CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Zolinza (vorinostat) — Coverage Criteria

Defines accepted indications, exclusions, coding, and documentation requirements for coverage of Zolinza (vorinostat) for members; applies to providers submitting medication requests processed by Evolent for Neighborhood Health Plan of Rhode Island.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyZolinza (vorinostat) — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization requests to Evolent with evidence from FDA labeling, recognized compendia, or NCCN/ASCO guidelines.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

400 mgsingle dose maximum for Zolinza

120 caps/momaximum monthly treatment limit

J8999billing code listed

Commercial; Medicaid; Exchangeapplicable lines of business

Coverage Criteria for Zolinza (vorinostat)

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Indication: Member has cutaneous T‑cell lymphoma (CTCL) with progressive, persistent, or recurrent cutaneous manifestations

based on FDA‑labeled and guideline‑supported indication

Supporting evidence: Use is supported by FDA approved product labeling, CMS‑recognized compendia, NCCN or ASCO clinical guidelines, or acceptable peer‑reviewed literature

per Purpose section

Dose limits: Single dose does not exceed 400 mg and monthly quantity does not exceed 120 (100 mg) capsulessingle dose <= 400 mg; monthly <= 120 x 100 mg capsules

per Exclusion Criteria

Continuation therapy criteria

Continuation authorization may be granted when ALL of the following are met

No progression: Member has not experienced disease progression on the requested medication

continuation requirement per policy

Recent prior authorization: Requested medication was used within the last year without a lapse of more than 30 days of having an active authorization<= 30 day lapse

continuation requirement per policy

No added medications: Additional medication(s) are not being added to the continuation request

continuation requirement per policy

Coverage will be excluded for requests meeting any of the stated exclusion triggers. Specifically, requests are not approvable when the member has experienced disease progression while taking Zolinza (vorinostat) or another histone deacetylase (HDAC) inhibitor (for example, romidepsin), when Zolinza is used concurrently with other cytotoxic chemotherapy, or when dosing exceeds established limits. The policy enforces a single dose limit of 400 mg and a maximum monthly supply of 120 (100 mg) capsules; exceeding either parameter is an exclusion and places the request at risk for denial.

Off‑label or investigational uses of Zolinza (vorinostat) that are not supported by sufficient evidence are considered not acceptable for coverage. The policy defines insufficient evidence as situations where published data do not adequately represent the patient or cancer clinical characteristics, the specific regimen under consideration, or clinically meaningful outcomes. Evidence deficiencies include reliance on case reports, abstracts without full peer‑reviewed articles, or studies lacking appropriate design to address the clinical question. Generally accepted thresholds for clinically meaningful benefit follow ASCO conventions (for example, a hazard ratio < 0.80 or survival benefit thresholds such as ≥ 3 months for OS/PFS); evidence failing to meet these standards, or not supported by CMS‑recognized compendia or acceptable peer‑reviewed literature, will render off‑label indications not medically supported and therefore not approvable.

Coding and Quantity Limits

Drug HCPCS codeHCPCSCovered

J8999

vorinostat

inv-06: Single dose limit — 400 mg

Single dose limit400 mg per single dose

Source contextDosing exceeds single dose limit of Zolinza (vorinostat) 400 mg.

Applies toAll requests for Zolinza (vorinostat)

inv-07: Maximum monthly capsules — 120 (100 mg) capsules per month

Maximum monthly capsules120 capsules per month (100 mg strength)

Source contextTreatment with Zolinza (vorinostat) exceeds the maximum duration limit of 120 (100 mg) capsules a month.

MeasurementCount based on 100 mg capsules dispensed per month

Provider Requirements, Authorization, and Exclusions

Prior Authorization

Prior authorization required

Prior authorization is required for Zolinza (vorinostat). Evolent processes all medication requests and will authorize Zolinza for treatment of cutaneous manifestations of CTCL when use is supported by accepted evidence sources.

Requests must be submitted to and processed by Evolent.

Step Therapy

Concurrent therapy restrictions

Concurrent cytotoxic chemotherapy with Zolinza is excluded. Zolinza may be used concurrently with skin-directed therapy or radiation therapy.

Do not prescribe Zolinza concurrently with other chemotherapy agents.

Documentation Required

Supporting documentation and continuation requirements

Use must be supported by FDA labeling, CMS‑recognized compendia, NCCN/ASCO guidelines, or acceptable peer‑reviewed literature. Continuation requests require no disease progression on the medication, prior use within the last year without a lapse greater than 30 days of active authorization, and that no additional medications are being added to the continuation request.

Support initial requests with one of: FDA label, CMS compendia, NCCN/ASCO guideline, or qualifying peer‑reviewed literature.
For continuation: confirm no disease progression; medication used within past year with ≤30‑day authorization lapse; no new medications added.

Denial Risk

Exclusion triggers — denial risks

Requests are excluded (and at risk for denial) if the member experienced disease progression while taking vorinostat or another histone deacetylase (HDAC) inhibitor, if dosing exceeds the single dose limit of 400 mg, or if monthly treatment exceeds 120 (100 mg) capsules.

Exclusion if member had disease progression on Zolinza or another HDAC inhibitor (e.g., romidepsin).
Exclusion if a single dose > 400 mg.
Exclusion if monthly supply > 120 (100 mg) capsules.

Background

Vorinostat (Zolinza) is a histone deacetylase (HDAC) inhibitor indicated for treatment of cutaneous T‑cell lymphoma (CTCL) to address cutaneous manifestations in patients with progressive, persistent, or recurrent disease. Clinical use and authorization decisions should align with FDA labeling and be supported by CMS‑recognized compendia, NCCN/ASCO guidelines, or acceptable peer‑reviewed literature. The background rationale for exclusions and continuation criteria includes the potential for disease progression on HDAC inhibitors and the need for adequate, clinically meaningful evidence when considering off‑label uses.

Definitions

inv-13: CTCL — Cutaneous T‑Cell Lymphoma (CTCL) indication

IndicationTreatment of cutaneous manifestations in members with cutaneous T‑Cell Lymphoma (CTCL) who have progressive, persistent, or recurrent disease.

Condition descriptionCutaneous T‑Cell Lymphoma (CTCL)

Evidence requirementUse should be consistent with the stated indication and supported by accepted evidence sources (per policy).

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyZolinza (vorinostat) — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization requests to Evolent with evidence from FDA labeling, recognized compendia, or NCCN/ASCO guidelines.

SourceLink

On This Page

OpenPayer

Zolinza (vorinostat) — Coverage Criteria

Coverage Criteria for Zolinza (vorinostat)

Coding and Quantity Limits

Provider Requirements, Authorization, and Exclusions

Background

Definitions

Line of Therapy