[Ip-health] MSF: Generic competition pushing down HIV drug prices, but patents keep newer drugs unaffordable

Joanna Keenan-Siciliano joanna.l.keenan at gmail.com
Tue Jul 2 02:40:20 PDT 2013

Médecins Sans Frontières releases 16th edition of ARV pricing and access
report, Untangling the Web of Antiretroviral Price Reductions, and Putting
HIV Treatment to the Test, a product guide on viral load and point of care
CD4 tests.

Generic competition pushing down HIV drug prices, but patents keep newer
drugs unaffordable


MSF pricing analysis also extends to HIV diagnostic and monitoring tools

Kuala Lumpur, 2 July 2013—The price of first- and second-line
antiretrovirals (ARVs) to treat HIV are falling because of increased
competition among generic producers, but newer ARVs continue to be priced
astronomically high, according to the annual report Untangling the Web of
ARV Price Reductions, released today by the international medical
humanitarian organisation Médecins Sans Frontières / Doctors Without
Borders (MSF) at the International AIDS Society conference in Kuala Lumpur.

“It’s good news that the price of key HIV drugs continues to fall as more
generic companies compete for the market, but the newer medicines are still
priced far too high,” said Dr. Jennifer Cohn, Medical Director at MSF’s
Access Campaign. “MSF and other care providers need the newer treatments
for people that have exhausted all other options, but patents keep them
priced beyond reach.  We also need to watch carefully as newer, better
medicines reach the market in coming years, as these are the drugs that
we’ll quickly be needing to roll out.  The price question is far from

With the arrival of additional quality-assured sources in the past year,
the ‘best possible’ price of a WHO-recommended one-pill-a-day first-line
combination (tenofovir/lamivudine/efavirenz) has fallen 19% since last year
(from $172 to $139 per person per year), with some countries able to
achieve even lower prices in large volume orders. Likewise, as new generic
competitors have emerged, the prices of two key medicines used in
second-line treatment— atazanavir/ritonavir and lopinavir/ritonavir—have
each fallen by 28% over the last year, with the most affordable second-line
combination (zidovudine/lamivudine + atazanavir/ritonavir) now priced at
$303 per year. This represents a 75% drop in the price of second-line
treatment since 2006. However, today’s lowest second-line price is still
more than double the cost of first-line treatment.

But for newer HIV medicines, including critical new classes of ARVs such as
integrase inhibitors, generic competition is mostly blocked because of
patents.  As a result, these are much more expensive. The best possible
price of a possible salvage regimen for people who have failed second-line
treatment (raltegravir + etravirine + darunavir + ritonavir) is $2,006 per
year in the poorest countries—nearly 15 times the price of first-line
treatment. Countries that do not have access to these lowest available
prices are paying many times more. For example, Thailand and Jamaica pay
$4,760 and $6,570 respectively for the new drug darunavir alone; Paraguay
pays $7,782 just for etravirine; and Armenia pays $13,213 just for
raltegravir—just one of the three or four drugs that are needed for a full

Securing the affordability of future medicines is also a priority.  HIV
experts highlight that new potent and well-tolerated drugs such as the
integrase inhibitor dolutegravir could in the future be used in improved
first- or second-line, making affordable access to these newer drugs even
more urgent.

“Scaling up HIV treatment and sustaining people on treatment for life will
depend on bringing the price of newer drugs down,” said Arax Bozadjian, HIV
Pharmacist at MSF’s Access Campaign.  “Today, there are no quality-assured
generic options for the large majority of the newer HIV drugs.  Prices in
middle-income countries are also a major concern. The terms of existing
voluntary licence agreements aren’t good enough, most of them don’t have
terms that are public-health oriented, and most middle-income countries are
excluded, which limits these countries access to much-needed regimens.”

It was thanks to ‘patent oppositions’ in generics-producing India that the
price of first- and second-line combinations were able to fall, as
additional generic producers entered the market. With newer HIV medicines
increasingly being patented in countries with significant generic
production capacity, like India, it will be critical for solutions to be
identified to bring prices down. Patent applications should be opposed when
they do not meet a country’s patentability requirements, as reaffirmed by
the Indian Supreme Court’s decision against Novartis in April 2013. When
patents prevent access, compulsory licences should be issued in the
interest of public health. India issued its first compulsory licence in
2012 for a cancer drug that was deemed unaffordable, and similar moves
should be taken to overcome unaffordable HIV drug prices.

“In our clinic in Mumbai, more and more patients need the newest expensive
HIV drugs, but we can’t afford these prices long-term, nor can the
government,” said Leena Menghaney, Manager of MSF’s Access Campaign in
India. “Countries need to tackle the problem of high drug prices head on,
by making sure unwarranted patents are not granted, and by issuing
compulsory licences when drugs are priced out of reach so that more
affordable generic versions can be made.”

A second report released today by MSF at the IAS conference, Putting HIV
Treatment to the Test, looks at the price of HIV viral load tests. Viral
load testing is the gold standard for HIV treatment monitoring in developed
countries, as compared with either clinical or immunological (CD4)
monitoring, it can more accurately and quickly detect when people are
having problems adhering to their treatment and need additional
counselling, or in fact are failing their treatment. WHO’s new treatment
recommendations strongly recommend the use of regular viral load monitoring
in developing countries.

But price and complexity so far have hindered the roll out of these
technologies in developing countries.

“The goal of all HIV treatment programmes should be for ARVs to suppress
the virus so people have ‘undetectable’ levels of virus in their blood,”
said Dr. Cohn. “Viral load testing is the best way to keep people on their
more affordable first-line combination of HIV drugs for as long as
possible, and to switch only those people to newer drugs who really need
it. With the price of second-line treatment coming down, it’s really time
to start testing people’s viral load and making sure people are on
treatment that works for them, instead of waiting until it’s too late and
they get sick again or die.”

MSF currently provides antiretroviral therapy to 285,000 people in 21

With support from UNITAID, MSF is seeking to compare and demonstrate the
feasibility of decentralised, routine viral load monitoring, point-of-care
CD4 testing for antiretroviral therapy initiation through comparative
operational research in seven countries in sub-Saharan Africa.

Joanna Keenan
Press Officer
Médecins Sans Frontières - Access Campaign
P: +41 22 849 87 45
M: +41 79 203 13 02
E: joanna.keenan[at]geneva.msf.org
T: twitter.com/joanna_keenan


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