Stakeholder Opinions: Back Pain - Gain competitive edge by targeting subpopulations

Published by: Datamonitor

Published: Mar. 19, 2009 - 145 Pages

Table of Contents

ABOUT DATAMONITOR HEALTHCARE

About the Central Nervous System pharmaceutical analysis team

CHAPTER 1 EXECUTIVE SUMMARY

Scope of analysis

Datamonitor insight into the back pain market

Contributing experts

Related reports

CHAPTER 2 CONDITION OVERVIEW AND PATIENT POTENTIAL

Introduction

Anatomy of the back

Definition of back pain

Back pain classification

Location

Duration

Etiology

Mechanism

Etiology of back pain

Back pain is a condition of many possible etiologies

Risk factors

Risk factors for back pain are multi-factorial

Genetic risk factors

Individual risk factors

Environmental risk factors

Epidemiology of back pain

Assessing the prevalence of back pain is fraught with methodological difficulties

Acute and chronic back pain is estimated to affect a total of 129 million adults in the seven major markets in 2009

Acute back pain is estimated to affect over 79 million adults across the seven major markets

Chronic back pain is estimated to affect 49 million adults across the seven major markets

Back pain prevalence increases with age

The prevalence rate of back pain during school age approaches that seen in adults

Back pain prevalence peaks among adults of working age

Epidemiological studies report only small gender differences in back pain prevalence

International studies lack consensus on the longitudinal prevalence of back pain

Reports of increased prevalence of back pain in recent years may be attributable to cultural factors

Although highly prevalent, key opinion leaders believe the patient presentation rate for back pain to be low

CHAPTER 3 DIAGNOSIS AND TREATMENT OF BACK PAIN

Diagnosis of back pain

Guidelines discourage routine use of diagnostic imaging

However, some physicians continue to order unnecessary and costly imaging tests

The majority of back pain cases are classified as non-specific

Key treating physicians

Primary care physicians are key prescribers of pharmacological treatments for back pain

Beyond primary care physicians, the management of back pain lacks a well-defined referral pathway

Overview of current treatment options

Pharmacotherapy

The key pharmacological drug classes prescribed for the treatment of back pain are discussed in further detail below.

Non-steroidal anti-inflammatory drugs: the cornerstone of pharmacological treatment of back pain

Opioids

Skeletal muscle relaxants

Non-traditional analgesics

Medical devices

Implantable systems

Transcutaneous electrical nerve stimulation (TENS)

Surgery

Complementary and alternative medicine

Treatment guidelines for back pain

The American College of Physicians and the American Pain Society Joint Clinical Practice Guideline

Clinical guidelines for use of chronic opioid therapy in chronic non-cancer pain

European guidelines for the management of chronic non-specific low back pain

UK: NICE is expected to publish clinical guidelines in May 2009

Unmet needs

Unmet need 1: More targeted treatments

Greater investment in basic science research is needed in order for treatments to become more targeted

Unmet need 2: Improved pain relief and control

Unmet need 3: Improved side effect and safety profile

Unmet need 4: Therapies that carry a lower risk of tolerance and dependence than opioid analgesics

CHAPTER 4 COMMERCIAL OPPORTUNITIES IN THE BACK PAIN MARKET

Introduction

The pain market is highly mature and dominated by non-branded drugs

Seeking back pain as a sole indication represents a high risk strategy

No marketed pharmacological product possesses an indication specifically for back pain

Gaining an indication for the treatment of back pain will serve as a key product differentiator

Gaining a back pain indication will enable marketing messages to become more targeted

Commitment to one condition was a winning strategy for UCB's Keppra

The US market offers the greatest commercial opportunity to drugs with a back pain indication due to the presence of direct-to-consumer (DTC) advertising

Hurdles lie in the path to securing a back pain indication

Difficulties of establishing efficacy in back pain clinical trials

Tougher post-Vioxx regulatory environment in the US

Targeting the neuropathic back pain population represents a more viable strategy

Key opinion leaders concur that targeting treatments towards back pain subpopulations would be of benefit

However, identifying subgroups of non-specific back pain patients amenable to specific drug treatments would require substantial research

Seeking a neuropathic back pain indication represents a viable strategy to companies marketing non-traditional analgesics

Pfizer's Lyrica has benefited from targeting neuropathic pain subtypes

At present no drug is approved for the treatment of neuropathic back pain

Newron's ralfinamide has the potential to become the first drug approved for the treatment of neuropathic low back pain

Topical formulations

Topical treatments account for a minority of pain-drug prescriptions

Development of further injectable formulations and medical devices is unlikely to be met with commercial success

There remains room in the market for further topical formulations

Three prescription topical formulations are presently available for the treatment of pain conditions

Key opinion leaders concur that topical is the preferred drug delivery method among back pain patients

The US will be the most receptive market to topical treatments for back pain

BIBLIOGRAPHY

Books and journal papers

Websites

Datamonitor reports

APPENDIX

Contributing experts

About Datamonitor

About Datamonitor Healthcare

About the CNS analysis team

Disclaimer

List of Tables

Table 1: Epidemiology surveys of back pain, published between 1994 and 2007

Table 2: Prevalence of acute back pain in adults in the seven major markets, 2009

Table 3: Prevalence of chronic back pain in adults in the seven major markets, 2009

Table 4: Epidemiology surveys of neuropathic pain among patients with chronic back pain

Table 5: Prevalence of neuropathic pain among adult patients with chronic back pain across the seven major markets, 2009

Table 6: Epidemiology surveys of back pain among men and women, published between 1995 and 2007

Table 7: Studies examining the longitudinal prevalence of back pain

Table 8: Advantages and disadvantages of two implantable systems in the treatment of back pain

Table 9: Key recommendations on the use of pharmacological treatments from the European guidelines for the management of chronic non-specific low back pain

Table 10: Side effects and risks associated with key drug classes prescribed for back pain, 2009

Table 11: Approved indications of the top 10 pain brands, 2007

Table 12: Key drugs in clinical trials for back pain, 2009

Table 13: Guidelines for clinical studies assessing the efficacy of drugs for the management of acute low back pain

List of Figures

Figure 1: Key regions of the spine

Figure 2: Key classifications of back pain

Figure 3: Key risk factors for developing back pain

Figure 4: Prevalence of back pain in the adult population across the seven major markets in 2009

Figure 5: Age distribution of 1-month and lifetime prevalence of back pain lasting more than 24 hours

Figure 6: Red flags associated with a higher risk of serious disorders as a cause of back pain

Figure 7: Use of lumbar magnetic resonance imaging (MRI) among US Medicare patients, 1994-2005

Figure 8: Current drug treatment for chronic back pain, according to treating physicians in Germany, 2006

Figure 9: Key recommendations of the clinical guideline for the use of chronic opioid therapy on chronic non-cancer pain

Figure 10: Key unmet needs in the treatment of back pain

Figure 11: Branded and unbranded sales value of the pain market across the seven major markets ($ billion), 2004-07

Figure 12: Pros and cons of key strategies to penetrate the back pain market

Figure 13: SWOT analysis for seeking a back pain indication

Figure 14: SWOT analysis: Ralfinamide in the treatment of neuropathic low back pain

Figure 15: Pain market sales volume (IMS standard units sold) by delivery method in the seven major markets, 2007

Figure 16: Seven major market pain market sales value dynamics by delivery method, 2007

Figure 17: Clinical advantages and disadvantages of topical administration of back pain treatments

Abstract

• Back pain overview including definition, risk factors, epidemiology and discussion of key unmet needs.
• Summary of the drug classes currently used for the treatment of back pain and an update of the latest treatment guidelines.
• Evaluation of three potentially viable market entry points to access the highly prevalent back pain population.
• Stakeholder opinions based on qualitative interviews with seven US and European key opinion leaders in the field of back pain.

• Understand the prevalence of acute and chronic back pain, including the proportion of chronic back pain attributable to neuropathic mechanisms.
• Identify the key clinical unmet needs in the treatment of back pain as gauged by the insight provided by interviewed key opinion leaders.
• Evaluate the potential of three strategies which companies can employ in order to increase their presence in the back pain sector of the pain market.

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