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    Top considerations when determining whether to approve expensive drugs

    Weighing the ethics of approving expensive cancer drugs for patients facing terminal disease is a multifaceted and inherently multidisciplinary endeavor.

    Managed Healthcare Executive (MHE) recently spoke with ethicist Jacqueline J. Glover, PhD, a professor in the University of Colorado Department of Pediatrics and Center for Bioethics and Humanities, about this issue.

    Glover spoke at the AMCP Managed Care & Specialty Pharmacy Annual Meeting, in Denver, during the March 29 session, “Ethical Dimensions of Approving Expensive Drugs for Patients with Terminal Cancer.”

    MHE: What are some of the ethical considerations pharmacies must weigh when it comes to approving expensive drugs (adding them to institutional formularies) for patients diagnosed with terminal cancers? 

    GloverGloverGlover: Firstly, good ethics starts with good facts. When you are weighing the benefit and burdens to see whether it is worth the increased burden of increased cost, it totally depends on the quality of the data. There can be problems with the data. Overall survival—the time from drug assignment to death from any cause—is meaningful to patients. But people who fund trials are interested in other things too; they want a shorter trial duration and to minimize the number of participants, enabling rapid access to the market. So many trials use surrogate endpoints: overall response rate of the tumor, early tumor shrinkage, progression-free survival (the time from drug assignment to progressive disease or death from any cause). These things don’t necessarily correlate with overall survival. 

    Also the impact on quality of life is very unclear and when there are studies about increased survival, the range is often two to three months, not years. It is a very good question, how these clinical trials really compare to the real world, the general population in the “real world.”

    A second example is how to weigh how much benefit is worth the burdens. In our individualist society where respect for individual autonomy is very important, some would want to say that that determination is always left to the patient to decide for himself or herself. But our clinicians do not usually talk about costs as a matter of informed consent—here are the potential benefits, here are the risks—and left off is how much it is going to cost you and your family—or mostly probably, your estate, after you die. They don’t normally talk about cost and they don’t really know how to do that.

    A third consideration is the role of the clinician as a professional. They shouldn’t consider cost, right? Clinicians should be the kind of gatekeepers that only keep the gate open. Only consider the needs of one patient at a time, the patient before them.

    But I don’t think that’s true. Clinicians have obligations of justice. All professional codes of ethics include something about obligations of justice.

    And uncontrolled spending by some puts at risk availability and access for others. Clinicians have obligations of justice because we all do as members of families, communities and nations.

    I realize that human needs are limitless but our resources to address them are limited. So that makes cost an ethical issue: how best to use our limited resources for both the individual and what we call the common good.

    A fourth ethical consideration is the value that we place on innovation and pushing limits. Our cancer centers are excellent and they participate in cutting edge research. We want our cancer centers to have access to new drugs for our patients. We use war metaphors—we are battling cancer and we want to win—and we don’t want to limit the weapons available to our warriors.

    So ethical considerations include good data, how to weigh it, the role of clinicians in talking about costs, and intentions to benefit others.

    Next: What about drug-cost transparency?

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