Cost-effectiveness of the Treatment of Attention Deficit/Hyperactivity Disorder With Methylphenidate Immediate-release in Brazil
Condition: Attention Deficit/Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Observational

Summary: 
      The first objective is to measure the QALYs (Quality Adjusted Life Years) of Brazilian
      children and adolescents, submitted to methylphenidate immediate-release treatment for
      Attention Deficit Hyperactivity Disorder (ADHD). For this, the Health Utility Index scale
      (HUI) will be completed by the patient and/or family, in two moments of an observation study
      with immediate-release methylphenidate: at the baseline and 6th month of treatment in the
      follow-up. The results provides information to calculate the utility measure and determine
      the QALYs (Quality Adjusted Life Years). After this, for the cost-effectiveness of the
      treatment, it will be used a Markov model of decision analysis, and a Monte Carlo simulation
      with 10,000 random trials.

      Subjects will be submitted to immediate-release methylphenidate treatment in a maximum dose
      of 0.5mg/kg/day. The total treatment monitoring is 06 (six) months, and patients will be
      evaluated at baseline, first, third and sixth month. The HUI rating scales are fulfilled by
      parents and patients (if >12 years old only) at baseline and 6th month. The period for
      inclusion of new patients comprises from 01/01/2011 to 31/12/2013.
    

Detailed description: 
      Currently, Brazil has no estimates for quality of life, and/or utilities for ADHD economy
      analysis. Such data is necessary to calculate the QALYs (Quality Adjusted Life Years). Thus,
      the investigators will implement the Health Utility Index tool (HUI) to be completed by the
      patient and/or family, in two moments of an observational study with immediate-release
      methylphenidate: at baseline and 6th month of treatment. The determination of the QALY as an
      outcome in the decision analysis is justified because HUI incorporates into a single measure
      morbidity and mortality. The results of the cost-effectiveness study will assist government
      agencies in the process of decision making.

      To determine the cost-effectiveness of methylphenidate immediate release available in the
      Brazilian market, the investigators will use a Markov model of decision analysis. The
      development of the model and analysis of the results will adopt the standards established in
      the Methodological Guidelines of the Brazilian Ministry of Health, and the perspective will
      be of the Brazilian National Health System. Medications prices will be obtained through the
      Board of Market Regulation of Medicines (CMED) at the site of ANVISA (National Health
      Surveillance Agency). For the treatment strategy that provides greatest cost ratio it will be
      calculated the incremental cost-effectiveness, compared to the lower cost. To estimate more
      accurately the impact on life, a Monte Carlo simulation with 10,000 random trials will be
      conducted.

      This is a one treatment group and observational study, with 140 patients, and no controls.
      Where indicated, it will be suggested the use of 10 mg methylphenidate in a maximum dose of
      0.5 mg / kg / day. The total treatment monitoring is 06 (six) months, and patients will be
      evaluated at baseline, first, third and sixth month. The HUI rating scales will be fulfilled
      by parents and patients (if >12 years old only) at baseline and 6th month. The period for
      inclusion of new patients comprises from 01/01/2011 to 31/12/2013.
    

Observational model: Ecologic or Community
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children and adolescents with indication of Attention Deficit/Hyperactivity Disorder
        treatment
      
Keywords: Attention Deficit/Hyperactivity Disorder; ADHD; Methylphenidate Immediate-release; Cost-effectiveness; Cost-utility; QALYs