To improve transparency and optimize the prior authorization (PA) process, speakers at AMCP 2023 suggested employing digital tools and adopting a patient-focused approach rather than tailoring criteria toward clinical trial requirements.

“Our goal is to focus on optimizing our patient outcomes through the use of medications that have established evidence of safety and efficacy while providing the highest value,” said Heather Odem, PharmD, director of pharmacy, UnitedHealthcare Community & State (Mississippi). “The prior authorization program is a living, evolving process.” 

Promoting Transparency

As the PA process evolves, it is important for managed care organizations (MCOs) to ensure transparency for providers and patients, Dr Odem said. She recommended several digital solutions to drive PA efficiency.

For prescribers, PA criteria transparency can be improved through tools implemented into the electronic health record. These may include real-time benefit check; electronic PA with real-time, automated approvals; and decision support tools. 

At pharmacies, automated point-of-sale reviews involving member demographics, medical claim histories, and pharmacy claim histories can be implemented to improve transparency, Dr Odem said. 

“A lot of [these tools] have been deployed with the goal…to create something that’s embedded in the provider’s electronic medical record,” Dr Odem said, adding that digital solutions can be implemented in “their day-to-day practice to remove unneeded administrative barriers.”

Publishing PA criteria online, such as on a public website, provider forum, or advisory group, can also promote access, Dr Odem said. Additionally, MCOs should review newly approved drugs as promptly as possible and provide advanced notice of program changes to providers to minimize disruptions in care, Dr Odem said.

Challenges for Creating PA Criteria

Dr Odem went on to describe how novel agents can present challenges for the PA process. New drugs do not have an established place in evidence-based treatment guidelines or may have been tested in clinical trials with narrow populations, limited follow-up, or surrogate endpoints. 

“Some trials give us information on the baseline characteristics of the population, or ways efficacy can or should be measured, but it might not always be that simple,” Dr Odem said. 

The conundrum, Dr Odem said, is that PA and clinical trial goals may not always overlap—randomized controlled trials aim to show efficacy through research, and PA criteria aim to drive effectiveness through treatment.

“Because of these differences, there may be some instances where parameters of the clinical trial require some additional thought or consideration to whether or not they would help achieve the goal of optimizing patient outcomes by being included in our criteria,” Dr Odem said.

To gain insight into the value of a novel drug, MCOs might seek the input of key opinion leaders, primary investigators from the clinical trials, and professional societies that represent physicians, Dr Odem said. Decision-making may also be supported by information from assessments by the Institute for Clinical and Economic Review and the US Food and Drug Administration’s Advisory Committee meetings. 

Dr Odem also advised MCOs to keep in mind the clinical trial pipeline in anticipation of receiving more data on a novel drug’s efficacy and safety.

Adopting Patient-Focused Criteria

In the second half of the session, Richard Ogletree, PharmD, pharmacy director, Alliant Health Solutions, advised how MCOs may tailor criteria to be more patient-centered.

For example, PA criteria for spinal muscular atrophy (SMA) therapies often require improvements in function. Patients must have motor function evaluations that show a meaningful clinically important difference to justify reauthorization, as these measures correspond with what is used in clinical trials, Dr Ogletree said.

However, a more patient-focused approach could involve a prescriber reporting disease stabilization or attesting that the medication slowed disease progression more than if the patient had not received the drug. 

Current literature also suggests patients with SMA and their families may value additional outcome measures related to functional ability, such as respiratory function, the ability to perform daily activities, and fatigue, among others.

“When we have a patient-focused approach, we want to be sure to think about the patients’ families and caregivers,” Dr Ogletree said. “Remember, this is not just about providing drugs; it’s about improving lives.”