Stakeholder Insight: Osteoarthritis - COX-2s wear down traditional NSAID use

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Publication Date: 2003-12-16

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Introduction
Osteoarthritis is characterized by the degeneration of the articular cartilage and is treated by PCPs, rheumatologists and orthopedic surgeons. It is the most prevalent form of arthritis, affecting approx. 10% of the population, equating to a patient population of over 73 million people in the seven major pharmaceutical markets.

Scope

COX-2 inhibitor focused analysis of data into prescribing patterns, switching and side effects from treating physicians and opinion leaders
Country specific drug-treated population is used to provide patient numbers for each drug class with each of the most commonly used drugs listed
Prescribing and influencing factors cited by the physicians surveyed for five classes of drug used in mono- and combination therapy
Clinical trial design with an in-depth case study of Prexige and reimbursement issues for each of the target markets

Highlights
COX-2 inhibitors are used in 34% of the total OA population. Uptake varies over the seven different markets with 40% of severe patients currently prescribed them in the US and only 26% of severe patients receiving them in the UK. Use increases with disease severity across all markets.

Traditional NSAID and COX-2 use is strongly influenced by switching trends between the two. Variation in prescribing rates is due to a number of influences including, DTC advertising, the high prices of COX-2s and the ability of different healthcare systems to deal with them.

Clinical trial design is critical, as shown by the FDA decision to delay the approval of Prexige. This is attributed to a number of factors including trial duration, choice of comparator, the VIGOR results or pharmacology issues in the US. To gain market share it needs to supplant Pfizer's Celebrex and Bextra as well as Merck's Vioxx and Arcoxia.

Why you should buy this report

Use prescription rates to predict product sales across the seven major markets
Target specific geographical areas and disease severities to ensure maximum product uptake
Plan clinical trials and provide useful marketing data using the trial analysis and suggestions for improvement in this report

CHAPTER 1 EXECUTIVE SUMMARY - page 3
- Scope of the analysis - page 3
- Datamonitor insight into the osteoarthritis market - page 5
  - COX-2 inhibitors are used in 34% of the total OA population. Uptake varies over the seven different markets with 40% of severe patients currently prescribed them in the US and only 26% of severe patients receiving them in the UK. Use increases with disease severity across all markets, but those areas where COX-2s are most successful physicians increasingly prescribe them to moderate and mild patients - page 6
  - Traditional NSAID and COX-2 use is strongly influenced by switching trends between the two. Variation in prescribing rates is due to a number of influences including, DTC advertising, the high prices of COX-2s and the ability of different healthcare systems to deal with them. The demand for COX-2s is high in the US, Japan and Italy, and is estimated through percentages of patients at risk from GI events. Another strong influencing factor is the divided opinion about side effects, with the consensus indicating that they do reduce GI events but opposing opinions on the possible CV effects - page 8
  - Prexige (lumiracoxib), developed by Novartis, was set to be the fourth COX-2 on the US market in late 2003. However, the FDA delayed its approval and it is now unlikely that it will be approved before 2005. The decision to delay can be attributed to a number of potential factors, including long-term effects, or the reaction to VIGOR results - page 10
- Key metrics - page 12
TABLE OF CONTENTS - page 15
CHAPTER 2 INTRODUCTION AND SCOPE - page 23
- Coverage of the Stakeholder Insight Survey - page 23
  - Registries and key non-government stakeholders - page 26
CHAPTER 3 COUNTRY TREATMENT TREES - page 28
CHAPTER 4 EPIDEMIOLOGY AND PATIENT SEGMENTATION - page 67
- Disease definition and classification - page 67
- Epidemiology of osteoarthritis - page 68
- Limitations, assumptions and caveats - page 70
  - Diagnosis inconsistencies - page 70
  - Underdiagnosis - page 71
  - Representative sample - page 72
  - Geographical limitations - page 72
- Changes in the OA population - page 72
- Key patient segmentations - page 74
- Severity of disease - page 76
- OA in different parts of the body - page 77
- Co-morbidities, complications and risk factors - page 78
CHAPTER 5 DIAGNOSIS AND TREATMENT OPTIONS - page 83
- Presentation and diagnosis - page 83
  - Diagnostics - page 85
  - Physical exam/patient history - page 86
  - X-rays - page 86
  - Blood tests - page 87
- Screening - page 87
- Treatment rates - page 88
  - Guidelines - page 88
  - Patient presentation and physician management - page 91
- Referral patterns - page 92
  - Type of physician - page 93
- Drug vs. non-drug therapy - page 94
  - Drug treated population - page 94
  - Non-pharmacological therapy - page 96
CHAPTER 6 PRESCRIBING TRENDS AND INFLUENCING FACTORS - page 99
- Prescribing trends - page 99
  - Monotherapy - page 106
  - Combination therapy - page 109
- Changes in therapy - page 113
- Alternative treatments - page 115
  - Hyaluronic acid - page 115
  - Glucosamine and chondroitin sulphate - page 118
  - Others - page 120
- Brand erosion - page 121
- Factors influencing physician decision making - page 123
- COX-2 trends and influencing factors - page 125
  - Gastrointestinal side effects - page 132
  - Cardiovascular side effects - page 133
CHAPTER 7 IMPROVING TREATMENT OUTCOMES - page 136
- Efficacy assessment - page 136
  - Pharmacological efficacy - page 136
  - Surgery - page 139
- Unmet needs - page 139
  - Diagnostic unmet needs - page 141
  - Physician/patient education - page 141
  - Therapeutic unmet needs - page 142
  - Other unmet needs - page 143
- New product development - page 144
  - Critical success factors - page 144
  - Awareness - page 148
  - Meeting the needs - page 148
- DMOADs - page 150
CHAPTER 8 OTHER STAKEHOLDER INFLUENCES - page 152
- Who are the other stakeholders in OA? - page 152
- Regulatory perspectives - page 154
  - Clinical trial design - page 154
- Prexige: a clinical trial case study - page 157
- Payer/provider perspectives - page 161
  - The importance of reimbursement status - page 162
- US pricing and reimbursement - page 164
- Japan pricing and reimbursement - page 167
- Europe pricing and reimbursement - page 169
  - France - page 169
  - Germany - page 170
  - Spain - page 172
  - Italy - page 174
  - The UK, NICE and the NHS - page 176
CHAPTER 9 OPINION LEADER AND STAKEHOLDER TRANSCRIPTS - page 181
- Tim Warner - page 181
- Marco Matucci-Cerinic - page 190
- Robin Poole - page 193
- Kevin Stone - page 198
- US leading rheumatologists and opinion leader - page 201
  - General and clinical trial data - page 208
  - Epidemiology sources - page 209
  - Key associations and conferences - page 211
- Physician research methodology - page 212
- The survey questionnaire - page 212
- The opinion leader discussion guide - page 234
  - Disclaimer - page 235

List of Tables
Table 1: Patient demand for COX-2 inhibitors, by country and disease severity (%), 2003 - page 9
Table 2: OA current and future estimated prevalence by country, 2003 and 2010 - page 12
Table 3: Disease severity classification - page 67
Table 4: OA current and future estimated prevalence by country, 2003 and 2010 - page 70
Table 5: Population age 60+, by country (%), 2000-10 - page 72
Table 6: OA prevalence, by country and age bracket (millions), 2003 - page 74
Table 7: US prevalence of radiographic knee OA in men and women (%), 1992-93 - page 75
Table 8: UK prevalence of radiographic knee OA in men and women (%), 1988 - page 76
Table 9: Comorbidities by country and OA population weighted total (%), 2003 - page 79
Table 10: Tests and strategies used in the diagnosis of osteoarthritis by country, 2002 - page 85
Table 11: Eight leading symptoms sited by physicians in diagnosing OA - page 86
Table 12: ACR pharmacologic therapy guidelines for OA - page 89
Table 13: Initial presentation and treatment of OA, by country and specialty (%), 2002 - page 92
Table 14: ACR non-pharmacologic therapy guidelines for OA - page 96
Table 15: Diagnosed OA patients receiving non-drug therapy alone in the seven major markets (%), 2003 - page 97
Table 17: Moderate OA patients per country receiving specific drug classes, split by mono/combination therapy (%), 2003 - page 102
Table 18: Severe OA patients per country receiving specific drug classes, split by mono/combination therapy (%), 2003 - page 103
Table 19: Sum of mild/moderate/severe totals in three previous tables - page 103
Table 20: Drug class breakdown of OA patients receiving at least one treatment, % of total country population, 2003 - page 105
Table 21: Patients receiving hyaluronic acid, by country and disease severity, % of total country OA population, 2003 - page 116
Table 22: Patients receiving glucosamine and chondroitin sulphate, by country and disease severity (%), 2003 - page 118
Table 23: Influencing factors by average global importance, 2003 - page 123
Table 24: Breakdown of COX-2 prescribing patterns by mono- and combination therapy, % of each countries total OA population, 2003 - page 126
Table 25: Patient demand for Cox-2 inhibitors, by country and disease severity (%), 2003 - page 133
Table 26: Summary of key Vioxx studies into CV side effects, 2001-03 - page 135
Table 27: Criteria used by physicians to measure treatment efficiency, by country, 2002 - page 138
Table 28: Comparative medication costs in the UK, 2002 - page 144
Table 29: Pipeline pain treatments, 2003 - page 147
Table 30: DMOADs in development, 2003 - page 150
Table 31: Patients prescribed diclofenac as a monotherapy, % of total OA population, by country and severity, 2003 - page 160
Table 32: Importance of reimbursement in prescribing decision (%) - page 162
Table 33: Co-payments for drugs/services in the Japanese reimbursement system, 2000 - page 168

List of Figures
Figure 1: Patients receiving COX-2 inhibitors, % of country total OA population, 2003 - page 7
Figure 2: OA drug treated population based on diagnosis rates and drug treatment rates, by country and severity, %, m, 2003 - page 13
Figure 3: Global mono and combination therapies with disease severities, %, 2003 - page 14
Figure 4: Diagrammatic overview of the coverage of the Osteoarthritis Stakeholder Insight survey, 2003 - page 25
Figure 5: Global mono- and combination therapies and disease severities (%), 2003 - page 30
Figure 6: US OA drug-treated and non-drug treated population by severity, 2003 - page 34
Figure 10: US OA combination treatments by disease severity, patient percentage and number, 2003 - page 35
Figure 11: Japan OA drug-treated and non-drug treated population by severity, 2003 - page 40
Figure 15: Japan OA combination treatments by disease severity, patient percentage and number, 2003 - page 41
Figure 16: France OA drug-treated and non-drug treated population by severity, 2003 - page 45
Figure 20: France OA combination treatments by disease severity, patient percentage and number, 2003 - page 46
Figure 21: Germany OA drug-treated and non-drug treated population by severity, 2003 - page 47
Figure 22: Germany mild OA monotherapy treatment, patient percentage and number, 2003 - page 48
Figure 23: Germany moderate OA monotherapy treatment, patient percentage and number, 2003 - page 49
Figure 24: Germany severe OA monotherapy treatment, patient percentage and number, 2003 - page 50
Figure 25: Germany OA combination treatments by disease severity, patient percentage and number, 2003 - page 51
Figure 26: Spain OA drug-treated and non-drug treated population by severity, 2003 - page 55
Figure 30: Spain OA combination treatments by disease severity, patient percentage and number, 2003 - page 56
Figure 31: Italy OA drug-treated and non-drug treated population by severity, 2003 - page 58
Figure 33: Italy moderate OA monotherapy treatment, patient percentage and number, 2003 - page 59
Figure 34: Italy severe OA monotherapy treatment, patient percentage and number, 2003 - page 60
Figure 35: Italy OA combination treatments by disease severity, patient percentage and number, 2003 - page 61
Figure 36: UK OA drug-treated and non-drug treated population by severity, 2003 - page 62
Figure 37: UK mild OA monotherapy treatment, patient percentage and number, 2003 - page 63
Figure 38: UK moderate OA monotherapy treatment, patient percentage and number, 2003 - page 64
Figure 39: UK severe OA monotherapy treatment, patient percentage and number, 2003 - page 65
Figure 40: UK OA combination treatments by disease severity, patient percentage and number, 2003 - page 66
Figure 41: OA prevalence population by country (millions), 2003 and 2010 - page 69
Figure 42: Relationship between radiographic and symptomatic OA - page 71
Figure 43: New patients per month, by country (%), 2003 - page 73
Figure 44: Breakdown of OA population by age, 2003 - page 75
Figure 45: Severity of OA populations, by country, % of diagnosed patients, 2003 - page 77
Figure 46: Global OA sufferers who present with the disease in specific parts of the body (%), 2003 - page 78
Figure 47: OA co-morbidities in the seven major markets - page 79
Figure 48: Diagnosed OA patient populations in seven major markets, 2003 - page 83
Figure 49: OA patients initially diagnosed by type of physician in the seven major markets (%), 2002 - page 84
Figure 50: EULAR treatment recommendations for knee OA, 2003 - page 90
Figure 51: Proportion of patients initially treated, by country and specialty (%), 2002 - page 91
Figure 52: OA patients referral by specialty (%), 2003 - page 93
Figure 53: Type of physician patient referred to, 2003 - page 94
Figure 54: OA drug treated population based on diagnosis rates and drug treatment rates, by country and severity, 2003 - page 95
Figure 55: Non-pharmacological treatments utilized by physicians for OA in seven major markets, 2003 - page 96
Figure 56: OA patients treated with pharmacological, non-pharmacological and combination therapy, by country and disease severity (%), 2003 - page 98
Figure 57: OA patients receiving more than one drug in the seven major markets (%), 2003 - page 100
Figure 58: US mild monotherapy analgesics, as a percentage of the total US OA population, calculation example - page 101
Figure 59: US patients receiving COX-2s, example calculation (%), 2003 - page 104
Figure 60: OA patients on monotherapy receiving specific drug classes in the seven major markets, by severity, %, 2003 - page 106
Figure 61: OA patients on specific combination therapies in the seven major markets, by severity (%), 2003 - page 110
Figure 62: Patients using most popular forms of therapy for both mono and combinations, in the seven major markets, 2003 - page 112
Figure 63: Proportion of patients taking analgesics that switch to NSAIDs, by country (%), 2003 - page 113
Figure 64: Patients switching from one NSAID to another due to lack of results, by country (%), 2003 - page 114
Figure 65: Patients receiving hyaluronic acid, by country and disease severity, % of total country OA population, 2003 - page 116
Figure 66: Patients receiving glucosamine and chondroitin sulphate, by country and disease severity (%), 2003 - page 119
Figure 67: Average use of branded products for traditional NSAIDs, oral steroids and injectable steroids, by country, %, 2003 - page 121
Figure 68: US brand erosion, %, 2003 - page 122
Figure 69: Factors influencing physician prescribing habits, in the US, EU and Japan, scores out of 10, factors in order of global average - page 124
Figure 70: Top six DTC advertised drugs in the US, 2002 - page 126
Figure 71: Breakdown of COX-2 prescribing patterns by mono- and combination therapy, % of each countries total OA population, 2003 - page 127
Figure 72: OA patients only taking traditional NSAIDs who are eventually switched to COX-2 inhibitors, by country, 2003 - page 128
Figure 73: Increase in percentage of COX-2 prescriptions in each disease severity, UK, 2002-03 - page 129
Figure 74: Effect of introduction of second generation COX-2s on physician prescribing patterns, by country, scores of one to 10 with 10 being the most influential, 2003 - page 130
Figure 75: Importance of price of second generation COX-2 inhibitors, by country, scores of one to 10 with 10 the most influential, 2003 - page 131
Figure 76: Patients considered at an increased risk for gastrointestinal side effects, by country (%), 2003 - page 132
Figure 77: Unmet needs in the treatment of OA in the seven major markets, 2003 - page 140
Figure 78: Patients receiving oral and topical NSAIDs, by country (%), 2003 - page 149
Figure 79: The effect of DMOAD research - page 151
Figure 80: Size and future dynamics of stakeholder influences - page 152
Figure 81: Chemical structures of Prexige (lumiracoxib) compared to leading COX-2 inhibitors and diclofenac - page 159
Figure 82: Diclofenac prescriptions averaged across all disease severities (%), 2003 - page 161
Figure 83: Influence of reimbursement, by country, 2003 - page 163
Figure 84: Influence of cost on prescribing decisions - page 164
Figure 85: German reimbursement structure - page 172
Figure 86: Hierarchy of authority in the Spanish approval, pricing and reimbursement system - page 174

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Stakeholder Insight: Osteoarthritis - COX-2s wear down traditional NSAID use

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