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

This publication has been discontinued on July 19, 2011.

Introduction

Abstract

Overview

Introduction

Almost 100 million post-menopausal women suffer from osteopenia and osteoporosis in the seven major markets. Those diagnosed are often identified through screening for low bone mineral density or after presenting with a fracture. Although not all guidelines are clear on when to initiate pharmacological treatment, most base their assessment of the type of drug to treat with on cost-benefit analyses

Scope

• Patient segmentation by disease severity as defined by the WHO; including osteopenia, osteoporosis, and severe/established osteoporosis
• Analysis of presentation, diagnosis, and treatment trends as well patient referral pathways in each of the major regions
• Treatment trends split by line of therapy and disease severities, including drug switching behaviors in each of the seven major market regions
• Prescriber scoring of key drug brands on factors including efficacy, side effects, dosing flexibility, formulations, patient compliance, and cost

Report Highlights

The asymptomatic characteristics of osteoporosis, the fact that the majority of fractures remain undetected and the lack of nationwide screening means that osteoporosis is severely under-diagnosed.

About two-thirds of the patients are treated initially by a specialist and stay with the specialist for long-term treatment across the seven major markets, although a small group of patients switch from initial treatment by a specialist to long-term treatment under their general practitioner

The most important factors that physicians consider when prescribing drugs for osteoporosis are efficacy on bone mineral density and fracture risk reduction. Bisphosphonates reached similar scores on efficacy and safety in Datamonitor' s physician survey, but are differentiated in terms of cost, flexibility of administration, and intermittent dosing

Reasons to Purchase

• 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.

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 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 location, 2008
  • Figure 28: Percentage of patients discontinuing pharmacological treatment due to non-compliance at different times across the seven major markets, 2008
  • Figure 29: Osteopenic, osteoporotic and severe/established osteoporotic patients receiving each drug class in the 7MM, 2008
  • Figure 30: Overview of the prescription of oral bisphosphonates across osteoporosis severities, per country, 2008
  • Figure 31: Overview of the prescription of injectable bisphosphonates across osteoporosis severities, per country, 2008
  • Figure 32: Overview of the prescription of selective estrogen receptor modulators (SERMs) across osteoporosis severities, per country, 2008
  • Figure 33: Overview of the prescription of parathyroid hormones across osteoporosis severities, per country, 2008
  • Figure 34: Overview of the prescription of calcitonins across osteoporosis severities, per country, 2008
  • Figure 35: Overview of the prescription of drugs from other drug classes across osteoporosis severities, per country, Figure 36: Percentage of patients switching from first-line therapy to second-line therapy due to a new or recurrent fracture, 2008
  • Figure 37: Percentage of patients switching from first-line therapy to second-line therapy for other reasons, 2008
  • Figure 38: Osteopenic, osteoporotic and severe/established osteoporotic patients receiving each drug class in first-line, second-line due to fracture and second-line for another reason, 2008
  • Figure 39: Sales of Fosamax and generic Fosamax in the five major European countries, 2003-07
  • Figure 40: Percentage of patients in the US and Japan who will be switched to generic alendronate from Fosamax, a different bisphosphonate or a drug from a different class, 2008
  • Figure 41: Number of points allocated to each factor to indicate its relative importance in each country or region, 2008
  • Figure 42: Brand map of the scoring attributes of osteoporosis drugs in relation to each other
  • Figure 43: Brand map of the scores of the individual products in relation to each other
  • Figure 44: Brand map highlighting the position of bisphosphonate products, 2008
  • Figure 45: Number of points allocated to each bisphosphonate on all factors, seven major markets, 2008
  • Figure 46: Osteopenic, osteoporotic and severe/established osteoporotic patients receiving each bisphosphonate brand, 2008
  • Figure 47: Brand map highlighting the position of selective estrogen receptor modulators (SERMs), 2008
  • Figure 48: Number of points allocated to each selective estrogen receptor modulator (SERM) on all factors, seven major markets, 2008
  • Figure 49: Osteopenic, osteoporotic and severe/established osteoporotic patients receiving each selective estrogen receptor modulator (SERM) brand, 2008
  • Figure 50: Brand map highlighting the position of products from other drug classes, 2008
  • Figure 51: Number of points allocated to products in other drug classes on all factors, seven major markets, 2008
  • Figure 52: Osteopenic, osteoporotic and severe/established osteoporotic patients receiving each drug from other drug classes, 2008

Related Reports