[Ip-health] MSF press release & briefing doc: First new TB drugs in half a century reach just 2% of people who need them

Michelle French Michelle.French at newyork.msf.org
Thu Dec 3 04:53:21 PST 2015


From the 46th Union Conference on Lung Health, currently being held this 
week in Cape Town, South Africa, Médecins Sans Frontières (MSF) is urging 
drug companies Johnson & Johnson (Janssen) and Otsuka to widen access and 
increase affordability of the first two new drugs in more than 50 years to 
treat tuberculosis. Currently, just a tiny 2% of people who are eligible 
for treatment with the new drugs have received them. 

Please find below our press release (also available online at 
http://msfaccess.org/about-us/media-room/press-releases/first-new-tb-drugs-half-century-reach-just-2-people-who-need-them
).

And please read our briefing paper, Out of Time: Access to DR-TB 
Treatment, which is available here: http://msfaccess.org/out_of_time

For all MSF press releases and publications, as well as the schedule of 
MSF events, please visit:: https://www.msf.org.za/union2015
** We will be posting our Union-related publications and press releases on 
this webpage, and in the schedule posted there you can find a list of our 
poster sessions as well.

MSF PRESS RELEASE:

First new TB drugs in half a century reach just 2% of people who need them
 
MSF calls for companies to make new drugs to treat drug-resistant TB 
available and affordable

Cape Town, 3 December 2015—Nearly three years since the first of two new 
tuberculosis (TB) medicines became available, the drugs remain out of 
reach for people who need them, with just two percent of people eligible 
for these treatments actually receiving them. The drugs bedaquiline, 
produced by Johnson & Johnson (Janssen) and delamanid, produced by Otsuka, 
are the first new TB treatments to become available in half a century, and 
offer hope for people with drug-resistant forms of TB. Médecins Sans 
Frontières (MSF) called on the two companies to ensure faster global 
access to these drugs by registering and making their products available 
in affected countries and offering affordable prices to low- and 
middle-income countries.

Tuberculosis is a curable disease that continues to kill around 1.5 
million people per year, with new cases of drug-resistant forms affecting 
nearly half a million people annually. According to World Health 
Organization, barely a quarter of people thought to have 
multidrug-resistant (MDR-TB) were put on treatment in 2014, with only 
about half of those successfully completing treatment. For people with an 
even more severe form of the disease, extensively drug-resistant TB 
(XDR–TB), the treatment success rate drops to just one in four.

“It’s beyond infuriating to know that there are medicines out there that 
could offer hope to people who have exhausted all other treatment options, 
but that so few people have access to them,” said Dr. Grania Brigden, MSF 
Access Campaign TB Advisor. “What’s the point of a new potentially 
life-saving treatment if the people who need it the most cannot access 
it?”

Data from MSF projects and elsewhere show improved responses in treatment 
using the drug bedaquiline with culture conversion rates of 84%, 97%, 75% 
and 77% after six months of treatment in XDR-TB patients in Armenia, 
France, Russian Federation (Chechnya) and South Africa respectively.

Access to bedaquiline and delamanid is severely limited. Less than 3000 
people have received bedaquiline as of November 2015. Only about 100 
people have received delamanid through compassionate use programmes. These 
numbers are pathetic considering there are an estimated 48,000 people with 
XDR-TB globally and at least twice as many with pre-XDR-TB and MDR-TB who 
would meet WHO criteria for the new drugs.

One major barrier to accessing these drugs is the fact that they remain 
registered in only a limited number of countries, with bedaquiline 
registered in just seven of the world’s 27 high MDR-TB burden countries, 
and delamanid registered in just four countries, none of which has a high 
MDR-TB burden (Japan, Germany, the UK and South Korea). Delamanid has not 
been registered in any of the countries where the clinical trials took 
place.

The companies that produce the two drugs have set up limited donation 
programmes, but the cap on the number of treatment courses is far below 
the need, and certain high-burden countries are completely excluded. South 
Africa, for example, is not eligible for the bedaquiline donation, and 
there is a quota on how many countries in Central Asia can receive the 
donation. Rollout has also been slow, with Georgia, the first recipient of 
the bedaquiline donation, starting to receive treatments a full ten months 
after the donation programme was first announced. Otsuka announced its own 
donation programme in April, committing to provide delamanid to 20 percent 
of people diagnosed with MDR-TB by 2020, however no further information 
has been provided by the company since it was announced. These donation 
programmes not only fail to meet the needs of patients today, but also 
serve to obscure the need for these drugs to be priced affordably for all 
developing countries, so that governments and treatment providers can 
procure adequate quantities to meet patient needs on a sustainable, 
long-term basis.

Another barrier is the high price set in countries where on-going donation 
programmes do not apply. The new drugs are being added to a treatment 
regimen that already costs between US$1,800 to $5,000 per treatment 
course. Bedaquiline has a tiered pricing structure ranging from $900 - 
$30,000 for a six month treatment and a six month course of delamanid 
currently sells for $33,600 in Japan. A recent study by researchers at 
Liverpool University showed future regimens containing bedaquiline or 
delamanid could be priced at less than $500 per treatment course.

“With two new TB drugs now available and increasing evidence of their 
potential value in treating MDR-TB, clinicians must have access to the 
full toolbox of potentially effective drugs, so they can create 
individualised regimens that offer DR-TB patients the best possible chance 
to survive,” said Dr. Brigden. “J&J and Otsuka need to commit to making 
their drugs available in all affected countries as soon as possible and 
provide affordable prices; no regimen should cost more than $500 per 
person, including with the use of these drugs.”

###

Editor’s notes:
The two new drugs were conditionally approved based on their phase IIb 
clinical data, although completion and publication of phase III data is 
still critically important. Delamanid’s phase III clinical trial completed 
enrolment in November 2013, with results expected in 2017. Bedaquiline’s 
phase III clinical trial, which expands on the existing STREAM trial 
looking at efficacy of shorter treatment regimens, has yet to commence.

Compassionate use is an early access mechanism which allows patients 
suffering from life-threatening diseases without any other treatment 
options to access a medicine before its clinical and regulatory approvals 
are finalized. Compassionate use programmes are only available to people 
living in countries with the necessary legal framework in place. 
Ultimately, however, compassionate use programmes are controlled at the 
discretion of pharmaceutical firms. Janssen has run a compassionate use 
programme for bedaquiline since 2011, but it is currently being phased 
out; Otsuka has run a compassionate use programme for delamanid since 
2014.

Médecins Sans Frontières (MSF) has been providing TB care to patients 
across the world for over three decades, often working alongside national 
health authorities to treat patients in a wide variety of settings, 
including conflict zones, urban slums, prisons, refugee camps, and rural 
areas. MSF’s first programmes to treat drug-resistant TB (DR-TB) opened in 
1999, and the organisation is now one of the largest non-governmental 
providers of DR-TB care in the world. In 2014, MSF provided TB treatment 
in over two dozen countries to more than 23,000 patients, including 1,800 
treated for DR-TB.

###

Michelle French
Sr. Communications Manager, MSF Access Campaign
Doctors Without Borders\Médecins Sans Frontières (MSF)
Office: +1.212.763.5735 | Mobile: +1.646.552.4600
michelle.french at newyork.msf.org | Skype: michellejfrench
www.msfaccess.org | twitter.com/MSF_access | www.facebook.com/MSFaccess

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