LCSP: The Market

Medical Unmet Need The Product Address

Market Analysis

Market opportunity

Benchmarking analysis

What is the competitive landscape

Burden of Disease

Natural history and progression of Chronic Hepatitis C

The rate of hepatitis C chronic infection and disease progression varies considerably. The majority of people w ith hepatitis C will not develop advanced liver disease. Of 100 people with the hepatitis C virus (HCV), approximately 25 people w ill spontaneously clear the virus. Between 30 and 40 people will continue to be infected w ith the virus but w ill not develop progressive liver disease.

Thirty five to 45 will develop some level of progressive liver disease associated w ith their hepatitis C. Symptoms related to hepatitis C and quality of life impairment may be present in both people with and without progressive liver disease. Of the 35 to 45 people with progressive liver disease, without treatment approximately 5 to 10 will develop cirrhosis (10 – 20% life time risk) and 1-3 will develop hepatocellular carcinoma. The heterogeneity in disease progression and symptomatic disease means that some people will require limited contact with the health profession and support systems associated with hepatitis C whereas others will require constant and on going contact. It is important to emphasise that high risk patterns of alcohol consumption can accelerate liver damage from hepatitis C.

Prevalence of chronic hepatitis C infection

Epidemiology of hepatitis C–

Approximately 3% (170 million) of the world’s population has been infected with HCV. For most countries, the prevalence of HCV infection is <3%. The prevalence is higher (up to 15%) in some countries in Africa and Asia and highest (>15%) in Egypt. The most frequent mode of transmission in the United States is through sharing drug-injecting equipment among people who inject drugs. Travelers’ risk for contracting HCV infection is generally low. For international travelers, the principal activities that can result in blood exposure are the following:

·Receiving blood transfusions that have not been screened for HCV

·Having medical or dental procedures

·Engaging in activities (such as acupuncture, tattooing, or injecting drug use) in which

equipment has not been adequately sterilized or disinfected, or in which contaminated equipment is reused

·Working in health care fields (medical, dental, or laboratory) that entail direct exposure to human blood

Transmission risk

Hepatitis C is a blood-borne virus affecting the liver. For successful transmission to occur the virus must be present in the blood of a person w ith hepatitis C in sufficient concentrations to present an infection threat to another person (people with even low viral loads may transmit HCV, depending on the type of exposure), and directly enter the bloodstream of another person by blood-to-blood contact through a rupture or opening in the skin.

Three patents La Roche

Suppliers for PEGINTERFERON ALFA-2A

Hoffman-la Roche

A sensitive search strategy was applied to several electronic bibliographic databases. Relevant studies were critically appraised and meta-analyzed. A hypothetical cohort of 1,000 patients entered a Markov model and were followed up for a more than 30-year period to predict natural history, duration spent in each health state, and treatment costs.

Results: Two fully published Phase III randomized controlled trials were included. Methodological quality was generally good. Dual therapy with pegylated interferon was significantly more effective than nonpegylated dual therapy with a pooled sustained virological response rate (SVR) of 55 percent (95 percent confidence interval [CI], 52–58 percent) compared with 46 percent (95 percent CI, 43–49 percent).

Conclusions: Pegylated interferon is clinically effective, represents good value for the money, and is a significant advance in the treatment of this insidious disease.