Off-Label Prescribing: Overcoming the Reimbursement Barrier

This publication has been discontinued on December 21, 2011.

Introduction

Abstract

Off-label prescribing accounts for most uses of certain drugs and reportedly is particularly common in oncology, neurology, and psychiatry. Although this practice holds the potential for tremendous financial rewards for pharmaceutical companies, the marketing of off-label prescribing is fraught with legal peril as regulators place increasing restrictions on off-label usage. This report examines the reimbursement barriers to off-label prescribing in the world's six largest pharmaceutical markets: the United States, France, Germany, Italy, the United Kingdom, and Japan. We analyze off-label usage in the United States of four key drug classes: antineoplastic drugs, antidepressants, antipsychotics, and anticonvulsants. We then review the hazards that manufacturers may face when they engage in off-label marketing and explore the reimbursement environment in the United States, focusing on Medicare, Medicaid, and private insurance. Next, we consider the reimbursement challenges in each of the other countries covered in this report. We conclude with a brief assessment of the outlook and implications for the pharmaceutical industry.

Table of Contents

Overview

United States

• Scale of Off-Label Prescribing
  • Antineoplastic Drugs
  • Antidepressants
  • Antipsychotics
  • Anticonvulsants
• Perils of Off-Label Marketing
• Reimbursement
  • Medicare
  • Medicaid
  • Private Insurers

France

Germany

Italy

United Kingdom

Japan

Outlook and Implications for the Pharmaceutical Industry

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