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Statement on Fuzeon Access in South Korea from Roche
  Roche has been in discussions for several years with the Ministry for Health in South Korea to address pricing and provide access to Fuzeon (enfuvirtide) for patients through the national health insurance program. The latest price offered to the government, in December 2007, was in line with the lowest price for Fuzeon that is available to other developed countries in the region, such as Taiwan. On October 7, 2008, we reiterated our offer to the government in response to requests from patient groups to make Fuzeon available. Now, Roche has been notified by the Ministry for Health that the matter has been closed for further consideration, effectively ending the dialogue on securing reimbursement for Fuzeon. However, there is an orphan drug center in Korea which is a vehicle to import non-reimbursed drugs and could be used to provide Fuzeon to individual patients.
Fuzeon - Its Price Explained
The offered price represents the lowest sustainable price at which Roche can provide Fuzeon to South Korea. The production process for this complex molecule requires more than 100 steps - 10 times more than other antiretrovirals. A single vial takes six months to produce, and 45 kg of raw materials are necessary to produce 1 kg of Fuzeon.
Since even before Fuzeon was initially approved in 2003, Roche undertook extensive efforts to help the HIV community understand why Fuzeon requires such a complex manufacturing process and why it is necessary that Fuzeon be priced higher than other antiretrovirals. We remain willing to engage in dialogue with HIV community activists in South Korea and other countries to share our rationale.
In regions with more mature HIV epidemics such as the US and Western Europe, the patient need for Fuzeon has declined significantly in the last year due to the introduction of newer HIV medications that, like Fuzeon, are effective in patients with resistance to the older classes of antiretrovirals. While Roche is committed to ensuring that Fuzeon remains available for patients, this declining demand means that our production costs have not decreased over time.
Access to Medicines
Roche takes its role to improve access to medicines very seriously. We seek sustainable and ethical ways to create partnerships, policies and programs that increase access to our medicines. We supply our antiretrovirals, Invirase and Viracept, at no profit and reduced prices for people living in Least Developed Countries (LDCs)[i]/ sub-Saharan Africa and low-income/lower-middle income countries respectively. (Viracept is not supplied by Roche in the United States, Canada or Japan.)
Roche has also established transparent no patent policies for all its medicines, so intellectual property is not a barrier to access for any of our medicines in the world's LDCs. This is extended to patents on antiretrovirals in sub-Saharan Africa, the poorest and hardest hit region by HIV/AIDS.
At the same time, it is essential that health authorities in developed countries such as South Korea do their part to help support access to the medicines their citizens need.
[i]UN list of Least Developed Countries (LDCs) can be found on (Accessed 29 February 2008)
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