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. 2023 May 26;60(8):1119–1151. doi: 10.1007/s00592-023-02107-x

Problem

Is the problem a priority?

Judgment Research evidence Additional considerations
Yes

Hypoglycemia has a major impact on quality of life of insulin-treated patients32, and it represents a major obstacle for attaining desired glycemic goals

Available data suggest that different long-acting insulin formulations are associated with different risk of hypoglycemia in type 2 diabetes33, 34

Desirable Effects

How substantial are the desirable anticipated effects?

Judgment Research evidence Additional considerations
Large

Effects of long-acting basal insulin analogues with longer vs shorter duration

Total hypoglycemia: -32%

Nocturnal hypoglycemia: -31%

No significant effect on severe hypoglycemia

Undesirable Effects

How substantial are the undesirable anticipated effects?

Judgment Research evidence Additional considerations
Trivial No relevant increase of any adverse event reported in clinical trials for the intervention vs comparator

Certainty of evidence

What is the overall certainty of the evidence of effects?

Judgment Research evidence Additional considerations
Low Low for total hypoglycemia; moderate for the other critical outcomes

Values

Is there important uncertainty about or variability in how much people value the main outcomes?

Judgment Research evidence Additional considerations
No important uncertainty or variability No expected uncertainty or variability

Balance of effects

Does the balance between desirable and undesirable effects favor the intervention or the comparison?

Judgment Research evidence Additional considerations
Favors the intervention The balance of effects of using the intervention instead of comparison is favorable for the reduction of total and nocturnal hypoglycemia

Resources required

How large are the resource requirements (costs)?

Judgment Research evidence Additional considerations
Varies Relevant direct costs35 The introduction of biosimilars reduced the average cost of out-of-patent long-acting insulin analogues

Certainty of evidence of required resources

What is the certainty of the evidence of resource requirements (costs)?

Judgment Research evidence Additional considerations
High Several good-quality studies explored this issue

Cost-effectiveness

Does the cost-effectiveness of the intervention favor the intervention or the comparison?

Judgment Research evidence Additional considerations
Probably favors the intervention Pharmaeconomic studies showed that direct costs of drugs is generally increased with newer formulations although the cost-effectiveness ratio generally suggests good value for money because of the implication in terms of both QALY and the effects on the risk of events, weight gain etc.; the availability of biosimilars contains the cost of out-of-patent insulin analogues The introduction of biosimilars reduced the average cost of out-of-patent long-acting insulin analogues, thus modifying the evaluation on cost-effectiveness ratio

Equity

What would be the impact on health equity?

Judgment Research evidence Additional considerations
Probably no impact No impact expected (long-acting analogues with longer duration are already the standard of care)

Acceptability

Is the intervention acceptable to key stakeholders?

Judgment Research evidence Additional considerations
Probably yes Long-acting analogues with longer duration are already the standard of care

Feasibility

Is the intervention feasible to implement?

Judgment Research evidence Additional considerations
Yes Long-acting analogues with longer duration are already the standard of care