Short-acting Insulin Analogues for Diabetes Mellitus: Meta-analysis of Clinical Outcomes and Assessment of Cost-effectiveness

See also CADTH's COMPUS report: Rapid-Acting Insulin Analogues for the Treatment of Diabetes Mellitus: Meta-analyses of Clinical Outcomes.

Technology and Condition Short-acting insulin analogues (SAIAs) for the treatment of type 1, type 2, and gestational diabetes mellitus (DM), including insulin lispro (ILis), insulin aspart (IAsp) and insulin glulisine (IGlu).

Issue
Over 2.25 million Canadians have DM. The annual cost of treating DM and its complications is more than $9 billion. The successful management of diabetes often requires medications. SAIAs, which were developed to more closely mimic the natural pattern of endogenous insulin in non-diabetic individuals, cost more than human insulin (HI). There is uncertainty about whether the use of SAIAs is justified.

Methods and Results
A systematic review and a meta-analysis were undertaken to evaluate the clinical and economic implications of using SAIAs for the treatment of DM, relative to HI and to oral anti-diabetic agents (OADs). A total of 86 randomized controlled trials reporting clinical outcomes were included: 47 on type 1 DM, 26 on type 2 DM, 10 on types 1 and 2 DM (combined), and three on gestational DM. A review of economic studies and a budget impact analysis were performed.

Implications for Decision Making

  • For type 1 DM, treatment with ILis or IAsp significantly reduced HbA1c levels, compared to HI. The episodes of overall and severe hypoglycemia were similar, but nocturnal hypoglycemia was less frequent with ILis than with HI.
  • For type 2 DM, treatment with SAIAs did not demonstrate differences in HbA1c levels, compared to HI. SAIAs did not result in significant reductions in hypoglycemic episodes. When compared with OADs, improvements in HbA1c were seen with ILis and IAsp.
  • Publicly funding SAIAs would increase drug budgets. For example, funding SAIAs in Ontario would be expected to cost an additional $116 and $240 yearly per patient switched. There is some evidence suggesting that these costs will be offset by other health care costs in the first 12 months.
  • Uncertainty remains regarding long-term impact and use in gestational DM. No differences in patient mortality or quality of life have been demonstrated in patients with DM. The impact on health care costs beyond 12 months is unknown. Patients with gestational DM did not experience significant differences in overall hypoglycaemia rates with ILis, compared to HI, although post-meal glucose levels were improved.

 

This summary is based on a comprehensive health technology assessment available from CADTH’s web site (www.cadth.ca): Banerjee S, Tran K, Li H, Cimon K, Daneman D, Simpson S, Campbell K, Short-acting insulin analogues for diabetes mellitus: meta-analysis of clinical outcomes and assessment of cost-effectiveness [Technology Report no 87]. Ottawa: Canadian Agency for Drugs and Technologies in Health; 2007.