Accessibility to New Drugs Versus SOC in Sweden

Completed

• Conditions: Anticoagulation
• Interventions: Drug: Standard of care (Warfarin)

• Registration Number: NCT03684395
• Lead Sponsor: Bayer

Brief Summary

The healthcare system in Sweden is publicly funded and aims to provide equal access to care irrespective of socioeconomic status. This includes ensuring equity in drug treatment. Socioeconomic disparities have been shown to influence patient management and health outcomes in certain Swedish populations. The Swedish Board of Health and Welfare has stated that the prescription of new drugs, which are more expensive than generic standard of care drugs, might be influenced by patients' socioeconomic status.

To evaluate the association between socioeconomic factors and use of a DOAC (rivaroxaban, dabigatran, or apixaban) or standard of care (warfarin) in patients with NVAF in Sweden.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2016-06-15
• Primary Completion: 2017-06-30
• Study Completion: 2017-06-30
• Study First Submitted: 2018-09-14
• Study First Submitted QC: 2018-09-24
• Study First Posted: 2018-09-25
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-28
• Last Update Posted: 2019-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68056

Inclusion Criteria

• Patients aged ≥18 years in Sweden with a diagnosis of NVAF (identified using International Classification of Diseases, version 10 [ICD-10]) codes in the National Patient Register) between 1 December 2011 and 31 December 2014 and with a first dispensed prescription for either a DOAC or warfarin following their NVAF diagnosis.

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Exclusion Criteria

• Patients with a dispensed prescription for a DOAC or warfarin prior to the index date (the date of first DOAC/warfarin purchase designated the index date)
• Patients with a dispensed prescription for more than one anticoagulant at index date.
• Patients with valvular atrial fibrillation

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Standard of care	Standard of care (Warfarin)	-

Primary Outcome Measures

Name	Time	Method
Correlation between socioeconomic factors and use of DOACs vs. Warfarin (as identified from the LISA database before the index date)	approximately 3 years	Between 1 December 2011 and 31 December 2014; Socioeconomic factors: * Occupation; * Education; * Income; * Family status; * Immigrant status

Secondary Outcome Measures

Name	Time	Method
Secular trends in the correlation between socioeconomic factors and use of DOACs (vs. warfarin) - Trends based on the date of prescription by year	approximately 3 years	Between 1 December 2011 and 31 December 2014; Relationship between socioeconomic factors and access to newly marketed drugs (DOACs as one class which includes Rivaroxaban, Dabigatran and Apixaban) versus standard of care (warfarin) for different calender period.