MEDICATION COVERAGE POLICY PHARMACY AND THERAPEUTICS ADVISORY COMMITTEE POLICY: Seasonal Allergy Medications LAST REVIEW: 9/20/2016 THERAPEUTIC CLASS: Rheumatologic/Immunologic REVIEW HISTORY: 5/16, 5/15, 9/14 LOB AFFECTED: MCL, SJHA (MONTH/YEAR) 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 weaknesses depending on each patient s specific symptomatology. While allergen avoidance is the firstline treatment, some conditions may be hard to avoid (i.e. seasonal 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 9/2016) Therapeutic Class Oral Antihistamines Oral Antihistamine & Decongestant Combinations Generic Name (Brand Name) Chlorpheniramine Tablet, ER Tablet, Syrup Clemastine Fumarate Cyproheptadine HCl Diphenhydarmine HCl Capsule, Chew Tablet, Tablet, ODT, Oral Solution, Syrup, Vial Hydroxyzine HCl Hydroxyzine Pamoate Capsule Promethazine HCl Cetirizine HCl Tablet, Oral Solution Fexofenadine Tablet, ODT, Oral Suspension Loratadine Tablet, Oral Solution Available Strengths IR: 4mg ER: 12mg Syrup: 2mg/5ml Oral Agents IR: 1.34mg, 2.68mg Syrup: 0.67mg/5ml IR: 4mg Syrup: 2mg/5ml IR: 25mg, 50mg Chewable: 12.5mg ODT: 12.5mg Soln: 12.5mg/5ml Syrup: 12.5mg/5ml Inj Vial: 50mg/ml IR: 10mg Syrup: 10mg/5ml Formulary Limits Average Cost per 30 days -- $3.09-10.77 -- $11.40-34.80 -- $24.71-28.53 -- $3.50-5.90 -- $8.31-12.12 25mg, 50mg, 100mg -- $7.52-44.81 IR: 12.5mg, 25mg, 50mg Syrup: 6.25mg/5ml IR: 5mg, 10mg Soln: 1mg/ml IR: 30mg, 60mg, 180mg ODT: 30mg Susp: 30mg/5ml IR: 10mg Soln: 5mg/5ml -- $5.86-6.64 -- $6.37-33.35 PA $10.69-20.14 -- $4.00-7.48 Desloratadine 5mg, 2.5mg NF $28.61 Levocetirizine 5mg, 2.5mg/5ml NF $70.75-180.15 Phenylephrine/ Promethazine Syrup Phenylephrine/ Brompheniramine Oral Solution Phenylephrine/ Chlorpheniramine 6.25-5mg/5ml -- $26.64 2.5-1mg/5ml -- $5.46 Drops: 3.5-1mg/5ml Syrup: 15-1mg/5ml -- $11.40 Notes failure to Cetirizine and Loratadine. Coverage Policy Rheumatology & Immunology Seasonal Allergies Page 1
Leukotriene Receptor Antagonists Therapeutic Class Oral Drops, Syrup Brompheniramine Oral Solution Triprolidine Cetirizine ER Tablet Fexofenadine ER Tablet Loratadine ER Tablet Montelukast Tablet, Chewable Tablet, Granules Generic Name (Brand Name) Ketotifen (Alaway, Refresh, Allergy Eye, Itchy Eye, Children s Alaway) 15-1mg/5ml -- $25.86 IR: 2.5mg-6mg Syrup: 1.25-30mg/5ml -- $5.31 5mg-120mg -- $42.53 60mg-120mg, 180mg-240mg 5mg-120mg, 10mg-240mg IR: 10mg Chewable: 4mg, 5mg Granules: 4mg Available Strengths Ocular Agents PA $35.13 -- $12.46-14.82 failure to Cetirizine and Loratadine. QL $6,228.32 Limit 1 per day. Formulary Limits Avg Cost/Rx Notes/Restriction Language 0.025% Drops PA, QL $11.29 Limit 10 ml per month. Antihistamines Olopatadine (Pataday) Olopatadine (Patanol) Alcaftadine (Lastacaft) 2.5% Drops PA, QL $128.73 Treatment failure to Azelastine + Ketotifen or Naphcon-A. Limit 2.5ml per month. 0.1% Drops NF $225.35 Non-Formulary. 0.25% Drops NF $162.40 Non-Formulary. Azelastine (Optivar) 0.05% Drops ST $73.07 ST to Ketotifen. Bepotastine (Bepreve) 1.5% NF $171.69 Naphazoline 0.1% Drops -- $7.92 Non-Formulary. Vasoconstrictors Naphazoline/ Pheniramine (Naphcon-A, Visine-A) 0.025%-0.3% Drops $7.20 Phenylephrine 2.5%, 10% Drops -- $12.50-22.90 Other Cromolyn Sodium Drops 4% -- $72.46 Therapeutic Class Nasal Antihistamine Generic Name (Brand Name) Azelastine HCl (Astelin) Available Formulary Strengths Limits Nasal Agents Avg Cost/Rx 137mcg ST $71.53 Flunisolide 25mcg -- $56.04 Notes/Restriction Language Coverage Policy Rheumatology & Immunology Seasonal Allergies Page 2
Nasal Corticosteroids Nasal Vasoconstrictors Other Epinephrine Epinephrine Fluticasone (Flonase) 50mcg -- $8.86 Fluticasone (Veramyst) Triamcinolone (Nasacort OTC) Beclomethasone (Beconase AQ) Beclomethasone (Qnasl) Budesonide (Rhinocort Aqua) Mometasone (Nasonex) Epinephrine HCl (Adrenaline) Oxymetazoline HCl (Afrin) Phenylephrine HCl Nasal Drops, Nasal Spray Cromolyn Sodium (Nasalcrom) Spray Epinephrine (Generic epinephrine) Auto-Injector Epinephrine (Epipen 2-Pak, Epipen Jr 2-Pak) Auto-Injector 27.5mcg AL $170.52 55mcg -- $14.74 42mcg PA $272.52 42mcg NF $137.28 32mcg PA $130.98 50mcg PA $220.52 1:1,000 (0.1%) -- $111.28 0.05% -- $4.55 Drops: 0.125%, 1% Spray: 0.25%, 0.5%, 1% -- $5.32-6.20 4% -- $6.63 Injectable Agents 0.3mg/0.3ml, 0.15/0.15ml 0.3mg/0.3ml, 0.15/0.3ml Reserved for use in 2-4 yo with treatment failure to Nasacort OTC. failure to 2 of the following: Fluticasone, Fluinisolide, Nasacort OTC. Formulary alternative = Beconase AQ. failure to 2 of the following: Fluticasone, Fluinisolide, Nasacort OTC. failure to Beconase AQ or Rhinocort AQ. Coverage Policy Rheumatology & Immunology Seasonal Allergies Page 3 NF -- $472.29-483.41 PA = Prior Authorization; QL = Quantity Limit; NF = Non-Formulary; AL = Age Limit; QL = Quantity Limit 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 HSPJ Medical Review Guidelines (UM06). 1 st Generation Oral Antihistamines Benadryl (Diphenhydramine), Periactin (Cyproheptadine), Chlor-Trimeton (Chlorpheniramine), Tavist (Clemastine), Hydroxyzine HCl, Hydroxyzine Pamoate, Promethazine HCl 2 st Generation Oral Antihistamines Claritin (Loratadine), Zyrtec (Cetirizine)
Allegra (Fexofenadine) Coverage Criteria: PA Required. Fexofenadine is reserved for patient with treatment failure of both loratadine and cetirizine. 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. Oral Antihistamine Combination Agents Phenylephrine/Promethazine, Phenylephrine/Brompheniramine, Phenylephrine/Chlorpheniramine, Brompheniramine, Tripolidine, Cetirizine, Loratadine Fexofenadine Coverage Criteria: PA Required. Fexofenadine is reserved for patient with treatment failure of both loratadine and cetirizine. 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. Leukotriene Receptor Blocker Singulair (Montelukast) Limits: 1 tablet/packet per day. Ocular Antihistamines Alaway (Ketotifen) Optivar (Azelastine) Coverage Criteria: Azelastine is step therapy to Ketotifen. Limits: 10 ml per 30 days Required Information for Approval: Clinical documentation or fill history of treatment failure of both Azelastine and either Visine-A or Alaway. Patanol (Olopatadine) Coverage Criteria: PA required. Olopatadine is reserved for treatment failure of [1] Azelastine AND either [2]Visine-A or Alaway. Limits: 10 ml per 30 days Required Information for Approval: Clinical documentation or fill history of treatment failure of both Azelastine and either Visine-A or Alaway. Other Notes: Pataday, Lastacaft, and Bepreve are non-formulary. Ocular Vasoconstrictors Naphazoline, Naphazoline/Pheniramine, Phenylephrine Coverage Policy Rheumatology & Immunology Seasonal Allergies Page 4
Nasal Antihistamines Astelin (Azelastine) Coverage Criteria: It is step therapy to failing a 14 day trial of formulary intranasal corticosteroids (e.g, fluticasone, flunisolide). Required Information for Approval: Drug refill history showing trials of a formulary first-line intranasal corticosteroid in the previous month and chart notes documenting inadequate control of allergy symptoms with intranasal corticosteroids alone. Other Notes: Consider use of oral antihistamines for a more convenient method of administration, or intranasal corticosteroids for increased efficacy over nasal antihistamines. Intranasal Corticosteroids Flonase (Fluticasone), Nasacort 24hr (Triamcinolone), Nasarel (Flunisolide) Flonase (Veramyst) Coverage Criteria: Reserved for use in children 2-4 years with treatment failure to Triamcinolone. (Nasacort OTC). Required Information for Approval: Drug fill history showing fills of Triamcinolone. Other Notes: Restricted to ages 2-4 years only. Rhinocort Aqua (Budesonide), Beconase AQ (Beclomethasone) Coverage Criteria: failure of an adequate trial (7-14 days) of any 2 (two) firstline agents (fluticasone, flunisolide, triamcinolone). Required Information for Approval: Drug refill history showing trials of 2 (two) formulary first-line intranasal corticosteroid in the recent past history and chart notes documenting inadequate control of allergy symptoms or intolerance to other intranasal corticosteroids. Other Notes: Qnasl (Beclomethasone) is non-formulary. Nasonex (Mometasone) Coverage Criteria: Nasonex is reserved for treatment failure of an adequate trial (7-14 days) of any 2 (two) first-line agents (fluticasone, flunisolide, Nasacort OTC) AND one second-line agent (Beconase AQ, Rhinocort Aqua). Limits: 1 inhaler per 30 days. Required Information for Approval: Drug refill history showing trials of 2 (two) formulary first-line intranasal corticosteroid and 1 (one) second line agent in the recent past history and chart notes documenting inadequate control of allergy symptoms or intolerance to other intranasal corticosteroids. Mast Cell Stabilizers Nasalcrom (Cromolyn Sodium Nasal Spray) Anaphylaxis Agents Epinephrine (Epipen 2-Pak, Epipen Jr 2-Pak, Generic) Coverage Policy Rheumatology & Immunology Seasonal Allergies Page 5
Other Notes: Epipen 2-Pak, Epipen Jr 2-Pak (Epinephrine) are non-formulary 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). 2 nd generation antihistamines are less sedating than first generation antihistamines and all 2 nd generation oral antihistamines have approximately the same level of efficacy and work quickly. All 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. NEWLY APPROVED MEDICATIONS NOT ON FORMULARY N/A GUIDELINE & LITERATURE REVIEW N/A CRITERIA REVIEW FOR UNNECESSARY BARRIERS Current requirements are appropriate REFERENCES 1. Am Fam Physician. 2010 Jun 15;81(12):1440-1446. REVIEW & EDIT HISTORY Document Changes Reference Date P&T Chairman Creation of Policy Azelastine 05-07.doc 5/2007 Allen Shek PharmD BCPS Update to Policy INC Class review 5-07.doc 5/2007 Allen Shek PharmD BCPS Update to Policy NSAH 5-07.doc 5/2007 Allen Shek PharmD BCPS Update to Policy Ophthalmics Feb 08.doc 2/2008 Allen Shek PharmD BCPS Update to Policy Veramyst monograph 6-08.doc 6/2008 Allen Shek PharmD BCPS Update to Policy NSAH 9-16-08.doc 9/2008 Allen Shek PharmD BCPS Update to Policy ICS Review 9-16-08.doc 9/2008 Allen Shek PharmD BCPS Update to Policy ICS post P&T survey recap.doc 3/2009 Allen Shek PharmD BCPS Update to Policy Azelastine Monograph 5-17-11.docx 5/2011 Allen Shek PharmD BCPS Update to Policy Allergy Review 2014-09-16.docx 9/2014 Jonathan Szkotak PharmD BCACP Update to Policy Ophthalmic & Otic Anti-Inflammatory Agents 2015-11.docx 11/2015 Johnathan Yeh, PharmD Note: All changes are approved by the HPSJ P&T Committee before incorporation into the utilization policy Coverage Policy Rheumatology & Immunology Seasonal Allergies Page 6