CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Tazverik (tazemetostat) coverage

Defines clinical coverage criteria and utilization management rules for tazemetostat (Tazverik) for Neighborhood Health Plan of Rhode Island members, including FDA and accepted off‑label indications and continuation rules.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyTazverik (tazemetostat) coverage

Policy CodePolicy N/A

Change TypeNo material change

Effective DateMay 31, 2024

Next Review DateN/A

Key ActionSubmit prior authorization with supporting documentation showing prior chemotherapy failure/intolerance for epithelioid sarcoma or relapsed/refractory status for follicular lymphoma.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

16+committee review/approval dates listed

>=16minimum age for epithelioid sarcoma

800 mgsingle dose maximum

240 tabsmonthly supply limit

2 indicationsdisease areas addressed

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Coverage Criteria for Tazverik (tazemetostat)

Epithelioid Sarcoma — Initial Therapy

Epithelioid sarcoma — initial therapy

Epithelioid sarcoma criteria: Member is an adult or pediatric member >=16 years with unresectable advanced or metastatic epithelioid sarcoma who is not a candidate for surgery and/or radiation; Tazverik (tazemetostat) is being used as a single agent; AND the member has contraindications, intolerance, or failure (disease progression) of anthracycline and/or gemcitabine‑based chemotherapy.age >=16

Follicular Lymphoma — Subsequent Therapy

Follicular lymphoma — subsequent therapy

Follicular lymphoma criteria: Tazverik (tazemetostat) used as monotherapy for relapsed or refractory follicular lymphoma as subsequent therapy; EZH2 mutation status is not required.relapsed or refractory status

Initial Therapy — Coverage Criteria

Initial coverage criteria by indication

Epithelioid sarcoma initial: Member is an adult or pediatric member >=16 years with unresectable advanced or metastatic epithelioid sarcoma who is not a candidate for surgery and/or radiation; Tazverik (tazemetostat) to be used as a single agent; AND member has contraindication, intolerance, or failure of anthracycline and/or gemcitabine‑based chemotherapy.age >=16

Step requirement: prior anthracycline and/or gemcitabine‑based chemotherapy contraindication, intolerance, or failure required.

Follicular lymphoma initial: Tazverik (tazemetostat) used as monotherapy for relapsed or refractory follicular lymphoma as subsequent therapy; EZH2 mutation status not required.relapsed or refractory status

Continuation Therapy — Criteria to Continue

Continuation requests

Continuation request criteria: The requested medication was used within the last year; the member has not experienced disease progression and/or intolerance to the requested medication; AND additional medication(s) are not being added to the continuation request.

Requests for Tazverik (tazemetostat) will be excluded when the drug is being used after documented disease progression on the same regimen. Concurrent administration with other systemic oncologic therapies is not allowed; Tazverik must be prescribed as a single agent when required by the indication. Prescriptions that would result in a single dose exceeding 800 mg are not permitted, and total dispensed product must not exceed 240 (200 mg) tablets per month. Lastly, use for investigational or off‑label indications that lack adequate evidence (not supported by FDA labeling, CMS‑recognized compendia, accepted peer‑reviewed literature, or guideline recommendations) will be denied.

Initial Therapy Requirements and Step Therapy

Initial Coverage Criteria by Indication

Initial coverage criteria by indication

Epithelioid sarcoma initiation: Member is an adult or pediatric member >=16 years with unresectable advanced or metastatic epithelioid sarcoma who is not a candidate for surgery and/or radiation; Tazverik (tazemetostat) will be used as a single agent; AND member has contraindications, intolerance, or failure (disease progression) of anthracycline and/or gemcitabine‑based chemotherapy.age >=16

Prior anthracycline and/or gemcitabine‑based chemotherapy required unless contraindicated or not tolerated.

Follicular lymphoma initiation: Tazverik (tazemetostat) used as monotherapy for relapsed or refractory follicular lymphoma as subsequent therapy; EZH2 mutation status is not required.relapsed or refractory status

Step	Requirement	Coverage
1
Member must be an adult or pediatric member >=16 years with unresectable advanced or metastatic epithelioid sarcoma who is not a candidate for surgery and/or radiation; Tazverik (tazemetostat) to be used as a single agent.
Requires prior use and contraindication, intolerance, or failure (disease progression) of anthracycline and/or gemcitabine-based chemotherapy before approval.

Continuation Therapy Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for continuation requests of tazemetostat. Providers must submit a prior authorization request and include documentation demonstrating the member meets the continuation criteria below.

Prior authorization required for continuation of therapy
Include supporting clinical documentation with the request (see criteria below)

Continuation Therapy — requirements

Covered when ALL of the following are met:

The requested medication was used within the last year.

There is no evidence of disease progression while on the medication and the member is tolerating therapy (no documented intolerance).

No additional medication(s) are being added to the continuation request.

For epithelioid sarcoma: the provider must have documented prior trial and failure (or intolerance) of at least one alternative systemic therapy unless a contraindication is documented.

Provider Actions and Authorization Requirements

Prior Authorization

Prior authorization required — evaluate against indication criteria

Prior authorization is required for Tazverik and requests will be reviewed against the policy's indication‑specific criteria for epithelioid sarcoma and follicular lymphoma.

Epithelioid sarcoma: member must meet age, disease, single‑agent, and prior chemotherapy criteria (see criteria).
Follicular lymphoma: used as monotherapy for relapsed or refractory disease as subsequent therapy.

Step Therapy

Step requirement — prior anthracycline and/or gemcitabine therapy

For epithelioid sarcoma, approval requires documented contraindication, intolerance, or disease progression/failure of anthracycline and/or gemcitabine‑based chemotherapy prior to Tazverik use.

Member must be >=16 years with unresectable advanced or metastatic disease and not a candidate for surgery/radiation.
Tazverik must be used as a single agent after anthracycline and/or gemcitabine‑based chemotherapy contraindication, intolerance, or failure.

Documentation Required

Required supporting documentation — accepted evidence sources

Requests must be supported by accepted sources of clinical evidence: FDA labeling, CMS‑recognized compendia, NCCN or ASCO guidelines, or peer‑reviewed literature that meets CMS criteria.

Accepted evidence includes FDA approved product labeling.
CMS‑recognized compendia, NCCN or ASCO clinical guidelines, or peer‑reviewed literature meeting CMS Medicare Benefit Policy Manual Chapter 15 standards.

Denial Risk

Denial triggers — excluded uses and thresholds

Requests will be excluded or denied for specified uses and threshold violations, including use after progression on the same regimen, concurrent systemic therapy, and dosing or quantity limit exceedances.

Use after disease progression with the same regimen is excluded.
Concurrent use with other systemic therapies will be denied.
Dosing that exceeds the single dose limit of 800 mg is excluded.
Treatment exceeding 240 (200 mg) tablets per month is excluded.
Investigational/off‑label indications lacking sufficient evidence per policy are excluded.

Dosing Limits and Coding Constraints

Single dose limit

Single dose maximum800 mg per single dose

ContextDosing that exceeds the single dose limit is listed as an exclusion criterion

ApplicabilityApplies to all Tazverik (tazemetostat) requests reviewed under this policy

Maximum monthly tablets

Maximum monthly tablets240 (200 mg) tablets per month

Alternate expressionUp to 240 tablets of 200 mg strength in a 30-day period

Exclusion if exceededTreatment exceeding this monthly limit is listed as an exclusion criterion

Tazverik (tazemetostat) quantity limit

ProductTazverik (tazemetostat)

Quantity limit240 (200 mg) tablets per month

Unit strength200 mg tablets

Perper month

Background

Tazemetostat (Tazverik) is an oral EZH2 inhibitor with regulatory and guideline‑based indications in specific oncology settings. In this policy the drug is addressed for two covered uses: as single‑agent therapy for unresectable advanced or metastatic epithelioid sarcoma in patients aged ≥16 years who are not candidates for surgery or radiation and who have contraindication/intolerance or failure of anthracycline and/or gemcitabine‑based chemotherapy, and as subsequent monotherapy for relapsed or refractory follicular lymphoma regardless of EZH2 mutation status. Clinical trial evidence and FDA labeling form the basis for these indications; prior authorization decisions will be evaluated against those indication‑specific criteria and the supporting literature/guidance cited in the policy.