CurrentHealth NetPolicy CP PHAR.712

Clinical Policy: Ensartinib (Ensacove)

Policy governs clinical coverage and authorization criteria for ensartinib (Ensacove) for treatment of adult patients with ALK-positive locally advanced or metastatic non-small cell lung cancer for Health Net lines of business (Commercial, HIM, Medicaid).

Policy Summary

PayerHealth Net

PolicyEnsartinib (Ensacove) for ALK-positive NSCLC

Policy CodePolicy CP PHAR.712

Change TypeNo material changes

Effective DateMar 1, 2025

Next Review Date

Key ActionProvider must submit documentation (office chart notes, lab results or other clinical information) supporting that the member has met all approval criteria.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

225 mg/dayMax authorized dose

150 mg/dayTypical continued dose

12 monthsApproval duration

25/100 mgProduct strengths

Coverage Criteria

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Initial Approval Criteria: 1. Diagnosis of locally advanced or metastatic non-small cell lung cancer (NSCLC); 2. Disease is ALK-positive; 3. Prescribed by or in consultation with an oncologist; 4. Age ≥ 18 years; 5. Prescribed as a single agent; 6. Member has not previously received an ALK‑inhibitor; 7. For Ensacove requests, member must use ensartinib if available unless contraindicated or clinically significant adverse effects are experienced; 8. Dose does not exceed 225 mg per day; 9. Prescribed regimen is FDA‑approved or recommended by NCCN;

Provider must submit supporting documentation per policy.

Continuation (Renewal) Therapy

Covered when ALL of the following are met

Continuation (Renewal) Therapy: 1. Member is currently receiving medication via the benefit or has documentation of receiving Ensacove for a covered indication for at least 30 days; 2. Member is responding positively to therapy; 3. For Ensacove requests, member must use ensartinib if available unless contraindicated or clinically significant adverse effects are experienced; 4. Dose of Ensacove is ≥150 mg per day; 5. If the request is for a dose increase, the new dose is supported by practice guidelines or peer‑reviewed literature or relevant off‑label evidence is provided, and the new dose does not exceed 225 mg per day; 6. Prescribed regimen is FDA‑approved or recommended by NCCN;

Approval duration: 12 months.

Coverage for ensartinib (Ensacove) does not extend to non‑FDA approved indications that are not specifically addressed in this policy. Such off‑label uses are excluded unless the provider supplies sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policies (CP.CPA.09 for Commercial, HIM.PA.154 for Health Insurance Marketplace, or CPPMN.53 for Medicaid) or other evidence of coverage documents.

Requests for ensartinib for indications not covered by this policy will be evaluated against the off‑label use requirements; absent the required supporting documentation, such requests will be considered not authorized (not medically necessary). Providers should submit the necessary off‑label evidence per the referenced policies when seeking coverage for non‑FDA indications.

Initial Therapy

Covered when ALL of the following are met

Initial Therapy: 1. Diagnosis of ALK‑positive locally advanced or metastatic NSCLC; 2. Age ≥ 18 years; 3. Prescribed by or in consultation with an oncologist; 4. Prescribed as a single agent; 5. No prior exposure to an ALK‑inhibitor; 6. For Ensacove requests, member must use ensartinib if available unless contraindicated or clinically significant adverse effects are experienced; 7. Dose does not exceed 225 mg per day; 8. Prescribed regimen is FDA‑approved or recommended by NCCN;

Provider documentation required.

Continuation Therapy

Criteria for ongoing coverage

Continuation Therapy: 1. Member is currently receiving Ensacove via the benefit or has documentation of at least 30 days of therapy for a covered indication; 2. Member is responding positively to therapy; 3. For Ensacove requests, member must use ensartinib if available unless contraindicated or clinically significant adverse effects are experienced; 4. Dose criteria met (dose ≥150 mg/day for continued therapy); 5. If a dose increase is requested, new dose is supported by practice guidelines or peer‑reviewed literature or relevant off‑label evidence and does not exceed 225 mg per day;

Approval duration is 12 months.

Provider Actions / Prior Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Provider must obtain prior authorization before initiating Ensacove (ensartinib) and submit documentation that the member meets all approval criteria.

Prior auth required for initiation and dose changes
Approval duration: 12 months

Documentation Required

Submission of Clinical Documentation

For all requests, the provider must submit supporting clinical documentation such as office chart notes, pathology reports, relevant laboratory results, imaging reports, and treatment history to demonstrate the member meets the criteria for coverage.

Include documentation of ALK-positive status (e.g., test results)
Include prior treatment history and oncologist consultation notes
If requesting a non‑FDA or off‑label use, include peer‑reviewed evidence or documentation per off‑label policies

Documentation Required

Oncology Involvement Required

Member must be under the care of an oncologist or the request must be made in consultation with an oncologist. Prior authorization requests should clearly document oncology involvement.

Prescribed by or in consultation with an oncologist
Document oncologist’s assessment and treatment plan

Denial Risk

Clinical Eligibility and Denial Risk

Member must meet age, diagnosis, and treatment history criteria. Requests lacking clear evidence of these elements may be denied.

Diagnosis: locally advanced or metastatic non‑small cell lung cancer (NSCLC) with ALK‑positive disease
Age: ≥ 18 years
Treatment history: member has not previously received an ALK‑inhibitor (unless criteria for continuation/other specific circumstances are met)
Agent: prescribed as a single agent

Step Therapy

Step‑Therapy / Product Availability Requirement

If ensartinib is available for the member, the member must use ensartinib prior to Ensacove (step‑therapy), unless ensartinib is contraindicated or the member experienced clinically significant adverse effects.

Member must use ensartinib if available and tolerable prior to approval of Ensacove
Exceptions: documented contraindication to ensartinib or prior clinically significant adverse reaction

Denial Risk

Non‑FDA Indications / Off‑Label Requests

Requests for non‑FDA approved indications that are not specifically addressed in this policy will be denied unless the provider supplies sufficient off‑label evidence of efficacy and safety consistent with Health Net off‑label/off‑policy requirements.

Non‑FDA indications require peer‑reviewed literature or evidence of coverage documentation
Absent adequate off‑label supporting evidence, requests will be denied

Coding & Dose Limits

inv-05: Maximum daily dose

Maximum daily dose225 mg/day

Typical continued-therapy dose (from policy stats)150 mg/day

Approval duration for continuation12 months

Product strengths availableCapsules: 25 mg, 100 mg

Step therapy requirementmixedCovered

ensartinib (Ensacove)

Member must use ensartinib if available for requests, unless contraindicated or clinically significant adverse effects are experienced

Dose constraints related to step therapymixed

225 mg/day	Dose does not exceed 225 mg per day (maximum authorized dose)
≥ 150 mg/day	Dose of Ensacove is ≥ 150 mg per day for continuation

Background

Ensartinib (Ensacove) is an ALK‑targeted kinase inhibitor used in the management of ALK‑positive locally advanced or metastatic non‑small cell lung cancer in adults who have not previously received an ALK inhibitor. Coverage and authorization for ensartinib are limited to the FDA‑approved or otherwise policy‑specified indications; off‑label use requires documentation per the applicable off‑label use policies.

Definitions

inv-11: ALK — define Anaplastic lymphoma kinase (ALK) as a molecular target

TermAnaplastic lymphoma kinase (ALK)

DefinitionA molecular target (anaplastic lymphoma kinase) used for targeted therapy in certain non‑small cell lung cancer (NSCLC) tumors.

Policy contextALK‑positive status is required for coverage of ensartinib (Ensacove) in locally advanced or metastatic NSCLC.

Step Therapy / Product Availability

Step	Requirement	Exception / Failure Criteria
1	Member must use ensartinib (Ensacove) if available for treatment of ALK‑positive locally advanced or metastatic non‑small cell lung cancer for initial and continuation therapy; request must be prescribed by or in consultation with an oncologist and as single‑agent therapy	Contraindication to ensartinib or clinically significant adverse effects to ensartinib
	Dose must not exceed 225 mg per day; for continuation requests dose of Ensacove should be ≥150 mg/day unless medically justified; any dose increase must be supported by practice guidelines or peer‑reviewed literature or relevant off‑label evidence	Requests that do not meet dosing limits (≤225 mg/day) or lack supporting evidence for dose increases