CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Zolinza (vorinostat) — Coverage Criteria for Cutaneous T‑Cell Lymphoma

Policy governs coverage criteria for Zolinza (vorinostat) for members receiving treatment for cutaneous T‑cell lymphoma, including FDA‑approved and compendial uses, and continuation/reauthorization criteria for the payer's membership.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyZolinza (vorinostat) — Coverage Criteria for CTCL

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization and document diagnosis plus history of two prior systemic therapies for FDA‑indicated CTCL.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsauthorization period granted for initial treatment

12 monthsauthorization period for continuation/reauthorization

2prior systemic therapies required by FDA indication

NCCNcompendia reference

Coverage Criteria for Zolinza (vorinostat)

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Covered Indications and Approval Criteria

Covered when ALL of the following are met for the FDA‑approved CTCL indication:

FDA CTCL indication

Prior therapies: Disease is progressive, persistent, or recurrent on or following two systemic therapies2 systemic therapies
FDA requirement (chunk 1)
Authorization period: Authorization may be granted for up to 12 months for treatment of CTCL (e.g., mycosis fungoides, Sézary syndrome)12 months
Authorization guidance (chunk 3)

Compendial uses: Mycosis fungoides or Sézary syndrome as supported by recognized compendia are considered covered when the above approval criteria are met

Compendial listing (chunk 2)

Not Medically Necessary / Experimental

Experimental/Investigational: All other indications not listed (beyond mycosis fungoides, Sézary syndrome, or the FDA‑approved CTCL indication) are considered experimental/investigational and not medically necessary

Policy exclusion (chunk 2)

Continuation Therapy

Continuation/Reauthorization criteria:

Continuation criteria: No evidence of unacceptable toxicity or disease progression while on the current regimen

Authorization of 12 months may be granted for continued treatment when criteria are met (chunk 4)

Indications other than mycosis fungoides (MF) or Sézary syndrome (SS), and those outside the FDA‑approved cutaneous T‑cell lymphoma (CTCL) indication, are excluded from coverage as they are considered experimental/investigational.

All other indications not specifically listed as FDA‑approved CTCL or compendial uses (MF/SS) are considered experimental/investigational and are not medically necessary.

Provider Requirements and Authorization Process

Prior Authorization

Prior Authorization Required

Prior authorization required. Authorization for initial treatment may be granted for up to 12 months for the FDA‑approved indication (cutaneous T‑cell lymphoma [CTCL], including mycosis fungoides and Sézary syndrome).

Affected diagnoses: CTCL (including MF, SS)
Authorization period: up to 12 months for initial approval

Prior Authorization

Reauthorization / Continuation

Prior authorization is required for continuation/reauthorization. Reauthorization may be granted for up to 12 months when there is no evidence of unacceptable toxicity or disease progression while on the current regimen.

Reauthorization eligibility: clinical benefit without unacceptable toxicity or disease progression
Reauthorization period: up to 12 months

Step Therapy

Prior Systemic Therapy Requirement

Per the FDA‑approved label, Zolinza is indicated for treatment of the cutaneous manifestations of CTCL in patients with progressive, persistent, or recurrent disease on or following two systemic therapies. Requests must document prior systemic therapies consistent with this requirement.

Required prior systemic therapy: progression/persistence/recurrence on or after two systemic therapies
Applies to FDA‑approved CTCL indication only

Documentation Required

Required Clinical Documentation

Documentation must be submitted to support the diagnosis of CTCL (e.g., mycosis fungoides or Sézary syndrome) and to verify prior therapies and treatment response. Include pathology reports, clinical notes, prior systemic therapy details (drug names, dates, responses), and evidence of disease progression or recurrence as applicable.

Diagnosis documentation: pathology report and clinical assessment confirming CTCL (MF or SS)
Prior therapy documentation: names of systemic agents, treatment dates, and response/outcome
Progression evidence: clinical or imaging notes demonstrating persistent, progressive, or recurrent disease after two systemic therapies

Definitions and Background

Compendial uses

Compendial indicationsMycosis fungoides (MF) and Sézary syndrome (SS)

Scope of compendial supportUses supported by recognized drug compendia as specified in the policy

Non‑compendial indicationsAll other indications are considered experimental/investigational and not medically necessary

Vorinostat (Zolinza) is indicated for treatment of the cutaneous manifestations of cutaneous T‑cell lymphoma (CTCL). The policy recognizes compendial support for treating mycosis fungoides (MF) and Sézary syndrome (SS) as examples of CTCL listed in drug compendia.