[Ip-health] MSF responds to BMS access plans on hep C drug daclatasvir

Joanna Keenan-Siciliano joanna.l.keenan at gmail.com
Mon Nov 3 03:11:30 PST 2014

MSF responds to BMS commercial strategy for hepatitis C drug daclatasvir in
developing countries

Pharmaceutical company Bristol-Myers Squibb (BMS) has recently revealed a
restrictive commercial strategy for sales of its new direct-acting
antiviral (DAA) hepatitis C drug daclatasvir in developing countries. This
new generation of drugs to treat hepatitis C is giving hope to the 185
million people infected with the disease today, as these drugs are expected
to improve treatment and provide significantly higher chances of cure.

But the prices of these drugs are of grave cause for concern. Gilead’s
sofosbuvir, the first DAA which received USFDA approval, is priced at
US$84,000 per three-month treatment course in the United States, and nearly
$95,000 per treatment when used in combination with another DAA,
ledipasvir. These prices will hinder any attempt to scale up treatment of
the disease.

But studies have suggested that the cost to produce these drugs is just a
tiny fraction of the price of the drug; sofosbuvir costs just $68 - $136
per treatment to produce. One of these studies, from Liverpool University,
suggests daclatasvir could cost as little as $10 - $30 to produce for a 12
week course of treatment. BMS has not yet announced the price for
developing countries for daclatasvir, but the company has announced that it
will create a tiered pricing strategy for the drug.  Tiered pricing is a
marketing strategy that sets different prices for different countries, most
often based on macroeconomic factors; the effect is that middle-income
countries – where nearly three-quarters of the world’s poor, and over 70
percent of people with hepatitis C, live – are required to pay high prices
that are unaffordable to treatment providers such as MSF, government health
programs, and patients who must pay for medicines out of pocket.

BMS also announced its intention to negotiate voluntary licenses – which
allow selected generic manufacturers to market cheaper versions of a drug –
but with a geographical coverage of only 90 developing countries.
Restrictive licensing terms can prevent generic competition where it is
needed most: the BMS policy could mean that many middle-income countries
with a significant burden of hepatitis C, including China, Egypt and
Ukraine, are excluded from access to more affordable generic versions of
daclatasvir and will have to pay higher prices. The ability to produce or
import generic versions of daclatasvir will be critical to significantly
reduce prices of these drugs, as well as to develop or sell fixed-dose
combinations that are expected to provide the best treatment outcomes for

Registration of daclatasvir in all countries will also be key; BMS has
indicated that it does not have plans to register the drug worldwide, which
will seriously hinder access in those countries where BMS chooses not
register the drug.

Finally, BMS has largely decided their plans in secret, sharing very few
details on plans for registration, price and access ahead of the
announcement, an approach that is reminiscent of industry approaches in the
early years of the AIDS epidemic and unacceptable by any standard today.
Details shared ahead of the announcement have been purposefully vague and
BMS has not yet committed to publishing any licence agreement it signs with
generic manufacturers in the future, or its tiered pricing structure for
developing countries.

BMS’ secrecy and very restrictive commercial plans for developing countries
is of grave concern, given the medical importance of daclatasvir; studies
have shown it to have high rates of cure when used in combination with
other DAAs.  Daclatasvir is also pan-genotypic, showing it is effective for
genotype 3, which has proven difficult to treat with other DAAs and is
highly prevalent among people living with hepatitis C in India and

Médecins Sans Frontières (MSF) responds to the news of BMS’s plans on
access and licensing for daclatasvir:

“Unfortunately, history seems to be repeating itself with BMS, who haven’t
learnt from the company’s poor track record responding to the HIV epidemic;
it is disappointing that BMS is choosing to lock out millions of people
from gaining affordable access to daclatasvir, and will not commit to
registering the drug in all countries that have a hepatitis C burden, even
those that do not represent a commercial opportunity for BMS.

“Once again, people in middle-income countries – where nearly
three-quarters of the world’s poor, and over 70 percent of people with
hepatitis C, live – are the ones left empty-handed. Affordable access to
daclatasvir has been intentionally blocked from most middle-income
countries, with BMS keen to extract as much profit as it possibly can.  MSF
hopes that excluded governments will take all relevant measures available
under global trade rules and national patent laws to secure access to
low-cost generic versions of these medicines.

“BMS’ secrecy portends an unwelcome approach that does not respond to the
urgent need for affordable access to hepatitis C drugs for millions of
people across the developing world.”

- Rohit Malpani, Director of Policy and Analysis, Médecins Sans Frontières
Access Campaign.

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: @joanna_keenan


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