Stakeholder Insight: Osteoporosis - Generic alendronate further establishes oral bisphosphonates as gold standard

Published by: Datamonitor

Published: Oct. 7, 2008 - 199 Pages

Table of Contents

ABOUT DATAMONITOR HEALTHCARE

About the Women's Health pharmaceutical analysis team

CHAPTER 1 EXECUTIVE SUMMARY

Scope of the analysis

Datamonitor insight into the osteoporosis market

Contributing experts

Related reports

CHAPTER 2 COUNTRY TREATMENT TREES

Introduction to treatment trees

US

Japan

France

Germany

Italy

Spain

UK

CHAPTER 3 DISEASE BACKGROUND AND EPIDEMIOLOGY

Disease background

Osteoporosis classification: primary and secondary

Patient segmentation

Severity: osteopenia, osteoporosis and severe/established osteoporosis

Gender

Ethnicity

Osteoporosis in children

Niche populations with osteoporosis

Epidemiology

Methodological difficulties in assessing prevalence

Differences in the definition of osteopenia, osteoporosis, severe/established osteoporosis and vertebral fractures

Disparities in the reference points (T-score) used for bone mineral density measurement

Differences in the skeletal sites scanned to measure bone mineral density and diagnose osteoporosis

Patient populations include different age groups

Prevalence of osteopenia, osteoporosis and severe/established osteoporosis in postmenopausal women

US

Japan

France

Germany

Italy

Spain

UK

Ageing population expands osteoporosis patient potential

CHAPTER 4 PRESENTATION, DIAGNOSIS AND TREATMENT RATES

Presentation

Similar number of patients are diagnosed after screening as those presenting with a fracture

Initial presentation is most often with a specialist in an out-patient hospital setting

There is not one particular reason most common for presentation

Diagnosis

Under-diagnosis is a major problem in osteoporosis

Patients are most often diagnosed by a specialist in the out-patient setting

The combination of primary assessment and additional diagnostic techniques to achieve an osteoporosis diagnosis is underused

Patient history and physical exam are the most important parts of primary assessment

Dual-energy X-ray absorptiometry (DXA) of the spine/hip is most widely used additional diagnostic technique

Treatment rates

Treatment rates have been increasing but are still low

Guidelines base initiation of pharmacological treatment on cost-effectiveness

The US National Osteoporosis Foundation guidelines on the prevention and treatment of osteoporosis

The European Guidance for the diagnosis and management of osteoporosis in postmenopausal women

The UK National Institute of Clinical Excellence guidelines on primary and secondary prevention of fractures

The German Dachverband Osteologie guideline osteoporosis in women after menopause and in men after age 60

The use of pharmacological treatment increases with disease severity

Type of physician responsible for initial and long-term treatment varies per country

Most patients treated by specialists are treated in the out-patient setting

CHAPTER 5 TREATMENT OPTIONS AND TRENDS

Non-pharmacological treatment of osteoporosis

Overview of the available drug classes

Bisphosphonates

Bisphosphonate combinations

Selective estrogen receptor modulators (SERMs)

Parathyroid hormone (PTH) and analogs

Calcitonins

Dual action bone agents (DABAs)

Hormone replacement therapy (HRT)

Vitamin D

Guidelines often favor bisphosphonates as first-line therapy but do not give detailed recommendations

The European Guidance for the Diagnosis and Management of Osteoporosis in Postmenopausal Women

The National Institute for Health and Clinical Excellence (NICE) guidelines for the primary prevention of fractures

The National Institute for Health and Clinical Excellence (NICE) guidelines for the secondary prevention of fractures

The German Dachverband Osteologie (DVO) guidelines

The guidelines published by the National Osteoporosis Foundation (NOF)

Trends in pharmacological treatment

Compliance is an important issue in the treatment of osteoporosis

Trends in first-line treatment

Oral bisphosphonates dominate all severities across the seven major markets

Injectable bisphosphonates are mainly reserved for most severe disease

Selective estrogen receptor modulators (SERMs) are most often prescribed in osteopenia

Parathyroid hormones (PTHs) are most often prescribed in severe osteoporosis

Calcitonins are still prominent in Japanese treatment regimens

Strontium ranelate particularly popular in France, Italy and Spain

Reasons to switch to second-line treatment

Trends in second-line treatment

Entry of generic alendronate in the US and Japan

CHAPTER 6 PRESCRIBING INFLUENCES AND BRAND ASSESSMENT

Factors influencing physician decision making

Physician perception of key brands

Total scores per drug per country

Interpreting a brand map

The bisphosphonate class

Bisphosphonates brand map

Bisphosphonates individual scores

Bisphosphonates treatment trends

Overview of key brands

The selective estrogen receptor modulator (SERM) class

Selective estrogen receptor modulator (SERM) brand map

Selective estrogen receptor modulator (SERM) individual scores

Selective estrogen receptor modulator (SERM) treatment trends

Overview of key brands

Products from other drug classes

Products from other drug classes brand map

Products from other drug classes individual scores

Products from other drug classes prescribing trends

Overview of key brands

BIBLIOGRAPHY

Articles

Websites

Press releases

APPENDIX A

Physician research methodology

Physician sample breakdown

US

Japan

France

Germany

Italy

Spain

UK

Contributing experts

APPENDIX B

The survey questionnaire

Section 1 - Patient Segmentation

Section 2 - Presentation and diagnosis

Section 3 - Treatment options

Section 4 - Treatments

Section 5 - Product Profiles

Section 6 -Generic Erosion

About Datamonitor

About Datamonitor Healthcare

About the Women's Health and Urology analysis team

Disclaimer

List of Tables

Table 1: Niche populations with osteoporosis

Table 2: Overview of studies estimating the prevalence of osteopenia in the seven major markets, 2008

Table 3: Overview of studies estimating the prevalence of osteoporosis in the seven major markets

Table 4: Overview of studies estimating the prevalence of severe/established osteoporosis in the seven major markets

Table 5: Prevalence of osteopenia in postmenopausal women across the seven major markets, 2008

Table 6: Prevalence of osteoporosis in postmenopausal women across the seven major markets, 2008

Table 7: Prevalence of severe/established osteoporosis in postmenopausal women across the seven major markets, 2008

Table 8: Overview of the postmenopausal patient populations across the seven major markets with each severity of osteoporosis, 2008

Table 9: Osteoporosis management of hip fracture patients by study site in the US

Table 10: Guideline recommendations on when to initiate pharmacological treatment of osteoporosis, 2008

Table 11: Overview of level of evidence for three bisphosphonates in the primary and secondary prevention of fractures in postmenopausal osteoporosis

Table 12: Overview of the key bisphosphonates available for osteoporosis (sales are osteoporosis-specific), 2008

Table 13: Overview of the key bisphosphonate combinations available for osteoporosis (sales are osteoporosis-specific), 2008

Table 14: Overview of the only selective estrogen receptor modulators (SERM) available for osteoporosis (sales are osteoporosis-specific), 2008

Table 15: Overview of the key parathyroid hormone (PTH) and analogs available for osteoporosis (sales are osteoporosis-specific), 2008

Table 16: Overview of the key calcitonins available for osteoporosis (sales are osteoporosis-specific), 2008

Table 17: Overview of the only dual action bone agent available for osteoporosis in the seven major markets, 2008

Table 18: First-line recommendations of a selection of osteoporosis guidelines, 2008

Table 19: Anti-fracture efficacy of the most frequently used treatments for postmenopausal osteoporosis when given with calcium and vitamin D, as derived from randomized controlled trials

Table 20: Number and percentage of physicians able to rate each osteoporosis drug, 2008

Table 21: Total scores (out of 100) of each osteoporosis drug for each of the individual seven major markets

Table 22: US physician sample breakdown, 2008

Table 23: Japan physician sample breakdown, 2008

Table 24: France physician sample breakdown, 2008

Table 25: Germany physician sample breakdown, 2008

Table 26: Italy physician sample breakdown, 2008

Table 27: Spain physician sample breakdown, 2008

Table 28: UK physician sample breakdown, 2008

List of Figures

Figure 1: US treatment tree, 2008

Figure 2: Japan treatment tree, 2008

Figure 3: France treatment tree, 2008

Figure 4: Germany treatment tree, 2008

Figure 5: Italy treatment tree, 2008

Figure 6: Spain treatment tree, 2008

Figure 7: UK treatment tree, 2008

Figure 8: Osteoporotic fractures occur most commonly at the spine, hip and wrist

Figure 9: World Health Organization classification of osteoporotic bone loss

Figure 10: Average prevalence according to osteoporosis severity across the seven major markets, 2008

Figure 11: Average age at diagnosis for each severity of osteoporosis across the seven major markets, 2008

Figure 12: Rising percentage of women over 50 years of age in the seven major markets, 2008 and 2020

Figure 13: Different routes of diagnosis: screening and presenting with a fracture - average across the seven major markets, 2008

Figure 14: Percentage of patients who present initially to each type of physician, 2008

Figure 15: Percentage of patients who present initially to a specialist in each location, 2008

Figure 16: Percentage of osteopenic and osteoporotic patients who present for each reason, 2008

Figure 17: Percentage of patients who are diagnosed by each type of physician, 2008

Figure 18: Percentage of patients who are diagnosed by a specialist in each location, 2008

Figure 19: Use of each method of patient assessment by PCPs/GPs and specialists in order to reach osteoporosis diagnosis, 2008

Figure 20: Potentially osteoporotic patients who receive each method of primary assessment, 2008

Figure 21: Potentially osteoporotic patients who receive each method of additional diagnostic technique, 2008

Figure 22: Advantages of central dual-energy X-ray absorptiometry (DXA)

Figure 23: Treatment of Caucasian women aged 60 years or older with osteoporosis or vertebral fractures by primary care physicians, by drug type, 1993-97

Figure 24: Management algorithm in postmenopausal women based on an health economic analysis for the UK, 2008

Figure 25: Osteopenic, osteoporotic and severe/established osteoporotic patients receiving each type of treatment, 2008

Figure 26: Percentage of patients who are treated (initially and long-term) by each type of physician, 2008

Figure 27: Percentage of patients who are treated by a specialist in each

Abstract

• Target physicians more effectively through an understanding of prescribing behavior and its influences.
• Validate new product forecasting based on diagnosis and treatment rates, and the likely rate of uptake for new products
• Benchmark brand awareness and perceptions surrounding product positioning in order to formulate competitive lifecycle management strategies.

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