BRENSOCATIB TAB

Clinical Criteria Summary

Adults with a diagnosis of NCFB (clinical symptoms for at least 3 months, including chronic cough and purulent sputum production) confirmed by CT scan.
History of >2 exacerbations in the prior year.
Indicated for patients despite use of chronic macrolide therapy or who are unable to use macrolides or inhaled antipseudomonal antibiotics.
Not recommended for patients with a primary diagnosis of COPD or asthma until more evidence is available.
Subgroup analyses indicate no benefit for patients with postbronchodilator FEV1 <50%, Bronchiectasis Severity Index (BSI) >9, and/or an asthma diagnosis.

Monitor for dermatologic adverse events, including new rash, dry skin, and hyperkeratosis; refer to a Dermatologist if a new rash or skin condition develops.
Monitor for increased risk of gingival and periodontal effects; advise patients to maintain routine dental hygiene and attend regular dental checkups.
Monitor liver function tests (AST/ALT elevation noted, resolving upon discontinuation).
Monitor for severe infections (pneumonia and severe infection rates reported).
Effectiveness and safety of live attenuated vaccines are unknown when administered during treatment.

No boxed warnings or contraindications listed.
Primary diagnosis of COPD or asthma excludes patients from trial eligibility and use should be avoided until more evidence is available.

Exacerbation/worsening symptoms are primarily due to asthma and/or COPD
Actively smoking
Diagnosis of cystic fibrosis
Known or suspected immunodeficiency disorder (history of invasive opportunistic infections)

Gingival and periodontal adverse events have been reported
Patients should be advised to perform routine daily dental hygiene
Regular dental checkups are recommended
Core Inclusion Criteria (All must be met)
Provider is a VA or VA Community Care pulmonologist or designated expert
Chronic cough and/or mucopurulent sputum production for at least 3 months within the past year
Diagnosis of non-cystic fibrosis bronchiectasis (NCFB) confirmed by CT scan (completed within the past 2 years with no case of pneumonia reported within 12 months of the CT scan)
> 2 pulmonary exacerbations requiring antibiotics or > 1 severe exacerbation requiring hospitalization in past 12 months
Continues to have exacerbations despite receiving long-term antibiotic therapy (e.g., > 3 months of macrolide or inhaled antipseudomonal antibiotic) with adherence confirmed by review of refill history, OR unable to take long-term antibiotics
Receiving guideline-directed therapies for NCFB including treatment of underlying causes, airway clearance techniques, mucoactive agents, inhalers, pulmonary rehabilitation, etc., as clinically indicated
Additional Inclusion Criteria (Select if applicable)
For females who can become pregnant: Counseling provided on potential risks vs benefits of treatment and the use of effective contraception during therapy