E-DRUG: Technology and Market Landscape Hepatitis C medicines August 2017
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AUGUST 2017
Unitaid and WHO
https://unitaid.eu/assets/HCV-Medicines-Landscape_Aug-2017.pdf
Hepatitis C virus (HCV) is a major global health problem. WHO estimates
that 71 million people worldwide are chronically infected with HCV. Of
those, 2.3 million people are coinfected with the human immunode ciency
virus (HIV) and HCV. In 2015, around 400 000 people died of HCV-related
liver disease, and evidence indicates that the HCV burden is increasing.
Direct acting antivirals (DAAs) have revolutionized treatment for hepatitis
C. Combinations of DAAs can cure infection with HCV in 12 weeks, are highly
e ective and have limited side-e ects. Pan-genotypic combinations (that are
e ective against all genotypes of HCV) have started to become available;
they can contribute to the simpli cation of both the diagnostic and
treatment algorithm, which would enable treatment to be rolled out in
resource-limited settings.
The market for direct-acting antivirals (DAAs) has significantly changed in the few years since they were launched. The relative importance of
regimens is becoming clearer. New DAAs and combinations thereof continue to
be launched, expanding the number of regimens. Nevertheless, to date,
sofosbuvir still is the backbone of most regimens.
DAAs are becoming available in more low- and middle-income countries,
although the pace should be quickened. There is still a long way to go
until all key products are registered and launched in all countries.
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Affordability of DAAs has improved significantly, but access remains
limited. Initially, due to their high prices, affordability of DAAs was limited in high-,
middle- and low-income countries alike. Now there is a divide between those
countries where, because of intellectual property barriers, prices have
remained (very) high and other countries where generics are, or can be,
available at much lower prices. The result is a dual market.
Where prices remain high, countries are rationing access or looking for
other ways to contain costs, such as negotiating prices, concluding
volume/price deals or exploring compulsory licensing. These strategies have
varying degrees of success. Where DAAs are provided only to patients who
are most in need of treatment - generally, the backlog of previously
diagnosed patients1 and those with advanced liver disease - volumes tend to
level after an initial pea, while willingness to pay may decline.
Where generics are available at affordable prices, financing is lacking. In
countries where intellectual property rights are not a barrier or where
licences enable generic competition, DAA prices are starting to approach
the lowest sustainable level, and a cure for HCV is no more costly than a
year of 1st-line HIV treatment. However, many of these countries lack
financing for the treatment of hepatitis C. This is further compounded by other
hurdles, most notably a lack of awareness about hepatitis C among patients
and policy-makers, limited health system readiness, high (out-of-pocket)
cost of diagnosis, and a lack of screening.
Some patients take matters in their own hands. Rather than waiting to
become eligible for treatment to be provided to them, they travel to
countries where they can purchase DAAs at prices they can a ord. Patients
are also ordering DAAs online or buy them through 'buyers' clubs' that
facilitate access for individual patients. In some cases, institutional
actors refer patients to buyers' clubs. While such imports are allowed in
most countries, these purchases bypass regulatory and quality control
systems, as well as treatment guidelines, in importing countries.
Meanwhile, most countries struggle to find the people with HCV infection after
they have treated the initial peak of previously diagnosed (backlog)
patients. This is because of a lack of screening and a lack of awareness of
or demand for HCV testing. The situation is compounded by the fact that
large-scale screening programmes are expensive.
Prioritization of high-risk groups that can be reached for HCV screening,
diagnosis and treatment could be a way forward, and some “path nder”
countries are reportedly considering this approach. Groups at high risk for
HCV infection include, among others, people living with HIV, people who
inject drugs, prisoners and children born to HCV-positive mothers. Offering
HCV screening in, for instance, ART clinics and harm reduction services may
therefore have the dual effect/benefit of facilitating the finding of
HCV-positive patients and reducing new infections (as some of these groups
are driving the HCV epidemic).
The market for generics has developed fast but remains fragile, because of
the various challenges related to demand and uptake that result in
uncertain volumes. The large number of generic suppliers of some DAAs,
resulting in signi cant competition, appears to contribute to this
uncertainty (while also spurring price decreases). Even so, since mid-2016,
more patients were treated with generics than with originator DAAs.
Bruneton Carinne <carinne.bruneton@gmail.com>
e-med@healthnet.org
e-drug@helthnet.org