Peek Behind the Poster: A Value Based Budget Impact Model For Dronedarone

In this feature, we take a ‘peek behind the poster’ with Jennifer Ken-Opurum et al. (Axtria, NJ, USA), to discuss their research presented at ISPOR 2022 – a study that examines the budgetary consequences of increasing utilization of dronedarone relative to other antiarrythmic drugs to a hypothetical US payer.

View the poster here >>>

What is the current usual care for patients with atrial fibrillation in the US and what is the economic impact of this?

Current treatments available for atrial fibrillation (AFib) include anticoagulants, rate control medications, antiarrhythmic drugs (AADs), and ablation surgery [1]. The estimated annual costs of AADs range from $166 for flecainide to $2,330 for dofetilide [2–7]. Costs for rate control medications are estimated at $1,571 per year [8], while the cost for a single ablation procedure is estimated at $22,640 [8]. Aside from medication / procedure costs, these treatments come with risks of events (such as ventricular arrhythmia, bradyarrhythmia, extracardiac toxicities, and hospitalization) [9,10], which have subsequent economic consequences. Among AAD, the estimated annual costs to treat events is reported to range from $7,665 for propafenone to $23,905 for flecainide [11–15].

Can you explain how you built the “budget impact model” featured in your recent research comparing the treatment of atrial fibrillation utilizing AADs versus the usual care?

The budget impact model (BIM) was built assuming a hypothetical plan population of 1 million US patients with AFib, and a 5-year time horizon. The model utilizes multiple strategies for individual treatments and combination therapies, including rate control medications, AADs (amiodarone, dofetilide, dronedarone, flecainide, propafenone, and sotalol), and ablation. Unique to our BIM is the ability to define whether the order of treatment should be considered or not, i.e., placing AADs as first-line vs. second- or third-line therapy in combination with rate control medications and/or ablation. The BIM also incorporates the risk of events that might occur during the treatment period and costs associated with the treatment of these events. Model inputs come from clinical trial evidence where available and are supplemented with results from an analysis of read-world data (RWD) and medical expert opinion. One additional feature of the BIM is inclusion of a one-way sensitivity analysis (OWSA), which evaluates the impact of individual parameters on model results. In the OWSA, users can specify a range of variation across parameters (set to 20% by default), which allows for investigation of hypothetical changes or differences that may occur in the real-world. Together, these factors resulted in a rigorous analysis with robust results that is likely to more closely reflect what patients may experience in real-world settings.

What were the main findings of this research?

Among AADs, although dronedarone had a higher medication cost, our research showed that dronedarone usage by patients over time resulted in lower risks for events (particularly stroke), and consequently resulted in lower overall treatment costs (total cost per patient in target population per-month decreased $37.69 by year 5 when share of dronedarone increased to 20%). Additionally, the placement of AADs as the first-line treatment resulted in cost savings (PPPM $0.24) compared to placement as the third line of treatment behind rate control and ablation. Incremental savings were observed over time.

What implications does this have on how atrial fibrillation should be treated going forward?

Clinical guidelines should put emphasis on the order of treatments and making AADs available to patients with AFib sooner, particularly as a first-line therapy. By extension, dronedarone demonstrated its cost-effectiveness via lowering stroke risk, and may be a preferred first-line treatment both for its clinical benefits to patients as well as its economic benefits to payers.

Treatment placement is being investigated through CHANGE AFib. CHANGE AFib, a new pragmatic clinical trial, will determine whether early treatment with the AAD dronedarone improves cardiovascular and long-term outcomes in patients hospitalized with first-detected AFib. The trial represents a collaboration between the American Heart Association, a global force for healthier lives for all, and the Duke Clinical Research Institute (DCRI), the world’s largest academic clinical research organization, with support from Sanofi US [16].

What regulatory issues may come into play with such changes?

This BIM is a unique example of leveraging the best available evidence and conducting RWD analysis to inform model inputs. This leads to not only results which are more specifically tailored to the research question but also results that are highly relevant to what patients may expect to experience in actual clinical practice. As the use of RWD becomes more widely accepted for pharmaceutical-related applications and decision making, and as evidenced by the results of our model and similar RWD-based modelling, our hope is that the FDA and other regulatory bodies across the globe may begin to consider and encourage development of economic models that incorporate real-world evidence (RWE) and allow for greater acceptance and use of this type of data.

How will patients be impacted by these changes in atrial fibrillation treatment?

Our research suggests that patients may expect to experience fewer events, have potentially improved long-term clinical outcomes, and ultimately enjoy significant treatment-related cost savings.

We hope the impact of this research provides evidence to guideline committees regarding the importance of earlier rhythm control intervention, which shows potential improvement in the treatment of patients with AFib.

Upcoming research at ISPOR Europe 2022 (6–9 November 2022, Vienna, Austria)

Axtria Inc. will be presenting further research at the upcoming ISPOR Europe 2022 meeting. Check out the below during the poster sessions:

• Monday, November 7, 2022 (15:00 to 18:15 [CET]): Clinical and Economic Outcomes Associated With Use of Anti-Arrhythmic Drugs Versus Ablation in Atrial Fibrillation (AFib)
• Tuesday, November 8, 2022 (15:00 to 18:15 [CET]): The Economic Value Of Insulin Glargine 300 U/Ml (GLA-300) In People ≥18 Years of Age With Type 2 Diabetes Mellitus: A Value-based Economic Model From A U.S. Payer Perspective