ALBUTEROL/ BUDESONIDE INHL,ORAL

Clinical Criteria Summary

Initial prescription is by or in consult with a VA/VA Community Care pulmonologist, allergist/immunologist, or designated expert
Diagnosis of asthma
Receiving medium- to high-dose inhaled corticosteroids (or maximally tolerated dose) AND at least 3 months of a long-acting beta-agonist and/or other controller medication such as tiotropium if appropriate
One or more severe asthma exacerbations in the prior 12 months
Inadequate symptom control (e.g., short-acting beta-agonist use more than 2 days per week, nighttime awakening due to asthma more than 1 time per week, limitation with normal activity, Asthma Control Test less than 19)
Adherent to asthma medications as evidence by a review of prescription refill history during the last 12 months
Patient has demonstrated correct inhaler technique (documented in chart)

Severe asthma exacerbation is defined as requiring systemic corticosteroids for at least 3 days, emergency room or urgent care visit during which systemic corticosteroids were used, or hospitalization due to asthma exacerbation
In appropriate patients with asthma, consider a trial of maintenance and reliever therapy (SMART) with ICS-formoterol before attempting albuterol/budesonide; SMART should only be prescribed by providers with experience using this therapy
Poor technique frequently is a cause of poor results in asthma

Indicated for the as-needed treatment or prevention of bronchoconstriction and to reduce the risk of exacerbations in patients with asthma.
Approved for use in patients 18 years of age and older.

Dosage form: Pressurized metered dose inhalation aerosol delivering albuterol 90 mcg and budesonide 80 mcg per actuation (120 actuations per canister).
Recommended dosage: 180 mcg/160 mcg administered as 2 actuations by oral inhalation as needed for asthma symptoms.
Maximum frequency: Do not take more than 6 doses (12 inhalations) in a 24-hour period.

Use should be reserved as an option for uncontrolled patients with asthma while receiving optimized therapy.
Clinical trial population characteristics informing use: uncontrolled moderate-to-severe asthma; ≥1 severe asthma exacerbation in the previous 12 months; FEV1 40% to <90% of predicted normal; FEV1 reversibility of at least 12% to albuterol; ACQ-5 ≥1.5; medium-high dose ICS or low-high dose ICS/LABA for at least 3 months with or without other controller agents.
Exclusions from clinical evaluation: COPD or other notable lung disease; use of systemic steroids within 3 months of screening; use of biologic drugs within 3 months or for a duration of 5 half-lives before screening.

If symptoms continue after using albuterol/budesonide, this may be a marker of destabilization of asthma and requires reevaluation of treatment.
Excessive use may be fatal; do not exceed the maximum recommended dosage.
Potential for misuse as maintenance therapy or in patients with COPD.
Potential for error or confusion in patients familiar with using ICS or ICS/LABA for maintenance and albuterol as needed for symptoms.

National and international guidelines position the use of ICS/SABA (either fixed combination or separately one after the other) as a treatment option.
Alternative formulary options include albuterol as needed, or albuterol combined with mometasone or ciclesonide used sequentially as needed (reserved for patients who clearly understand how to use).