Under some plans, including plans that use an open or closed formulary, Alupent is subject to precertification. If precertification requirements apply Aetna considers Alupent to be medically necessary for those members who meet the following precertification criteria:
A. Member, while using Alupent, will be monitored for cardiac adverse effects, such as excessive cardiac stimulation and tachycardia
Medical Exception Criteria
Alupent, Atrovent HFA, Brethine, Proventil, Serevent Diskus, Ventolin, Ventolin HFA and Xopenex HFA are currently Not Covered Part D drugs under the Aetna Medicare Prescription Drug Plan.* Therefore, they are excluded from coverage for members enrolled in prescription drug benefits plans that use a closed formulary, unless a medical exception is granted. Aetna considers Alupent, Atrovent HFA, Brethine, Proventil, Serevent Diskus, Ventolin, Ventolin HFA and Xopenex HFA to be medically necessary for those members who meet ANY of the following criteria:
For Atrovent HFA and Brethine
A. Member has a documented:
Contraindication to one preferred alternative OR,
Allergy to one preferred alternative OR,
Intolerance to one preferred alternative OR,
Failure of an adequate trial of one week of one preferred alternative for the member's condition.
For Alupent inhaler
A. Member, while using Alupent, will be monitored for cardiac adverse effects, such as excessive cardiac stimulation and tachycardia
AND
B. Member has a documented:
Contraindication to two inhaled covered alternatives indicated for the member's condition OR
Allergy to two inhaled covered alternatives indicated for the member's condition OR
Intolerance to two inhaled covered alternatives indicated for the member's condition OR
Failure of an adequate trial of one week each of two inhaled covered alternatives indiacted for the member's condition.
For Proventil and Ventolin
A. Member has a documented:
Contraindication to two inhaled covered alternatives indicated for the member's condition OR
Allergy to two inhaled covered alternatives indicated for the member's condition OR
Intolerance to two inhaled covered alternatives indicated for the member's condition OR
Failure of an adequate trial of one week each of two inhaled covered alternatives indicated for the member's condition.
For Ventolin HFA and Xopenex HFA
A. Member has a documented:
Contraindication to one covered alternative albuterol CFC-free inhaler OR
Allergy to one covered alternative albuterol CFC-free inhaler OR
Intolerance to one covered alternative albuterol CFC-free inhaler OR
Failure of an adequate trial of one week of one covered alternative albuterol CFC-free inhaler.
For Serevent Diskus
A. A documented:
Contraindication to one inhaled corticosteroid (Aerobid, Aerobid M, Asmanex, Azmacort, Flovent, Pulmicort Flexhaler/Turbuhaler, QVAR, etc) indicated for the member's condition OR,
Intolerance to one inhaled corticosteroid (Aerobid, Aerobid M, Asmanex, Azmacort, Flovent, Pulmicort Flexhaler/Turbuhaler, QVAR, etc) indicated for the member's condition OR,
Allergy to one inhaled corticosteroid (Aerobid, Aerobid M, Asmanex, Azmacort, Flovent, Pulmicort Flexhaler/Turbuhaler, QVAR, etc) indicated for the member's condition OR,
Failure of an adequate trial of one month of one inhaled corticosteroid (Aerobid, Aerobid M, Asmanex, Azmacort, Flovent, Pulmicort Flexhaler/Turbuhaler, QVAR, etc) indicated for the member's condition OR,
If member has diagnosis of COPD (Chronic obstructive pulmonary disease), Serevent may be approved if member has a contraindication, intolerance, allergy or failure of an adequate trial of one week of the covered alternative Foradil.
Place of Service:
Outpatient
The above policy is based on the following references:
National Institutes of Health, National Heart, Lung and Blood Institute, National Asthma Education and Prevention Program. Expert Panel Report Number 2: Guidelines for the Diagnosis and Management of Asthma. Clinical Practice Guidelines. NIH Publication No. 97-4051. Bethesda, MD: NIH, July 1997.
National Institutes of Health, National Heart, Lung and Blood Institute, National Asthma Education and Prevention Program.Expert Panel Report: Guidelines for the Diagnosis and Management of Asthma – Update on Selected Topics 2002. Clinical Practice Guidelines. NIH Publication No. 02-5075. Bethesda, MD: NIH, July 2002.
Global Initiative For Asthma (GINA), Global Strategy for Asthma Management and Prevention, NHLBI/WHO Workshop Report, 1998. www.ginasthma.com
Apter AJ. Clinical advances in adult asthma.J Allergy Clin Immunol. 2003;111:S780-4.
Lemanske Jr FR, Busse WW. Asthma.J Allergy Clin Immunol. 2003;111:S502-19.
Spahn JD, Szefler SJ. Childhood asthma: New insights into management.J Allergy Clin Immunol. 2002;109:3-13
Kwong KYC, Jones CA. Chronic asthma therapy. Pediatr Rev. 1999;20:327-34.
Drugs for asthma. Med Lett Drugs Ther. 2000;42(1073):19-24.
Busse WW, Lemanske RF. Asthma. N Engl J Med. 2001;344:350-62.
Eggleston PA. Are beta-adrenergic bronchodilators safe? Pediatrics. 1997;99:729-30.
Sears MR, Taylor DR. The b2-agonist controversy. Drug Safety. 1994;11:259-83.
Beasley R, Pearce N, Crane J, Burgess C. Beta agonists: what is the evidence that their use increases the risk of asthma morbidity and mortality? J Allergy Clin Immunol. 1999;104(part 2):S18-30.
Ramsdell JW, Klinger NM, Edholm BP, Colice GL. Safety of long-term treatment with HFA albuterol. Chest. 1999;115:945-51.
Ross D, Carlson S, June D. Comparison of a new HFA albuterol metered dose inhaler (MDI): Effect of storage orientation, end of vial life and temperature on dosing consistency (abstr).Am Rev Resp Med Crit Care 1996 153:A62.
Tinkelman DG, Bleecker ER, Ramsdell J, et al. Proventil HFA and Ventolin have similar safety profiles during regular use. Chest;13:290- 6.
Bronsky E, Ekholm BP, Klinger NM, Colice GL. Switching patients with asthma from chlorofluorocarbon (CFC) albuterol to hydrofluoroalkane-134a(HFA) albuterol.J Asthma. 1999;36:107-14.
IndPW. Salbutamol enantiomers: Early clinical evidence in humans. Thorax 1997;52:839-40.
Bakale RP, et al. Albuterol: A pharmaceutical chemistry review of R-, S-, and RS-albuterol. Clin Rev Allergy Immunol 1996;14:7-35.
Penn RB, et al. Comparison of R-, S-, and RS-albuterol interaction with human ß1-and ß2-adrenergic receptors. Clin Rev Allergy Immunol 1996;14:37-45.
Cockcroft DW, Swystun VA. Effect of single doses of S-salbutamol, R-salbutamol, racemic salbutamol, and placebo on the airway response to methacholine. Thorax 1997;52:845-8.
Perrin-Fayolle M, et al. Differential responses of asthmatic airways to enantiomers of albuterol: Implications for clinical treatment of asthma. Clin Rev Allergy Immunol 1996;14:139-47.
Jenne JW. The debate on S-enantiomers of β-agonists: Tempest in a teapot or gathering storm?J Allergy Clin Immunol. 1998;102(6 part 1):893-5.
Ahrens R, Weinberger M. Levalbuterol and recemic albuterol: Are there therapeutic differences?J Allergy Clin Immunol. 2001;108:681-4.
Baramki D, Koester J, Anderson AJ, Borish L. Modulation of T-cell function by (R)- and (S)-isomers of albuterol: Anti-inflammatory influences of (R)-isomers are negated in the presence of the (S)-isomer.J Allergy Clin Immunol. 2002;109:449-54.
Lotvall J, Palmqvist M, Arvidsson P, et al. The therapeutic ratio of R-albuterol is comparable with that of RS-albuterol in asthmatic patients.J Allergy Clin Immunol. 2001;108:726-31.
Rodenberg H. Effect of levalbuterol on prehospital patient parameters.Am J Emerg Med. 2002;20:481-83.
Milgrom H, Skoner DP, Bensch G, et al. Low-dose levalbuterol in children with asthma: Safety and efficacy in comparison with placebo and racemic albuterol.J Allergy Clin Immunol. 2001;108:938-45.
Asmus MJ, Hendeles L, Weinberger M, et al. Levalbuterol has not been established to have therapeutic advantage over racemic albuterol.J Allergy Clin Immunol. 2002;110:325.
Chowdhury BA. Comparative efficacy of levalbuterol and racemic albuterol in the treatment of asthma. J Allergy Clin Immunol. 2002;110:324.
Milgrom H, Skoner D, Bensch, et al. Reply: Levalbuterol has not been established to have therapeutic advantage over racemic albuterol.J Allergy Clin Immunol. 2002;110:325-27.
Slattery D, Wong SW, Colin AA. Levalbuterol hydrochloride.Pediatr Pulmonol. 2002;33:151-7.
Truitt T, Witko J, Halpern M. Levalbuterol compared to racemic albuterol: Efficacy and outcomes in patients hospitalized with COPD or asthma. Chest. 2003;123:128-35.
Richard M.Nowak, Charles L. Emarman, et al. Levalbuterol Compared with racemic Albuterol in the treatment of Acute Asthma: Results of a Pilot Study. Am J Emerg Med 2004;22:29-36.
John C. Carl, Timothy R. Myeres, et, al. Comparison of racemic albuterol and levalbuterol for treatment of acute asthma. J Pediatr 2003; 143:731-6.
Xopenex Product Information. Sepracor Inc., Marlborough, MA. January 2002.
Accuneb Product Information. Dey, Napa, CA. September 2001.
Ventolin HFA Product Information. Glaxo Wellcome (GlaxoSmithKline), Research Triangle Park, NC. December 2000.
Alupent Product Information. Boehringer Ingelheim, Ridgefield, CT. July 1995.
Tornalate Product Information. Dura Pharmaceuticals, San Diego, CA. November 1996.
USPDI Drug Information for the HealthCare Professional(online). Thomson MICROMEDEX, Greenwood Village, Colorado; 2004.
McEvoy GK, editor. AHFS Drug Information (online). American Society of Health-Systems Pharmacists, Bethesda, Maryland; 2004.
Olin BR, editor. Drugs Facts and Comparisons (electronic online version). St. Louis: J.B. Lippincott Company, 2004.
Medical Economics, Inc., PDR Electronic Library. Thomson Medical Economics, Montvale, NJ; 2003.
Fick DM, Cooper JW, Wade WE, et al. Updating the Beers criteria for potentially inappropriate medication use in older adults.Arch Intern Med. 2003;163:2716-24.
Zahn C, Sangl J, Bierman AS, et al. Potentially inappropriate medication use in the community-dwelling elderly.JAMA. 2001;286:2823-29.
Property of Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.
*C = Covered, copay amount depends on benefits plan
NC = Not Covered Part D drug
PR-B/D = Precertification review criteria to determine coverage as Part B or Part D
PR = Precertification
QL = Quantity Limits
AL = Age Limits
ST = Step-Therapy
‡M EX = Medical Exception
§TOC = Transition of Coverage
*The lists above are subject to change. Not all programs - for example step-therapy, precertification, and quantity limits - are available in all service areas.