1. What is the decision or change (e.g., clinical topic, practice guideline, system design, delivery of care) you are facing or struggling with where a summary of the evidence would be helpful?
We are interested in the effects of third-party payer pharmacy formulary restrictions (i.e., prior authorization, step therapy) across disease states on: clinical outcomes, medication adherence, healthcare resource utilization, economic outcomes, and drug utilization. Further, we would like to better understand what effects pharmacy formulary restrictions have, if any, on disparities in these dependent variables based on race and/or ethnicity.
Question 1: What are the effects of pharmacy formulary restrictions such as prior authorization and step therapy on the following dependent variables across disease states: clinical outcomes, medication adherence, healthcare resource utilization, economic outcomes, and drug utilization?
Question 2: Across disease states, do pharmacy formulary restrictions such as prior authorization and step therapy (defined as use of lower-cost alternatives to the prescription medication before payment is authorized by a health insurance plan) contribute to disparities in the dependent variables (clinical outcomes, medication adherence, healthcare resource utilization, economic outcomes, and drug utilization) based on race and/or ethnicity?
Population: Adult and pediatric patients (any disease state)
Outcomes: Clinical outcomes, medication adherence, healthcare resource utilization, economic outcomes, and drug utilization
Comparators: Required to undergo prior authorization or step therapy vs. Not required to undergo prior authorization or step therapy (or similar variation on this comparison); OR before and after implementation of a prior authorization/step therapy policy
2. Why are you struggling with this issue?
Based on two prior systematic reviews (the most recent is attached to this submission), the evidence regarding the impact of pharmacy formulary restrictions on patient outcomes (the aforementioned dependent variables) is mixed. Additionally, there is a dearth of evidence regarding the effects of pharmacy formulary restrictions on health disparities based on race and/or ethnicity. Therefore, further study is warranted.
3. What do you want to see changed? How will you know that your issue is improving or has been addressed?
The change we would like to see is the prior authorization and step therapy policies will be modified to align with optimization of desired patient outcomes across disease states and racial/ethnic groups. We will know that the issue is improving when studies consistently demonstrate that prior authorization and step therapy have positive affects on patient outcomes across disease states, and that there are no disparities in outcomes based on race and/or ethnicity.
4. When do you need the evidence report?
Tue, 12/31/2024
5. What will you do with the evidence report?
The evidence report will be used to advocate at state and federal levels for third-party payer prior authorization and step therapy policies that support patient well-being while also achieving reduced prescription drug expenditures.
Supporting Documentation
Upload Document
JMCP.2017.23.8.893 (PDF, 302 KB)
Optional Information About You
What is your role or perspective? Researcher and Administrator
May we contact you if we have questions about your nomination? Yes
