CurrentCignaPolicy N/A

Oncology - Exkivity Prior Authorization Policy

Defines prior authorization requirements for Exkivity (mobocertinib capsules) prescription benefit coverage for Cigna-administered health plans, including medical necessity criteria for NSCLC with EGFR exon 20 insertion. Affects providers requesting coverage under applicable Cigna plans.

Policy Summary

PayerCigna

PolicyOncology - Exkivity Prior Authorization Policy

Policy CodePolicy N/A

Change TypeOperational change — approval limited to current recipients

Effective DateN/A

Next Review DateSep 3, 2025

Key ActionObtain prior authorization and document that the patient is currently receiving Exkivity, is ≥18, has EGFR exon 20 insertion-positive locally advanced or metastatic NSCLC confirmed by an FDA-approved test, and has tried at least one platinum-based chemotherapy.

SourceLink

POLICY UPDATE CHANGES

A requirement was added to limit approval to patients who are currently receiving Exkivity due to withdrawal from the market.

1 yearapproval duration

Adults (≥18)age

EGFR exon 20 insertionrequired biomarker

≥1 platinum chemoprior therapy

Withdrawn Apr 2024

Policy Summary

PayerCigna

PolicyOncology - Exkivity Prior Authorization Policy

Policy CodePolicy N/A

Change TypeOperational change — approval limited to current recipients

Effective DateN/A

Next Review DateSep 3, 2025

SourceLink

On This Page

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Coverage Criteria for Exkivity (mobocertinib)

Initial Therapy (FDA-approved)

Covered when ALL of the following are met:

FDA-Approved Indication for NSCLC: A) Patient is currently receiving Exkivity; AND B) Patient is ≥ 18 years of age; AND C) Patient has locally advanced or metastatic non-small cell lung cancer; AND D) Patient has EGFR exon 20 insertion-positive disease; AND E) The EGFR exon 20 insertion mutation was determined by an FDA-approved test; AND F) Patient has previously tried at least one platinum-based chemotherapy (examples include carboplatin, cisplatin, oxaliplatin).none

Approve for 1 year when all criteria met

Exkivity (mobocertinib) is not medically necessary for any indication other than the specified FDA‑approved use described in this policy. Requests for coverage for uses outside the FDA‑approved indication will be considered not medically necessary and are not covered.

Use of Exkivity outside the FDA‑approved indication is not medically necessary. Coverage criteria and requirements in this policy apply only to the approved indication; any off‑label or other uses will be denied as not medically necessary.

Change	Implication
NCCN guideline change (v8.2025)	Exkivity is no longer recommended as a subsequent treatment option for EGFR exon 20 insertion-positive metastatic NSCLC; Rybrevant is the preferred subsequent therapy.

Program	Access / Prior Authorization
Takeda Compassionate Use program	Continued access provided for patients initiated on Exkivity prior to April 1, 2024; prior authorization is limited to patients who are currently receiving the drug.

Coding and Approval Details

DrugNDC | mixed

mobocertinib

Exkivity (mobocertinib capsules - Takeda)

inv-05: Approval duration — 1 year

Approval duration1 year

Condition for durationApprovals provided when all FDA‑approved indication criteria (A–F) are met

Renewal noteApproval aligns with policy statement duration; prior authorization is recommended

Provider Actions and Prior Authorization Requirements

Prior Authorization

Prior authorization required — 1 year approvals

Prior authorization is recommended for Exkivity; when all FDA‑approved indication criteria are met, approvals are provided for a duration of 1 year.

Step Therapy

Prior chemotherapy required (≥1 platinum regimen)

Patient must have previously tried at least one platinum-based chemotherapy regimen before approval. Examples of platinum-based chemotherapy include carboplatin, cisplatin, and oxaliplatin.

Must have tried ≥1 platinum-based chemotherapy regimen
Examples: carboplatin; cisplatin; oxaliplatin

Definitions

inv-11: EGFR exon 20 insertion-positive — presence determined by an FDA-approved test.

DefinitionEGFR exon 20 insertion-positive: presence of an EGFR exon 20 insertion mutation determined by an FDA-approved test

Indication linkRequired biomarker for Exkivity treatment in locally advanced or metastatic NSCLC

Test requirementMutation must be identified by an FDA‑approved test as stated in the FDA‑Approved Indication

Age/populationApplies to adults (≥18 years) with NSCLC

Biomarker Requirements

inv-13: EGFR exon 20 insertion — determined by an FDA‑approved test

Biomarker requirementEGFR exon 20 insertion must be determined by an FDA‑approved test

Clinical contextRequired for treatment with Exkivity for locally advanced or metastatic NSCLC

Regulatory noteSpecified in product indication; Exkivity received accelerated approval for this mutation-specific indication

Line of Therapy

Subsequent

Prior systemic therapy requirement: Disease has progressed on or after platinum-based chemotherapy; patient must have previously tried at least one platinum-based chemotherapy.none

NCCN no longer recommends Exkivity as a subsequent option; Rybrevant is preferred.

Background

Exkivity (mobocertinib) is an oral EGFR inhibitor supplied as capsules and identified in this policy by brand and generic name. The manufacturer has withdrawn commercial availability of the product; as a result, this policy limits prior authorization to the FDA‑approved indication and to circumstances described elsewhere in the policy (including continued access pathways). Any use of Exkivity other than the specified FDA‑approved indication is considered not medically necessary.

Covered Regimens and Access

Regimen / Setting	Coverage stance	Notes
Exkivity for subsequent therapy (EGFR exon 20 insertion-positive metastatic NSCLC)	Not Covered	NCCN (v8.2025) no longer recommends Exkivity as a subsequent option; Rybrevant is preferred (category 1).

Situation	Coverage / Authorization
Patients initiated on Exkivity prior to market withdrawal (April 2024)	Covered — continued access available through Takeda Compassionate Use program; prior authorization approvals are limited to patients who are currently receiving the drug.