier 2 product exists).

*Xyzal is only covered for members 0-20 years of age. (Syrup is covered from 6 months of age to 6 years of age)

For all antihistamine authorizations, the diagnosis must be for a chronic allergic condition. 

Prior Authorization form   

Tier 1

Tier 2

Tier 3

• OTC cetirizine 5mg & 10mg tablets, syrup  (Zyrtec®)
• OTC loratadine (Claritin®)

• OTC levocetirizine (Xyzal®)*

• desloratadine (Clarinex®)
• clemastine

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  

• Tier-1 products are available without prior authorization.
• Tier-2 authorization requires:

       1) Approved or clinically accepted indication, and
       2) Specific reason member cannot use all available tier-1 products

Tier 1

Tier 2

• albuterol HFA (ProAir HFA®) BRAND Preferred
• albuterol sulfate inhalation powder (ProAir® RespiClick)*
• albuterol HFA (Proventil HFA®)
• albuterol HFA (Ventolin HFA®)
• levalbuterol HFA (Xopenex HFA®)BRAND Preferred

• albuterol HFA (ProAir® HFA) Generic
• levalbuterol HFA (Xopenex HFA) Generic

 levalbuterol (Xopenex® Nebulizer Solution) PA criteria:

• PA required for use of this product in excess of 90 days of therapy in a 360 day period.
• A quantity limit of 288 units every 30 days will apply to Xopenex solution.
• Please state need of this product over albuterol.
  • In the prior authorization request, the prescriber should explain why the member is unable to use long acting bronchodilators and/or inhaled corticosteroid (ICS) therapy for long-term control as recommended in the NAEPP guidelines 
    
   

Prior Authorization form

Tier 1 products are available without prior authorization.

Tier 2 Approval Criteria:

• The member must be age 18 or older, AND
• Have a diagnosis of COPD, chronic bronchitis, or emphysema, AND
• A 4 week trial of at least one LABA and a four week trial of one LAMA within the past 90 days, OR
• A documented adverse effect, drug interaction, or contraindication to all available Tier 1 products. 
• A clinical exception will be made for members who are unable to effectively use hand-actuated devises, such as Spiriva Handihaler® or those who are stable on nebulized therapy.

glycopyrrolate/formoterol fumarate (Bevespi Aerosphere™) Approval Criteria:                 

• Member must be 18 years of age or older; AND
• An FDA approved diagnosis of chronic obstructive pulmonary disease (COPD); AND
• A patient-specific, clinically significant reason why the member cannot use Tier-1 long-acting beta2 agonist (LABA) and long-acting muscarinic antagonist (LAMA) individual components. 

indacaterol/glycopyrrolate (Utibron™ Neohaler®) Approval Criteria:

• Member must be 18 years of age or older; AND
• An FDA approved diagnosis of chronic obstructive pulmonary disease (COPD); AND
• A patient-specific, clinically significant reason why the member cannot use Tier-1 long-acting beta2 agonist (LABA) and long-acting muscarinic antagonist (LAMA) individual components.

tiotropium/olodaterol (Stiolto™ Respimat®) Approval Criteria:                 

• Member must be 18 years of age or older; AND
• An FDA approved diagnosis of chronic obstructive pulmonary disease (COPD); AND
• A patient-specific, clinically significant reason why the member cannot use Tier-1 long-acting beta2 agonist (LABA) and long-acting muscarinic antagonist (LAMA) individual components.

tiotropium bromide soft mist inhaler (Spiriva® Respimat®) Approval Criteria for Asthma Diagnosis:

• Member must have an FDA approved diagnosis of asthma; AND
• Member must be 12 years of age or older; AND
• Member must have used a high-dose inhaled corticosteroid and long-acting beta2 agonist (ICS/LABA) product for at least one month immediately prior to request for authorization; AND
• Member must have had a trial of a leukotriene receptor antagonist for at least one month in the last 90 days; AND
• Member must have a history of exacerbations despite required trials; AND
• Member must remain on an ICS or ICS/LABA while on tiotropium therapy; AND
• Member’s asthma must be considered uncontrolled by prescriber:
• Member requires rescue inhaler more than two days per week for reasons other than prevention of exercise induced bronchospasms; OR  
• Member requires oral systemic corticosteroids; OR 
• Clinical situation warranting initiation of tiotropium therapy in addition to an ICS/LABA due to severity of asthma; AND 
• A clinically significant reason the member is unable to use Spiriva® Handihaler® (tiotropium) which does not require prior authorization.

umeclidinium/vilanterol inhalation powder (Anoro™ Ellipta®) Approval Criteria:

• Member must be 18 years of age or older; AND  
• An FDA approved diagnosis of chronic obstructive pulmonary disease (COPD); AND  
• A patient-specific, clinically significant reason why the member cannot use Tier-1 long-acting beta2 agonist (LABA) and long-acting muscarinic antagonist (LAMA) individual components

Prior Authorization form

Tier 1

Tier 2

Special PA

Long-Acting Beta2 Agonists (LABA)

•  salmeterol inhalation powder (Serevent®)

• formoterol nebulizer solution (Perforomist®) 
• arformoterol nebulizer solution Brovana®) 
• indacaterol inhalation powder (Arcapta®) 
• olodaterol inhalation spray Striverdi® Respimat®) 

 Long-Acting Anticholinergics (LAMA)

•  tiotropium inhalation powder Spiriva®)

• aclidinium inhalation powder (Tudorza®)
• glycopyrrolate (Seebri™ Neohaler®) 
• glycopyrrloate inhalation solution (Lonhala™ Magnair™)
• revefenacin inhalation solution (Yupelri™)
• tiotropium soft mist inhaler (Spiriva® Respimat®)* 
• umeclidinium inhalation powder (Incruse™ Ellipta®) 

LABA/LAMA Combination Products

• tiotropium/olodaterol (Stiolto™ Respimat®) 
• indacaterol/glycopyrrolate (Utibron™ Neohaler®) 

Tier 1

Tier 2

• budesonide (Pulmicort®)
• budesonide/formoterol (Symbicort® )
• ciclesonide (Alvesco®) 
• fluticasone propionate (Flovent®)
• fluticasone/salmeterol (Advair® ) 
• mometasone furoate (Asmanex®)
• mometasone/formoterol (Dulera® HFA)

• Fluticasone furoate/vilanterol(Breo® Ellipta®)
• fluticasone propionate (ArmonAir™ RespiClick®) 
• fluticasone propionate/salmeterol (AirDuo™ RespiClick®)
• fluticasone furoate/umeclidinium/vilanterol(Trelegy™ Ellipta®)

Approval Criteria:

• 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 12 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 high-dose ICS (≥880mcg/day fluticasone propionate or equivalent daily dose or ≥440mcg/day in ages 12 to 17 years) used compliantly for at least the past 12 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 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 [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.

Prior Authorization form

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 high-dose ICS (≥880mcg/day fluticasone propionate or equivalent daily dose or ≥440mcg/day in ages 12 to 17 years) used compliantly for at least the past 12 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
• 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 per 56 days will apply.   

nintedanib (Ofev® ) Approval Criteria:

• An FDA approved diagnosis of idiopathic pulmonary fibrosis (IPF) or systemic sclerosis-associated interstitial lung disease(SSC-ILD); AND  
• Member must be 18 years of age or older; AND
• Medication must be prescribed by 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
• Medication must be prescribed by 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:

1). The following criteria are required for approval of a Tier 2 product:

• Documented adverse effect or contraindication to the preferred products.
• Failure with all tier 1 medications defined as no beneficial response after at least three weeks use at the maximum recommended dose. 

2). The following criteria are required for approval of a Tier 3 product:

• All tier 2 criteria must be met.
• Failure with all available tier 2 products defined as no beneficial response after at least three weeks use at the maximum recommended dose. 

3). Approvals will be for the duration of three months, except for members with chronic diseases such as asthma or COPD, in which case authorizations will be for the duration of one year.

4). No grandfathering of tier 2 or tier 3 products will be allowed for this category.

5). For 2 to 4 year olds, the age appropriate lower-tiered generic products must be used prior to the use of higher tiered products.

Xhance™ (Fluticasone Propionate Nasal Spray) Approval Criteria:   

• An FDA approved diagnosis of nasal polyps; AND
• A patient-specific, clinically significant reason why the member cannot use intranasal fluticasone, budesonide, mometasone, and/or other cost-effective therapeutic equivalent medication(s) must be provided; AND
• Current Tier structure rules will also apply.   

 Prior Authorization form   

Tier 1

Tier 2

Tier 3

• beclomethasone (Beconase AQ®)
• fluticasone (Flonase®)

• azelastine ( Astelin®)
• beclomethasone/dipropionate (Qnasl®)
   

• azelastine (Astepro®)
• azelastine/fluticasone (Dymista®)
• ciclesonide (Omnaris®)
• ciclesonide (Zetonna®) 
• flunisolide (Nasalide®, Nasarel®)
• fluticasone (Veramyst®)
• fluticasone (Xhance™)
• mometasone (Nasonex®)
• olapatadine (Patanase®)

PA Criteria:

Member Selection: 

• Infants less than 12 months old at the start of RSV season:
  • Born before 29 weeks, 0 days gestation; or
  • With moderate-to-severe pulmonary hypertension or with acyanotic heart disease on medications to control congestive heart failure and will require cardiac surgical procedures; or
  • Infants with neuromuscular disease or 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 with cystic fibrosis with clinical evidence of chronic lung disease (CLD) and/or nutritionally compromised
   
• Infants less than 24 months old at the start of RSV season: 
  • Born before 32 weeks, 0 days gestation and develop chronic lung disease (CLD) of prematurity (require >21% oxygen supplementation for at least 28 days 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
  • Infants who are profoundly immunocompromised during RSV season; or
  • Infants less than 24 months of age with cystic fibrosis with manifestations of severe lung disease or weight for length less than the 10th percentile
   

Length of treatment:  Palivizumab is approved for use only during RSV season. Approval dates will be November 1st through March 31st.

Units authorized:  The maximum duration of therapy is five (5) doses, with a dose 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 Form - Synagis - Available Fall 2018

omalizumab (Xolair®) Approval Criteria for Asthma:

• 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 high dose ICS (≥880mcg/day fluticasone propionate or equivalent daily dose or ≥440mcg/day in ages 12 to 17 years) for at minimum the past three months; AND
• Prescribed Xolair® dose must be an FDA approved regimen per Xolair® prescribing information; AND
• Xolair® must be administered in a healthcare setting by a healthcare professional prepared to manage anaphylaxis; 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.
• 12. Initial approvals will be for the duration of six months after which time compliance will be evaluated for continued approval.

Omalizumab (Xolair®) Approval Criteria for Chronic Idiopathic Uritcaria:

• 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
• 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 
• Universal Petition for Medication Authorization

PA 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 for at least the past 12 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

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
• Nucala® must be administered in a healthcare setting by a healthcare professional prepared to manage anaphylaxis; AND
• A quantity limit of 3 vials 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 high-dose ICS (≥880mcg/day fluticasone propionate or equivalent daily dose or ≥440mcg/day in ages 12 to 17 years) used compliantly for at least the past twelve months (for ICS/LABA combination products, 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
• Nucala® must be administered in a healthcare setting by a healthcare professional prepared to manage anaphylaxis; 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 per 28 days will apply.    

PHARM - 47

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 6 months of age or older; AND
• A quantity limit of two tablets or 2 granule packets per day, (56 per 28 days) will apply; AND
• An age restriction of 6 months 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.
• Initial approval will be for six months, after which time, compliance and information regarding efficacy, such as improvement in FEV₁, will be required for continued approval.

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 2 years of age or older; AND
• Members using Orkambi™ must be supervised by a pulmonary specialist; 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
• 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 2 years to 5 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.
• Initial approval will be for the duration of three months, after which time, compliance will be required for continued approval. After six months of utilization, compliance and information regarding efficacy, such as improvement in FEV1, will be required for continued approval.
  

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.
• Authorization of Tobi® Podhaler™ requires a trial of tobramycin nebulized solution or a patient-specific, clinically significant reason why tobramycin nebulized solution is not appropriate for the member.
• Tobramycin nebulized solution (including Bethkis®, Kitabis™ Pak, and generic 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
• 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.
• Initial approval will be for the duration of 3 months, after which time compliance will be required for continued approval. 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®.
  

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