The cost of access to hepatitis C treatment varies
enormously according to where you live, Isabelle Meyer-Andrieux of MSF told a
symposium organised by Treatment Action Group. The cost of a course of pegylated
interferon and ribavirin ranges from around US$2000 in Egypt to $28,000 in
Vietnam, and new HCV protease inhibitors are unaffordable in most settings.
Reducing the cost of treatment is not simple. In the HIV
field, it has been possible to reduce the cost because the first and second
generation of antiretroviral drugs were never protected by patents in India. As
a result, Indian manufacturers were able to produce high-quality generic
versions very cheaply, making access to treatment possible for millions of people
in low- and middle-income countries.
But in the case of hepatitis C, treatment is based on a
biopharmaceutical, pegylated interferon, which is produced through a biological
process. Regulators need to be satisfied that any new version of pegylated interferon
is manufactured to a high standard and achieves similar outcomes to existing
branded products, pegylated interferon alfa 2a (Pegasys) and alfa 2b (PegIntron).
The World Health Organization (WHO) has a review process called
pre-qualification that is used to check whether generic versions of HIV and TB
drugs meet the quality standards that guarantee an active and safe drug.
Pre-qualification by WHO allows new medicines to be licensed quickly in
countries that may not have the expertise or staff capacity to review lots of
In contrast, WHO has no procedure for pre-qualifying
biotherapeutic products like interferon, and doesn’t yet list pegylated
interferon as an Essential Medicine. Inclusion on the WHO Essential Medicines
List would help advocates to lobby for registration at country level.
The lack of biosimilar products means that there is no price
competition, said Meyer-Andrieux, but there is potential for that to change.
The Indian patent for Pegasys was
revoked in November 2012, allowing Indian manufacturers to begin the
application process for biosimilar versions of pegylated interferon.