Sheila R. Shulman Elaine M. Healy Louis Lasagna Editors PBMs: Reshaping the Pharmaceutical Distribution Network PBMs: Reshaping the Pharmaceutical Distribution Network has been co-published simultaneously as Journal ofP har maceutical Marketing & Management, Volume 12, Num bers 2/3 1998. "T Pre-publication his book would be of greatest in- REVIEWS, terest to those interested in under standing how patients receive pharma COMMENTARIES, ceutical therapies in this country. The EVALUATIONS . .. pharmaceutical marketplace has been reshaped in the 1990s through the rapid development of employer-based phar maceutical benefits, through the devel opment of pharmaceutical benefit man agers (PBMs) to manage these benefits, and through integration. of PBMs with pharmaceutical manufacturers in a rapid series of controversial mergers. This book presents a comprehensive overview of the pharmaceutical benefit industry today, both the design and structure of PBMs, the legal implications of PBM management practices, the legal ramifications of PBM-pharmaceutical man ufacturer mergers, and the implications of these networks on pharmacies them selves. More pre-publication !&VIEWS, COMMENTARIES, EVALUATIONS. The work is clear and interesting and represents several competing perspectives on these issues. For readers with little knowledge of the area, the work will serve as an im portant introduction to the topic. For readers with a working knowledge of the field, the up-to-date legal re· views may be of most interest. PBMs are rapidly evolving orga nizations. However, their design and current role in the marketplace is fraught with ethical issues. This work helps the reader to under stand some of the issues leading to these concerns." Kevin A. Schulman, MD Director Clinical Economics Research Unit; Associate Professor ofM edicine Georgetown University Medical Center Washington, DC The Pharmaceutical Products Press ( •, ~r I (~I <y< I 'l"' I (~I (y( I PBMs: Reshaping the Pharmaceutical Distribution Network PBMs: Reshaping the Pharmaceutical Distribution Network has been co-published simultaneously as Journal ofP harmaceutical Marketing & Management, Volume 12, Numbers 2/3 1998. The Journal ofP harmaceutical Marketing & Management Monographs/ "Separates" Marketing Pharmaceutical Services: Patron Loyalty, Satisfaction, and Preferences, edited by Harry A. Smith and Stephen Joel Coons Promotion ofP harmaceuticals: Issues, Trends, Options, edited by Dev S. Pathak, Alan Escovitz, and Suzan Kucukarslan Pharmaceutical Marketing in the 21st Century, edited by Mickey C. Smith PBMs: Reshaping the Pharmaceutical Distribution Network, edited by Sheila R. Shulman, Elaine M. Healy, and Louis Lasagna These books were published simultaneously as special thematic issues of the Journal of Pharmaceutical Marketing & Management and are avail able bound separately. Visit Haworth's website at http://www.haworth.com to search our online catalog for complete tables of contents and ordering information for these and other publications. Or call l-800-HAWORTH (outside US/Canada: 607 -722-5857), Fax: l-800-895-0582 (outside US/ Canada: 607-771-00 12), or e-mail [email protected] PBMs: Reshaping the Pharmaceutical Distribution Network Sheila R. Shulman Elaine M. Healy Louis Lasagna Editors PBMs: Reshaping the Pharmaceutical Distribution Network has been co-published simultaneously as Journal ofP harmaceutical Marketing & Management, Volume 12, Numbers 2/3 1998. The Pharmaceutical Products Press An Imprint of The Haworth Press, Inc. New York • London Published by The Pharmaceutical Products Press, 10 Alice Street, Binghamton, NY 13904-1580 USA The Pharmaceutical Products Press is an imprint of The Haworth Press, Inc., 10 Alice Street, Bing hamton, NY 13904-1580 USA. PBMs: Reshaping the Pharmaceutical Distribution Network has been co-published simultaneously as Journal of Pharma ceutical Marketing & Management, Volume 12, Numbers 2/3 1998. © 1998 by The Haworth Press, Inc. All rights reserved. No part of this work may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying, microfilm and recording, or by any information storage and retrieval system, without permission in writing from the publisher. Printed in the United States of America. Reprint _ 2007 The development, preparation, and publication of this work has been undertaken with great care. However, the publisher, employees, editors, and agents of The Haworth Press and all imprints of The Haworth Press, Inc., including The Haworth Medical Press and The Pharmaceutical Products Press, are not responsible for any errors contained herein or for consequences that may ensue from use of materials or information contained in this work. Opinions expressed by the author(s) are not necessarily those of The Haworth Press, Inc. Cover design by Thomas J. Mayshock Jr. Library of Congress Cataloging-in-Publication Data PBMs: reshaping the pharmaceutical distribution network I Sheila R. Shulman, Elaine M. Healy, Louis Lasagna, editors. p. cm.-(Journal of pharmaceutical marketing & management: v. 12, no. 213) "Co-published simultaneously as Journal of pharmaceutical marketing & management, volume 12, numbers 213 1998." "Proceedings of a roundtable on PBM issues sponsored by the Tufts Center for the Study of Drug Development, Tufts University, October 24, 1996"-P. Includes bibliographical references and index. ISBN 0-7890-0512-3 (alk. paper) I. Drugs-Marketing--Congresses. 2. Pharmaceutical industry--Congresses. I. Shulman, Sheila R. II. Healy, Elaine M. Ill. Lasagna, Louis, 1923- . IV. Journal of pharmaceutical marketing & management. V. Series. [DNLM: WI J0829H v. 12 no. 213 1998 I W 265 AA I P3 1998) HD9665.5.P374 1998 380.1 '456151-DC21 DNLMIDLC for Library of Congress 98-12622 CIP INDEXING & ABSTRACTING Contributions to this publication are selectively in dexed or abstracted in print, electronic, online, or CD-ROM version(s) of the reference tools and in formation services listed below. This list is current as of the copyright date of this publication. See the end of this section for additional notes. • ABVINFORM Global (broad-coverage indexing & abstracting service that includes numerous English-language titles outside the USA available from University Microfilms International (UMI), 300 North Zeeb Road, P.O. 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PBMs: Reshaping the Pharmaceutical Distribution Network Proceedings of a Roundtable on PBM Issues Sponsored by the Tufts Center for the Study of Drug Development, Tufts University, October 24, 1996 CONTENTS Foreword xi Henry Grabowski PBMs of the 1990s: Why They Deserve a Second Look Sheila R. Shulman Louis Lasagna Placing PBMs in Context 7 Wilbur B. Pittinger How PBMs Work 15 Margaret McGlynn PBMs: A Purchaser's Perspective 29 Robert J. Rubin Anne Hawk Elisa Cascade A Perspective from the Food and Drug Administration 43 Mary Pendergast A Perspective from the General Accounting Office 51 John C. Hansen The PBM Industry: Is It Reinforcing the Shift to Centralized Decision Making? 55 Henry Blissenbach The Effect ofPBM Clinical Programs and Services on Access to Prescription Drug Coverage 61 J. Russell Teagarden Off-Label Indications, Expensive Therapies, Fast-Track Drugs: How Do PBMs Structure Prior Approval, Prescribing Restrictions, and Appeal Procedures? 71 Michael Manolalds Legal Issues Arising from Managing the Pharmacy Benefit 77 Ann Tobin Rebekah Crosby A Framework for Research and Evaluation into the Effects of Managed Care on the Pharmaceutical Marketplace 10 9 Bonnie B. Wilford Statistical Appendix. Private Managed Care: Issues and Trends 117 Richard Fehring Appendix A. Minefields for the Unwary: Fraud and Abuse Issues Affecting Pharmaceutical Manufacturers 125 Elizabeth B. Carder Joseph W. Metro Appendix B. The Impact of Drug Manufacturer Acquisitions ofPharmacy Benefit Management Companies. Volume I: Effects and Recommendations 145 John Coster Appendix C. The Effects ofPBMs on the Marketplace: A Pharmacy Perspective 177 Calvin J. Anthony Index 181