EFFECTIVE SHARE CARE AGREEMENT. FOR THE off license use of GLP1 mimetics in combination with insulin IN DUDLEY

Transcription

1 Specialist details Patient identifier Name Tel: EFFECTIVE SHARE CARE AGREEMENT FOR THE off license use of GLP1 mimetics in combination with insulin IN DUDLEY The aim of Effective Shared Care Guidelines (ESCA) is to provide information to General Practitioners (GP s) about complex or high cost therapies that their patients may receive following specialist referral. Guidelines will only be written when it has been agreed that shared care is an appropriate option and will include a statement of Specialist and GP responsibilities. Shared Care Guidelines will ensure that all GP s have sufficient information to enable them to undertake prescribing responsibility for specialist therapies and other therapies which may affect/interact with specialist therapies. This guidance is not intended to be prescriptive and may be amended according to the individual clinicians view and patient circumstances. It is not the intention to insist that GP s prescribe this therapy and any doctor who does not wish to undertake the clinical and legal responsibility is not so obliged. If the GP decides not to agree on the shared care the GP is advised to inform the specialist in writing.

2 The off license use of GLP-1 mimetics (Exenatide weekly & Liraglutide) in combination with Insulin ESCA: For the treatment of type 2 diabetes AREAS OF RESPONSIBILITY FOR THE SHARING OF CARE This shared care agreement outlines suggested ways in which the responsibilities for managing the offlicense prescribing of the GLP-1 mimetics in combination with insulin for the treatment of type 2 diabetes mellitus can be shared between the Specialist (Consultant Endocrinologist & Clinicians (including Diabetes Specialist Nurses) operating at level 3 of the Diabetes LES) and general practitioner (GP).* GPs are invited to participate. If the GP is not confident to undertake these roles, then he or she is under no obligation to do so. In such an event, the total clinical responsibility for the patient for the diagnosed condition remains with the Specialist. If the specialist asks the GP to prescribe this drug, if the GP does not wish to take part in the ESCA, then they should reply to this request as soon as practicable. Sharing of care assumes communication between the Specialist, GP and patient. The intention to share care is usually explained to the patient by the clinician initiating treatment. It is important that patients are consulted about treatment and are in agreement with it. Patients on a GLP-1 mimetic should be under regular follow-up, which provides opportunities to discuss drug therapy. The clinician who prescribes the medication legally assumes clinical responsibility for the drug and the consequences of its use. RESPONSIBILITIES and ROLES Specialist (Consultant Endocrinologist & Clinicians (including Diabetes Specialist Nurses) operating at level 3 of the Diabetes LES) responsibilities 1 Initiate exenatide weekly or liraglutide as per NICE guidance and titrate dose to achieve optimal clinical outcome. (Exenatide weekly (Bydureon) is approved for use in Dudley for patients who experience side effects with exenatide twice daily or those who would benefit from weekly injections from a compliance/ concordance perspective. It is to be prescribed by diabetes specialists or those practices working at Tier 3 of the LES only. When Exenatide weekly or Liraglutide are prescribed in combination with insulin (off license indication) - it is to be Specialist (consultant endocrinologist or clinicians operating at level 3 of the Diabetes LES) initiation only and continued prescribing to be under their supervision, and in line with this ESCA. 2 Adjust the dose of insulin and other antidiabetes treatments as necessary to achieve optimal control and minimise risks of hypoglycaemia 3 Discuss the benefits and side effects of using this treatment combination with the patient. 4 Ask the GP whether he or she is willing to participate in shared care (ensuring it is clear the request is for the unlicensed use of this combination of drugs), it is the responsibility of the clinician initiating the treatment combination to explain this to the patient 5 Regular follow-up of patient and at least at 6 months to ensure a beneficial metabolic response has been shown (defined as a reduction of at least 1% in Hba1c and a weight loss of at least 3% of initial body weight at 6 months. 6 Communicate promptly with the GP when treatment is changed. 7 Have a mechanism in place to receive rapid referral of a patient from the GP in the event of deteriorating clinical condition. 8 Advise GP on dosage adjustment and when and how to stop treatment. 9 Report adverse events to the CSM. 10 Ensure that clear backup arrangements exist for GPs to obtain advice and support. 11 Where a beneficial response to treatment has not been achieved, the specialist needs to ensure that treatment is stopped and that the patient is reviewed General Practitioner responsibilities 1 Reply to the request for shared care as soon as practicable. 2 Prescribe exenatide weekly or liraglutide and insulin in combination at the dose recommended. 3 Adjust the dose as advised by the Specialist (Consultant Endocrinologist or clinician operating at level 3 of the diabetes LES) 4 Monitor patient as advised by the Specialist (Consultant Endocrinologist or clinician operating at level 3 of the diabetes LES 5 Report to and seek advice from the Specialist (Consultant Endocrinologist or clinician operating at level 3 of the diabetes LES) on any aspect of patient care that is of concern and may affect treatment. 6 Refer patient to the Specialist (Consultant Endocrinologist or clinician operating at level 3 of the diabetes LES)

3 if his or her condition deteriorates i.e. HBA1c increases or clinical condition changes. 7 Stop treatment on the advice of the Specialist (Consultant Endocrinologist or clinician operating at level 3 of the diabetes LES) or immediately if an urgent need to stop treatment arises. 8 Report adverse events to the specialist and CSM. Patient's role (or that of carer) 1 Report to the Specialist (Consultant Endocrinologist or clinician operating at level 3 of the diabetes LES) or GP if he or she does not have a clear understanding of the treatment. 2 Share any concerns in relation to the combined use of these treatments 3 Report any adverse effects to the Specialist (Consultant Endocrinologist or clinician operating at level 3 of the diabetes LES) or GP whilst taking the exenatide weekly or liraglutide in combination with insulin. BACK-UP ADVICE AND SUPPORT Contact details Telephone No. Bleep: Fax: address: Consultant Endocrinologist: GP: Other: * Or any primary care prescriber Name of GLP1 initiated Dose and frequency of administration Changes made to original insulin dose Date of next review/ follow up by specialist SUPPORTING INFORMATION (see SPC for Exenatide and Liraglutide for complete details available at : Exenatide once-weekly (Bydureon ) Licensed indications Exenatide is indicated for the treatment of type 2 diabetes mellitus in combination with: metformin, sulphonylureas, thiazolidinediones, metformin and a sulphonylurea, metformin and a thiazolidinedione; in patients who have not achieved adequate glycaemic control on maximally tolerated doses of these oral therapies. Bydureon is not licensed for use in combination with insulin Therapeutic Use The current guidance from NICE on Type 2 Diabetes: newer agents (partial update of CG 66). NICE Clinical Guideline 87 (2009). Monitoring The use of BYDUREON does not require additional self-monitoring. However, when initiating treatment with exenatide in combination with a sulphonylurea, blood glucose self-monitoring may become necessary to adjust the dose of the sulphonylurea. Patients switching from exenatide twice daily (BYETTA) to BYDUREON may experience transient elevations in blood glucose concentrations, which generally improve within the first two weeks after initiation of therapy. People who do not achieve the desired reduction in HbA1c and weight at 6 months in accordance with NICE guidelines should have their treatment reviewed and stopped. Dosage and Administration The recommended dose is 2 mg exenatide once weekly. BYDUREON should be administered once a week on the same day each week. The day of weekly administration can be changed if necessary as long as the next dose is administered at least one day (24 hours) later. BYDUREON can be administered at any time of day, with or without meals.

4 Adverse Effects GI disturbances (including Nausea, vomiting, diarrhoea), pancreatitis, hypoglycaemia (when used in combination with other oral hypoglycaemic agents), weight loss Contraindications Exenatide is not recommended in those with an egfr < 30ml/min. Pregnancy and breast feeding Cautions for use Pancreatitis Renal Failure Drug Interactions The effect of exenatide to slow gastric emptying may reduce the extent and rate of absorption of orally administered medicinal products. exenatide should be used with caution in patients receiving oral medicinal products that require rapid gastrointestinal absorption and medicinal products with a narrow therapeutic ratio. For oral medicinal products that are particularly dependent on threshold concentrations for efficacy, such as antibiotics, patients should be advised to take those medicinal products at least 1 hour before exenatide injection. Gastro-resistant formulations containing substances sensitive for degradation in the stomach, such as proton pump inhibitors, should be taken at least 1 hour before or more than 4 hours after exenatide injection

5 Liraglutide (Victoza ) Licensed indications Victoza is indicated for treatment of adults with type 2 diabetes mellitus to achieve glycaemic control in combination with: Metformin or a sulphonylurea, in patients with insufficient glycaemic control despite maximal tolerated dose of monotherapy with metformin or sulphonylurea. In combination with: Metformin and a sulphonylurea or metformin and a thiazolidinedione in patients with insufficient glycaemic control despite dual therapy. Liraglutide is not licensed for use in combination with insulin Therapeutic Use The current guidance from NICE on Type 2 Diabetes: newer agents (partial update of CG 66). NICE Clinical Guideline 87 (2009) and NICE Technology Appraisal Guidance 203: Liraglutide for the treatment of Type 2 diabetes (2010) Monitoring Self-monitoring of blood glucose is not needed in order to adjust the dose of liraglutide. However, when initiating treatment with liraglutide in combination with a sulphonylurea, blood glucose self-monitoring may become necessary to adjust the dose of the sulphonylurea People who do not achieve the desired reduction in HbA1c or weight at 6 months in accordance with NICE guidelines should have their treatment reviewed and stopped.. Dosage and Administration 6 mg/ml solution for injection in pre-filled pen. One pre-filled pen contains 18 mg liraglutide in 3 ml. To improve gastro-intestinal tolerability, the starting dose is 0.6 mg liraglutide daily. After at least one week, the dose should be increased to 1.2 mg. Liraglutide 1.8mg is not recommended for the treatment of people with Type 2 Diabetes Adverse Effects GI disturbances (including Nausea, vomiting, diarrhoea), pancreatitis, hypoglycaemia (when used in combination with other oral hypoglycaemic agents), weight loss Contraindications Exenatide is not recommended in those with an egfr < 30ml/min. Pregnancy and breast feeding Cautions for use Pancreatitis Renal Failure Heart Failure Drug Interactions The effect of liraglutide to slow gastric emptying may reduce the extent and rate of absorption of orally administered medicinal products. liraglutide should be used with caution in patients receiving oral medicinal products that require rapid gastrointestinal absorption and medicinal products with a narrow therapeutic ratio. For oral medicinal products that are particularly dependent on threshold concentrations for efficacy, such as antibiotics, patients should be advised to take those medicinal products at least 1 hour before liraglutide injection. Gastro-resistant formulations containing substances sensitive for degradation in the stomach, such as proton pump inhibitors, should be taken at least 1 hour before or more than 4 hours after liraglutide injection