AMCP Nexus Conference Insider

A recent study aimed to investigate the relationship between race, ethnicity, wage status, and the utilization of specialty medications among employees with autoimmune conditions (AICs) enrolled in employer-sponsored health insurance. The research was conducted in 2018 using retrospective data from the IBM Watson MarketScan database, focusing on full-time, benefits-enrolled employees, and presented at AMCP Nexus 2023.

Demographic factors such as race, ethnicity, and wage level were explored to understand their impact on specialty medication use and adherence patterns. Employees were divided into subgroups based on their race and ethnicity as per employer-provided data. Wage data was used to classify employees into annual income quartiles, with the lowest quartile further subdivided into 2 groups for closer examination.

The study analyzed the following outcomes: the number of days’ supply of specialty medications for AICs per month, the proportion of days covered (PDC), and medication discontinuation rates. Generalized linear regression was employed to assess differences while adjusting for various patient and other characteristics.

The study included over 2 million enrollees, and race and ethnicity data were available for 617,117 (29.8%) of them. Among these, 47,839 (7.8%) were identified as having an AIC, with varying prevalence rates of AICs across different race and wage categories.

The results revealed significant disparities in specialty medications utilization by race and ethnicity, with Black and Hispanic populations experiencing lower specialty medications utilization rates compared with White individuals across different wage categories. The highest wage category was an exception, where the differences in specialty medications utilization were not significant.

Specifically, Black enrollees had notably lower specialty medication-AIC utilization rates than White enrollees in various wage groups, indicating disparities in access to these specialized medications. Similarly, Hispanic enrollees had lower specialty medication-AIC utilization rates compared with White enrollees in specific wage categories.

However, when examining PDC and 90-day discontinuation rates, there were no significant differences observed among race and ethnicity groups within their respective wage bands. This suggests that once individuals initiated specialty medication treatment, their adherence and medication discontinuation rates were relatively consistent regardless of their racial or ethnic background.

In conclusion, this study highlights the existence of racial, ethnic, and wage-related disparities in the use of specialty medications for AICs among employees with employer-sponsored insurance. The findings
underscore the likelihood that these disparities contribute to inequities in health care outcomes for non-White and low income populations with such insurance coverage. These insights call for a closer examination of health care access and equity for these marginalized groups to ensure more equitable health outcomes.

The study was sponsored by the National Pharmaceutical Council, emphasizing the importance of addressing these disparities in access to specialty medications and promoting health equity among diverse employee populations.

Payers surveyed for a study presented at AMCP Nexus 2023 said they expect a financial impact on Part D plans due to the implementation of the Inflation Reduction Act (IRA).

“Drug pricing and the Part D benefit redesign provisions within the [IRA] will have sweeping implications for US health care payers,” explained study authors. “Insight into how US payers plan to respond to Part D policies included in the IRA is needed to forecast how IRA implementation may affect patient access and affordability.”

The double-blind, web-based survey of US health care payers was conducted to better assess and understand payer perceptions of the IRA and any potential impact on Medicare Part D plans.

“Payers believe IRA-related changes to Medicare Part D will have a financial impact on their portfolio of Part D plans; some forecast an adverse financial impact (44%, n=22), others expect a relatively limited financial impact (34%, n=17), and some believe it will reduce the number of Part D plans they offer (20%, n=10),” wrote the study team.

Study findings revealed only 10% of payers surveyed think the changes will result in a positive financial impact, and only 8% believed the IRA would increase the number of Part D plans offered by their organization.

“The most significant outcome of the redesign is likely to be narrower formularies, hampering patient access.”

Further findings showed that roughly payers anticipate somewhat (52%) or significantly (24%) more narrow formularies compared with 20% of respondents who expect similar formulary coverage compared with current designs.

Of note, most payers “expect greater utilization management (UM) because of increased financial liability for Part D plans, with some anticipating greater UM across the board (42%, n=21) whereas others anticipate greater UM for high-cost medications (32%, n=16) or on a case-by-case basis (16%, n=8),” explained the authors. “Very few expect no change in current UM levels (10%, n=5).”

According to most payers surveyed, they anticipate IRA implementation will increase Part D premiums between 5 to 10%, and few expect to maintain Part D plan premiums at current levels.

Notably, no payers surveyed expect reduced premiums below current levels.

“As a result, most payers anticipate an increase in Part D premiums as well as greater use of UM strategies to contain costs,” they concluded. “Additional analysis is needed to examine the extent to which these changes will impact patient access to treatments.”

Researchers recently found that the Institute for Clinical and Economic Review (ICER) rejects most of the Unsupported Price Increase (UPI) evidence submissions. These findings were presented at AMCP Nexus 2023.

“In its [UPI] reports, [ICE]) aims to identify drugs with substantial price increases that lack new evidence to justify the increases,” explained study authors.

To better understand how ICER reviews evidence provided by manufacturers, trends in manufacturer submissions, as well as ICER’s rejection and acceptance criteria, the study authors used 4 national UPI reports from 2019-2022. They developed a codebook to categorize the different types of evidence submitted and ICER’s reasons for rejecting and accepting evidence.

“We identified trends regarding the quantity and quality of evidence as well as study characteristics for evidence accepted in support of a price increase,” they said.

According to the reports, manufacturers submitted evidence for 34 of the 44 drugs reviewed—totaling 1145 pieces of evidence, which averaged 34 pieces per drug. Per the reports, the reported average decreased over time (n=67 in 2019; n=28 in 2020 and 2021; and n=17 in 2022). Further, 97% of evidence submissions were rejected by ICER, with a slight downward trend (99% in 2019, 97% in 2020, 93% in 2021, and 94% in 2022).

Findings also showed 64% of rejected evidence submissions because the UPI criteria was not met and 36% were rejected for not meeting the criteria for new moderate- to high-quality evidence.

“Trends in ICER’s rejection reasons shifted toward the latter (19% in 2019, 38% in 2020, 52% in 2021, and 61% in 2022).”

Importantly, only 38 pieces were accepted as high quality evidence in support of a price increase—representing 18 randomized controlled trials.

The study authors reported that ICER described the impact of accepted evidence using a single category: longer term data with improved outcomes (n=5) in 2019.

“In subsequent years, ICER moved to more descriptive categories, including evidence that supported US Food and Drug Administration (FDA) label expansion for a new (n=5) or existing (n=4) indication, supported accelerated approval (n=2), extended the evidence base to new populations excluded in previous trials (n=1), and strengthened the existing guideline recommendations (n=1).”

Overall, the study showed that ICER rejects 97% of UPI evidence submissions.

“Accepted evidence was typically from phase 3 double-blinded [randomized control trials] that demonstrated new information on improved outcomes or supported FDA label expansion,” they concluded.

“Manufacturers appeared to become increasingly selective over time with the evidence they submitted to ICER’s UPI reports.”