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Commercial Insight: Antidiabetics in Australia - Reimbursement status shapes novel classes

http://www.reportlinker.com/p0157514/Commercial-Insight-Antidiabetics-in-Australia---Reimbursement-status-shapes-novel-classes.html#utm_source=prnewswire&utm_medium=pr&utm_campaign=prnewswire

Introduction

The author expects the Australian antidiabetics market to reach $416m by 2018. The growth will be driven by the launch of new drug classes, notably the incretin mimetics, and large growth in patient numbers. Although strongest growth is expected in the non-insulin market, the insulin market will continue to dominate, generating revenues of $224m 10 years from now.

Scope

*Forecast for marketed and late-stage pipeline antidiabetic products in Australia

*Assessment of Australia-specific drivers and resistors likely to impact the market

*Future market outlook for individual products taking into account key market events, in particular patent expiry and competitor launch dates

*Case study examining the approval and reimbursement process in Australia in general and for several antidiabetics in specific

Highlights

The Australian antidiabetics market is expected to grow from $233m in 2008 to $416m in 2018 at a rate of 6% CAGR. Significant unmet needs in diabetes fuel a large pipeline. The epidemiological growth of the market, impacted by the obesity epidemic and improved diagnosis rates, is further driving the market.

In 2008, the long- and fast-acting insulin classes dominated the insulin market. This situation is not expected to change throughout the forecast period as there is very limited activity within the insulin antidiabetic pipeline and no serious challenges to the market leading therapies.

The strong market position of Avandia in 2007 has all but been destroyed by a meta-analysis published in mid-2007. Despite positive outcomes from GlaxoSmithKline's RECORD trial in 2009, the product will not regain market share before its patent expiry.

Reasons to Purchase

*Identify key opportunities and threats that will impact the use and uptake of new and existing products

*Quantify the future size and Scope of the Australian antidiabetics market and predict the performance of key compounds

*Understand critical success factors in growing and defending antidiabetic brand franchises from new entrants and generics

ABOUT DATAMONITOR HEALTHCARE 2

About the Cardiovascular and Metabolic pharmaceutical analysis team 2

CHAPTER 1 EXECUTIVE SUMMARY 3

Strategic scoping and focus 3

Datamonitor insight into the disease market 3

Related reports 4

Upcoming related reports 5

CHAPTER 2 MARKET DEFINITION 7

Market definition for this report 7

CHAPTER 3 MARKET OVERVIEW 9

Current and future market overview 9

The total Australian antidiabetic market is expected to rise from $233m in 2008 to $416m in 2018 10

The current insulin market: Lantus leads both its class and the overall insulin market in Australia 11

The future insulin market: growth will eventually slow down 13

The current non-insulin market: sales in thiazolidinedione class hit by Avandia scare, but class still dominates 16

The future non-insulin market: incretin mimetics will dominate 18

Opportunities and threats 20

Opportunities 20

Diabetes prevalence in Australia will continue to rise 20

There are over 1 million people with diabetes in Australia 20

The increase of obesity in Australia is linked to a surge in type 2 diabetes 23

Physical inactivity as a risk factor for type 2 diabetes 24

The impact of Australia's aging population on the prevalence of type 2 diabetes 25

The Aboriginal and Torres Strait Islander population has a higher risk of developing diabetes 26

Half of Australian diabetes patients do not reach HbA1c target of

HbA1c targets are loosened 29

The Australian government subsidizes diabetes-related products 30

Launch of novel compounds will replace generics and stimulate the non-insulin market 31

Dipeptidyl peptidase-IV inhibitors will move to second-line therapy 32

Threats 32

Health reforms aim to decrease the spending on antidiabetic drugs and diabetes overall 32

Australian government attempts to reduce overweight and obesity numbers 34

High costs in the treatment of complications of diabetes further incentivizes government to prevent increasing incidence 35

Novel drugs may struggle to get on the Pharmaceutical Benefits Scheme, as Byetta's case shows 36

Impact of biosimilars on insulins will become a threat in the future 36

The Therapeutic Goods Administration may follow the US Food and Drug Administration in its focus on cardiovascular risks 37

Shift towards private insurance may translate into significant growth opportunities for branded pharmaceuticals 39

CHAPTER 4 BRAND DYNAMICS 42

Overview of competitive landscape 42

Patient acquisition process 46

Patient care paths 46

Points of influence in the patient care path 48

Trigger point 1: ensure high-risk individuals are screened 48

Trigger point 2: promote use of metformin straight after diagnosis 49

Trigger point 3: influence initial choice of oral hypoglycemic agent 50

Trigger point 4: impact switching decisions 50

Trigger point 5: influence choice of insulin treatment 51

Treatment guidelines 53

Australian formulary status 57

Actos (pioglitazone; Takeda/Eli Lilly) 59

Drug profile 59

Product positioning 60

SWOT analysis 62

Brand forecast to 2018 63

Scare around Avandia will continue to contribute to Actos's sales 65

Positive results from the PPAR trial would add further support to Actos's competitive profile 68

The launch of Actoplus Met will boost Actos's franchise 68

The launch of generics will greatly impact Actos's revenues from 2011 onwards 69

The launch of novel drug classes will significantly slow down growth in sales over the next decade 70

Januvia (sitagliptin; Merck & Co) 70

Drug profile 70

Product positioning 71

SWOT analysis 73

Brand forecast to 2018 73

Approval and reimbursement of further indications would give revenues a boost 75

Positive clinical trial outcomes would help to build Januvia's profile 76

The launch of a sitagliptin/pioglitazone fixed-dose combination in Australia will strengthen the sitagliptin franchise 78

Avandia safety scare led some physicians to switch to Januvia 79

Novel dipeptidyl peptidase-IV inhibitors coming to market will significantly slow down growth in Januvia sales over the next decade 79

Launch of saxagliptin/metformin fixed-dose combination will impact Janumet's sales 83

Byetta (exenatide; Amylin/Eli Lilly) 83

Drug profile 83

Product positioning 84

SWOT analysis 87

Brand forecast to 2018 87

Positive outcome of pricing negotiations will be essential for improved uptake of Byetta 89

The launch of once-daily glucagon-like peptide-1 agonists will significantly slow Byetta's growth in sales over the next decade 90

Once-weekly glucagon-like peptide-1 agonists will dominate their class 92

Lantus (insulin glargine; Sanofi-Aventis) 96

Drug profile 96

Product positioning 97

SWOT analysis 100

Brand forecast to 2018 100

Brand loyalty will protect Lantus from main competitor Levemir, despite a number of new clinical trials 102

Cancer safety scare predicted to have minimal impact 106

NovoRapid (insulin aspart; Novo Nordisk) 108

Drug profile 108

Product positioning 108

SWOT analysis 109

Brand forecast to 2018 110

Number of clinical trials aim to shift even more patients to NovoRapid 111

CHAPTER 5 CASE STUDY - THE PROCESS FROM TGA APPROVAL TO PBS LISTING 114

Role of the Therapeutic Goods Administration 116

Reforms aim to make Therapeutic Goods Administration's approval process faster and more transparent 116

Role of the Pharmaceutical Benefits Advisory Committee 117

High level of evidence needed to show clinical and cost-effectiveness points to a barrier of market entry 117

Role of the Pharmaceutical Benefits Pricing Authority 119

Reforms split the Pharmaceutical Benefits Scheme into two formularies 120

Pricing methods used by the Pharmaceutical Benefits Pricing Authority 123

Reference pricing method is mainly used for products in Formulary 1 123

Cost Plus method is mainly used for products in Formulary 2 124

Need for cost-effectiveness analysis slows down Pharmaceutical Benefits Scheme listing considerably 125

Byetta's reimbursement is held up over pricing negotiations 126

The difficulty lies in the number of units of insulin glargine that Byetta should be compared with 128

Possible outcomes and their impact 129

Uptake Januvia is low due to limited approval and reimbursement 132

BIBLIOGRAPHY 135

Articles 135

Websites 143

Press releases 144

APPENDIX A - THERAPEUTIC RELATIVITY SHEET FOR ANTIDIABETICS 145

ATC A10 - Drugs used in diabetes (effective date: May 2009) 145

APPENDIX B - MARKET ASSUMPTIONS 148

Data definitions, limitations and assumptions 148

Standard units 148

Derivation of sales forecasts and pricing trends 148

Exchange rates used in this report 149

Forecast methodology 149

APPENDIX C 150

Contributing experts 150

Conferences attended 150

Report methodology 150

About Datamonitor 151

About Datamonitor Healthcare 151

About the Cardiovascular and Metabolic pharmaceutical analysis team 152

Disclaimer 154

LIST OF TABLES

Table 1: Sales and growth of antidiabetics in Australia by class, 2008 and 2018 9

Table 2: Prevalence estimates of diabetes mellitus (type 1 and 2) in Australia and the seven major markets, 2007 21

Table 3: Prevalence of known diabetes mellitus and newly diagnosed diabetes mellitus by age and sex in Australia, 1999-2000 22

Table 4: Summary of opportunities and threats in the antidiabetics market in Australia, 2009 41

Table 5: Sales forecasts of antidiabetics in Australia ($m), 2008-2018 43

Table 6: Formulary status in Australia for leading antidiabetic therapies, 2009 58

Table 7: Actos (pioglitazone) - Drug profile, 2009 60

Table 8: Impacting factors on the revenues of Actos in Australia, 2008-2018 65

Table 9: Januvia (sitagliptin) - Drug profile, 2009 71

Table 10: Impacting factors on the revenues of Januvia in Australia, 2008-2018 75

Table 11: Key clinical trial summary for Januvia (sitagliptin), 2009 77

Table 12: Clinical profile of Januvia, Galvus and Onglyza 81

Table 13: Byetta (exenatide) - Drug profile, 2009 84

Table 14: Impacting factors on the revenues of Byetta in Australia, 2008-2018 89

Table 15: Outcomes of the DURATION-1 and DURATION-2 trials compared with pivotal trial outcomes of Byetta, Januvia and Actos 95

Table 16: Lantus (insulin glargine) - Drug profile, 2009 97

Table 17: Impacting factors on the revenues of Lantus in Australia, 2008-2018 102

Table 18: Key clinical trial summary for Levemir (insulin detemir), 104

Table 19: Key clinical trial summary for Lantus (insulin glargine), 2009 105

Table 20: NovoRapid (insulin aspart) - Drug profile, 2009 108

Table 21: Impacting factors on the revenues of NovoRapid in Australia, 2008-2018 111

Table 22: Key clinical trial summary for NovoRapid (insulin aspart), 2009 112

Table 23: Calculation of monthly price ($) of 25 and 75 units of insulin glargine (Lantus) 131

Table 24: Exchange rates from USD, 2008 149

List of Figures

Figure 1: Sales of the Australian insulin and non-insulin diabetes market, 2004-2018 11

Figure 2: Indexed total insulin sales by class in Australia, 2004-08 12

Figure 3: Insulin sales by class in Australia, 2008-2018 14

Figure 4: Insulin sales by company in Australia, 2008-2018 15

Figure 5: Indexed total non-insulin sales by type in Australia, 2004-08 17

Figure 6: Non-insulin sales by class in Australia, 2008-2018 19

Figure 7: Prevalence of diabetes in Australia by body mass index category, 1981 and 1999-2000 23

Figure 8: Population pyramids for Australia, 2009 and 2047 26

Figure 9: Changing diabetes map, 2008 29

Figure 10: Projected health and residential aged care expenditure for type 1 and 2 diabetes in Australia, 2002-03 to 2032-2033 33

Figure 11: Type 2 diabetes patient care path 47

Figure 12: Type 1 diabetes patient care path 48

Figure 13: Common one and two insulin injection regimens 52

Figure 14: Treatment tree as recommended by the 2008/09 edition of the Australian Diabetes Management in General Practice guidelines 56

Figure 15: Actos (pioglitazone) SWOT analysis, 2009 62

Figure 16: Sales of Actos, Avandia and generics in Australia, 2008-2018 64

Figure 17: Indexed volume (standard units) sold for Actos, Avandia and the total thiazolidinedione class in Australia, 2007-08 67

Figure 18: Sales of Actoplus Met, Avandamet and generics in Australia, 2008-2018 69

Figure 19: Januvia (sitagliptin) SWOT analysis, 2009 73

Figure 20: Sales of Januvia in Australia, 2008-2018 74

Figure 21: Sales of Januvia and sitagliptin/pioglitazone in Australia, 2008-2018 78

Figure 22: Sales of Januvia, Galvus, Onglyza and Ondero in Australia, 2008-2018 82

Figure 23: Byetta (exenatide) SWOT analysis, 2009 87

Figure 24: Sales of Byetta in Australia, 2008-2018 88

Figure 25: Sales of Byetta and Victoza in Australia, 2008-2018 91

Figure 26: Sales of Byetta, Victoza, Byetta LAR and taspoglutide in Australia, 2008-2018 93

Figure 27: Indexed sales of Lantus and Levemir and their price per standard unit in Australia, 2004-08 99

Figure 28: Lantus (insulin glargine) SWOT analysis, 2009 100

Figure 29: Sales of Lantus and Levemir in Australia, 2008-2018 101

Figure 30: NovoRapid (insulin aspart) SWOT analysis, 2009 109

Figure 31: Sales of NovoRapid, Humalog, Actrapid, Apidra and Humulin in Australia, 2008-2018 110

Figure 32: Path of approval on the Australian Pharmaceutical Benefits Scheme 115

Figure 33: Factors that the Australian Pharmaceutical Benefits Advisory Committee has identified as informing its decision-making 119

Figure 34: Factors that the Australian Pharmaceutical Benefits Pricing Authority has identified as informing its decision-making 120

Figure 35: The split between the Australian Formulary 1 (F1) and Formulary 2 (F2) 122

Figure 36: Average time from ADEC recommendation to Australian PBS listing for major submissions using a cost-effectiveness analysis approach 126

Figure 37: Timeline of Januvia's approvals by the FDA, EMEA and TGA 133

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Commercial Insight: Antidiabetics in Australia - Reimbursement status shapes novel classes

http://www.reportlinker.com/p0157514/Commercial-Insight-Antidiabetics-in-Australia---Reimbursement-status-shapes-novel-classes.html#utm_source=prnewswire&utm_medium=pr&utm_campaign=prnewswire

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