Download Referral Criteria for consideration of treatment with exanatide (Byetta

Assessment and treatment
pathway for GLP-1 mimetics
Inclusion criteria
For the treatment of adults with Type 2 Diabetes Mellitus (T2DM) as follows:
Triple therapy regimes



In combination with metformin and either a sulphonylurea (SU) or a thiazolidinedione when these
treatments alone have failed to provide adequate glycaemic control defined as HbA1c < 7.5% (<58
mmol/mol) or other higher level agreed with the individual, AND
BMI ≥ 35 kg/m2 in those of European descent (adjusted to BMI 32 kg/m2 for other ethnic groups) AND
specific health/psychological problems associated with obesity, OR
BMI < 35 kg/m2 (BMI 32 kg/m2 in ethnic groups) but insulin treatment is unacceptable because of
occupational implications, or weight loss would benefit other obesity-related comorbidities.
Dual therapy regimes
This is only an option for people unable to take multiple oral therapy options and whose only current
alternative treatment is the early initiation of insulin. GLP-1s can be combined with metformin or an SU only 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 (TZD) AND DPP-4 inhibitors (‘gliptins’), OR treatment with
thiazolidinediones AND DPP-4 inhibitors is contraindicated.
Exclusion criteria




Type 1 diabetes or history of diabetic ketoacidosis
Children & adolescents below 18 years of age
Patients with severe osmotic symptoms and weight
loss secondary to hyperglycaemia
Refer to SPC & BNF for specific details on use in
heart failure or hepatic & renal impairment
Clinic schedule
GLP-1s can be initiated by prescribers with expertise in
diabetes in primary, intermediary or secondary care.
First clinic visit
 Prescriber to assess & prescribe GLP-1 and supply
needles & yellow bin (sharps container)
 Prescriber to give education & info pack + book next
review
 HbA1c & weight to be recorded
Month 1
 Record weight
 Give script for 2 months supply and book appointment
for 2 months
Diabetes clinic only - if treatment is to be continued:
 Write to GP to request they take over prescribing
 Ensure patient has sufficient supply until GP has agreed
Month 3
 Record HbA1c & weight
 Arrange follow-up appointment in further 3 months.






Previous history of pancreatitis
Severe gastrointestinal disease
Inflammatory bowel disease
Diabetic gastroparesis
Pregnancy or breastfeeding
Older patients (75+) - therapeutic experience limited
Metformin
and/or
TZD dose
GLP-1
dose
All
patients
All
patients
Group 1 (Car/
Motorcycle)
Group 2
(LGV/PCV drivers)
Dose as
per BNF
Half dose
Consider stopping
Telephone
review after
1-2 weeks
& titrate
dose up
as
appropriate
Consider
maintaining at
half dose
If necessary,
reintroduce at low
dose
Continue
as before
Sulphonylurea dose
REVIEW
REVIEW
Advice to patients







Administer via subcutaneous injection only & importance of rotating injection sites
What to do if a dose is missed: administer as soon as practical and then continue with the next scheduled
dose (except twice daily exenatide - proceed to next dose). Do not exceed prescribed dose in 24hr period
Educate on dose timing, test doses, storage and how to use kit as per manufacturer’s instructions
Prolonged release version: administer immediately after suspension of powder into solvent
Safe sharps disposal (does the patient have a yellow bin for sharps?)
Nurse specialist/prescriber to observe patient giving 1st injection and to wait 30 minutes post injection
Advise patient regarding nausea as per manufacturer’s instructions and instruct patient to seek prompt
medical attention if they develop any symptoms suggestive of pancreatitis
Developed by Medicines & Prescribing Team, NHS Solihull CCG & Solihull Community Diabetes Service, Heart of England NHS Trust, May 2015
Approved for use in the NHS by Medicines & Prescribing Subcommittee, NHS Solihull CCG, July 2015. Not for commercial use.
Assessment and treatment
pathway for GLP-1 mimetics

Check driver status and advise patient regarding the DVLA guidance as appropriate.
If the patient is to continue taking a sulphonylurea:
 LGV PCV Drivers - advise to inform DVLA if continuing sulphonylurea
 Give additional advice related to risks specific to job where appropriate
 Re-visit hypoglycaemia education – will need to test blood glucose levels
Prescriber checklist
Concomitant Drug
Recommended action
More frequent monitoring will be required until GLP-1 dose is stabilised.
Check INR within 7 days of GLP-1 initiation and after any dose adjustment
Metformin &/or Thiazolidinedione (TZD) The current dose of metformin and/or TZD can be continued
Reduce the dose of the sulphonylurea to prevent hypoglycaemia.
Sulphonylurea
The prescriber should write specific instructions in the medical notes
to this effect. If no specific details are given, advise the patient to reduce
the dose as in the clinic schedule above
DPP-4 inhibitor, repaglinide or SGLT2
Advise patient to stop these medications when GLP-1 is commenced
Insulin
Only lixisenatide should be prescribed in combination with insulin (only
NPH insulin). Refer to hospital diabetes clinic for advice – see local RiCAD
NOTE this is a summary only: please refer to SPC data sheet &/or BNF for full prescribing information
Warfarin
Home blood glucose monitoring
Therapy
GLP-1 + sulphonylurea (+/- metformin or TZD)
GLP-1 + metformin or TZD
Recommendations
Test once daily, at different times of day, for first 2 weeks.
Adjust dose of SU as necessary
Increase frequency of monitoring if unwell or symptoms.
Once on stable dose, monitoring not required.
Monitoring not required
Ongoing review


Prescriber to review after 6 months from start of therapy & assess response to GLP-1 therapy
Community Diabetes Service: If treatment is to be continued, write to GP with on-going management
plan and review requirements. Discharge from the service.
Dual therapy including
GLP-1
Continuation
criteria after
6 months
Triple therapy
including GLP-1
1% (11 mmol/mol)
decrease in HbA1c
1% (11 mmol/mol)
decrease in HbA1c AND
AND tolerability
3% reduction in weight
(STOP if
unmet)
LGV/PCV drivers taking GLP-1 with Metformin
or TZD +/- sulphonulyurea
1% (11 mmol/mol) decrease in HbA1c OR
maintenance of HbA1c (in exceptional cases
only) AND
3% reduction in weight (if GLP-1 prescribed as
part of triple therapy regime)
AND tolerability
AND tolerability
Discontinuation criteria






Failure to achieve beneficial metabolic response after 6 months (as defined in the criteria above)
Treatment not tolerated
Compelling indication for insulin ONLY therapy (weight loss with worsening symptoms/increased HbA1c)
Symptoms suggestive of pancreatitis such as unexplained persistent abdominal pain with or without
vomiting. If pancreatitis is confirmed, do not restart GLP-1 unless an alternative aetiology for the
pancreatitis is identified.
If a different anti-diabetic treatment is started after the discontinuation of a prolonged release GLP-1,
consideration should be given to the prolonged effect of GLP-1 therapy.
Caution: Rapid weight loss at a rate of 1.5 kg per week has been reported in patients treated with
exenatide. Weight loss of this rate may have harmful consequences e.g. cholelithiasis
References NICE TA248, NICE TA203, NICE CG87
Developed by Medicines & Prescribing Team, NHS Solihull CCG & Solihull Community Diabetes Service, Heart of England NHS Trust, May 2015
Approved for use in the NHS by Medicines & Prescribing Subcommittee, NHS Solihull CCG, July 2015. Not for commercial use.
Hepatic
impairment
Elderly patients
> 65 years
Annual
Cost
NICE criteria for
clinical use
Lixisenatide
10mcg once
daily for 14
days then
increase to
20mcg daily
on day 15
At the same
time each
day within
the hour prior
to a meal.
Do not use in
ESRD or if
GFR is <
30ml/min.
No dose
adjustment
No dose
adjustment but
experience in
>75 years is
limited
£649
Follow existing
NICE criteria.
5mcg BD
increased to
10mcg BD
after 1 month.
Within the
hour prior to
a meal, with
at least 6 hrs
between
injections.
Do not use in
ESRD or if
GFR is <
30ml/min
Increase from
5mcg to 10mcg
with caution in
those > 70 years
£818
(Lyxumia®)
Exenatide
(Byetta®)
Exenatide
prolonged
release
2mg once
weekly
(Bydureon®)
Liraglutide
(Victoza®)
0.6mg once
daily. Increase
after at least
one week to
1.2mg daily.
Avoid 1.8mg
(NICE)
No dose
adjustment
Do not use in
ESRD or if
GFR is <
50ml/min
No dose
adjustment
At the same
time each
day
independent
of meals.
Do not use in
ESRD or if
GFR is <
30ml/min
Do not use
Licensed indication
Triple
Insulin
therapy





Yes – when
added to
basal insulin
+/-oral agents
(except SU)
Refer to local
RICaD*
Experience in >
75 is very limited
On the same
day each
week at any
time,
independent
of meals.
Dual
therapy
+ met
+ pio
Renal
impairment
+ met
+ SU
Timing
+ pio
Dose
+ SU
Drug
+ met
GLP-1 mimetics: Doses, licensed indications, NICE criteria & cost comparison
Use only as part
of triple therapy
regime in
combination with
met + SU





Yes – when
added to
basal insulin
with met or
pio, or met
plus pio.
NICE CG87
No dose
adjustment but
experience in
>75 years is
limited
£953
No dose
adjustment but
experience in
>75 years is
limited
£954
Use as part of
dual therapy
regime added to
met or SU, or
triple therapy
added to met+SU
or met+pio
NICE TA 248
Dual therapy
added to met or
SU, or triple
therapy added to
met+SU or
met+pio. The
1.8mg dose is not
recommended
NICE TA 203
Not licensed
for use with
insulin





Yes – when
added to
basal insulin
only.





NOTE: information correct as at May 2015. Please refer to the individual SPCs for full details and up to date information. KEY: Met = metformin, Pio = pioglitazone, SU = sulphonylurea. Boxes
shaded in grey are not covered by NICE &/or local guidance. * Lixisenatide is the only GLP-1 approved for use with insulin by the Area Prescribing Committee Formulary & needs a RICaD
Developed by Medicines & Prescribing Team, NHS Solihull CCG & Solihull Community Diabetes Service, Heart of England NHS Trust, May 2015
Approved for use in the NHS by Medicines & Prescribing Subcommittee, NHS Solihull CCG, July 2015. Not for commercial use.