Self-monitoring of blood glucose (SMBG) in patients with type 2 diabetes on oral anti-diabetes drugs: cost-effectiveness in France, Germany, Italy, and Spain

Abstract

Objective:Stakeholders in Europe remain interested in assessments of country-specific value of self-monitoring of blood glucose (SMBG) for patients with type 2 diabetes treated with oral anti-diabetes drugs (OADs). This study used the IMS-CORE Diabetes Model to project the long-term (40-year) cost-effectiveness of SMBG at once, twice, or three times per day (vs. no SMBG) for this population from national reimbursement system perspectives in France, Germany, Italy, and Spain.Methods:SMBG input costs (strips, lancets, meters, nurse training) were supplied by LifeScan in €2007 values and applied as appropriate for each country's reimbursement policy. Cohort characteristics and assumed HbA1c effects came from a US Kaiser Permanente longitudinal analysis of new SMBG users. Country-specific estimations for use of screening programs and several concomitant medications, as well as mortality rates were used. Country-specific complication costs from published sources were inflated to €2007. Base case outcomes were discounted at 3% per annum for France, Germany, and Italy; 6% for Spain. Sensitivity analyses varied time horizon and discount rates for each country. They also included a −0.036 dis-utility for SMBG in year 1.Main outcome measures:Primary outcomes included total direct costs, gains in quality-adjusted life years (QALYs), and incremental cost-effectiveness ratios (ICERs) over 40 years.Results:ICERs were largest in France (with meter costs included), and in Italy (with highest reimbursed costs for strips/lancets). ICERs for SMBG once, twice, and three times per day were €12 114, €6282, and €7958 (respectively) in France; and €12 694, €11 934, and €15 368 in Italy. ICERs for SMBG once or twice per day were <€2000 in Germany and <€4000 in Spain. ICERs for SMBG three times per day were <€6000/QALY in both countries. Results were most sensitive to the 5-year time horizon, although ICERs for SMBG once per day were below €50 000/QALY in all countries but Italy (ICER = €77 064). Five-year ICERs for SMBG twice per day were below €40 000/QALY for all four countries, and those for SMBG three times per day were below €45 000/QALY. With the SMBG dis-utility, ICERs increased modestly (€321– €2264/QALY) in all scenarios except SMBG once per day in France (€9578 increase) and Italy (€5979 increase). Study limitations include the use of relatively short-term data from a single US observational study for SMBG clinical effects, unknown levels of patient adherence, and assumptions regarding the duration of clinical effects.Conclusions:With cost assumptions reflecting current reimbursement levels in France, Germany, Italy, and Spain, SMBG was found to be cost-effective across a 40-year time horizon, with all base case ICERs <16 000/QALY. This study adds to the literature on the country-specific, long-term value of SMBG for type 2 diabetes patients treated with OADs. Under current model assumptions, variations in cost-effectiveness results stemmed primarily from payer reimbursement practices for SMBG within each country.