Economic Evaluation of Systemic Treatments for Moderate-to-severe Psoriasis

Sponsor

Jochen Schmitt. (Other)

Overall Status

Completed

CT.gov ID

NCT01812954

Collaborator

Merck Sharp & Dohme LLC (Industry)

Enrollment

Duration (Months)

Study Details

Study Description

Brief Summary

This study is health economic analysis of medicinal treatment options for moderate-to-severe psoriasis vulgaris from the societal perspective. Efficacy data and other clinical outcomes will be derived from an up-to-date meta-analysis of randomized clinical trials (RCTs) for moderate-to-severe psoriasis. Direct and indirect costs will be extracted from various different sources, including summary of product characteristics (SPCs) and the German S3 guideline on psoriasis care, health care utilization data and official statistics.

The study aims to investigate the comparative cost-effectiveness of biologic and conventional systemic treatments currently (as of June 1st, 2012) approved for moderate-to-severe plaque-type psoriasis in Germany. Effectiveness will be measured by means of the pooled (Psoriasis Area and Severity Index) PASI-75 response rates as reported in RCTs Direct cost as well as indirect cost will be considered.

Condition or Disease	Intervention/Treatment	Phase
Psoriasis	Drug: Methotrexate Drug: Cyclosporins Drug: fumaric acid Drug: Acitretin Drug: Infliximab Drug: etanercept Drug: Adalimumab Drug: Ustekinumab

Study Design

Study Type:

Observational

Actual Enrollment :

1 participants

Observational Model:

Other

Time Perspective:

Retrospective

Study Start Date :

Mar 1, 2013

Actual Primary Completion Date :

Jun 1, 2014

Actual Study Completion Date :

Jun 1, 2014

Outcome Measures

Primary Outcome Measures

Cost per quality-adjusted life year (QALY) gained through treatment with each individual agent compared to supportive care as well as compared to placebo [1 year]