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Medication Coverage Policy MEDICATION COVERAGE POLICY PHARMACY AND THERAPEUTICS ADVISORY COMMITTEE POLICY: Asthma/COPD P&T DATE 2/11/2020 CLASS: Respiratory Disorders REVIEW HISTORY 2/19, 12/17,12/16, 5/15, LOB: Medi-Cal (MONTH/YEAR) 9/14, 2/13, 5/12 This policy has been developed through review of medical literature, consideration of medical necessity, generally accepted medical practice standards, and approved by the HPSJ Pharmacy and Therapeutic Advisory Committee OVERVIEW Asthma is a reversible, chronic, inflammatory disorder that involves narrowing of the respiratory airways leading to wheezing, chest tightness, and shortness of breath. Inhaled corticosteroids are the mainstay of therapy and the goal of treatment is to reverse airway obstruction and maintain respiratory control. Chronic obstructive pulmonary disease (COPD) is another chronic airway disorder. Unlike asthma, COPD is not reversible. The goal of COPD management is to slow disease progression. COPD is managed with a combination of inhaled corticosteroids and anticholinergics. Some patients exhibit both features of asthma and COPD; this is called Asthma-COPD Overlap Syndrome (ACOS). The below criteria, limits, and requirements for asthma & COPD agents are in place to ensure appropriate use and to help members achieve control of their Asthma or COPD. Table 1: Available Asthma/COPD Medications (Current as of 1/2020) Avg Cost Generic Name Strength & Formulary per 30 Notes/Restriction Language (Brand Name) Dosage form Limits days Single Agents Short Acting Beta Agonist (SABA) Limit 2 inhalers per 30 days; Limit 7 inhalers per 180 days. Albuterol 90 mcg/act QL $53.28 Overuse of Short Acting Bronchodilators may indicate poor Asthma/COPD control. Albuterol ProAir: (ProAir HFA, $97.40 Proventil HFA, Proventil: ProAir Digihaler (108 90 mcg/act NF Non-Formulary: Alternative is Ventolin $157.33 mcg/act), ProAir Respiclick Respiclick, Ventolin $61.91 HFA) Non-Formulary: Alternatives are Albuterol Syrup 2 mg/5 mL Syrup NF -- Ventolin, Albuterol nebulizer solution Albuterol Sulfate IR, 2 mg, 4 mg IR Tablet -- Non-Formulary: Alternatives are ER Tablets NF 4 mg, 8 mg ER Tablet Ventolin, Albuterol nebulizer solution (Vospire ER) Ephedrine/ Guaifenesin Tablets 12.5/200 mg Tablets NF -- (Primatene Asthma) .Limit 2 inhalers per 30 days; Limit 7 inhalers per 180 days. 45 mcg/act QL $56.57 Overuse of Short Acting Bronchodilators Levalbuterol may indicate poor Asthma/COPD (Xopenex HFA) control. Xopenex HFA NF $69.75 10 mg/5 mL Syrup, Metaproterenol NF -- 10 mg, 20 mg Tablet Coverage Policy – Respiratory Disorders – Asthma & COPD Page 1 Short Acting Anticholinergic (SAMA) Limit 2 packages per 30 days. 17 mcg/act Overuse of Short Acting Bronchodilators QL $11.01 Ipratropium may indicate poor Asthma/COPD (Atrovent HFA) control. Atrovent HFA NF $397.05 Long Acting Beta Agonist (LABA) Salmeterol Xinafoate Non-Formulary: Alternative is Striverdi 50 mcg/act NF $395.03 (Serevent Diskus) Respimat For Asthma: Concurrent use of ICS is required. Formoterol Fumarate 12 mcg Inhalation PA; ST; QL -- For COPD: Restricted to COPD Grade II (Foradil) Capsule or worse, group B or worse Limit 1 package per 30 days. Indacaterol Maleate Non-Formulary: Alternative is Striverdi 75 mcg/act NF -- (Arcapta Neohaler) Respimat For Asthma: Concurrent use of ICS is Olodaterol required. Hydrochloride 2.5 mcg/act PA; ST; QL $216.07 For COPD: Restricted to COPD Grade II (Striverdi Respimat) or worse, group B or worse Limit 1 package per 30 days. Long Acting Anticholinergic (LAMA) Handihaler: Handihaler 18 mcg Inhalation Documentation of diagnosis of COPD Tiotropium Bromide PA; QL $437.05 Capsule GOLD Group B is required for approval. (Spiriva) (Respimat) Respimat: Respimat: Respimat: Limit 1 package per 30 days. $437.41 2.5 mcg/act Step therapy to Montelukast AND one of the following: Tiotropium Bromide Symbicort (160 mcg/4.5 mcg), 1.25mcg/act ST $437.49 (Spiriva Respimat) AirDuo(232 mcg/14 mcg), OR Dulera (200 mcg/5 mcg) within the last 30 days. Documentation of diagnosis of COPD Aclidinium Bromide 400 mcg/act PA; QL $406.01 GOLD Group B is required for approval. (Tudorza Pressair) Limit 1 package per 30 days. Seebri Neohaler 15.6mcg NF -- -- (glycopyrrolate) Umeclidinium Non-Formulary: Alternatives are Spiriva Bromide (Incruse 62.5 mcg/act NF $340.46 Handihaler, Spiriva Respimat 2.5 mcg, Ellipta) Tudorza Inhaled Corticosteroid (ICS) Beclomethasone 40 mcg/act dipropionate (Qvar QL $244.54 Limit 1 package per 30 days 80 mcg/act Redihaler) Non-Formulary: Alternatives are Budesonide Flovent HFA 44 mcg, Flovent Diskus 90 mcg/act NF $329.86 (Pulmicort Flexhaler) 50 mcg, Asmanex Twisthaler 110 mcg, Qvar 40 mcg Budesonide 180 mcg/act QL $466.58 Limit 1 package per 30 days (Pulmicort Flexhaler) Non-Formulary: Alternatives are Ciclesonide 80 mcg/act Pulmicort Flexhaler, Asmanex NF -- (Alvesco) 160 mcg/act Twisthaler, Qvar, Flovent HFA/Diskus, Arnuity Ellipta Coverage Policy – Respiratory Disorders – Asthma & COPD Page 2 Non-Formulary: Alternatives are Flunisolide Pulmicort Flexhaler, Asmanex 80 mcg/act NF -- (Aerospan) Twisthaler, Qvar, Flovent HFA/Diskus Fluticasone furoate 100 mcg/act Restricted to patients 12 years and AL; QL $403.77 (Arnuity Ellipta) 200 mcg/act older. Limit 1 device per 30 days. Diskus: 50 mcg/act 100 mcg/act Diskus: Fluticasone propionate 250 mcg/act $406.71 Limit 1 package per 30 days QL (Flovent HFA/Diskus) HFA: HFA: 44 mcg/act $546.61 110 mcg/act 220 mcg/act 55 mcg Fluticasone propionate 113 mcg NF -- Limit 1 package per 30 days (ArmonAir Respiclick) 232 mcg 110 mcg/act (30 Limit 1 package per 30 days. Mometasone furoate doses) AL (110 $467.07 110 mcg: Restricted to patients (Asmanex Twisthaler) 220 mcg/act (30, 60, mcg); QL under the age of 12. or 120 doses) Non-Formulary: Alternatives are Mometasone furoate 100 mcg/act Pulmicort Flexhaler, Asmanex NF -- (Asmanex HFA) 200 mcg/act Twisthaler, Qvar, Flovent HFA/Diskus Combination Agents Short Acting Combination Ipratropium/Albuterol Limit 1 package per 30 days. Should 20 mcg/100 mcg QL $377.48 (Combivent Respimat) not be used with Tiotropium. Long Acting Combination Budesonide/ 80 mcg/4.5mcg Formoterol 160 mcg/4.5 mcg QL $311.00 Limit 1 package per 30 days (Symbicort) Respiclick: 55/14 mcg 113/14 mcg $83.66 232/14 mcg Fluticasone/ Diskus: QL Salmeterol 100 mcg/50 mcg Limit 1 package per 30 days (AirDuo Respiclick, 250 mcg/50 mcg Advair Diskus or HFA) 500 mcg/50 mcg Diskus: $711.87 HFA: HFA: 45 mcg/21mcg $401.38 115 mcg/21mcg 230 mcg/21 mcg Fluticasone/Vilanterol 100 mcg-25 mcg QL $671.20 Limit 1 package per 30 days. (Breo Ellipta) 200 mcg-25 mcg Aclidinium/Formoterol NF (Duklir) [1] Reserved for patients with COPD Fluticasone, GOLD grade 3 or 4 Group D with Umeclidinium, and 100 mcg/ 62.5 PA -- compliant use of ICS+LABA or Vilanterol mcg/25 mcg LABA+LAMA (Trelegy Ellipta) [2] Limit: 1 Inhaler per 30 days Coverage Policy – Respiratory Disorders – Asthma & COPD Page 3 Mometasone/ 100 mcg-5mcg QL $313.46 Limit 1 package per 30 days Formoterol 200 mcg-5mcg (Dulera) Tiotropium/ Otodaterol 2.5 mcg-2.5 mcg PA, QL $373.41 (Stiolto Respimat) Reserved for patients with at least B COPD confirmed by PFTs. Limit 1 Umeclidinium/ inhaler per 30 days. Vilanterol 62.5 mcg-25 mcg PA, QL -- (Anoro Ellipta) Glycopyrrolate/ Non-Formulary: Alternatives include Indacaterol 27.5 mcg-15.6 mcg NF -- AirDuo, Symbicort, Dulera, (Utibron Neohaler) Combivent, Stiolto Respimat Glycopyrrolate/ Non-Formulary: Alternatives include Formoterol 9 mcg-4.8 mcg NF -- AirDuo, Symbicort, Dulera, (Bevespi Aerosphere) Combivent, Stiolto Respimat Leukotriene Receptor Antagonist 4 mg, 5 mg Chewable Tablets Montelukast Sodium Tablet QL $5.55 Limit 30 tablets per 30 days (Singulair) 10 mg Tablet 4 mg Oral Granules NF $112.63 Non-Formulary: Alternative is Zafirlukast (Accolate) 10 mg, 20 mg Tablet NF $101.14 montelukast 5-Lipoxygenase Inhibitor Zileuton 600 mg Tablet NF $2,611.59 Indicated for Asthma only (Zyflo, Zyflo CR) 600 mg ER Tablet Xanthine/Phosphodiesterase Enzyme Inhibitor, Nonselective 80mg/15mL Oral Elixir/Solution 100 mg, 200 mg, 300 Theo-24: mg, ER Cap (Theo-24) $109.40 Theophylline 100 mg, 200 mg, 300 Narrow therapeutic window. Should (Theo-24, Elixophyllin, mg ER Tab -- Theophylli be reserved as last line therapy. Theochron) (Theochron, 12-hr) ER : 400 mg, 600 mg ER $43.29 Tab (24-hr) 450 mg ER Tab (Theochron, 12-hr) Non-Formulary: Alternative is Theophylline (Theo-24) 400 mg ER Cap NF -- theophylline 400 mg ER tablet 400 mg, 800 mg IV Theophylline NF -- Solution 25 mg/ml, 50 mg/ml Aminophylline NF -- injection PDE-4 Inhibitor [1] Reserved for patients with GOLD Grade 4, Group D [2] Limit: Daliresp 250 mcg #30 in Roflumilast 250 mcg, 500 mcg 365 days. Daliresp 500 mcg #30 per PA; ST $1,228.79 (Daliresp) Tablet 30 days. [3] Treatment failure or intolerant to high dose ICS plus LABA plus LAMA in the past 12 weeks. Coverage Policy – Respiratory Disorders – Asthma & COPD Page 4 Monoclonal Antibody, Anti-Asthmatic For Eosinophilic asthma: Reserved as an add on therapy for patients 12 years and older with moderate to severe asthma. For Oral corticosteroid dependent 200 mg/1.14 ml, Dupilumab (Dupixent) PA, ST, SP $2,918.36 asthma: 300 mg/2 ml syringe Reserved as an add on therapy for patients 12 years and older who are dependent on oral steroid See below for detailed information Reserved for inadequate asthma 75 mg/ 0.5 ml, Omalizumab (Xolair) PA $2,312.14 control or uncontrolled chronic 150 mg/ ml syringes idiopathic urticaria 100 mg Vial $2,921.43 Autoinjector 100 Reserved for patients ages 6 and -- Mepolizumab (Nucala) mg/ml PA, SP older with poorly controlled, severe Prefilled syringes 100 eosinophilic asthma -- mg/ml Reserved for patients with poorly Benralizumab 30mg Injection NF -- controlled, severe eosinophilic (Fasenra) asthma Reslizumab 100 mg/10 mL IV Indicated for Asthma only.
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