1. Nalley, Catlin

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A recent study explored the association between insurance plan, prior authorization, and time to receipt of oral anti-cancer drugs (OACDs). The data showed that 72 percent of delivered OACDs require prior authorization, which is associated with delayed time to drug receipt, according to a presentation at the 2021 ASCO Quality Care Symposium (Abstract 6).

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"Oral anti-cancer drugs, or OACDs, provide critical treatment for many malignancies," said study author Morgan Lichtenstein, MD, of Columbia University Medical Center. "The past decade has seen a dramatic increase in the number of OACDs approved by the FDA. For example, in 2020, 67 percent of newly approved cancer treatments were oral agents.


"Most OACD prescriptions require coordination between multiple providers and payers, which can delay drug receipt," she continued. "In this study, we examined clinical and process-related factors associated with prescription receipt and time to receipt."


Methods & Findings

The researchers prospectively collected data on new OACD prescriptions for adult oncology patients at Columbia University Irving Medical Center from January 2018 to December 2019.


"In our first analysis, we performed logistic regression, looking at factors associated with medication receipt within 7 days, and separately, factors associated with prior authorization," explained Lichtenstein. "In both of these models, we included only patients who received their prescriptions.


"In our second analysis, we used a cure rate model and cumulative incidence curves to capture all prescriptions received and not received, stratified by drug class (targeted agents vs. chemotherapy) and adjusted for patient and prescription characteristics," she continued. "Our primary outcome was time to event, defined as time to medication receipt."


When discussing prescription and patient characteristics, Lichtenstein noted, "Nearly three-quarters of drugs had a prior authorization issued. Seventy percent of drugs were targeted treatments and 30 percent were chemotherapy," she outlined. "Looking at drug outcomes, 87 percent of prescriptions were received, and 13 percent of prescriptions were never delivered."


Patients were equally distributed across age and sex. Forty-five percent of patients identified as White. Other races/ethnicities represented included Hispanic (29%), Black (14%), and Asian/Pacific Islander (7%).


In terms of medical insurance, patients fell into three primary categories: Medicare (59%), commercial insurance only (26%), and Medicaid only (16%), according to Lichtenstein, who noted that these categories were used to approximate prescription insurance coverage. As for cancer type, the majority of patients had solid tumor (79%) diagnoses.


The median time to drug receipt was 7 days. Twenty-five percent of patients waited longer than 14 days to receive their medications and 5 percent waited longer than 30 days, Lichtenstein reported.


"In our initial logistic regression looking at time to receipt, we concluded that prior authorization was associated with time to receipt over 7 days and Medicaid was associated with time to receipt of less than 7 days," she said. "Our subsequent logistic regression looking at factors associated with prior authorization concluded that prior authorizations were more likely issued for patients with Medicaid compared to Medicare, and targeted or hormone OACDs compared to oral chemotherapy."


In their second analysis, researchers used a cure rate model. "We chose this approach because it gives us the ability to include all prescriptions and look at two important outcomes," Lichtenstein said. "One, whether the prescription was ultimately received or not received, and two, the time it took to receive the prescription or time to event."


As the researchers hypothesized, the data showed that targeted OACDs, given their increased costs and logistics often associated with these medications, had a longer time to event compared with oral chemotherapy. Additionally, they found that targeted therapy is significantly more likely to have a prior authorization issued and more likely to have a time to event greater than 30 days, according to Lichtenstein.


Looking at only targeted OACDs, the researchers observed no significant difference in time to event or proportion of prescriptions received between insurance types, However, Lichtenstein noted that prescriptions with prior authorization had a trend toward longer time to event, particularly within the first 2 weeks, but were more likely to succeed in the end.


Lichtenstein and colleagues then used the cure rate model to identify factors associated with drug receipt and time to event. They reported that prior authorization and solid tumor diagnosis were each associated with a higher likelihood of receiving the drug. In terms of time to event, prior authorization is associated with a longer time to event and older age is associated with a shorter time to event.


"Importantly, in this analysis, we found an interaction between insurance type and prior authorization, indicating that prior authorization is associated with a shorter time to event for Medicaid patients despite being associated with a longer time to event overall," Lichtenstein said.


Conclusions & Necessary Next Steps

Summarizing her presentation, Lichtenstein emphasized that the current process for obtaining OACDs is complex and multifaceted, and differs by prior authorization, cancer type, age, drug class, and insurance.


"In our study, we saw that among prescriptions received, median time to receipt was 7 days, though approximately a quarter of patients waited over 2 weeks, and 5 percent waited over 30 days," she said. "Importantly, 13 percent of prescriptions were never received for reasons we explore in a separate analysis."


More than 70 percent of all OACD prescriptions require prior authorization, which appears to be associated with a higher likelihood of drug receipt and a longer time to receipt for both targeted OACDs and overall, according to Lichtenstein. For targeted drugs, she noted, the effect of prior authorization differs by insurance type.


"In conclusion, earlier intervention and new health policies are needed to minimize barriers for all patients and all prescriptions, with the goal of reducing the time to OACD receipt," she stated.


Catlin Nalley is a contributing writer.