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TrendsRx Alert

®

ZolinzaTM (vorinostat)

histone deacetylase (HDAC) inhibitors.

October

2006

DRUG AVAILABILITY

Zolinza (vorinostat, Merck & Co.) was approved by the U.S. Food and Drug Administration (FDA) on October 6, 2006, 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.1,2

Mechanism of action1 Adverse effects1 Launch Comments

ß Zolinza is the first oral anti-tumor agent approved in a new class of agents called ß most common adverse effects associated with the use of this medication include: The

nausea, diarrhea, fatigue, thrombocytopenia, anorexia and change in taste.

ß October 10, 2006 ß CTCL occurs in many forms, and an individualized treatment plan is required.4 ß There are different options for the treatment of CTCL (e.g., topical, systemic, and light

therapies).4 ß Other oral agents used for the treatment of CTCL include Targretin (bexarotene) and methotrexate.4

BACKGROUND

ß CTCL is a disease in which certain white blood cells of the lymph (T-lymphocytes)

become cancerous.4 ß CTCL is a type of non-Hodgkin's lymphoma that often develops slowly over many years.4 ß Unlike other forms of non-Hodgkin's lymphoma, CTCL mainly affects the skin.4 ß CTCL affects approximately 20,000 people in the United States, with 1,500 new cases diagnosed per year.4 ß CTCL occurs more frequently in men with an average age of 50 years.1, 4

ExpECTED BUDGET IMpACT

CAREMARK INITIAL RECOMMENDATION

ß Zolinza therapy will cost approximately $7,200.00 per plan participant per month. ß wholesale acquisition cost of Zolinza is approximately $60.00 per capsule. The ß Patients needing assistance in obtaining Zolinza, or those who require help with

insurance reimbursement issues, can enroll in Merck's optional Accessing Coverage Today (ACT) program by calling 1-866-363-6379 once they have received a prescription.2

ß Caremark recognizes the unique needs of plan participants with CTCL. ß Caremark recommends for your consideration and at your discretion, the management of

Zolinza with the same clinical management tools you use for other oral oncology therapies. ß Zolinza is available through the Caremark Specialty Pharmacy Network. ß Caremark will continue to monitor the development of Zolinza to determine if any clinical programs are needed. For more information call your Caremark account representative or Caremark Connect® toll-free at 1-800-237-2767.

Please note: This document provides a brief overview of the subject. This review is provided as a reference only, and is based in part on information derived from third parties.

CAREMARK CONTACT

References: 1. Zolinza prescribing information. Whitehouse Station, NJ: Merck and Co.; October 2006. 2. U.S. Food and Drug Administration. FDA News. FDA Approves New Drug for Skin Cancer, Zolinza. Available at http://www.fda.gov/bbs/topics/NEWS/2006/NEW01484.html. Accessed October 9, 2006. 3. ADIS R&D Insight. AdisInsight Web site. Available with subscription at: http://bi.adisinsight.com/login/login.aspx. Accessed September 28, 2006. 4. The Leukemia and Lymphoma Society. Cutaneous T Cell Lymphoma. Available at http://www.leukemia-lymphoma.org/attachments/National/br_1098116753.pdf. Accessed September 28, 2006.

©2006 Caremark. All rights reserved. 10-24-06

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