Printer Friendly Printed from http://www.researchandmarkets.com/reports/42618 Stakeholder Insight: Osteoarthritis - COX-2s wear down traditional NSAID use Description: 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 Report 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. Reasons to Purchase 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 Contents: Table of Contents Chapter 1 Executive Summary 2 Scope of the analysis 2 Datamonitor insight into the osteoarthritis market 2 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 2 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 2 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 2 Key metrics 2 Chapter 2 INTRODUCTION AND SCOPE 2 Coverage of the Stakeholder Insight Survey 2 Registries and key non-government stakeholders 2 International 2 Europe 2 US 2 Japan 2 Chapter 3 COUNTRY TREATMENT TREES 2 US 2 Japan 2 France 2 Germany 2 Spain 2 Italy 2 UK 2 Chapter 4 EPIDEMIOLOGY AND PATIENT SEGMENTATION 2 Disease definition and classification 2 Epidemiology of osteoarthritis 2 Limitations, assumptions and caveats 2 Diagnosis inconsistencies 2 Underdiagnosis 2 Representative sample 2 Geographical limitations 2 Changes in the OA population 2 Key patient segmentations 2 Age 2 Gender 2 Severity of disease 2 OA in different parts of the body 2 Co-morbidities, complications and risk factors 2 Age-related disorders 2 GI disorders 2 Depression 2 Rheumatoid arthritis 2 Previous trauma 2 Obesity/weight-related disorders 2 Hypertension 2 Others 2 Chapter 5 DIAGNOSIS AND TREATMENT OPTIONS 2 Presentation and diagnosis 2 Diagnostics 2 Physical exam/patient history 2 X-rays 2 Blood tests 2 Screening 2 Treatment rates 2 Guidelines 2 American College of Rheumatology 2 European League Against Rheumatism 2 Patient presentation and physician management 2 Referral patterns 2 Type of physician 2 Drug vs. non-drug therapy 2 Drug treated population 2 Non-pharmacological therapy 2 Chapter 6 PRESCRIBING TRENDS AND INFLUENCING FACTORS 2 Prescribing trends 2 Class breakdown 2 Monotherapy 2 Combination therapy 2 Comparison between the top three mono and combo therapies 2 Changes in therapy 2 Alternative treatments 2 Hyaluronic acid 2 Glucosamine and chondroitin sulphate 2 Others 2 Brand erosion 2 Factors influencing physician decision making 2 COX-2 trends and influencing factors 2 Gastrointestinal side effects 2 Cardiovascular side effects 2 Chapter 7 IMPROVING TREATMENT OUTCOMES 2 Efficacy assessment 2 Pharmacological efficacy 2 ACR values 2 Pain scales 2 Surgery 2 Hospital stays 2 Unmet needs 2 Diagnostic unmet needs 2 Physician/patient education 2 Therapeutic unmet needs 2 Other unmet needs 2 New product development 2 Critical success factors 2 Awareness 2 Meeting the needs 2 Efficacy 2 Opioids 2 Reformulation 2 DMOADs 2 Chapter 8 OTHER STAKEHOLDER INFLUENCES 2 Who are the other stakeholders in OA? 2 Industry regulators 2 Manufacturers 2 Non-government organizations 2 Regulatory perspectives 2 Clinical trial design 2 Effective endpoint selection 2 Clinical trial duration 2 Complexity of patient cohorts 2 Comparator drugs 2 Validation 2 Prexige: a clinical trial case study 2 More data required? 2 Pharmacology issues 2 Payer/provider perspectives 2 The importance of reimbursement status 2 US pricing and reimbursement 2 The US pricing system 2 Private health coverage 2 Medicare 2 Medicare 2003 2 Japan pricing and reimbursement 2 Europe pricing and reimbursement 2 France 2 Germany 2 Spain 2 Italy 2 The UK, NICE and the NHS 2 Reimbursement in the UK: healthcare through the NHS 2 Reimbursement guidelines 2 The implementation of NICE 2 Chapter 9 OPINION LEADER AND STAKEHOLDER TRANSCRIPTS 2 Tim Warner 2 Marco Matucci-Cerinic 2 Robin Poole 2 Kevin Stone 2 US leading rheumatologists and opinion leader 2 APPENDIX A BIBLIOGRAPHY 2 General and clinical trial data 2 Epidemiology sources 2 US 2 Japan 2 France 2 Italy 2 Spain 2 UK 2 Key associations and conferences 2 Physician research methodology 2 The survey questionnaire 2 The opinion leader discussion guide 2 Disclaimer 2 Ordering: Order Online - visit http://www.researchandmarkets.com/reports/42618 Order by Fax - using the order form below Order By Post - print the order form below and send to Research and Markets, Guinness Centre, Taylors Lane, Dublin 8, Ireland. 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