Commercial Insight: Top 20 Oncology Therapy Brands in Australia Revenues of targeted therapies soar while sales of cytotoxics and antihormonals decline

Introduction

The Top 20 cancer therapy brands in Australia reached sales of about $545m in 2008, growing at a CAGR of 30% since 2005. Datamonitor forecasts this growth to slow down considerably to a CAGR of 5.6% between 2008 and 2018 mainly due to maturing markets and the entry of generics for several key products. Sales of the Top 20 brands are expected to reach a total of $940m in 2018.

Scope

*This report focuses on the Top 20 cancer therapy brands in Australia sales and volume forecasts to 2018

*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 indication expansion and patent expiry

*Case study examining the approval and reimbursement process in Australia

Highlights

Datamonitor forecasts that the molecular targeted therapies will continue to drive growth in the Australian Top 20 cancer therapies market over the forecast period 20082018, with sales increasing from $320m in 2008 to $750m 2018.

The highest-selling brand in Australia in 2008 was Herceptin (trastuzumab; Roche) with sales of just under $120m and a CAGR between 2005 and 2008 of 61%. This drug is well positioned in the HER-2-positive breast cancer market where it received an exceptional reimbursement status.

In 2018, the Australian Top 20 will be led by Rituxan/MabThera (rituximab; Roche) with sales of $225m, followed by Avastin (bevacizumab; Roche) and Herceptin with revenues of $190m and $160m, respectively. Avastin will be the fastest growing brand with a 20082018 CAGR of 38% due to aggressive indication expansion in the coming years.

Reasons to Purchase

*Identify key opportunities and threats that will impact the Australian oncology market as a whole and the Top 20 in particular

*Quantify the future size and scope of the Top 20 Australian cancer therapies market and predict the performance of its key compounds

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

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ABOUT DATAMONITOR HEALTHCARE 2
About the Oncology pharmaceutical analysis team 2
CHAPTER 1 EXECUTIVE SUMMARY 3
Strategic scoping and focus 3
Datamonitor insight into the oncology market 3
Related reports 5
Upcoming related reports 6
CHAPTER 2 MARKET DEFINITION 8
Market definition for this report 8
Key data assumptions 9
Accounting for missing Pharmatel Fresenius Kabi sales 9
Split of rituximab sales 13
CHAPTER 3 MARKET OVERVIEW 14
Current and future market overview 14
The molecular targeted therapies class will continue to dominate 17
Herceptin will surrender its leading position to Rituxan/MabThera by 2018 18
Opportunities 20
The number of Australian cancer patients is on the rise, with prostate and breast cancer being most common 20
End-of-life debate highlights need for more funding of high-cost oncology drugs 22
National screening programs aim to detect cancer in early stages 23
Government grants support local cancer research 23
Expensive oncology products are financed by government- and company-backed programs 24
Threats 24
Health reforms aim to lower cancer expenditure 24
The Intravenous Chemotherapy Supply Program is feared to affect pharmacists' reimbursement 25
The impending impact of biosimilars 26
Novel drugs may struggle to get on the Pharmaceutical Benefits Scheme, as Erbitux's case shows 28
CHAPTER 4 BRAND DYNAMICS OVERVIEW 30
Overview of competitive landscape 30
Reimbursement is a key driver of brand choice 30
Special programs fund the use of certain oncology drugs 33
The Chemotherapy Pharmaceuticals Access Program 34
The Herceptin Program 35
Herceptin via the Special Authority Program 37
Risk-sharing agreements 38
CHAPTER 5 BRAND DYNAMICS - MOLECULAR TARGETED THERAPIES 39
Herceptin (trastuzumab; Roche) 39
Drug profile 39
Product positioning 42
HER-2-positive breast cancer 42
SWOT analysis 43
Brand forecast to 2018 43
Launch of subcutaneous formulation may have small impact on sales 44
New clinical trial data may drive use in adjuvant breast cancer setting 45
Approval for neoadjuvant treatment of breast cancer 46
Herceptin's approval in gastric cancer would be first indication outside breast cancer 46
Further uptake of Tykerb/Tyverb in HER-2-positive breast cancer will impact Herceptin's revenues 47
Uptake of biosimilar trastuzumab products 51
Glivec/Gleevec (imatinib; Novartis) 52
Drug profile 53
Product positioning 56
Chronic myeloid leukemia (CML) 56
Gastrointestinal stromal tumors (GIST) 59
Acute lymphoblastic leukemia (ALL) 60
Myelodysplastic syndromes/myeloproliferative diseases (MDS/MPD) 61
Other indications 61
SWOT analysis 61
Brand forecast to 2018 63
Tasigna's and Sprycel's use in first-line CML could significantly impact imatinib sales 64
Recent PBS listing of Sutent in second-line GIST treatment unlikely to take sales away from imatinib 66
Glivec/Gleevec's ability to gain reimbursement for its use in adjuvant GIST treatment is doubtful 67
Slight uptake of Glivec/Gleevec use upon PBS listing for MDS/MPD, ASM, HES, CEL and DFSP 68
PBS listing of Vidaza should not impact Glivec/Gleevec's MDS sales significantly 68
Uptake of generic imatinib products 69
Avastin (bevacizumab; Roche) 69
Drug profile 70
Product positioning 71
Colorectal cancer 72
Breast cancer 77
Non-small cell lung cancer (NSCLC) 79
Renal cell carcinoma (RCC) 81
SWOT analysis 81
Brand forecast to 2018 83
PBS listing of Vectibix in colorectal cancer should not impact Avastin's sales 83
Lack of PBS listing for renal cell carcinoma drugs also hits Avastin 84
Development of Avastin in other indications may add clout to future sales 85
Other Top 20 molecular targeted therapies 86
Rituxan/MabThera (rituximab; Roche) 86
Brand forecast to 2018 87
Thalidomide Pharmion (thalidomide; Celgene) 90
Brand forecast to 2018 91
Velcade (bortezomib; Janssen-Cilag) 94
Brand forecast to 2018 95
Sprycel (dasatinib; Bristol-Myers Squibb) 97
Brand forecast to 2018 98
Tarceva (erlotinib; Roche) 100
Brand forecast to 2018 101
Erbitux (cetuximab; Merck Serono) 104
Brand forecast to 2018 105
CHAPTER 6 BRAND DYNAMICS - CYTOTOXIC THERAPIES 111
Taxotere (docetaxel; Sanofi-Aventis) 111
Drug profile 111
Product positioning 114
Breast cancer 114
Non-small cell lung cancer (NSCLC) 114
Prostate cancer 115
Ovarian cancer 116
Squamous cell carcinoma of the head and neck (SCCHN) 117
SWOT analysis 118
Brand forecast to 2018 119
A possible approval in gastric cancer 119
Launch of 'super generic' Abraxane not likely to impact Taxotere's sales dramatically 120
Uptake of generic docetaxel products 120
Gemzar (gemcitabine; Eli Lilly) 121
Drug profile 121
Product positioning 122
Pancreatic cancer 122
Ovarian cancer 123
Non-small cell lung cancer (NSCLC) 124
Bladder cancer 124
Breast cancer 124
SWOT analysis 125
Brand forecast to 2018 125
Uptake of generic gemcitabine products 126
Other Top 20 cytotoxic therapies 127
Temodal/Temodar (temozolomide; Merck/Schering-Plough) 127
Brand forecast to 2018 127
Xeloda (capecitabine; Roche) 129
Brand forecast to 2018 130
Alimta (pemetrexed; Eli Lilly) 134
Brand forecast to 2018 135
CHAPTER 7 BRAND DYNAMICS - ANTIHORMONAL THERAPIES 139
Zoladex (goserelin; AstraZeneca) 139
Drug profile 139
Product positioning 140
Prostate cancer 141
Breast cancer 141
SWOT analysis 141
Brand forecast to 2018 142
Arimidex (anastrozole; AstraZeneca) 143
Drug profile 144
Product positioning 145
Breast cancer 145
SWOT analysis 147
Brand forecast to 2018 148
Uptake of generic anastrozole products 149
Other Top 20 antihormonal therapies 149
Lupron (leuprorelin; Abbott) 149
Brand forecast to 2018 150
Femara (letrozole; Novartis) 152
Brand forecast to 2018 153
Androcur (cyproterone; Bayer Schering) 156
Brand forecast to 2018 156
Casodex (bicalutamide; AstraZeneca) 157
Brand forecast to 2018 158
CHAPTER 8 CASE STUDY - THE PROCESS FROM TGA APPROVAL TO PBS LISTING 160
Role of the Therapeutic Goods Administration (TGA) 162
Reforms aim to make Therapeutic Goods Administration's approval process faster and more transparent 162
Role of the Pharmaceutical Benefits Advisory Committee 163
High level of evidence needed to show clinical and cost-effectiveness points to a barrier of market entry 163
Role of the Pharmaceutical Benefits Pricing Authority 165
Reforms split the Pharmaceutical Benefits Scheme into two formularies 166
Pricing methods used by the Pharmaceutical Benefits Pricing Authority 169
Reference pricing method is mainly used for products in Formulary 1 169
Cost Plus method is mainly used for products in Formulary 2 170
Need for cost-effectiveness analysis slows down Pharmaceutical Benefits Scheme listing considerably 170
BIBLIOGRAPHY 172
Papers and articles 172
Press releases 187
Websites 189
Datamonitor reports 190
APPENDIX A - THERAPEUTIC RELATIVITY SHEETS RELEVANT TO ONCOLOGY 191
Section 100 items (effective date: May 2009) 191
ATC L01 - Antineoplastic agents (effective date: May 2009) 191
ATC L02 - Endocrine therapy (effective date: May 2009) 194
APPENDIX B - MARKET ASSUMPTIONS 197
Data definitions, limitations and assumptions 197
Standard units 197
Derivation of sales forecasts and pricing trends 197
Exchange rates used in this report 197
Forecast methodology 198
APPENDIX C 199
Contributing experts 199
Report methodology 199
About Datamonitor 200
About Datamonitor Healthcare 200
About the Oncology analysis team 201
Disclaimer 203
List of Tables
Table 1: Definition of the cancer therapies market in Australia, 2010 8
Table 2: Top 20 cancer therapy brands in Australia, 2008-2018 9
Table 3: Overview of Top 20 cancer therapy molecules with additional sales calculations, 2008 12
Table 4: Sales forecasts of the Top 20 cancer therapy brands in Australia ($m), 2008-2018 15
Table 5: Summary of opportunities and threats in the Australian oncology market, 2010 29
Table 6: The Top 20 cancer therapy brands in Australia, 2008-2018 30
Table 7: Eligibility for Herceptin via the Herceptin Program in Australia, 2009 36
Table 8: Herceptin (trastuzumab) - drug profile, 2010 40
Table 9: Herceptin (trastuzumab) - TGA approval and PBS listing, 2010 41
Table 10: Clinical trial summary for Tykerb/Tyverb for the neoadjuvant and maintenance treatment of HER-2-positive breast cancer 51
Table 11: Glivec/Gleevec (imatinib) - drug profile, 2010 53
Table 12: Glivec/Gleevec (imatinib) - TGA approval and PBS listing, 2010 54
Table 13: Avastin (bevacizumab) - drug profile, 2010 70
Table 14: Avastin (bevacizumab) - TGA approval and PBS listing, 2010 71
Table 15: Rituxan/MabThera (rituximab) - TGA approval and PBS listing, 2010 87
Table 16: Thalidomide Pharmion (thalidomide) - TGA approval and PBS listing, 2010 91
Table 17: Velcade (bortezomib) - TGA approval and PBS listing, 2010 94
Table 18: Sprycel (dasatinib) - TGA approval and PBS listing, 2010 98
Table 19: Tarceva (erlotinib) - TGA approval and PBS listing, 2010 100
Table 20: Erbitux (cetuximab) - TGA approval and PBS listing, 2010 105
Table 21: Taxotere (docetaxel) - drug profile, 2010 111
Table 22: Taxotere (docetaxel) - TGA approval and PBS listing, 2010 112
Table 23: Gemzar (gemcitabine) - drug profile, 2010 121
Table 24: Gemzar (gemcitabine) - TGA approval and PBS listing, 2010 122
Table 25: Temodal/Temodar (temozolomide) - TGA approval and PBS listing, 2010 127
Table 26: Xeloda (capecitabine) - TGA approval and PBS listing, 2010 130
Table 27: Clinical trial summary for Xeloda in combination with Avastin for the treatment of metastatic colorectal cancer 133
Table 28: Alimta (pemetrexed) - TGA approval and PBS listing, 2010 135
Table 29: Zoladex (goserelin) - drug profile, 2010 139
Table 30: Zoladex (goserelin) - TGA approval and PBS listing, 2010 140
Table 31: Arimidex (anastrozole) - drug profile, 2010 144
Table 32: Arimidex (anastrozole) - TGA approval and PBS listing, 2010 145
Table 33: Lupron (leuprorelin) - TGA approval and PBS listing, 2010 150
Table 34: Femara (letrozole) - TGA approval and PBS listing, 2010 153
Table 35: Clinical trial summary for Femara for the (neo)adjuvant treatment of breast cancer 155
Table 36: Androcur (cyproterone) - TGA approval and PBS listing, 2010 156
Table 37: Casodex (bicalutamide) - TGA approval and PBS listing, 2010 158
Table 38: Exchange rates from US dollars, 2008 198
List of Figures
Figure 1: Assumptions to account for missing Pharmatel Fresenius Kabi data 11
Figure 2: Performance of the Top 20 cancer therapy brands in Australia by class, 2008 vs. 2018 17
Figure 3: Performance of the Top 10 cancer therapy brands in Australia, 2008 vs. 2018 19
Figure 4: Average 2001-05 incidence per 100,000 persons of all cancers combined in Australia, by state and territory 21
Figure 5: Projected health and residential aged care expenditure for cancer in Australia, 2002/03-2032/33 25
Figure 6: Overview of different funding programs for oncology products in Australia, 2010 34
Figure 7: Herceptin (trastuzumab) SWOT analysis, 2010 43
Figure 8: Herceptin sales ($m) in Australia, 2008-2018 44
Figure 9: Position of imatinib, dasatinib and nilotinib in the treatment of chronic phase chronic myeloid leukemia (CML) 58
Figure 10: Glivec/Gleevec (imatinib) SWOT analysis, 2010 62
Figure 11: Glivec/Gleevec sales ($m) in Australia, 2008-2018 64
Figure 12: Indexed Avastin sales in the US, five major European markets and Australia, 2004-08 72
Figure 13: Avastin (bevacizumab) SWOT analysis, 2010 82
Figure 14: Avastin sales ($m) in Australia, 2008-2018 83
Figure 15: Rituxan/MabThera sales ($m) in Australia, 2008-2018 88
Figure 16: Thalidomide Pharmion sales ($m) in Australia, 2008-2018 92
Figure 17: Velcade sales ($m) in Australia, 2008-2018 95
Figure 18: Sprycel sales ($m) in Australia, 2008-2018 99
Figure 19: Tarceva sales ($m) in Australia, 2008-2018 101
Figure 20: Erbitux sales ($m) in Australia, 2008-2018 106
Figure 21: Taxotere (docetaxel) SWOT analysis, 2010 118
Figure 22: Taxotere sales ($m) in Australia, 2008-2018 119
Figure 23: Gemzar (gemcitabine) SWOT analysis, 2010 125
Figure 24: Gemzar sales ($m) in Australia, 2008-2018 126
Figure 25: Temodal/Temodar sales ($m) in Australia, 2008-2018 128
Figure 26: Xeloda sales ($m) in Australia, 2008-2018 131
Figure 27: Alimta sales ($m) in Australia, 2008-2018 136
Figure 28: Zoladex (goserelin) SWOT analysis, 2010 142
Figure 29: Zoladex sales ($m) in Australia, 2008-2018 143
Figure 30: Arimidex (anastrozole) SWOT analysis, 2010 148
Figure 31: Arimidex sales ($m) in Australia, 2008-2018 149
Figure 32: Lupron sales ($m) in Australia, 2008-2018 151
Figure 33: Indexed Lupron and Eligard sales in Australia, 2004-08 152
Figure 34: Femara sales ($m) in Australia, 2008-2018 154
Figure 35: Androcur sales ($m) in Australia, 2008-2018 157
Figure 36: Casodex sales ($m) in Australia, 2008-2018 159
Figure 37: Path of approval on the Australian Pharmaceutical Benefits Scheme 161
Figure 38: Factors that the Australian Pharmaceutical Benefits Advisory Committee has identified as informing its decision-making 165
Figure 39: Factors that the Australian Pharmaceutical Benefits Pricing Authority has identified as informing its decision-making 166
Figure 40: The split between the Australian Formulary 1 (F1) and Formulary 2 (F2) 168
Figure 41: Average time from ADEC recommendation to Australian PBS listing for major submissions using a cost-effectiveness analysis approach 171

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