CurrentCignaPolicy N/A

Oncology - Farydak Prior Authorization Policy

Defines Cigna's prior authorization requirements and coverage criteria for Farydak (panobinostat capsules) for members receiving prescription benefits, including FDA‑approved multiple myeloma use and investigational exclusions.

Policy Summary

PayerCigna

PolicyOncology - Farydak Prior Authorization Policy

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization documenting current Farydak use, prior treatment with bortezomib and at least one immunomodulatory drug, and that panobinostat will be given with bortezomib and dexamethasone.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1 yearinitial approval duration for covered indication

≥2 prior regimensFDA approved population requirement noted in overview

market withdrawalmanufacturer removed Farydak from market (Dec 2021)

Annual Revisionpolicy reviewed annually (most recent 06/12/2024)

Coverage Criteria for Farydak (panobinostat)

inv-01: FDA-Approved Indication

Covered when ALL of the following are met:

FDA-Approved Indication - Multiple Myeloma: 1) Patient is currently receiving Farydak (panobinostat); AND 2) Patient has previously tried bortezomib injection; AND 3) Patient has tried one immunomodulatory drug (thalidomide, lenalidomide, or pomalidomide); AND 4) Panobinostat will be taken in combination with bortezomib injection and dexamethasone.Approve for 1 year

Approvals are provided for 1 year when criteria are met.

inv-02: Experimental/Investigational

Not covered when any of the following apply:

Investigational/Unproven Uses: Use of Farydak (panobinostat) for any indication other than the specified multiple myeloma criteria is considered experimental, investigational, or unproven (example: pancreatic cancer where a Phase II study of panobinostat + bortezomib was discontinued early for toxicity and lack of response).

Policy Summary

PayerCigna

PolicyOncology - Farydak Prior Authorization Policy

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

SourceLink

On This Page

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Regimens and Indications Covered

Regimen	Indication	Coverage status	Notes / Requirements
Panobinostat + bortezomib + dexamethasone
Multiple myeloma (patients who have received at least two prior regimens including bortezomib and an immunomodulatory drug)
Covered
Approve for 1 year when ALL criteria are met: patient is currently receiving panobinostat; prior bortezomib use; prior use of one immunomodulatory agent (thalidomide, lenalidomide, or pomalidomide); and panobinostat will be taken in combination with bortezomib injection and dexamethasone.

Regimen	Indication / Study context	Coverage status	Notes
Panobinostat + bortezomib
Pancreatic cancer (Phase II study population) — regimen was studied in patients progressing on gemcitabine-based therapy
Not covered
Study of panobinostat + bortezomib in pancreatic cancer was discontinued early due to toxicity and lack of response; use for this indication is considered experimental, investigational, or unproven.

Prior Authorization and Provider Requirements

Prior Authorization

Prior Authorization Required

Prior Authorization is required. Approvals are provided for 1 year when all clinical criteria are met.

Approval duration: 12 months

Step Therapy

Required Prior Therapies and Combination Use

Required prior therapies and combination use must be documented. Approve only when the patient has previously tried specified agents and Farydak will be used in combination as indicated.

Required prior therapies: bortezomib injection AND at least one immunomodulatory agent (thalidomide, lenalidomide, or pomalidomide).
Required combination use: Farydak must be taken in combination with bortezomib injection and dexamethasone.

Documentation Required

Required Documentation for Approval

Documentation must be provided to support prior therapies, current treatment status, and planned combination regimen.

Documentation of current Farydak use if applicable.
Medical records showing prior use of bortezomib injection.
Medical records showing prior use of one immunomodulatory drug (thalidomide, lenalidomide, or pomalidomide).
Plan of care indicating Farydak will be used with bortezomib injection and dexamethasone.

Denial Risk

Investigational/Unproven Uses — Denial Risk

Use outside the specified multiple myeloma criteria (including other cancer types) is considered experimental, investigational, or unproven and is not covered.

Examples include use for pancreatic cancer and other non‑specified indications without supportive evidence.

Background

Panobinostat (Farydak) is a histone deacetylase (HDAC) inhibitor that was granted accelerated FDA approval for use in combination with bortezomib injection and dexamethasone for multiple myeloma in patients who had received at least two prior regimens including bortezomib and an immunomodulatory agent. The policy specifies that approvals are granted when the drug is used in combination with bortezomib and dexamethasone and that prior therapy requirements are met.

Prior authorization is recommended for prescription benefit coverage of Farydak. When the coverage criteria are satisfied, approvals are issued for 1 year. Documentation should demonstrate current use of Farydak, prior treatment with bortezomib and at least one immunomodulatory drug (thalidomide, lenalidomide, or pomalidomide), and that panobinostat will be administered in combination with bortezomib injection and dexamethasone.

OpenPayer

Oncology - Farydak Prior Authorization Policy

Coverage Criteria for Farydak (panobinostat)

Regimens and Indications Covered

Prior Authorization and Provider Requirements

Line of Therapy / Positioning

Definitions

Background