The Pharmaceutical Industry: A Discussion of Competitive and Antitrust Issues in an Environment of Change

Authors:
Roy Levy

Executive Summary

Over the last 15 years, the pricing and other competitive strategies of pharmaceutical companies have been altered by revolutionary developments in information technology, new state drug substitution laws, federal legislation, and the emergence of market institutions that include health maintenance organizations (HMOs) and pharmacy benefit managers (PBMs). The industry has also undergone significant structural changes that include growth of the generic drug segment and substantial horizontal and vertical consolidation (e.g., acquisitions of PBMs by drug companies) by drug companies. This report first examines these institutional and structural changes, and then focuses on the nature of competition in the new environment. The purpose of the report is to identify and discuss both possible antitrust concerns and plausible procompetitive explanations of the emerging pricing and other competitive strategies of pharmaceutical companies in this changing environment. Definitive conclusions on whether particular strategies are anticompetitive, competitively neutral, or procompetitive are likely to involve facts specific to these strategies and must await further study. This report is intended as an initial step in developing a more complete understanding of the competitive dynamics of pharmaceutical markets subject to ongoing informational, institutional, and structural changes.

The report covers four primary areas of analysis. First, the report examines how information technology has altered competition among drug companies. Less than two decades ago, the information flows in the prescription drug industry were relatively simple. A pharmacist would fill each prescription as specified by the doctor, unless the patient was willing to accept a generic substitute. Retail pharmacies would manually order drugs from drug wholesalers, who would deliver the product and replenish their own inventories with drugs ordered from pharmaceutical companies. Physicians obtained drug information from reports on clinical trials published in medical journals and distributed by drug company salesmen, or in their regular practice by observing the success or failure of drugs prescribed for their patients. Competition among drug companies was focused on gaining the allegiance of prescribing physicians.

More recently, as described in the report, the doctor's prescription has become just the starting point in determining what drug the pharmacist dispenses. Today, pharmacies are typically part of PBM networks that administer the drug benefits portion of health insurer plans for employers and others. Computers linking network pharmacies to PBMs enable pharmacists to check which brand name or generic substitutions are required by the patient's health insurer, whether the doctor is prescribing according to health plan policy, what co-payment amount applies, and when drug stocks are low. The same computer technology allows pharmacies to manage their drug inventories. The drug dispensing records of pharmacies are increasingly being used to develop new products and services. Most importantly, prescription drug usage and cost information can theoretically be merged with the patient care records of doctors and hospitals, conceivably placing significant numbers of patients in large, possibly nationwide clinical trials for existing prescription drugs. Through disease state management (DSM), the firms administering prescription drug insurance plans can learn more than was previously known about how well various drugs work, both relative to other drugs and to non-drug therapies. This information enables insurers and other drug buyers to focus more attention on comparisons of drug alternatives and their prices. While the traditional focus was on gaining the allegiance of prescribing physicians, drug companies now also compete for placement in health plan protocols and for contracts with HMOs.

Second, the report describes how this evolving information technology, coupled with other industry changes, has increasingly prompted drug companies to charge different prices to different groups of buyers. The report also discusses the competitive implications of this differential pricing. In recent years, price discounts offered by pharmaceutical companies have spread beyond large hospitals, the traditional recipients of discounts, to involve other segments of demand, and these price discounts may be linked to ongoing changes in the drug industry. These practices may have evolved partly because certain groups of buyers have adopted cost-containment measures similar to those used historically by hospitals. In addition, information technology has permitted some groups of buyers to substitute more easily among alternative drug treatments.

As described in the report, price differences -- two-tiered pricing (i.e., lower prices to HMOs and PBMs and higher prices to others), special prices to Medicaid recipients, and drug company rebate programs -- may simply reflect unrecognized cost or service differences associated with the sale of pharmaceutical products. Alternatively, these price differences may amount to competitive forms of price discrimination. While such price discrimination may be consistent with competition, the report describes the conditions under which alternative forms of price discrimination may harm competition. In particular, competitive harm is most likely to emerge when doctors and patients have few therapeutic drug alternatives, and when entry into drug markets is difficult. These conditions may apply to a number of drug categories as discussed in the report.

Third, following the discussion of pricing and other strategies of pharmaceutical companies in this new competitive environment, the report discusses different forms of vertical consolidation that have emerged in this changing industry. The focus of attention is on the potential for these vertical strategies to lead to anticompetitive pricing by pharmaceutical companies. The major vertical issues addressed in the report are information exchanges among vertically integrated drug companies, vertical contracting practices, and vertical integration. Possible anticompetitive exchanges of information arise because acquisitions of PBMs by drug companies may permit more effective monitoring of deviations from price coordination arrangements within prescription drug markets. Drug companies could better monitor and detect deviations because ownership of a PBM can provide drug companies with direct information on competitors' bids and transaction prices. If a drug company learns through its PBM that its rebate offers to PBM customers are higher than rival offers, it could reduce its rebate offers to these PBMs. Other factors necessary for effective coordination are discussed, along with possible efficiency explanations for these exchanges of information.

The report also examines why vertical contracting practices and vertical integration have become more widespread, and focuses attention on how pharmaceutical companies might use these arrangements to increase drug prices. Importantly, the computer-based distribution of drugs at retail and mail-order pharmacies crucially depends on provisions in vertical contracts between drug companies and HMOs or PBMs. The competitive implications of key contract provisions, including most-favored-nation (MFN) and volume-based rebate provisions, are addressed in this report. In addition to efficiency explanations for these provisions, their possible use as devices to raise prices is considered. For example, volume discounts in drug company contracts with HMOs could induce them to maximize their rebates by transacting exclusively with those companies offering the most attractive terms. Exclusive dealing arrangements like this might force competing drug companies to use more costly means of marketing their drugs or could otherwise foreclose competition among them. The report outlines the conditions under which such vertical contract provisions may lead to higher prices. These require an assessment of the marketing alternatives available to rivals and an evaluation of conditions of entry in drug and other downstream markets. Similar foreclosure analyses are applied to examine the competitive implications of PBM acquisitions by pharmaceutical companies.

Fourth, the substantive analysis concludes by addressing some ways in which the changing environment in the drug industry may affect an antitrust analysis of horizontal mergers between and among pharmaceutical companies. Following summaries of public information about both horizontal mergers and Federal Trade Commission (FTC) enforcement actions in this industry, the discussion focuses broadly on possible forms of merger-related anticompetitive conduct. Given the growing importance of bidding competition among drug companies for contracts with buyer agents that include HMOs, the report reviews bidding models to consider the possibility of merger-related price increases to these buyers across multiple product categories.

Overall, among other findings, the report raises several possible antitrust concerns and a number of potential efficiency explanations involving the conduct of pharmaceutical companies.

  • Legislative mandates and the application of information technology have transformed this industry in ways that have shifted the focus away from non-price forms of competition (e.g., competition for the allegiance of physicians) toward forms of price competition (e.g., competition for HMO contracts and preferred drug formulary placements). Along with describing these new forms of competition, the report raises the possibility that information technology networks might facilitate price coordination among pharmaceutical companies.
  • Industry transformations raise the possibility of anticompetitive forms of price discrimination in drug markets that are difficult to enter and in situations where doctors and patients have few alternative therapies. Price differences in these markets, however, may also be consistent with competitive forms of price discrimination.
  • MFN provisions in vertical contracts between drug companies and PBMs may facilitate price coordination in either upstream prescription drug or downstream PBM service markets by making it costly for firms to engage in selective price cutting, or by raising competitor costs in other ways. These provisions are also the same as those found to produce efficiencies in the supply of other products that include their use as an efficient mechanism for adjusting prices in rapidly changing markets.
  • Volume rebate provisions in vertical contracts between drug companies and buyers could amount to exclusive dealing arrangements that could lead to higher drug prices if, for instance, they result in anticompetitive foreclosure. Exclusive dealing agreements could, at the same time, reduce the risks of buyers by guaranteeing them adequate supplies of drugs or by otherwise generating efficiencies in the sale of prescription drugs.
  • Vertical acquisitions of PBMs by drug companies could lead to higher drug prices if the transactions result in anticompetitive foreclosure or if they facilitate anticompetitive exchanges of drug price information. These acquisitions can also produce transaction-cost and other efficiencies, even if they lead to the anticompetitive foreclosure explained in the report or otherwise cause higher prices.
  • Horizontal mergers in this environment of change may lead to broader forms of anticompetitive conduct that include anticompetitive bidding in a multi-product setting under certain conditions described in the report.

These findings suggest that antitrust authorities need to apply the standard case-by-case approach to antitrust analyses of vertical and horizontal issues that arise in this industry. The report raises the potential for competitive harm in a number of areas, but also highlights the need to evaluate alternative efficiency explanations before challenging any of the pricing or other strategies at issue.