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Formulary Decision Making in the United States

Decision Resources
March 31, 2009
27 Pages - SKU: DECR2219123

Abstract Table of Contents Related Reports

Countries covered: United States

Introduction

The U.S. pharmaceutical industry is facing the worst combination of pressures in memory-the most severe recession in decades, a dramatic slowdown in pharmaceutical sales, a new U.S. administration intent on slashing healthcare costs, and a host of blockbuster patent expirations. In this exceptionally challenging reimbursement environment, manufacturers must have a thorough understanding of the formulary decision-making process. This report uses data from 13 different surveys to examine how pharmacy and therapeutics (P&T) committees make coverage decisions.

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P&T committees are generally entrusted with the responsibility for formulary decision making in the United States. Who are the key players in P&T committees? How frequently do these committees meet, and when do they begin formulary decision making for new drugs? What role do pharmacy benefi t management companies (PBMs) play in decision making?
In 2000, the Academy of Managed Care Pharmacy introduced the Format for Formulary Submissions, a template for manufacturers' formulary submissions. How do managed care organizations (MCOs) and manufacturers compare in their opinions regarding the Format's uptake and value. What changes would MCOs like manufacturers to make to their reimbursement dossiers?
Efficacy is generally by far the most important factor in formulary decision making. What other criteria carry particular weight with P&T committees? How does formulary decision making vary by indication? What factors have a bearing on tier placement within formularies?
The reimbursement environment in the United States is expected to undergo dramatic changes in the coming decade. How does the new U.S. administration plan to promote the use of generics and biosimilars? How will government funding for comparative effectiveness research infl uence formulary decision making? How are MCOs likely to respond to the launch in the United States of the fi rst biosimilars? How can the pharmaceutical industry respond to this changing environment?

Scope

Identity of formulary decision makers: role and composition of P&T committees; frequency of P&T committee meetings; timing of formulary decision making; role of PBMs.
Academy of Managed Care Pharmacy's Format for Formulary Submissions: origins and objectives; frequency of use; MCO assessment of the quality and value of submissions based on the Format; common criticisms of manufacturer dossiers.
Key factors in formulary inclusion and tier placement: most important criteria overall; case studies of hospital anti-infectives, HIV therapies, rheumatoid arthritis (RA) biologics, and obesity therapies; factors infl uencing tier placement; decision making for specialty pharmaceuticals.
Outlook and implications for the pharmaceutical industry: regulation of generics and biosimilars; comparative effectiveness research; changes in benefi t design; coverage of biosimilars; pharmaceutical industry responses to the changing environment.

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Formulary Decision Making in the United States

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