SUMMER  2001 
Volume 6 / Number 3

Legal & Ethical Issues of Pharmaceutical Coverage

Mark Cloutier, MPP MPH, Priorities Group
Denise Henry, The Legislative Strategies Group
Joseph Addiego, Jr., M.D., Caremark Inc.

Ethics come into play in pharmacy benefit design because there are resource allocation issues involved in most cost management strategies. Mr. Cloutier noted that the health implications of various strategies must be considered and that managers have a responsibility for keeping health benefits affordable (thus saving employee wages and shareholder dividends). In addition, insurance brings with it responsibilities related to collective funds because those insured trust the insurer to say 'no' when a consumer wants to use pooled monies for something that is not medically necessary. This is problematic as it relates to drugs because there is not always sufficient data to compare one brand to another brand ­ most clinical trials compare a drug to a placebo.

Ms. Henry spoke of ongoing efforts in Washington D.C. related to pharmacy benefits, including HIPAA. She noted that "you cannot win in Washington D.C. if you are not focused on the impact on the patient." Much of her effort is spent convincing congressmen that the healthcare private sector is trying to "do the right thing." She gave brief updates on a variety of political activities related to HIPAA, drug pricing investigations, outpatient prescription coverage, Internet pharmacies and HCFA reform.

Dr. Addiego talked specifically to the processes that should be used in developing a drug benefit plan. He noted, for example, that the Pharmacy & Therapeutics Committee should include an ethicist among its members, and that the committee should meet face-to-face at least quarterly. The P&T committee should include representatives of every medical specialty. Special attention must be paid in the evaluation of generic drugs (not all are A-B rated, and some, especially for medicines with a narrow therapeutic index must be considered carefully), and handling "quality of life" drugs. This is an important P&T function since new lifestyle drugs are always in the pipeline. Formulary development should also take into account the fact that prescriptions used appropriately can often reduce medical, hospital and emergency medicine costs.

Although each of the speakers appeared to address different issues, these issues all must be considered when designing a prescription drug benefit. Ethics and the legal or governmental environment have a significant impact on drug benefit design. The P&T process is a good example of how this applies.

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