Download NICE TA 315. Shared Care available

Reduced Shared Care Protocol –remains open to review in light of any new evidence
Amber with guidance (Amber-G) = To be initiated and titrated to a stable dose by a specialist prescriber with follow up
prescribing by primary care. Once medical condition and drug dosage is stable, there is no specific requirement for ongoing
monitoring.
Dapagliflozin (Forxiga®) / Dapagliflozin/Metformin (Xigduo®) /
Canagliflozin (Invokana®) / Canagliflozin/Metformin
(Vokanamet®)
Reduced Shared Care Guideline for Dapagliflozin (Forxiga®),
Dapagliflozin/Metformin (Xigduo®), Canagliflozin (Invokana®) and
Canagliflozin/Metformin (Vokanamet®)
Introduction
Indication/Licensing information



Dapagliflozin and Canagliflozin are licensed for use in type 2 diabetes as monotherapy (if metformin
not tolerated), or in combination with insulin or other antidiabetic drugs (if existing treatment fails to
achieve adequate glycaemic control). However, NICE guidance recommend these for the indications
listed below.
For patients established on dapagliflozin 5mg and metformin 850mg or 1000mg, a combination product
is available in two different strengths: dapagliflozin 5mg/metformin 850mg or dapagliflozin
5mg/metformin 1000mg (Xigduo®). This may be a more cost-effective option for those patients who
are already stabilised on the above doses of the individual drugs.
For patients established on canagliflozin 100mg daily and metformin 850mg twice daily or canagliflozin
100mg daily and metformin 1g twice daily, then a combination preparation is available in two different
strengths: canagliflozin 50mg/metformin 850mg and canagliflozin 50mg/metformin 1g
(Vokanamet®). This may be a more cost-effective option for those patients who are already stabilised
on the above doses of the individual drugs.
NICE Guidance
Dapagliflozin: TA2881 - NICE guidance states the following:
1. Dual therapy regimen in combination with metformin as an option for treating type 2 diabetes, only if it
is used as described for dipeptidyl peptidase-4 (DPP-4) inhibitors in Type 2 diabetes: the management
of type 2 diabetes (NICE clinical guideline 87). NICE Clinical Guideline 872 advises the following in
relation to the use of a DPP-4 inhibitor:
 Consider adding as a second-line therapy instead of a sulfonylurea to first-line metformin when
control of blood glucose remains or becomes inadequate:
o
if the person is at significant risk of hypoglycaemia or its consequences or,
o
the person does not tolerate a sulfonylurea or a sulfonylurea is contraindicated.
 Only continue if the person has had a beneficial metabolic response [reduction of at least 56mmols/mol in HbA1c in 6 months (0.5%)].
2. In combination with insulin with or without other anti-diabetic drugs for treating type 2 diabetes.
3. Triple therapy regimen in combination with metformin and a sulfonylurea is not recommended for
treating type 2 diabetes, except as part of a clinical trial.
4. Dapagliflozin should not be used in combination with GLP-1 receptor agonists or with pioglitazone.
5. People currently receiving dapagliflozin in a dual or triple therapy regimen that is not recommended for
them as above, should be able to continue treatment until they and their clinician consider it
appropriate to stop.
Page 1 of 6
Dapagliflozin/Canagliflozin Shared care Guideline
Date Prepared: September 2014
Review Date: September 2016
Reduced Shared Care Protocol –remains open to review in light of any new evidence
Amber with guidance (Amber-G) = To be initiated and titrated to a stable dose by a specialist prescriber with follow up
prescribing by primary care. Once medical condition and drug dosage is stable, there is no specific requirement for ongoing
monitoring.
Canagliflozin: TA3153 – NICE Guidance states the following:
1. Canagliflozin in a dual therapy regimen in combination with metformin is recommended as an option
for treating type 2 diabetes, only if:
 a sulfonylurea is contraindicated or not tolerated or
 the person is at significant risk of hypoglycaemia or its consequences.
2. Canagliflozin in a triple therapy regimen is recommended as an option for treating type 2 diabetes in
combination with:
 metformin and a sulfonylurea or
 metformin and a thiazolidinedione.
3. Canagliflozin in combination with insulin with or without other antidiabetic drugs is recommended as
an option for treating type 2 diabetes.
4. People currently receiving treatment initiated within the NHS with canagliflozin that is not
recommended for them by NICE in this guidance should be able to continue treatment until they and
their NHS clinician consider it appropriate to stop.
What does this mean in practice?
NICE do not specify place in therapy for these drugs other than as an option in patients uncontrolled on
metformin alone, where a sulfonylurea is not suitable. Other treatment options at this stage are
summarised:
 DPP-4 inhibitors (gliptins)
 Thiazolidinediones (pioglitazone) – The use of pioglitazone may be decreasing due to safety concerns
relating to a possible increased risk of bladder cancer. (Drug Safety Update. MHRA. August 2011
available at: http://www.mhra.gov.uk/Safetyinformation/DrugSafetyUpdate/CON125962
 Liraglutide or exenatide can be used as part of dual therapy in line with NICE guidance4.5 if:
 Treatment with metformin or a sulfonylurea is contraindicated or not tolerated and
 Treatment with a thiazolidinediones or a dipeptidylpeptidase-4 inhibitor is contraindicated or not
tolerated.
Responsibilities of the specialist* initiating treatment
*Specialist refers to either Consultant, Diabetes Specialist Nurse or a GP with specialist interest and training.
Summary
 To assess the suitability of the patient for treatment.
 To discuss the benefits and side effects of treatment with the patient/carer.
 To perform baseline tests (HbA1c, weight and renal function).
 To prescribe until the patient is stabilised. Review the patient approximately 4 weeks after starting therapy.
Continue prescribing and monitoring for a further 4 weeks. The GP can be asked to take on prescribing by
week 7/8, provided the patient is stable.
 Adjust dose of concomitant insulin or drugs that stimulate insulin secretion where applicable.
 To ask the GP whether they are willing to participate in shared care.
 To provide the GP with a summary of information relating to the individual patient to support the GP in
undertaking reduced shared care (See Appendix A). Provide the GP with a starting HbA1c, weight and
renal function.
 To advise the GP of any dosage adjustments required, when to refer back, when and how to stop treatment
(if appropriate) and when the patient will next be reviewed by the specialist.
 To monitor the patient for adverse events and report to the GP and where appropriate Commission on
Human Medicines/MHRA (Yellow card scheme).
 To provide the GP with contact details in case of queries.
Page 2 of 6
Dapagliflozin/Canagliflozin Shared care Guideline
Date Prepared: September 2014
Review Date: September 2016
Reduced Shared Care Protocol –remains open to review in light of any new evidence
Amber with guidance (Amber-G) = To be initiated and titrated to a stable dose by a specialist prescriber with follow up
prescribing by primary care. Once medical condition and drug dosage is stable, there is no specific requirement for ongoing
monitoring.
Baseline Tests
Baseline HbA1c, weight and renal function should be recorded prior to initiating either dapagliflozin or
canagliflozin.
Routine Tests (if applicable)
Monitor the patient’s response to the treatment by measuring HbA1c and weight at 3 months and 6 months and,
once stable, 6 monthly thereafter.
Daily blood glucose monitoring is not routinely required. However, blood glucose monitoring is necessary for
patients who are also taking a sulfonylurea or basal insulin where a dose adjustment of the sulfonylurea or
insulin may be necessary.
Renal function should be monitored annually, or more frequently in patients whose renal function is
approaching moderate impairment. Renal function should also be monitored prior to initiating concomitant
medication that may affect renal function and periodically thereafter.
Disease monitoring
The patient will be reviewed by the Specialist if the need arises.
Responsibilities of other prescribers
Acceptance of Responsibility by the Primary Care Clinician
It is optional for GPs to participate in taking on responsibility for shared care for the patient. GPs will take on
shared care only if they are willing and able.
Summary
 To reply to the request for shared care as soon as possible.
 To prescribe and adjust the dose as recommended by the specialist.
 To ensure there are no interactions with any other medications initiated in primary care.
 To monitor patient’s ongoing response to treatment, weight and HbA1c at 3 months, 6 months and 6
monthly thereafter.
 To review therapy or refer back to the specialist where appropriate. For example:
o Patient or general practitioner is not comfortable to continue with the existing regime due to either
change in condition or drug side effects
o Blood glucose levels become unstable
o Appropriate reduction (≥0.5%) in HbA1c and/or weight loss (eg ≥5% reduction at 6 months) are not
achieved
o The patient experiences any unmanageable side effects.
 Discontinue the drug as directed by the specialist if required.
 To identify adverse events if the patient presents with any signs and liaise with the hospital specialist
where necessary. To report adverse events to the specialist and where appropriate the Commission on
Human Medicines/MHRA (Yellow card scheme).
Page 3 of 6
Dapagliflozin/Canagliflozin Shared care Guideline
Date Prepared: September 2014
Review Date: September 2016
Reduced Shared Care Protocol –remains open to review in light of any new evidence
Amber with guidance (Amber-G) = To be initiated and titrated to a stable dose by a specialist prescriber with follow up
prescribing by primary care. Once medical condition and drug dosage is stable, there is no specific requirement for ongoing
monitoring.
Adverse drug reactions, precautions, contraindications and interactions
Please see the full Summary of Product Characteristics for more information. 6
http://www.medicines.org.uk/emc/
Dapagliflozin
Canagliflozin
Dosage and
administration


Adult over 18 years – 10mg od
Over 75 years – not recommended
Cautions

Dose of concomitant insulin or drugs that stimulate insulin secretion may need to
be reduced
Hepatic impairment: Initiate dapagliflozin at 5mg daily in severe impairment and
increase according to response. Canagliflozin is not recommended in severe
hepatic impairment
Dapagliflozin and canagliflozin can both cause increase diuresis associated with a
modest decrease in blood pressure. This may be more pronounced in patients
with very high blood glucose concentrations. Caution should be exercised in
patients for whom a dapagliflozin/canagliflozin-induced drop in blood pressure
could pose a risk, such as patients with known cardiovascular disease, patients on
anti-hypertensive therapy with a history of hypotension or elderly patients.
Dapagliflozin is not recommended for use in patients receiving loop diuretics or
who are volume depleted, e.g. due to acute illness such as GI illness. Elderly
patients are at a greater risk for volume depletion
Elderly patients are more likely to have impaired renal function, and/or to be
treated with anti-hypertensive medicinal products that may cause changes in renal
function such as angiotensin-converting enzyme inhibitors (ACE-I) and
angiotensin II type 1 receptor blockers (ARB).





Adult over 18 years of age – 100mg
od. Increased to 300mg od if needed.
Contraindications
Known hypersensitivity to active substance or to any excipients. Type 1 diabetes
mellitus, ketoacidosis, severe gastro-intestinal disease, pregnancy, breast-feeding,
children under 18 years, end-stage renal disease or moderate to severe renal
impairment (creatinine clearance <60 ml/min), severe hepatic dysfunction.
Adverse drug
reactions
The most common adverse drug reactions are:
 Hypoglycaemia
 Urogenital infection (UTIs, candidal infection) is increased in patients taking
dapagliflozin or canagliflozin, although this isn’t usually a reason to discontinue
treatment
 Adverse drug reactions related to volume depletion (dehydration, hypovolaemia,
hypotension) have been reported.
Interactions
Diuretics: Dapagliflozin or canagliflozin may add to the diuretic effect of thiazide and
loop diuretics and may increase the risk of dehydration and hypotension.
Insulin and insulin secretagogues: Insulin and insulin secretagogues, such as
sulfonylureas, cause hypoglycaemia. Therefore, a lower dose of insulin or an insulin
secretagogue may be required to reduce the risk of hypoglycaemia when used in
combination with dapagliflozin or canagliflozin.
Page 4 of 6
Dapagliflozin/Canagliflozin Shared care Guideline
Date Prepared: September 2014
Review Date: September 2016
Reduced Shared Care Protocol –remains open to review in light of any new evidence
Amber with guidance (Amber-G) = To be initiated and titrated to a stable dose by a specialist prescriber with follow up
prescribing by primary care. Once medical condition and drug dosage is stable, there is no specific requirement for ongoing
monitoring.
Communication
Specialist to GP
The specialist will inform the GP when they have initiated dapagliflozin or canagliflozin. When the patient is
near completing the satisfactory initiation period, the specialist will write to the GP to request they take over
prescribing and where possible give an indication as to the expected length of treatment. The Specialist will
also send a Shared care request form to support the GP in undertaking reduced shared care. (Appendix A)
GP to specialist
If the GP has concerns over the prescribing of dapagliflozin or canagliflozin, they will contact the specialist
as soon as possible.
Contact Name
Telephone number Email
Dr K Sands
Consultant Endocrinologist
01226 434050
[email protected]
Dr E Uchegbu
Consultant Diabetologist
01226 432598
[email protected]
Dr Z Merza
Consultant Endocrinologist and Diabetologist
01226 435366
[email protected]
Prof TH Jones
Consultant Endocrinologist and Diabetologist
01226 432147
[email protected]
Natasha Kelly
Diabetes Specialist Nurse
Community Diabetes Specialist Nurse Team
Apollo Court – Sue Jones
Gillian Smith
Medicines Information Pharmacist
[email protected]
01226 209884
[email protected]
01226 432857
[email protected]
References
1. NICE Technology Appraisal TA288: Dapagliflozin in combination therapy for treating type 2 diabetes.
June 2013. Available at: http://publications.nice.org.uk/dapagliflozin-in-combination-therapy-for-treatingtype-2-diabetes-ta288 Accessed <15.7.13>
2. NICE Clinical Guideline 87. Type 2 diabetes: The management of Type 2 diabetes. May 2009.
Available at: http://publications.nice.org.uk/type-2-diabetes-cg87/guidance#oral-glucose-controltherapies-2-other-oral-agents-and-exenatide Accessed <04.11.13>
3. NICE Technology Appraisal TA315: Canagliflozin in combination therapy for treating type 2 diabetes.
June 2014. Available at: http://www.nice.org.uk/guidance/TA315 Accessed <16.07.14>
4. Diabetes (type 2) – Liraglutide. NICE technology appraisal TA203. October 2010. Available at:
http://guidance.nice.org.uk/TA203 Accessed <6.11.13>
5. NICE Technology Appraisal TA 248. Exenatide prolonged release suspension for injection in
combination with oral antidiabetic therapy for the treatment of type 2 diabetes. Available at:
http://publications.nice.org.uk/exenatide-prolonged-release-suspension-for-injection-in-combinationwith-oral-antidiabetic-therapy-ta248 Accessed <6.11.13>
6. Summary of Product Characteristics Available at: www.medicines.org.uk Accessed <15.7.13>
Development Process
This guidance has been produced by Caron Applebee, Medicines Management Pharmacist, following an
AMBER-G classification status of dapagliflozin and canagliflozin by the Barnsley Area Prescribing Committee.
This guideline has been subject to consultation and endorsement by the Area Prescribing Committee on 8th
October 2014 and the LMC on 14th October 2014.
Page 5 of 6
Dapagliflozin/Canagliflozin Shared care Guideline
Date Prepared: September 2014
Review Date: September 2016
Reduced Shared Care Protocol –remains open to review in light of any new evidence
Amber with guidance (Amber-G) = To be initiated and titrated to a stable dose by a specialist prescriber with follow up
prescribing by primary care. Once medical condition and drug dosage is stable, there is no specific requirement for ongoing
monitoring.
Appendix A – Reduced Shared Care (Amber-G) request form



Specialist to complete when requesting GP to enter a shared care arrangement.
GP to return signed copy of form.
Both parties should retain a signed copy of the form in the patient’s record.
From (Specialist):
To (GP):
Patient details
Name:
ID Number:
Address:
DOB:
Diagnosed condition:
Amber-G Drug details
Drug name:
Dose:
Date of initiation:
Length of treatment:
The patient will be reviewed by the Consultant on:
Telephone number(s) for contact:
The patient should be reviewed by the GP by:
Consultant:
Date:
Communication
Consultant
Telephone number:
Fax number:
Email address:
Specialist Nurse
Telephone number:
Fax number:
Email address:
Confirmation of acceptance of shared care
Specialist name:
Specialist signature:
Date:
I, Dr
can confirm I :
□
□
accept the request to participate in shared care for the patient named above.
reject the request to participate in shared care for the patient named above. The reason for
this being ………………………………………………………………………………………..
GP signature:
Date:
Page 6 of 6
Dapagliflozin/Canagliflozin Shared care Guideline
Date Prepared: September 2014
Review Date: September 2016