Stakeholder Insight: Epilepsy - Neurologists remain loyal to brands in genericized market

Introduction

The epilepsy market has become increasingly competitive following the launch of Vimpat (lacosamide; UCB) in the US in May 2009 and patent expiries of the top four second-generation anticonvulsant drugs over 2008–09. However, the switching of stable epilepsy patients to a generic alternative remains controversial due to physicians’ concerns surrounding compromised seizure control.
Features and benefits

* Forecasts of diagnosed active epilepsy cases in the seven major markets based on a comprehensive epidemiological review.* Estimated diagnosis rates, care pathway, and segmentation of epilepsy cases by partial onset and generalized seizures.* In-depth analysis of treatment patterns and regimens prescribed for epilepsy by line of therapy.* Analysis of five key brands, including established players and recent market entrants based upon physician perception and therapeutic role.* Review of patient outcomes including prevalence of drug-resistant epilepsy.
Highlights

Despite the launch of generic equivalents of four second generation anticonvulsants over 2008–09, branded anticonvulsants are the clear treatment of choice for neurologists when treating epilepsy patients. It is evident that neurologists are reluctant to switch epilepsy patients to generic products due to concerns over compromised seizure control.Neurologists initiate treatment of epilepsy with first generation anticonvulsants before progressing to, second generation products. However, throughout three lines of pharmacotherapy, fewer generalized epilepsy patients than partial onset epilepsy patients receives treatment with second generation anticonvulsants.Keppra is perceived as possessing the best overall efficacy and tolerability, and as such is positioned as the current gold-standard pharmacotherapy. This favorable perception is keeping with the drug’s market leading status in terms of 2009 sales revenues.
Your key questions answered

* How large is the population of patients with diagnosed active epilepsy? How do these patients progress through the care pathway?* Which anticonvulsants are prescribed the most and what is their most common therapeutic role? How does this change at second- and third-line therapy?* Which factors influence neurologists' prescribing decisions the most?* How do neurologists perceive the efficacy and tolerability of Vimpat (lacosamide) - UCB's follow-on to its market leading epilepsy product, Keppra.

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Executive Summary
Scope of the analysis
Datamonitor insight into the epilepsy market
Related reports
OVERVIEW
Catalyst
Summary
1. INTRODUCTION AND SCOPE
Coverage of the Stakeholder Insight Survey
Country treatment trees
Epidemiology
Diagnosis and patient segmentation
Treatment options and clinical guidelines
Treatment trends
Prescribing influences and brand assessment
Treatment outcomes
2. COUNTRY TREATMENT TREES
Introduction to treatment trees
US
Japan
France
Germany
Italy
Spain
UK
3. EPIDEMIOLOGY
Introduction
Key points
Disease definition and diagnosis criteria
Global variation and temporal trends
Prevalence: highest in low socioeconomic areas
Incidence: highest in children and in developing countries
Survival: influenced by accident-related deaths
Mortality: highest in children or soon after diagnosis
Co-morbidities of epilepsy
Risk factors
Cerebrovascular disease: most common identifiable cause in adults
Head injury: severity dependent
Central nervous system infection and tumors: cysticercosis is the most common
Perinatal factors: most prevalent in developing countries
Other factors: family history, alcohol
Epidemiologic forecasting of epilepsy
Sources of epidemiologic data
Description of methods
US
Japan
European markets
Results
Current prevalent cases and future trends
Discussion
Strengths and limitations of Datamonitor’s epidemiologic projections
Conclusions
4. DIAGNOSIS AND PATIENT SEGMENTATION
Diagnosis of epilepsy
Techniques used in diagnosing epilepsy
Datamonitor’s survey indicates that a relatively low proportion of people with epilepsy receive a confirmed epilepsy diagnosis
Patient segmentation
Subtypes of epilepsy: partial onset, generalized, and unclassified
Age distribution of epilepsy patients
5. TREATMENT OPTIONS AND CLINICAL GUIDELINES
Pharmacological treatment options
A plethora of anticonvulsant drugs are available, but no true broad spectrum agent exists
Non-pharmacological treatment options
Neurosurgery
Vagus nerve stimulation
Treatment guidelines
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American Epilepsy Society and the American Academy of Neurology
Scottish Intercollegiate Guidelines Network
National Institute of Health and Clinical Excellence (NICE)
6. TREATMENT TRENDS BY LINES OF THERAPY: PARTIAL ONSET EPILEPSY
First-line pharmacotherapy
Surveyed neurologists state that 84% of their partial onset epilepsy patients ever receives first-line pharmacotherapy
Monotherapy versus combination therapy
Branded anticonvulsants versus generics
First-generation versus second-generation anticonvulsants
Most commonly prescribed anticonvulsants for first line treatment of partial onset epilepsy
Second line pharmacotherapy
An average 39% of patients with partial onset epilepsy progress from first- to second-line pharmacotherapy
Monotherapy versus combination therapy
Branded anticonvulsants versus generics
First-generation versus second-generation anticonvulsants
Most commonly prescribed drugs for second-line treatment of partial onset epilepsy
Third-line pharmacotherapy
Almost a quarter of partial onset epilepsy patients progress from second- to third-line pharmacotherapy
Monotherapy versus combination therapy
Branded anticonvulsants versus generics
First generation versus second generation anticonvulsants
Most commonly prescribed drugs for third-line treatment of partial onset epilepsy
Treatment of drug-resistant partial onset epilepsy
A greater proportion of patients with drug-resistant partial epilepsy will undergo surgery than receive VNS
7. TREATMENT TRENDS BY LINES OF THERAPY: GENERALIZED EPILEPSY
First-line pharmacotherapy
A lower proportion of generalized epilepsy patients than expected ever receives first-line pharmacotherapy
Monotherapy versus combination therapy
Branded anticonvulsants versus generics
First-generation versus second-generation anticonvulsants
Most commonly prescribed anticonvulsants for first-line treatment of partial onset epilepsy
Second-line pharmacotherapy
An average of 37% of patients with generalized epilepsy progress from first- to second-line pharmacotherapy across the seven major markets
Monotherapy versus combination therapy
Branded anticonvulsants versus generics
First-generation versus second-generation anticonvulsants
Most commonly prescribed drugs for second-line treatment of generalized epilepsy
Third line pharmacotherapy
Just over one fifth of generalized epilepsy patients progress from second to third-line pharmacotherapy
Monotherapy versus combination therapy
Branded anticonvulsants versus generics
First-generation versus second-generation anticonvulsants
Most commonly prescribed drugs for third-line treatment of generalized epilepsy
Treatment of drug-resistant generalized epilepsy
On average, 5% of generalized epilepsy patients with drug-resistant epilepsy will undergo surgery
8. PRESCRIBING INFLUENCES AND BRAND ASSESSMENT
Clinical factors influencing physician decision-making
Overall efficacy in reducing seizure frequency is the principal prescribing influence in the treatment of epilepsy
For physicians in Japan, recommendation of drugs in treatment guidelines is a key prescribing influence
Cost issues exert the least influences over physicians’ prescribing decisions for epilepsy patients
Physician perception of key brands
Banzel is the least well known of the anticonvulsants rated by surveyed neurologists
Keppra (levetiracetam; UCB)
Drug overview
Use by line of therapy
Physician perception
Topamax (topiramate; Johnson & Johnson)
Drug overview
Use by line of therapy
Physician perception
Lamictal (lamotrigine; GlaxoSmithKline)
Drug overview
Use by line of therapy
Physician perception
Banzel/Inovelon (rufinamide; Eisai)
Drug overview
Use by line of therapy
Physician perception
Vimpat (lacosamide; UCB)
Drug overview
Use by line of therapy
Physician perception
9. TREATMENT OUTCOMES
Treatment outcomes: Reduction in seizure frequency
Survey highlights lack of optimism among neurologists in terms of reduction in seizure frequency
Drug-resistant epilepsy
Drug-resistant epilepsy is most prevalent among patients with partial onset epilepsy
BIBLIOGRAPHY
Epidemiology
Publications and online articles
Diagnosis and patient segmentation
Publications and online articles
Datamonitor reports and products
Treatment options and clinical guidelines
Publications and online articles
Treatment trends by line of therapy: partial onset epilepsy
Publications and online articles
Datamonitor reports and products
Treatment trends by line of therapy: generalized epilepsy
Publications and online articles
Prescribing influences and brand assessment
Publications and online articles
Datamonitor reports and products
Treatment Outcomes
Publications and online articles
Datamonitor reports and products
APPENDIX A
Physician research methodology
Physician sample breakdown
APPENDIX B
The survey questionnaire
Screener questions
Questionnaire
Contributing experts
Datamonitor consulting
Disclaimer

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