Vorinostat (Zolinza)

[cab678]

Just wondering if plans are covering Vorinostat? Seems very expensive for information based on two studies. Any input would be helpful.

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[chantell.reagan]

Zolinza (vorinostat) is an oral histone deacetylase (HDAC) inhibitor indicated for the treatment of cutaneous manifestations in patients with cutaneous T cell lymphoma (CTCL) who have progressive, persistent or recurrent disease on or following two systemic therapies. There is another HDAC inhibitor, Istodax (romidepsin), which was approved in 11/09 for CTCL for patients who have failed 1 systemic therapy, but it is in IV formulation. Istodax also competes with Folotyn (pralatrexate) IV, which was approved in 9/09 for relapsed or refractory peripheral T-cell lymphoma (PTCL).

PTCL and CTCL are rare types of non-Hodgkin's lymphoma (NHL), with CTCL affecting the mature t-cells and starting in the skin. The most common subtype of CTCL is mycosis fungoides, which can progress to Sezary syndrome, affecting a larger area and is much more serious. The 2 studies leading to the FDA approval produced enough evidence for the National Comprehensive Cancer Network (NCCN) to include vorinostat in its latest NHL guidelines (published 1/10). Both vorinostat and romidepsin were noted as suggested treatment regimens (Systemic Category A) for Mycosis fungoides/Sezary syndrome and are "preferred over traditional chemotherapy for patients who do not respond to initial skin-directed therapies". The NCCN noted that they should be used as 2nd line therapy, but didn't specify whether they should be used after 1 or 2 therpaies.

Additionally, we surveyed 7 national and regional health plans with publically available policies for vorinostat*. Please note the following findings:

-6/7 plans require prior authorization for these drugs, based on the labeling (failure of 2 systemic therapies)
-4/7 plans also have a quantity limit, ranging from 30-34 day supply (120 capsules/month)

*a comprehensive policy analysis for Folotyn, Istodax, and Zolinza will be forthcoming once plan policies are published

Of note, vorinostat is currently being studied alone and in combination in a variety of other cancers, including breast, colorectal, ovarian, fallopian tube, peritoneal, non-small cell, pancreatic, melanoma, acute myelogenous leukemia, myelodysplastic ayndrome, multiple myeloma, brain metastases, glioblastoma multiforme, mesothelioma and upper GI cancer.

Sources:
American Cancer Society: What is Non-Hodgkin's Lymphoma?
Lymphoma-info.net:Cutaneous T-Cell Lymphoma, Mycosis Fungoides, and Sezary Syndrome
Istodax prescribing information
Zolinza prescribing information
National Comprehensive Cancer Network: Non-Hodgkin's Lymphoma Clinical Practice Guidelines (must log-in to access)
National Institutes of Health: Clinical Trials (vorinostat)
Aetna (non-Medicare) Antineoplastics
AmeriHealth oral chemotherapy policy
BCBS Western New York Zolinza policy
Cigna Zolinza policy
Excellus Clinical Review Prior Authorization
Horizon BCBS Zolinza policy
Regence BCBS of Oregon Zolinza policy

[participant2]

Zolinza is covered with Prior authorization

[chantell.reagan]

An anonymous member had the following response:

"covered 4th tier - no PA or step"

[chantell.reagan]

We received this response from another one of our members:

"Currently pending review @ Premera. Meanwhile it is Tier 3 on incentive formulary with no PA requirements. (But that will likely change!)"

[diana.papshev]

Anonymous feedback:

"I did not see it on any formulary list. The drug was FDA approved in 2006. Cost is about $60.00 per dose. It is not a high utilizer – even to treat cutaneous T-cell (CTCL). The treatment of cutaneous T-cell lymphoma (CTCL) is different from that of lymphomas that mainly affect lymph nodes. The chemotherapy that is effective for common types of non-Hodgkin's lymphoma is not effective in patients with CTCL.
Treatment options depend on several factors, including the extent of skin involved, the type of lesions, and the involvement of nodes or other organs. Those whose disease is limited to the skin have excellent responses to treatment. For those with visceral organ or node involvement, however, the aim of treatment is palliation (controlling symptoms and improving the quality of life).
Electron beam therapy:
Radiation is an effective treatment for CTCL. Electron beams are a type of radiation that treats superficial tissues like the skin but does not penetrate deeply enough to affect other organs. This type of treatment is ideal for CTCL as large areas of the skin need to be treated, without causing radiation damage to bone marrow and several other organs. Unless only a small area of skin is involved, the entire skin of the body is treated with electron beams. This kind of treatment requires a specialized and experienced facility for treatment. Treatment lasts for several weeks.
Topical chemotherapy (chemo on the skin):
Chemotherapy agents like nitrogen mustard and carmustine can be used as treatment for CTCL. These drugs are available as ointment-based preparations, and need to be applied to the skin for several weeks. An allergy-like skin reaction indicates that the drug is effective and is a pointer to the correct dose for each patient. Both agents are effective and lead to disappearance of disease in the majority of patients, though maintenance treatment may be required to prevent the lesions from coming back.
Phototherapy with UV light:
Ultraviolet (UV) light can cause DNA damage in lymphocytes (the cells that turn into lymphomas), but ordinary skin cells are unaffected because they have means to protect themselves from UV light damage. Both UV-A and UV-B light – different in terms of their wavelength – are effective against CTCL. UV-A light is used with a substance called psoralen (this is called PUVA therapy). Psoralen is administered by mouth, or occasionally on the skin dissolved in bath water. Both forms of UV light can clear 60 to 90 percent of skin lesions and some patients may be controlled for a long time or even cured.
Bexarotene (Targretin):
Bexarotene (Targretin) belongs to the class of drugs called retinoids. Retinoids are useful for a variety of skin disorders including lymphomas of the skin. Bexarotene gel is used once or twice a day for one or two months in early stage CTCL with limited skin involvement. A skin inflammation (dermatitis) occurs and the dose is reduced for two more months. Once the drug is stopped the skin lesions reduce. For those with extensive involvement and in patients with relapse of skin lymphoma, oral formulations of bexarotene are available. When used alone, oral bexarotene has relatively good response rates.
Denileukin Difitox:
Denileukin difitox is a type of drug called a monoclonal antibody. Monoclonal antibodies are drugs that target a specific molecule on the surface of cells. Denileukin difitox is a monoclonal antibody that binds to the receptor for interleukin-2 (IL-2), a substance that activates T-cells to multiply and become cancerous. Attached to the monoclonal antibody is a toxin or poison that kills the cell to which it binds. Denileukin difitox binds to T-cells that have become the cancer cells of cutaneous T-cell lymphoma and the toxin kills the cell. It is used mostly as salvage treatment after other treatments have failed.
Interferon alpha :
Interferon alpha is a biological agent that is used in many conditions including cancers. Though not commonly used for CTCL, it produces good results when used with PUVA therapy or a salvage treatment of this lymphoma. Interferon alpha is used as an injection that is administered subcutaneously (just below the skin).
Chemotherapy infusions or oral pills:
Chemotherapy agents are used rarely in CTCL, mainly as a treatment of advanced disease. Chemotherapy may be administered either as infusions in the veins or as oral pills. The most common chemotherapy pills used are methotrexate, chlorambucil or etoposide. Pegylated doxorubicin is the most effective chemotherapy infusion. Some short-term benefit may be gained by chemotherapy to those who have advanced disease that has not responded to other therapies.
http://lymphoma.about.com/od/treatment/p/ctcltreatment.htm"

[chantell.reagan]

We’ve updated this analysis to include a new table comparing pralatrexate, romidepsin, and vorinostat policies for 6 national and regional health plans. Please note the following findings:

•3/6 plans restrict these therapies to oncologists or hematologists
•6/6 plans have criteria for Zolinza consistent with labeling (CTCL diagnosis and failure of ≥ 2 systemic therapies)
•There are more variations among Istodax policies – 3/5 plans require failure of ≥ 1 systemic therapy (one of them requires failure of Zolinza first), 1 plan requires failure of ≥ 2 systemic therapies, while another plan has no step therapy requirements
•4/5 plans also require failure of ≥ 1 systemic therapy before initiating Folotyn in patients with PTCL

Sneak preview:


To view the full tabulated analysis, you must login first (if you haven't registered yet, please click here, registration is free). After you have logged-in, please scroll down and click on the attached PDF file at the bottom of this page.

Additional sources:

NCCN Clinical Practice Guidelines (must log-in to access) (see full link in the attached tabulated analysis)

Folotyn prescribing information (see full link in the attached tabulated analysis)

Istodax prescribing information (see full link in the attached tabulated analysis)

Zolinza prescribing information (see full link in the attached tabulated analysis)

BlueCross Blue Shield of Michigan. Prior authorization/Step Therapy programs (Medicare) (see full link in the attached tabulated analysis)

Blue Care Network of Michigan. Member Custom Formulary (see full link in the attached tabulated analysis)

Blue Cross Blue Shield of Tennessee. Folotyn policy (effective 6/12/10) (see full link in the attached tabulated analysis)

Blue Cross Blue Shield of Tennessee. Istodax policy (effective 6/12/10) (see full link in the attached tabulated analysis)

Blue Cross Blue Shield of Tennessee. Zolinza policy (see full link in the attached tabulated analysis)

Excellus. Clinical Review Prior Authorization (see full link in the attached tabulated analysis)

The Regence Group. Folotyn policy (see full link in the attached tabulated analysis)

The Regence Group. Istodax policy (see full link in the attached tabulated analysis)

The Regence Group. Zolinza policy (see full link in the attached tabulated analysis)

Aetna. Clinical Policy Bulletin: Folotyn (see full link in the attached tabulated analysis)

Aetna. Clinical Policy Bulletin. Antineoplastics (Medicare) (see full link in the attached tabulated analysis)

Humana Medical Coverage Policies (see full link in the attached tabulated analysis)

Humana. Folotyn policy (see full link in the attached tabulated analysis)

Humana. Istodax policy (see full link in the attached tabulated analysis)

Humana. Zolinza policy (see full link in the attached tabulated analysis)

[diana.papshev]

Anonymous response:

"These three are on our next wave of SPecialty Rxnprograms. Our SPPRx program works with our Enterprise Medical Policy to do the review of Clinical studies."