ModifiedCignaPolicy IP0772

Pulmonary - Antifibrotics - Jascayd

Defines prior authorization, clinical criteria, and coverage conditions for Jascayd (nerandomilast) for adults with idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF) under Cigna Individual and Family Plans.

Policy Summary

PayerCigna

PolicyPulmonary - Antifibrotics - Jascayd

Policy CodePolicy IP0772

Change TypeMaterial additions and clarifications

Effective Date

Next Review Date

Key ActionObtain prior authorization and ensure medication is prescribed by or in consultation with a pulmonologist (approvals provided for 1 year).

SourceLink

POLICY UPDATE CHANGES

Progressive Pulmonary Fibrosis condition of approval was added to the policy with specific initial and continuation criteria.

Prior authorization requirement and specialist prescribing/consultation requirement for Jascayd established.

Employer Plans preferred product requirements introduced requiring step therapy through pirfenidone or Ofev for IPF and through Ofev for Progressive Pulmonary Fibrosis (with Individual and Family Plans limitations).

Clarified that patients initiating Jascayd may be on concomitant Ofev (nintedanib) therapy.

Policy name changed to 'Pulmonary - Antifibrotics - Jascayd' from prior policy title.

≥18minimum patient age for approvals

≥40%FVC threshold for initiation

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Coverage Criteria for Jascayd (nerandomilast)

Plan-level product selection and exceptions

Plan-specific additional criteria for product selection and exceptions apply:

Employer Plan IPF/PPF alternatives: Patient must meet ONE of listed exceptions or have trialed preferred products

Options include prior trial of pirfenidone or Ofev, hepatic impairment, eGFR < 30 mL/min, inability to swallow, pregnancy, cardiovascular/bleeding/GI perforation risk, or already on Jascayd

Initial Therapy

Covered when ALL of the following are met

Initial therapy for progressive pulmonary fibrosis: Patient is ≥ 18 years of age; Forced vital capacity is ≥ 40% of the predicted value; prescriber documents fibrosing lung disease impacting > 10% of lung volume on high-resolution CT; prescriber documents clinical signs of progression; medication prescribed by or in consultation with a pulmonologist.see node texts

Clinical signs examples: FVC decline ≥10% predicted or FVC decline 5%–<10% with worsening symptoms and/or imaging.

Continuation Therapy

Covered when ALL of the following are met

Continuation therapy for patients currently receiving Jascayd: Patient is ≥ 18 years of age; patient has experienced a beneficial response to therapy over the last year while receiving Jascayd; medication prescribed by or in consultation with a pulmonologist.see node texts

Examples of beneficial response: reduced anticipated decline in FVC, six-minute walk distance, and/or fewer or less severe ILD-related exacerbations.

Employer Plan Step Therapy Requirements

For Employer Plans only

Employer Plan step therapy for Idiopathic Pulmonary Fibrosis: Step through either pirfenidone or Ofev is required for a diagnosis of Idiopathic Pulmonary Fibrosis.

Individual and Family Plans preferred product requirements only apply to Idiopathic Pulmonary Fibrosis.

Employer Plan step therapy for Progressive Pulmonary Fibrosis: Step through Ofev is required for a diagnosis of Progressive Pulmonary Fibrosis.

Jascayd (nerandomilast) is not covered for indications outside the specified approval criteria described in this policy. Use of Jascayd for any other purpose is considered not medically necessary. The policy will be updated if new published data change the coverage stance.

Use of Jascayd for indications other than the specified Idiopathic Pulmonary Fibrosis (IPF) and Progressive Pulmonary Fibrosis (PPF) criteria in this policy is considered not medically necessary. Coverage is limited to the conditions and criteria explicitly listed.

Coding and Clinical Thresholds

No explicit CPT/HCPCS/ICD-10/NDC codes listed in this segmentmixed

No codes listed

Codes mentionedmixed

N/A	No specific CPT/HCPCS/ICD/NDC codes listed in this segment

FVC percent predicted

FVC percent predicted (initiation)≥ 40% of predicted (required for initiation of therapy)

FVC observed in clinical trials≥ 45% reported as a trial-based entry threshold

Documentation noteBaseline FVC percent predicted is required (documentation required)

DLCO

DLCO trial entry threshold≥ 25% (DLCO corrected for hemoglobin used as a trial entry threshold)

Measurement contextDLCO decline ≥ 10% over 1 year is an example physiologic progression metric for PPF

Provider Actions, Documentation, and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required for Jascayd. All approvals are provided for 1 year. Because of the specialized skills required for evaluation, diagnosis, and monitoring of patients treated with Jascayd, the medication must be prescribed by or in consultation with a physician who specializes in the condition being treated (e.g., pulmonologist).

Prior authorization required for Jascayd; approvals are provided for 1 year.
Medication must be prescribed by or in consultation with a specialist (pulmonologist).

Step Therapy

Prior Authorization and Step Therapy Requirements

For Individual and Family Plans and Employer Plans, prior authorization is required and step-therapy/ prior trial requirements apply as specified below. Employer Plans: a step through either pirfenidone or Ofev is required for Idiopathic Pulmonary Fibrosis; a step through Ofev is required for Progressive Pulmonary Fibrosis. Individual and Family Plans: preferred product (step) requirements apply for Idiopathic Pulmonary Fibrosis as detailed in criteria.

Background

Idiopathic pulmonary fibrosis (IPF) is a chronic, progressive fibrosing interstitial lung disease characterized by the histologic or radiologic pattern of usual interstitial pneumonia and predominantly affects older adults with a poor median survival. Progressive pulmonary fibrosis (PPF) refers to fibrosing interstitial lung diseases other than IPF that demonstrate physiologic or radiologic progression (for example, an absolute decline in FVC or DLCO or worsening imaging). This policy defines coverage for Jascayd for adults aged ≥ 18 years with either IPF or PPF who meet the specific initial or continuation criteria, and notes that use outside those criteria is considered not medically necessary.

Key Definitions

Idiopathic pulmonary fibrosis (IPF)

DefinitionIdiopathic pulmonary fibrosis (IPF) is a chronic interstitial lung disease characterized by the histologic pattern of usual interstitial pneumonia on HRCT or lung biopsy.

Clinical featuresManifests with progressive dry cough and exertional dyspnea; predominantly affects older adults with mean survival 3–5 years after symptom onset.

Diagnostic confirmationDiagnosis established by usual interstitial pneumonia pattern on HRCT or by surgical lung biopsy demonstrating usual interstitial pneumonia.

Progressive pulmonary fibrosis (PPF)

DefinitionProgressive pulmonary fibrosis (PPF) describes progressive fibrosing interstitial lung disease (ILD) other than IPF with physiologic or radiologic evidence of progression.

Physiologic progression example

Policy Summary

PayerCigna

PolicyPulmonary - Antifibrotics - Jascayd

Policy CodePolicy IP0772

Change TypeMaterial additions and clarifications

Effective Date

Next Review Date

Key ActionObtain prior authorization and ensure medication is prescribed by or in consultation with a pulmonologist (approvals provided for 1 year).

SourceLink

On This Page

Denial Risk

Denial Triggers

Claims submitted without a covered diagnosis or without meeting the Coverage Policy criteria will be denied as not covered. Denial may be triggered if required criteria are not met or not documented (for example: age ≥ 18 years, baseline FVC ≥ 40% predicted where required, prescriber-documented >10% lung involvement on HRCT for progressive disease, or clinical signs of progression).

Claims lacking covered diagnosis or procedure codes will be denied as not covered.
Denial triggers include missing required criteria such as age ≥18, FVC ≥40% predicted (when required), prescriber documentation of >10% lung involvement on HRCT for progressive disease, or absence of documented clinical signs of progression.

Documentation Required

Required Documentation

Documentation is required where noted in the criteria. Documentation may include chart notes, laboratory tests, imaging, and other supporting records and must include patient-specific identifying information. Examples of required documentation include baseline FVC percent predicted, high-resolution CT findings indicating usual interstitial pneumonia or prescriber statement of fibrosing lung disease extent (>10% lung volume) for Progressive Pulmonary Fibrosis, surgical lung biopsy reports when applicable, and records of prior trials of pirfenidone or Ofev when required.

Baseline FVC value (percent predicted) [documentation required].
HRCT findings indicating usual interstitial pneumonia OR surgical lung biopsy demonstrating usual interstitial pneumonia [documentation required] for IPF.
Prescriber statement documenting fibrosing lung disease impacting >10% of lung volume on HRCT and clinical signs of progression for Progressive Pulmonary Fibrosis [documentation required].
Documentation of prior trials of pirfenidone or Ofev (including brand/generic) when step requirements apply [documentation required].

Progressive Pulmonary Fibrosis — examples

Example conditionsHypersensitivity pneumonitis; idiopathic nonspecific interstitial pneumonitis; unclassifiable idiopathic interstitial pneumonia; autoimmune ILD (e.g., rheumatoid arthritis-related ILD); exposure-related ILD; mixed connective tissue disease ILD.

Clinical coursePPF has a clinical course similar to IPF with gradual and irreversible pulmonary fibrosis and progressive respiratory impairment.

Concomitant therapy notePatients initiating Jascayd may be on concomitant Ofev (nintedanib).