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Brensocatib (Brinsupri) — coverage criteria for non‑cystic fibrosis bronchiectasis

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Criteria and coverage considerations for brensocatib (Brinsupri) as a non-PDL single-agent review for treatment of non-cystic fibrosis bronchiectasis; intended for providers prescribing or requesting prior authorization. Applies to MedImpact members covered under this payer's pharmacy review process.

Policy Summary

Payermedimpact

PolicyBrensocatib (Brinsupri) — coverage criteria for non‑cystic fibrosis bronchiectasis

Policy CodePolicy N/A

Change TypeN/A

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization with provider attestation of CT‑confirmed non‑cystic fibrosis bronchiectasis, specialist involvement, and documentation of required antibiotic‑treated exacerbations.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 mo / 12 moapproval duration: initial / renewal

CT-confirmedCT-confirmed diagnosis required

≥2adult exacerbation threshold

≥1adolescent exacerbation threshold

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DraftmedimpactPolicy N/A

Brensocatib (Brinsupri) — coverage criteria for non‑cystic fibrosis bronchiectasis

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Policy Summary

Payermedimpact

PolicyBrensocatib (Brinsupri) — coverage criteria for non‑cystic fibrosis bronchiectasis

Policy CodePolicy N/A

Change TypeN/A

Effective DateN/A

Next Review DateN/A

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 mo / 12 moapproval duration: initial / renewal

CT-confirmedCT-confirmed diagnosis required

≥2adult exacerbation threshold

≥1adolescent exacerbation threshold

12 monthsexacerbation lookback

oral DPP-1 inhibitordrug class / route

Coverage Criteria and Clinical Eligibility

Initial Therapy

Covered when ALL of the following are met:

Initial approval requirements

Age/exacerbation specifics: Patient meets ONE of the following age-based exacerbation thresholds:Adults (≥18): ≥2 exacerbations; Adolescents (12–17): ≥1 exacerbation
Exacerbations must have required antibiotic treatment in the past 12 months
Adult criterion: Aged 18 years and older AND has ≥ 2 exacerbations (recorded);≥ 2 exacerbations
Exacerbations must have required antibiotic treatment in the past 12 months
Adolescent criterion: Aged 12 to 17 years AND has ≥ 1 exacerbation (recorded);≥ 1 exacerbation
Exacerbations must have required antibiotic treatment in the past 12 months

Initial Therapy

Covered when ALL of the following are met for initial approval:

Initial Approval Criteria: 1) Provider attests to non‑cystic fibrosis bronchiectasis diagnosis confirmed by chest CT; 2) Medication prescribed by, or in consultation with, a pulmonologist or other specialist; 3) Patient meets ONE of the age‑based exacerbation criteria: (a) Age ≥18 years with ≥2 exacerbations OR (b) Age 12–17 years with ≥1 exacerbation; 4) Exacerbations required antibiotic treatment in the past 12 months.Adults ≥2 / Adolescents 12–17 ≥1; antibiotic-treated exacerbations in past 12 months

Document CT confirmation, specialist involvement, dates and antibiotic treatment for exacerbations.

Initial Approval

Covered when ALL of the following are met:

Initial Approval Criteria: 1) Provider attestation of non-cystic fibrosis bronchiectasis diagnosis confirmed by chest CT; 2) Prescribed by, or in consultation with, a pulmonologist or other specialist; 3) Patient meets ONE of: (a) Age ≥18 with ≥2 exacerbations OR (b) Age 12–17 with ≥1 exacerbation; 4) Patient experienced exacerbations that required antibiotic treatment in the past 12 months; 5) Provider attestation that the patient may not be a current smoker (if a smoker, counseling documented).Adult ≥2, Adolescent ≥1; antibiotic-treated exacerbations within past 12 months

All items must be documented for initial approval.

Initial Approval

Covered when ALL of the following are met:

Initial Approval Criteria: Provider attestation of non-cystic fibrosis bronchiectasis confirmed by chest CT; prescribed by or in consultation with a pulmonologist or relevant specialist; patient meets age-specific exacerbation threshold; patient experienced exacerbations requiring antibiotic treatment in the past 12 months; provider attests the patient may not be a current smoker (or documents smoking counseling if smoker).Adults (≥18): ≥2 exacerbations; Adolescents (12–17): ≥1 exacerbation; exacerbations treated with antibiotics in past 12 months

Age/exacerbation item is an OR between adult and adolescent thresholds.

Initial Approval Criteria

Covered when ALL of the following are met:

Initial Approval: Provider attestation of non-cystic fibrosis bronchiectasis diagnosis confirmed by chest CT; prescribed by or in consultation with a pulmonologist or specialist; documentation that patient experienced exacerbations requiring antibiotic treatment in the past 12 months; provider attestation that the patient is not a current smoker or documentation that a smoker was counseled; AND patient meets the age/exacerbation criteria below.

Age-specific exacerbation requirement: Patient meets ONE of the following age-based exacerbation counts:

Adult criterion: Aged 18 years and older with ≥ 2 exacerbations (in the past 12 months that required antibiotics).≥ 2 exacerbations

Adolescent criterion: Aged 12 to 17 years with ≥ 1 exacerbation (in the past 12 months that required antibiotics).

Initial Approval

Covered when ALL of the following are met for initial approval:

Initial Approval Criteria: 1) Provider attestation of non-cystic fibrosis bronchiectasis diagnosis confirmed by chest CT; 2) Prescribed by, or in consultation with, a pulmonologist or other specialist; 3) Patient meets ONE of: (a) age ≥18 years with ≥2 exacerbations OR (b) age 12–17 years with ≥1 exacerbation; 4) Patient experienced exacerbations that required antibiotic treatment in the past 12 months; 5) Provider attestation that the patient may not be a current smoker (or counseling documented if smoker).Adult ≥2 / Adolescent ≥1; antibiotic-treated exacerbations within past 12 months

All five conditions must be documented for initial approval.

Initial Therapy

Covered when ALL of the following are met

Initial approval for brensocatib: 1) Provider attestation of non-cystic fibrosis bronchiectasis diagnosis confirmed by chest CT; 2) Prescribed by or in consultation with a pulmonologist or other specialist; 3) Patient meets ONE of: (a) age ≥18 years AND has ≥2 exacerbations OR (b) age 12–17 years AND has ≥1 exacerbation; 4) Patient experienced exacerbations that required antibiotic treatment in the past 12 months; 5) Provider attestation that the patient may not be a current smoker (if a current smoker, counseling documented).Adult ≥2 / Adolescent ≥1; antibiotic-treated exacerbations in past 12 months

All conditions required.

Initial Therapy

Covered when ALL of the following are met

Initial Approval Criteria: 1) Provider attestation of non-cystic fibrosis bronchiectasis diagnosis confirmed by chest CT; 2) Prescribed by, or in consultation with, a pulmonologist or other specialist; 3) Patient meets ONE of the following age/exacerbation criteria: (a) Aged 18 years and older with ≥2 exacerbations OR (b) Aged 12 to 17 years with ≥1 exacerbation; 4) Patient experienced exacerbations that required antibiotic treatment in the past 12 months; 5) Provider attestation that the patient may not be a current smoker (if a smoker, counseling documented).Adults ≥2 / Adolescents 12–17 ≥1; antibiotic-treated exacerbations within past 12 months

Logic requires all items; the age/exacerbation item is an OR between adult and adolescent thresholds.

Brensocatib - Initial Therapy

Covered when ALL of the following are met

Brensocatib initial approval: Provider attestation of non-cystic fibrosis bronchiectasis diagnosis confirmed by chest CT; prescribed by or in consultation with a pulmonologist or other specialist; patient meets ONE of the following age/exacerbation criteria; patient experienced exacerbations that required antibiotic treatment in the past 12 months; provider attests the patient may not be a current smoker (if smoker, counseling documented).Adults ≥2 / Ages 12–17 ≥1; antibiotic-treated exacerbations within past 12 months

Brensocatib-specific prior authorization requirements mirror the general initial criteria.

Age/exacerbation criteria: Either: (1) Aged 18 years and older with ≥ 2 exacerbations; OR (2) Aged 12 to 17 years with ≥ 1 exacerbationAdults ≥2 / Ages 12–17 ≥1

Orlynvah - Initial Approval

Covered when ALL of the following are met

Orlynvah initial approval: Patient is female AND age ≥18 years and weight ≥40 kg; documented clinical diagnosis of uncomplicated UTI with at least 2 signs/symptoms; urinalysis confirming pyuria and/or positive nitrites; urine culture confirming or high clinical suspicion of uUTI caused by E. coli, K. pneumoniae, or P. mirabilis; documented allergy/intolerance/contraindication or therapeutic failure to at least 2 first-line oral agents; provider attests Orlynvah is not being used as step-down therapy following IV antibiotics.

Quantity limit: 10 tablets per 5-day course.

Dawnzera - Initial Approval

Covered when ALL of the following are met

Dawnzera initial approval: Diagnosis of hereditary angioedema (HAE); AND documentation of confirmed diagnosis of HAE by one of the listed tests (e.g., complement testing or C1 inhibitor protein and functional tests).

Specific confirmatory tests referenced in policy; see documentation requirements.

Initial Therapy — HAE prophylaxis

Covered when ALL of the following are met

HAE Initial Approval: Diagnosis of hereditary angioedema (HAE); documentation of confirmed diagnosis by complement testing or C1 inhibitor protein and functional tests; prescribed for prophylactic use; prescribed by, or in consultation with, an immunologist, hematologist, or other HAE specialist; patient is not on concurrent alternative HAE prophylactic agent; patient meets package insert minimum age.

Quantity limit: 0.8 mL (80 mg) per 28 days; Renewal requires prescriber attestation of improvement in attack frequency or severity; Approval duration examples: 6 months initial, 12 months renewal.

Initial and Renewal Therapy — Leqembi (Alzheimer's)

Covered when ALL of the following are met

Leqembi Initial Approval: Diagnosis of mild cognitive impairment (MCI) due to Alzheimer disease or mild dementia due to AD; prescribed by, or in consultation with, a neurologist, geriatrician, psychiatrist, or other dementia specialist; prior confirmation of beta-amyloid plaques; baseline disease severity documented with MMSE, MoCA, or CDR-Global; brain MRI prior to initiation; genotype testing for ApoE ε4 status prior to initiation; Leqembi IV will not be combined with other amyloid beta-directed antibodies.

Patient must have completed 18 months of IV infusions of Leqembi per policy; Quantity limit and age limits apply; Renewal requires documented clinical response (stabilization or slowing).

Initial Therapy — Rilzabrutinib (ITP)

Covered when ALL of the following are met

Rilzabrutinib Initial Approval (ITP): Diagnosis of persistent or chronic immune thrombocytopenia (ITP); prescribed by, or in consultation with, a hematologist or liver disease specialist; documentation of platelet count within the past 30 days; trial and failure of at least one other therapy for persistent/chronic ITP; trial and failure/allergy/contraindication/intolerance to Promacta (eltrombopag).

Age ≥18; Quantity limit: 2 tablets/day; Approval duration per excerpt.

Initial Therapy — Gepotidacin (Blujepa) for uUTI and gonorrhea

Covered when ALL of the following are met (separate branches per indication):

Gepotidacin for uUTI: Patient is female aged ≥12 years and weighing ≥40 kg; documented clinical diagnosis of uncomplicated UTI with ≥2 signs/symptoms; urinalysis confirming pyuria and/or positive nitrites; urine culture confirming or high clinical suspicion of infection by a susceptible organism (E. coli, K. pneumoniae, C. freundii complex, S. saprophyticus, or E. faecalis); documented allergy/intolerance/contraindication/therapeutic failure to at least 2 first-line oral agents as appropriate based on susceptibilities.

Quantity limit: 20 tablets per 5-day course; Approval duration: 12 months initial.

Gepotidacin for urogenital gonorrhea: Patient is ≥12 years and weighs ≥45 kg; documented diagnosis of uncomplicated urogenital gonorrhea confirmed by NAAT, culture, or Gram stain demonstrating susceptible N. gonorrhoeae; documentation that patient has limited or no alternative treatment options (e.g., allergy/intolerance/contraindication/treatment failure/resistance to standard therapies).

Quantity limit consistent with product; Approval duration: 12 months initial.

Initial and Renewal Therapy — Remibrutinib (CSU)

Covered when ALL of the following are met

Remibrutinib Initial Approval (CSU): Diagnosis of chronic spontaneous urticaria (CSU); trial and failure of ≥14 days (or intolerance/contraindication) to H1-antihistamines; trial and failure of ≥1 month (or intolerance/contraindication) to BOTH Xolair and Dupixent; prescribed by, or in consultation with, an allergist, immunologist, or other specialist; patient meets package insert minimum age.

Quantity limit: 2 tablets/day; Renewal requires documented disease improvement or stabilization.

Initial Therapy (CSU)

Initial approval for chronic spontaneous urticaria (CSU)

CSU initial approval: Diagnosis of chronic spontaneous urticaria (CSU); AND trial and failure of (≥14-day treatment course), contraindication, or intolerance to H1 antihistamine; AND trial and failure of (≥1-month treatment course), contraindication, or intolerance to BOTH Xolair and Dupixent; AND prescribed by or in consultation with an allergist, immunologist, or other applicable specialist; AND patient meets minimum age in package insert.

Renewal (CSU)

Renewal criteria for CSU

CSU renewal: Patient has experienced disease improvement and/or stabilization as assessed by the prescriber.

Quantity limit: 2 tablets per day.

Initial Therapy (IPF/PPF)

Initial approval for idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF)

IPF/PPF initial approval: Diagnosis of IPF or PPF consistent with current guidelines; provider attests other causes of pulmonary fibrosis have been ruled out; patient has FVC ≥ 45% of predicted; prescribed by, or in consultation with, a pulmonologist or relevant specialist; patient meets package insert minimum age.FVC ≥ 45% predicted

Approval duration and renewal criteria require documentation of stability or slowing of decline.

Renewal (IPF/PPF)

Renewal criteria for IPF/PPF

IPF/PPF renewal: Physician attestation that the patient has experienced stability or slowing of decline based on an objective measure (e.g., absolute change from baseline in FVC).

Quantity limit examples and monitoring per policy.

Initial Therapy (MDD)

Initial approval for major depressive disorder (MDD) with gepirone

MDD initial approval: Diagnosis of major depressive disorder; prescriber attests to EKG monitoring during titration and periodically; prescribed by or in consultation with a psychiatrist, neurologist, or other qualified provider; patient had at least a 2-week trial and failure, allergy, contraindication, or intolerance to 2 SSRIs or 2 SNRIs; patient meets package insert minimum age.

Approval duration examples: 6 months initial or per excerpt; quantity limit: 1 tablet/day.

Renewal (MDD)

Renewal criteria for MDD

MDD renewal: Patient has experienced disease improvement and/or stabilization as assessed by the prescriber.

Quantity limit: 1 tablet per day; renewal duration: 1 year per excerpt.

Initial Therapy (Menopause)

Initial approval for menopause vasomotor symptoms (elinzanetant)

Menopause initial approval: Diagnosis of menopause with moderate to severe vasomotor symptoms; patient does not have moderate to severe hepatic impairment; patient does not have end-stage renal disease; if female of childbearing potential, not pregnant or planning pregnancy; patient will avoid concomitant strong CYP3A4 inhibitors and moderate-strong CYP3A4 inducers; prescriber attests baseline LFTs (total/direct bilirubin, ALT, AST, ALP) not elevated ≥2x ULN and follow-up LFT testing will be conducted; patient has trialed and failed or is not a candidate for hormone therapy.LFTs < 2x ULN

Age limit ≥18; quantity limit 2 capsules/day; initial approval duration per excerpt.

Renewal (Menopause)

Renewal criteria for menopause

Menopause renewal: Patient continues to meet initial criteria; patient has symptom improvement; patient has not experienced treatment-limiting adverse effects (e.g., ALT/AST thresholds or signs of liver injury).ALT/AST thresholds as specified

Quantity limit 2 capsules/day; age ≥18.

This policy addresses coverage for brensocatib (Brinsupri), an oral DPP‑1 inhibitor indicated for treatment of non‑cystic fibrosis bronchiectasis. Prior authorization is required. For initial approval the provider must attest that the diagnosis of non‑CF bronchiectasis is confirmed by chest computed tomography (CT), the prescription is by or in consultation with a pulmonologist or relevant specialist, and the patient meets the age‑based exacerbation thresholds (Adults ≥18 years: ≥2 exacerbations; Ages 12–17: ≥1 exacerbation), with qualifying exacerbations having required antibiotic treatment in the past 12 months. Providers should also attest that the patient is not a current smoker (or document counseling if the patient is a smoker).

None explicitly listed in these chunks.

Cystic fibrosis bronchiectasis is not included in the brensocatib coverage criteria: the approval logic specifically requires a diagnosis of non‑cystic fibrosis bronchiectasis confirmed by chest CT, thereby excluding CF‑related bronchiectasis from this policy.

The requirement for a CT‑confirmed diagnosis explicitly limits eligibility to non‑cystic fibrosis bronchiectasis; requests for patients with cystic fibrosis‑related bronchiectasis do not meet the stated diagnosis criterion.

This policy and the brensocatib criteria apply only to patients with non‑cystic fibrosis bronchiectasis. The documentation requirements repeatedly specify CT confirmation of a non‑CF diagnosis and specialist involvement.

No additional coverage criteria beyond those shown in the initial approval language are specified in the provided excerpt.

In this document segment there are no other explicit coverage criteria beyond the CT‑confirmed non‑CF bronchiectasis diagnosis, specialist prescribing/consult, exacerbation counts by age, antibiotic‑treated exacerbation timeframe, and smoking‑status attestation.

Repeated language across the policy reiterates the limitation to non‑cystic fibrosis bronchiectasis by requiring a CT‑confirmed non‑CF diagnosis for eligibility.

For Orlynvah, the policy requires a provider attestation that the product is not being used as step‑down therapy following IV antibiotics; providers must attest to this when requesting coverage.

For hereditary angioedema (HAE) prophylaxis agents, the policy disqualifies patients who are receiving concurrent prophylactic HAE therapies (examples listed include Takhzyro, Haegarda, Cinryze, Dawnzera, Orladeyo). Concurrent treatment with alternate HAE prophylactic agents must not be present for approval.

Leqembi (lecanemab‑irmb) initial approval will not be granted if the patient is being treated concurrently with other amyloid beta‑directed antibodies (for example, aducanumab); combination therapy with other anti‑amyloid antibodies is excluded.

For the menopause indication (elinzanetant), initial approval excludes patients with moderate to severe hepatic impairment or end‑stage renal disease; these conditions are listed as exclusions for that specific therapy.

Key Numeric Criteria and Coding-relevant Thresholds

Exacerbation count — quick reference

Adults (≥18 years)≥ 2 exacerbations

Adolescents (12–17 years)≥ 1 exacerbation

ContextExacerbations defined as events that required antibiotic treatment

Exacerbation count by age — supporting excerpt

Adults (≥18 years)Must have ≥2 exacerbations

Adolescents (12–17 years)Must have ≥1 exacerbation

RequirementProvider attestation of CT‑confirmed non‑cystic fibrosis bronchiectasis and specialist involvement required

Required Documentation, Prior Authorization, and Denial Risk

Prior Authorization

Prior authorization required; approval durations

Prior authorization is required for this non‑PDL new product (Brinsupri/brensocatib). Initial approval duration: 6 months; renewal duration: 12 months.

Prior Authorization

CT confirmation, specialist involvement, exacerbation documentation

Prior authorization requires provider attestation that the patient has non‑cystic fibrosis bronchiectasis confirmed by chest CT, that the medication is prescribed by or in consultation with a pulmonologist or other specialist, and documentation of exacerbation history meeting age‑based thresholds.

Adults (≥18 years): ≥2 exacerbations
Ages 12–17: ≥1 exacerbation
Exacerbations must have required antibiotic treatment in the past 12 months

Definitions and Background

Brensocatib is an oral, reversible inhibitor of dipeptidyl peptidase‑1 (DPP‑1) that reduces activation and activity of neutrophil serine proteases (NSPs), proteolytic enzymes implicated in airway inflammation and bronchiectasis pathophysiology. This mechanism underlies the indication and the coverage rationale.

DPP‑1 / NSPs — definition and role

DPP‑1 definitionDipeptidyl peptidase 1 (DPP‑1) is an enzyme that activates proinflammatory neutrophil serine proteases (NSPs) during neutrophil maturation

RoleActivation of NSPs contributes to airway inflammation and bronchiectasis pathophysiology

Therapeutic targetInhibiting DPP‑1 reduces NSP activity (mechanism of brensocatib)

Brensocatib / DPP‑1 inhibitor — mechanism and target

Brensocatib definitionOral, competitive, reversible DPP‑1 inhibitor that targets neutrophil serine proteases (NSPs)

Quick Provider Summary and Metrics

FVC eligibility reminder for IPF/PPF

FVC eligibility reminderFVC ≥ 45% predicted required for IPF/PPF initial approval

ContextEnsure documented FVC (% predicted) and that other causes of fibrosis ruled out

Specialist involvementPrescribed by or in consultation with a pulmonologist or relevant specialist

Policy Revision History

2026-01-20policy_presentationLatest

Brensocatib (Brinsupri) presented as a New Product to Market (Non-PDL) with proposed approval duration 6 months initial and 12 months renewal at the P&T Advisory Committee meeting agenda.

internal_draft

Drafted initial approval criteria requiring CT‑confirmed non‑cystic fibrosis bronchiectasis, specialist prescribing/consultation, age-based exacerbation thresholds, antibiotic‑treated exacerbations in past 12 months, and smoking-status attestation.

Policy Summary

Payermedimpact

PolicyBrensocatib (Brinsupri) — coverage criteria for non‑cystic fibrosis bronchiectasis

Policy CodePolicy N/A

Change TypeN/A

Effective DateN/A

Next Review DateN/A

SourceLink

On This Page

Antibiotic‑treated exacerbation timeframe

Lookback periodExacerbations that required antibiotic treatment in the past 12 months

DocumentationDates and record that exacerbations required antibiotics should be documented

UseApplies to age‑based exacerbation counts for initial approval

Exacerbation count (alternate excerpt)

Adults (≥18 years)≥2 exacerbations (policy text)

Adolescents (12–17 years)≥1 exacerbation (policy text)

NoteProvider attestation that patient may not be a current smoker (or counseling documented if smoker)

Exacerbation timeframe — alternate excerpt

Time windowExacerbations requiring antibiotic treatment in the past 12 months

CounselingIf a smoker, counseling on harmful effects of smoking and cessation options should be provided

SpecialistPrescribed by or in consultation with a pulmonologist or specialist

Adult exacerbation threshold (badge)

Adults (≥18 years)2

Unitexacerbations

PurposeNumeric badge for adult threshold

Adolescent exacerbation threshold (badge)

Adolescents (12–17 years)1

Unitexacerbation

PurposeNumeric badge for adolescent threshold

Time window for antibiotic‑treated exacerbation — supporting chunks

Time windowPast 12 months

RequirementExacerbations must have required antibiotic treatment

DocumentationRecord dates and antibiotics used

Exacerbation count thresholds — summary

Adults (18+)≥2 exacerbations

Adolescents (12–17)≥1 exacerbation

LookbackExacerbations required antibiotic treatment within past 12 months

Exacerbation count (document cluster)

Document clusterMultiple chunks reiterate: CT‑confirmed non‑CF bronchiectasis, specialist involvement, age‑based exacerbation counts, and antibiotic‑treated exacerbations in past 12 months

Policy repetitionThresholds repeated across document to emphasize requirements

Denial riskRequests lacking these documented items may be denied

Adult exacerbation threshold (single‑chunk)

Adult threshold (single chunk)≥ 2 exacerbations

Source chunkChunk 108 contains the adult threshold in policy text

Applies toPatients aged ≥18 years for initial approval

Adolescent exacerbation threshold (single‑chunk)

Adolescent threshold (single chunk)≥ 1 exacerbation (ages 12–17)

Source chunkChunk 18 lists the adolescent threshold explicitly

Applies toPatients aged 12–17 years for initial approval

Antibiotic‑treated exacerbation lookback — single‑chunk

Lookback (single chunk)Past 12 months

ContextExacerbations must have required antibiotic treatment within this timeframe

SourceChunk 30 contains the explicit lookback statement

Adult exacerbation threshold — supporting chunks

Adult threshold (supporting)Aged 18 years and older with ≥ 2 exacerbations

Document evidenceSupported across chunks 134 and 138 in the criteria language

RequirementExacerbations must be antibiotic‑treated in past 12 months

Adolescent exacerbation threshold — supporting chunks

Adolescent threshold (supporting)Aged 12 to 17 years with ≥ 1 exacerbation

Document evidenceRepeated in supporting chunks to confirm policy intent

LookbackExacerbations required antibiotics in past 12 months

Exacerbation counts — brensocatib summary

Adults≥2 exacerbations

Ages 12–17≥1 exacerbation

AgentBrensocatib (Brinsupri) — thresholds apply for prior authorization

Orlynvah age/weight requirement

Age requirement (Orlynvah)Female ≥18 years

Weight requirementWeight ≥40 kg

ContextListed as part of Orlynvah initial approval criteria (non‑related agent)

Orlynvah quantity limit

Quantity limit10 tablets per 5‑day course

IndicationOrlynvah for uncomplicated UTI — quantity limit stated in policy

DocumentationProvider must attest Orlynvah is not step‑down therapy after IV antibiotics

Forced Vital Capacity (FVC) threshold

FVC threshold≥ 45% of predicted

ContextRequired for IPF/PPF initial approval in policy

DocumentationPrescriber attestation that other causes of pulmonary fibrosis ruled out

Prior Authorization

CT confirmation, specialist prescribing/consult, exacerbation thresholds

Provider must attest chest CT confirmation of non‑CF bronchiectasis, show that prescriber is a pulmonologist or consulted one, and document age‑specific exacerbation counts with antibiotic‑treated events in the past 12 months.

Adult threshold: ≥2 exacerbations
Adolescent (12–17) threshold: ≥1 exacerbation
Antibiotic‑treated exacerbations within past 12 months

Prior Authorization

CT confirmation plus specialist consult and exacerbation counts

Prior authorization requires chest CT confirmation of non‑CF bronchiectasis, pulmonologist prescribing or consultation, and meeting age‑specific exacerbation counts with antibiotic‑treated events in the prior 12 months.

Adults (≥18): ≥2 exacerbations
Ages 12–17: ≥1 exacerbation
Document that exacerbations required antibiotics in past 12 months

Prior Authorization

CT confirmation, specialist involvement, exacerbation and smoking status

Provider must attest to chest CT‑confirmed non‑cystic fibrosis bronchiectasis, that the prescriber is a pulmonologist or consulted one, and provide exacerbation history including antibiotic‑treated events and smoking‑status attestation.

Exacerbation counts by age: adults ≥2; adolescents (12–17) ≥1
Evidence that exacerbations required antibiotics in past 12 months
Attest patient is not a current smoker or document counseling if smoker

Prior Authorization

Composite prior authorization requirements

Prior authorization requires provider attestation of CT‑confirmed non‑CF bronchiectasis, pulmonologist prescribing/consultation, age‑ and exacerbation‑based criteria, antibiotic‑treated exacerbations in past 12 months, and smoking status attestation.

Adults (≥18): ≥2 exacerbations; Ages 12–17: ≥1 exacerbation
At least one exacerbation in prior 12 months required antibiotics
Attestation patient is not a current smoker or counseling documented if smoker

Prior Authorization

Initial approval requires CT confirmation and pulmonologist involvement

For initial approval the provider must attest the diagnosis is non‑cystic fibrosis bronchiectasis confirmed by chest CT and that the medication was prescribed by or in consultation with a pulmonologist; age‑ and exacerbation‑based criteria and antibiotic‑treated exacerbation documentation are required.

Adults (≥18): ≥2 exacerbations; Adolescents (12–17): ≥1 exacerbation
Exacerbations required antibiotics within past 12 months
Pulmonologist prescriber or consult required

Prior Authorization

CT confirmation, specialist consult, age/exacerbation specifics

Prior authorization requires chest CT confirmation of non‑CF bronchiectasis, documentation that prescriber is a pulmonologist or consulted one, and age‑specific exacerbation counts with antibiotic‑treated events in the prior 12 months.

Adults (≥18): ≥2 exacerbations; Ages 12–17: ≥1 exacerbation
Antibiotic‑treated exacerbations within past 12 months
Provider attestation of smoking status/counseling if smoker

Prior Authorization

Brensocatib: CT confirmation and specialist attestation required

Brensocatib prior authorization requires chest CT confirmation of non‑cystic fibrosis bronchiectasis, that the drug is prescribed by or in consultation with a pulmonologist or relevant specialist, documentation of exacerbation counts by age, antibiotic‑treated exacerbations in past 12 months, and provider attestation regarding smoking status.

Adults: ≥2 exacerbations; Ages 12–17: ≥1 exacerbation
Exacerbations required antibiotics in past 12 months
Attest patient is not a current smoker or document counseling if smoker

Prior Authorization

Orlynvah: female/age/weight and uUTI documentation required

Orlynvah prior authorization requires documentation that the patient is female, ≥18 years and ≥40 kg, clinical uUTI diagnosis with ≥2 signs/symptoms, urinalysis showing pyuria/positive nitrites, urine culture (or high clinical suspicion) for listed organisms, and prior allergy/intolerance/failure to ≥2 first‑line oral agents; provider must attest Orlynvah is not step‑down after IV antibiotics.

Quantity limit: 10 tablets per 5‑day course
Organisms: E. coli, K. pneumoniae, P. mirabilis
Document failure/intolerance to ≥2 first‑line oral agents

Prior Authorization

Dawnzera: HAE diagnosis and lab confirmation required

Dawnzera prior authorization requires a diagnosis of hereditary angioedema (HAE) with documentation confirming the diagnosis by one of the listed tests.

Documentation of confirmatory testing (e.g., complement testing or C1 inhibitor protein and functional tests) is required

Prior Authorization

HAE prophylaxis: confirmed diagnosis, specialist prescriber, no concurrent prophylactics

For HAE prophylaxis, initial authorization requires confirmed HAE diagnosis documented by specified testing, prophylactic intent, prescription by or consultation with an HAE specialist (immunologist/hematologist), and that the patient is not on concurrent alternative HAE prophylactic agents.

No concurrent treatment with agents like Takhzyro, Haegarda, Cinryze, Dawnzera, Orladeyo
Patient meets package‑insert minimum age

Prior Authorization

Leqembi: specialist prescriber and baseline testing required

Leqembi (lecanemab‑irmb) initial approval requires diagnosis of MCI due to AD or mild AD dementia, prescribed by or in consultation with a dementia specialist, confirmation of beta‑amyloid plaques, baseline cognitive testing (MMSE/MoCA/CDR‑Global), brain MRI, and ApoE ε4 genotype testing prior to initiation.

Leqembi must not be combined with other amyloid beta‑directed antibodies

Prior Authorization

Rilzabrutinib (ITP): specialist consult, recent platelet count, prior therapy documented

Rilzabrutinib for persistent/chronic ITP requires a specialist prescriber or consultation, documentation of a platelet count within the past 30 days, and evidence of trial and failure of at least one other therapy plus trial/failure/allergy/contraindication/intolerance to Promacta.

Document platelet count within 30 days
Evidence of prior therapy failure

Prior Authorization

Gepotidacin (Blujepa): female, age/weight, and urinalysis/culture documentation required

Gepotidacin (Blujepa) authorization for uUTI requires the patient be female aged ≥12 and ≥40 kg, have clinical signs/symptoms with urinalysis confirming pyuria/positive nitrites and urine culture showing a susceptible organism, and documented allergy/intolerance/contraindication or therapeutic failure to at least two first‑line oral agents.

Quantity limit for uUTI: 20 tablets per 5‑day course (per gepotidacin section)

Prior Authorization

Remibrutinib (CSU): prior trials and specialist prescriber required

Remibrutinib (Rhapsido) initial approval for chronic spontaneous urticaria requires diagnosis of CSU, prior trial/failure/intolerance to H1 antihistamines and to both Xolair and Dupixent, prescription by or consultation with an allergist/immunologist or specialist, and meeting package‑insert minimum age.

Antihistamine trial ≥14 days; Xolair and Dupixent trials ≥1 month each

Prior Authorization

PA requires documented trials/failures and specialist involvement

Prior authorization is required and, unless otherwise specified, requests must include documentation of indication‑specific trials/failures and evidence of specialist prescriber or consultation as outlined in the criteria.

Document trials/failures per indication
Include prescriber specialty or consult documentation

Step Therapy

Brensocatib: no explicit step therapy stated

No explicit step therapy requirement for brensocatib is stated in the provided document chunks.

Documentation Required

Smoking counseling and documentation for current smokers

If the patient is a current smoker, the provider must counsel the patient on the harmful effects of smoking on pulmonary disease and document smoking cessation resources or counseling.

Attest patient is not a current smoker OR document counseling if smoker

Step Therapy

Orlynvah: step therapy — failure/intolerance to ≥2 first‑line agents required

Orlynvah is covered only after documented allergy/intolerance/contraindication or therapeutic failure to at least two first‑line oral agents for uUTI; provider must attest Orlynvah is not being used as step‑down therapy after IV antibiotics.

Document failure/intolerance/allergy to ≥2 first‑line oral agents
Attestation that Orlynvah is not step‑down after IV antibiotics

Step Therapy

Gepotidacin step therapy: trial/failure of ≥2 first‑line agents required

Gepotidacin for uUTI requires documented allergy/intolerance/contraindication or therapeutic failure to at least two first‑line oral agents prior to approval.

Document prior failure/intolerance/allergy to ≥2 first‑line agents relevant to organism susceptibilities

Step Therapy

Rilzabrutinib step therapy: prior therapy trials required

Rilzabrutinib (ITP) requires trial and failure of at least one other therapy for persistent/chronic ITP and documented trial/failure/allergy/contraindication/intolerance to Promacta prior to approval.

Evidence of prior therapy failure; trial/failure/allergy/contraindication/intolerance to Promacta

Step Therapy

Composite step therapy requirements — document prior trials/failures

Step therapy requirements across indications mandate specified prior trials/failures where noted (e.g., CSU, MDD, menopause, uUTI); providers must document the required prior therapies and durations to avoid denial.

CSU: antihistamines then Xolair and Dupixent trials
MDD: trials of 2 SSRIs or 2 SNRIs
Menopause: trial/failure or contraindication to hormone therapy

Documentation Required

Attest CT‑confirmed diagnosis and document exacerbation history

Providers must attest that the bronchiectasis diagnosis was confirmed by chest CT and submit documentation of exacerbation history including number, dates, and evidence that exacerbations required antibiotic treatment within the past 12 months.

CT confirmation of non‑CF bronchiectasis
Number and dates of exacerbations and records showing antibiotic treatment in past 12 months

Documentation Required

Document CT confirmation and pulmonologist prescribing/consult

Clinical documentation must include chest CT confirmation of non‑CF bronchiectasis and documentation that the prescriber is a pulmonologist or that a pulmonologist was consulted.

CT report or imaging note confirming diagnosis
Prescriber specialty or consult note showing pulmonologist involvement

Documentation Required

Documentation: CT confirmation and antibiotic‑treated exacerbations

Provider must attest the diagnosis is confirmed by chest CT and provide exacerbation history with documentation that episodes required antibiotic treatment in the past 12 months.

Exacerbation counts per age threshold
Records of antibiotic treatment for each exacerbation within prior 12 months

Documentation Required

Attest pulmonologist prescribing or consultation and CT confirmation

Attest chest CT confirmation of non‑CF bronchiectasis and that the medication is prescribed by or in consultation with a pulmonologist or other relevant specialist.

CT confirmation
Prescriber specialty or documented specialist consultation

Documentation Required

Required attestations: CT, prescriber specialty, exacerbations, smoking status

Provider must attest CT confirmation of non‑CF bronchiectasis, document exacerbation counts and antibiotic‑treated events in past 12 months, and attest smoking status (or document counseling if smoker).

Number/dates of exacerbations and evidence of antibiotic treatment
Attestation that patient is not a current smoker or documentation of counseling if smoker

Documentation Required

Initial approval documentation: CT confirmation and pulmonologist involvement

For initial approval providers must submit chest CT confirmation and documentation that the prescriber is a pulmonologist or consulted a pulmonologist; include patient age and exacerbation count consistent with adult/adolescent thresholds.

Age and exacerbation count: adults ≥2, ages 12–17 ≥1
Evidence of antibiotic treatment for exacerbations in past 12 months

Documentation Required

Document CT confirmation and smoking‑status attestation/counseling

Documentation must include chest CT confirmation and attestation that the patient is not a current smoker (or record of smoking cessation counseling if smoker).

CT confirmation
Smoking‑status attestation or counseling documentation

Documentation Required

Attest CT‑confirmed diagnosis and prescriber specialty

Providers must attest the diagnosis by chest CT and document the prescriber specialty (pulmonologist) when submitting prior authorization requests.

CT confirmation
Prescriber specialty or pulmonologist consult note

Documentation Required

Brensocatib documentation: CT confirmation and smoking‑status attestation

For brensocatib the provider must attest the diagnosis is non‑CF bronchiectasis confirmed by chest CT and attest the patient's smoking status (or document cessation counseling if smoker).

CT confirmation attestation
Smoking status attestation or counseling note

Documentation Required

Orlynvah documentation: uUTI signs/symptoms, UA and culture required

Orlynvah documentation must include clinical diagnosis of uUTI with ≥2 signs/symptoms, urinalysis confirming pyuria and/or positive nitrites, and urine culture demonstrating a susceptible organism (E. coli, K. pneumoniae, or P. mirabilis) plus evidence of prior failure/intolerance to ≥2 first‑line oral agents.

At least 2 uUTI signs/symptoms
Urinalysis showing pyuria and/or positive nitrites
Urine culture identifying a susceptible organism

Documentation Required

Dawnzera: confirmatory HAE testing required

Dawnzera documentation requires confirmatory testing for hereditary angioedema as specified in the criteria (e.g., complement testing or C1 inhibitor protein and functional assays).

Provide results of complement testing or C1 inhibitor protein and functional tests

Documentation Required

HAE diagnostic testing: complement or C1 inhibitor tests required

For HAE, documentation must include complement testing or C1 inhibitor protein and functional test results to confirm the diagnosis prior to approval.

Specify which confirmatory test was used and include results

Documentation Required

Leqembi baseline documentation: amyloid confirmation and baseline testing

Before starting Leqembi IV, providers must document confirmation of beta‑amyloid plaques and baseline disease severity using MMSE, MoCA, or CDR‑Global, and provide a brain MRI and ApoE ε4 genotype testing.

Beta‑amyloid confirmation
Baseline cognitive score (MMSE, MoCA, or CDR‑Global)
Brain MRI prior to initiation
ApoE ε4 genotype testing

Documentation Required

ITP lab and prior therapy documentation required

For rilzabrutinib (ITP), submit a platelet count from within the past 30 days and evidence of prior trial and failure of at least one other therapy; document trial/failure or intolerance to Promacta.

Platelet count within prior 30 days
Evidence of prior therapy failure and Promacta trial/failure or intolerance

Documentation Required

uUTI diagnostic documentation: UA and culture required

For uUTI indications (gepotidacin or Orlynvah), urinalysis confirming pyuria and/or positive nitrites and urine culture demonstrating a susceptible organism (or high clinical suspicion) must be submitted.

UA showing pyuria and/or positive nitrites
Urine culture identifying susceptible organism

Documentation Required

CSU documentation: trial durations and specialist attestation required

For CSU, document trials and failures with specified durations (≥14 days for antihistamines; ≥1 month for Xolair and Dupixent) and include specialist prescriber or consultation.

Antihistamine trial ≥14 days
Xolair and Dupixent trials ≥1 month each
Specialist prescriber/consult note

Documentation Required

IPF/PPF documentation: rule out causes, FVC, specialist involvement

For IPF/PPF, providers must document that other causes of pulmonary fibrosis were ruled out, record FVC (% predicted), and show specialist involvement.

FVC % predicted (must be ≥45%)
Documentation ruling out other causes of fibrosis
Pulmonologist prescriber or consult

Documentation Required

Monitoring and prior therapy documentation requirements

Monitoring and prior therapy documentation is required where specified (e.g., EKG monitoring for MDD; baseline and follow‑up LFTs for menopause) and must be included with PA requests.

EKG monitoring attestation for MDD during titration and periodically
Baseline and follow‑up LFTs for menopause per prescribing information

Denial Risk

Denial risk: missing CT confirmation, exacerbation history, or specialist consult

Failure to provide provider attestation of chest CT confirmation of non‑CF bronchiectasis, lack of documented exacerbation history including antibiotic‑treated events in the past 12 months, or absent pulmonologist prescribing/consultation may trigger denial of the prior authorization request.

Missing CT confirmation
No documentation that exacerbations required antibiotics in past 12 months
No pulmonologist prescriber or consult

Denial Risk

Denial risk: missing evidence of antibiotic‑treated exacerbations

Requests without documentation that the patient experienced exacerbations requiring antibiotic treatment in the past 12 months may not meet initial approval criteria and risk denial.

Denial Risk

Denial triggers: missing diagnosis confirmation, exacerbation history, or specialist involvement

Requests lacking provider attestation of a non‑CF bronchiectasis diagnosis confirmed by chest CT, absent required exacerbation history, or without pulmonologist involvement may be denied.

Missing CT attestation
Exacerbation counts below required thresholds (adults <2; adolescents <1)
No pulmonologist prescriber/consult

Denial Risk

Denial triggers: missing attestations (CT, specialist, exacerbation counts)

Failure to attest CT confirmation, specialist prescribing/consultation, required exacerbation counts by age, or absence of antibiotic‑treated exacerbation documentation in the past 12 months may trigger denial.

Denial Risk

Denial risk: missing smoking‑status attestation/counseling

Missing attestations including smoking‑status documentation or counseling (if smoker) in addition to absent CT confirmation or exacerbation history may be grounds for denial.

Attest patient is not a current smoker or include counseling documentation if smoker

Denial Risk

Denial risk specific to brensocatib: missing CT or pulmonologist attestation

Failure to provide CT confirmation of non‑CF bronchiectasis or pulmonologist attestation will likely result in denial of Brensocatib requests.

Denial Risk

Orlynvah denial triggers: missing demographic or uUTI diagnostic documentation

Missing required Orlynvah documentation (female status, age ≥18, weight ≥40 kg, uUTI signs/symptoms, UA with pyuria/positive nitrites, urine culture with susceptible organism, or evidence of failure/intolerance to ≥2 first‑line agents) may result in denial.

Denial Risk

Dawnzera denial triggers: missing HAE diagnosis or confirmatory tests

For Dawnzera, absence of documented HAE diagnosis or missing confirmatory laboratory testing may trigger denial of the request.

Denial Risk

HAE prophylaxis exclusion: no concurrent alternative prophylactic agents

Concurrent use of alternative prophylactic HAE agents (e.g., Takhzyro, Haegarda, Cinryze, Dawnzera, Orladeyo) disqualifies the patient from approval for HAE prophylaxis.

MechanismReduces NSP activity by inhibiting activation during neutrophil maturation

Indication contextReviewed for non‑cystic fibrosis bronchiectasis (Brinsupri)

DPP‑1 inhibitor / Brensocatib — alternate definition

Alternate DPP‑1 descriptionAn enzyme that activates proinflammatory NSPs during neutrophil maturation; brensocatib inhibits this enzyme

Clinical relevanceNSPs drive airway inflammation in bronchiectasis

Policy tie‑inDPP‑1 inhibition is the rationale for brensocatib coverage criteria

Exacerbation (policy context)

Exacerbation (policy definition)An event that required antibiotic treatment in the past 12 months

Use in criteriaSpecified number of such exacerbations required for initial approval

DocumentationDates and antibiotic treatment must be recorded for prior authorization

DPP‑1 — enzyme definition (supporting chunk)

DPP‑1 (supporting chunk)DPP‑1 activates proinflammatory NSPs during neutrophil maturation

ImplicationTargeting DPP‑1 reduces airway inflammation via lower NSP activity

SourceChunk 1 describes DPP‑1 and brensocatib mechanism

NSPs — definition and role

NSPs definitionNeutrophil serine proteases — proinflammatory enzymes implicated in bronchiectasis pathophysiology and airway inflammation

ActivationActivated during neutrophil maturation by DPP‑1

Therapeutic impactReducing NSP activity is the therapeutic goal of brensocatib

DPP‑1 / NSPs (alternate)

DPP‑1 / NSPs (alternate)DPP‑1 activates NSPs which drive airway inflammation; brensocatib reduces NSP activity

PathophysiologyNSP activity contributes to bronchiectasis airway damage and inflammation

Clinical relevanceExplains inclusion of exacerbation‑based criteria in policy

NSPs / DPP1 target (alternate)

NSPs / DPP‑1 target (alternate)NSPs are proteolytic enzymes activated by DPP‑1; brensocatib targets this activation step

RoleNSPs implicated in airway inflammation and bronchiectasis progression

Therapeutic consequenceInhibition may reduce exacerbation frequency

Neutrophil serine proteases (NSPs) — definition and role

NSPs detailedNeutrophil serine proteases are enzymes that activate proinflammatory pathways during neutrophil maturation and are key drivers of bronchiectasis airway inflammation

Clinical linkTargeting NSPs is central to brensocatib's rationale

Policy relevanceExplains requirement for documented exacerbations in criteria

Brensocatib — enzyme inhibitor (short)

Brensocatib short definitionOral DPP‑1 inhibitor that reduces NSP activity (enzyme inhibitor)

Mechanism summaryCompetitive, reversible inhibition of DPP‑1

Indication contextReviewed for non‑cystic fibrosis bronchiectasis (Brinsupri)

Exacerbation definition (single chunk)

Exacerbation (single chunk)An event requiring antibiotic treatment in the past 12 months

Policy useUsed to qualify patients for initial approval based on count thresholds

DocumentationProvider must document antibiotic‑treated exacerbations

Non‑cystic fibrosis bronchiectasis — definition

Non‑CF bronchiectasisBronchiectasis not due to cystic fibrosis; diagnosis must be confirmed by chest CT

RequirementProvider attestation of CT confirmation required for prior authorization

PrescriberPrescribed by or in consultation with a pulmonologist or relevant specialist

Uncomplicated UTI (uUTI) — definition

uUTI (uUTI) definitionClinical diagnosis in adult women with ≥2 signs/symptoms and supporting urinalysis/culture

OrganismsE. coli, K. pneumoniae, or P. mirabilis commonly listed as susceptible organisms

DocumentationUrinalysis and culture required per policy for Orlynvah

Lecanemab‑irmb (Leqembi) — brief definition

Lecanemab (Leqembi)Humanized IgG1 monoclonal antibody directed against aggregated amyloid beta

ContextIncluded as separate agent review in document (Alzheimer's agents)

Approval duration6 months initial, 12 months renewal (per chunk 166)

Remibrutinib — brief definition

RemibrutinibBTK inhibitor that blocks mast cell and basophil degranulation

UseReviewed for chronic spontaneous urticaria (CSU)

Mechanism notePrevents release of histamine and other proinflammatory mediators

Nerandomilast — brief definition

NerandomilastPDE4 inhibitor with anti‑fibrotic and immunomodulatory effects via PDE4‑B inhibition

ContextReviewed for IPF/PPF with 12‑month approval durations in document

MechanismElevates intracellular cAMP and reduces pro‑fibrotic/inflammatory mediators

Gepirone — brief definition

GepironeAgent thought to modulate serotonergic activity via 5‑HT1A agonism

ContextReviewed for MDD in document with specified approval/renewal guidance

Mechanism noteSelective 5‑HT1A receptor agonist activity

Elinzanetant — brief definition

ElinzanetantNK1 and NK3 receptor antagonist for vasomotor symptoms of menopause

MechanismModulates thermoregulation via antagonism on KNDy neurons

Approval notesInitial and renewal durations specified within document

Smoking counseling and smoking-status attestation language included for current smokers; quantity/approval durations referenced for multiple agents in the single-agent review document.