First, Do No Harm: AJMC Commentary Calls for New Framework for Comparative Effectiveness Research

PLAINSBORO, N.J., July 29, 2014 — Have you ever met an “average” patient? That individual does not exist in person, but the theoretical “average” patient drives hundreds of decisions made in healthcare today: from what drugs to include in a formulary, to what order they are prescribed, to what tests doctors order and when.

To be sure, healthcare guidelines are based on evidence. But, as a commentary published this month in The American Journal of Managed Care observes, allowing too many decisions to be guided by “averages” can work against those patients whose responses are atypical, which raises both clinical and ethical issues. For the full commentary, click here.

Jennifer S. Graff, PharmD, and her co-authors call for a new framework for comparative effectiveness research, or CER, which evaluates which treatments work for which patients under which circumstances. Graff, who is director of CER for the National Pharmaceutical Council, seeks a framework that offers a balance between population-based approaches and individualized decision-making.

The framework calls for offering the greatest flexibility when failure to do so could cause irreversible harm to the patient, and the authors include examples. In some therapeutic areas, such as certain allergies, a patient who is asked to use a less expensive drug before switching might suffer itchy eyes or a runny nose, but these symptoms are not life-threatening. In treating schizophrenia or severe depression, however, patients who only respond to a specific drug and are denied access could suffer serious consequences, such as a relapse or suicide attempt.

The higher the degree of risk and clinical impact, the authors write, the greater the flexibility required. CER research should aim to offer more clarity in areas where the risk is highest. The authors note that this concept challenges the approach of some payers. “Payers typically make population-based rather than highly individualized coverage and reimbursement decisions. This choice reflects limitations in the available information as well as the need to avoid creating an overly complex benefit design,” they write.

This risk-based approach confronts ethical issues that currently exist in reimbursement, the authors write. If a patient responds best to a drug that is not the preferred one on the formulary, or is not covered at all, he or she may have to pay more out of pocket. This can have the effect of limiting or denying the patient access to the drug they need. But a risk-based approach, coupled with better use of data and genetic tools, could make these situations obsolete.

“With the increased sophistication of benefit design and electronic records, it may be feasible to account for biology or genetics and tailor co-payments accordingly,” the authors conclude.

About the Journal

The American Journal of Managed Care, now in its 20^th year of publication, is the leading peer-reviewed journal dedicated to issues in managed care. Other titles in the AJMC family of publications are The American Journal of Pharmacy Benefits, which provides pharmacy and formulary decision makers with information to improve the efficiency and health outcomes in managing pharmaceutical care. In December 2013, AJMC introduced The American Journal of Accountable Care, which publishes research and commentary devoted to understanding changes to the healthcare system due to the 2010 Affordable Care Act. AJMC’s news publications, the Evidence-Based series, bring together stakeholder views from payers, providers, policymakers and pharmaceutical leaders in the areas of oncology, diabetes management, and immunology and infectious disease. To order reprints of articles appearing in AJMC publications, please call (609) 716-7777, x 131.

CONTACT: Nicole Beagin (609) 716-7777 x 131

nbeagin@ajmc.com

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