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.

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 euro values and applied as appropriate for each country's reimbursement policy. Cohort characteristics and assumed Hb(A1c) 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 euro. 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 euros, 6282 euros, and 7958 euros (respectively) in France; and 12,694 euros, 11,934 euros, and 15,368 euros in Italy. ICERs for SMBG once or twice per day were <2000 euros in Germany and <4000 euros in Spain. ICERs for SMBG three times per day were <6000 euros/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 euros/QALY in all countries but Italy (ICER = 77,064 euros). Five-year ICERs for SMBG twice per day were below 40,000 euros/QALY for all four countries, and those for SMBG three times per day were below 45,000 euros/QALY. With the SMBG dis-utility, ICERs increased modestly (321 euros- 2264 euros/QALY) in all scenarios except SMBG once per day in France (9578 euros increase) and Italy (5979 euros 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.