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 |
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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 |
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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 |