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

Table of Contents

CHAPTER 1 EXECUTIVE SUMMARY

Scope of the analysis

Datamonitor insight into the osteoarthritis market

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

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

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

Key metrics

CHAPTER 2 INTRODUCTION AND SCOPE

Coverage of the Stakeholder Insight Survey

Registries and key non-government stakeholders

CHAPTER 3 COUNTRY TREATMENT TREES

US

Japan

France

Germany

Spain

Italy

UK

CHAPTER 4 EPIDEMIOLOGY AND PATIENT SEGMENTATION

Disease definition and classification

Epidemiology of osteoarthritis

Limitations, assumptions and caveats

Diagnosis inconsistencies

Underdiagnosis

Representative sample

Geographical limitations

Changes in the OA population

Key patient segmentations

Severity of disease

OA in different parts of the body

Co-morbidities, complications and risk factors

CHAPTER 5 DIAGNOSIS AND TREATMENT OPTIONS

Presentation and diagnosis

Diagnostics

Physical exam/patient history

X-rays

Blood tests

Screening

Treatment rates

Guidelines

Patient presentation and physician management

Referral patterns

Type of physician

Drug vs. non-drug therapy

Drug treated population

Non-pharmacological therapy

CHAPTER 6 PRESCRIBING TRENDS AND INFLUENCING FACTORS

Prescribing trends

Monotherapy

Combination therapy

Changes in therapy

Alternative treatments

Hyaluronic acid

Glucosamine and chondroitin sulphate

Others

Brand erosion

Factors influencing physician decision making

COX-2 trends and influencing factors

Gastrointestinal side effects

Cardiovascular side effects

CHAPTER 7 IMPROVING TREATMENT OUTCOMES

Efficacy assessment

Pharmacological efficacy

Surgery

Unmet needs

Diagnostic unmet needs

Physician/patient education

Therapeutic unmet needs

Other unmet needs

New product development

Critical success factors

Awareness

Meeting the needs

DMOADs

CHAPTER 8 OTHER STAKEHOLDER INFLUENCES

Who are the other stakeholders in OA?

Regulatory perspectives

Clinical trial design

Prexige: a clinical trial case study

Payer/provider perspectives

The importance of reimbursement status

US pricing and reimbursement

Japan pricing and reimbursement

Europe pricing and reimbursement

France

Germany

Spain

Italy

The UK, NICE and the NHS

CHAPTER 9 OPINION LEADER AND STAKEHOLDER TRANSCRIPTS

Tim Warner

Marco Matucci-Cerinic

Robin Poole

Kevin Stone

US leading rheumatologists and opinion leader

General and clinical trial data

Epidemiology sources

Key associations and conferences

Physician research methodology

The survey questionnaire

The opinion leader discussion guide

Disclaimer

List of Tables

Table 1: Patient demand for COX-2 inhibitors, by country and disease severity (%), 2003

Table 2: OA current and future estimated prevalence by country, 2003 and 2010

Table 3: Disease severity classification

Table 5: OA current and future estimated prevalence by country, 2003 and 2010

Table 6: Population age 60+, by country (%), 2000–10

Table 7: OA prevalence, by country and age bracket (millions), 2003

Table 8: US prevalence of radiographic knee OA in men and women (%), 1992–93

Table 9: UK prevalence of radiographic knee OA in men and women (%), 1988

Table 4: Comorbidities by country and OA population weighted total (%), 2003

Table 5: Tests and strategies used in the diagnosis of osteoarthritis by country, 2002

Table 6: Eight leading symptoms sited by physicians in diagnosing OA

Table 12: ACR pharmacologic therapy guidelines for OA

Table 7: Initial presentation and treatment of OA, by country and specialty (%), 2002

Table 8: ACR non-pharmacologic therapy guidelines for OA

Table 9: Diagnosed OA patients receiving non-drug therapy alone in the seven major markets (%), 2003

Table 11: Moderate OA patients per country receiving specific drug classes, split by mono/combination therapy (%), 2003

Table 12: Severe OA patients per country receiving specific drug classes, split by mono/combination therapy (%), 2003

Table 13: Sum of mild/moderate/severe totals in three previous tables

Table 14: Drug class breakdown of OA patients receiving at least one treatment, % of total country population, 2003

Table 15: Patients receiving hyaluronic acid, by country and disease severity, % of total country OA population, 2003

Table 16: Patients receiving glucosamine and chondroitin sulphate, by country and disease severity (%), 2003

Table 17: Influencing factors by average global importance, 2003

Table 18: Breakdown of COX-2 prescribing patterns by mono- and combination therapy, % of each countries total OA population, 2003

Table 19: Patient demand for Cox-2 inhibitors, by country and disease severity (%), 2003

Table 20: Summary of key Vioxx studies into CV side effects, 2001–03

Table 21: Criteria used by physicians to measure treatment efficiency, by country, 2002

Table 22: Comparative medication costs in the UK, 2002

Table 23: Pipeline pain treatments, 2003

Table 24: DMOADs in development, 2003

Table 25: Patients prescribed diclofenac as a monotherapy, % of total OA population, by country and severity, 2003

Table 26: Importance of reimbursement in prescribing decision (%)

Table 27: Co-payments for drugs/services in the Japanese reimbursement system, 2000

List of Figures

Figure 1: Patients receiving COX-2 inhibitors, % of country total OA population, 2003

Figure 2: OA drug treated population based on diagnosis rates and drug treatment rates, by country and severity, %, m, 2003

Figure 3: Global mono and combination therapies with disease severities, %, 2003

Figure 4: Diagrammatic overview of the coverage of the Osteoarthritis Stakeholder Insight survey, 2003

Figure 5: Global mono- and combination therapies and disease severities (%), 2003

Figure 6: US OA drug-treated and non-drug treated population by severity, 2003

Figure 10: US OA combination treatments by disease severity, patient percentage and number, 2003

Figure 11: Japan OA drug-treated and non-drug treated population by severity, 2003

Figure 15: Japan OA combination treatments by disease severity, patient percentage and number, 2003

Figure 16: France OA drug-treated and non-drug treated population by severity, 2003

Figure 20: France OA combination treatments by disease severity, patient percentage and number, 2003

Figure 21: Germany OA drug-treated and non-drug treated population by severity, 2003

Figure 22: Germany mild OA monotherapy treatment, patient percentage and number, 2003

Figure 23: Germany moderate OA monotherapy treatment, patient percentage and number, 2003

Figure 24: Germany severe OA monotherapy treatment, patient percentage and number, 2003

Figure 25: Germany OA combination treatments by disease severity, patient percentage and number, 2003

Figure 26: Spain OA drug-treated and non-drug treated population by severity, 2003

Figure 30: Spain OA combination treatments by disease severity, patient percentage and number, 2003

Figure 31: Italy OA drug-treated and non-drug treated population by severity, 2003

Figure 33: Italy moderate OA monotherapy treatment, patient percentage and number, 2003

Figure 34: Italy severe OA monotherapy treatment, patient percentage and number, 2003

Figure 35: Italy OA combination treatments by disease severity, patient percentage and number, 2003

Figure 36: UK OA drug-treated and non-drug treated population by severity, 2003

Figure 37: UK mild OA monotherapy treatment, patient percentage and number, 2003

Figure 38: UK moderate OA monotherapy treatment, patient percentage and number, 2003

Figure 39: UK severe OA monotherapy treatment, patient percentage and number, 2003

Figure 40: UK OA combination treatments by disease severity, patient percentage and number, 2003

Figure 41: OA prevalence population by country (millions), 2003 and 2010

Figure 42: Relationship between radiographic and symptomatic OA

Figure 43: New patients per month, by country (%), 2003

Figure 44: Breakdown of OA population by age, 2003

Figure 45: Severity of OA populations, by country, % of diagnosed patients, 2003

Figure 46: Global OA sufferers who present with the disease in specific parts of the body (%), 2003

Figure 47: OA co-morbidities in the seven major markets

Figure 48: Diagnosed OA patient populations in seven major markets, 2003

Figure 49: OA patients initially diagnosed by type of physician in the seven major markets (%), 2002

Figure 50: EULAR treatment recommendations for knee OA, 2003

Figure 51: Proportion of patients initially treated, by country and specialty (%), 2002

Figure 52: OA patients referral by specialty (%), 2003

Figure 53: Type of physician patient referred to, 2003

Figure 54: OA drug treated population based on diagnosis rates and drug treatment rates, by country and severity, 2003

Figure 55: Non-pharmacological treatments utilized by physicians for OA in seven major markets, 2003

Figure 56: OA patients treated with pharmacological, non-pharmacological and combination therapy, by country and disease severity (%), 2003

Figure 57: OA patients receiving more than one drug in the seven major markets (%), 2003

Figure 58: US mild monotherapy analgesics, as a percentage of the total US OA population, calculation example

Figure 59: US patients receiving COX-2s, example calculation (%), 2003

Figure 60: OA patients on monotherapy receiving specific drug classes in the seven major markets, by severity, %, 2003

Figure 61: OA patients on specific combination therapies in the seven major markets, by severity (%), 2003

Figure 62: Patients using most popular forms of therapy for both mono and combinations, in the seven major markets, 2003

Figure 63: Proportion of patients taking analgesics that switch to NSAIDs, by country (%), 2003

Figure 64: Patients switching from one NSAID to another due to lack of results, by country (%), 2003

Figure 65: Patients receiving hyaluronic acid, by country and disease severity, % of total country OA population, 2003

Figure 66: Patients receiving glucosamine and chondroitin sulphate, by country and disease severity (%), 2003

Figure 60: Average use of branded products for traditional NSAIDs, oral steroids and injectable steroids, by country (%), 2003

Figure 67: US brand erosion, %, 2003

Figure 68: Factors influencing physician prescribing habits, in the US, EU and Japan, scores out of 10, factors in order of global average

Figure 69: Top six DTC advertised drugs in the US, 2002

Figure 70: Breakdown of COX-2 prescribing patterns by mono- and combination therapy, % of each countries total OA population, 2003

Figure 71: OA patients only taking traditional NSAIDs who are eventually switched to COX-2 inhibitors, by country, 2003

Figure 72: Increase in percentage of COX-2 prescriptions in each disease severity, UK, 2002–03

Figure 73: 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

Figure 63: Importance of price of second generation COX-2 inhibitors, by country, scores of one to 10 with 10 the most influential, 2003

Figure 74: Patients considered at an increased risk for gastrointestinal side effects, by country (%), 2003

Figure 75: Unmet needs in the treatment of OA in the seven major markets, 2003

Figure 76: Patients receiving oral and topical NSAIDs, by country (%), 2003

Figure 77: The effect of DMOAD research

Figure 78: Size and future dynamics of stakeholder influences

Figure 79: Chemical structures of Prexige (lumiracoxib) compared to leading COX-2 inhibitors and diclofenac

Figure 80: Diclofenac prescriptions averaged across all disease severities (%), 2003

Figure 81: Influence of reimbursement, by country, 2003

Figure 82: Influence of cost on prescribing decisions

Figure 83: German reimbursement structure

Figure 84: Hierarchy of authority in the Spanish approval, pricing and reimbursement system