[Ip-health] MSF statement on patented TB drug delamanid

leena menghaney leenamenghaney at gmail.com
Wed Oct 9 22:03:45 PDT 2019

*MSF calls for new price of anti TB drug delamanid to be lowered and
offered outside of South Africa  *

*Geneva, 9 October 2019* - Médecins Sans Frontières (MSF) *acknowledges the
lower price offered to the government of South Africa
*for newer anti-tuberculosis (TB) drug, delamanid, but calls for it to be
significantly lower and expanded to all countries in need. Mylan, which
licenses the drug from the patent-holder Otsuka, will charge US$940* for a
six-month treatment course ($157 per month) as of 1 June 2020 in South
Africa. Delamanid is used in combination with other drugs to treat people
with drug-resistant TB (DR-TB), including the hard to treat extensively
drug-resistant TB (XDR-TB)

Delamanid is one of the most expensive drugs used to treat drug-resistant
tuberculosis (DR-TB), priced at $1,700** for a six-month treatment course
($283 a month) through the Global Drug Facility, a TB drug and diagnostic
procurement mechanism operating out of a UN agency. It is just one of
multiple drugs needed to treat the disease. Its high price is a key driver
of the high overall cost of treating people with multidrug-resistant TB
(MDR-TB) and XDR-TB. A full 20-month treatment course for one person can
cost $8,000 to $12,000 through GDF, depending upon the length of treatment
and the other drugs that make up the treatment regimen.

The high price has had a chilling effect on treatment scale-up: although
delamanid was conditionally approved by the European Medicines Agency in
April 2014, as of the end of August 2019, only 2,902 people have ever been
treated with delamanid according to the DR-TB Scale-Up Treatment Action Team
of global TB experts, which receives updates from National TB Programmes
and large treatment providers, such as MSF.

The World Health Organization’s (WHO) treatment guidelines
the use of newer drugs as part of all-oral regimens for the treatment of
MDR-TB and XDR-TB. MSF urges more countries to make the switch
older, toxic treatments that need to be injected to all-oral regimens that
contain the newer drugs, including delamanid. These newer drugs are
critical to improving the otherwise abysmal cure rates of 55% and 34% for
MDR-TB and XDR-TB, respectively. Use of the newer TB drugs is also urgently
needed for children with MDR-TB in order to improve treatment outcomes and
reduce the risks of side effects.

However, the $940 price for delamanid offered by Mylan to South Africa
remains too high. It is also not clear whether Mylan plans to offer this
price to all countries. Countries facing high rates of resistance
especially to fluoroquinolone*** drugs, like India, should take effective
measures including overriding patents through compulsory licenses so that
generic manufacturers can enter the supply chain and bring the price down
further. Researchers from the University of Liverpool have calculated that
delamanid could be produced and sold at a profit for much less – ranging
from $5-16 per month if the drug is scaled up by national TB programmes.

*Dr Stobdan Kalon, MSF **Medical Advisor,** India *

“We constantly struggle to successfully treat people with XDR-TB that have
fluoroquinolone resistance and children with MDR-TB at our Mumbai clinic,
which is a grave concern given the unacceptably high rates of treatment
failure and death. In order to improve the chance for a cure, these
patients need effective treatment regimens and immediate access to newer
drugs, bedaquiline and delamanid.

Even at $940, delamanid remains one of the most expensive DR-TB drugs, and
its high price will continue to have a chilling effect on the scale-up of
this drug in national TB programmes. As long as these new drugs are priced
out of reach for TB programmes, an all-oral treatment regimen for people
everywhere with pre-XDR and XDR and children with MDR-TB will remain a
distant reality and people will continue to suffer the devastating side
effects of older drugs that have to be injected, including permanent
deafness. Otsuka and Mylan must further drop the price of delamanid to
ensure that TB programmes are able to afford and scale-up the use of
all-oral treatment regimens.”

*Editor’s Notes:*

* Price includes charges for shipping, handling and insurance (15% approx.)
but excludes Value Added Tax (VAT) (15%)

**Ex works price: Price of the drug that does not include additional
charges of loading, shipment, insurance, import duties etc.

***Fluoroquinolones (FQ): A class of antibiotics that play an essential
role in the treatment of DR-TB. *High levels of resistance to
fluoroquinolones in countries like India
is a serious concern because it is associated with treatment failure and
death for people with DR-TB who are resistant to this class of drugs.

For more information on delamanid, please read:

Issue Brief: *Making the Switch <https://msfaccess.org/making-the-switch>*

Leena Menghaney
Mobile: 9811365412

More information about the Ip-health mailing list