ABHB CEPP 2013/14 GLP-1 agonists for the treatment of type 2 diabetes Clinical audit tool

Transcription

1 ABHB CEPP 2013/14 GLP-1 agonists for the treatment of type 2 diabetes Clinical audit tool This document can be used as a local clinical audit project that aims to ensure that treatment with glucagon-like peptide-1 (GLP-1) agonists is started and continued in accordance with NICE guidance. It contains: clinical audit standards a data collection form an action plan template. The audit sample should include people prescribed the GLP-1 agonists exenatide, liraglutide or prolonged-release exenatide for the treatment of type 2 diabetes. The audit standards are based on NICE clinical guideline 87, and NICE technology appraisal guidance 203 and 248. They include reference to the guidance, and any associated NICE quality standard statements and exceptions. Exceptions not explicitly referred to in the guidance can be added locally, for example, patients declining treatment. NICE recommends compliance of 100%. If this is not achievable an interim local target could be set, although 100% should remain the ultimate aim. A data collection form should be completed at each practice. Patient identifiable information should never be recorded. Following the audit the action plan template can be used to develop and implement an action plan to take forward any s made. Local Context. The graph below (Figure 1) indicates a large increase in the prescribing of these new agents in the treatment of type 2 diabetes. NICE guidelines have been produced to oversee the introduction of these drugs to this therapeutic area and these agents should be used in accordance with this NICE guidance (NICE guidance on Exenatide prolonged-release suspension for injection in combination with oral antidiabetic therapy for the treatment of type 2 diabetes, Liraglutide for the treatment of type 2 diabetes mellitus and Type 2 diabetes: the management of type 2 diabetes). Figure 1. Page 1 of 6

2 This illustrates that ABHB is on course to spend more than 1.4m on these two agents in , whilst these drugs have been assessed as being a treatment option in type 2 diabetes by NICE, it is important to audit their use in practice. This audit aims to assess: The specific patient types using these agents The monitoring that patients receive following initiation of the agent The extent of use of 1.8mg Liraglutide. It also aims to examine the level of follow up monitoring in assessing the agents effectiveness in the treatment of type 2 diabetes. The audit will be fed into the ABHB Medicines Management Programme Board and will be disseminated to all relevant stakeholders for comment and discussion. The following graph (Figure 2) shows that Liraglutide is the favoured agent within ABHB and the increasing trend for use Figure 2. Page 2 of 6

3 This is a high growth area in prescribing for ABHB and forms part of the diabetes medicines management workstream which sets out to optimise the use of all agents within the therapeutic area of type 2 diabetes. The tables that follow set out the standards for the use of the GLP-1 agonists that have been set out by NICE: Standards for GLP-1 agonists for the treatment of type 2 diabetes clinical audit Audit standards Guidance reference Exceptions Definitions Triple therapy regimens Exenatide, liraglutide 1.2 mg daily and prolonged-release exenatide in triple therapy regimens should only be started when control of blood glucose remains or becomes inadequate, and: the person has a body mass index (BMI) 35 kg/m² in those of European family origin (with appropriate adjustment for other ethnic groups) and specific psychological or medical problems associated with high body weight or a BMI < 35 kg/m², and therapy with insulin would have significant occupational implications or weight loss would benefit other significant obesity-related comorbidities. NICE clinical guideline 87 (CG87) , NICE technology appraisal guidance 203 (TA203) 1.1 and NICE technology appraisal guidance 248 (TA248) 1.1 A People receiving liraglutide 1.2 mg daily before publication of TA203 in October They should have the opportunity to continue their current treatment until they and their clinicians consider it appropriate to stop. Triple therapy regimens are a GLP-1 agonist in combination with metformin and a sulphonylurea, or metformin and a thiazolidinedione. Sulfonylureas listed in the British national formulary (BNF) (edition 62) are glibenclamide, gliclazide, glimepiride, glipizide and tolbutamide. Pioglitazone is listed as a thiazolidinedione in the BNF (edition 62). Control of blood glucose is inadequate if HbA 1c 7.5% [59 mmol/mol] or other higher level agreed with the individual. Page 3 of 6

4 Audit standards Guidance reference Exceptions Definitions Treatment with exenatide, liraglutide 1.2 mg daily and prolonged-release exenatide in triple therapy regimens should only be continued if a beneficial metabolic response has been shown. See data collection form, question 1, 2, 3 and 5. CG , TA and TA None A beneficial metabolic response is a reduction of at least 1 percentage point in HbA 1c [11 mmol/mol] and a weight loss of at least 3% of initial body weight at 6 months. Dual therapy regimens Liraglutide 1.2 mg daily and prolonged-release exenatide in dual therapy regimens should only be started if: the person is intolerant of either metformin or a sulphonylurea, or treatment with metformin or a sulphonylurea is contraindicated and the person is intolerant of thiazolidinediones and dipeptidyl peptidase-4 (DPP-4) inhibitors, or treatment with thiazolidinediones and DPP-4 inhibitors is contraindicated. TA and TA A People receiving liraglutide 1.2 mg daily before publication of TA203 in October They should have the opportunity to continue their current treatment until they and their clinicians consider it appropriate to stop. Dual therapy regimens are a GLP-1 agonist in combination with metformin or a sulphonylurea. Sitagliptin and vildagliptin are listed as DPP-4 inhibitors used in combination with metformin in the BNF (edition 62). NICE clinical guideline 87 does not address the role of exenatide in dual therapy regimens. Treatment with liraglutide 1.2 mg daily and prolonged-release exenatide in dual therapy regimens should only be continued if a beneficial metabolic response has been shown. TA and TA None A beneficial metabolic response is a reduction of at least 1 percentage point in HbA 1c [11 mmol/mol] at 6 months. Liraglutide 1.8 mg daily Liraglutide 1.8 mg daily should not be prescribed. TA B People receiving liraglutide 1.8 mg before publication of TA203 in October They should have the opportunity to continue their current treatment until they and their clinicians consider it appropriate to stop. NICE recommends liraglutide 1.2 mg daily in triple or dual therapy regimens. Page 4 of 6

5 Licensed indications for Current GLP-1 Agonists BNF65 March-September Exenatide. Exenatide is licensed in combination with metformin or a sulfonylurea, or both, or with pioglitazone, or with both metformin and pioglitazone, in patients who have not reached adequate glycaemic control with these drugs, alone or in combination; standard-release exenatide is also licensed in combination with basal insulin alone or with metformin or pioglitazone (or both). Liraglutide Liraglutide is licensed for the treatment of type 2 diabetes mellitus in combination with metformin or a sulfonylurea, or both, in patients who have not achieved adequate glycaemic control with these drugs alone or in combination. Liraglutide is also licensed for use in combination with both metformin and pioglitazone when dual therapy with these drugs fails to achieve adequate glycaemic control. Page 5 of 6

6 Appendix D: Audit Summary Sheet (Part 2) 1. Is there anything that the practice has identified that they can do to improve prescribing in this area? (Please specify below) 2. How will this information be discussed with all relevant members of the practice team and any relevant changes to practice taken forward? (Please specify below) Practice: Date: Signed: Designation: When making improvements to practice, organisations may like to use the tools developed by NICE to help implement the NICE guidance on Exenatide prolonged-release suspension for injection in combination with oral antidiabetic therapy for the treatment of type 2 diabetes, Liraglutide for the treatment of type 2 diabetes mellitus and Type 2 diabetes: the management of type 2 diabetes. Page 6 of 6