Respiratory

PA Criteria:

Tier 1 products are covered with no authorization necessary for members under age 21.

• 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 Tabs are not covered for members under age 6. (Syrup is covered down to 6 months of age)
• For all antihistamine authorizations, the diagnosis must be for a chronic allergic condition.
• Prior Authorization form

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

• 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.

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.

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

• albuterol HFA (ProAir HFA®)
• albuterol HFA (Proventil HFA®)

• albuterol HFA (Ventolin HFA®)
• levalbuterol HFA (Xopenex HFA®)

PA criteria:Xopenex

• 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.

Criteria for approval:

• 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.

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.

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

• salmeterol inhalation powder (Serevent®)
• formoterol aerosolized powder (Foradil®)

• formoterol nebulizer solution (Perforomist®)
• arformoterol nebulizer solution (Brovana®)
• indacaterol inhalation powder (Arcapta®)

• tiotropium inhalation powder (Spiriva®)

• aclidinium inhalation powder (Tudorza®)
• tiotropium soft mist inhaler (Spiriva® Respimat®)
• umeclidinium inhalation powder (Incruse™Ellipta®)

fluticasone/salmeterol (Advair®)
budesonide/formeterol (Symbicort®)
mometasone/formoterol (Dulera®)
fluticasone/vilanterol (Breo Ellipta®)

PA Criteria:

1) Diagnosis of COPD, or
2) Diagnosis of Asthma:

• Member must be at or above the minimum age indicated
• Member must have used an inhaled corticosteroid ( Aerospan, Alvesco, Asmanex, Flovent, Pulmicort, or QVAR) for at least one month immediately prior to request for authorization, AND;
• Member’s asthma considered uncontrolled by the prescriber requires rescue inhaler more than 2 days per week for reasons other than prevention of exercise induced bronchospasms, and/or requires oral systemic corticosteroids, or;
• Clinical situation warranting initiation with combination therapy due to severity of asthma;
• Consideration for approval of Breo Ellipta® requires the following:
  • FDA approved diagnosis of COPD or chronic bronchitis and/or emphysema associated with COPD; and
  • Trials of Advair® and Symbicort®, at FDA approved COPD doses, consisting of at least 30 days each within the last 90 days that did not adequately control COPD symptoms.

nintedanib (Ofev® ) 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 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 per 30 days will apply.

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.

• fluticasone (Flonase®)
• flunisolide (Nasalide®, Nasarel®)

• beclomethasone (Beconase AQ®)

• azelastine ( Astelin®, Astepro®)
• azelastine/fluticasone (Dymista®)
• beclomethasone/dipropionate (Qnasl®)
• budesonide (Rhinocort AQ®)
• ciclesonide (Omnaris®)
• mometasone (Nasonex®)
• olapatadine (Patanase®)
• fluticasone (Veramyst®)
• ciclesonide (Zetonna®)

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; o
  • 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, bronchodilator 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.

PA Criteria:

• Member must be between 12-75 years of age.
• Member must have a diagnosis of severe persistent asthma (as per NAEPP guidelines).
• Member must have a positive skin test to at least one perennial aeroallergen. Specific positive perennial allergens must be listed on the petition.
• Member must have a pretreatment serum IgE level between 30-700 IU/ml.
• Member weight must be between 30-150kg.
• Member must have been on high dose ICS (as per NAEPP Guidelines) for a minimum of 3 months.
• Medication must be prescribed by either a pulmonary or an allergy/asthma specialist.
• Member must have been in the ER or hospitalized, due to an asthma exacerbation, twice in the past 6 months. Date of visits must be listed on petition, or
• Have been determined to be dependent on systemic steroids to prevent serious exacerbations.

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 (see below); 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
• Member has tried and failed to obtain relief from other treatments including the following trials within the last 6 months (member must fail all classes unless contraindicated):
  • At least two different H1 -antihistamine trials for a minimum duration of two weeks each:
    • One trial must be a second generation antihistamine dosed four times the maximum FDA dose; AND
    • One trial must be tried in combination with an H2-antihistamine; AND
  • A 4-week trial of a leukotriene receptor antagonist in combination with a 4-week trial of doxepin 10-50mg daily; 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.

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

ivacaftor (Kalydeco®) Approval Criteria:

• Consideration will be based on the following criteria:
• An FDA approved indication of cystic fibrosis with a G551D, G1244E, G1349D, G178R, G551S, R117H, S1251N, S1255P, S549N, or S549R mutation in the CFTR gene detected by genetic testing; AND
• Age of 2 years or older.
• A quantity limit of two tablets per day, 56 tablets per 28 days will apply.
• 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; AN
• 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; AN
• Orkambi™ will not be approved for patients with CF other than those homozygous for the F508del mutation; AND
• Member must be 12 years of age or older; AND
• Members using Orkambi™ must be supervised by a pulmonary specialist; an
• 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; AN
• Members must not be taking any of the following medications concomitantly with Orkambi™: rifampin, rifabutin, phenobarbital, carbamazepine, phenytoin, and St. John’s wort; AN
• A quantity limit of four tablets per day or 112 tablets per 28 days will apply.
• 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.

Tobi/Pulmozyme Approval Criteria: tobramycin(Bethkis®, Tobi® and Tobi® Podhaler™) and Pulmozyme®(dornase alfa):Use of inhaled tobramycin products and Pulmozyme® are reserved for members who have a diagnosis of cystic fibrosis.

• These medications 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 will be restricted to 28 days of therapy per 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 petition with a patient-specific, clinically significant reason why the patient would need treatment outside of the FDA approved dosing.
• The pharmacy will need to process the prescription claim with a 56 day supply.

PA criteria:

• Member must be 5 years of age or older; AND
• Member must have a positive skin test or in vitro testing for pollen specific 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 trails 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 12 weeks prior to the start of the grass pollen season 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 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.
• Prescriber must be an allergist, immunologist or be an advanced care practitioner with a supervising physician that is an allergist or immunologist.

PA criteria:

• Member must be 18 years of age or older; AND
• Member must have a positive skin test or in vitro testing for pollen specific 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 trails 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 12 weeks prior to the start of ragweed pollen season 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 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.
• Prescriber must be an allergist, immunologist or be an advanced care practitioner with a supervising physician that is an allergist or immunologist.