Accessibility to New Drugs Versus SOC in Sweden

NCT03684395 | Completed

• 1 other identifier: 18984
• Study Type: observational
• Target: 68,056
• Locations: 1 country
• Sites: 1

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.

Conditions

Anticoagulation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (2)

DOACs (Direct Oral Anticoagulants)

Drug: DOACs: Rivaroxaban, Dabigatran, Apixaban

Standard of care

Drug: Standard of care (Warfarin)

Interventions

DOACs: Rivaroxaban, Dabigatran, Apixaban DRUG

Routinely collected clinical data (secondary data from patients with non-valvular atrial fibrillation in Sweden); no primary data collection

DOACs (Direct Oral Anticoagulants)

Standard of care (Warfarin) DRUG

Routinely collected clinical data (secondary data from patients with non-valvular atrial fibrillation in Sweden); no primary data collection

Standard of care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Unknown Facility

Stockholm, Sweden

Location

MeSH Terms

Interventions

Dabigatran; apixaban; Standard of Care; Warfarin

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; 4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2018
• First Posted: September 25, 2018
• Study Start: June 15, 2016
• Primary Completion: June 30, 2017
• Study Completion: June 30, 2017
• Last Updated: March 29, 2019

Record last verified: 2019-03

Locations

SE (1)