Brensocatib (Brinsupri) — Coverage Criteria for Non‑Cystic Fibrosis Bronchiectasis
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Defines medical necessity criteria, authorization, and dosing for brensocatib (Brinsupri) for commercial, HIM, and Medicaid members and specifies requirements for prior authorization and continued therapy for patients age ≥12.
No material clinical or coverage changes in this revision.
Coverage Criteria for Brensocatib (Brinsupri)
inv-01: Initial Therapy
Covered when ALL of the following are met:
Approval duration: 12 months
inv-02: Continuation Therapy
Covered when ALL of the following are met:
Approval duration: 12 months
This policy does not authorize coverage for non‑FDA approved indications that are not explicitly addressed. Requests for off‑label use must include sufficient documentation of efficacy and safety consistent with the applicable off‑label/no‑coverage policies referenced in this document (for example: CP.CPA.09, HIM.PA.154, CP.PMN.53). Absent adequate supporting evidence per those policies, coverage for non‑FDA indications will not be granted.
For diagnoses or indications that do not meet the specified coverage criteria (for example, lacking chest CT confirmation of non‑cystic fibrosis bronchiectasis, not prescribed by or in consultation with a pulmonologist, patient age <12 years, absence of documentation showing the required pulmonary exacerbation history, not having documented at least 3 months of optimal supportive therapy, active smoking without a recent negative cotinine test, or a primary diagnosis of asthma/COPD), the request is considered not medically necessary and may be denied. Additionally, requests for non‑FDA indications without sufficient off‑label documentation are subject to denial per the referenced off‑label/no‑coverage policies.
Product Coding and Dosing
| 10 mg | Tablet strength — 10 mg |
| 25 mg | Tablet strength — 25 mg |
Prior Authorization & Documentation Requirements
Prior Authorization Required
Prior authorization is required. Provider must submit documentation (such as office chart notes, lab results, consultation notes, imaging reports) supporting that the member meets all approval criteria for initial and continued therapy.
- A documented CT chest confirming non-CF bronchiectasis (initial requests)
- Pulmonologist prescriber or consultation note (initial requests)
- Recent nicotine metabolite test (within 30 days) showing negative cotinine for non-smokers (initial requests)
- Documentation of prior pulmonary exacerbations and systemic antibiotic use per age-specific thresholds (see Initial Approval Criteria 5)
- Evidence of enrollment in continuity-of-care program or prior approval history for continuation requests
Supportive Therapy Requirement — Provider Attestation Required
Provider must attest that the member is currently receiving optimal supportive therapy before initial approval will be granted. Examples of optimal supportive therapy include airway clearance techniques, pulmonary rehabilitation, mucoactive agents (e.g., nebulized hypertonic saline, mannitol, dornase alfa, acetylcysteine), and appropriate antibiotic therapy (e.g., oral azithromycin or erythromycin; inhaled tobramycin or aztreonam).
- Attestation must appear in the submitted documentation (office notes, care plan, or consultation note).
- Supportive therapy must have been used for at least 3 months prior to meeting exacerbation criteria (see Initial Approval Criteria 5).
Required Documentation
Acceptable documentation must be submitted with the prior authorization request to demonstrate that all criteria are met. Incomplete documentation may lead to denial.
- Office chart notes or progress notes documenting diagnosis, supportive therapy, and clinical course
- CT chest report confirming bronchiectasis (initial requests)
- Pulmonologist consultation or prescriber note
- Laboratory results, including recent cotinine/nicotine metabolite test (within 30 days) to confirm non-smoking status
- Medication history and records of systemic antibiotic treatment for pulmonary exacerbations (dates and indication)
- Pulmonary rehabilitation or airway clearance therapy documentation, as applicable
Denial Triggers for Coverage
Coverage may be denied if required conditions are not met or documentation is incomplete. Requests for non‑FDA approved indications will be denied unless sufficient supporting evidence is provided per applicable off‑label/medical necessity policies.
- Missing provider attestation of current optimal supportive therapy (Initial Approval Criteria 4)
- Lack of CT chest confirming bronchiectasis for initial requests
- Insufficient documentation of required number of pulmonary exacerbations despite ≥3 months of supportive therapy (Initial Approval Criteria 5)
- Positive nicotine metabolite (cotinine) test within 30 days indicating active smoking (Initial Approval Criteria 6)
- Primary diagnosis of asthma or COPD listed as the primary reason for treatment (Initial Approval Criteria 7)
- Dose request exceeding 25 mg (1 tablet) per day
- Requests for indications not FDA‑approved without evidence meeting off‑label use policy requirements
Clinical Background
Brensocatib is a dipeptidyl peptidase 1 (DPP1) inhibitor approved for treatment of non‑cystic fibrosis bronchiectasis in patients aged ≥12 years. Dosing options include 10 mg or 25 mg once daily with a maximum daily dose of 25 mg. The pivotal trial definition for a pulmonary exacerbation required worsening of multiple major symptoms over a specified interval leading to systemic antibiotic treatment (see Appendix D in the clinical documentation).
Definitions
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