TRULICITY (dulaglutide)

Key points

Favourable opinion for reimbursement only in the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise in addition to other medicinal products for the treatment of diabetes, including insulin, only: 

• as dual therapy with metformin,
• as triple therapy with metformin and insulin or with metformin and a sulfonylurea.

 Unfavourable opinion for reimbursement as monotherapy and as dual therapy with insulin.

What therapeutic improvement?

Therapeutic improvement with TRULICITY 0.75 mg and 1.5 mg (dulaglutide) in the same way as liraglutide (VICTOZA), in the treatment of adults with type 2 diabetes mellitus to improve glycaemic control, in addition to other medicinal products for the treatment of diabetes, including insulin, when the current treatment, combined with diet and exercise, does not provide adequate glycaemic control, only:

• as dual therapy with metformin,
• as triple therapy with metformin and insulin or with metformin and a sulfonylurea.

No clinical added value of TRULICITY 3 mg and 4.5 mg (dulaglutide) compared with the existing forms.

Role in the care pathway?

The objective of treatment of type 2 diabetes is to prevent the numerous serious and disabling complications, such as microangiopathy (affecting the retina, nerves, heart and kidneys) and sudden complications of macroangiopathy, such as myocardial infarction, stroke, etc. Diabetes promotes the development of heart failure. The Committee also highlights the importance of ensuring patients are well informed and the importance of their compliance with treatment for successful management of the disease. The initial management of type 2 diabetes is based on non-medicinal interventions and, in particular, the implementation of lifestyle and dietary measures. In the event of failure to meet the blood glucose target, medicinal treatment with metformin or, in the event of contraindications, a sulfonylurea is recommended as first-line therapy, in addition to these measures. Drug combinations are envisaged following the failure of monotherapy.

Role of the medicinal product in the care pathway

Following the failure of monotherapy with metformin or a sulfonylurea, a new treatment line with an antidiabetic drug from a different therapeutic class will be added to the first-line treatment.  The choice between the different drug families that can be used as second or third-line treatment (gliflozins, gliptins, alphaglucosidase inhibitors, GLP1 analogues and insulins) will notably be determined on the basis of the safety profile of the medicinal products, the availability of conclusive cardiovascular or renal morbidity and mortality study results and the preferences of patients after they have been given appropriate information.

If the decision is to prescribe a GLP-1 analogue, given the results observed in terms of reduction of the 3P-MACE endpoint with dulaglutide at a dosage of 1.5 mg/week compared to placebo in the REWIND study, TRULICITY (dulaglutide) may be chosen as first-line treatment, in the same way as liraglutide (VICTOZA), for which the results in the LEADER study provide a similar demonstration in terms of reduction of the 3P-MACE endpoint.

In the absence of usable clinical data concerning monotherapy and the combination of dulaglutide with basal insulin alone, TRULICITY (dulaglutide) has no role in the therapeutic strategy for type 2 diabetes as monotherapy and as dual therapy with basal insulin.