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Company Confidential © 2012 Eli Lilly and Company Prescribing human insulin: What do the guidelines say and what does this mean in practice? Speaker name and affiliation Prescribing information is available on the last slide. © 2013 Eli Lilly and Company UKDBT01519b September 2013

Company Confidential © 2012 Eli Lilly and Company Prescribing human insulin: What do the guidelines say and what does this mean in practice? Speaker name

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Page 1: Company Confidential © 2012 Eli Lilly and Company Prescribing human insulin: What do the guidelines say and what does this mean in practice? Speaker name

Company Confidential © 2012 Eli Lilly and Company

Prescribing human insulin: What do the guidelines say and what does this mean in practice?

Speaker name and affiliation

Prescribing information is available on the last slide.

© 2013 Eli Lilly and Company

UKDBT01519b September 2013

Page 2: Company Confidential © 2012 Eli Lilly and Company Prescribing human insulin: What do the guidelines say and what does this mean in practice? Speaker name

Company Confidential © 2012 Eli Lilly and Company© 2013 Eli Lilly and Company

This session will discuss:

NICE (and SIGN) guideline regarding human NPH insulin prescribing in type 2 diabetes

What does NICE (and SIGN) recommend regarding use of pre-mixed human insulin in type 2 diabetes?

The health economics of the situation and the impact of the QIPP agenda

Discussion of the local situation regarding prescribing human NPH insulin

2

NPH=neutral protamine Hagedorn; QIPP=Quality, Innovation, Productivity and Prevention

Page 3: Company Confidential © 2012 Eli Lilly and Company Prescribing human insulin: What do the guidelines say and what does this mean in practice? Speaker name

What does NICE say about initiating insulin in type 2 diabetes?Section subhead copy here if needed or section presenter info

Page 4: Company Confidential © 2012 Eli Lilly and Company Prescribing human insulin: What do the guidelines say and what does this mean in practice? Speaker name

Company Confidential © 2012 Eli Lilly and Company© 2013 Eli Lilly and Company

Starting insulin therapy in type 2 diabetes: NICE advice (2009)

4

NPH=neutral protamine HagedornNICE. Type 2 diabetes: newer agents for blood glucose control in type 2 diabetes. CG87. London: NICE; May 2009. www.nice.org.uk

Begin with human NPH insulin

injected at bedtime or twice daily according to need.

If other measures do not keep HbA1c <58 mmol/mol (<7.5%; or other agreed target), discuss the benefits and risks of insulin treatment

Alternatively, consider a once-dailylong-acting insulin analogue

(insulin detemir, insulin glargine) if• The person needs help with injecting insulin

and a long-acting insulin analogue would reduce injections from twice to once daily, or

• The person’s lifestyle is restricted by recurrent symptomatic hypoglycaemic episodes, or

• The person would otherwise need twice-daily NPH insulin injections plus oral glucose lowering drugs, or

• The person cannot use the device to inject NPH insulin.

Page 5: Company Confidential © 2012 Eli Lilly and Company Prescribing human insulin: What do the guidelines say and what does this mean in practice? Speaker name

Company Confidential © 2012 Eli Lilly and Company© 2013 Eli Lilly and Company

Starting insulin therapy in type 2 diabetes: NICE advice (2009)

5

NICE. Type 2 diabetes: newer agents for blood glucose control in type 2 diabetes. CG87. London: NICE; May 2009. www.nice.org.uk

Consider twice-dailybiphasic human insulin

(pre-mixed)(particularly if HbA1c ≥75mmol/mol [≥9%])A once-daily regimen may be an option.

Considerpre-mixed preparations of

insulin analogues (including short-acting

insulin analogues) rather than pre-mixed human insulin preparations if:• Immediate injection before a meal

is preferred, or• Hypoglycaemia is a problem, or• Blood glucose levels rise markedly

after meals.

If other measures do not keep HbA1c <58 mmol/mol (<7.5%; or other agreed target), discuss the benefits and risks of insulin treatment

Page 6: Company Confidential © 2012 Eli Lilly and Company Prescribing human insulin: What do the guidelines say and what does this mean in practice? Speaker name

What does SIGN say about initiating insulin in type 2 diabetes?

Section subhead copy here if needed or section presenter info

Page 7: Company Confidential © 2012 Eli Lilly and Company Prescribing human insulin: What do the guidelines say and what does this mean in practice? Speaker name

Company Confidential © 2012 Eli Lilly and Company© 2013 Eli Lilly and Company

Starting insulin: SIGN advice

7

NPH=neutral protamine HagedornSIGN. Management of diabetes. 116. March 2010. www.sign.ac.uk

When commencing insulin therapy, bed-time basal insulin should be initiated and the dose titrated against morning (fasting) glucose. If the HbA1c level does not reach target then addition of prandial insulin should be considered

A once daily bed-time human NPH insulin should be used when adding insulin to metformin and/or sulphonylurea therapy. Basal insulin analogues should be considered if there are concerns regarding hypoglycaemia risk

A soluble human insulin or rapid-acting insulin analogues can be used when intensifying insulin regimens to improve or maintain glycaemic control

Page 8: Company Confidential © 2012 Eli Lilly and Company Prescribing human insulin: What do the guidelines say and what does this mean in practice? Speaker name

Insulin prescribing: Health economics considerations

Section subhead copy here if needed or section presenter info

Page 9: Company Confidential © 2012 Eli Lilly and Company Prescribing human insulin: What do the guidelines say and what does this mean in practice? Speaker name

Company Confidential © 2012 Eli Lilly and Company© 2013 Eli Lilly and Company

The financial cost of diabetes

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Hex N et al (2012) Diabet Med 29: 855–62

Overall 2010/2011 cost

£23.7bn

Direct costs£9.8bn

Type 2 direct costs

£8.8bn

Type 1 direct costs

£1.0bn

Indirect costs£13.9bn

Type 2 indirect costs

£13.0bn

Type 1 indirect costs

£0.9bn

“…the estimate that the cost of diabetes accounts for approximately one tenth of NHS expenditure is accurate.”

“…less than a quarter of that cost relates to the treatment and ongoing management of diabetes, with the rest being accounted for by the costs of treating the complications of diabetes.”

Page 10: Company Confidential © 2012 Eli Lilly and Company Prescribing human insulin: What do the guidelines say and what does this mean in practice? Speaker name

Company Confidential © 2012 Eli Lilly and Company© 2013 Eli Lilly and Company

Between 1997 and 2007, expenditure on diabetes therapies increased

10

Currie CJ et al (2010) Diabetic Medicine 27: 938–48

Retrospective study in the UK from 1997 to 2007 n=126,052: 11,300 (8.9%) with type 1 diabetes; 114,752 (91.1%) with

type 2 diabetes Expenditure on type 2 diabetes (per person per year):

1997 2007 Change

Overall mean prescribing cost £391 £740 +89%

Mean number of primary care consultations

5.4 11.5 +112%

Total mean cost of primary care treatment

£602 £1080 +79%

Page 11: Company Confidential © 2012 Eli Lilly and Company Prescribing human insulin: What do the guidelines say and what does this mean in practice? Speaker name

Company Confidential © 2012 Eli Lilly and Company© 2013 Eli Lilly and Company

Has the increasing expenditure on diabetes therapies improved glycaemic control?

11

Currie CJ et al (2010) Diabetic Medicine 27: 938–48

Retrospective study in the UK from 1997 to 2007 n=126,052: 11,300 (8.9%) with type 1 diabetes; 114,752 (91.1%) with

type 2 diabetes Expenditure on type 2 diabetes (per person per year):

1997 2007 Change

Overall mean prescribing cost £391 £740 +89%

Mean number of primary care consultations 5.4 11.5 +112%

Total mean cost of primary care treatment £602 £1080 +79%

• However, over the 10 year period, the mean HbA1c values did not improve at all!

Page 12: Company Confidential © 2012 Eli Lilly and Company Prescribing human insulin: What do the guidelines say and what does this mean in practice? Speaker name

Company Confidential © 2012 Eli Lilly and Company© 2013 Eli Lilly and Company

The cost of basal insulin preparations in 2013

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• Insulin analogues have become increasingly popular despite their greater cost compared with human insulin1

Examples of comparative costs of human and analogue insulins2

£72*

£42 £41.50

£22.90 £19.08 £17.50

£72*

£42 £41.50

£21.70 £20.40 £19.80

*Relates to the 100 unit/mL preparations; a 200 unit/mL preparation is also available at a cost of £86.40 for a 3 x 3mL prefilled pen1. Holden SE et al (2011) BMJ Open 1: e000258 2. MIMS Online (2013) Insulins. Available at: http://www.mims.co.uk/Drugs/diabetes/insulins (accessed 19.03.2013)

Page 13: Company Confidential © 2012 Eli Lilly and Company Prescribing human insulin: What do the guidelines say and what does this mean in practice? Speaker name

Company Confidential © 2012 Eli Lilly and Company© 2013 Eli Lilly and Company

UK NHS spend on basal insulins during 2012 (IMS data)1

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Only 8.3% of the basal insulin spend nationally is on human NPH insulin1

If all prescriptions dispensed for analogue insulin between 2000 and 2009 had used a human insulin alternative, the NHS would have saved an estimated £625 million2

NHS spend during 2012

Insulin glargine £96,201,765

Insulin detemir £52,157,155

Sub-total for basal insulin analogues £148,358,920

All human NPH insulins £13,473,090

NPH=neutral protamine Hagedorn1. DATA ON FILE: UK NHS spend on basal insulins during 2012 2. Holden SE et al (2011) BMJ Open 1: e000258 )

Page 14: Company Confidential © 2012 Eli Lilly and Company Prescribing human insulin: What do the guidelines say and what does this mean in practice? Speaker name

Company Confidential © 2012 Eli Lilly and Company© 2013 Eli Lilly and Company

Quality, Innovation, Productivity and Prevention (QIPP)

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1. NHS Improvement (2013) QIPP - Resources. Available at: http://bit.ly/d0aQqk (accessed 08.04.2013)2. NICE (2013) Key therapeutic topics – Medicines management options for local implementation. Available at: http://bit.ly/11nsJ4r (accessed 08.04.2013)

QIPP is a national Department of Health strategy for the NHS, involving all NHS staff, clinicians, patients and the voluntary sector. It aims to improve the quality and delivery of NHS care whilst reducing costs to make £20 billion of efficiency savings by 2014–15. These savings will be reinvested to support the front line.1

In terms of long-acting and intermediate-acting insulins, QIPP states:

“Review and, if appropriate, revise prescribing of long-acting insulin analogues for type 2 diabetes mellitus to ensure that it is in line with NICE guidance”2

Page 15: Company Confidential © 2012 Eli Lilly and Company Prescribing human insulin: What do the guidelines say and what does this mean in practice? Speaker name

Company Confidential © 2012 Eli Lilly and Company© 2013 Eli Lilly and Company

NICE: QIPP Key therapeutic topicsMedicines management options for local implementation

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Long-acting insulin analogues:

The net ingredient cost of all insulin therapy in primary care in 2011/12 was £314.7 million; a growth of 42.5% from 2005/6.

– In 2011, 1.3 million items of insulin glargine were prescribed at a cost of just over £77 million, and just over 600,000 items of insulin detemir at a cost of nearly £40 million

– This compared with nearly 350,000 items of NPH (isophane) insulin at a cost of just over £12 million

In most PCTs more than 80% of all intermediate or long-acting insulin items (excluding biphasic insulins) were for insulin glargine or insulin detemir

However, the trend of increased preference for prescribing long or intermediate-acting insulin analogues over other types has recently reversed

NICE (2013) Key therapeutic topics – Medicines management options for local implementation. Available at: http://bit.ly/11nsJ4r (accessed 19.03.2013)

Page 16: Company Confidential © 2012 Eli Lilly and Company Prescribing human insulin: What do the guidelines say and what does this mean in practice? Speaker name

Company Confidential © 2012 Eli Lilly and Company© 2013 Eli Lilly and Company

Variation in the percentage of long-acting insulin analogues prescribed across PCTs

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PCT=Primary Care TrustNICE (2012) Cardiovascular – type 2 diabetes Data focused commentary: Type 2 diabetes: long-acting insulin analogues . Available at: http://bit.ly/XWr57r (accessed 19.03.2013)

Across PCTs, long-acting insulin analogues make up between 36–98% of the prescribing of all long- and intermediate-acting insulins (excluding biphasics)

In the majority of PCTs, more than 80% of all intermediate or long-acting insulin items (excluding biphasic insulins) are long-acting insulin analogues and in many PCTs the proportion is more than 90%

Therefore, in many PCTs, only 10% of all intermediate or long-acting insulin items prescribed are for human NPH insulin

Page 17: Company Confidential © 2012 Eli Lilly and Company Prescribing human insulin: What do the guidelines say and what does this mean in practice? Speaker name

Company Confidential © 2012 Eli Lilly and Company© 2013 Eli Lilly and Company

Let’s discuss

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How much do you think you are spending on prescribing basal insulins in your locality?

Page 18: Company Confidential © 2012 Eli Lilly and Company Prescribing human insulin: What do the guidelines say and what does this mean in practice? Speaker name

Company Confidential © 2012 Eli Lilly and Company© 2013 Eli Lilly and Company

Local insulin prescribing costs

18

<<Local data be added by the presenter and submitted for approval by Lilly if available>>

Page 19: Company Confidential © 2012 Eli Lilly and Company Prescribing human insulin: What do the guidelines say and what does this mean in practice? Speaker name

Local guidelines regarding the prescribing of insulin in type 2 diabetes

Section subhead copy here if needed or section presenter info

Page 20: Company Confidential © 2012 Eli Lilly and Company Prescribing human insulin: What do the guidelines say and what does this mean in practice? Speaker name

Company Confidential © 2012 Eli Lilly and Company© 2013 Eli Lilly and Company

Let’s discuss

20

What do your local guidelines recommend regarding the prescribing of insulin in type 2 diabetes?

Page 21: Company Confidential © 2012 Eli Lilly and Company Prescribing human insulin: What do the guidelines say and what does this mean in practice? Speaker name

Company Confidential © 2012 Eli Lilly and Company© 2013 Eli Lilly and Company

Local guidelines for insulin prescribing

21

<<Local example be added by the presenter and submitted for approval by Lilly if available>>

Page 22: Company Confidential © 2012 Eli Lilly and Company Prescribing human insulin: What do the guidelines say and what does this mean in practice? Speaker name

Company Confidential © 2012 Eli Lilly and Company© 2013 Eli Lilly and Company

Session 2 summary

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National guidelines recommend initiating insulin for people with type 2 diabetes by using human NPH insulin

National guidelines suggest that long-acting insulin analogues are considered as options in specific circumstances

Insulin analogues have come under increasing scrutiny due to their widespread use and greater cost compared with human NPH insulin

– In England, the QIPP agenda is encouraging cost savings in diabetes, and insulin prescribing is one area of focus

NPH=neutral protamine Hagedorn; QIPP=Quality, Innovation, Productivity and Prevention

Page 23: Company Confidential © 2012 Eli Lilly and Company Prescribing human insulin: What do the guidelines say and what does this mean in practice? Speaker name

UKDBT01519b September 2013