##### Criteria for Use of Montelukast 

###### VHA Pharmacy Benefits Management Service and Medical Advisory Panel

*These criteria were based on the best clinical evidence currently
available. The recommendations in this document are dynamic, and will be
revised as new clinical information becomes available. This guidance is
intended to assist practitioners in providing consistent, high-quality,
cost-effective drug therapy. These criteria are not intended to
interfere with clinical judgment; the clinician must ultimately decide
the course of therapy based on individual patient situations.*

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| **Exclusion Criteria**                                                |
+-----------------------------------------------------------------------+
|  To treat acute asthma exacerbation                                  |
|                                                                       |
|  Patient has COPD only (e.g., does not have mixed COPD/asthma)       |
|                                                                       |
| There are insufficient data supporting the use of montelukast in      |
| COPD. Patients with features of both asthma and COPD may consider     |
| montelukast per criteria for use in asthma                            |
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| **Inclusion Criteria for Persistent Asthma (must select as least      |
| one)**                                                                |
+-----------------------------------------------------------------------+
|  Patient is unable to use an inhaled corticosteroid (e.g.,           |
| contraindication or adverse event)                                    |
|                                                                       |
|  Patient is on an inhaled corticosteroid and is unable to use a      |
| long-acting beta-agonist (e.g., contraindication or                   |
|                                                                       |
| adverse event) for step up therapy                                    |
|                                                                       |
| NOTE: There is no evidence for additional benefit of montelukast in   |
| patients with asthma who are already on an inhaled corticosteroid AND |
| long-acting beta-agonist; however, due to the adverse effects of      |
| chronic oral corticosteroids, a 1-2 month trial to assess             |
| responsiveness may be considered before maintenance oral              |
| corticosteroid therapy is initiated.                                  |
|                                                                       |
| Recommendations based on NHLBI Guidelines for the Diagnosis and       |
| Management of Asthma (EPR-3)                                          |
| <http://www.nhlbi.nih.gov/guidelines/asthma/index.htm>                |
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| **Inclusion Criteria for Exercise-Induced Asthma (both must be        |
| selected)**                                                           |
+-----------------------------------------------------------------------+
| **In general, pre-treatment with a short-acting beta agonist is       |
| considered the treatment of choice for preventing exercise-induced    |
| asthma**                                                              |
|                                                                       |
|  Patient has been evaluated for the need for initiation or           |
| optimization of chronic asthma therapy                                |
|                                                                       |
|  Short acting beta agonist is not adequately effective; including    |
| situations where a metered dose inhaler cannot be used                |
|                                                                       |
| properly, exercise duration exceeds the duration of short-acting      |
| beta-agonist coverage, or regular /daily use is necessary             |
|                                                                       |
| (potential for tolerance).                                            |
|                                                                       |
| For prevention of exercise-induced asthma, a single dose should be    |
| taken at least 2 hours before exercise. **All patients should still   |
| have a short-acting beta-agonist available in case of symptoms.**     |
| Patients already taking one tablet daily for another indication       |
| (including chronic asthma) should not take an additional dose to      |
| prevent exercise-induced asthma.                                      |
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| **Inclusion Criteria for Allergic Rhinitis**                          |
+-----------------------------------------------------------------------+
| **[Monotherapy (both must be selected)]{.underline}**                 |
|                                                                       |
|  Patient is not a candidate for or has had an adverse event(s) to 2  |
| nasal steroids                                                        |
|                                                                       |
|  Patient has not responded to or is unable to tolerate oral 2^nd^    |
| generation antihistamines after a trial of 2 agents                   |
|                                                                       |
| **[Combination Therapy (e.g., nasal steroid + montelukast OR          |
| antihistamine + montelukast)]{.underline}**                           |
|                                                                       |
| □   Patient has had an insufficient response to combination therapy   |
| with a nasal steroid and a 2^nd^ generation oral antihistamine        |
|                                                                       |
| (2 different agents from each category should be tried, if necessary, |
| before concluding that there is insufficient response).               |
|                                                                       |
| **OR**                                                                |
|                                                                       |
| □  Combination therapy is desired but the patient is unable to        |
| tolerate one of the two classes of medications mentioned above        |
|                                                                       |
| after a trial of 2 different agents from the particular class) or the |
| patient is physically unable to use a nasal steroid inhaler.          |
|                                                                       |
| NOTE: At present, there is no evidence for triple therapy use         |
| (antihistamine + nasal steroid + leukotriene modifying agents)        |
|                                                                       |
| Consider the use of an oral decongestant (or nasal decongestant if    |
| use is occasional or short-term [\<]{.underline}3days) if continued   |
| congestion is the reason for insufficient response **OR** nasal       |
| ipratropium if continued rhinorrhea is the reason for insufficient    |
| response                                                              |
|                                                                       |
| Clinical trials have shown that nasal steroids are more effective     |
| than leukotriene modifying agents                                     |
|                                                                       |
| Clinical trials have shown no significant difference between          |
| leukotriene modifying agents and 2^nd^ generation oral                |
| antihistamines. Because of their easy availability (OTC status) and   |
| significantly lower cost, oral antihistamines should be tried before  |
| montelukast                                                           |
|                                                                       |
| Clinical trials have shown that monotherapy with nasal steroids is    |
| equal to or superior to leukotriene modifying agents + antihistamine  |
|                                                                       |
| Clinical trials have shown that the combination of leukotriene        |
| modifying agents + antihistamine is more effective than either agent  |
| alone. There are insufficient data regarding combination of           |
| montelukast + nasal steroid. One small study showed no difference     |
| between the combination vs. nasal steroid alone.                      |
+-----------------------------------------------------------------------+
| **Inclusion Criteria for OFF-LABEL Use in Chronic Urticaria**         |
+-----------------------------------------------------------------------+
|  Patient has insufficient response to or is unable to tolerate       |
| antihistamines after a trial of ≥ 2 agents                            |
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**[Selected References]{.underline}**

Nayak A, Langdon RB. Montelukast in the treatment of allergic rhinitis:
An evidence-based review.

Drugs 2007; 67: 887-901.

Wallace DV, et al. The diagnosis and management of allergic rhinitis: an
updated practice parameter.

J Allergy Clin Immunol 2008; 122: S1-S84.

Bousquet J, et al.  Allergic Rhinitis and its Impact on Asthma (ARIA)
2008 update (in collaboration with the World Health Organization,
GA(2)LEN and AllerGen). Allergy 2008; 63 Suppl 86:8-160.

Morgan M, Khan DA. Therapeutic alternatives for chronic urticaria: an
evidence-based review, part 1. Ann Allergy Asthma Immunol 2008;
100:403-412.