Experts Call for a More Patient-Focused Approach to Prior Authorization

On the first full day of conference activity at AMCP 2023, a morning session examined prior authorization (PA) through a lens of refining the current process and the potential role of clinical trial data in PA criteria.

On the first full day of conference activity at AMCP 2023, a pair of pharmacists examined the current process for making prior authorization (PA) decisions by focusing their lens on the need for a more patient-focused approach to this often confusing, cumbersome, and drawn-out process. Inclusion and exclusion criteria are the current standard for most PA decisions, but stakeholders may want to start placing greater emphasis on the potential of incorporating baseline and outcomes data from clinical trials into PA criteria.

In “Prior Authorization Criteria: Looking Beyond Clinical Trial Populations,” Heather Odem, PharmD, director of pharmacy, UnitedHealthcare Community & State – Mississippi, and Richard Ogletree, PharmD, pharmacy director, Alliant Health Solutions, noted the importance of trial- and patient-focused baseline and outcome data and how best to use a patient-focused approach for PAs.

“What is prior authorization?” Odem asked the standing-room only crowd.

In addition to it being a utilization management tool that sees health care providers needing coverage approval if they want to deliver a particular treatment or product to a patient, this living process exists, she continued, to ensure the treatment wanting to be delivered is appropriate—for example, is the dosing correct? Does the patient have the appropriate condition?—safe, and cost-effective.

Still, there is room for efficiency improvements, “because ‘prior authorization’ are words no one likes to hear,” she stated.

Digital solutions can be employed at both the prescriber and provider levels to remove unnecessary barriers, not create an additional platform to process information. At the prescriber level, this might encompass integrating a real-time benefit check into an electronic medical record (EMR), using electronic PA with real-time automated approvals, or incorporating decision support tools into the provider portal. And at the pharmacy level, automated point-of-sale review could take place based on information contained in the patient record, such as demographics, medical claim history, and pharmacy claim history.

Transparency in communication about the PA process is another potential way to improve the PA process, and Odem noted that this is a current goal of many managed care organizations. To make this a success, health care providers and stakeholders should consider making criteria for PA easily accessible.

Managed care organizations could also provide advance notice of any changes in the PA process, such as alerting providers to PAs that are broaching their expiration date and promoting the need for ongoing access to medications to avoid patient care disruptions. Odem also advised a multipronged approach to communication about PAs: via a public-facing website, within the EMR, and through provider forums and advisory groups.

She stressed the importance of managed care organizations leveraging as many resources as they can, including relationships with both professional societies that represent physician communities, who take care of patients, and key opinion leaders; FDA advisory committee meetings; and ICER assessments.

“Really foster that dynamic discussion to help understand what’s working well and maybe where the pain points are for providers,” she stated. “As managed care organizations, we advocate for developing criteria that promotes use, that has evidence of efficacy and safety, and the populations likely to use that treatment.”

Ogletree echoed her sentiments, and he continued the PA discussion by focusing on the role that clinical trial information can play in developing PA criteria. He noted that trial inclusion/exclusion criteria can be helpful in this regard “to support patient selection for medications with unknown long-term safety or durability of effect.” At the same time, he didn’t shy away from discussing the inherent challenges in developing PA criteria.

Can clinical trial criteria be successfully implemented into the PA process, he posited? Because a hiccup can arise when clinical trials enter the mix with their evidence-based criteria development and when attempting to reconcile the goals of a randomized controlled trial and of PA criteria, highlighted Ogletree.

Within a clinical trial, for example, there are strict clinical and treatment guidelines, which are usually disease-state based; an ongoing need for systematic reviews; and continuous review and revision from evidence generation. And with novel agents being developed that are a first-in-class medication or potentially indicated for a rare disease, the findings from the narrow clinical trial population may not extrapolate to the general population, leaving unknown long-term safety and durability outcomes in the latter and how to effectively incorporate clinical trial knowledge into PA criteria.

In addition, the former’s goal is to establish study conditions that show efficacy via research and the latter’s goal is to promote safety and effectiveness across a population. They don’t always overlap. Because of this, it’s important to consider additional types of evidence, and these include real-world evidence, physician experts, and patient-reported outcomes.

Drilling down on the patient-focused approach, he stressed the importance of considering not just the patient, but their families and caregivers as well, because this approach is not just about providing a drug, it’s about improving lives as well.

“It’s becoming increasingly important to provide additional context to ensure criteria is patient focused,” he stated. “I wish I had all the answers on this. We could write a book.”

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