Isturisa denied as not FDA-approved for this use by Cigna?

Cigna's specific coverage criteria for isturisa are defined in its own published medical/coverage policy and the FDA-approved prescribing label. A successful appeal documents that your medical records satisfy each criterion those sources list — confirmed diagnosis, any required prior treatments (with dates and outcomes), and clinical severity. If the exact criteria weren't included with your denial, request them in writing; your appeal then maps each requirement to the matching fact in your chart.

## Why Cigna Denied Isturisa as Not FDA-Approved

A "not FDA-approved" denial for Isturisa (osilodrostat) is, in most cases, factually incorrect for the standard use of this drug, and correcting that factual error is the central task of your appeal. Isturisa carries FDA approval for Cushing's disease in adults, and that approval is a matter of public record on the FDA website.

This type of denial sometimes occurs because the clinical indication documented in the authorization request did not match the exact wording of the approved indication in the FDA label, or because Cigna's system flagged the drug incorrectly. It may also arise when osilodrostat is being prescribed for a use that genuinely falls outside the FDA-approved indication — in that scenario the appeal strategy shifts to compendia-listed and guideline-supported off-label use.

## Federal Appeal Framework

• ACA §2719 / ERISA §503: You are entitled to a full-and-fair internal appeal with a written decision that specifies the exact regulatory or clinical basis for the denial.
• Right to information: Request in writing the specific policy language and clinical criteria Cigna applied, and the basis on which it concluded the FDA-approval requirement was not met.
• External review: If the internal appeal is denied, you may escalate to an IRO. You generally have approximately four months from the denial date to file; confirm the exact deadline from the denial letter.
• Expedited option: Available if your health is at serious risk from delay.

## Concrete Appeal Process and Timeline

1. Obtain the FDA-approved prescribing label for Isturisa (publicly available from the FDA website) and confirm the approved indication aligns with the documented clinical use. 2. File a written internal appeal within Cigna's stated deadline (typically 180 days from the denial), attaching the FDA label as a primary exhibit. 3. If the use is off-label, have the prescriber prepare documentation of compendia listings (such as NCCN Drugs and Biologics Compendium) and applicable endocrinology society guidelines supporting the use. 4. Cigna must respond within 30 days (prospective) or 60 days (retrospective). 5. If denied internally, file for IRO external review before your four-month window closes.

## Documentation to Gather

• FDA label: A copy of the current FDA-approved prescribing information for Isturisa, clearly showing the approved indication.
• Diagnosis confirmation: Endocrinology records confirming the diagnosis and documenting that the clinical use of Isturisa matches the approved (or compendium-listed) indication.
• Prescriber medical-necessity letter: A letter from the treating endocrinologist that cites the FDA label directly, maps the patient's documented diagnosis to the approved indication, and — if off-label — cites the specific compendia listing and applicable clinical guidelines.
• Clinical record: Office notes, biochemical workup, and treatment history documenting the active condition and clinical rationale for this prescription.

## Criteria-Mapping Structure

Obtain Cigna's policy language on FDA-approval requirements. Then map directly:

| Policy Criterion | Evidence | |---|---| | Drug is FDA-approved for the submitted indication | [FDA label, approval date, exact indication language] | | Prescriber has documented the approved indication in the chart | [Office note date, documented diagnosis matching approved use] | | If off-label: listed in recognized drug compendium | [Compendium name and listing, applicable guideline reference] |

A denial that is factually incorrect about FDA approval should be corrected at the internal appeal stage. If it is not, IRO reviewers — who are required to apply objective clinical standards — have a clear basis to overturn it.