CurrentCignaPolicy IP0772

Idiopathic Pulmonary Fibrosis and Related Lung Disease - Jascayd for Individual and Family Plans

This policy governs prior authorization and coverage criteria for Jascayd (nerandomilast) for treatment of idiopathic pulmonary fibrosis (IPF) for members of Cigna-administered Individual and Family Plans.

Policy Summary

PayerCigna

PolicyIdiopathic Pulmonary Fibrosis and Related Lung Disease - Jascayd for Individual and Family Plans

Policy CodePolicy IP0772

Change TypeNew policy

Effective Date02/01/2026

Next Review Date

Key ActionObtain prior authorization and document baseline FVC and diagnosis evidence; approvals granted for 1 year when criteria are met.

SourceLink

POLICY UPDATE CHANGES

New policy established for coverage of Jascayd (nerandomilast) for IPF.

1 yearstandard approval duration

≥18minimum age

FVC ≥40%baseline FVC threshold

IP0772policy number

Coverage Criteria for Jascayd (nerandomilast)

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FDA-Approved Indication - Initial Therapy

Approve for 1 year if the patient meets ALL of the following (A - Initial Therapy):

Initial therapy criteria: (i) Patient is ≥ 18 years of age; AND (ii) Forced vital capacity is ≥ 40% of the predicted value at baseline [documentation required]; AND (iii) Diagnosis confirmed by ONE of: (a) findings on high-resolution computed tomography indicating usual interstitial pneumonia [documentation required] OR (b) surgical lung biopsy demonstrating usual interstitial pneumonia [documentation required]; AND (iv) Medication is prescribed by or in consultation with a pulmonologist; AND (v) Preferred product criteria is met for the product(s) as listed in the Individual and Family Plans table.FVC ≥ 40% of predicted

Initial therapy refers to a patient not currently receiving Jascayd; patient may be taking concomitant Ofev or pirfenidone.

FDA-Approved Indication - Currently Receiving Jascayd

Approve for 1 year if the patient meets ALL of the following (B - Currently Receiving Jascayd):

Continuation criteria: (i) Patient is ≥ 18 years of age; AND (ii) Patient has experienced a beneficial response to therapy over the last year while receiving Jascayd (for <1 year of therapy, response compared to baseline prior to initiating Jascayd); AND (iii) Medication is prescribed by or in consultation with a pulmonologist.

Examples of beneficial response: reduction in anticipated decline in FVC, six-minute walk distance, and/or number or severity of IPF exacerbations.

Individual and Family Plans - Preferred Product Criteria

For Individual and Family Plans (Coverage Policy Number IP0772), patient must meet ONE of the following:

IFP product preference: 1) Patient has tried generic pirfenidone tablets or capsules [documentation required]; OR 2) Patient has hepatic impairment; OR 3) Patient's glomerular filtration rate (eGFR) is < 30 mL/min; OR 4) Patient cannot swallow tablets or capsules OR has difficulty swallowing tablets or capsules; OR 5) Patient has already been started on therapy with Jascayd.eGFR < 30 mL/min (where applicable)

If the patient has tried Esbriet capsules or pirfenidone tablets this satisfies the trial requirement. Trial of the brand version of a generic equivalent also counts.

Clinical Thresholds and Coding-related Values

inv-06: Forced vital capacity (FVC) — ≥ 40% of predicted value.

Forced vital capacity (FVC) thresholdFVC ≥ 40% of predicted value at baseline (documentation required)

Baseline definitionBaseline = before starting any antifibrotic therapies (e.g., Jascayd, Ofev, pirfenidone)

Documentation requirementBaseline FVC must be documented in the medical record to support approval

inv-07: Age — ≥ 18 years (policy) / ≥ 40 years (clinical trials enrollment criteria referenced).

Policy minimum age for approvalPatient must be ≥ 18 years of age for coverage approval

Clinical trials enrollment ageTrials required patients to be ≥ 40 years of age

Documentation implicationAge must be verifiable in the medical record or claims documentation

inv-08: eGFR for step therapy exception — < 30 mL/min.

eGFR threshold for step therapy exceptioneGFR < 30 mL/min (qualifies for the Individual and Family Plans exception)

Context of useOne of the allowable conditions under IFP preferred product criteria to bypass trial of generic pirfenidone

Documentation requirementeGFR must be documented to support the exception

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior authorization required for Jascayd

Prior authorization is required for benefit coverage of Jascayd. All approvals are provided for 1 year when the coverage criteria are met; the medication must be prescribed by or in consultation with a pulmonologist.

Step Therapy

Step therapy / product preference for Individual & Family Plans

For members on Individual and Family Plans (Policy IP0772), the patient must meet ONE of the listed conditions before Jascayd is preferred: prior trial of generic pirfenidone (or Esbriet), hepatic impairment, eGFR < 30 mL/min, inability or difficulty swallowing tablets/capsules, or already being started on Jascayd.

A prior trial of generic pirfenidone tablets or capsules (trial of Esbriet or brand version of a generic equivalent also satisfies this requirement) [documentation required].
Hepatic impairment.
eGFR < 30 mL/min.
Cannot swallow or has difficulty swallowing tablets or capsules.
Already started on therapy with Jascayd.

Documentation Required

Provide required documentation

Documentation is required where noted in the criteria (marked as [documentation required]) and may include chart notes, laboratory tests, claims records, and other information; all documentation must include patient-specific identifying information.

Examples specifically requested in criteria: baseline FVC measurement, HRCT findings indicating usual interstitial pneumonia, or surgical lung biopsy demonstrating usual interstitial pneumonia.
Documentation of prior trial of generic pirfenidone when applicable.

Billing Rule

Use covered codes when billing

Claims submitted for services that are not accompanied by covered code(s) under the applicable Coverage Policy will be denied as not covered.

Denial Risk

Do not use Jascayd outside IPF

Use of Jascayd for any indication other than idiopathic pulmonary fibrosis (IPF) is considered not medically necessary and may be denied.

Background

Idiopathic pulmonary fibrosis (IPF) is the sole indication supported for Jascayd in this coverage policy. Any application of Jascayd for other conditions is listed in the policy’s "Conditions Not Covered" section and is considered not medically necessary until and unless new published evidence prompts a change to the criteria.

Definitions

inv-15: Idiopathic pulmonary fibrosis (IPF) — A chronic interstitial lung disease characterized by the histologic pattern of usual interstitial pneumonia, established by clinical feat...

Definition of IPFA chronic interstitial lung disease characterized by the histologic pattern of usual interstitial pneumonia

Diagnostic criteriaDiagnosis is established by clinical features plus either UIP on histology or classic HRCT pattern

Clinical featuresTypically affects older adults with progressive dyspnea and cough and has a variable clinical course

inv-16: Jascayd (nerandomilast) — A phosphodiesterase 4 (PDE4) inhibitor indicated for treatment of idiopathic pulmonary fibrosis in adults.

Drug class and indicationJascayd (nerandomilast) is a phosphodiesterase 4 (PDE4) inhibitor indicated for treatment of idiopathic pulmonary fibrosis in adults

Adult indicationIndicated specifically for adults with IPF

Regulatory statementOverview describes Jascayd as FDA-indicated for IPF treatment