ModifiedCignaPolicy IP0772

Idiopathic Pulmonary Fibrosis and Related Lung Disease – Jascayd for Individual and Family Plans - (IP0772)

Defines prior authorization, clinical criteria, documentation requirements, duration of approval, and product-preference/step therapy exceptions for Jascayd (nerandomilast) for treatment of idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF) for Cigna Individual & Family Plans and Employer Plans.

Policy Summary

PayerCigna

PolicyIdiopathic Pulmonary Fibrosis and Related Lung Disease – Jascayd for Individual and Family Plans - (IP0772)

Policy CodePolicy IP0772

Change TypeMODIFIED

Effective Date

Next Review Date

Key ActionPrior Authorization is required for Jascayd; submit required documentation and ensure prescribing specialist involvement (pulmonologist for IPF; pulmonologist or rheumatologist for PPF).

SourceLink

POLICY UPDATE CHANGES

Progressive Pulmonary Fibrosis condition of approval was added to the policy, including initial therapy and criteria for patients currently receiving Jascayd.

Employer Plans preferred product requirements added requiring step through pirfenidone or Ofev for IPF and Ofev for PPF.

Policy title changed to 'Pulmonary - Antifibrotics - Jascayd'.

New policy created.

2Covered Indications (IPF, PPF)

Typical approval duration

>=40%Minimum baseline FVC requirement

10%HRCT fibrotic extent threshold for PPF

Coverage Summary

Coverage stance: covered_with_criteria for both Idiopathic Pulmonary Fibrosis (IPF) and Progressive Pulmonary Fibrosis (PPF) under Coverage Policy Number IP0772. Scope: defines prior authorization, clinical criteria, documentation requirements, duration of approval, and product-preference/step therapy exceptions for Jascayd (nerandomilast) for IPF and PPF. Typical approval duration: 1 year. Key thresholds: age ≥ 18 years; baseline forced vital capacity (FVC) ≥ 40% of predicted; for PPF, fibrosing lung disease affecting > 10% of lung volume on HRCT (and clinical progression criteria as specified).

FDA-Approved Indication - Idiopathic Pulmonary Fibrosis (IPF)

Approve for 1 year if the patient meets the following (A or B):

ANY of the following

A) Initial Therapy
- Patient is ≥ 18 years of ageage >= 18 years
- Forced vital capacity is ≥ 40% of the predicted value at baseline [documentation required]FVC >= 40% of predicted
  Baseline is before a patient has started any antifibrotic therapies.
- Diagnosis is confirmed by ONE of the following
  - Findings on high-resolution computed tomography indicate usual interstitial pneumonia [documentation required]HRCT shows UIP
  - A surgical lung biopsy demonstrates usual interstitial pneumonia [documentation required]surgical lung biopsy shows UIP
- Medication is prescribed by or in consultation with a pulmonologistspecialist: pulmonologist
- Preferred product criteria is met for the product(s) as listed in the below table(s)employer/individual plan preferred product requirements
  See plan-specific preferred product/step therapy requirements.
B) Patient is Currently Receiving Jascayd
- Patient is ≥ 18 years of ageage >= 18 years
- Patient has experienced a beneficial response to therapy over the last year while receiving Jascaydclinical benefit from Jascayd (see examples)
  For <1 year of therapy, response is from baseline prior to initiating Jascayd.
- Medication is prescribed by or in consultation with a pulmonologistspecialist: pulmonologist

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FDA-Approved Indication - Progressive Pulmonary Fibrosis (PPF)

Approve for 1 year if patient meets ONE of the following (A or B):

ANY of the following

A) Initial Therapy
- Patient is ≥ 18 years of ageage >= 18 years
- Forced vital capacity is ≥ 40% of the predicted value [documentation required]FVC >= 40% of predicted
- According to the prescriber, the patient has fibrosing lung disease impacting more than 10% of lung volume on high-resolution computed tomographyHRCT fibrosing extent > 10% of lung volume

Examples / Notes (definitions supporting criteria)

Notes provided in policy to clarify clinical signs and response metrics:

Baseline is before a patient has started any antifibrotic therapies (examples: Jascayd, Ofev, pirfenidone)

Examples of clinical signs of progression include an absolute FVC decline ≥ 10% within 1 year OR FVC decline ≥ 5% to <10% with worsening symptoms and/or worsening imagingFVC decline criteria

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

PPF examples of underlying conditions: hypersensitivity pneumonitis; idiopathic non-specific interstitial pneumonitis; unclassifiable idiopathic interstitial pneumonia; autoimmune ILD (e.g., rheumatoid arthritis ILD); exposure-related ILD; mixed connective tissue disease ILD

Plan-Specific Preferred Product / Step Therapy

Employer Plans - Preferred Product / Step Therapy Exceptions

For Employer Plans, criteria require meeting ONE of listed allowances for each diagnosis:

ALL of the following

IPF Employer Plan exceptions (one of A-G)
- A: Patient has tried or is currently receiving generic pirfenidone tablets or capsules OR Ofevtrial of pirfenidone or Ofev
  If brand/generic equivalent tried, counts toward requirement.
- B: Patient has hepatic impairmenthepatic impairment

Provider Actions / Prior Authorization

Prior Authorization

Prior authorization required

Prior authorization is required for benefit coverage of Jascayd. All approvals are provided for the duration noted (typically 1 year).

Documentation Required

Documentation requirements

Documentation is required where noted in the criteria. Required examples include baseline forced vital capacity (FVC) and diagnostic evidence of usual interstitial pneumonia (either HRCT findings or a surgical lung biopsy). Acceptable documentation may include chart notes, laboratory tests, claims records, and other records and must include patient-specific identifying information.

Baseline FVC (documentation required)
HRCT showing usual interstitial pneumonia (documentation required) or surgical lung biopsy demonstrating UIP (documentation required)

Applicable Codes & Identifiers

Coverage Policy Numbermixed

IP0772

Coverage Policy Number

Clinical Evidence

1,177FIBRONEER‑IPF enrollment — adults; Jascayd showed a smaller decline in FVC vs placebo (52 weeks)

1,176FIBRONEER‑ILD (PPF) enrollment — adults; Jascayd led to a statistically significantly smaller decline in FVC vs placebo (52 weeks)

Jascayd (nerandomilast) is a phosphodiesterase 4 (PDE4) inhibitor FDA-indicated for treatment of IPF and PPF in adults. Randomized double-blind placebo‑controlled trials (FIBRONEER‑IPF, Trial 2, and FIBRONEER‑ILD) demonstrated smaller declines in FVC with Jascayd versus placebo. Context: existing antifibrotic therapies for these conditions include nintedanib (Ofev) and pirfenidone.

Background & Definitions

Mechanism: Jascayd is a PDE4 inhibitor. FDA indications: treatment of idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF) in adults. Clinical trial context: Jascayd was evaluated in FIBRONEER‑IPF and Trial 2 for IPF and FIBRONEER‑ILD for PPF; these randomized, double‑blind, placebo‑controlled studies supported efficacy on lung function endpoints. Other antifibrotic agents used in practice include nintedanib (Ofev) and pirfenidone as background or alternative therapies.

Revision History

04/01/2026additionLatest

Progressive Pulmonary Fibrosis (PPF) condition of approval was added, including examples of underlying conditions, initial therapy and 'currently receiving Jascayd' pathways, clinical progression definitions (eg, FVC decline ≥10% or ≥5% to <10% with worsening symptoms/imaging), and a note that patients initiating Jascayd may be on concomitant Ofev. This change was marked as material.

04/15/2026additionLatest

Employer Plans preferred product / step therapy requirements were added requiring trial of pirfenidone or Ofev for IPF and trial of Ofev for PPF; clarified that Individual & Family Plans preferred product requirements only apply to IPF. This change was marked as material.

Policy Summary

PayerCigna

PolicyIdiopathic Pulmonary Fibrosis and Related Lung Disease – Jascayd for Individual and Family Plans - (IP0772)

Policy CodePolicy IP0772

Change TypeMODIFIED

Effective Date

Next Review Date

Key ActionPrior Authorization is required for Jascayd; submit required documentation and ensure prescribing specialist involvement (pulmonologist for IPF; pulmonologist or rheumatologist for PPF).

SourceLink

On This Page

According to the prescriber, the patient has clinical signs of progressionclinical progression (see examples)

Examples include FVC decline >=10% in 1 year or FVC decline >=5% to <10% with worsening symptoms and/or imaging.

Medication is prescribed by or in consultation with a pulmonologist or a rheumatologistspecialist: pulmonologist or rheumatologist

Preferred product criteria is met for the product(s) as listed in the below table(s)employer/individual plan preferred product requirements

See plan-specific preferred product/step therapy requirements.

B) Patient is Currently Receiving Jascayd

Patient is ≥ 18 years of ageage >= 18 years
Patient has experienced a beneficial response to therapy over the last year while receiving Jascaydclinical benefit from Jascayd (see examples)
For <1 year of therapy, response is from baseline prior to initiating Jascayd.
Medication is prescribed by or in consultation with a pulmonologist or a rheumatologistspecialist: pulmonologist or rheumatologist

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C: Patient's eGFR is < 30 mL/mineGFR < 30 mL/min

D: Patient cannot swallow tablets or capsules OR has difficulty swallowing tablets or capsulesswallowing difficulty

E: Patient is pregnant (approve if patient tried pirfenidone tablets or capsules)pregnancy with trial of pirfenidone

F: According to the prescriber, patient has or is at risk of coronary artery disease, bleeding events, or gastrointestinal perforation and the patient tried pirfenidone tablets or capsulesclinician-assessed risk with prior pirfenidone trial

G: Patient has already been started on therapy with Jascaydprior Jascayd initiation

PPF Employer Plan exceptions (one of A-G)

A: Patient has tried or is currently receiving Ofevtrial of Ofev
B: Patient has hepatic impairmenthepatic impairment
C: Patient's eGFR is < 30 mL/mineGFR < 30 mL/min
D: Patient cannot swallow tablets or capsules OR has difficulty swallowing tablets or capsulesswallowing difficulty
E: Patient is pregnantpregnancy
F: According to the prescriber, patient has or is at risk of coronary artery disease, bleeding events, or gastrointestinal perforationclinician-assessed risk
G: Patient has already been started on therapy with Jascaydprior Jascayd initiation

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title": "Employer Plans - Preferred Product / Step Therapy Exceptions

Individual and Family Plans - Preferred Product Requirements

Individual & Family Plans criteria for IPF (PPF uses the above PPF criteria):

ALL of the following

IPF Individual & Family Plans (one of A-E)
- A: Patient has tried or is currently receiving generic pirfenidone tablets or capsules [documentation required]trial of generic pirfenidone
  documentation required
- B: Patient has hepatic impairmenthepatic impairment
- C: Patient's eGFR is < 30 mL/mineGFR < 30 mL/min
- D: Patient cannot swallow tablets or capsules OR has difficulty swallowing tablets or capsulesswallowing difficulty
- E: Patient has already been started on therapy with Jascaydprior Jascayd initiation

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ref": "b1_1

title": "Individual and Family Plans - Preferred Product Requirements

Acceptable document types: chart notes, labs, claims records, other records with patient identifiers

Documentation Required

Specialist prescribing requirement

The medication must be prescribed by or in consultation with a specialist: a pulmonologist is required for IPF; for PPF the prescriber must be a pulmonologist or a rheumatologist.

IPF: prescribed by or in consultation with a pulmonologist
PPF: prescribed by or in consultation with a pulmonologist or rheumatologist

Step Therapy

Preferred product/step requirements (Employer Plans)

For Employer Plans, patients must meet step/ preferred product requirements prior to approval: for IPF, trial of generic pirfenidone tablets or capsules or Ofev is required unless one of the Employer Plan exceptions is met; for PPF, trial of Ofev is required unless an Employer Plan exception applies. See the Employer Plan exceptions criteria group for allowable exceptions (e.g., hepatic impairment, eGFR <30 mL/min, inability to swallow, pregnancy, prescriber-identified risks, or already started on Jascayd).

IPF Employer Plan step: trial of pirfenidone or Ofev required (unless an exception applies)
PPF Employer Plan step: trial of Ofev required (unless an exception applies)
Refer to Employer Plan exceptions group for allowable exceptions (A–G)

Denial Risk

Not medically necessary if outside indications

Use of Jascayd for any indication other than idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF) as defined in the policy is considered not medically necessary and will be denied.

04/15/2026revisedLatest

Policy title was changed to 'Pulmonary - Antifibrotics - Jascayd' (previously 'Idiopathic Pulmonary Fibrosis and Related Lung Disease - Jascayd PA policy'). This change was non-material.

02/01/2026new

New policy created (New policy entry dated 02/01/2026). This entry was non-material.