CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Jascayd (nerandomilast) — Coverage Criteria for Idiopathic Pulmonary Fibrosis (IPF) and Progressive Pulmonary Fibrosis (PPF)

Covers medical necessity criteria and authorization requirements for Jascayd (nerandomilast) for treatment of idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF) in adults for Neighborhood Health Plan of Rhode Island members.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyJascayd (nerandomilast) — Coverage Criteria for IPF and PPF

Policy CodePolicy N/A

Change TypeNew policy entry

Effective DateMay 1, 2026

Next Review DateN/A

Key ActionSubmit prior authorization with required documentation (pulmonology consult, baseline FVC, HRCT/biopsy evidence, and prior trial or intolerance to comparator therapies).

SourceLink

POLICY UPDATE CHANGES

Jascayd (nerandomilast) is listed with FDA-approved indications for treatment of IPF and PPF with specific approval criteria.

2FDA-approved indications

6 monthsInitial authorization period

60/30dQuantity limit

>=18Age requirement

Coverage Criteria for Jascayd (nerandomilast)

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Initial Therapy — IPF

Covered when ALL of the following are met:

IPF Initial Authorization: 1) The requested drug is prescribed by or in consultation with a pulmonologist; 2) Member is at least 18 years of age; 3) Documented diagnosis of idiopathic pulmonary fibrosis (IPF) with exclusion of other known causes of interstitial lung disease (e.g., environmental exposures, connective tissue disease, drug toxicity) AND either (a) HRCT or lung biopsy consistent with a usual interstitial pneumonia (UIP) pattern OR (b) HRCT not showing UIP (e.g., probable UIP or indeterminate) with supporting lung biopsy, or if no biopsy available, multidisciplinary discussion between an experienced radiologist and pulmonologist supporting the diagnosis; 4) Documentation of the member's baseline forced vital capacity (FVC); 5) Documentation of inadequate response, intolerance, or contraindication to a 6-month trial of pirfenidone (Esbriet) or nintedanib (Ofev); 6) If prescribed in combination with pirfenidone or nintedanib, documentation that the member experienced disease progression on at least a 6-month trial of monotherapy with pirfenidone or nintedanib at maximum tolerated dose.

Authorization may be granted for 6 months.

Initial Therapy — PPF

Covered when ALL of the following are met:

PPF Initial Authorization: 1) The requested drug is prescribed by or in consultation with a pulmonologist; 2) Member is at least 18 years of age; 3) Documented diagnosis of progressive pulmonary fibrosis (PPF) with both (a) HRCT showing fibrosis affecting at least 10% of the lungs AND (b) evidence of progressive disease defined as either FVC decline ≥10% predicted, OR FVC decline ≥5% and <10% with worsening respiratory symptoms or imaging, OR worsening respiratory symptoms and imaging with increased extent of fibrosis on HRCT; 4) Documentation of the member's baseline forced vital capacity (FVC); 5) Documentation of inadequate response, intolerance, or contraindication to nintedanib (Ofev); 6) If prescribed in combination with nintedanib, documentation that the member experienced disease progression on at least a 6-month trial of monotherapy with nintedanib at maximum tolerated dose.

Authorization may be granted for 6 months.

Continuation Therapy

Covered when ALL of the following are met:

Continuation — Monotherapy: Authorization of 6 months may be granted when the member has documentation of a positive clinical response to Jascayd (e.g., reduction in anticipated decline in FVC, improvement or stability in six‑minute walk distance, and/or reduction in number or severity of exacerbations) and the medication is prescribed by or in consultation with a pulmonologist.

Authorization period: 6 months.

Continuation — Combination Therapy: Authorization of 6 months may be granted when the member has documentation of a clinically meaningful improvement on combination therapy (Jascayd plus pirfenidone or nintedanib) compared to monotherapy (e.g., reduction in anticipated decline in FVC, six‑minute walk distance, and/or exacerbations) and the medication is prescribed by or in consultation with a pulmonologist.

Authorization period: 6 months.

All indications other than the FDA‑approved uses for Jascayd—specifically idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF) in adults—are considered experimental/investigational and are not a covered benefit.

Use of Jascayd for clinical conditions outside the FDA‑approved indications of IPF and PPF in adults is considered not medically necessary/experimental and will not be covered.

Provider Requirements and Authorization

Prior Authorization

Prior Authorization Required

Prior authorization required for initiation. Initial approvals are for 6 months. Requests must meet diagnostic, age, and specialist criteria (pulmonologist involvement).

Initial approval duration: 6 months
Prescriber: pulmonologist or in consultation with a pulmonologist
Member age: ≥ 18 years
Diagnostic requirements: see documentation callout

Step Therapy

Step Therapy / Prior Treatment Requirement

Step therapy / prior treatment required. Prior inadequate response, intolerance, or contraindication to specified therapies is required before authorization.

For IPF: 6-month trial, intolerance, or contraindication to pirfenidone (Esbriet) or Ofev (nintedanib) is required
For PPF: 6-month trial, intolerance, or contraindication to Ofev (nintedanib) is required
If combination therapy is requested, documentation of disease progression on at least a 6-month trial of monotherapy at maximum tolerated dose is required

Documentation Required

Required Clinical Documentation

Required clinical documentation. Include all items below with the authorization request to establish diagnosis and baseline status.

Pulmonologist involvement: prescription by or consultation with a pulmonologist
Age documentation: member is ≥ 18 years
Diagnostic imaging/biopsy: HRCT of the chest and/or lung biopsy consistent with UIP for IPF; for non‑UIP patterns, HRCT plus supportive lung biopsy or multidisciplinary discussion
For PPF: HRCT showing fibrosis affecting ≥ 10% of the lungs
Baseline pulmonary function: documented baseline forced vital capacity (FVC)
Evidence of progression for PPF: FVC decline ≥10% predicted, or FVC decline ≥5% and <10% with worsening symptoms or imaging, or worsening symptoms and increased fibrosis on HRCT
Prior therapy documentation: records demonstrating a 6-month trial (or intolerance/contraindication) of required comparator agents as noted in step therapy

Note

Non‑Approved Indications

Non‑approved indications. Uses other than the FDA‑approved indications for idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF) are considered experimental/investigational and are not covered.

Covered FDA indications: IPF and PPF in adult patients
All other indications: experimental/investigational — not a covered benefit

Denial Risk

Missing Required Clinical Documentation

Missing required clinical documentation may result in denial. Denials are likely if key items are absent from the request.

Missing HRCT report or lung biopsy supporting diagnosis
Missing baseline FVC
Missing documentation of prior 6‑month trials, intolerance, or contraindications to pirfenidone or nintedanib as applicable
Missing pulmonologist prescription or consultation note
Incomplete evidence of progression for PPF (e.g., no FVC decline data or imaging/symptom documentation)

Product Listing and Key Clinical Thresholds

Listed products/strengthsmixed

Jascayd 9mg	Jascayd (nerandomilast) 9 mg tablet — quantity limit reference
Jascayd 18mg	Jascayd (nerandomilast) 18 mg tablet — quantity limit reference

inv-07: HRCT fibrosis extent

HRCT fibrosis extent thresholdFibrosis involving at least 10% of the lungs on high‑resolution CT (HRCT)

Imaging requirementHRCT study of the chest documenting extent of fibrosis is required for PPF diagnosis

Role in authorizationDocumentation of HRCT showing ≥10% fibrosis is required for initial PPF authorization (may be granted for 6 months)

inv-08: Progression by FVC

Major FVC progressionAbsolute FVC decline ≥10% of predicted

Moderate FVC progression with corroborationFVC decline ≥5% and <10% of predicted PLUS worsening respiratory symptoms or worsening imaging

Documentation requirementBaseline FVC must be documented to establish and confirm progression

Definitions and Diagnostic Terms

inv-15: Progressive disease (PPF)

PPF definition — primary criterionProgressive pulmonary fibrosis (PPF) defined by FVC decline ≥10% predicted

PPF alternate criterionFVC decline ≥5% and <10% predicted accompanied by worsening respiratory symptoms or worsening imaging

PPF alternate patternWorsening respiratory symptoms and imaging with increased extent of fibrosis on HRCT also qualifies as progression

inv-16: UIP pattern

UIP pattern — definitionUsual interstitial pneumonia (UIP) pattern demonstrated on HRCT or lung biopsy supports the diagnosis of idiopathic pulmonary fibrosis (IPF)

Non‑UIP HRCTIf HRCT shows a non‑UIP pattern (e.g., probable UIP, indeterminate for UIP), diagnosis must be supported by lung biopsy or multidisciplinary discussion

Multidisciplinary supportWhen no biopsy available, a multidisciplinary discussion between experienced radiologist and pulmonologist can support IPF diagnosis

OpenPayer

Jascayd (nerandomilast) — Coverage Criteria for Idiopathic Pulmonary Fibrosis (IPF) and Progressive Pulmonary Fibrosis (PPF)

Coverage Criteria for Jascayd (nerandomilast)

Provider Requirements and Authorization

Product Listing and Key Clinical Thresholds

Definitions and Diagnostic Terms

Background