NICE (National Institute for Health and Clinical Excellence) has announced, in its Final Appraisal Determination (FAD), that Baraclude(R) (entecavir) is recommended as an option for treatment of eligible patients with chronic hepatitis B (CHB). Entecavir is a potent anti-viral treatment for chronic Hepatitis B that has been shown to be more effective at suppressing the virus than the most widely used anti-viral treatment (lamivudine)(1) and is less prone to the development of treatment resistance.(2) The recommendation in this FAD is due to be published as final NICE guidance in August of this year.

Richard Marsh, Director of External Affairs and Market Access, Bristol-Myers Squibb said, "Bristol-Myers Squibb welcomes the news that NICE has issued a positive FAD recommending Baraclude as a treatment option for all chronic Hepatitis B patients, in line with its licence.

"Chronic Hepatitis B is a leading cause of liver cirrhosis and liver cancer. It is highly infectious, growing in prevalence in the UK and an increasing cost to NHS resources. Baraclude is a clinically effective and cost effective treatment for all eligible patients with chronic Hepatitis B. Its favourable resistance profile, in particular, makes it a very valuable treatment option for patients and for the NHS."

"If the FAD remains unchanged, it will be published as final guidance in August this year. PCTs will then be required to make funding available for Baraclude for patients prescribed it by their specialist. Bristol-Myers Squibb will continue to work proactively with clinicians and PCTs to enable access to Baraclude for those patients who will benefit from it."

NICE Final Appraisal Determination (FAD)

- Entecavir, within its marketing authorisation, is recommended as an option for the treatment of people with chronic HBeAg-positive or HBeAg-negative hepatitis B in whom antiviral treatment is indicated.(10) This guidance does not apply to people with chronic hepatitis B who also have hepatitis C, hepatitis D or HIV. Further information can be found at nice/guidance/index

Treatment of Chronic Hepatitis B (CHB)

- CHB is a highly infectious and potentially fatal disease which is effectively treated with anti-viral drugs that reduce the amount of virus (viral load) in the blood to an undetectable level

- Over 60%(3) of patients treated with the most widely-used (over 5 years) anti-viral (lamivudine) (1) develop resistance.(3) This identifies the need to access treatment options to which patients do not develop resistance

- The aims of CHB treatment with antivirals are to achieve sustained suppression of the virus, avoid treatment resistance and prevent serious liver disease. The preferred anti-viral therapy should combine superior efficacy (compared to other antiviral treatments) with low resistance rates

- It is estimated that management of CHB could cost the NHS from GBP26m to GBP375m annually(4). The total cost to the economy, including time lost at work, is likely to be substantially higher

Background on CHB

- Hepatitis B is the most serious type of viral hepatitis(5)

- HBV is 100 times more infectious than HIV4 and is the 10th most common cause of death worldwide(9)

- 325,000 people in the UK suffer from chronic HBV5 which is the leading cause of liver cancer and cirrhosis of the liver(7)

- There is an estimated 7,700 new cases of CHB each year(4)

- 15 to 25 percent of chronic hepatitis B patients will die of liver-related diseases(7)

- The cost of treating CHB is less than one third of the cost of caring for patients whose disease becomes too far advanced to treat effectively with anti-virals(6)

Baraclude (Entecavir)

- Entecavir is an oral antiviral therapy specifically designed to provide rapid and sustained suppression of viral replication with minimal development of resistance, reducing viral load to undetectable levels in the majority of new patients with CHB. It is available as 0.5mg and 1mg tablets and is prescribed for once a day use(2)

- Entecavir is generally well tolerated(2)

- There is minimal emergence of resistance in new patients treated with entecavir for up to 5 years(8)

- Entecavir is approved for use in more than 60 countries/regions around the world

References

(1) IMS prescription data on file, February 2008.

(2) Baraclude (entecavir) SPC, January 2008.

(3) Lok, A. S. F., et al. Long-Term Safety of. Lamivudine Treatment in Patients With Chronic Hepatitis B, Gastroenterology 2003;125:1714-1722

(4) Foundation for Liver Research. Hepatitis B: Out of the Shadows; October 2004

(5) Hep B Foundation UK. Rising Curve - Discussion paper Nov 2007

(6) Brown RE, et al.Hepatitis B management costs in France, Italy, Spain and the United Kingdom. J Clin Gastroenterol 2004;38 (Suppl. 3):S169- S174

(7) Wyoming Department of Health. Basic Information on Hepatitis A, Hepatitis B and Hepatitis C. Available here. Accessed March 17, 2006

(8) Tenney DJ et al. Asia-Pacific Association for the Study of the Liver (APASL), Seoul, 23-26 March 2008 (0212).

(9) Lavanchy, D. Hepatitis B epidemiology, disease burden, treatment, and current and emerging prevention and control measures. Journal of Viral Hepatitis. 2004; 11(2):97.

(10) NICE Entecavir FAD, June 2008.

Bristol-Myers Squibb

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