Checkpoint Inhibitor denied for failing step therapy by Cigna?

Cigna's specific coverage criteria for checkpoint inhibitor 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 Your Checkpoint Inhibitor — Step Therapy

Step therapy (also called "fail-first") requires that a patient try one or more lower-cost treatments before Cigna will approve the requested agent. In oncology, however, step-therapy protocols frequently conflict with standard-of-care guidelines, because the sequence of treatment lines is clinically determined based on tumor biology, biomarker status, and prior response — not cost. Many states have enacted step-therapy reform laws that require exemptions when the protocol conflicts with an applicable clinical guideline or when prior therapy has already been tried and failed.

## Federal Appeal Framework

• Internal appeal: File within 180 days. Expedited review (72 hours) is available when delay would seriously jeopardize health or ability to regain maximum function.
• Step-therapy exemption request: Most state step-therapy laws and Cigna's own policies require an exemption process. File this concurrently with the appeal.
• ACA §2719 external review: Available after the internal process; the external reviewer will evaluate whether the step-therapy protocol is consistent with generally accepted standards of medical practice for your cancer type.
• ERISA §503 (employer plans): You are entitled to the specific clinical criteria and step-therapy protocol applied; request the full file.

## Documentation to Gather

1. Prior treatment history with outcomes: Detailed chart notes, infusion records, and response assessments documenting every prior systemic therapy — with start/stop dates, doses, and reason for discontinuation (progression, toxicity, or contraindication). 2. Contraindication or clinical unsuitability documentation: If the step-therapy drug(s) Cigna requires are clinically inappropriate for this patient, the oncologist must document why with specific chart evidence (e.g., organ dysfunction, prior toxicity, genomic contraindication). 3. Applicable clinical guideline reference: Ask the oncologist to cite the relevant NCCN guideline (or applicable specialty society guideline) stating that the requested checkpoint inhibitor is a preferred or recommended first-line or second-line agent for this histology and biomarker profile. 4. Prescriber medical-necessity letter: Should explain the clinical reasoning for bypassing step therapy, referencing guideline support and patient-specific factors. 5. Cigna's step-therapy protocol: Request the specific protocol applied to this denial so the appeal can address each requirement directly.

## Criteria-Mapping Structure

Build a two-column response: left column lists each step Cigna's protocol requires; right column documents what happened in the patient's treatment history at each step — either confirming it was completed (with dates and outcomes) or explaining with clinical evidence why it was clinically inappropriate or contraindicated. Attach the relevant NCCN guideline section as an exhibit. The goal is to demonstrate either that all required steps have been completed, or that a recognized guideline and patient-specific clinical factors justify bypassing them.