Accessibility to New Drugs Versus SOC in Sweden

Study Overview
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Brief Summary
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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.

Official Title
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Association Between Socioeconomic Factors and Use of Direct Oral Anticoagulants Versus Standard of Care (Warfarin) in Patients With Non-valvular Atrial Fibrillation in Sweden

Conditions
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Anticoagulation

Intervention / Treatment
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* Drug: DOACs: Rivaroxaban, Dabigatran, Apixaban
* Drug: Standard of care (Warfarin)


Participation Criteria
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Eligibility Criteria
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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. 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| DOACs (Direct Oral Anticoagulants)<br> | Drug: DOACs: Rivaroxaban, Dabigatran, Apixaban<br>* Routinely collected clinical data (secondary data from patients with non-valvular atrial fibrillation in Sweden); no primary data collection<br>|
| Standard of care<br> | Drug: Standard of care (Warfarin)<br>* Routinely collected clinical data (secondary data from patients with non-valvular atrial fibrillation in Sweden); no primary data collection<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secular trends in the correlation between socioeconomic factors and use of DOACs (vs. warfarin) - Trends based on the date of prescription by year | 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. | approximately 3 years |