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Brensocatib (Brinsupri) and class-level PA updates — Coverage Criteria

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Defines P&T recommendations and prior authorization criteria for Brinsupri (brensocatib) for non‑cystic fibrosis bronchiectasis and adds multiple new products with specified initial/renewal criteria and PA requirements.

Policy Summary

Payermedimpact

PolicyCoverage criteria — Brensocatib (Brinsupri) and related product additions

Policy CodePolicy N/A

Change TypeAdded new product(s) and material PA/criteria updates

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization with provider attestation of CT‑confirmed non‑CF bronchiectasis, specialist prescribing/consult, and documented antibiotic‑treated exacerbations in the past 12 months.

SourceLink

POLICY UPDATE CHANGES

New product Brinsupri (brensocatib) added as Non‑PDL with initial approval 6 months and 12‑month renewal; multiple other new products (remibrutinib, nerandomilast, gepirone, elinzanetant) added with specified criteria and quantity limits; PA required for new chemical entities until P&T review.

Initial approval requires provider attestation of CT‑confirmed non‑cystic fibrosis bronchiectasis and that the medication is prescribed by or in consultation with a pulmonologist/specialist.

Prescriber must attest patient meets one of: age ≥18 with ≥2 exacerbations OR age 12–17 with ≥1 exacerbation, with exacerbations requiring antibiotic treatment in the past 12 months.

Renewal requires provider attestation of demonstrated positive response to therapy (improvement/stabilization or reduced/stabilized exacerbations or slowing FEV1 decline) and documentation of smoking status or counseling if smoker.

6minitial approval duration

12mrenewal approval duration

5-0P&T vote

≥2adult exacerbation threshold

≥1adolescent exacerbation threshold

12 monthsexacerbation lookback

Coverage and Medical Necessity Criteria

Initial Therapy

Covered when ALL of the following are met:

Initial Approval - all required

Diagnosis and prescriber: Provider attestation of non‑cystic fibrosis bronchiectasis confirmed by chest computed tomography (CT) scan; prescribed by, or in consultation with, a pulmonologist or other specialist in the treatment of this disease.
Age/exacerbation criteria: Patient meets ONE of: aged ≥18 years with ≥2 exacerbations OR aged 12–17 years with ≥1 exacerbation.

Age/exacerbation detail: Aged 18 years and older with ≥2 exacerbations OR aged 12 to 17 years with ≥1 exacerbation.

Initial Approval Criteria

Covered when ALL of the following are met:

Initial Approval: Provider attestation of CT‑confirmed non‑cystic fibrosis bronchiectasis; prescribed by, or in consultation with, a pulmonologist or other specialist; prescriber attestation that the patient meets the age-based exacerbation criteria; documentation that the patient experienced exacerbations requiring antibiotic treatment in the past 12 months; provider attestation regarding smoking status (patient is not a current smoker or, if a smoker, counseling documented).

Initial coverage criteria

Covered when ALL of the following are met:

Required attestations and conditions: 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) Prescriber attestation that the patient meets ONE of: (a) aged ≥18 with ≥2 exacerbations; OR (b) aged 12–17 with ≥1 exacerbation; 4) Patient experienced exacerbations that required antibiotic treatment in the past 12 months; 5) Provider attestation of smoking status and counseling if current smoker.

Initial and Renewal Coverage Criteria

Covered when ALL of the following are met (initial and renewal criteria repeated throughout):

Prescriber/Consult: Prescribed by, or in consultation with, a pulmonologist or other specialist in the treatment of this disease.

Age/exacerbation requirement: Prescriber attestation that the patient meets ONE of the following: aged ≥18 years with ≥2 exacerbations; OR aged 12–17 years with ≥1 exacerbation.

Recent antibiotic-treated exacerbation: Patient experienced exacerbations that required antibiotic treatment in the past 12 months.

Smoking attestation/counseling: Provider attestation that the patient is not a current smoker; if a smoker, documentation that counseling on harms and smoking cessation options was provided.

Initial therapy and Renewal criteria

Covered when ALL of the following are met

Age and exacerbation frequency: Prescriber attestation that the patient meets ONE of: (a) aged ≥18 years with ≥2 exacerbations; OR (b) aged 12–17 years with ≥1 exacerbation.

Antibiotic-treated exacerbations: Patient experienced exacerbations that required antibiotic treatment in the past 12 months.

Smoking status attestation: Provider attestation that the patient is not a current smoker; if a smoker, documentation that smoking harms and cessation options were discussed.

Initial and Renewal Therapy Criteria

Covered when ALL of the following are met (prescriber attestation required):

Main renewal criteria: Prescriber attestation that the patient meets ONE of: (A) aged ≥18 years with ≥2 exacerbations; OR (B) aged 12–17 years with ≥1 exacerbation; AND patient experienced exacerbations requiring antibiotic treatment in the past 12 months; AND provider attestation that the patient is not a current smoker (if smoker, counseling documented); AND provider attestation that the patient has demonstrated a positive response to therapy (e.g., improvement or stabilization of symptoms).

Renewal / Continued Coverage

Renewal coverage supported when ALL of the following provider-attested conditions are met

Renewal criteria: 1) Patient experienced exacerbations that required antibiotic treatment in the past 12 months; AND 2) Provider attestation that the patient is not a current smoker (if a smoker, counseling documented); AND 3) Provider attestation of positive response to therapy by ONE of: improvement or stabilization of symptoms; OR reduction in or stabilization of frequency, severity, or duration of exacerbations.

Renewal Criteria

Renewal covered when ALL of the following are met

Renewal criteria: 1) Provider attests patient is not a current smoker (or documents counseling if smoker); AND 2) Provider attests the patient has demonstrated a positive response to therapy by at least one of: improvement or stabilization of symptoms; OR reduction in or stabilization of frequency, severity, or duration of exacerbations; OR reduction in the decline of FEV1; AND 3) Documentation that the patient experienced exacerbations requiring antibiotic treatment in the past 12 months when referenced.

Renewal Criteria

Renewal covered when ALL of the following are met:

Renewal conditions: 1) Provider attestation that the patient has demonstrated a positive response to therapy by ONE of: improvement or stabilization of symptoms; OR reduction in or stabilization of frequency, severity, or duration of exacerbations; OR reduction in the decline of FEV1; AND 2) Provider attestation that the patient is not a current smoker (if a smoker, documentation that counseling on cessation was provided); AND 3) Where applicable, documentation that the patient experienced exacerbations requiring antibiotics in the past 12 months (as referenced for interval-specific reviews).

Renewal Criteria

Renewal covered when ALL of the following are met

Demonstrated clinical benefit: Provider attestation that the patient has demonstrated a positive response to therapy by ONE of: improvement or stabilization of symptoms; OR reduction in or stabilization of the frequency, severity, or duration of exacerbations; OR reduction in the decline of FEV1.

Smoking status attestation: Provider attestation that the patient may not be a current smoker. If the patient is a smoker, documentation that counseling on the harmful effects of smoking and available cessation options was provided.

Orlynvah — Initial Therapy

Covered when ALL of the following are met

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

Donidalorsen — Initial and Renewal Criteria

Covered when ALL of the following are met

Donidalorsen initial criteria: Diagnosis of hereditary angioedema (HAE); AND documentation of confirmed diagnosis by complement testing OR C1 inhibitor protein/function tests; AND prescribed for prophylactic use; AND prescribed by, or in consultation with, an immunologist, hematologist, or HAE specialist; AND patient is not on concurrent alternative prophylactic HAE agent; AND patient meets minimum age per package insert.

Donidalorsen renewal: Prescriber attestation of improvement compared to baseline in HAE attacks (e.g., reductions in attack frequency or severity).

Leqembi IQLIK — Initial and Renewal Criteria

Covered when ALL of the following are met

Leqembi IQLIK initial criteria: Diagnosis of MCI due to Alzheimer's disease or mild dementia due to AD; AND prescribed by, or in consultation with, a dementia specialist; AND patient has completed 18 months of IV Leqembi; AND pre‑IV confirmation of beta‑amyloid plaques; AND baseline disease severity documented by MMSE OR MoCA OR CDR‑Global; AND pre‑initiation brain MRI; AND ApoE ε4 genotype testing; AND not combined with other amyloid beta‑directed antibodies.

Leqembi renewal: Positive clinical response evidenced by stabilization or slowing of disease progression documented by MMSE, MoCA, or CDR‑Global measures as specified in the policy.

Blujepa — uUTI and Gonorrhea

Covered when ALL of the following are met

Blujepa for uUTI: Patient is female; AND patient is ≥12 years of age and ≥40 kg; AND documented clinical diagnosis of uUTI with ≥2 signs/symptoms; AND urinalysis confirming pyuria and/or positive nitrites; AND urine culture confirming or highly suspicious for uUTI caused by E. coli OR K. pneumoniae OR Citrobacter freundii complex OR S. saprophyticus OR E. faecalis; AND documented allergy/intolerance/contraindication/therapeutic failure to at least 2 first-line oral agents.

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

Rhapsido — Initial Therapy

Covered when ALL of the following are met

Rhapsido initial criteria: Diagnosis of chronic spontaneous urticaria (CSU); AND trial and failure (≥14 days), contraindication, or intolerance to an H1 antihistamine; AND trial and failure (≥1 month), 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 the minimum age per package insert.

Remibrutinib (Rhapsido) Initial Therapy

Initial approval for remibrutinib (Rhapsido®) is provided when ALL of the following are met:

Remibrutinib initial - diagnosis: Diagnosis of chronic spontaneous urticaria (CSU).

H1 antihistamine trial: Trial and failure (≥14 days), contraindication, or intolerance to a histamine‑1 antihistamine.>=14 days

Biologic agents trial: Trial and failure (≥1 month), contraindication, or intolerance to BOTH Xolair and Dupixent.>=1 month

Prescriber specialty: Prescribed by, or in consultation with, an allergist, immunologist, or other applicable specialist in CSU.

Age requirement: Patient meets the minimum age recommended by the package insert for this FDA‑approved indication.

Remibrutinib Renewal

Renewal criteria for remibrutinib:

Remibrutinib renewal: Patient has experienced disease improvement and/or stabilization such as improvement in CSU symptoms, as assessed by the prescriber.

Nerandomilast (Jascayd) Initial Therapy

Initial approval for nerandomilast (Jascayd®) is provided when ALL of the following are met:

Diagnosis: Patient has a diagnosis of idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF) consistent with current guidelines.

Rule out other causes: Provider attests that other underlying causes for pulmonary fibrosis have been ruled out.

FVC threshold: Patient has Forced Vital Capacity (FVC) ≥ 45% of predicted normal.>= 45%

Prescriber specialty: Prescribed by, or in consultation with, a pulmonologist or other specialist in treating IPF/PPF.

Age requirement: Patient meets the minimum age recommended by the package insert for the indication.

Nerandomilast Renewal

Renewal criteria for nerandomilast:

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).

Gepirone (Exxua) Initial Therapy

Initial approval for gepirone (Exxua™) is provided when ALL of the following are met:

Diagnosis of major depressive disorder (MDD).

EKG monitoring: Prescriber attests to monitoring of EKG during dosage titration and periodically during treatment.

Prescriber specialty: Prescribed by, or in consultation with, a psychiatrist, neurologist, or other qualified provider experienced in treating depression.

Prior SSRI/SNRI trials: Patient has had at least a 2‑week trial and failure, allergy, contraindication, or intolerance to 2 SSRIs or 2 SNRIs.>=2 weeks

Age requirement: Patient meets the minimum age recommended by the package insert.

Gepirone Renewal

Renewal criteria for gepirone:

Renewal: Patient has experienced disease improvement and/or stabilization such as improvement in depressive symptoms, as assessed by the prescriber.

Elinzanetant (Lynkuet) Initial Therapy

Initial approval for elinzanetant (Lynkuet®) is provided when ALL of the following are met:

Diagnosis: Patient has a diagnosis of menopause with moderate to severe vasomotor symptoms.

Hepatic impairment exclusion: Patient does not have moderate to severe hepatic impairment.

Renal exclusion: Patient does not have end‑stage renal disease (with or without hemodialysis).

Pregnancy exclusion: If female of childbearing potential, patient is not pregnant and not planning pregnancy.

CYP3A4 interaction avoidance: Patient will avoid concomitant strong CYP3A4 inhibitors and grapefruit juice, and avoid moderate‑to‑strong CYP3A4 inducers.

Baseline LFTs: Prescriber attests baseline LFTs (total/direct bilirubin, ALT, AST, ALP) are not elevated ≥2× ULN and will follow recommended monitoring.>=2x ULN

Prior hormone therapy trial: Patient has trialed and failed, or is not a candidate for, hormone therapy.

Age limit: Patient is ≥18 years of age.>=18

Elinzanetant Renewal and Safety

Renewal criteria and safety limits for elinzanetant:

Renewal conditions: Patient continues to meet initial criteria and has symptom improvement.

Treatment-limiting LFTs: Treatment is limited if any of: ALT or AST >5× ULN; OR ALT or AST >3× ULN with total bilirubin >2× ULN; OR signs/symptoms suggesting liver injury.

Class-level PA requirements

Therapeutic class PA policy statements:

Preferred selection: DMS to select preferred agent(s) based on economic evaluation; at least one unique chemical entity should be preferred for the Bronchodilators, Beta‑Agonist class; agents not selected as preferred will be considered non‑preferred and require PA.

New chemical entities: For any new chemical entity in the Bronchodilators, Beta‑Agonist and other listed classes, require prior authorization until reviewed by the P&T Committee.

Cystic fibrosis–related bronchiectasis is effectively excluded by the policy’s requirement for a non‑cystic fibrosis bronchiectasis diagnosis confirmed by chest computed tomography (CT). The approval criteria explicitly require provider attestation that the diagnosis is non‑CF bronchiectasis confirmed by chest CT, which means patients with cystic fibrosis as the underlying cause do not meet the stated diagnostic requirement.

The policy requires a provider attestation that the patient may not be a current smoker; where the patient is a current smoker the prescriber must document counseling on the harms of smoking and available cessation options. This language creates an implicit exclusion for untreated current smokers unless the required documentation/counseling is provided and attested by the prescriber.

Beyond the non‑CF diagnostic requirement and the smoking‑status attestation, the excerpt does not enumerate other explicit exclusions. Coverage determinations are based on fulfillment of the listed attestations and clinical criteria (diagnosis confirmed by chest CT, specialist involvement, age/exacerbation thresholds, and antibiotic‑treated exacerbation history); failure to meet those requirements would preclude approval but no additional standalone exclusion conditions are specified in this excerpt.

Key Clinical Thresholds and Coding-related Values

Exacerbation thresholds — Adults and Adolescents

Adults (≥18 years)≥2 exacerbations

Adolescents (12–17 years)≥1 exacerbation

ContextCounts referenced as part of prescriber attestation for initial and renewal authorization

Age-based exacerbation threshold

Age ≥18≥2 exacerbations

Age 12–17≥1 exacerbation

UseApplied as prescriber attestation criterion for prior authorization

Exacerbation lookback period

Lookback periodExacerbations requiring antibiotic treatment in the past 12 months

DocumentationNumber of antibiotic-treated exacerbations must be documented/attested by prescriber

ApplicabilityRequired for initial approval and renewal criteria

Exacerbation count threshold

Adults (≥18 years)≥2 exacerbations (within prior 12 months)

Adolescents (12–17 years)≥1 exacerbation (within prior 12 months)

EvidencePrescriber attestation that exacerbations required antibiotic treatment in past 12 months

Exacerbation lookback period

Lookback windowPast 12 months for exacerbations requiring antibiotic treatment

RequirementApplies to both initial authorization and renewal attestations

SourcePrescriber attestation per policy language

Exacerbation counts

Age ≥18≥2 exacerbations

Age 12–17≥1 exacerbation

RequirementCounts integrate with attestation that exacerbations required antibiotic treatment in past 12 months

Antibiotic-treated exacerbation timeframe

TimeframeExacerbations required antibiotic treatment in the past 12 months

DocumentationProvider must document number of antibiotic-treated exacerbations in prior 12 months

RoleUsed in prescriber attestation for PA and renewal

Exacerbation count

Adults (≥18 years)≥2 exacerbations

Adolescents (12–17 years)≥1 exacerbation

ContextPart of repeated attestation language across initial and renewal sections

Prior timeframe

Prior timeframeExacerbations requiring antibiotic treatment within the past 12 months

RequirementMust be attested/documented by prescriber for authorization

Applies toInitial approval and renewals

Exacerbation count threshold

Adults (≥18 years)≥2 exacerbations (within past 12 months; required antibiotic treatment)

Adolescents (12–17 years)≥1 exacerbation (within past 12 months; required antibiotic treatment)

AttestationPrescriber must attest exacerbations required antibiotic therapy in prior 12 months

Exacerbation counts by age

Age 12–17≥1 exacerbation

Age ≥18≥2 exacerbations

ReferenceCounts appear in renewal criteria and other repeated sections

Exacerbation timeframe

TimeframeIn the past 12 months

ApplicationSpecifies lookback for antibiotic-treated exacerbations used in criteria and renewals

DocumentationPrescriber attestation required

Exacerbation lookback

LookbackPatient experienced exacerbations that required antibiotic treatment in the past 12 months

UseRequired element for initial approval and renewals per policy text

EvidenceAttestation/documentation by prescriber

Exacerbation count threshold (antibiotic-treated)

Adults (≥18 years)≥2 exacerbations (within past 12 months requiring antibiotics)

Adolescents (12–17 years)≥1 exacerbation (within past 12 months requiring antibiotics)

DocumentationPrescriber attestation that exacerbations required antibiotic treatment

Required Provider Documentation, Prior Authorization, and Denial Triggers

Prior Authorization

Prior authorization required for Brinsupri

Brensocatib (Brinsupri) is designated Non‑PDL and requires prior authorization. Initial approvals are for 6 months with renewals for 12 months.

Non‑PDL product — prior authorization required
Initial approval duration: 6 months
Renewal approval duration: 12 months

Prior Authorization

PA requires CT confirmation, specialist prescriber, and age/exacerbation attestation

Prior authorization must include prescriber attestation that the patient has CT‑confirmed non‑cystic fibrosis bronchiectasis, that the medication is prescribed by or in consultation with a pulmonologist or other specialist, and that the patient meets age‑based exacerbation thresholds (≥2 exacerbations if ≥18 years; ≥1 exacerbation if 12–17 years).

CT‑confirmed non‑CF bronchiectasis (provider attestation)
Prescribed by or in consultation with a pulmonologist/appropriate specialist
Age/exacerbation attestation: ≥18 y with ≥2 exacerbations OR 12–17 y with ≥1 exacerbation

Prior Authorization

Document antibiotic‑treated exacerbations and smoking attestation

Authorization additionally requires documentation that the patient experienced exacerbations that required antibiotic treatment within the past 12 months and prescriber attestation regarding smoking status (patient not a current smoker or counseling documented if a smoker).

Exacerbations requiring antibiotic treatment in the past 12 months (documented)
Attestation patient is not a current smoker, or if smoker, documentation of counseling

Prior Authorization

PA attestation and clinical thresholds required

Prior authorization must include prescriber attestations of CT‑confirmed non‑CF bronchiectasis, specialist involvement (prescribe or consult), age‑based exacerbation counts (≥2 for adults ≥18; ≥1 for adolescents 12–17) and that prior exacerbations required antibiotic treatment in the past 12 months.

CT confirmation of non‑CF bronchiectasis (attestation)
Specialist prescribing or consult documented
Age‑based exacerbation counts and antibiotic‑treated events in past 12 months

Prior Authorization

Specialist prescriber/consult and exacerbation documentation required for PA

The medication must be prescribed by, or in consultation with, a pulmonologist or other disease specialist; prescriber must attest the patient meets the age‑based exacerbation criteria and that exacerbations required antibiotic treatment in the prior 12 months.

Prescribed by or in consultation with pulmonologist/specialist
Attest age/exacerbation threshold met
Document antibiotic‑treated exacerbations in past 12 months

Prior Authorization

Prescriber must attest age/exacerbation frequency and antibiotic requirement

Prescriber attestation must confirm the patient meets the age/exacerbation condition (≥18 with ≥2 exacerbations or 12–17 with ≥1 exacerbation) and that prior exacerbations required antibiotic treatment in the past 12 months.

Attest ≥2 exacerbations if ≥18 years, or ≥1 if 12–17 years
Confirm those exacerbations required antibiotics within past 12 months

Prior Authorization

Renewal requires attestation of response, smoking status, and exacerbation history

For renewal, the provider must attest to clinical response and document smoking status; renewal requests must also include the number of exacerbations requiring antibiotic treatment in the prior 12 months.

Attestation of positive clinical response (improvement/stabilization or reduced/stabilized exacerbations/FEV1)
Document number of antibiotic‑treated exacerbations in past 12 months
Attest smoking status or document counseling if a smoker

Prior Authorization

Renewal attestation: smoking status and positive response required

Renewal requests must include provider attestation that the patient is not a current smoker or, if a smoker, that counseling was provided, and demonstration of positive response to therapy as specified.

Attest patient is not a current smoker or document cessation counseling
Attest positive response: improvement/stabilization of symptoms OR reduced/stabilized exacerbations OR reduced decline in FEV1

Prior Authorization

Renewal requires attestation of clinical benefit and smoking counseling if needed

Provider must attest the patient has shown clinical benefit for renewal — improvement or stabilization of symptoms, reduction/stabilization of exacerbations, or reduction in FEV1 decline — and confirm smoking status/counseling if applicable.

Attest one form of clinical benefit for renewal
Attest non‑smoker status or document counseling if smoker

Note

Documentation Required

PA documentation must include diagnosis, tests, prior therapy history, and specialist involvement

Prescribers must submit documentation that meets the product‑specific approval criteria: diagnosis, required diagnostic tests (e.g., chest CT for bronchiectasis), prior therapy trials or contraindications, and specialist consultation/prescribing as applicable.

Document diagnosis and required imaging/tests (chest CT for non‑CF bronchiectasis)
Document prior trials/failures or contraindications where required
Document specialist prescribing or consultation

Prior Authorization

PA required for new products and new chemical entities

New products listed (e.g., remibrutinib, nerandomilast, gepirone, elinzanetant) require prior authorization per their specific initial and renewal criteria; any new chemical entity in listed inhaled classes will require PA until P&T review.

PA required for remibrutinib, nerandomilast, gepirone, elinzanetant per their criteria
Any new chemical entity in Bronchodilators, Beta‑Agonist class requires PA until P&T Committee review

Step Therapy

uUTI agents require trial/failure of ≥2 first‑line oral agents prior to approval

For Orlynvah and gepotidacin (Blujepa) used for uUTI, prior authorization requires a trial and failure (or documented allergy/contraindication/intolerance) to at least two first‑line oral agents for uUTI before approval.

Document trial/failure or allergy/contraindication/intolerance to ≥2 first‑line oral uUTI agents
Applicable to Orlynvah and gepotidacin (Blujepa) uUTI indications

Step Therapy

Step therapy requirements for remibrutinib and select agents

Select agents have step therapy requirements: remibrutinib for CSU requires trial/failure (≥14 days) of an H1 antihistamine and trial/failure (≥1 month) of both Xolair and Dupixent (unless contraindicated/intolerant); elinzanetant requires trial and failure or not a candidate for hormone therapy.

Remibrutinib (CSU): trial/failure ≥14 days H1 antihistamine and ≥1 month trial/failure of Xolair and Dupixent
Elinzanetant: trial/failed or not candidate for hormone therapy

Documentation Required

Required documentation: CT confirmation, specialist involvement, and age/exacerbation attestation

Provider must attest non‑cystic fibrosis bronchiectasis diagnosis confirmed by chest CT, that the prescriber is the treating pulmonologist or that a pulmonologist was consulted, and that the prescriber attests the patient meets the age/exacerbation criteria.

Attestation of CT‑confirmed non‑CF bronchiectasis
Document pulmonologist as prescriber or consult
Attest age/exacerbation criteria met

Documentation Required

Document exacerbation history, specialist involvement, and CT confirmation

Provider must document exacerbation history including the number of antibiotic‑treated exacerbations in the past 12 months, specialist involvement (prescribed by or consulted pulmonologist), and the prescriber attestation of diagnosis confirmed by chest CT.

Number of exacerbations requiring antibiotics in past 12 months (documented)
Evidence of pulmonologist prescribing or consultation
CT confirmation of non‑CF bronchiectasis (attestation)

Documentation Required

Complete clinical documentation required for PA (diagnosis, exacerbations, specialist, smoking)

Required clinical documentation includes provider attestation of non‑CF bronchiectasis confirmed by chest CT, prescriber attestation that the patient meets age‑specific exacerbation thresholds, documentation of antibiotic‑treated exacerbations in the past 12 months, specialist involvement, and smoking status with counseling documented if current smoker.

CT confirmation of non‑CF bronchiectasis (attestation)
Age‑specific exacerbation thresholds (≥2 adults; ≥1 adolescents) attested
Antibiotic‑treated exacerbations in prior 12 months documented
Prescriber is pulmonologist or consult documented
Smoking status attestation and counseling if current smoker

Documentation Required

Document age threshold, antibiotic‑treated exacerbations, prescriber specialty, and smoking status

Provider must attest the patient meets the age‑based exacerbation threshold and document exacerbations that required antibiotic treatment in the past 12 months; also document that the prescriber is a pulmonologist or consulted one and include smoking attestation/counseling if applicable.

Attest age‑based threshold (≥2 if ≥18; ≥1 if 12–17)
Document antibiotic‑treated exacerbations in past 12 months
Confirm pulmonologist prescriber or consultation
Provide smoking status attestation or counseling note if smoker

Documentation Required

For PA and renewal document exacerbation count, smoking status, and response to therapy

Provider must document the number of exacerbations requiring antibiotic treatment in the past 12 months, the patient's smoking status (and counseling if a smoker), and evidence of positive response to therapy for renewals (improvement/stabilization or reduction/stabilization of exacerbations or FEV1).

Number of antibiotic‑treated exacerbations in prior 12 months
Attest non‑smoker or document cessation counseling if smoker
For renewal: document positive response to therapy (one of listed clinical benefits)

Documentation Required

Required documentation for renewal: smoking attestation and demonstrated positive response

For renewal the provider must attest the patient is not a current smoker or, if a smoker, that counseling was provided; the provider must also document a positive clinical response to therapy (improvement/stabilization of symptoms OR reduction/stabilization of exacerbations OR reduction in decline of FEV1).

Attest non‑smoker status or document smoking cessation counseling if smoker
Attest positive response to therapy using one of the acceptable measures
Include documentation of antibiotic‑treated exacerbations in prior 12 months when referenced

Documentation Required

Renewal: attest clinical benefit and smoking status/counseling

Renewal requires provider attestation that the patient has demonstrated a positive response to therapy (improvement/stabilization of symptoms; OR reduction/stabilization of exacerbation frequency, severity, or duration; OR reduction in decline of FEV1) and attestation that the patient is not a current smoker or that smoking counseling was provided if a smoker.

Attest one form of clinical benefit for renewal
Attest non‑smoker or document counseling if smoker

Documentation Required

Renewal documentation must show clinical benefit and smoking counseling when applicable

Provider must attest the patient has demonstrated positive response to therapy (by improvement/stabilization of symptoms OR reduction/stabilization of exacerbations or FEV1 decline) for renewal and document smoking status or counseling if the patient is a smoker.

Document clinical benefit per renewal criteria
Document smoking status or counseling if smoker

Documentation Required

Provider attestation of response and smoking status required for renewal

For renewal the provider must attest to a positive response to therapy by one of the listed outcomes (improvement/stabilization of symptoms; reduction/stabilization of exacerbations; or reduction in decline of FEV1) and must attest that the patient is not a current smoker or provide documentation that smoking cessation counseling occurred if the patient is a smoker.

Attest positive response to therapy using acceptable measures
Attest non‑smoker or document counseling if smoker

Note

Denial Risk

Triggers for denial: missing CT confirmation, specialist involvement, or exacerbation history

Lack of provider attestation of CT‑confirmed non‑cystic fibrosis bronchiectasis, absence of specialist prescriber/consult, or missing documentation of required exacerbation history are triggers for denial.

No attestation of CT‑confirmed non‑CF bronchiectasis
No pulmonologist/specialist prescriber or consult documented
Missing exacerbation count or antibiotic‑treated exacerbation history

Denial Risk

Denial risk for missing core attestations (diagnosis, specialist, exacerbation)

If the prescriber fails to attest to CT‑confirmed non‑CF bronchiectasis, fails to document specialist prescribing/consultation, or omits the required exacerbation attestations, the request may be denied.

Absent attestation of CT‑confirmed diagnosis
No specialist prescribing/consultation documented
No age/exacerbation attestation present

Denial Risk

Denied if core attestation or clinical criteria are missing

Requests will be denied when core attestations or clinical criteria are missing: specifically, if there is no prescriber attestation of CT‑confirmed non‑CF bronchiectasis, no specialist prescription/consult, or no documentation that prior exacerbations required antibiotic treatment in the past 12 months.

No CT‑confirmed non‑CF bronchiectasis attestation
No pulmonologist/specialist prescribing or consult documented
No documentation that exacerbations required antibiotics in prior 12 months

Denial Risk

Potential denial triggers: missing exacerbation counts, antibiotic requirement, specialist or smoking attestations

Potential denial triggers include failure to document prescriber attestation of exacerbation counts (≥2 for adults ≥18 or ≥1 for ages 12–17), absence of documentation that exacerbations required antibiotics in the prior 12 months, and missing specialist involvement or smoking attestation.

Missing exacerbation count attestation per age thresholds
No documentation that prior exacerbations required antibiotic treatment within 12 months
No pulmonologist involvement or smoking attestation provided

Denial Risk

Potential denial for missing age/exacerbation or antibiotic‑treatment documentation

If the prescriber does not attest that the patient meets the age/exacerbation criteria or does not document that prior exacerbations required antibiotic treatment in the past 12 months, the PA may be denied.

No attestation that age/exacerbation criteria met
No record that prior exacerbations required antibiotics within 12 months

Denial Risk

Missing prescriber attestations may lead to denial

Missing attestations identified in prior authorization requests — e.g., failure to attest the patient meets the age/exacerbation criteria or that exacerbations required antibiotic treatment in the past 12 months — are grounds for non‑approval.

Absent attestation of age/exacerbation thresholds
Absent documentation that exacerbations required antibiotics in past 12 months

Denial Risk

Denial risk for missing antibiotic‑treated exacerbation or smoking attestations

Lack of provider attestation of required criteria (antibiotic‑treated exacerbations in past 12 months; non‑smoker status or documented counseling) may trigger denial of initial or renewal requests.

No documentation of antibiotic‑treated exacerbations in prior 12 months
No attestation that patient is not a current smoker or no counseling documented if smoker

Denial Risk

Smoking status attestation required — missing attestation may trigger denial

Absence of provider attestation that the patient is not a current smoker or absence of documented smoking cessation counseling when the patient is a smoker may result in denial.

No attestation patient is not a current smoker
No documentation of counseling when patient is a current smoker

Denial Risk

Exacerbation documentation required — missing antibiotic‑treated event history may cause denial

Failure to document that the patient experienced exacerbations requiring antibiotic treatment in the past 12 months may result in denial of initial approval or renewal.

Missing documentation that exacerbations required antibiotics within past 12 months
May result in denial of PA or renewal

Denial Risk

Potential denial triggers at renewal: missing response attestation or smoking counseling

Lack of provider attestation demonstrating a positive response to therapy for renewal, or failure to document smoking status/counseling, are potential denial triggers for continuation.

No attestation of positive clinical response for renewal
No smoking status attestation or counseling documented if smoker

Denial Risk

Missing required attestations for renewal may trigger denial

Missing required attestation of demonstrated positive response to therapy or absence of smoking counseling/attestation at renewal may lead to denial of continued coverage.

No attestation of clinical benefit per renewal criteria
No smoking cessation counseling documented if patient is a smoker

Denial Risk

Orlynvah denial triggers: missing demographics, diagnostics, or step‑therapy evidence

For Orlynvah, denial triggers include failure to document patient demographics (female, ≥18 years, ≥40 kg) or lacking required diagnostic confirmations (≥2 signs/symptoms, urinalysis, urine culture) or absence of trial/failure of ≥2 first‑line oral agents.

No documentation patient is female, ≥18 years and ≥40 kg
No urinalysis/urine culture or ≥2 signs/symptoms documented
No trial/failure to ≥2 first‑line oral uUTI agents recorded

Denial Risk

Dawnzera (donidalorsen) denial triggers: missing diagnostic confirmation or specialist involvement

For donidalorsen (Dawnzera), lack of documented confirmed diagnosis of HAE (complement testing or C1 inhibitor protein/function tests), lack of specialist prescribing/consultation, or concurrent prophylactic HAE therapy may lead to denial.

No confirmatory HAE testing documented (complement or C1 inhibitor tests)
No immunologist/hematologist/HAE specialist prescribing or consult documented
Concurrent alternative prophylactic HAE agent present

Denial Risk

CSU initial therapy requirements — missing prior therapy trials may cause denial

For CSU initial therapy (e.g., remibrutinib), failure to document trials and failures (or contraindication/intolerance) to required prior therapies — H1 antihistamine trial ≥14 days and trial/failure of Xolair and Dupixent ≥1 month each — may trigger denial.

No documentation of ≥14‑day H1 antihistamine trial/failure or contraindication/intolerance
No documentation of ≥1‑month trial/failure or contraindication/intolerance to both Xolair and Dupixent

Denial Risk

IPF/PPF baseline criteria required — FVC ≥45% and rule‑out of other causes

For nerandomilast in IPF/PPF, if baseline FVC is <45% predicted or if other underlying causes of pulmonary fibrosis have not been ruled out, coverage may be denied.

FVC must be ≥45% predicted at baseline
Provider must attest other causes of pulmonary fibrosis have been ruled out

Clinical Background and Definitions

Brensocatib (Brinsupri) is described as an oral, competitive, reversible dihpeptidyl peptidase‑1 (DPP‑1) inhibitor that targets neutrophil serine proteases (NSPs). DPP‑1 activates proinflammatory NSPs during neutrophil maturation; by inhibiting DPP‑1 brensocatib reduces NSP activity, which is implicated in bronchiectasis pathophysiology and airway inflammation.

DPP‑1 / NSPs

MechanismDPP‑1 activates neutrophil serine proteases (NSPs)

Clinical relevanceNSPs are proinflammatory mediators implicated in bronchiectasis airway inflammation

Therapeutic targetBrensocatib inhibits DPP‑1 to reduce NSP activity

Exacerbation (policy definition)

DefinitionAn acute worsening of respiratory symptoms that required antibiotic treatment

Use in policyCounts of such exacerbations in past 12 months determine eligibility

DocumentationEvents must be attested by the prescriber

Confirmed diagnosis — CT-confirmed non-CF bronchiectasis

Required diagnostic confirmationCT-confirmed non-cystic fibrosis bronchiectasis

DocumentationProvider attestation that diagnosis is confirmed by chest CT

ApplicabilityRequired for prior authorization

Exacerbation requiring antibiotic treatment

DefinitionExacerbation within prior 12 months that required antibiotic therapy

RequirementMust be documented for initial approval and renewals

EvidencePrescriber attestation suffices per policy language

CT‑confirmed non‑cystic fibrosis bronchiectasis

ImagingChest CT confirmation documented in record

TerminologyCT‑confirmed non‑cystic fibrosis bronchiectasis

PurposeDifferentiates non-CF bronchiectasis from cystic fibrosis-related disease for coverage

Exacerbation — antibiotic-treated (policy)

DefinitionExacerbation = episode requiring antibiotic treatment (past 12 months)

RoleUsed repeatedly across initial and renewal criteria as qualifying event

DocumentationPrescriber attestation required

Exacerbation — renewal-context

Definition (renewal)Prior 12 months exacerbation requiring antibiotic treatment (provider attestation)

UseReferenced as required documentation for renewal approval

VerificationProvider attestation of events and antibiotic treatment required

Positive response to therapy (renewal)

Renewal evidenceProvider-attested improvement or stabilization of symptoms OR reduction/stabilization of exacerbations OR reduction in decline of FEV1

PurposeUsed to justify continued coverage at renewal

DocumentationPrescriber attestation required per policy

Policy Revision History

as recorded (P&T meeting)P&T vote & listing

P&T Committee recommended Brinsupri (brensocatib) as Non-PDL with a recorded vote of 5 For, 0 Against and approval duration of 6 months initial, 12 months renewal.

as recorded (P&T meeting)New product additions

New products Rhapsido (remibrutinib), Jascayd (nerandomilast), Exxua (gepirone), and Lynkuet (elinzanetant) were added with specified initial and renewal approval durations and quantity limits (e.g., remibrutinib: 12 months initial/renewal; nerandomilast and remibrutinib: quantity limit 2 tablets per day).

as recorded (P&T meeting)Class-level PA directiveLatest

Policy directed DMS to select preferred agent(s) based on economic evaluation and required prior authorization for any new chemical entity in the Bronchodilators, Beta-Agonist class until reviewed by the P&T Committee.

Policy Summary

Payermedimpact

PolicyCoverage criteria — Brensocatib (Brinsupri) and related product additions

Policy CodePolicy N/A

Change TypeAdded new product(s) and material PA/criteria updates

Effective DateN/A

Next Review DateN/A

SourceLink

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Brensocatib (Brinsupri) and class-level PA updates — Coverage Criteria

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Coverage and Medical Necessity Criteria

Initial Therapy

Covered when ALL of the following are met:

Initial Approval - all required

Diagnosis and prescriber: Provider attestation of non‑cystic fibrosis bronchiectasis confirmed by chest computed tomography (CT) scan; prescribed by, or in consultation with, a pulmonologist or other specialist in the treatment of this disease.
Age/exacerbation criteria: Patient meets ONE of: aged ≥18 years with ≥2 exacerbations OR aged 12–17 years with ≥1 exacerbation.