ModifiedCentenePolicy CP PHAR.452

Clinical Policy: Tazemetostat (Tazverik)

Defines medical necessity, prior authorization, and coverage criteria for tazemetostat (Tazverik) for epithelioid sarcoma and follicular lymphoma across Centene lines of business.

Policy Summary

PayerCentene

PolicyTazemetostat (Tazverik) coverage

Policy CodePolicy CP PHAR.452

Change TypeAnnual review — material revisions to FL redirect options and line‑of‑therapy language

Effective Date03.01.20

Next Review Date

Key ActionSubmit prior authorization with documentation that the patient meets the diagnosis‑specific criteria and required supporting clinical information.

SourceLink

POLICY UPDATE CHANGES

1Q 2025 annual review: for EZH2 mutation status is negative or unknown, removed option for redirection to Aliqopa as this is no longer NCCN recommended, clarified second-line use for relapsed/refractory disease with no satisfactory alternatives, and added option for third-line and subsequent therapy.

Revised approval duration for Commercial line of business from length of benefit to 12 months or duration of request, whichever is less.

For follicular lymphoma (FL), clarified EZH2 wild type mutation status as negative and added unknown mutation status for completeness.

1,600 mg/dayMaximum daily dose allowed

800 mg BIDTypical dosing regimen

12 monthsInitial approval (Commercial)

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Coverage Criteria

Initial Therapy - Epithelioid Sarcoma

Covered when ALL of the following are met:

Epithelioid Sarcoma initial criteria: 1) Diagnosis of epithelioid sarcoma; 2) Prescribed by or in consultation with an oncologist; 3) Age ≥ 16 years; 4) Disease is metastatic or locally advanced and not eligible for complete resection; 5) Tumor demonstrates loss of INI1 (SMARCB1) gene expression through inactivation, deletion, or mutation; 6) Tazemetostat is prescribed as monotherapy; 7) Request meets one of the following: a) dose does not exceed 1,600 mg (8 tablets) per day, OR b) dose is supported by practice guidelines or peer‑reviewed literature for the relevant off‑label use (prescriber must submit supporting evidence); 8) For brand Tazverik requests, member must use generic tazemetostat if available unless contraindicated or clinically significant adverse effects are experienced.dose <= 1600 mg/day

Prescribed regimen must be FDA‑approved or recommended by NCCN

Initial Therapy - Follicular Lymphoma

Covered when ALL of the following are met:

Follicular Lymphoma initial criteria: 1) Diagnosis of follicular lymphoma; 2) Prescribed by or in consultation with an oncologist or hematologist; 3) Age ≥ 18 years; 4) One of the following applies: a) If tumor is positive for EZH2 mutation: member has relapsed/refractory disease after ≥ 2 prior systemic therapies (see Appendix B for examples) OR request is for second‑line therapy and member has relapsed/refractory disease with no satisfactory alternative treatment options; b) If EZH2 mutation status is negative or unknown: request is for third‑line or subsequent therapy OR relapsed/refractory disease with no satisfactory alternative treatment options as supported by NCCN; 5) Member does not have a history of or current CNS metastases; 6) Request meets one of the following: a) dose does not exceed 1,600 mg (8 tablets) per day, OR b) dose is supported by practice guidelines or peer‑reviewed literature for the relevant off‑label use (prescriber must submit supporting evidence); 7) For brand Tazverik requests, member must use generic tazemetostat if available unless contraindicated or clinically significant adverse effects are experienced.dose <= 1600 mg/day

Prescribed regimen must be FDA‑approved or recommended by NCCN

Continuation Therapy

Covered when ALL of the following are met:

Continued therapy criteria: 1) Member is currently receiving tazemetostat via the Centene benefit with documentation that the member has received the medication for at least 30 days; 2) Member is responding positively to therapy; 3) If the request is for a dose increase, the new dose meets one of the following: a) does not exceed 1,600 mg (8 tablets) per day, OR b) is supported by practice guidelines or peer‑reviewed literature for the relevant off‑label use (prescriber must submit supporting evidence); 4) For brand Tazverik requests, member must use generic tazemetostat if available unless contraindicated or clinically significant adverse effects are experienced.dose <= 1600 mg/day

Approval durations differ by line of business

Requests for indications that are not FDA‑approved and are not specifically addressed in this policy are not authorized unless the provider submits sufficient documentation demonstrating efficacy and safety in accordance with the applicable off‑label use policies: CP.CPA.09 (commercial), HIM.PA.154 (health insurance marketplace), or CP.PMN.53 (Medicaid), or unless coverage is established by the member's evidence of coverage documents.

Per the 1Q 2025 annual review, the policy was updated to remove Aliqopa as a redirect option for relapsed/refractory follicular lymphoma when EZH2 mutation status is negative or unknown, because Aliqopa is no longer recommended by the NCCN compendium.

Use of tazemetostat for non‑FDA approved indications without submission of sufficient supporting documentation per the referenced off‑label use policies is considered not authorized.

Coding and Dosing Limits

Maximum daily dose — 1,600 mg/day

Maximum daily dose1,600 mg/day

Typical dosing regimen800 mg orally twice daily (800 mg BID)

Dose increase guidanceDose increases must not exceed 1,600 mg/day unless supported by practice guidelines or peer‑reviewed literature (prescriber must submit supporting evidence)

Provider Actions and Authorization

Prior Authorization

Prior Authorization Required

Prior authorization required — Prior authorization is required. Requests must include documentation that the patient meets the diagnosis-specific criteria in this policy (e.g., epithelioid sarcoma or follicular lymphoma).

Prior authorization may be required for brand requests when a generic is available (see Therapeutic Alternatives Appendix B).
Approval durations vary by line of business; commercial approvals historically revised to 12 months (see Policy History).

Documentation Required

Provider Must Submit Documentation

Provider must submit documentation — The provider must submit clinical documentation (for example, office chart notes, pathology reports, tumor testing results such as EZH2 or INI1/SMARCB1 status, and prior therapy records) to support that the member meets all approval criteria.

Include documentation of prior treatments and response/relapse history for follicular lymphoma.

Initial Therapy Criteria

Initial Therapy — Initial therapy requirements by diagnosis

Covered when ALL of the following are met:

Initial therapy entries: Separate diagnostic‑specific initial criteria for epithelioid sarcoma and follicular lymphoma as detailed: see 'Initial Therapy - Epithelioid Sarcoma' and 'Initial Therapy - Follicular Lymphoma' criteria for required elements including prescriber specialty, age, diagnosis‑specific requirements, tumor mutation/expression status where applicable, dosing limits, and generic substitution requirements.

Continuation Therapy Criteria

Continued Therapy — Continuation therapy requirements

Covered when ALL of the following are met:

Continuation therapy requirements: 1) Member has received tazemetostat via the Centene benefit for at least 30 days with documentation; 2) Member is responding positively to therapy; 3) Dose increases must not exceed 1,600 mg (8 tablets) per day unless supported by practice guidelines or peer‑reviewed literature (prescriber must submit supporting evidence); 4) For brand requests, generic substitution is required if a generic is available unless contraindicated or clinically significant adverse effects are experienced.dose <= 1600 mg/day

Approval durations: Medicaid/HIM 12 months; Commercial 12 months or duration of request, whichever is less.

Step Therapy and Redirects

Step	Requirement / Notes
1	Therapeutic alternatives listed in Appendix B may be considered or required depending on formulary status and line of business; Appendix B lists examples of first‑, second‑, and subsequent‑line therapies for follicular lymphoma and notes that agents may require prior authorization.

Edit summary	Effect on follicular lymphoma (FL) step/redirect options
Policy edits reflect NCCN compendium updates during annual reviews (notably 1Q 2023 and 1Q 2025).	Clarifies that for relapsed/refractory FL with EZH2 negative or unknown status, tazemetostat may be used as second‑line therapy when there are no satisfactory alternative treatment options; also removed redirection to Aliqopa (copanlisib) in 1Q 2025 as it is no longer NCCN recommended and added explicit allowance for third‑line and subsequent use per NCCN guidance.

Quantity Limits

tazemetostat — 1,600 mg

Drug name (generic)tazemetostat

Brand nameTazverik

Typical formulationTablet, 200 mg

Definitions and Abbreviations

enhancer of zeste homolog 2 — EZH2

Termenhancer of zeste homolog 2 (EZH2)

RoleMethyltransferase target inhibited by tazemetostat

AbbreviationEZH2

epithelioid sarcoma — ES

Termepithelioid sarcoma (ES)

Indication contextTazemetostat indicated for metastatic or locally advanced ES not eligible for complete resection with INI1 loss

AbbreviationES

Background

Tazemetostat is an EZH2 (methyltransferase) inhibitor approved for specific indications including epithelioid sarcoma and certain relapsed/refractory follicular lymphoma scenarios. The policy history notes that the 1Q 2025 annual review clarified coverage for follicular lymphoma by removing Aliqopa as a redirect for EZH2 negative/unknown disease and by defining second‑line use when no satisfactory alternatives exist, with additional options for third‑line and subsequent therapy. Providers should follow the diagnosis‑specific coverage criteria and submit required documentation to support medical necessity.