Respiratory

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 5 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.

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

• Member must be 1 to 17 years of age to initiate initial dose escalation (maintenance dosing may be continued for members 1 year 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. 

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.

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

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)

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

 

Short-Acting Beta2 Agonists
Tier-1	Tier-2
albuterol HFA (ProAir® HFA, Proventil® HFA, Ventolin® HFA)	levalbuterol HFA (generic)
albuterol inhalation powder (ProAir® RespiClick®)
levalbuterol HFA (Xopenex® HFA) – Brand Preferred

 

Maintenance Asthma and COPD Medications:

Short-Acting Beta2 Agonists Tier-2 Approval Criteria:

• An FDA approved or clinically accepted indication; and
• A patient-specific, clinically significant reason why the member cannot use all available Tier-1 medications must be provided; and
• Approval of generic levalbuterol HFA requires a patient-specific, clinically significant reason the member cannot use the brand formulation.

Long-Acting Beta₂ Agonist (LABA) and Long-Acting Muscarinic Antagonist (LAMA) Tier-2 Approval Criteria:

• Member must be 18 years of age or older; and
• An FDA approved diagnosis of chronic obstructive pulmonary disease (COPD), chronic bronchitis, or emphysema; and
• A 4-week trial of at least 1 LABA and a 4-week trial of 1 LAMA within the past 90 days; or
• A documented adverse effect, drug interaction, or contraindication to all available Tier-1 products; or
• A clinical exception may apply for members who are unable to effectively use hand-actuated devices, such as Spiriva^® HandiHaler^®, or who are stable on nebulized therapy.

Prior Authorization form

Long-Acting Beta2 Agonists (LABA) and Long-Acting Anticholinergics (LAMA)
Tier 1	Tier 2
Long-Acting Beta2 Agonists (LABA)
salmeterol inhalation powder (Serevent®)	arformoterol nebulizer solution Brovana®)  formoterol nebulizer solution (Perforomist®)  formoterol nebulizer solution kit olodaterol inhalation spray Striverdi® Respimat®)
Long-Acting Anticholinergics (LAMA)
aclidinium inhalation powder (Tudorza® PressAir®) tiotropium inhalation powder (Spiriva® HandiHaler®) – Brand Preferred tiotropium soft mist inhaler (Spiriva® Respimat®) umeclidinium inhalation powder (Incruse® Ellipta®)	revefenacin inhalation solution (Yupelri™)

*Combination agents that contain a Tier-1 ingredient qualify as Tier-1 agents.

Tier-1 medications do not require prior authorization.

Tier structure based on supplemental rebate participation and/or National Average Drug Acquisition Costs (NADAC), Wholesale Acquisition Costs (WAC), or State Maximum Allowable Costs (SMAC).

INHALED CORTICOSTEROIDS (ICS) and Combination products
Tier 1	Tier 2
beclomethasone dipropionate (QVAR® RediHaler®) budesonide (Pulmicort Flexhaler®) budesonide/formoterol (Symbicort®)β - Brand Preferred fluticasone furoate (Arnuity® Ellipta®) fluticasone/salmeterol (Advair®) mometasone furoate/formoterol (Dulera®)◊ mometasone furoate (Asmanex®)¥	budesonide/formoterol (Symbicort Aerosphere®) ciclesonide (Alvesco®) fluticasone propionate (Flovent®) fluticasone furoate/vilanterol (Breo® Ellipta®) - Brand Preferred fluticasone propionate/salmeterol (AirDuo RespiClick®) mometasone furoate/formoterol 50mcg/5mcg (Dulera®)

Tier structure based on supplemental rebate participation and/or National Average Drug Acquisition Costs (NADAC), Wholesale Acquisition Costs (WAC), or State Maximum Allowable Costs (SMAC).

*Unique criteria apply to each Tier-2 product.

βDoes not include Breyna™; authorization of Breyna™ requires a reason why the member cannot use the brand formulation (Symbicort®).

◊Includes all strengths other than Dulera® 50mcg/5mcg.

Inhaled Corticosteroids (ICS) and Combination Products Tier-1 Approval Criteria:

• Tier-1 products indicated for the member’s age are covered with no prior authorization required; or
• Tier-1 products will be approved for members younger than the FDA approved age range if prescribed by a pulmonologist, immunologist, or an allergist (or a mid-level practitioner supervised by a pulmonologist, immunologist, or an allergist).

Alvesco^® (Ciclesonide) and Fluticasone Propionate (Generic Flovent^®) Approval Criteria:  

• An FDA approved diagnosis of asthma; and
• A trial of all available Tier-1 inhaled corticosteroids appropriate to the members' age or a patient-specific, clinically significant reason why they are not appropriate for the member must be provided.

AirDuo RespiClick^® (Fluticasone Propionate/Salmeterol) Approval Criteria:

• An FDA approved diagnosis of asthma; and
• Member must be at or above the minimum age indicated; and
• Failure of Advair^®, Dulera^®, and Symbicort^® or a reason why Advair^®, Dulera^®, and Symbicort^® are not appropriate for the member; and
• Member must have used an inhaled corticosteroid for at least 1 month immediately prior; and
• Member must be considered uncontrolled by provider [required rescue medication >2 days a week (not for prevention of exercise induced bronchospasms) and/or needed oral systemic corticosteroids]; or
• A clinical situation warranting initiation with combination therapy due to severity of asthma.

Airsupra^® (Albuterol/Budesonide) Approval Criteria:

• An FDA approved diagnosis of asthma; and
• Member must be 18 years of age or older; and
• A patient-specific, clinically significant reason why the member cannot use specific individual ICS and short-acting beta₂ agonist (SABA) components; and
• Initial approvals will be for the duration of 3 months. For continued consideration, prescriber must verify the member has had a positive clinical response to therapy; and
• Subsequent approvals will be for the duration of 1 year. 

Breo^® Ellipta^® (Fluticasone Furoate/Vilanterol) Approval Criteria:

• An FDA approved diagnosis of chronic obstructive pulmonary disease (COPD) or chronic bronchitis and/or emphysema associated with COPD; and
  • For a diagnosis of COPD or chronic bronchitis and/or emphysema associated with COPD, trials of Advair^® and Symbicort^®, consisting of at least 30 days each within the last 90 days that did not adequately control COPD symptoms; or
• An FDA approved diagnosis of asthma in members 5 years of age and older; and
  • For a diagnosis of asthma, trials of Advair^®, Dulera^®, and Symbicort^® consisting of at least 30 days each within the last 120 days that did not adequately control asthma symptoms; and
  • Requests for generic fluticasone furoate/vilanterol will require a patient-specific, clinically significant reason why brand name Breo^® Ellipta^® cannot be used.

Breyna™ (Budesonide/Formoterol Fumarate) Approval Criteria:

• A patient-specific, clinically significant reason why the member cannot use brand name Symbicort^® must be provided (brand formulation is preferred and does not require a prior authorization).

Daliresp® (Roflumilast) Approval Criteria:

• An FDA approved diagnosis of chronic obstructive pulmonary disease (COPD) with history of chronic bronchitis; and
• Forced expiratory volume (FEV) ≤50% of predicted; and
• Member is inadequately controlled on long-acting bronchodilator therapy (must have 3 or more claims for long-acting bronchodilators in the previous 6 months)

Dulera^® (Mometasone Furoate/Formoterol) 50mcg/5mcg Approval Criteria:

• An FDA approved diagnosis of asthma; and
• Member must be between 5 and 11 years of age; and
• Failure of Advair^® and Symbicort^® or a reason why Advair^® and Symbicort^® are not appropriate for the member must be provided; and
• Member must have used an inhaled corticosteroid for at least 1 month immediately prior; and
• Member must be considered uncontrolled by provider [required rescue medication >2 days a week (not for prevention of exercise induced bronchospasms) and/or needed oral systemic corticosteroids]; or
• A clinical situation warranting initiation with combination therapy due to severity of asthma.

Anoro^® Ellipta^® (Umeclidinium/Vilanterol), Bevespi Aerosphere^® (Glycopyrrolate/Formoterol Fumarate), Duaklir^® Pressair^® (Aclidinium Bromide/Formoterol Fumarate), and Stiolto^® Respimat^® (Tiotropium/Olodaterol) 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 must be provided.

Breztri Aerosphere™ (Budesonide/Glycopyrrolate/Formoterol) and Trelegy Ellipta (Fluticasone Furoate/Umeclidinium/Vilanterol) Approval Criteria:

• An FDA approved diagnosis; and
• Member must be 18 years of age or older; and
• A 4-week trial of at least 1 long-acting beta₂ agonist (LABA) and a 4-week trial of 1 long-acting muscarinic antagonist (LAMA) within the past 90 days used concomitantly with an inhaled corticosteroid (ICS); and
• A patient-specific, clinically significant reason why the member requires the triple combination therapy in place of the individual components or use of a LABA/ICS combination with a LAMA must be provided.

Ohtuvayre™ (Ensifentrine) Approval Criteria:

• An FDA approved diagnosis of chronic obstructive pulmonary disease (COPD); and
• Member must be 18 years of age or older; and
• Member has moderate to severe disease [i.e., GOLD 2 or GOLD 3 airflow obstruction as demonstrated by forced expiratory volume in 1 second (FEV1) ≥30% and <80% predicted] and is symptomatic [i.e., modified Medical Research Council (mMRC) dyspnea scale grade ≥2]; and
• Member is inadequately controlled on dual or triple combination long-acting bronchodilator therapy (must have ≥3 claims for long-acting bronchodilators in the previous 6 months); and
• Member must not be taking Daliresp® (roflumilast) concurrently with Ohtuvayre™; and
• A quantity limit of 60 ampules (150mL) per 30 days will apply.

Xopenex^® (Levalbuterol) Nebulizer Solution Approval Criteria:

• A free-floating 90 days of therapy per 365 days will be in place.
• Use of this product in excess of 90 days of therapy in a 365-day period will require a patient-specific, clinically significant reason why the member is unable to use a preferred controller and reliever treatment option [e.g., combination inhaled corticosteroid (ICS) and formoterol or ICS and short-acting beta₂ agonist (SABA)] appropriate to the member’s age as recommended in the Global Initiative for Asthma (GINA) guidelines; and
• A patient-specific, clinically significant reason why the member cannot use a metered-dose inhaler (MDI) must be provided; and
• Clinical exceptions will be made for members with chronic obstructive pulmonary disease (COPD); and
• A quantity limit of 288mL per 30 days will apply.

PRIOR AUTHORIZATION FORM

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

Dupixent^® (Dupilumab injection) Approval Criteria [Chronic Obstructive Pulmonary Disease (COPD) Diagnosis]:

• An FDA approved indication for add-on maintenance treatment of members with inadequately controlled COPD; and
• Member must be 18 years of age or older; and
• Member has moderate to severe disease [i.e., GOLD 2 or GOLD 3 airflow obstruction as demonstrated by forced expiratory volume in 1 second (FEV₁) ≥30% and <80% predicted] and is symptomatic [i.e., modified Medical Research Council (mMRC) dyspnea scale grade ≥2]; and
• Member must have a blood eosinophil count of ≥300 cells/mcL; and
• Member must have experienced ≥2 moderate exacerbations (e.g., required treatment with systemic corticosteroids and/or antibiotics) or ≥1 severe exacerbation (e.g., required hospitalization or 24-hour observation in emergency department) in the last 12 months; and
• Member is inadequately controlled on triple therapy combination [long-acting beta₂ agonist/long-acting muscarinic agonist/inhaled corticosteroid (LABA/LAMA/ICS)] used compliantly within the last 3-6 consecutive months, unless contraindicated; and
• Prescriber must verify the member has been counseled on proper administration and storage of Dupixent^®; and
• Dupixent^® must be prescribed by a pulmonologist or pulmonary specialist or the member must have been evaluated by a pulmonologist or pulmonary specialist within the last 12 months (or an advanced care practitioner with a supervising physician who is a 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 [Eosinophilic Phenotype Asthma or Oral Corticosteroid-Dependent 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 meet 1 of the following: 
  • 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); or
  • 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
• Member’s body surface area (BSA) of atopic dermatitis involvement must be provided and the member must have a documented BSA involvement of ≥10% (can apply to member’s current BSA or a historical value prior to treatment); and
• A patient-specific, clinically significant reason the member cannot use Adbry^® (tralokinumab-ldrm) must be provided; 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 for the duration of 1 year 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 12 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 defined as:
  • The presence of clinical symptoms of EoE ≥2 times per week (i.e., dysphagia, emesis, epigastric pain); and
  • Intraepithelial eosinophilia [≥15 eosinophils per high-power field (eos/hpf) in the esophagus]; and 
• Member must be 1 years of age or older and weigh ≥15kg; 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 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 for PN 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 [Eosinophilic Granulomatosis with Polyangiitis (EGPA) Diagnosis]:

• An FDA approved indication for the treatment of EGPA; and
• Member must be 18 years of age or older; and
• Member meets 1 of the following:
  • Member must have a past history of at least 1 confirmed EGPA relapse [requiring increase in oral corticosteroid (OCS) dose, initiation/increased dose of immunosuppressive therapy, or hospitalization] with in the past 12 months; or
  • Member must have refractory disease within the last 6 months following induction of standard treatment regimen administered compliantly for at least 3 months; and
• Diagnosis of granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA) will not be approved; and
• Failure to achieve remission despite corticosteroid therapy (oral prednisone equivalent equal to or greater than 7.5mg/day) for a minimum of 4 weeks duration; and
• Fasenra^® 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 for EGPA within the last 12 months (or an advanced care practitioner with a supervising physician who is an allergist, pulmonologist, pulmonary specialist, or rheumatologist); and
• For authorization of Fasenra^® in a health care facility, 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 for self-administration, 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
• A quantity limit of 1 prefilled syringe or prefilled autoinjector pen per 28 days will apply.
• 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 Fasenra^® as demonstrated by a Birmingham Vasculitis Activity Score (BVAS) of 0 (zero), fewer EGPA relapses from baseline, or a decrease in daily OCS dose regimen from baseline. 

Fasenra^® (Benralizumab Injection) Approval Criteria [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 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 (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® in a health care facility, 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 for self-administration, 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
• For members who require weight-based dosing, the member’s recent weight, taken within the last 3 weeks, must be provided on the prior authorization request in order to authorize the appropriate dose according to package labeling; 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.   

Fasenra PA

Singulair® (Montelukast) Approval Criteria:

• Montelukast tablets and chewable tablets are available without prior authorization.
• A prior authorization is required for the granual formulation of montelukast
  • Use of the granule formulation requires a patient-significant, clinically significant reason why the member cannot use montelukast tablets or chewable tablets.

Zyflo® and Zyflo CR® (Zileuton) Approval Criteria:

• An FDA approved diagnosis of mild or moderate persistent asthma; and
• Member must be 12 years of age or and older; and
• Member must meet the following trial requirements:
  • A trial of an inhaled corticosteroid (ICS) and ICS/long-acting beta₂ agonist (LAB2A) therapy within the previous 6 months, and the reason for trial failure must be provided; and
  • A recent trial with at least one 1 other available leukotriene modifier that did not yield adequate response. 

Prior Authorization form  

Nasal Allergy Medications Tier-2 Approval Criteria:

• Member must have failure with all tier 1 medications defined as no beneficial response after at least three weeks use at the maximum recommended dose; or
• Documented adverse effect or contraindication to all Tier-1 medications; and
• For members 2 to 4 years of age, the age-appropriate, lower-tiered generic medications must be tried prior to the approval of higher-tiered medications; and
• Approvals will be for the duration of 3 months, except for members with chronic diseases such as asthma or chronic obstructive pulmonary disease (COPD), in which case authorizations will be for the duration of 1 year.

Nasal Allergy Medications Tier-3 Approval Criteria:

• All Tier 2 criteria must be met; and
• Failure with all available tier 2 products defined as no beneficial response after at least three weeks use at the maximum recommended dose; or
• Documented adverse effect or contraindication to all Tier-2 medications; and
• For members 2 to 4 years of age, the age-appropriate, lower-tiered generic medications must be tried prior to the approval of higher-tiered medications; and
• Approvals will be for the duration of 3 months, except for members with chronic diseases such as asthma or COPD, in which case authorizations will be for the duration of 1 year.

Xhance™ (Fluticasone Propionate Nasal Spray) Approval Criteria:   

• An FDA approved diagnosis; 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.   

Sinuva^® (Mometasone Furoate Sinus Implant) Approval Criteria:

• An FDA approved indication of chronic rhinosinusitis with nasal polyps in adults 18 years of age and older who have had ethmoid sinus surgery; and
• Date of ethmoid sinus surgery must be provided; and
• Sinuva^® must be prescribed and implanted by a physician specializing in otolaryngology; and
• Failure of intranasal corticosteroids after at least a 3-month trial at the maximum recommended dose in combination with a 14-day trial of oral corticosteroids within the last 6 months (if not contraindicated); and
• Prescriber must confirm the member has recurrent nasal obstruction/ congestion symptoms and recurrent bilateral sinusitis or chronic sinusitis due to nasal polyps; and
• A quantity limit of 2 implants per member will apply. 

 Prior Authorization form

TIER 1	TIER 2	TIER 3
azelastine (Astelin®) ciclesonide (Omnaris®, Zetonna®) fluticasone (Flonase®)	azelastine (Astepro®) mometasone (Nasonex®) olopatadine (Patanase®)	azelastine/fluticasone (Dymista®) beclomethasone (Qnasl® 80mcg, 40mcg)  flunisolide (Nasalide®, Nasarel®) fluticasone (Xhance™) olopatadine/mometasone (Ryaltris™)

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 must be 18 years of age or older; 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 for EGPA 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® in a health care facility, 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 for self-administration, 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® in a health care facility, 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 for self-administration, 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.  

Nucala® (Mepolizumab Injection) Approval Criteria [Hypereosinophilic Syndrome (HES) Diagnosis]:

• 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/increased 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^® in a health care facility, 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 for self-administration, 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.

Nucala (Mepolizumab Injection) Approval Criteria [Chronic Rhinosinusitis with Nasal Polyposis (CRSwNP) Diagnosis]:

• An FDA approved indication for add-on maintenance treatment in adult members 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
• Nucala 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
• For authorization of Nucala in a health care facility, 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 for self-administration, 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
• Requests for concurrent use of Nucala 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 1 vial, prefilled autoinjector, or prefilled syringe per 28 days will apply.

Prior Authorization Form - Nucala

• 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
• Members who are stabilized inpatient and who have a PAH diagnosis will be approved for continuation of therapy; and
• A quantity limit of 60 tablets per 30 days will apply.

• An FDA approved diagnosis of pulmonary arterial hypertension (PAH) 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 or have a contraindication to use of all alternatives:
    • 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
• Members who are stabilized inpatient and who have a PAH or CTEPH diagnosis will be approved for continuation of therapy; and
• A quantity limit of 90 tablets per 30 days will apply.

Liqrev^® (Sildenafil Suspension) Approval Criteria:

• An FDA approved diagnosis of pulmonary arterial hypertension (PAH); and
• Member must be 18 years of age or older; and
• Medical supervision by a pulmonary specialist or cardiologist; and
• A patient-specific, clinically significant reason why the member cannot use generic sildenafil 20mg oral tablets, even when tablets are crushed, must be provided; and
• A patient-specific, clinically significant reason why the member cannot use generic sildenafil oral suspension (generic Revatio^®) must be provided. 

• 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 or have a contraindication to use of all alternatives:
  • Revatio^® (sildenafil) or Adcirca^® (tadalafil); and
  • Letairis^® (ambrisentan) or Tracleer^® (bosentan); and
• Medical supervision by a pulmonary specialist or cardiologist; and
• Requests for Opsynvi^® will also require a patient-specific, clinically significant reason why the member cannot use Opsumit^® in combination with generic sildenafil or tadalafil; and 
• Female members and all health care professionals (prescribers and dispensing pharmacies) must be enrolled in the Opsumit^® REMS program or the Macitentan-Containing Products REMS program; and
• A quantity limit of 30 tablets per 30 days will apply.

Tadliq^® (Tadalafil Oral Suspension) Approval Criteria:

• An FDA approved diagnosis of pulmonary arterial hypertension (PAH); 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. 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 cannot use generic tadalafil 20mg oral tablets, even when the tablets are crushed; and
• Members who are stabilized inpatient and who have a PAH diagnosis will be approved for continuation of therapy; and
• A quantity limit of 300mL per 30 days (2 bottles) will apply. 

• An FDA approved diagnosis of pulmonary arterial hypertension (PAH); and
• Member must have previous failed trials of at least 1 medication in each of the following categories or have a contraindication to use of all alternatives:
  • Revatio^® (sildenafil) or Adcirca^® (tadalafil); and
  • Letairis^® (ambrisentan) or Tracleer^® (bosentan); and
• Medical supervision by a pulmonary specialist or cardiologist; and
• Members who are stabilized inpatient and who have a PAH diagnosis will be approved for continuation of therapy; 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 90 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.

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 or have a contraindication to use of all alternatives:
    • 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 (PAH); 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) or have a contraindication to use of all alternatives:
  • Revatio^® (sildenafil), Adcirca^® (tadalafil), or Adempas^® (riociguat); and
  • Letairis^® (ambrisentan) or Tracleer^® (bosentan); and
• Medical supervision by a pulmonary specialist and/or cardiologist; and
• Members who are stabilized inpatient and who have a PAH diagnosis will be approved for continuation of therapy; and
• A quantity limit of 2 tablets daily will apply for all strengths with an upper dose limit of 1,600mcg twice daily.

Winrevair™ (Sotatercept-csrk) Approval Criteria:

• An FDA approved diagnosis of pulmonary arterial hypertension (PAH); and
• Member must be 18 years of age or older; and
• Member is currently taking PAH medications from at least 2 of the following categories for ≥90 days or has a contraindication to use of all alternatives:
  • Phosphodiesterase-5 (PDE-5) inhibitor (e.g., sildenafil, tadalafil) or soluble guanylate cyclase stimulator (e.g., riociguat); or
  • Endothelin-receptor antagonist (e.g., ambrisentan, bosentan); or
  • Prostacyclin analogue or receptor agonist (e.g., epoprostenol, treprostinil); and
• Prescriber must verify that Winrevair™ will be used concurrently with member’s current PAH therapies; and
• Medical supervision by a pulmonary specialist and/or cardiologist; and
• Prescriber must confirm the member or caregiver has been trained by a health care professional on the preparation, subcutaneous (sub-Q) administration, and proper storage of Winrevair™; and
• Prescriber must agree to monitor hemoglobin and platelet counts prior to each dose for the first 5 doses and periodically thereafter; and
• Female members of reproductive potential must not be pregnant, must have a negative pregnancy test prior to initiation of therapy, and must agree to use effective contraception during therapy and for at least 4 months after the last dose; and
• The member’s recent weight must be provided on the prior authorization request in order to authorize the appropriate amount of drug required according to package labeling; and
• A quantity limit of 1 kit every 3 weeks will apply.
  • Members requiring (2) 45mg or (2) 60mg vials based on their body weight will not be approved for multiple 1-vial kits but should use the 2-vial kits to achieve the dose required. 

Ofev® (Nintedanib) Approval Criteria:

• An FDA approved indication of 1 of the following:
  • Treatment of idiopathic pulmonary fibrosis (IPF); or
  • Treatment of chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype; or
  • To slow the rate of decline in pulmonary function in members 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 consultation 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.

Esbriet® (Pirfenidone) 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 patient-specific, clinically significant reason why the member cannot use Ofev® (nintedanib) must be provided; 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 543mg and 801mg strength tablets.

Synagis^® (Palivizumab) Approval 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 through 19 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) and Enflonsia™ (clesrovimab-cfor) as recommended by the CDC, must be provided. Per AAP recommendations, palivizumab is not recommended for routine use. Additionally, the prescriber must confirm the member has not already received Beyfortus™ or Enflonsia™ for the current RSV season. Concomitant use with Beyfortus™ or Enflonsia™ 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™ and Enflonsia™.  

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^® in a health care facility, prescriber must verify that the injection will be administered by a health care provider prepared to manage anaphylaxis; or
• For authorization of Tezspire^® pre-filled pen for self-administration, 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

 

Xolair^® (Omalizumab) Approval Criteria [Immunoglobulin E (IgE)-Mediated Food Allergy Diagnosis]:

• An FDA approved diagnosis of IgE-mediated food allergy for the reduction of allergic reactions; and
• Member must be 1 year of age or older; and
• Member must have a diagnosis of peanut, milk, egg, wheat, cashew, hazelnut, or walnut allergy confirmed by a positive skin test, positive in vitro test for food-specific IgE, or positive clinician-supervised oral food challenge (documentation of allergy testing results must be submitted); and
• Prescriber must confirm member will use Xolair^® with an allergen-avoidant diet; and
• Member must have a pretreatment serum IgE level between 30 and 1,850 IU/mL; and
• Member’s weight must be between 10kg and 150kg; and
• Member or family member 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
• Prescribed Xolair^® dose must be an FDA approved regimen per package labeling; and
• For authorization of Xolair^® in a health care facility, 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 Xolair^® prefilled autoinjector or prefilled syringe for self-administration, 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 or immunologist or the member must have been evaluated by an allergist or immunologist within the last 12 months (or an advanced care practitioner with a supervising physician who is an allergist or immunologist); and
• Approvals will be for the duration of 1 year. Reauthorization may be granted if the prescriber documents the member is responding well to therapy. Additionally, compliance will be evaluated for continued approval. 

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® in a health care facility, prescriber must verify the injection will be administered in a healthcare setting by a healthcare professional prepared to manage anaphylaxis; or
• For authorization of Xolair^® prefilled autoinjector or prefilled syringe for self-administration, 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 package labeling; and
• For authorization of Xolair^® in a health care facility, 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 Xolair^® prefilled autoinjector or prefilled syringe for self-administration, 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]:

• An FDA approved diagnosis of CIU; and
• Member must be 12 years of age or older; 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^® in a health care facility, 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 Xolair^® prefilled autoinjector or prefilled syringe for self-administration, 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, or dermatologist (or an advanced care practitioner with a supervising physician that is an allergist, immunologist, or dermatologist); and
• A trial of a second generation antihistamine dosed at 4 times the maximum FDA dose within the last 3 months for at least 4 weeks (or less if symptoms are intolerable); and
• Initial dosing will only be approved for 150mg every 4 weeks. If the member has 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 at which time compliance will be evaluated for continued approval. 

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