CurrentCignaPolicy N/A

Zolinza Coverage Policy

Defines prior authorization recommendations, covered indications, duration of approval, and non-covered uses for Zolinza (vorinostat capsules) under Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyZolinza Coverage Policy

Policy CodePolicy N/A

Change TypeAdded approval for Classic Hodgkin Lymphoma (other use)

Effective Date

Next Review Date

Key ActionPrior Authorization is recommended; document age ≥18, at least three prior systemic regimens, and use in combination with pembrolizumab for Classic Hodgkin Lymphoma approvals.

SourceLink

POLICY UPDATE CHANGES

Classic Hodgkin Lymphoma: Added as a new condition for approval under Other Uses with Supportive Evidence section.

Annual review dated 07/02/2025 with no criteria changes noted in summary.

2Covered Indications

AnyNot covered (catch-all)

Coverage Summary & Indications

This policy defines coverage for Zolinza (vorinostat) under Cigna‑administered health benefit plans and the recommended prior authorization process. The policy stance is covered with criteria: Zolinza is covered for its FDA‑approved use for the cutaneous manifestations of cutaneous T‑cell lymphoma in patients with progressive, persistent, or recurrent disease following two systemic therapies, with approvals provided for 1 year. The policy also includes an Other Uses with Supportive Evidence pathway for Classic Hodgkin Lymphoma that provides coverage for 1 year when all specified criteria are met (patient ≥18 years, at least three prior systemic regimens, and vorinostat used in combination with pembrolizumab). The policy references the FDA prescribing information and NCCN guidance supporting these placements.

FDA-Approved Indication

Covered when ALL of the following are met:

ALL of the following

Diagnosis: Cutaneous T-Cell Lymphoma including Mycosis Fungoides/Sezary Syndrome
Duration: Coverage duration: Approve for 1 year

FDA-Approved Indication (grouped)

Diagnosis: Cutaneous T-Cell Lymphoma including Mycosis Fungoides/Sezary Syndrome
Duration: Approve for 1 year

FDA-Approved Indication (leaf): Cutaneous T-Cell Lymphoma including Mycosis Fungoides/Sezary Syndrome: Approve for 1 year

Other Uses with Supportive Evidence — Classic Hodgkin Lymphoma

Approve for 1 year if patient meets ALL of the following (A, B, and C):

Classic Hodgkin Lymphoma criteria

A: Patient is ≥ 18 years of age
B: Patient has tried at least three systemic regimens
Examples of systemic regimens are ABVD (doxorubicin, bleomycin, vinblastine, dacarbazine) + rituximab; CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone) + rituximab; CVbP (cyclophosphamide, vinblastine, prednisolone) + rituximab; Adcetris (brentuximab vedotin) + AVD (doxorubicin, vinblastine, dacarbazine)
C: Medication is used in combination with Keytruda (pembrolizumab intravenous infusion)
Duration: Coverage duration: Approve for 1 year

Hodgkin lymphoma (leaf): Classic Hodgkin Lymphoma: Approve for 1 year if patient is ≥ 18 years, has tried at least three systemic regimens, and the medication is used in combination with Keytruda (pembrolizumab intravenous infusion)

Examples of systemic regimens provided

Prior Authorization & Documentation Requirements

Prior Authorization

Prior authorization required

Prior Authorization is recommended for prescription benefit coverage of Zolinza; approvals are provided for the duration noted (1 year for covered indications).

Documentation Required

Documentation of prior therapies for Hodgkin lymphoma

For Classic Hodgkin Lymphoma coverage, document all of the following:

Patient is ≥ 18 years of age.
Documentation that the patient has tried at least three prior systemic regimens (examples include ABVD + rituximab; CHOP + rituximab; CVbP + rituximab; Adcetris [brentuximab vedotin] + AVD).
A statement that vorinostat will be used in combination with Keytruda (pembrolizumab).

Evidence & Guidelines

Evidence sources cited in the policy: FDA prescribing information: Zolinza capsules, Merck; July 2022; and NCCN guidance: NCCN Primary Cutaneous Lymphomas (version 3.2025) and NCCN Hodgkin Lymphoma (version 2.2025). The NCCN guidance includes Zolinza as a recommended systemic therapy for primary cutaneous lymphomas and recommends Zolinza in combination with pembrolizumab as subsequent therapy for Hodgkin lymphoma refractory to at least three prior lines of therapy (category 2A).

Background

Zolinza (vorinostat) is a histone deacetylase inhibitor indicated by the FDA for the treatment of the cutaneous manifestations of cutaneous T‑cell lymphoma in patients with progressive, persistent, or recurrent disease on or following two systemic therapies. The NCCN guidelines discuss Zolinza for primary cutaneous lymphomas (mycosis fungoides/Sezary syndrome) as a systemic therapy for primary or relapsed/persistent/refractory disease, and for Hodgkin lymphoma as a subsequent therapy in combination with pembrolizumab for disease refractory to at least three prior lines of therapy. Prior authorization is recommended for Zolinza under Cigna‑administered plans; approvals are provided for the durations noted in the policy (typically 1 year for covered indications), and the policy specifies that Zolinza is not medically necessary for any other uses.

Policy Revision History

07/31/2024material_addition

Classic Hodgkin Lymphoma: Added as a new condition for approval under Other Uses with Supportive Evidence. Approval: 1 year when patient is ≥18, has tried at least three systemic regimens (examples provided), and vorinostat is used in combination with pembrolizumab.

07/02/2025annual_reviewLatest

Annual review dated 07/02/2025 with no criteria changes noted.