CurrentMass General Brigham Health PlanPolicy N/A

Jascayd (nerandomilast) prior authorization for idiopathic pulmonary fibrosis and progressive pulmonary fibrosis

Defines prior authorization, coverage criteria, and specialty pharmacy requirements for Jascayd (nerandomilast) for adults with idiopathic pulmonary fibrosis or progressive pulmonary fibrosis under the Mass General Brigham Health Plan commercial/exchange pharmacy benefit.

Policy Summary

PayerMass General Brigham Health Plan

PolicyJascayd (nerandomilast) prior authorization for idiopathic pulmonary fibrosis and progressive pulmonary fibrosis

Policy CodePolicy N/A

Change TypeNew policy

Effective DateJun 1, 2026

Next Review DateN/A

Key ActionObtain prior authorization through the pharmacy benefit and submit required clinical documentation, including HRCT/biopsy results and prior therapy details.

SourceLink

POLICY UPDATE CHANGES

New policy created for Jascayd (nerandomilast) with coverage criteria for IPF and progressive pulmonary fibrosis.

12 monthsinitial and reauthorization approval duration

2/dayquantity limit for Jascayd tablet

>=10%HRCT fibrosis extent threshold

Commercial/Exchangeplan applicability

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Coverage Criteria for Jascayd (nerandomilast)

Idiopathic Pulmonary Fibrosis (Initial Authorization)

Authorization may be granted when ALL of the following are met for Idiopathic Pulmonary Fibrosis (IPF):

IPF overall

Diagnosis of idiopathic pulmonary fibrosis (IPF)
Exclude other causes: Other known causes of interstitial lung disease (e.g., domestic and occupational environmental exposures, connective tissue disease, drug toxicity) have been excluded
Diagnostic confirmation
- UIP on HRCT or biopsy: Member has completed a high-resolution computed tomography (HRCT) study of the chest or a lung biopsy which reveals a result consistent with the usual interstitial pneumonia (UIP) pattern
- Non-UIP HRCT and supporting evidence: HRCT not UIP PLUS either lung biopsy supporting diagnosis OR multidisciplinary discussion between an experienced radiologist and pulmonologist
Prior antifibrotic therapy
- Trial/failure of antifibrotic: Trial and failure, contraindication, or intolerance to ONE of: pirfenidone OR nintedanib (Ofev)
- Combination therapy: Member will be continuing therapy with pirfenidone OR nintedanib in combination with Jascayd (nerandomilast)

New-to-plan documentation: If member is new to the plan (coverage effective ≤90 days), submit medical records documenting the member is currently receiving treatment with the requested drug

Progressive Pulmonary Fibrosis (Initial Authorization)

Authorization may be granted when ALL of the following are met for Progressive Pulmonary Fibrosis:

Progressive PF overall

Diagnosis of progressive pulmonary fibrosis
HRCT extent: Member has completed an HRCT study of the chest that shows fibrosis affecting at least 10 percent of the lungs>= 10%
Progression evidence: Member has progressive disease (e.g., forced vital capacity [FVC] decline greater than or equal to 10% of the predicted value, worsening respiratory symptoms, increased extent of fibrosis on HRCT)
Prior therapy or add-on:

Reauthorization Criteria

Continuation of Therapy

Reauthorization

Clinical response: Member demonstrates a positive clinical response to therapy

This policy applies to the Commercial/Exchange pharmacy benefit. Jascayd (nerandomilast) is designated as a specialty medication and must be dispensed through a contracted specialty pharmacy. Prior authorization is required through the pharmacy benefit, and approvals (initial and reauthorization) are granted for 12 months. Quantity limits apply as stated in the policy (Jascayd tablet: 2 tablets/day).

Use of Jascayd (nerandomilast) for indications other than idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis is not consistent with the coverage criteria and will not meet medical necessity. Requests that do not document the required diagnostic criteria — for IPF: exclusion of other known causes and diagnostic confirmation by HRCT or lung biopsy (or HRCT plus biopsy/multidisciplinary discussion when HRCT is not UIP); for progressive pulmonary fibrosis: HRCT showing fibrosis involving at least 10 percent of the lungs plus evidence of clinical progression — or that lack required prior therapy information (e.g., trial/failure, contraindication, or intolerance to specified antifibrotics) should be considered not medically necessary.

Prior Authorization, Documentation, and Dispensing Requirements

Prior Authorization

Prior Authorization and Specialty Pharmacy

Prior authorization required through the pharmacy benefit. These products are designated specialty and must be dispensed by a contracted specialty pharmacy.

Pharmacy benefit prior authorization required
Specialty pharmacy dispensing required — fill at contracted specialty pharmacy
Contact pharmacy benefit PA: Phone 800-711-4555, Fax 844-403-1029

Documentation Required

Required Clinical Documentation

Authorization may be granted when medical records show the member is currently receiving the requested drug (for members new to the plan with coverage effective ≤ 90 days) or when all clinical criteria below are met. Include documentation of diagnosis, prior therapies, HRCT and/or lung biopsy reports, multidisciplinary discussion notes (if applicable), and objective measures of disease progression (e.g., FVC decline, HRCT extent of fibrosis).

If member is new to the plan (coverage effective ≤ 90 days): submit medical records documenting current treatment with the requested drug (exclude samples or manufacturer assistance program supplies).
Required documentation: diagnosis documentation, HRCT report, lung biopsy pathology or multidisciplinary discussion notes, treatment history, evidence of intolerance/contraindication to prior agents, recent pulmonary function tests (including FVC) and clinical notes showing disease progression.

Step Therapy

Prior Therapy Requirements

For idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis indications, a trial and failure, intolerance, or contraindication to pirfenidone or nintedanib (Ofev) is required unless the request is for continuing combination therapy with Jascayd and one of those agents, or the member is already receiving add‑on therapy with nintedanib.

IPF: Trial and failure, contraindication, or intolerance to ONE of: pirfenidone or nintedanib (Ofev) — OR request is for continuation in combination with pirfenidone or nintedanib.
Progressive pulmonary fibrosis: Trial and failure, contraindication, or inadequate response to nintedanib (Ofev) — OR member currently treated with nintedanib and requires add‑on therapy.

Denial Risk

Documentation or Criteria Missing — Denial Risk

Incomplete or missing required documentation (diagnosis, HRCT/lung biopsy reports, prior therapy history, PFTs, or multidisciplinary discussion notes) may result in denial. Ensure all requested clinical notes and objective testing are submitted with the PA request to avoid processing delays.

Missing proof of current therapy for members new to plan (coverage effective ≤ 90 days) is denial-risk.
Absent documentation of trial/failure/contraindication to pirfenidone or nintedanib when required is denial-risk.
Lack of HRCT report, lung biopsy, multidisciplinary discussion notes, or recent pulmonary function tests is denial-risk.

Background

Jascayd (nerandomilast) is indicated in this policy for the treatment of adults with idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis. The policy requires diagnostic confirmation for IPF by HRCT or lung biopsy demonstrating a usual interstitial pneumonia (UIP) pattern, or HRCT plus biopsy or multidisciplinary discussion when HRCT is non‑UIP. For progressive pulmonary fibrosis the policy requires HRCT evidence of fibrosis affecting at least 10 percent of the lungs and objective evidence of progression such as an absolute or relative decline in forced vital capacity (FVC) of >= 10% of predicted, worsening respiratory symptoms, or increased fibrosis on HRCT. Prior authorization and specialty pharmacy dispensing are required for covered use under the Commercial/Exchange pharmacy benefit.

OpenPayer

Jascayd (nerandomilast) prior authorization for idiopathic pulmonary fibrosis and progressive pulmonary fibrosis

Coverage Criteria for Jascayd (nerandomilast)

Key Clinical Thresholds and Coding-Adjacent Criteria

Prior Authorization, Documentation, and Dispensing Requirements

Key Definitions

Background