Inhaled Corticosteroids Drug Class Prior Authorization Protocol

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1 Inhaled Corticosteroids Drug Class Prior Authorization Protocol Line of Business: Medi-Cal P&T Approval Date: February 21, 2018 Effective Date: April 1, 2018 This policy has been developed through review of medical literature, consideration of medical necessity, generally accepted medical practice standards, and approved by the IEHP Pharmacy and Therapeutics Subcommittee. Drugs Requiring Prior Authorization Review: Aerospan (flunisolide), Advair Diskus, Advair HFA (fluticasone/salmeterol), Alvesco (ciclesonide), Arnuity Ellipta (fluticasone furoate), Asmanex (mometasone), Breo Ellipta (fluticasone/vilanterol), Dulera (mometasone/formoterol), Symbicort (budesonide/formoterol) Formulary Drugs: Airduo RespiClick (fluticasone/salmeterol), Flovent HFA, Flovent Diskus (fluticasone), Fluticasone propionate/salmeterol, Pulmicort Respules, Pulmicort Flexhaler (budesonide), Qvar (beclomethasone) Criteria: 1. Drug: Advair HFA (fluticasone/salmeterol), Dulera (mometasone/formoterol) a. Asthma Criteria: Must meet all of the following requirements: a. Ages 12 and older; b. Failure or clinically significant adverse effects to optimal and regular use of formulary Fluticasone propionate/salmeterol inhaler.

2 Reauthorization Criteria: Must meet all of the following requirements: 2. Drug: Advair Diskus (fluticasone/salmeterol) 100/50mcg, 250/50mcg a. Asthma Criteria: Must meet 1 of 2 requirements: a. Must meet all 2 requirements: 1) Ages 12 and older; 2) Failure or clinically significant adverse effects to optimal and regular use of formulary Fluticasone propionate/salmeterol inhaler or AirDuo. b. Must meet all 2 requirements: 1) Ages 4 to 11 years; 2) Failure or clinically significant adverse effects to optimal and regular use of two formulary inhaled corticosteroids (e.g. Asmanex, Qvar, Flovent). Reauthorization Criteria: Must meet all of the following requirements: a. COPD Criteria: Must meet the following requirement: a. Failure or clinically significant adverse effects to one formulary long acting bronchodilator: Incruse Ellipta, Stiolto Respimat, Tudorza or Serevent. Reauthorization Criteria: Must meet all of the following requirements:

3 3. Drug: Advair Diskus (fluticasone/salmeterol) 500/50mcg a. Asthma Criteria: Must meet all of the following requirements: a. Ages 12 and older; b. Failure or clinically significant adverse effects to optimal and regular use of formulary Fluticasone propionate/salmeterol inhaler. Reauthorization Criteria: Must meet all of the following requirements a. COPD Criteria: Must meet the following requirement: a. Failure or clinically significant adverse effects to one formulary long acting bronchodilator: Incruse Ellipta, Stiolto Respimat, Tudorza or Serevent. Reauthorization Criteria: Must meet all of the following requirements: 4. Breo Ellipta (fluticasone/vilanterol) a. Asthma Criteria: Must meet all 2 requirements: a. Ages 18 and older;

4 b. Failure or clinically significant adverse effects to optimal and regular use of formulary Fluticasone propionate/salmeterol inhaler. Reauthorization Criteria: Must meet all of the following requirements: a. COPD Criteria: Must meet the following requirement: a. Failure or clinically significant adverse effects to one formulary long acting bronchodilator: Incruse Ellipta, Stiolto Respimat, Tudorza or Serevent. Reauthorization Criteria: Must meet all of the following requirements: 5. Symbicort (budesonide/formoterol) a. Asthma Criteria: Must meet 1 of the 3 requirements: a. Must meet all 2 requirements: 1) Ages 5 to 11 years; 2) Failure or clinically significant adverse effects to optimal and regular use of two formulary inhaled corticosteroids (e.g. Asmanex, Qvar, Flovent). b. Must meet all 2 requirements 1) Ages 12 or older; 2) Failure or clinically significant adverse effects to optimal and regular use of formulary Fluticasone propionate/salmeterol inhaler or AirDuo. c. Must meet all 2 requirements 1) Ages 18 and older;

5 2) At least one asthma exacerbation in the last year (12 months). 3) Failure or clinically significant adverse effects to optimal and regular use of two formulary inhaled corticosteroids (e.g. Asmanex, Qvar, Flovent). Reauthorization Criteria: Must meet all of the following requirements: a. COPD Criteria: Must meet the following requirement: a. Failure or clinically significant adverse effects to one formulary long acting bronchodilator: Incruse Ellipta, Stiolto Respimat, Tudorza or Serevent. Reauthorization Criteria: Must meet all of the following requirements: 6. Alvesco (ciclesonide), Aerospan (flunisolide), Arnuity Ellipta (fluticasone furoate), Asmanex HFA (mometasone) a. Asthma Criteria: Must meet the following requirement: a. Failure or clinically significant adverse effects to adequate trial with two formulary inhaled corticosteroids (e.g. Qvar, Pulmicort Flexhaler, Asmanex).

6 Reauthorization Criteria: Must meet all of the following requirements:

7 Clinical Justification: 2011 Guidelines from the National Asthma Education and Prevention Program Expert Panel Report 3

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12 2018 Global Initiative for Chronic Obstructive Lung Disease Key points for inhalation of drugs Choice of inhaler device has to be individually tailored and will depend on access, cost, prescriber, and most importantly, patient s ability and preference It is essential to provide instructions and to demonstrate the proper inhalation technique when prescribing a device, to ensure that inhaler technique is adequate and re-check at each visit that patients continue to use their inhaler correctly Inhaler technique and adherence to therapy should be assessed before concluding that the current therapy requires modifications Key points for the use of bronchodilators LABAs and LAMAs are preferred over short acting agents except for patients with only occasional dyspnea Patients may be started on single long acting bronchodilator therapy or dual long acting bronchodilator therapy. In patients with persistent dyspnea on one bronchodilator treatment should be escalated to two. Inhaled bronchodilators are recommended over oral bronchodilators Theophylline os not recommended unless other long term treatment bronchodilators are unavailable to unaffordable Key points for the use of anti-inflammatory agents Long term monotherapy with ICS is not recommended Long term treatment with ICS may be considered in association with LABAs for patients with a history of exacerbations despite appropriate treatment with long acting bronchodilators Long term therapy with oral corticosteroids is not recommended In patients with exacerbations despite LABA/ICS or LABA/LAMA/ICS, chronic bronchitis and severe to very severe airflow obstruction, the addition of a PDE4 inhibitor can be considered In former smokers with exacerbations despite appropriate therapy, macrolides can be considered Statin therapy is not recommended to prevention of exacerbation Antioxidant mucolytics are recommended only in select patients Key points for the use of other pharmacological treatments Patients with severe hereditary alpha-1 antitrypsin deficiency and established emphysema may be candidates for alpha-1 antitrypsin augmentation therapy Antitussives cannot be recommended

13 Drugs approved for primary pulmonary hypertension are not recommended for patients with pulmonary hypertension secondary to COPD Low dose long acting oral and parenteral opioids may be considered for treating dyspnea in COPD patients with severe disease References: 1. Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease (Updated Global Initiative for Chronic Obstructive Lung Disease, Inc. 2. National Asthma Education and Prevention Program. Expert Panel Report 3:

14 Guidelines for the Diagnosis and Management of Asthma. Bethesda, MD. National Heart, Lung, and Blood Institute, Facts and Comparisons Formulary Monograph Service. Wolters Kluwer Health, St. Louis, MO. 4. Lasserson TJ, Cates CJ, Ferrara G, Casali L. Combination fluticasone and salmeterol versus fixed dose combination budesonide and formoterol for chronic asthma in adults and children. Cochrane Database Syst Rev 2008 Jul 16;(3):CD National Institutes for Health and Clinical Excellence (NICE). Inhaled corticosteroids for the treatment of chronic asthma in adults and children aged 12 years and over. March, Available at: 6. Oregon Drug Effectiveness Review Project. Drug class review. Controller Medications for Asthma. Portland, OR: Oregon Health and Sciences University; Global Initiative For Chronic Obstructive Lung Disease. Global Strategy for the Diagnosis, Management and Prevention of Chronic Obstructive Pulmonary Disease 2018 Report. Change Control Date Change 02/21/2018 Updated Symbicort criteria Updated to 2018 GOLD Guidance

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