CurrentCignaPolicy N/A

Oncology - Tazverik Prior Authorization Policy

Defines prior authorization requirements for Tazverik (tazemetostat tablets) for Cigna-administered health benefit plans, covering FDA‑approved indications of epithelioid sarcoma and follicular lymphoma and related coverage decisions.

Policy Summary

PayerCigna

PolicyOncology - Tazverik Prior Authorization Policy

Policy CodePolicy N/A

Change TypeClinical criteria revised

Effective DateN/A

Next Review DateMar 19, 2025

Key ActionSubmit prior authorization; approvals are issued for 1 year when coverage criteria are met.

SourceLink

POLICY UPDATE CHANGES

The requirement that follicular lymphoma patients have an EZH2 mutation was removed to align with guidelines.

A note with examples of systemic therapy for follicular lymphoma was added.

2FDA‑approved indications covered

1 yearStandard approval duration

≥16Min age (epithelioid sarcoma)

≥18Min age (follicular lymphoma)

Policy Summary

PayerCigna

PolicyOncology - Tazverik Prior Authorization Policy

Policy CodePolicy N/A

Change TypeClinical criteria revised

Effective DateN/A

Next Review DateMar 19, 2025

Key ActionSubmit prior authorization; approvals are issued for 1 year when coverage criteria are met.

SourceLink

On This Page

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Medical necessity criteria — FDA‑approved indications

Covered when ALL of the following are met for the indicated FDA‑approved use:

Epithelioid sarcoma (approve 1 year): Approve if ALL: A) patient is >= 16 years of age; AND B) patient has metastatic or locally advanced disease; AND C) patient is not eligible for complete resection.

Follicular lymphoma (approve 1 year): Approve if ALL: A) patient is >= 18 years of age; AND B) patient has relapsed or refractory disease; AND C) patient meets ONE of: (i) has tried at least two prior systemic therapies; OR (ii) prescriber states there are no appropriate alternative therapies.

Tazverik (tazemetostat) is considered experimental, investigational, or unproven for any use(s) other than the FDA‑approved indications specified in this policy.

Covered Regimens

Regimen	Indication	Coverage
Tazverik (tazemetostat)
Epithelioid sarcoma — metastatic or locally advanced disease not eligible for complete resection (patient ≥ 16 years)
Covered when ALL criteria are met: A) patient is ≥ 16 years of age; AND B) patient has metastatic or locally advanced disease; AND C) patient is not eligible for complete resection. Approval duration: 1 year.

Regimen	Indication	Coverage
Tazverik (tazemetostat)
Relapsed or refractory follicular lymphoma (patient ≥ 18 years) — third‑line or subsequent therapy; may be used when no appropriate alternative therapies exist
Covered when ALL criteria are met: A) patient is ≥ 18 years of age; AND B) patient has relapsed or refractory disease; AND C) patient meets ONE of: (i) has tried at least two prior systemic therapies (examples include bendamustine, obinutuzumab, rituximab, cyclophosphamide, doxorubicin, vincristine, or lenalidomide); OR (ii) prescriber states there are no appropriate alternative therapies. Approval duration: 1 year.

Provider Actions & Requirements

Prior Authorization

Prior authorization required — 1‑year approvals

Prior authorization is required for Tazverik; when the medical necessity criteria for the indicated FDA‑approved condition are met, approvals are issued for a duration of 1 year.

Step Therapy

Prior systemic therapy — ≥2 prior regimens or prescriber attestation

For follicular lymphoma, the patient must have tried at least two prior systemic therapies OR the prescriber must state there are no appropriate alternative therapies; examples of systemic therapies include bendamustine, obinutuzumab (Gazyva), rituximab, cyclophosphamide, doxorubicin, vincristine, or lenalidomide.

Documentation Required

Required clinical documentation

Include documentation that supports the patient's age and diagnosis (metastatic or locally advanced epithelioid sarcoma not eligible for complete resection, or relapsed/refractory follicular lymphoma), and, for follicular lymphoma, records of prior systemic therapies tried or a prescriber statement that no appropriate alternatives exist.

Denial Risk

Not covered indications — experimental/investigational

Requests for Tazverik for any indication not listed as an FDA‑approved use or supported by this policy are considered experimental, investigational, or unproven and may be denied.

Biomarker Requirements

EZH2 mutation — biomarker requirement details

Current policy requirementEZH2 mutation is NOT required for follicular lymphoma per the revised policy; the EZH2 requirement was removed to align with guidelines.

Historical languagePreviously, follicular lymphoma approval required the presence of an EZH2 mutation detected by an approved test in adults who had received ≥2 prior systemic therapies.

Scope of changeRemoval applies to follicular lymphoma indication only; other indication criteria (epithelioid sarcoma) unchanged.

Documentation implicationFor follicular lymphoma, prescribers should document relapsed/refractory status and prior therapies or lack of satisfactory alternatives; EZH2 test results are not required.

Source rationaleChange made to align policy with NCCN guideline recommendations which list Tazverik for follicular lymphoma irrespective of EZH2 mutation status.

Definitions

Accelerated approval — definition

DefinitionAccelerated approval: FDA approval based on surrogate endpoints (overall response rate and duration of response) with continued approval potentially contingent on verification of clinical benefit in confirmatory trials.

Typical endpointsSurrogate endpoints cited include overall response rate and duration of response.

Confirmatory requirementContinued approval may depend on verification and description of clinical benefit in confirmatory trial(s).

Applicability in this policyBoth approved indications for Tazverik are under accelerated approval and therefore subject to confirmatory evidence requirements.

NCCN regimen categories — preferred/other recommended regimens

NCCN categories — preferred vs other'Preferred Regimen' indicates recommended use in a given setting (e.g., Tazverik is 'Preferred' for metastatic/locally advanced epithelioid sarcoma - category 2A).

'Other Recommended Regimen' meaningDesignates regimens recommended for use in later lines; NCCN lists Tazverik as 'Other Recommended Regimen' for third-line and subsequent therapy in follicular lymphoma (category 2A), irrespective of EZH2 status.

Line-of-therapy guidanceNCCN places Tazverik as third-line and subsequent therapy for follicular lymphoma, and as second-line 'Preferred' for elderly/infirm patients when other therapies are not tolerable.

Evidence categoryRecommendations cited are category 2A in NCCN guidelines (consistent consensus, lower-level evidence).

Background

Tazverik (tazemetostat) is an oral EZH2 methyltransferase inhibitor with FDA approvals for treatment of epithelioid sarcoma (metastatic or locally advanced and not eligible for complete resection) and for specific uses in relapsed or refractory follicular lymphoma. The drug received accelerated approval for some indications; continued approval may depend on confirmatory trial results. National Comprehensive Cancer Network (NCCN) guidelines reference Tazverik as a recommended option for epithelioid sarcoma and as a later‑line therapy for follicular lymphoma.

OpenPayer