Anticoagulation reversal: The current treatment landscape and unmet needs in the USA

Abstract text (incl. references and figure legends)

Introduction

Specific direct oral anticoagulation (DOAC) inhibitors and 4-factor prothrombin complex concentrates (4F-PCCs) may be used for urgent anticoagulation reversal owing to major bleeding/surgery. However, guidelines acknowledge the need for consistent and appropriate use of DOAC reversal agents.¹ This market research study aimed to examine real-world treatment patterns of anticoagulation reversal in the USA.

Materials & Methods

This double-blind study recruited healthcare professionals (HCPs) and pharmacy and therapeutics (P&T) committee members (July–August 2021) to gain their insights on the anticoagulation reversal treatment landscape in the USA and identify any unmet needs associated with the current standard of care. Data were gathered from 60-min telephone interviews based on two discussion guides and conducted by an independent research firm. All participants received a fee.

Results

In total, 18 HCPs and 6 P&T committee members were interviewed (Fig. 1). Data showed that the disease burden was dependent on the site/severity of bleed and type of anticoagulation reversal agent; gastrointestinal and intracranial bleeds were most common. The cost of treatment was considered higher in patients with intracranial bleeds versus other bleeds. The efficacy, safety and availability in the hospital formulary were key in driving the choice of reversal agent (Fig. 2). The need to add an indication specific to DOAC reversal to the 4F-PCC label was rated between 5 and 7 by 50% (9/18) of HCPs (1=least important; 7=most important). HCPs agreed there is a need for a regulatory-approved reversal agent with improved efficacy and thromboembolic safety, reduced reconstitution time, a DOAC-level detection assay to guide treatment decisions, and availability of a universal reversal agent.

Conclusions

There is an unmet need for an effective, feasible and universal regulatory-approved agent for rapid anticoagulation reversal.

References

Cuker A et al. Am J Hematol 2019;94:697–709.

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Conflicts of interest

CA and DR are employees of Takeda Development Center Americas, Inc., as well as a stockholder of Takeda Pharmaceutical Company Limited.

HA is an employee of Massachusetts General Hospital and Takeda Development Center Americas, Inc., as well as a stockholder of Takeda Pharmaceutical Company Limited.

MKK is an employee of Takeda Pharmaceuticals International AG and a stockholder of Takeda Pharmaceutical Company Limited.

This study was funded by Takeda Pharmaceuticals USA, Inc. Medical writing support was provided by Jessica Boles, PhD, of PharmaGenesis London, London, UK, and funded by Takeda Pharmaceuticals International AG.