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Medication Coverage Policy MEDICATION COVERAGE POLICY PHARMACY AND THERAPEUTICS ADVISORY COMMITTEE POLICY: Allergy Medications LAST REVIEW: 2/12/2019 THERAPEUTIC CLASS: Rheumatologic/Immunologic REVIEW HISTORY: 9/17, 9/16, 5/15, LOB AFFECTED: MCL (MONTH/YEAR) 9/14 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 Many treatment modalities exist for the treatment of seasonal allergies. Each treatment modality has benefits and limitations depending on each patient’s specific symptomatology. While allergen avoidance is the first-line treatment, some conditions may be hard to avoid (e.g. seasonal allergies, vasomotor allergies) and may require treatment with pharmacologic agents. The below criteria, limits, and requirements for certain agents are in place to ensure appropriate use of those agents. Seasonal Allergy Medications Formulary Positioning: (Current as of 11/2018) Oral Agents Therapeutic Generic Name Available Fml Avg. Notes Class (Brand Name) Strengths Limits Cost/Rx IR: 4mg -- $0.91 Chlorpheniramine ER: 12mg -- $17.88 Tablet, ER Tablet, Syrup Syrup: 2mg/5ml -- -- Syrup: 2 mg/ml NF -- Clemastine Fumarate IR: 1.34mg NF -- Tablet, Syrup IR: 2.68mg -- $66.95 Cyproheptadine HCl IR: 4mg $18.84 -- Tablet, Syrup Syrup: 2mg/5ml $19.45 IR tab: 25mg $0.87 IR cap: 25 mg $0.51 Diphenhydramine HCl IR cap: 50mg $0.38 Capsule, Chew Tablet, Tablet, Chewable: 12.5mg -- -- ODT, Elixir, Oral Solution, ODT: 12.5mg -- Syrup, Vial Elixir: 12.5mg/5ml $1.08 Soln: 12.5mg/5ml $1.25 Syrup: 12.5mg/5ml -- IR: 10mg $4.64 Hydroxyzine HCl (Atarax) IR: 25 mg $3.63 -- Tablet, Syrup IR: 50 mg $13.53 Syrup: 10mg/5ml $9.59 Oral Hydroxyzine Pamoate IR: 25mg $3.97 IR: 50mg $7.15 Antihistamines (Vistaril) -- Capsule IR: 100mg $40.71 IR: 12.5mg $2.95 Promethazine HCl IR: 25mg $1.57 -- Tablet, Syrup IR: 50mg $5.82 Syrup: 6.25mg/5ml $3.42 IR tab: 5mg -- $1.19 IR tab: 10mg -- $1.79 Cetirizine HCl (Zyrtec) Soln: 1mg/ml (Rx) -- $4.80 Tablet, Oral Solution, Soln: 1 mg/ml (OTC) -- Soln: 5mg/5ml NF -- Chewable Tablet, ODT, Chew: 5mg NF -- Capsule Chew: 10mg NF -- ODT: 10mg NF -- IR cap: 10mg NF -- IR: 30mg NF -- PA $20.68 Reserved for treatment Fexofenadine (Allegra) IR: 60mg IR: 180mg PA $9.35 failure to Cetirizine and Tablet, ODT, Suspension ODT: 30mg PA $36.91 Loratadine. Susp: 30mg/5ml PA $17.90 IR: 10mg Loratadine (Claritin) -- $2.54 Soln: 5mg/5ml Coverage Policy – Rheumatology & Immunology – Seasonal Allergies Page 1 Tablet, Oral Solution, Chew: 5 mg -- $5.86 Chewable Tablet, ODT ODT: 10 mg NF -- NF -- IR: 5mg NF $13.50* Desloratadine (Clarinex) Syrup: 0.5 mg/ml NF -- Tablet, Syrup, ODT ODT: 2.5mg NF -- ODT: 5 mg NF -- Levocetirizine (Xyzal) IR: 5mg NF $8.28 Tablet, Solution Soln: 2.5mg/5ml NF -- Phenylephrine/ Promethazine 6.25-5mg/5ml -- $21.52 Syrup Phenylephrine/ Brompheniramine 2.5-1mg/5ml -- $2.16 Oral Solution Phenylephrine/ Drops: 3.5-1mg/5ml Chlorpheniramine -- -- Syrup: 15-1mg/5ml Oral Drops, Syrup Pseudoephedrine/ Brompheniramine 15-1mg/5ml -- $4.06 Oral Solution Oral Antihistamine Pseudoephedrine/ IR: 2.5mg-60mg $4.11 & Decongestant Triprolidine -- Syrup: 1.25-30mg/5ml -- Combinations Tablet, Syrup Pseudoephedrine/ Cetirizine 5mg-120mg -- $17.16 ER Tablet Pseudoephedrine/ Reserved for treatment 60mg-120mg -- Fexofenadine PA failure to Cetirizine and 180mg-240mg -- ER Tablet Loratadine. Pseudoephedrine/ 5mg-120mg $14.83 Loratadine -- 10mg-240mg $6.93 ER Tablet Pseudoephedrine/ $361.44 Desloratadine 2.5mg-120mg NF * ER Tablet $4.35 Montelukast IR: 10mg Chew: 4mg QL $5.59 Limit 1 per day Leukotriene Tablet, Chewable Tablet Chew: 5mg $6.71 Receptor Formulary alternative = Antagonists Montelukast Granules: 4mg NF $112.63 Montelukast tablets, Granules chewable tablets Therapeutic Generic Name Available Fml Avg Notes/Restriction Class (Brand Name) Strengths Limits Cost/Rx Language Nasal Agents Azelastine HCl (Astelin) 137mcg (0.1%) ST $24.95 Nasal 205.5mcg Formulary alternative = Azelastine HCl (Astepro) NF $42.00* Antihistamine (0.15%) Azelastine 137 mcg (0.1%) Olopatadine (Patanase) 665 mcg (0.6%) NF $183.91 Solution Step therapy to an adequate trial (7-14 days) of any 2 (two) first-line Flunisolide 25mcg ST $55.74 Nasal agents (fluticasone, Corticosteroids budesonide, triamcinolone). Fluticasone propionate 50mcg (Rx) -- $11.47 (Flonase) Coverage Policy – Rheumatology & Immunology – Seasonal Allergies Page 2 Fluticasone propionate 50mcg (OTC) -- $9.39 (Flonase) Fluticasone furoate 27.5mcg NF $15.47* (Flonase Sensimist) Triamcinolone (Nasacort) 55mcg (OTC) -- $12.55 Beclomethasone (Beconase Formulary alternative = 42mcg NF $352.03* AQ) Qnasl Formulary alternatives = Beclomethasone (Qnasl) 40 mcg NF $251.62* Flonase, Nasacort, Rhinocort Allergy Step therapy to an adequate trial (7-14 days) of any 2 (two) first-line Beclomethasone (Qnasl) 80mcg ST $207.99 agents (fluticasone, budesonide, triamcinolone) AND flunisolide. Budesonide (Rhinocort 32mcg -- $6.00 Allergy) Ciclesonide (Omnaris, Solution: 37 mcg NF $262.45* Zetonna) Aerosol Solution, Susp: 50 mcg NF $336.55* Suspension Step therapy to an adequate trial (7-14 days) of any 2 (two) first-line Mometasone (Nasonex) 50mcg ST $160.81 agents (fluticasone, budesonide, triamcinolone) AND flunisolide. Oxymetazoline HCl (Afrin) 0.05% -- $1.66 Nasal Drops: 0.125% $3.07 Drops: 1% $3.78 Vasoconstrictors Phenylephrine HCl Spray: 0.25% -- $3.23 Nasal Drops, Nasal Spray Spray: 0.5% $3.95 Spray: 1% $1.66 Spray: 137mcg- Azelastine HCl/fluticasone 50mcg (0.1%- $214.43* Formulary alternative = Combination propionate (Dymista, 0.037%) Kit: 137mcg-50mcg NF Astelin + Flonase nasal Nasal Sprays Ticalast) Nasal Spray, Nasal $4,789.43* (0.1%-0.037%) + sprays as separate agents Kit sterile saline wash (0.9%) Cromolyn Sodium 5.2 mg (4%) -- $6.00 (Nasalcrom) Spray Ipratropium (Atrovent) 21 mcg (0.03%) $29.73 Other NF Solution 42 mcg (0.06%) $29.73 Sodium Chloride (Ocean 0.65% NF $0.78 Nasal) Spray Injectable Agents Epinephrine HCl 1:1,000 (0.1%) -- -- (Adrenaline) Ampule Epinephrine (Generic 0.3mg/0.3ml -- $250.14 epinephrine) 0.15mg/0.3ml -- $261.08 Epinephrine Auto-Injector Epinephrine (Epipen 2-Pak, 0.3mg/0.3ml $620.78 Epipen Jr 2-Pak) NF 0.15mg/0.3ml $621.80 Auto-Injector Coverage Policy – Rheumatology & Immunology – Seasonal Allergies Page 3 Diphenhydramine Diphenhydramine HCl Vial 50mg/ml NF $2.24 PA = Prior Authorization; QL = Quantity Limit; NF = Non-Formulary; AL = Age Limit; QL = Quantity Limit Clinical Justification: Allergen avoidance should be recommended to all patients. Take steps to reduce poor air quality in the home and make strides to eliminate the offending allergen. During allergy season, time outdoors should be limited. Patients should close windows, wash bedding frequently, and use vacuum cleaners with HEPA filters. Oral allergy medications can provide symptom relief for the broadest range of allergy symptoms (rhinitis, conjunctivitis, itching). 2nd generation antihistamines are less sedating than first generation antihistamines and all 2nd generation oral antihistamines have approximately the same level of efficacy and work quickly. Intranasal corticosteroids also all have approximately the same level of efficacy. These medications may take up to a week or more to control symptoms, but are effective for a broad range of symptoms when used regularly. Please refer to Table 1 for age-specific restrictions for each agent. Ocular antihistamines are a good target for patients with conjunctivitis not controlled by an oral antihistamine alone. Ketotifen is dosed less frequently than Visine-A, and may be a more convenient option for patients. EVALUATION CRITERIA FOR APPROVAL/EXCEPTION CONSIDERATION Below are the coverage criteria and required information for each agent. These coverage criteria have been reviewed approved by the HPSJ Pharmacy & Therapeutics (P&T) Advisory Committee. For conditions not covered under this Coverage Policy, HPSJ will make the determination based on Medical Necessity as described in HPSJ Medical Review Guidelines (UM06). 1st Generation Oral Antihistamines Benadryl (Diphenhydramine), Periactin (Cyproheptadine), Chlor-Trimeton (Chlorpheniramine), Tavist (Clemastine) 2.68 mg Tablet, Hydroxyzine HCl, Hydroxyzine Pamoate, Promethazine HCl Coverage Criteria: None Limits: None Required Information for Approval: N/A Other Notes: None Non-Formulary: Chlorpheniramine syrup; Clemastine 1.34 mg Tablet, 0.67 mg/ml Syrup 2st Generation Oral Antihistamines Claritin (Loratadine Tablet, Solution); Zyrtec (Cetirizine) Tablet, 1 mg/ml Solution Coverage Criteria: None Limits: None Required Information for Approval: N/A Other Notes: None Non-Formulary: Loratadine chewable tablet, ODT; Cetirizine chewable tablets, ODT, capsules, 5 mg/5 ml solution; Desloratadine; Levocetirizine Allegra (Fexofenadine) 60 mg Tablet, 180 mg Tablet; ODT, Suspension Coverage Criteria: Fexofenadine is reserved for patient with treatment failure of both loratadine and cetirizine. Limits: None Required Information for Approval: Drug refill history showing trials of both loratadine and cetirizine and chart notes documenting an intolerance or treatment failure to Loratadine and Cetirizine. Other Notes: None Non-Formulary: Fexofenadine 30 mg Tablet Oral Antihistamine Combination Agents Phenylephrine/Promethazine, Phenylephrine/Brompheniramine, Phenylephrine/Chlorpheniramine, Pseudoephedrine/Brompheniramine, Pseudoephedrine/Tripolidine, Pseudoephedrine/Cetirizine,
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