yorkshire & humber academic health science network – hypo project 22 ccgs mike stansfield, nhs...

Yorkshire & Humber Academic Health Science Network – Hypo project 22 CCGs

Mike Stansfield, NHS Outcomes Manager

Sanofi

Prescribing Information can be found at the end of this presentation

GBIE.DIA.12.09.13(4)Date of Prep – October 2015


Analysis of Diabetes Activity and Spend- overview


● The information in this presentation has been reproduced accurately without amendment or alteration, except to produce visual representations in order to improve clarity and understanding.

● Every effort has been taken to ensure the information provided is up to date and accurate and complete, but no warranties or representations are given in this regard.

Data Disclaimer


AIREDALE,

WHARFE

DALE AND CRAVEN

(02N)

BARNSLEY (

02P)

BASSET

LAW

(02Q)

BRADFORD (0

2Q & 02R)

CALDER

DALE (02T)

DONCASTER

(02X)

EAST

RIDING OF Y

ORKSHIRE (

02Y)

GREATE

R HUDDERSF

IELD (0

3A)

HARROGATE AND RURAL D

ISTRICT (

03E)

HULL (03F)

LEEDS(0

2V & 03G &

03C)

NORTH KIRKLEE

S (03J)

NORTHER

N LINCOLN

SHIRE (

03H & 03K)

ROTHER

HAM (03L)

SCARBOROUGH AND RYE

DALE (03M)

SHEF

FIELD

(03N)

VALE OF Y

ORK (03Q)

WAKEF

IELD (0

3R)0.00

5,000.00

10,000.00

15,000.00

20,000.00

25,000.00

30,000.00

35,000.00

40,000.00

Diabetes Register Size (sum)

Register Size (sum)


AIREDALE,

WHARFE

DALE AND CRAVEN

(02N)

BARNSLEY (

02P)

BASSET

LAW

(02Q)

BRADFORD (0

2Q & 02R)

CALDER

DALE (02T)

DONCASTER

(02X)

EAST

RIDING OF Y

ORKSHIRE (

02Y)

GREATE

R HUDDERSF

IELD (0

3A)


ISTRICT (

03E)

HULL (03F)

LEEDS(0

2V & 03G &

03C)

NORTH KIRKLEE

S (03J)

NORTHER

N LINCOLN

SHIRE (

03H & 03K)

ROTHER

HAM (03L)

SCARBOROUGH AND RYE

DALE (03M)

SHEF

FIELD

(03N)

VALE OF Y

ORK (03Q)

WAKEF

IELD (0

3R)0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

The percentage of patients with diabetes, on the register, in whom the last IFCC-HbA1c is 59 mmol/mol or less in the preceding 12 months (DM007)The percentage of patients with diabetes, on the register, in whom the last IFCC-HbA1c is 64 mmol/mol or less in the preceding 12 months (DM008)The percentage of patients with diabetes, on the register, in whom the last IFCC-HbA1c is 75 mmol/mol or less in the preceding 12 months (DM009)

QOF HbA1c Achievement by Indicator and CCG


2014-04

2014-05

2014-06

2014-07

2014-08

2014-09

2014-10

2014-11

2014-12

2015-01

2015-02

2015-03

0

2,000

4,000

6,000

8,000

10,000

12,000

14,000

16,000

18,000

All admissions with a diabetes codeNon Elective admissions with a diabetes code

All Diabetes Admissions and Non-Elective Diabetes Admissions per Month


AIREDALE,

WHARFE

DALE AND CRAVEN

(02N)

BARNSLEY (

02P)

BASSET

LAW

(02Q)

BRADFORD (0

2Q & 02R)

CALDER

DALE (02T)

DONCASTER

(02X)

EAST

RIDING OF Y

ORKSHIRE (

02Y)

GREATE

R HUDDERSF

IELD (0

3A)


ISTRICT (

03E)

HULL (03F)

LEEDS(0

2V & 03G &

03C)

NORTH KIRKLEE

S (03J)

NORTHER

N LINCOLN

SHIRE (

03H & 03K)

ROTHER

HAM (03L)

SCARBOROUGH AND RYE

DALE (03M)

SHEF

FIELD

(03N)

VALE OF Y

ORK (03Q)

WAKEF

IELD (0

3R)0

5,000

10,000

15,000

20,000

25,000

Diabetes admissionsNE diabetes admissions

All Diabetes Admissions vs Non-Elective Diabetes Admissions


2014-04 2014-05 2014-06 2014-07 2014-08 2014-09 2014-10 2014-11 2014-12 2015-01 2015-02 2015-030

50

100

150

200

250

300

350

400

NE Pri & sec diag hypoNE Pri diag hypo

NE Hypo Primary & Secondary Diagnosis and Primary Only Admissions


AIREDALE,

WHARFE

DALE AND CRAVEN

(02N)

BARNSLEY (

02P)

BASSET

LAW

(02Q)

BRADFORD (0

2Q & 02R)

CALDER

DALE (02T)

DONCASTER

(02X)

EAST

RIDING OF Y

ORKSHIRE (

02Y)

GREATE

R HUDDERSF

IELD (0

3A)


ISTRICT (

03E)

HULL (03F)

LEEDS(0

2V & 03G &

03C)

NORTH KIRKLEE

S (03J)

NORTHER

N LINCOLN

SHIRE (

03H & 03K)

ROTHER

HAM (03L)

SCARBOROUGH AND RYE

DALE (03M)

SHEF

FIELD

(03N)

VALE OF Y

ORK (03Q)

WAKEF

IELD (0

3R)0

100

200

300

400

500

600

700

800

900

NE Pri & sec diag hypoNE Pri diag hypo

NE Hypo Primary & Secondary Diagnosis and Primary Only Admissions


AIREDALE,

WHARFE

DALE AND CRAVEN

(02N)

BARNSLEY (

02P)

BASSET

LAW

(02Q)

BRADFORD (0

2Q & 02R)

CALDER

DALE (02T)

DONCASTER

(02X)

EAST

RIDING OF Y

ORKSHIRE (

02Y)

GREATE

R HUDDERSF

IELD (0

3A)


ISTRICT (

03E)

HULL (03F)

LEEDS(0

2V & 03G &

03C)

NORTH KIRKLEE

S (03J)

NORTHER

N LINCOLN

SHIRE (

03H & 03K)

ROTHER

HAM (03L)

SCARBOROUGH AND RYE

DALE (03M)

SHEF

FIELD

(03N)

VALE OF Y

ORK (03Q)

WAKEF

IELD (0

3R)0.0000

0.0050

0.0100

0.0150

0.0200

0.0250

0.0300

0.0350

0.0400

Hypo admission by reg Pri or SecHypo admisson by reg Pri

NE Hypo Admissions per Head of Diabetes Register


AIREDALE,

WHARFE

DALE AND CRAVEN

(02N)

BARNSLEY (

02P)

BASSET

LAW

(02Q)

BRADFORD (0

2Q & 02R)

CALDER

DALE (02T)

DONCASTER

(02X)

EAST

RIDING OF Y

ORKSHIRE (

02Y)

GREATE

R HUDDERSF

IELD (0

3A)


ISTRICT (

03E)

HULL (03F)

LEEDS(0

2V & 03G &

03C)

NORTH KIRKLEE

S (03J)

NORTHER

N LINCOLN

SHIRE (

03H & 03K)

ROTHER

HAM (03L)

SCARBOROUGH AND RYE

DALE (03M)

SHEF

FIELD

(03N)

VALE OF Y

ORK (03Q)

WAKEF

IELD (0

3R)0

100

200

300

400

500

600

700

800

900

NE Hypo patients pri or secNE Pri & sec diag hypo

NE All Hypo Patients and Admissions by CCG


AIREDALE,

WHARFE

DALE AND CRAVEN

(02N)

BARNSLEY (

02P)

BASSET

LAW

(02Q)

BRADFORD (0

2Q & 02R)

CALDER

DALE (02T)

DONCASTER

(02X)

EAST

RIDING OF Y

ORKSHIRE (

02Y)

GREATE

R HUDDERSF

IELD (0

3A)


ISTRICT (

03E)

HULL (03F)

LEEDS(0

2V & 03G &

03C)

NORTH KIRKLEE

S (03J)

NORTHER

N LINCOLN

SHIRE (

03H & 03K)

ROTHER

HAM (03L)

SCARBOROUGH AND RYE

DALE (03M)

SHEF

FIELD

(03N)

VALE OF Y

ORK (03Q)

WAKEF

IELD (0

3R)0

0.005

0.01

0.015

0.02

0.025

0.03

0.035

0.04

NE Hypo patients pri or sec per regNE Pri & sec diag hypo per reg

NE Hypo Patients and Admissions per Register Size by CCG


£-

£500,000.00

£1,000,000.00

£1,500,000.00

£2,000,000.00

£2,500,000.00

£3,000,000.00

NE Hypo's Tariff cost

NE Primary & Secondary Hypo Diagnosis ££


AIREDALE,

WHARFE

DALE AND CRAVEN

(02N)

BARNSLEY (

02P)

BASSET

LAW

(02Q)

BRADFORD (0

2Q & 02R)

CALDER

DALE (02T)

DONCASTER

(02X)

EAST

RIDING OF Y

ORKSHIRE (

02Y)

GREATE

R HUDDERSF

IELD (0

3A)


ISTRICT (

03E)

HULL (03F)

LEEDS(0

2V & 03G &

03C)

NORTH KIRKLEE

S (03J)

NORTHER

N LINCOLN

SHIRE (

03H & 03K)

ROTHER

HAM (03L)

SCARBOROUGH AND RYE

DALE (03M)

SHEF

FIELD

(03N)

VALE OF Y

ORK (03Q)

WAKEF

IELD (0

3R) £-

£20.00

£40.00

£60.00

£80.00

£100.00

£120.00

£140.00

NE Hypo's tariff cost per register

NE Primary and Secondary Hypos per Register ££


0

20

40

60

80

100

120

140

160

180

200

NE Pri diag Hypo

NE Pri diag Hypo plus sec diag insulin dependent

NE Pri diag Hypo plus sec diag non insulin dependent

Comparison of Insulin vs Non-Insulin Dependent Hypo Admissions


0

0.001

0.002

0.003

0.004

0.005

0.006

0.007

NE Pri diag Hypo per reg

NE Pri diag Hypo plus sec diag in-sulin dependent per reg

NE Pri diag Hypo plus sec diag non insulin depen-dent per reg

Comparison of Insulin vs Non-Insulin Dependent Hypo Admissions Primary Diagnosis per Register


£-

£50,000.00

£100,000.00

£150,000.00

£200,000.00

£250,000.00

£300,000.00

£350,000.00

Total Tariff Cost NE Pri Hypo diagnosis

Total Tariff Cost NE Pri Hypo diagnosis + Insulin dependent

Total Tariff Cost NE Pri Hypo diagnosis + non Insulin depen-dent

Tariff Cost – NE Primary Diagnosis Hypo & Insulin vs Non-Insulin Dependent


£-

£1.00

£2.00

£3.00

£4.00

£5.00

£6.00

£7.00

£8.00

£9.00

£10.00

Total Tariff Cost NE Pri Hypo di-agnosis per reg

Total Tariff Cost NE Pri Hypo di-agnosis + Insulin dependent per reg

Total Tariff Cost NE Pri Hypo diag-nosis + non Insulin dependent per reg

Tariff Cost – NE Primary Diagnosis Hypo Insulin and Non-Insulin Dependent By Register Size


AIREDALE,

WHARFE

DALE AND CRAVEN

BARNSLEY

BASSET

LAW

BRADFORD CITY

BRADFORD DIST

RICTS

CALDER

DALE

DONCASTER

EAST

RIDING OF Y

ORKSHIRE

GREATE

R HUDDERSF

IELD


ISTRICT

HULL

LEEDS N

ORTH

LEEDS S

OUTH AND EA

ST

LEEDS W

EST

NORTH EA

ST LIN

COLNSH

IRE

NORTH KIRKLEE

S

NORTH LIN

COLNSH

IRE

ROTHER

HAM

SCARBOROUGH AND RYE

DALE

SHEF

FIELD

VALE OF Y

ORK

WAKEF

IELD

0

10

20

30

40

50

60

Age 0-39Age 40-64Age 65-74Age 75-84Age 85+

NE Primary Hypo Admissions by Age


AIREDALE,

WHARFE

DALE AND CRAVEN

(02N)

BARNSLEY (

02P)

BASSET

LAW

(02Q)

BRADFORD (0

2Q & 02R)

CALDER

DALE (02T)

DONCASTER

(02X)

EAST

RIDING OF Y

ORKSHIRE (

02Y)

GREATE

R HUDDERSF

IELD (0

3A)


ISTRICT (

03E)

HULL (03F)

LEEDS(0

2V & 03G &

03C)

NORTH KIRKLEE

S (03J)

NORTHER

N LINCOLN

SHIRE (

03H & 03K)

ROTHER

HAM (03L)

SCARBOROUGH AND RYE

DALE (03M)

SHEF

FIELD

(03N)

VALE OF Y

ORK (03Q)

WAKEF

IELD (0

3R)0

50

100

150

200

250

300

350

400

Total Bed days Age 0-39Total Bed days Age 40-64Total Bed days Age 65-74Total Bed days Age 75-84Total Bed days Age 85+

NE Primary Diagnosis Hypo Bed Days by Age


£-

£20,000.00

£40,000.00

£60,000.00

£80,000.00

£100,000.00

£120,000.00

£140,000.00

Tariff cost £ Age 0-39




Tariff cost £ Age 85+

NE Primary Diagnosis Hypo Admissions – Tariff Cost by Age


AIREDALE,

WHARFE

DALE AND CRAVEN

(02N)

BARNSLEY (

02P)

BASSET

LAW

(02Q)

BRADFORD (0

2Q & 02R)

CALDER

DALE (02T)

DONCASTER

(02X)

EAST

RIDING OF Y

ORKSHIRE (

02Y)

GREATE

R HUDDERSF

IELD (0

3A)


ISTRICT (

03E)

HULL (03F)

LEEDS(0

2V & 03G &

03C)

NORTH KIRKLEE

S (03J)

NORTHER

N LINCOLN

SHIRE (

03H & 03K)

ROTHER

HAM (03L)

SCARBOROUGH AND RYE

DALE (03M)

SHEF

FIELD

(03N)

VALE OF Y

ORK (03Q)

WAKEF

IELD (0

3R)0

5

10

15

20

25

30

35

40

45

Re-admission 28 daysRe-admission 90 days

NE Hypo Primary Diagnosis Re-admissions


NE Hypo Primary Diagnosis Re-admission per Register

AIREDALE,

WHARFE

DALE AND CRAVEN

(02N)

BARNSLEY (

02P)

BASSET

LAW

(02Q)

BRADFORD (0

2Q & 02R)

CALDER

DALE (02T)

DONCASTER

(02X)

EAST

RIDING OF Y

ORKSHIRE (

02Y)

GREATE

R HUDDERSF

IELD (0

3A)


ISTRICT (

03E)

HULL (03F)

LEEDS(0

2V & 03G &

03C)

NORTH KIRKLEE

S (03J)

NORTHER

N LINCOLN

SHIRE (

03H & 03K)

ROTHER

HAM (03L)

SCARBOROUGH AND RYE

DALE (03M)

SHEF

FIELD

(03N)

VALE OF Y

ORK (03Q)

WAKEF

IELD (0

3R)0

0.0005

0.001

0.0015

0.002

0.0025

Re-admission 28 days per regRe-admission 90 days per reg


AIREDALE,

WHARFE

DALE AND CRAVEN

(02N)

BARNSLEY (

02P)

BASSET

LAW

(02Q)

BRADFORD (0

2Q & 02R)

CALDER

DALE (02T)

DONCASTER

(02X)

EAST

RIDING OF Y

ORKSHIRE (

02Y)

GREATE

R HUDDERSF

IELD (0

3A)


ISTRICT (

03E)

HULL (03F)

LEEDS(0

2V & 03G &

03C)

NORTH KIRKLEE

S (03J)

NORTHER

N LINCOLN

SHIRE (

03H & 03K)

ROTHER

HAM (03L)

SCARBOROUGH AND RYE

DALE (03M)

SHEF

FIELD

(03N)

VALE OF Y

ORK (03Q)

WAKEF

IELD (0

3R) £-

£10,000.00

£20,000.00

£30,000.00

£40,000.00

£50,000.00

£60,000.00

£70,000.00

£80,000.00

£90,000.00

Re-admission Cost 28 daysRe-admission Cost 90 days

NE Primary Diagnosis Re-admission Costs


NE Primary Diagnosis Re-admission Cost per Register

AIREDALE,

WHARFE

DALE AND CRAVEN

(02N)

BARNSLEY (

02P)

BASSET

LAW

(02Q)

BRADFORD (0

2Q & 02R)

CALDER

DALE (02T)

DONCASTER

(02X)

EAST

RIDING OF Y

ORKSHIRE (

02Y)

GREATE

R HUDDERSF

IELD (0

3A)


ISTRICT (

03E)

HULL (03F)

LEEDS(0

2V & 03G &

03C)

NORTH KIRKLEE

S (03J)

NORTHER

N LINCOLN

SHIRE (

03H & 03K)

ROTHER

HAM (03L)

SCARBOROUGH AND RYE

DALE (03M)

SHEF

FIELD

(03N)

VALE OF Y

ORK (03Q)

WAKEF

IELD (0

3R) £-

£0.50

£1.00

£1.50

£2.00

£2.50

£3.00

£3.50

£4.00

£4.50

£5.00

Re-admission Cost 28 days per regRe-admission Cost 90 days per reg


0.00

2,000,000.00

4,000,000.00

6,000,000.00

8,000,000.00

10,000,000.00

12,000,000.00

14,000,000.00

Drugs in Diabetes - Net Cost (sum)

Drugs in Diabetes – Net Cost (sum)


0.00

50.00

100.00

150.00

200.00

250.00

300.00

350.00

400.00

Drugs in diabetes/register -net cost

Drugs in Diabetes/Register – Net Cost



NE diabetes admissions

NE Hypo Pri & sec diag admissions

NE Hypo Pri diag admissions

85042 3871 1296

Hypo project CCGs Summary Numbers

Hypo Pri diag Tariff cost £1,936,593Hypo Pri and sec diag ££ £11,321,035

Pri diag Hypo ££ by age0-39 £151,55840-64 £306,53065-74 £304,90575-84 £818,83285+ £354,215

28 day readmissions ££ £251,39590 day readmissions ££ £508,027



●Thank You


Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to the Sanofi drug safety department on 01483 554242.

Lantus Prescribing InformationLantus® (insulin glargine). Please refer to Summary of Product Characteristics prior to use of Lantus. Lantus cartridges and Solostar prefilled pens each contain 300 Units of insulin glargine in 3ml, equivalent to 10.92mg. Lantus vials contain 1000 Units insulin glargine in 10ml, equivalent to 36.4mg.

Indications: Treatment of diabetes mellitus in adults, adolescents and children of 2 years or above.

Dosage and administration: Lantus is administered subcutaneously once daily, at any time but at the same time each day. Do not administer intravenously. Insulin glargine dosage should be individually adjusted. In type 2 diabetes mellitus, Lantus can also be used in combination with orally active antidiabetic medicinal products. Close metabolic monitoring is recommended during, and for a period after, transition from other insulins to Lantus. Dose and timing of other antidiabetic medicines may need to be adjusted. Dose adjustments may also be required if the patient’s weight or lifestyle changes, the timing of insulin dose is changed or other circumstances arise that increase susceptibility to hypo- or hyperglycaemia. Lantus must not be mixed with other insulins or diluted. Insulin requirements may be diminished in the elderly or patients with renal or hepatic impairment. The safety and efficacy of Lantus has not been established in children below 2 years of age. No data are available.

Contraindications: Hypersensitivity to insulin glargine or any excipients.

Precautions and warnings: Switch from twice daily NPH: To reduce the risk of nocturnal and early morning hypoglycaemia, patients who are changing to a once daily regimen with Lantus should reduce their daily dose of basal insulin by 20-30% during the first weeks of treatment. Switch from Toujeo (insulin glargine 300 units/ml): Lantus and Toujeo are not bioequivalent and are not directly interchangeable. To reduce the risk of hypoglycaemia, patients changing from once daily insulin glargine 300 units/ml to once daily Lantus should reduce their dose by approximately 20%. Close metabolic monitoring is recommended during the switch and in the initial weeks thereafter. Lantus is not the insulin of choice for treatment of diabetic ketoacidosis. In case of insufficient glucose control or a tendency to hypo/hyperglycaemic episodes all relevant factors must be reviewed before dose adjustment is considered. Particular caution should be exercised, and intensified blood monitoring is advisable for patients in whom hypoglycaemic episodes might be of clinical relevance and in those where dose adjustments may be required. Warning signs of hypoglycaemia may be changed, less pronounced or absent in certain risk groups, potentially resulting in severe hypoglycaemia and loss of consciousness. Risk groups include patients in whom glycaemic control is markedly improved, hypoglycaemia develops gradually, an autonomic neuropathy is present, or in elderly patients. The prolonged effect of subcutaneous insulin glargine may

delay recovery from hypoglycaemia. Due to more sustained basal insulin supply with Lantus, less nocturnal but more early morning hypoglycaemia can be expected. Insulin administration may cause insulin antibodies to form. Rarely, this may necessitate dose adjustment. Cases of cardiac failure have been reported when pioglitazone was used in combination with insulin, especially in patients with risk factors for development of cardiac heart failure. Patients on this combination should be observed for signs and symptoms of heart failure, weight gain and oedema. Pioglitazone should be discontinued if any deterioration in cardiac symptoms occurs.

Pregnancy and lactation: No clinical data on exposed pregnancies from controlled clinical trials are available. A large amount of post-marketing data indicates no specific adverse effects of insulin glargine on pregnancy and no specific malformative nor feto/neonatal toxicity. Use of Lantus in pregnancy can be considered if clinically needed. Insulin requirements may decrease during the first trimester and generally increase during the second and third trimesters. Immediately after delivery, insulin requirements decline rapidly (increased risk of hypoglycaemia). Careful monitoring of glucose control is essential. It is unknown if insulin glargine is excreted in breast milk. Adverse reactions: Very common: hypoglycaemia. Prolonged or severe hypoglycaemia may be life-threatening. Common: lipohypertrophy, injection site reactions, including redness, itching, pain, hives, swelling or inflammation. Rarely: immediate-type allergic reactions; which may be associated with generalised skin reactions, angio-oedema, bronchospasm, hypotension and shock and may be life threatening; visual impairment, retinopathy and oedema. Very rare: dysgeusia, myalgia Overdose may lead to severe and sometimes long-term and life-threatening hypoglycaemia. Please consult Summary of Product Characteristics for full details of the recognised side effects with Lantus.

NHS price: 1 x 10ml vial £30.68; 5 x 3ml cartridge £41.50; 5 x 3ml SoloStar £41.50 Legal category: POM.

MA holder: Sanofi Aventis Deutschland GmbH, D-65926 Frankfurt am Main, Germany. MA Numbers: Lantus cartridge: EU/1/00/134/006. Lantus vial EU/1/00/134/012. Lantus SoloStar: EU/1/00/134/033. Full prescribing information is available from: Sanofi, One Onslow Street, Guildford, Surrey, GU1 4YS. Tel: 01483 505515 or the Sanofi Diabetes Care Line 08000 35 25 25.

Date of PI Revision: August 2015

http://www.mhra.gov.uk/yellowcard


Apidra Prescribing InformationPrescribing Information Apidra® (insulin glulisine). Please refer to Summary of Product Characteristics prior to use of Apidra. Apidra cartridges and Solostar prefilled pens each contain 300 Units of insulin glulisine in 3ml, equivalent to 10.47mg. Apidra vials contain 1000 Units insulin glulisine in 10ml, equivalent to 34.9mg. Indications: Treatment of diabetes mellitus in adults, adolescents and children of 6 years or above. Dosage and administration: Intravenous: Apidra can be administered intravenously by health care professionals. Apidra must not be mixed with glucose or Ringer’s solution or with any other insulin. Subcutaneous: Apidra can be given subcutaneously shortly (0-15 min) before or soon after meals or by continuous subcutaneous pump infusion. When administered as a subcutaneous injection, Apidra must not be mixed with other medicinal products except NPH human insulin. When used with a subcutaneous insulin infusion pump, Apidra must not be mixed with diluents or any other insulin. Patients must follow the Apidra specific instructions in the SPC when using Apidra in a pump. Failure to do so may lead to serious adverse events. Apidra should be used with an intermediate or long acting insulin or basal insulin analogue and can be used with oral hypoglycaemic agents. The dosage of Apidra should be individually adjusted. There is insufficient clinical information on the use of Apidra in children under 6 years. The pharmacokinetic properties of insulin glulisine are generally maintained in patients with renal impairment. Insulin requirements may be diminished in the elderly or patients with renal or hepatic impairment. Contraindications: Hypersensitivity to insulin glulisine or any excipients. Precautions and warnings: Use of inadequate dosages or discontinuation of treatment, especially in insulin-dependent diabetics, may lead to hyperglycaemia and diabetic ketoacidosis; conditions which are potentially lethal. Dosage adjustment may be necessary if patients undertake increased physical activity or change their meal plan. Uncorrected hypoglycaemic or hyperglycaemic reactions can cause loss of consciousness, coma or death. Cases of cardiac failure have been reported when pioglitazone was used in combination with insulin, especially in patients with risk factors for development of cardiac heart failure. Patients on this combination should be observed for signs and symptoms of heart failure, weight gain and oedema. When administered by continuous subcutaneous infusion, malfunction of the insulin pump or infusion set or handling errors can rapidly lead to hyperglycaemia, ketosis and diabetic ketoacidosis. Patients using continuous subcutaneous insulin infusion pump therapy must have an alternative insulin delivery system available in case of pump failure. Pioglitazone should be discontinued if any deterioration in cardiac symptoms occurs.

Pregnancy and lactation: There are no adequate data on the use of insulin glulisine in pregnant women therefore caution should be exercised. It is unknown if insulin glulisine is excreted in breast milk. Adverse reactions: Very common: hypoglycaemia. Hypoglycaemia can become severe and may lead to unconsciousness and/or convulsions and may result in temporary or permanent impairment of brain function or even death. Common: injection site reactions and local hypersensitivity reactions, which are usually transitory and normally disappear during continued treatment. Uncommon: Systemic hypersensitivity reactions, which may include urticaria, chest tightness, dyspnea, allergic dermatitis and pruritus. Severe cases of generalized allergy, including anaphylactic reaction, may be life-threatening. Rare: lipodystrophy. Unknown; Hyperglycaemia (potentially leading to Diabetic ketoacidosis - Most of these cases were related to handling errors or pump system failure when Apidra was used with CSII). Please consult Summary of Product Characteristics for full details of the recognised side effects with Apidra. NHS price: 1 x 10ml vial £16.00; 5 x 3ml cartridge £28.30; 5 x 3ml SoloStar £28.30. Legal category: POM. MA holder: Sanofi Aventis Deutschland GmbH, D-65926 Frankfurt am Main, Germany. MA Numbers: Apidra vial: EU/1/04/285/001; Apidra cartridge: EU/1/04/285/008; Apidra SoloStar: EU/1/04/285/032. Full prescribing information is available from: Sanofi, One Onslow Street, Guildford, Surrey, GU1 4YS. Tel: 01483 505515. Date of Revision: December 2013

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard.

Adverse events should also be reported to the Sanofi drug safety department on 01483 505515.




Prescribing Information

Insuman® (insulin human).

Please refer to Summary of Product Characteristics prior to use of Insuman.

Insuman Basal, Comb 15, Comb 25, Comb 50 and Rapid cartridges, in addition to the Insuman Basal and Comb 25 Solostar pens each contain 300 IU of insulin human in 3ml, equivalent to 10.5mg. Insuman Basal and Comb 25 vials contain 500 IU of insulin human in 5ml, equivalent to 17.5mg. Insuman Rapid contains neutral insulin solution (regular insulin). Insuman Basal contains isophane insulin suspension. Insuman Comb 15, 25 and 50 contain 15% regular and 85% isophane, 25% regular and 75% isophane, and 50% regular and 50% isophane insulin, respectively. Indications: Diabetes mellitus. Insuman Rapid cartridges are also suitable for the treatment of hyperglycaemic coma, ketoacidosis, and for achieving pre-, intra- and post-operative stabilisation. Dosage and administration: Insulin doses and timings should be determined individually. There are no fixed rules for insulin dosage. Average insulin requirement is often 0.5 to 1.0 IU/kg body weight/day. Basal metabolic requirement is 40% to 60% of total daily requirement. Insuman should be injected subcutaneously: Insuman Rapid should be injected 15 to 20 minutes before a meal; Insuman Basal should be injected 45 to 60 minutes before a meal; Insuman Comb 15 and 25 should be injected 30 to 45 minutes before a meal; Insuman Comb 50 should be injected 20 to 30 minutes before a meal. Insuman Rapid cartridges may also be administered intravenously under close medical supervision. Close metabolic monitoring is recommended during, and for a period after, transition from other insulins to Insuman. Dose and timing of other antidiabetic medicines may need to be adjusted. Dose adjustments may also be required if the patient’s weight or lifestyle changes, the timing of insulin dose is changed or other circumstances arise that increase susceptibility to hypo- or hyperglycaemia. Insulin requirements may be diminished in the elderly or patients with renal or hepatic impairment. Contra-indications: Hypersensitivity to human insulin or to any excipients. IV administration contraindicated in all preparations except Insuman Rapid. Insuman Basal contraindicated in infusion pumps or external or implanted insulin pumps. Insuman Rapid must not be used in external or implanted insulin pumps or in peristaltic pumps with silicone tubing. Precautions and warnings: Patients hypersensitive to Insuman Rapid, Basal or Comb 15, 25 or 50 for whom no better tolerated preparation is available must only continue treatment under close medical supervision, in conjunction with anti-allergic treatment if necessary. In patients allergic to animal insulin, intradermal skin testing is recommended prior to initiation. Hypoglycaemia may occur. Particular caution should be exercised, and intensified blood monitoring is advisable for patients in

whom hypoglycaemic episodes might be of clinical relevance and in those where dose adjustments may be required. Warning signs of hypoglycaemia may be changed, less pronounced or absent in certain risk groups, potentially resulting in severe hypoglycaemia and loss of consciousness. Risk groups include patients in whom glycaemic control is markedly improved, hypoglycaemia develops gradually, an autonomic neuropathy is present, or in elderly patients. Intensified metabolic monitoring is necessary during intercurrent illness. Cases of cardiac failure have been reported when pioglitazone was used in combination with insulin, especially in patients with risk factors for development of cardiac heart failure. Patients should be observed for signs and symptoms of heart failure, weight gain and oedema. Pioglitazone should be discontinued if any deterioration in cardiac symptoms occurs. Pregnancy and lactation: There is no clinical data on the use of Insuman in pregnant women. Insuman can be used during breast feeding. Adverse Reactions: Hypoglycaemia is the most common reaction. Prolonged or severe hypoglycaemia may be life-threatening. Severe hypoglycaemic attacks, especially if recurrent, may lead to neurological damage. Common: oedema, injection site reactions. Uncommon: shock, injection site urticaria. Immediate type allergic reactions to insulin or to the excipients may be life-threatening (hypotension, angioneurotic oedema, bronchospasm, generalised skin reactions). Insulin administration may cause insulin antibodies to form and may, in rare cases, necessitate adjustment of the insulin dose.

Legal category: POM. MA holder: Sanofi Aventis Deutschland GmbH, D-65926 Frankfurt am Main, Germany. Full prescribing information is available from: Sanofi, One Onslow Street, Guildford, Surrey, GU1 4YS. Tel: 0845 372 7101. Date of Revision: October 2014

Insuman Prescribing Information

Product Pack NHS Price MA NumberInsuman Rapid 5 cartridges of 3ml £17.50 EU/1/97/030/030Insuman Basal 1 vial of 5ml: £5.61 EU/1/97/030/033Insuman Basal 5 cartridges of 3ml £17.50 EU/1/97/030/035Insuman Basal 5 SoloSTAR pens of 3ml £19.80 EU/1/97/030/148Insuman Comb 15 5 cartridges of 3ml £17.50 EU/1/97/030/040Insuman Comb 25 1 vial of 5ml £5.61 EU/1/97/030/043Insuman Comb 25 5 cartridges of 3ml £17.50 EU/1/97/030/045Insuman Comb 25 5 SoloSTAR pens of 3ml £19.80 EU/1/97/030/160Insuman Comb 50 5 cartridges of 3ml £17.50 EU/1/97/030/050




Lyxumia Prescribing InformationPrescribing Information Lyxumia▼® (lixisenatide). Please refer to Summary of Product Characteristics prior to use of Lyxumia. Lyxumia 10 micrograms solution for injection:Each dose (0.2 ml) contains 10 micrograms (mcg) of lixisenatide (50 mcg per ml).Lyxumia 20 micrograms solution for injection:Each dose (0.2 ml) contains 20 micrograms (mcg) of lixisenatide (100 mcg per ml). Indications: Treatment of adults with type 2 diabetes mellitus to achieve glycaemic control in combination with oral glucose‑lowering medicinal products and/or basal insulin when these, together with diet and exercise, do not provide adequate glycaemic control. Dosage and administration: Lyxumia is to be injected subcutaneously in the thigh, abdomen or upper arm. Starting dose: dosing is initiated at 10 mcg Lyxumia once daily for 14 days. Maintenance dose: a fixed maintenance dose of 20 mcg Lyxumia once daily is started on Day 15. Lyxumia 20 micrograms solution for injection is available for the maintenance dose. Lyxumia is administered once daily, within the hour prior to any meal of the day, preferably the same meal each day. If a dose of Lyxumia is missed, it should be injected within the hour prior to the next meal. The clinical experience in patients ≥75 years is limited. Limited therapeutic experience in patients with moderate renal impairment (creatinine clearance: 30‑50 ml/min) and Lyxumia should be used with caution in this population. There is no therapeutic experience in patients with severe renal impairment (creatinine clearance less than 30 ml/min) or end-stage renal disease and therefore, it is not recommended to use Lyxumia in these populations. The safety and efficacy of Lyxumia in children and adolescents less than 18 years of age have not yet been established. Contraindications: Hypersensitivity to Lyxumia or to any of the excipients Precautions and warnings: No therapeutic experience with Lyxumia in patients with type 1 diabetes mellitus and it should not be used in these patients. Lyxumia should not be used for treatment of diabetic ketoacidosis. Use of glucagon‑like peptide-1 (GLP‑1) receptor agonists has been associated with a risk of developing acute pancreatitis. There have been few reported events of acute pancreatitis with Lyxumia although a causal relationship has not been established. If pancreatitis is suspected, Lyxumia should be discontinued; if acute pancreatitis is confirmed, Lyxumia should not be restarted. Caution should be exercised in patients with a history of pancreatitis. Lyxumia has not been studied in patients with severe gastrointestinal disease, including severe gastroparesis and therefore, the use of Lyxumia is not recommended in these patients. There is limited therapeutic experience in patients with moderate renal impairment (creatinine clearance: 30‑50 ml/min) and no therapeutic experience in patients with severe renal impairment (creatinine clearance less than 30 ml/min) or end-stage renal disease. Lyxumia should be used with caution in patients with moderate renal impairment. Use is not recommended in patients with severe renal impairment or end-stage renal disease. Patients receiving Lyxumia with a sulphonylurea or with a basal insulin may have an increased risk of hypoglycaemia. Lyxumia should not be given in combination with basal insulin and a sulphonylurea due to increased risk of hypoglycaemia. Lyxumia should be used with caution in patients receiving oral medicinal products that require rapid gastrointestinal absorption, require careful clinical monitoring or have a narrow therapeutic ratio. Lyxumia has not been studied in combination with dipeptidyl peptidase 4 (DPP-4) inhibitors.

There is limited experience in patients with congestive heart failure. Patients treated with Lyxumia should be advised of the potential risk of dehydration in relation to gastrointestinal adverse reactions and take precautions to avoid fluid depletion. This medicinal product contains metacresol, which may cause allergic reactions. Interactions: Paracetamol: No dose adjustment for paracetamol is required but the delayed tmax observed when paracetamol is administered 1-4 hours after Lyxumia should be taken into account when a rapid onset of action is required for efficacy. Oral contraceptives: The reduction in Cmax is of limited clinical relevance and no dose adjustment for oral contraceptives is required. Atorvastatin: Changes to tmax and Cmax are not clinically relevant and therefore, no dose adjustment for atorvastatin is required when co‑administered with Lyxumia. Warfarin and other coumarin derivatives: Frequent monitoring of INR in patients on warfarin and/or coumarin derivatives is recommended at the time of initiation or ending of Lyxumia treatment. Digoxin: No dose adjustment for digoxin is required when co‑administered with Lyxumia. Ramipril: No dose adjustment for ramipril is required when co‑administered with Lyxumia. Adverse reactions: Very common: Hypoglycaemia (in combination with a sulphonylurea and / or a basal insulin). Headache. Nausea, vomiting & diarrhoea; These tend to be mostly mild and transient during the first 3 weeks after starting treatment. Thereafter, they progressively decrease during the following weeks. Common: Influenza, upper respiratory tract infection, cystitis & viral infection. Hypoglycaemia (in combination with metformin alone). Dizziness, somnolence, dyspepsia, back pain, injection site pruritus. Uncommon: Anaphylactic reaction and urticaria. Please consult the Summary of Product Characteristics in relation to other adverse reactions NHS price: Lyxumia 10 mcg: 1 pre-filled pen: £31.67, Lyxumia 20 mcg: 2 pre-filled pens: £57.93, Lyxumia 10 mcg + 20 mcg: 1 pre-filled pen + 1 pre-filled pen: £57.93Legal category: POM. MA holder: sanofi-aventis groupe, 54, rue La Boétie, F – 75008 Paris, FranceMA Number(s): Lyxumia 10 mcg: 1 pre-filled pen: EU/1/12/811/001, Lyxumia 20 mcg: 2 pre-filled pens: EU/1/12/811/003, Lyxumia 10 mcg + 20 mcg: 1 pre-filled pen + 1 pre-filled pen: EU/1/12/811/005Full prescribing information is available from: Sanofi, One Onslow Street, Guildford, Surrey, GU1 4YS. Tel: 0845 372 7101. Date of Revision: June 2015




29

Toujeo® Prescribing Information


Toujeo® (insulin glargine 300 U/ml). Please refer to Summary of Product Characteristics prior to use of Toujeo®. Toujeo® SoloStar® pre-filled pens each contain 450 Units of insulin glargine in 1.5 ml of solution for injection, equivalent to 10.91 mg/ml. Indications: Treatment of diabetes mellitus in adults. Administration: Toujeo® is administered subcutaneously once daily, at any time of the day, preferably at the same time every day. Do not administer intravenously. Insulin glargine dose regimen (dose and timing) should be individually adjusted. In type 1 diabetes mellitus, Toujeo® must be combined with short-/rapid-acting insulin to cover mealtime insulin requirements. In patients with type 2 diabetes mellitus, Toujeo® can also be given together with other anti-hyperglycaemic medicinal products. Close metabolic monitoring is recommended during the switch and in the initial weeks thereafter. Dose and timing of other antidiabetic medicines may need to be adjusted. Dose adjustments may also be required if the patient’s weight or lifestyle changes, the timing of insulin dose is changed or other circumstances arise that increase susceptibility to hypo- or hyperglycaemia. Toujeo® must not be mixed or diluted with any other insulin or other medicinal products. Mixing or diluting Toujeo® changes its time/action profile and mixing causes precipitation. Insulin requirements may be diminished in the elderly or patients with renal or hepatic impairment. The safety and efficacy of Toujeo® have not been established in children and adolescents below 18 years of age. No data are available.Contraindications: Hypersensitivity to insulin glargine or any excipients. Precautions and warnings: Insulin glargine 100 units/ml and Toujeo® are not bioequivalent and are not directly interchangeable. When switching from insulin glargine 100 units/ml to Toujeo®, this can be done on a unit‑to‑unit basis, but a higher Toujeo® dose (approximately 10-18%) may be needed to achieve target ranges for plasma glucose levels. When switching from Toujeo® to insulin glargine 100 units/ml, the dose should be reduced (approximately by 20%) to reduce the risk of hypoglycaemia. Close metabolic monitoring is recommended during the switch and in the initial weeks thereafter. Toujeo® is not the insulin of choice for treatment of diabetic ketoacidosis. In case of insufficient glucose control or a tendency to hyper/hypoglycaemic episodes, the patient's adherence to the prescribed treatment regimen, injection sites and proper injection technique and all other relevant factors must be reviewed before dose adjustment is considered. Insulin administration may cause insulin antibodies to form. Rarely, this may necessitate dose adjustment. Particular caution should be exercised, and intensified blood glucose monitoring is advisable for patients in whom hypoglycaemic episodes might be of clinical relevance and in those where dose adjustments may be required. Warning signs of hypoglycaemia may be changed, less pronounced or absent in certain risk groups, potentially resulting in severe hypoglycaemia and loss of consciousness. Risk groups include patients in whom glycaemic control is markedly improved, hypoglycaemia develops gradually, an autonomic neuropathy is present, or who are elderly. The prolonged effect of subcutaneous insulin glargine may delay recovery from hypoglycaemia. Cases of cardiac failure have been reported when pioglitazone was used in combination with insulin, especially in patients with risk factors for development of cardiac heart failure. If the combination is used, patients should be observed for signs and symptoms of heart failure, weight gain and oedema. Pioglitazone should be discontinued if any deterioration in cardiac symptoms occurs.

Pregnancy and lactation: No clinical data on exposed pregnancies from controlled clinical trials are available. A large amount of data on pregnant women (more than 1000 pregnancy outcomes with a medicinal product containing insulin glargine 100 units/ml (Lantus®)) indicate no specific adverse effects on pregnancy and no specific malformative nor feto/neonatal toxicity of insulin glargine. Animal data do not indicate reproductive toxicity. The use of Toujeo® may be considered during pregnancy, if clinically needed. Insulin requirements may decrease during the first trimester and generally increase during the second and third trimesters. Immediately after delivery, insulin requirements decline rapidly (increased risk of hypoglycaemia). Careful monitoring of glucose control is essential. It is unknown if insulin glargine is excreted in breast milk. Adverse reactions: Very common: Hypoglycaemia. Prolonged or severe hypoglycaemia may be life-threatening. Common: Lipohypertrophy, injection site reactions, including redness, pain, itching, hives, swelling, or inflammation. Uncommon: Lipoatrophy. Rarely: Immediate-type allergic reactions; which may be associated with generalised skin reactions, angio-oedema, bronchospasm, hypotension and shock and may be life threatening; visual impairment, retinopathy and oedema. Very rare: Dysgeusia, myalgia. Insulin administration may cause insulin antibodies to form and may, in rare cases, necessitate adjustment of the insulin dose. Overdose may lead to severe and sometimes long-term and life-threatening hypoglycaemia. Please consult Summary of Product Characteristics for full details of the recognised side effects with Toujeo®. NHS price: £33.13 for pack of x3 1.5ml pensLegal category: POM. MA holder: Sanofi Aventis Deutschland GmbH, D-65926 Frankfurt am Main, Germany. MA Numbers: SoloStar ®: 3 Pen pack: EU/1/00/133/034Full prescribing information is available from: Sanofi, One Onslow Street, Guildford, Surrey, GU1 4YS. Tel: 01483 505515 or the Sanofi Diabetes Care Line 08000 35 25 25. Date of PI Revision: May 2015



References and links

● DOVE – accessed 05/15 at http://www.yhpho.org.uk/resource/view.aspx?RID=88739

● Diabetes Community Health Profiles – accessed 05/15 at http://www.yhpho.org.uk/diabetescommunityhealthprofiles/default.aspx

● National General Practice Profiles – accessed 05/15 at http://fingertips.phe.org.uk/profile/general-practice

● NHS Business Services Authority MO KTT indicators accessed 05/15 via https://apps.nhsbsa.nhs.uk/infosystems/home/homepage.do

Data in this presentation are from publicly available websites courtesy of Public Health England which host NCVIN (National Cardiovascular Intelligence Network) and NDIS (National Diabetes Intelligence Service); and NHS BSA (NHS Business Services Authority)

http://www.yhpho.org.uk/resource/view.aspx?RID=88739

http://www.yhpho.org.uk/diabetescommunityhealthprofiles/default.aspx

http://fingertips.phe.org.uk/profile/general-practice

https://apps.nhsbsa.nhs.uk/infosystems/home/homepage.do

https://apps.nhsbsa.nhs.uk/infosystems/home/homepage.do

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