JASCAYD (nerandomilast) prior authorization
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Defines prior authorization requirements for JASCAYD (nerandomilast) for treatment of idiopathic pulmonary fibrosis and progressive pulmonary fibrosis in adults for Mississippi Division of Medicaid members.
No material clinical or coverage changes in this revision.
Coverage Criteria for JASCAYD (nerandomilast)
Initial Authorization
Covered when ALL of the following are met:
Prescriber must attest
For IPF, prescriber must attest that other underlying causes for pulmonary fibrosis have been ruled out
Re-Authorization
Covered when ALL of the following are met:
Document clinical benefit (symptoms, function, or objective measures) in the medical record
Approvals for JASCAYD (nerandomilast) require that the patient meet all listed authorization criteria. For initial authorization, the member must meet the package insert minimum age requirement, have a qualifying diagnosis of idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis consistent with current guideline definitions (for IPF the prescriber must attest other causes were ruled out), and have a documented baseline pulmonary function with Forced Vital Capacity (FVC) ≥ 45% predicted. The request must be prescribed by or in consultation with a pulmonologist or a clinician experienced in pulmonary fibrosis, and the patient must have had an inadequate response to all preferred agents in the same PDL drug class indicated for the diagnosis. Prescribed dosing must not exceed 2 tablets per day.
Therapy will be considered not meeting authorization criteria (and may be denied) when use is inconsistent with the listed indications, when required baseline assessments are not met, or when dosing limits are exceeded. Specific examples include lack of a guideline-consistent diagnosis or missing prescriber attestation that other causes of pulmonary fibrosis were excluded for IPF, failure to document a baseline FVC of at least 45% predicted, or a prescribed dose above the policy maximum of 2 tablets per day. For re-authorization, failure to demonstrate continued eligibility or a positive clinical response may also result in non-coverage.
Formulations, Dosing, and Coding
| 9 mg | JASCAYD oral tablet strength |
| 18 mg | JASCAYD oral tablet strength |
| 18 mg every 12 hours | Recommended dose |
| 9 mg every 12 hours | Reduced dose if not tolerated (except with concomitant pirfenidone) |
Provider Actions, Prior Authorization & Documentation
Prior authorization required
Prior authorization is required for JASCAYD (nerandomilast). Prior authorization approval will be considered when the listed clinical criteria are met; include the Universal PA Form and any supporting clinical documentation with the request.
Step therapy / prior trials required
The patient must have tried and had an inadequate response to all preferred agents under the same PDL drug class that are indicated for the diagnosis before JASCAYD will be approved.
Required documentation to support PA
Submit a completed Universal PA Form plus supporting clinical documentation with the request, including documentation of diagnosis consistent with guideline criteria, baseline FVC, prior therapy trials, and prescriber specialty or consultation notes (prescriber attestation that other causes were ruled out for IPF when applicable).
- Universal PA Form
- Diagnosis consistent with guideline criteria (IPF or progressive pulmonary fibrosis)
- Prescriber attestation that other causes for pulmonary fibrosis have been ruled out (for IPF)
- Baseline Forced Vital Capacity (FVC) documentation showing ≥ 45% predicted
- Documentation of prior trials and inadequate response to preferred agents in the same PDL class
- Prescriber specialty or consultation note (pulmonologist or provider experienced in pulmonary fibrosis)
Grounds for denial
Requests may be denied if the patient does not meet the listed diagnosis criteria, baseline FVC requirement, prescriber qualification/consultation requirement, prior trial of preferred agents in the class, or if the prescribed dose exceeds the allowed limit.
- Diagnosis not consistent with IPF or progressive pulmonary fibrosis per guidelines
- Baseline FVC < 45% predicted
- Not prescribed by or not in consultation with a pulmonologist or experienced provider
- Lack of documented prior trials and inadequate response to preferred agents in the same PDL class
- Prescribed dose exceeding 2 tablets per day
- Lack of documented positive clinical response on re-authorization
Definitions
Background
JASCAYD (nerandomilast) is a phosphodiesterase-4 (PDE4) inhibitor indicated for the treatment of adults with idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis. Prescribing is aligned with guideline-defined diagnoses and requires baseline lung function assessment and specialist involvement as part of appropriate use.
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