CurrentCentenePolicy CP.PHAR.452

Tazemetostat (Tazverik) (PDF)

Defines medical necessity criteria, approval durations, dosing limits, and documentation requirements for Tazemetostat (Tazverik) for epithelioid sarcoma and follicular lymphoma across Commercial, HIM, and Medicaid lines of business administered by Centene.

Policy Summary

PayerCentene

PolicyTazemetostat (Tazverik) (PDF)

Policy CodePolicy CP.PHAR.452

Change TypeAnnual review revisions and template updates

Effective Date03.01.20

Next Review Date

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

SourceLink

POLICY UPDATE CHANGES

1Q 2026 annual review revised initial approval duration from 6 to 12 months and added requirement that requests do not exceed health plan-approved quantity limit, if applicable.

1Q 2025 annual review clarified EZH2-negative/unknown FL options and removed redirection to Aliqopa; added third-line therapy option.

1Q 2023 annual review clarified that ≥2 prior therapies applies to EZH2 mutation positive FL and adjusted options for EZH2-negative/unknown disease.

Revised approval duration for Commercial line of business to 12 months or duration of request, whichever is less (effective 01.20.22).

2Covered Indications

1600 mg/day

200 mgTablet Strength

Coverage Summary

Coverage stance: covered_with_criteria. Scope: policy defines medical necessity criteria, approval durations, dosing limits, and documentation requirements for Tazemetostat (Tazverik) for epithelioid sarcoma and follicular lymphoma across Commercial, HIM, and Medicaid lines of business administered by Centene.

Indications covered: epithelioid sarcoma (ES) in patients aged ≥ 16 years with metastatic or locally advanced disease not eligible for complete resection and tumor loss of INI1 (SMARCB1); and relapsed/refractory follicular lymphoma (FL) in adults ≥ 18 years (EZH2‑mutant after ≥ 2 prior systemic therapies, or EZH2‑negative/unknown in specified second‑ or later‑line settings).

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

Dosing limit: maximum recommended dose is 1,600 mg/day (8 tablets) (standard regimen 800 mg PO BID until progression or unacceptable toxicity); requests exceeding this require guideline or peer‑reviewed literature justification.

Initial Therapy Criteria — Epithelioid Sarcoma

Initial Approval Criteria - Epithelioid Sarcoma

Must meet ALL of the following:

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Initial Therapy Criteria — Follicular Lymphoma

Initial Approval Criteria - Follicular Lymphoma

Must meet ALL of the following:

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Continuation Therapy Criteria

Continuation/Renewal Criteria (All Indications in Section I)

Must meet ALL of the following:

ALL of the following

Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Tazverik for a covered indication and has received this medication for at least 30 days
clinical documentation required
Member is responding positively to therapy
For brand Tazverik requests, member must use generic tazemetostat, if available, unless contraindicated or clinically significant adverse effects are experienced
applies to brand requests
Request does not exceed health plan-approved quantity limit, if applicable

Other Diagnoses / Unapproved Indications

Other Diagnoses/Indications (when not covered by sections above)

Must meet ONE of the following:

ANY of the following

If recent label change within last 6 months
- Refer to formulary/no coverage or non-formulary policies as applicable: CP.CPA.190 (commercial), HIM.PA.33 (marketplace) or CP.PMN.255 (Medicaid) for formulary; CP.CPA.190 (commercial), HIM.PA.103 (marketplace) or CP.PMN.16 (Medicaid) for non-formulary
For other off-label uses
- If requested use is NOT listed under section III and criterion 1 above does not apply, refer to off-label use policy: CP.CPA.09 (commercial), HIM.PA.154 (marketplace), CP.PMN.53 (Medicaid)

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Applicable Codes & Dosing

Relevant dosing information (Product availability)mixed

Tablet: 200 mg

Product availability - tablet strength

Key thresholds

Maximum daily dose1,600 mg/day (8 tablets)

Age - Epithelioid Sarcoma (ES)≥ 16 years

Age - Follicular Lymphoma (FL)≥ 18 years

Prior therapies for EZH2+ FL≥ 2 prior systemic therapies

Minimum exposure for continuation≥ 30 days on therapy

Provider Actions & Documentation Requirements

Documentation Required

Documentation submission required

Submit documentation such as office notes, laboratory results, and other clinical information that verify the patient meets all approval criteria for Tazemetostat (diagnosis, staging, prior therapies, molecular test results, dose limits, and treatment plan).

Office/clinic notes describing diagnosis and staging
Relevant lab and pathology reports
Documentation of prior therapies received
Prescriber consultation notes if applicable

Prior Authorization

Prescriber specialty requirement

Requests must be prescribed by or in consultation with an oncologist for epithelioid sarcoma. For follicular lymphoma, prescriptions must be by or in consultation with an oncologist or a hematologist.

Clinical Evidence & References

Key evidence and references supporting the policy include: Prescribing Information (Tazverik PI, August 2024), NCCN Compendium listings for B‑cell Lymphomas and Soft Tissue Sarcoma (2024–2025 versions), and the pivotal phase 2 international open‑label basket study by Gounder et al., Lancet Oncology 2020 evaluating tazemetostat in advanced epithelioid sarcoma with loss of INI1/SMARCB1.

Background

Background: Tazemetostat (Tazverik) is an EZH2 methyltransferase inhibitor. It has accelerated FDA approvals for metastatic or locally advanced epithelioid sarcoma and for relapsed/refractory follicular lymphoma in specified populations. These accelerated indications are based on overall response rate and duration of response; continued approval for these indications may be contingent on verification of clinical benefit in confirmatory trials.

Glossary:

ES: epithelioid sarcoma

FL: follicular lymphoma

EZH2: enhancer of zeste homolog 2

INI1 (SMARCB1): gene whose loss of expression is required for the ES indication

NCCN: National Comprehensive Cancer Network

Revision History

1Q 2026References reviewed and updated; template additions applied.Latest

1Q 2026 annual review revised initial approval duration from 6 to 12 months and added requirement that requests do not exceed health plan-approved quantity limit, if applicable.

1Q 2025Aligned with NCCN compendium changes.

1Q 2025 annual review clarified EZH2-negative/unknown FL options and removed redirection to Aliqopa; added third-line therapy option.

1Q 2023Removed Copiktra and Zydelig as redirect options per NCCN; references updated.

Policy Summary

PayerCentene

PolicyTazemetostat (Tazverik) (PDF)

Policy CodePolicy CP.PHAR.452

Change TypeAnnual review revisions and template updates

Effective Date03.01.20

Next Review Date

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

SourceLink

On This Page

Dose increase requirement (one of)

New dose does not exceed 1,600 mg (8 tablets) per day≤ 1600 mg/day
New dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence)

Prescribed regimen must be FDA-approved or recommended by NCCN

Diagnoses/Indications Not Authorized

Coverage is NOT authorized for:

Non-FDA approved indications which are not addressed in this policy, unless sufficient documentation of efficacy and safety per off-label use policies or evidence of coverage documents is provided

Documentation Required

Molecular testing proof for ES

For the epithelioid sarcoma indication, document tumor demonstration of loss of INI1 (SMARCB1) gene expression (inactivation, deletion, or mutation) with the testing results included in the submission.

Documentation Required

EZH2 mutation testing for FL

For the EZH2‑positive follicular lymphoma indication, include documentation of an EZH2 mutation detected by an FDA‑approved test (test result report) to support the EZH2+ indication.

Billing Rule

Dose limit enforcement

Dose requests exceeding 1,600 mg per day must be supported by practice guideline recommendations or peer‑reviewed literature submitted by the prescriber; doses >1,600 mg/day without such supporting evidence will not meet the dose criteria.

Documentation Required

Continuation documentation

For renewals, provide documentation that the member has been on Tazemetostat for at least 30 days and is responding positively to therapy (chart notes, treatment response assessment, or other clinical documentation).

1Q 2023 annual review clarified that ≥2 prior therapies applies to EZH2 mutation positive FL and adjusted options for EZH2-negative/unknown disease.

01.20.22Administrative change to approval duration.

Revised approval duration for Commercial line of business to 12 months or duration of request, whichever is less (effective 01.20.22).