CurrentNeighborhood Health Plan of Rhode IslandPolicy UM ONC_1518

Ensacove (ensartinib) coverage criteria

Defines coverage and utilization management criteria for ensartinib (Ensacove) for treatment of cancer, specifically ALK-positive locally advanced or metastatic non-small cell lung cancer (NSCLC); applies to UM processing of medication requests by Evolent/Neighborhood Health Plan of Rhode Island.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyEnsacove (ensartinib) coverage criteria

Policy CodePolicy UM ONC_1518

Change TypeNo material changes

Effective DateJan 31, 2025

Next Review Date

Key ActionSubmit authorization requests to Evolent Utilization Management and include supporting evidence (FDA labeling, CMS compendia, NCCN/ASCO guidelines, or peer-reviewed literature) for off-label indications as required.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1FDA-indication(s) listed (ALK+ NSCLC)

225single-dose maximum allowed

60maximum monthly capsule limit

J8999HCPCS billing code listed

Medical Necessity Criteria for Ensacove (ensartinib)

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Inclusion / Covered Indications

Ensacove (ensartinib) is covered when ALL of the following are met:

ALL of the following

Member is an adult.
Diagnosis of locally advanced or metastatic non-small cell lung cancer (NSCLC).
Tumor is anaplastic lymphoma kinase (ALK)-positive.
Member has not previously received an ALK-inhibitor.

ALL of the following

Member is an adult.
Diagnosis of locally advanced or metastatic non-small cell lung cancer (NSCLC).
Tumor is anaplastic lymphoma kinase (ALK)-positive.
Member has not previously received an ALK-inhibitor.

Continuation (exemptions from policy requirements)

Continuation requests for medications that would otherwise be not-approvable are exempt when ALL of the following are met:

ALL of the following

The member has not experienced disease progression while on the requested medication.
The requested medication was used within the last year without a lapse of more than 30 days of having an active authorization.
No additional medication(s) are being added to the continuation request.

ALL of the following

The member has not experienced disease progression while on the requested medication.

Exclusion / Not covered

Ensacove (ensartinib) is not covered when ANY of the following apply:

ANY of the following

Disease progression while taking Ensacove (ensartinib).
Concurrent use with other anticancer therapies.
NSCLC that is ALK-negative.
Previous receipt of an ALK-inhibitor (examples: crizotinib, alectinib, ceritinib, brigatinib, lorlatinib).
Dosing exceeds single dose limit of 225 mg.single dose <= 225 mg

Evidence sufficiency criteria (for off-label uses)

When evaluating off-label uses, the following aspects are considered to determine sufficiency of evidence:

ALL of the following

Whether patient and cancer clinical characteristics are adequately represented in published evidence.
Whether the therapy regimen is adequately represented in published evidence.
Whether reported study outcomes represent clinically meaningful outcomes (ASCO guidance: e.g., Hazard Ratio < 0.80; OS/PFS benefit generally ≥ 3 months).
Whether the experimental design is appropriate to the question (randomization/blinding may not always be needed).
Non-randomized trials with a significant number of subjects may support accepted use.

Utilization Management & Documentation Requirements

Prior Authorization

Utilization Management review required

All medication requests for ensartinib (Ensacove) are processed by Evolent Utilization Management and require prior authorization; medications not authorized by Evolent may be deemed not approvable and not reimbursable.

J8999

Documentation Required

Support for off-label use

For off-label indications, requesters must provide supporting evidence that meets the policy’s evidence sufficiency criteria, using FDA labeling, CMS-recognized compendia, NCCN/ASCO guidelines, or acceptable peer‑reviewed literature as defined by CMS Medicare Benefit Policy Manual Chapter 15.

FDA approved product labeling
CMS-recognized compendia
NCCN or ASCO clinical guidelines
Peer-reviewed literature meeting CMS Chapter 15 standards (see Evidence sufficiency criteria)

Denial Risk

Denial conditions

Requests may be denied when any exclusion criterion is met, including disease progression on ensartinib, planned concurrent anticancer therapy, ALK‑negative NSCLC, prior ALK‑inhibitor exposure, dosing or quantity limits exceeded, or insufficient evidence for off‑label use.

Affected code: J8999
Disease progression while taking Ensacove (ensartinib)
Concurrent use with other anticancer therapies
NSCLC that is ALK‑negative
Previous receipt of an ALK‑inhibitor (e.g., crizotinib, alectinib, ceritinib, brigatinib, lorlatinib)
Single dose limit exceeded (> 225 mg) or monthly capsule limit exceeded (> 60 capsules/month for 25 mg or 100 mg formulations)
Off‑label use lacking sufficient evidence per the policy’s Evidence sufficiency criteria

Clinical and Policy Background

Ensartinib (Ensacove) is an anaplastic lymphoma kinase (ALK) inhibitor indicated for adult patients with ALK-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) who have not previously received an ALK-inhibitor. Coverage and utilization determinations for Ensacove follow the FDA-approved product labeling and are supported by CMS-recognized compendia, NCCN/ASCO clinical guidance, or acceptable peer-reviewed literature consistent with the standards outlined in the CMS Medicare Benefit Policy Manual Chapter 15.

Key references:

• Ensacove prescribing information 2024. Xcovery Holdings, Inc.

• Horn L, et al. JAMA Oncol. 2021;7(11):1617-1625.

• Clinical Pharmacology Elsevier Gold Standard 2025; Micromedex Drugdex 2025; NCCN Cancer Guidelines and Drugs & Biologics Compendium 2025; Medicare Benefit Policy Manual Chapter 15.

Defined Terms

Definitions

Continuation requestA request to continue therapy previously authorized; exempt from some policy requirements when the continuation criteria are met (no disease progression on the medication, used within the last year without a lapse >30 days of active authorization, and no additional medications are being added)

Sufficient evidenceEvidence supported by FDA labeling, CMS-recognized compendia, NCCN/ASCO guidelines, or peer-reviewed literature meeting CMS Medicare Benefit Policy Manual Chapter 15 standards; includes the considerations listed under the 'Evidence sufficiency criteria' section (representation of patient/cancer characteristics, regimen representation, clinically meaningful outcomes, appropriate experimental design, role of non-randomized trials, and limits of case reports/abstracts)

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyEnsacove (ensartinib) coverage criteria

Policy CodePolicy UM ONC_1518

Change TypeNo material changes

Effective DateJan 31, 2025

Next Review Date

SourceLink

On This Page

ANY of the following

Disease progression while taking Ensacove (ensartinib).
Concurrent use with other anticancer therapies.
NSCLC that is ALK-negative.
Previous receipt of an ALK-inhibitor (examples: crizotinib, alectinib, ceritinib, brigatinib, lorlatinib).
Dosing exceeds single dose limit of 225 mg.single dose <= 225 mg
Treatment exceeds the maximum limit of 60 capsules per month (applies to 25 mg or 100 mg capsules).
Applies to either 25 mg or 100 mg capsule formulations.
Investigational use for off-label indications lacking sufficient evidence or not accepted by the medical community.
Sufficient evidence must be supported by FDA label, CMS-recognized compendia, NCCN/ASCO guidelines, or acceptable peer-reviewed literature per CMS Medicare Benefit Policy Manual Chapter 15.

ALL of the following

Whether patient and cancer clinical characteristics are adequately represented in published evidence.
Whether the therapy regimen is adequately represented in published evidence.
Whether reported study outcomes represent clinically meaningful outcomes (ASCO guidance: e.g., Hazard Ratio < 0.80; OS/PFS benefit generally ≥ 3 months).
Whether the experimental design is appropriate to the question (randomization/blinding may not always be needed).
Non-randomized trials with a significant number of subjects may support accepted use.
Case reports are generally insufficient as supportive evidence.
Abstracts without full peer-reviewed articles lack sufficient supporting evidence.

OpenPayer

Ensacove (ensartinib) coverage criteria

Medical Necessity Criteria for Ensacove (ensartinib)

Numeric Thresholds and Limits

Billing Codes

Utilization Management & Documentation Requirements

Clinical and Policy Background

Defined Terms

Policy Dates & Review