Background:
DOAC use has shown improvements in safety and efficacy when compared to warfarin. Patients prefer DOACs over warfarin due to lack of monitoring and diet restrictions. Public insurance plans, like Medicare and Medicaid, manage medication coverage differently from commercial plan. Health plans use utilization management criteria (UMC) like step therapy, prior authorization, quantity limit and tiering status to optimize use of cost-effective therapies and to restrict utilization of high-cost therapies. This approach can impact patient care by limiting access. We suspect DOACs are susceptible to UMCs due to high cost and lack of generics available.
Objective:
To describe formulary status, tier status and frequency of UMC applied to DOACs offered by Medicare, Medicaid, and Private plans.
Methods:
Our descriptive study purchased data through Breakaway Partners. The data was queried in September 2019. All national insurance policies offering apixaban, rivaroxaban, dabigatran, and edoxaban were collected. Commercial insurance policies were excluded. The data set was separated into Medicare and Medicaid and private groups. Within each insurance policy group, the data was separated by DOAC agents. The formulary status, tier status, and UMC applied to each DOAC was counted and percentages were calculated. The three types of UMC counted were quantity limit (QL), prior authorization (PA), and step therapy (ST). All data analysis was performed with Microsoft Excel.
Result:
Apixaban and rivaroxaban were consistently listed as being on formulary more often than dabigatran and edoxaban (Table 1). Likewise, apixaban and rivaroxaban were more frequently listed as a lower tier compared to dabigatran and edoxaban across public and private payers (Table 1). When listed as being on formulary, QL was the most frequent UMC applied to a health plan. The exception was edoxaban offered by Medicaid plans which was most commonly restricted using PA.
Among all private health plans, apixaban and rivaroxaban were most commonly found as tier 2 medications. Whereas, dabigatran and edoxaban were most commonly found in tier 3 or 4 (table 1). Quantity limit was the most common UM criteria placed on DOACs. Among all DOACs that are included in this study edoxaban had the most restrictions (table 2).
Conclusion:
Our study shows public insurance plans prefer apixaban and rivaroxaban over edoxaban and dabigatran. Our data set did not provide claims data or pricing structures. Future studies are needed to determine appropriateness of DOAC insurance policy management.
Our data shows that private health plans are making apixaban and rivaroxaban more readily available to patients when compared to dabigatran and edoxaban. Also, quantity limit is frequently utilized to restrict all four DOACs. Future research should evaluate the implementation of UM criteria of DOACs in the context of cost-effectiveness analyses done by ICER and other agencies.
Responses
Brian – Congratulations for this nice work. I wonder if you have any insights on why apixaban and rivaroxaban are preferred over edoxaban and dabigatran. What kind of criteria are used to support decision makers to choose what therapy in their formulary? Did you have a chance to get insights from talking to any managers dealing with formulary decision to get a sense of the reasons? Just curious.
Hello Dr. Chaiyakunapruk,
Unfortunately, we were not able to interview managers dealing with formulary decisions. This is a great suggestion and I do think they would provide valuable insight in the decision process. We attributed the difference in formulary status due to some combination of organization cost of acquiring a DOAC, ease of use, and differences in indications. Organizations could be receiving different rebates or pricing structures with certain DOACs, we simply did not have that information. Additionally, rivaroxaban has an advantage of being once daily dosing along with least restrictive storage and handling precautions compared to dabigatran. Finally, if an organization has to decide on certain DOACs to list on formulary, the DOACs with the most approved indications have the added advantage to be used in more of the population being managed. Rivaroxaban and apixaban have the most approved indications compared to dabigatran and edoxaban. Thank you for your interest in my poster!
Best,
Brian Ortega
Great work, Brian! Any thoughts of why edoxaban is so underutilized. Should there be any concerns that insurance payers are preferring DOACs that are potentially clinically inferior (e.g., less impressive outcomes from the clinical trials)?
Hello Dr. Witt,
I think edoaxaban is limited simply because it was last to the market. More studies have assessed the efficacy and safety of other DOACs compared to edoxaban. That being said, edoxaban does have some advantages like once daily dosing and some studies suggests its closer to apixaban in efficacy and safety. Edoxaban is the most expensive of the four DOACs.
If insurance payers are preferring inferior DOACs it could put patients and providers in a difficult situation. Providers may prefer a certain DOAC for efficacy and safety reasons but without proper insurance coverage patients may only be able to afford a potentially interior medication. In an ideal world, insurance payers would design policies would make it easier to access the most cost-effective medication to maximize coverage for their beneficiaries. While we could not assess the appropriateness of the policies, we do believe our study justifies a more in depth analysis of insurance plans offering DOACs.
Best,
Brian Ortega
Well I learned what DOAC means. ‘Direct Oral AntiCoagulant’, another wrinkle in my brain, thanks. Once I figured this out, the subject became very clear. It would seem that perhaps insurance is guiding the prescriptions per your study.
Hello Jane,
Adding a few brain wrinkles was definitely one of my project goals! haha. I learned a lot during my project from start to now. Insurance payers play a big role in the healthcare system and it does seem that they are preferring some DOACs over others. We are hoping to better assess the appropriateness of their decisions in the future.
Brian, nicely presented poster. It is very clear, with a well-developed conceptual foundation, clear data presentation, and logical conclusions based on the data provided. Excellent work! One does wonder, as raised in the questions below, why payers are prioritizing medications that were shown in clinical trials to be less efficacious. Do you have thoughts on that?
Hello Dr. Keefe,
I partially addressed this in my responses above. I think this study justifies a more in-depth analysis of how appropriate the insurance plans are. If I had to play the role of payer, I would prefer DOACs that had most approved indications and were competitively priced. Apixaban and rivaroxaban fit that description. While rivaroxaban may not be as effective or safe as edoxaban or even dabigatran, it does provide once daily dosing, more indications, and significantly cheaper than edoxaban. In that sense, I understand why insurance plans are designed the way they are.
It is interesting that apixaban was the first generic approved. I suspect by the time it is available on the market it will significantly preferred all other DOACs and possibly even warfarin as more data is collected on DOAC safety and effectiveness. Thank you for your interest in my poster!
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