Addressing Fair Access Barriers: Payers Must Improve Transparency

Among the ongoing legislative and policy efforts to address the escalating cost and increasingly limited access to prescription drugs, is a recently published report by the Institute for Clinical and Economic Review (ICER) which lays a foundation for erecting a stronger and more sustainable framework to ensure fair access to treatments.

Called an exploratory analysis by Sarah K Emond, MPP, executive vice president and chief operating officer at ICER, the “Assessment of Barriers to Fair Access” report published December 1, 2021 builds on a 2020 white paper titled “Cornerstones of ‘Fair’ Drug Coverage: Appropriate Cost-Sharing and Utilization Management Policies for Pharmaceuticals” that laid out a set of criteria on which to evaluate fair access. The goal of the report is to serve as a starting point for dialogue and action to achieve fair access, according to Ms Emond during a December 3, 2021 webinar.

Emphasizing the exploratory tenor of the report was more than rhetorical, it was a main takeaway from the webinar. Ms Emond opened the webinar by discussing the limitations of the report, something often held until the end of a study long after the main findings and conclusions. She discussed the limitations up front as a way of highlighting what the report was not able to do primarily given the lack of available data from payers.

Douglas White, MD, PhD, chair, rheumatology department, head, rheumatology research lab, Gundersen Health System and Gundersen Medical Foundation, was a panelist who spoke during the webinar and reiterated these limitations. “I see [the report] as a first glance that highlights how little information we have and how hard it is to get that information,” he said, emphasizing the need for more transparency from payers.

With these limitations in mind, what did the report find that can serve as a starting point to address the barriers to fair access to prescription drugs?

ICER, with consultation from a multistakeholder working group, evaluated fair access to 28 selected drugs in 15 of the largest US commercial formularies. The 28 drugs selected for review were ones ICER determined as fairly priced (ie, within $100-$150K/QALY/equal value of life years gained cost-effectiveness range), and the 15 formularies included are those with the most covered lives as identified by MMIT Analytics Market Access Database.

Specific criteria within four domains including cost-sharing, clinical eligibility, step therapy and required switching, and prescriber restrictions were used to evaluate fair access. Fair access was determined by assessing drug formulary policies among the 15 formularies meeting fair access criteria (concordance).

The report demonstrates the most variation observed in concordance with cost-sharing, with only a 77% rate of concordance among the payers with available information. In contrast, all three of the other domains showed a high concordance: 96% concordance for clinical eligibility, 99% for step therapy, and 100% for prescriber restrictions.

Ms Emond said that since cost-sharing is what patients feel, it’s not a surprise that we hear a lot about the need for fairer drug prices. The low concordance in cost-sharing, she said, “shows that everyone feels we’re doing something wrong with pricing.”

Dr White also was not surprised by the discordance for cost-sharing. “The rubber meets the road at cost-sharing,” he said, noting, however, that the use of tiering as a surrogate marker for cost-sharing used in the report needs to be more fine-tuned to better address this issue.

In the report, one criteria assessing fair access based on cost-sharing was whether the drug or at least one of its equivalent options had to be placed on the lowest relevant tier of the formulary. In her opening remarks on the limitations of the report, Ms Emond acknowledged that some people would find this as a limited way to assess cost-sharing.

In the report, the authors discuss this more thoroughly and noted that further discussion is needed on four-tier formularies given the finding that, for example, these formularies had lower concordance on cost-sharing than three-tiered formularies (23%-36% vs 82%-95% concordance, respectively).

When looking at concordance by drug, cost-sharing again had the lowest rate of concordance among the 4 fair access criteria. For example, the report found that 6 payers did not have dupilumab on the lowest relevant tier despite no alternative drugs in this class. According to the report, payers acknowledged that a common practice is to start such drugs on the highest tier even if they are fairly priced and move them to a lower tier when competing drugs become available as an incentive to lower their price.

During the webinar, Ms Emond raised the hypothesis on whether concordance with tiering/cost-sharing criterion will be lower for fairly priced drugs that have higher net prices, noting that the report showed cost-sharing concordance in 81% of drugs below the median annual net price ($27,000 for all 28 drugs) and 72% for drugs above the median annual net price. She cautioned that no clear conclusion can be drawn from that analysis, as the difference in concordance rates was not that significant.

One key takeaway from the report is the need for access to payers’ coverage policies in order to more accurately and thoroughly assess fair access to prescription drugs. In short, transparency.

When looking at the results, the impact of limited available data can be observed in the drop in concordance when factoring this into the analysis: 60% for cost-sharing, 69% for clinical eligibility, 75% for step therapy, and 74% for prescriber restrictions. When looking at drug-formulary policies not meeting fair access criteria (discordant rates) among the 15 formularies, 19% did not meet cost-sharing fair access criteria, 3% did not meet clinical eligibility, 1% did not meet step therapy, and 0% did not meet prescriber restrictions.

Cat Davis Ahmed, MBA, vice president of policy and outreach, Familial Hypercholesterolemia Foundation, one of the panelists who spoke during the webinar, stressed the importance of highlighting the limitations of the report given the erroneous conclusions drawn by some media outlets that the high concordance among payers [particularly in domains other than cost-sharing] found in the study as indicating fair access. “That doesn’t reflect real-world experience of patients and providers of the lack of access even when data on paper show concordance,” she said.

Dr White also cautioned superficial reading of the results that does not reflect reality on the ground of the difficulties patients have of getting appropriate drugs in a timely fashion.

As an advocate for patients, Rebecca Kirch, JD, executive vice president of policy and programs, National Patient Advocate Foundation, also emphasized the importance of transparency for patients and the need to further shed a light on policies that affect what is most important to them—access to medications, services, and affordability. She encouraged plans to start using patients and caregivers to help develop policies and sees the report as a tool for getting plans to involve patient perspective early and often in the process of developing formulary policies.

As ICER moves forward beyond this first exploratory step of fair access, the panelists all emphasized the importance of implementation in getting the results of the report and future reports into the real world. “We know these problems are significant in the real world and [the difference] of what happens in theory when policy gets made in the room, and what happens out of the room,” said Ms Kirch.

As of mid-January 2022, the report already has had some impact. Of the 15 payers included in the analysis, 6 have changed policies or tiering to bring their coverage into concordance with fair access. Examples include moving dupilumab from tier 3 (nonpreferred brand) to tier 2 (preferred brand), adding rimegepant to its formulary as preferred brand, adding ubrogepant to its formulary as preferred brand, among others.

“Just the act of transparency and asking questions about concordance led to changed policies in 10 ways among 6 payers,” said Ms Emond, adding many payers said the changes were already underway. She encourages others in the system to use the results of the report to advocate for these changes to motivate payers to improve their formulary policies.