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Medication Coverage Policy MEDICATION COVERAGE POLICY PHARMACY AND THERAPEUTICS ADVISORY COMMITTEE POLICY: Asthma/COPD P&T DATE 12/14/2016 CLASS: Respiratory Disorders REVIEW HISTORY 9/15, 5/15, 9/14, 2/13, LOB: Medi-Cal, SJHA (MONTH/YEAR) 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 9/2016) Average Therapeutic Generic Name Strength & Dosage Formulary Cost per Limits Notes/Restriction Language Class (Brand Name) form 30 days* Single Agents Limit 2 inhalers per 30 days; Limit 7 inhalers per 180 days. Albuterol (Ventolin 90 mcg/act QL $57.07 Overuse of Short Acting HFA) Bronchodilators may indicate poor Asthma/COPD control. ProAir: Albuterol (ProAir HFA, $55.81 Non-Formulary: Alternative is 90 mcg/act NF Proventil HFA) Proventil: Ventolin $96.71 Short Acting Non-Formulary: Alternatives are Beta Agonist Albuterol Syrup 2 mg/5 mL Syrup NF $10.13 Ventolin, Albuterol nebulizer (SABA) solution IR Tab: Non-Formulary: Alternatives are $462.55 Albuterol Sulfate 2 mg, 4 mg Tablet NF Ventolin, Albuterol nebulizer 4 mg, 8 mg ER Tablet ER Tab: solution $129.04 Reserved for treatment failure or intolerance of albuterol sulfate HFA. Levalbuterol (Xopenex 45 mcg/act PA $73.81 Overuse of Short Acting HFA) Bronchodilators may indicate poor Asthma/COPD control. Limit 2 packages per 30 days. Short Acting Ipratropium (Atrovent Overuse of Short Acting 17 mcg/act QL $284.24 Anticholinergic HFA) Bronchodilators may indicate poor Asthma/COPD control. Fluticasone Furoate 100 mcg/act Restricted to patients 12 years and AL; QL $172.65 (Arnuity Ellipta) 200 mcg/act older. Limit 1 device per 30 days. Diskus: Inhaled 50 mcg/act Corticosteroid 100 mcg/act Diskus: Fluticasone Propionate 250 mcg/act $171.34 (ICS) QL Limit 1 package per 30 days (Flovent HFA/Diskus) HFA: HFA: 44 mcg/act $201.70 110 mcg/act 220 mcg/act Coverage Policy – Respiratory Disorders – Asthma & COPD Page 1 Therapeutic Generic Name Strength & Dosage Formulary Average Notes/Restriction Language Class (Brand Name) form Limits Cost per 30 days* Limit 1 package per 30 days. Mometasone Furoate 110 mcg/act (30 doses) AL (110 220 mcg/act (30, 60, or $195.61 110 mcg: Restricted to patients (Asmanex Twisthaler) mcg); QL 120 doses) under the age of 12. Non-Formulary: Alternatives are Mometasone Furoate Pulmicort Flexhaler, Asmanex 100 mcg/act NF $233.30 (Asmanex HFA) 200 mcg/act Twisthaler, Qvar, Flovent HFA/Diskus Beclomethasone 40 mcg/act QL $178.76 Limit 1 package per 30 days Dipropionate (Qvar) 80 mcg/act Non-Formulary: Alternatives are Budesonide (Pulmicort Flovent HFA 44 mcg, Flovent Diskus 90 mcg/act NF $159.94 Flexhaler) 50 mcg, Asmanex Twisthaler 110 mcg, Qvar 40 mcg Budesonide (Pulmicort 180 mcg/act QL $192.23 Limit 1 package per 30 days Flexhaler) Non-Formulary: Alternatives are Pulmicort Flexhaler, Asmanex Flunisolide (Aerospan) 80 mcg/act NF $235.31 Twisthaler, Qvar, Flovent HFA/Diskus Non-Formulary: Alternatives are 80 mcg/act Pulmicort Flexhaler, Asmanex Ciclesonide (Alvesco) NF $186.62 160 mcg/act Twisthaler, Qvar, Flovent HFA/Diskus, Arnuity Ellipta Salmeterol Xinafoate Non-Formulary: Alternative is 50 mcg/act NF $314.79 (Serevent Diskus) Striverdi Respimat Formoterol Fumarate Concurrent use of ICS is required. 12 mcg Inhalation ST; QL $246.66 (Foradil) Capsule Limit 1 package per 30 days. Long Acting Indacaterol Maleate Non-Formulary: Alternative is Beta Agonist 75 mcg/act NF $256.33 (LABA) (Arcapta Neohaler) Striverdi Respimat Olodaterol Concurrent use of ICS is required. Hydrochloride 2.5 mcg/act ST; QL $201.79 Limit 1 package per month. (Striverdi Respimat) Documentation of diagnosis of Handihaler: Handihaler: GOLD Grade II COPD is required for Tiotropium Bromide 18 mcg Inhalation PA; QL $332.65 Capsule approval. Respimat: (Spiriva) Respimat: (Respimat) $340.95 Respimat: Limit 1 package per 30 2.5 mcg/act days. Step therapy to Montelukast AND one of the following: Symbicort (160 Tiotropium Bromide 1.25mcg/act ST $348.85 mcg/4.5 mcg), Advair (500 mcg/50 Long Acting (Spiriva Respimat) mcg), or Dulera (200 mcg/5 mcg) Anticholinergic within the last 30 days. Documentation of diagnosis of GOLD Aclidinium Bromide Grade II COPD is required for 400 mcg/act PA; QL $290.32 (Tudorza Pressair) approval. Limit 1 package per 30 days. Non-Formulary: Alternatives are Umeclidinium Bromide 62.5 mcg/act NF $327.30 Spiriva Handihaler, Spiriva Respimat (Incruse Ellipta) 2.5 mcg, Tudorza 4 mg Oral Granules Montelukast Sodium 4 mg, 5 mg Chewable Leukotriene QL $12.39 Limit 30 tablets per 30 days (Singulair) Tablet Receptor 10 mg Tablet Antagonist Non-Formulary: Alternative is Zafirlukast (Accolate) 10 mg, 20 mg Tablet NF $98.93 montelukast 5-Lipoxygenase Zileuton (Zyflo, Zyflo 600 mg Tablet NF $2,980.00 Indicated for Asthma only Inhibitor CR) 600 mg ER Tablet Coverage Policy – Respiratory Disorders – Asthma & COPD Page 2 Therapeutic Generic Name Strength & Dosage Formulary Average Notes/Restriction Language Class (Brand Name) form Limits Cost per 30 days* 80mg/15mL Oral Elixophyllin: Elixir/Solution $378.39 100 mg, 200 mg, 300 mg, Theo-24: ER Cap (Theo-24) $116.07 Theophylline (Theo- 100 mg, 200 mg, 300 mg Theochron: Narrow therapeutic window. Should Xanthine/Phos 24, Elixophyllin, ER Tab (Theochron, 12- -- $17.24 be reserved as last line therapy. phodiesterase Theochron) hr) 400 mg, 600 mg ER Tab 24-hr tabs Enzyme (400 mg, Inhibitor, (24-hr) 450 mg ER Tab 600 mg): Nonselective (Theochron, 12-hr) $42.57 Theophylline (Theo- Non-Formulary: Alternative is 400 mg ER Cap NF $131.51 24) theophylline 400 mg ER tablet Theophylline 400 mg, 800 mg IV NF $21.02 Solution Indicated for COPD only. Reserved for GOLD Grade III COPD PDE-4 Inhibitor Roflumilast (Daliresp) 500 mcg Tablet PA; ST $278.08 in patients compliant on ICS/LABA and Spiriva/Tudorza. Reserved for inadequate asthma Omalizumab (Xolair) 150 mg Vial PA $2,014.88 control or uncontrolled chronic idiopathic urticaria Monoclonal Reserved for patients with Antibody, Anti- Mepolizumab (Nucala) 100 mg Vial PA $3,090.00 poorly controlled, severe Asthmatic eosinophilic asthma 100 mg/10 mL IV $100.20 Indicated for Asthma only. Dose is Reslizumab (Cinqair) NF Solution per vial weight-dependent (3 mg/kg). Combination Agents Short Acting Ipratropium/Albuterol Limit 1 package per 30 days. Should 20 mcg-100 mcg QL $312.42 Combination (Combivent Respimat) not be used with Tiotropium. Budesonide/ 80 mcg-4.5mcg Formoterol 160 mcg-4.5 mcg QL $277.37 Limit 1 package per 30 days (Symbicort) Mometasone/ 100 mcg-5mcg QL $265.98 Limit 1 package per 30 days Formoterol (Dulera) 200 mcg-5mcg Diskus: 100 mcg-50 mcg Diskus: Fluticasone/ 250 mcg-50 mcg $337.11 Salmeterol (Advair 500 mcg-50 mcg QL Limit 1 package per 30 days HFA: HFA: Diskus or HFA) 45 mcg-21mcg $340.58 115 mcg-21mcg 230 mcg-21 mcg Non-Formulary: Alternatives include Fluticasone/Vilanterol 100 mcg-25 mcg NF $272.74 Advair, Symbicort, Dulera, Long Acting (Breo Ellipta) 200 mcg-25 mcg Combination Combivent Reserved for patients with at least Tiotropium/ Grade II (moderate) COPD Otodaterol (Stiolto 2.5 mcg-2.5 mcg PA; QL $318.49 confirmed by PFTs. Limit 1 inhaler Respimat) per 30 days. Umeclidinium/ Non-Formulary: Alternatives include Vilanterol (Anoro 62.5 mcg-25 mcg NF $378.82 Advair, Symbicort, Dulera, Ellipta) Combivent, Stiolto Respimat Glycopyrrolate/ Non-Formulary: Alternatives include Indacaterol (Utibron 27.5 mcg-15.6 mcg NF $357.37 Advair, Symbicort, Dulera, Neohaler) Combivent, Stiolto Respimat Glycopyrrolate/ Non-Formulary: Alternatives include Formoterol (Bevespi 9 mcg-4.8 mcg NF $378.82 Advair, Symbicort, Dulera, Aerosphere) Combivent, Stiolto Respimat Coverage Policy – Respiratory Disorders – Asthma & COPD Page 3 Therapeutic Generic Name Strength & Dosage Formulary Average Notes/Restriction Language Class (Brand Name) form Limits Cost per 30 days* Solution for Nebulization 0.63 mg/3 mL 1.25 mg/3 mL Albuterol Sulfate 2.5 mg/0.5 mL (0.083%) QL $19.85 Limit 375 mL per 30 days Short Acting 2.5 mg/3 mL Beta Agonist 5 mg/mL (0.5%) (SABA) 0.31 mg/3 mL Reserved for patients with Levalbuterol 0.63 mg/3 mL PA $292.60 intolerance/contraindication to Hydrochloride 1.25 mg/3 mL 1.25 mg/0.5 mL Albuterol Short Acting Ipratropium Bromide 0.02% Nebulization -- $15.16 Anticholinergic Solution Short Acting Ipratropium/ 0.5 mg-3 mg(2.5 mg QL $33.08 Limit 375 mL per 30 days Combination Albuterol (Duoneb) Base)/3 mL Inhaled 0.25 mg/2 mL Limit 120 mL per 30 days. Budesonide 0.5 mg/2 mL AL; QL $297.51 Corticosteroid 1 mg/2 mL Restricted to members ≤ 4 years old. Formoterol Fumarate Non-Formulary: Formulary Dihydrate 20 mcg/2 mL NF $666.42 Long Acting alternative is Serevent Diskus (Perforomist) Beta Agonist Arformoterol Non-Formulary: Formulary 15 mcg/2 ml NF $612.39 (Brovana) alternative is Serevent Diskus Mast Cell Cromolyn Sodium 20 mg/2 mL -- -- -- Stabilizer Medical Equipment Peak Air Peak Flow Meter QL $17.89 Limit 1 per lifetime Limit 1 per lifetime.
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