Ethical Practice Mgmt and Patient Step Therapy

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Health plans and other third-party payers use a number of tools in an attempt to manage, or minimize, the cost of the prescription drug benefit (drug spend) to patients. In some situations, these tools help promote rational drug therapy, especially when considering that resources (financial, human) are finite. For example, using prior authorization to promote the use of diuretics and certain generically available ACE inhibitors makes perfect sense when use of those drugs correspond with accepted clinical guidelines, versus use of an alternative new drug without significant clinical advantages that might cost 10 times more, or greater. Additionally, when implemented based upon the best evidence, tools like prior authorization might help prevent potentially inappropriate prescribing such as with drugs contraindicated for certain patients based upon diagnosis, age, or drug-drug interactions. However, other tools sometimes do not work to the best of the patient. This might be the case at least for some instances with step therapy, a “fail-first” policy where the patients must “fail” on one or more therapies before being placed on the optimal drug(s) for their condition.

Burns argues that if insurers insist that physicians use lower-cost drugs first, the burden is on the health plan to respond to their requests for different medications quickly, nimbly, and appropriately, but that insurers’ responses might be anything but that.1 Ethicists have argued for the need to apply certain ethical frameworks in pharmacy benefit design, such as defining what clinical failure means, having a more expeditious timeline for progression to more preferred therapies, and allowing practitioners more leeway in identifying cases where the step approach is inappropriate. In a study on implementing a step-therapy limitation on the use of guanfacine extended-release, Suehs et al found that coverage denials resulted in decreased utilization of treatment for ADHD yet with no cost-savings to the health plan.2 Other studies have shown similar results, sometimes with significant decrements in patients’ therapeutic outcomes.

Pharmacists and pharmacy managers must apply ethical decision-making in all facets of their practice. They also should be knowledgeable of the health care system and patients’ insurance policies. The application of ethics in situations like these would require that the pharmacist advocate for the patient, and incorporate effective communication with prescribers and insurers on their behalf, in addition to leveraging technology and systems to optimize medication therapy-related outcomes.

Additional information about Ethical Decision Making and Problem Solving and Ensuring Quality in Pharmacy Operations can be found in Pharmacy Management: Essentials for All Practice Settings, 5e. If you or your institution subscribes to AccessPharmacy, use or create your MyAccess Profile to sign-in to Pharmacy Management: Essentials for All Practice Settings, 5e. If your institution does not provide access, ask your medical librarian about subscribing.

1Burns J. Is step therapy a move in the wrong direction? J Manag Care. 2017;26:32-35.

2Suehs BT, Sikirica V, Mudumby P, Dufour R, Patel NC. Impact of step-therapy on guanfacine extended-release on medication utilization and health care expenditures among individuals receiving treatment for ADHD. J Manag Care Spec Pharm. 2015;21:793-802.

Go to the profile of Shane Desselle

Shane Desselle

Professor of Social and Behavioral Pharmacy, Touro University California

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Go to the profile of Shane Desselle
Shane Desselle 5 months ago

Do you believe in a culture of patient advocacy?