ModifiedUnitedHealthcarePolicy 2025 P 1329-7

Zolinza (vorinostat) prior authorization / coverage criteria

UnitedHealthcare prior authorization/notification policy for Zolinza (vorinostat) specifying initial and reauthorization medical necessity criteria for cutaneous T-cell lymphoma (CTCL) and Classic Hodgkin Lymphoma, age-based automatic approval for members <19, authorization durations, and references to NCCN and state mandates.

Policy Summary

PayerUnitedHealthcare

PolicyZolinza (vorinostat) prior authorization / coverage criteria

Policy CodePolicy 2025 P 1329-7

Change TypeModified — added Classic Hodgkin Lymphoma criteria; CTCL criteria updated per NCCN

Effective DateJan 1, 2026

Next Review Date

Key ActionProviders must obtain prior authorization for Zolinza for members 19 years and older; authorization issued for 12 months when criteria met.

POLICY UPDATE CHANGES

10/2025 annual review updated coverage criteria for cutaneous T-cell lymphoma per NCCN recommendation and added new criteria for Classic Hodgkin Lymphoma per NCCN recommendation.

10/2024 annual review updated background and references.

10/2022 annual review added state mandate footnote and updated references.

10/2021 updated criteria to align with label and updated references.

9/2020 new prior authorization program for Zolinza (vorinostat).

2Covered Indications (CTCL, Classic Hodgkin Lymphoma)

12 moAuthorization Duration

>=3Prior lines required for Classic Hodgkin Lymphoma

Coverage Summary

Coverage: Zolinza (vorinostat) is covered with criteria for cutaneous T‑cell lymphoma (CTCL) and Classic Hodgkin Lymphoma when policy requirements are met. For members under 19 years the prescription will automatically process without coverage review. When criteria are met, prior authorization is issued for 12 months. The policy references the NCCN Drugs and Biologics Compendium and the product label; applicable state mandates or member‑specific benefit plans may supersede these criteria.

Authorization duration and prior‑lines threshold

Authorization duration12 months when criteria met (initial and reauthorization)

Prior lines required for Classic Hodgkin Lymphoma>= 3 prior lines of subsequent therapy

Reauthorization requirementNo evidence of progressive disease while on Zolinza therapy

Automatic processing for pediatric patientsMembers <19 years: authorization issued for 12 months and processes without coverage review

Initial Authorization — Cutaneous T‑Cell Lymphoma (CTCL)

Initial Authorization for CTCL (cutaneous T-cell lymphoma)

Zolinza will be approved based on both of the following criteria:

ALL of the following

Diagnosis of CTCL: Diagnosis of cutaneous T-cell lymphoma (CTCL) [e.g., mycosis fungoides (MF) syndrome)]
One of the following uses
- Primary treatment - Stage IB - IIA: Used as primary treatment in one of the following settings: Stage IB - IIA
- Primary treatment - Stage IIB limited lesions: Used as primary treatment in one of the following settings: Stage IIB with limited tumor lesions

Reauthorization — Cutaneous T‑Cell Lymphoma (CTCL)

Reauthorization for CTCL

Zolinza will be approved for reauthorization when the following is met:

Reauthorization criterion: Patient does not show evidence of progressive disease while on Zolinza therapy

Authorization will be issued for 12 months.

Initial Authorization — Classic Hodgkin Lymphoma

Initial Authorization for Classic Hodgkin Lymphoma

Zolinza will be approved based on all of the following criteria:

Diagnosis of Classic Hodgkin Lymphoma
Prior lines of therapy: Disease is refractory to at least 3 prior lines of subsequent therapy>= 3 prior lines
Examples: rituximab, doxorubicin, cyclophosphamide, ifosfamide, carboplatin, etoposide, etc.
Concurrent therapy: Used in combination with Keytruda (pembrolizumab)

Reauthorization — Classic Hodgkin Lymphoma

Reauthorization for Classic Hodgkin Lymphoma

Zolinza will be approved for reauthorization when the following is met:

Reauthorization criterion: Patient does not show evidence of progressive disease while on Zolinza therapy

Authorization will be issued for 12 months.

NCCN Recognition / Compendia

NCCN Recommended Regimens / General

Recognition by NCCN Drugs and Biologics Compendium applies

NCCN recognition: Drug recognized for treatment of the cancer indication by the NCCN Drugs and Biologics Compendium with Category of Evidence and Consensus of 1, 2A, or 2BCategory 1, 2A, or 2B

This policy references the NCCN Drugs and Biologics Compendium and the Zolinza (vorinostat) product label for clinical guidance. State mandates and member‑specific benefit plans may alter or supersede coverage described in this document.

Applicable Codes

ICD-10 / diagnosis codes referenced (examples)ICD-10

	Cutaneous T-cell lymphoma (CTCL) and mycosis fungoides referenced as diagnosis; specific ICD-10 codes not listed in policy text
	Classic Hodgkin Lymphoma referenced as diagnosis; specific ICD-10 codes not listed in policy text

Provider Actions / Authorization Requirements

Prior Authorization

Prior authorization required for Zolinza (vorinostat)

Providers must obtain prior authorization for Zolinza (vorinostat) for members 19 years and older. Members under 19 years of age will automatically process without a coverage review. When criteria are met, authorization is issued for 12 months.

Documentation Required

Document diagnosis and prior therapies

Document the patient’s diagnosis (cutaneous T-cell lymphoma or Classic Hodgkin Lymphoma). For CTCL include disease stage (e.g., Stage IB–IIA, IIB, III, IVA1/IVA2/Sezary syndrome) and whether use is primary or subsequent. For Classic Hodgkin Lymphoma document refractory disease to at least 3 prior lines of subsequent therapy and concurrent use with pembrolizumab (Keytruda) when applicable.

Background & Definitions

Vorinostat (Zolinza) is a histone deacetylase (HDAC) inhibitor. The labeled indication is for treatment of cutaneous manifestations in patients with CTCL who have progressive, persistent, or recurrent disease on or following two systemic therapies. The NCCN also recommends vorinostat as a systemic therapy for CTCL and for Classic Hodgkin Lymphoma. This policy references the product label and the NCCN Drugs and Biologics Compendium for coverage determinations.

Cutaneous T‑cell lymphoma (CTCL): a group of non‑Hodgkin lymphomas that include mycosis fungoides and Sézary syndrome, involving cutaneous manifestations of disease.

Clinical Evidence & References

Evidence and references: P&T approval and program history include approval dates of 9/2020, 9/2021, 10/2021, 10/2022, 10/2023, 10/2024, 10/2025. Key references cited in the policy are the Zolinza package insert (July 2022) and the NCCN Drugs and Biologics Compendium.

Revision History

10/2025revisedLatest

Material expansion: annual review updated coverage criteria for cutaneous T‑cell lymphoma per NCCN recommendation and added new criteria for Classic Hodgkin Lymphoma requiring use in combination with pembrolizumab and prior therapy requirements (disease refractory to at least 3 prior lines).

10/2024revised

Annual review with no changes to coverage criteria; updated background and references.

10/2022revised

Policy Summary

PayerUnitedHealthcare

PolicyZolinza (vorinostat) prior authorization / coverage criteria

Policy CodePolicy 2025 P 1329-7

Change TypeModified — added Classic Hodgkin Lymphoma criteria; CTCL criteria updated per NCCN

Effective DateJan 1, 2026

Next Review Date

Key ActionProviders must obtain prior authorization for Zolinza for members 19 years and older; authorization issued for 12 months when criteria met.

On This Page

Primary treatment - Stage IIB generalized lesions with skin-directed therapy: Used as primary treatment in one of the following settings: Stage IIB with generalized tumor lesions, in combination with skin-directed therapy (e.g., phototherapy, topical corticosteroids, topical imiquimod)

Primary treatment - Stage III with skin-directed therapy: Used as primary treatment in one of the following settings: Stage III, in combination with skin-directed therapy (e.g., phototherapy, topical corticosteroids, topical imiquimod)

Primary treatment - Stage IVA1/IVA2 Sezary syndrome with skin-directed therapy: Used as primary treatment in one of the following settings: Stage IVA1 or IVA2 Sezary syndrome, in combination with skin-directed therapy (e.g., phototherapy, topical corticosteroids, topical imiquimod)

Subsequent treatment: Used as subsequent treatment in progressive, persistent, or recurrent disease

Denial Risk

Reauthorization denial risk if progressive disease

Reauthorization requires that the patient does not show evidence of progressive disease while on Zolinza therapy. Evidence of progression while on therapy may result in denial of reauthorization.

Billing Rule

State mandates and benefit plan may supersede

State mandates, federal regulatory requirements, member-specific benefit plans, or other utilization management programs may supersede or modify coverage described in this policy. Check applicable mandates and benefit documents.

Annual review with no changes to coverage criteria; added state mandate footnote and updated references.

10/2021revised

Updated criteria to align with product labeling and updated references. (Material change to align with label.)

9/2020added

New prior authorization program established for Zolinza (vorinostat).