E-DRUG: Hain's price-doubling of MDR-TB diagnostic tool puts fragile gains at risk
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[Respond by sending an email to access@msf.org DO NOT CLICK REPLY]
[SIGN-ON LETTER]
Dear colleagues,
I am writing to ask you to sign an open letter asking Hain Lifescience to
reconsider its decision to more than double the price of its GenoType
MTBDRplus product, an important rapid diagnostic tool that can detect
multi-drug-resistant tuberculosis.
This massive price hike comes just as efforts to implement new rapid
diagnostic tools are beginning to have real effects in improving diagnosis
and shortening time to treatment for drug-sensitive TB, drug-resistant TB,
and TB/HIV co-infection. For example, MSF's implementation of new
molecular-based rapid diagnostics has shown an overall 50% increase in
laboratory-based diagnosis of TB when compared to the most commonly used TB
test, sputum smear microscopy.
Hain's GenoType MTBDRplus is a Line Probe Assay used by MSF and other
treatment providers to confirm resistance to first-line TB drugs rifampicin
and isoniazid, in accordance with WHO guidelines. Hain's product is
endorsed by the WHO and is being rolled-out in the Expand TB project
(funded by UNITAID) aimed at increasing laboratory capacity in high MDR-TB
burden countries as well being implemented in several endemic countries
outside of the Expand TB project.
However, Hain Lifescience has made the decision to more than double the
price per test for the new version of GenoType MTBDRplus, placing undue
burden on stretched TB programme budgets and jeopardizing fragile progress
that has been made in implementing improved diagnostic tools that can
increase access to life-saving treatment. The previous version of the test
cost approximately EUR 3.50, but the new version is priced at EUR 7.50,
including training and technical support services.
New molecular-based rapid diagnostic tools represent the first real
technological leap in half a century for TB care, but implementation of
these new technologies has been slowed by prohibitive costs of new
platforms. New rapid diagnostics tools are helping to expose the true size
of the drug-resistant TB epidemic and get people on treatment faster.
Please join us by signing our open letter (attached) to Hain Lifescience to
ensure that its critical diagnostic tool is not priced out of reach of TB
programme budgets. Ensuring accessibility of these critical tools is
urgently needed if we are to address the growing global crisis of MDR-TB,
and massive price hikes, like the one Hain has implemented, will only serve
to hinder implementation and put more lives at risk.
Please let us know by Monday 5 August if you can join this effort by
sending an email to access@msf.org with your organisation's name and
location.
Go to http://www.msfaccess.org/our-work/tuberculosis for more information
and updates about the critical need to test and treat TB and its
drug-resistant forms.
Thank you,
Sharonann Lynch
Medecins Sans Frontieres (MSF)
Sign on letter:
Dear Mr Hain,
We wish to bring to your attention our concerns about the preferential
price established for the new version of the Genotype MTBDRplus (version
2). The preferential price, which has more than doubled compared to the
old test, represents an unacceptably steep increase, which will have
serious consequences on the budgets of TB projects. We believe common
sense changes to the pricing scheme could reduce prices while ensuring Hain
earns a fair return for its investment.
Worldwide, MDR-TB is being increasingly recognised as a public health
emergency. Access to rapid DST represents a critical tool for the
implementation of successful TB control programs. The drastic increase in
price for Genotype MTBDRplus will introduce a barrier to diagnosis and
treatment of TB.
In prior conversations, the company has justified the price increase for
three reasons. These justifications are not satisfactory.
Firstly, your company has indicated that a price increase is justified due
to significant technological improvements in the follow-on version of the
test. We acknowledge these improvements on the new version of the test,
including improved performance of the test on smear negative specimens,
inclusion of DNA polymerase enzyme in the amplification mix and
improvements on reagent stability. The most relevant added value of these
improvements could be the better performance of the test on smear negative
specimens. National TB programmes and most NGOs, however, can not exploit
this improvement since WHO policy still recommends use of Line Probe Assays
for smear positive specimens only, and to our knowledge there are no plans
to revise these recommendations in the near future.
Secondly, your company has justified a higher price by bundling the cost of
the test with installation and training. We disagree with this pricing
arrangement. As stated on the FIND website, the prices for the assay
include training and installation costs (in addition to a separate
maintenance and service contract for the instrumentation). The pricing
should be transparent.
This pricing is also unnecessarily expensive - installation only happens
once and training needs and services costs will differ significantly from
site to site. We agree that that there must be mechanisms that guarantee
rapid and efficient access to training and technical support services, but
adding services costs to each order is not necessary. If a need for
further training and frequent technical support is identified, customers
should be given the option to agree on additional services separately and
costs should be included in service contracts rather than into the price of
reagents.
Thirdly, your company has indicated that insufficient volume requires
higher prices to recuperate costs. We agree that the 3.50 euro per test
price for the first version needed to be revised and recalculated based on
a more realistic volume. Improving demand forecasting and take-up is a
worthwhile goal and should be used to mitigate your risk. However,
integrating unnecessary training and services into the cost of the
diagnostic to safeguard against low volume is not appropriate. We are
ready to work with Hain to identify ways to improve demand forecasting and
volume, but only if the price of the diagnostic can ensure uptake.
In the light of the facts stated above we urge Hain to reconsider its
pricing strategy and
1. make the pricing of Genotype MTBDRplus (version 2) more transparent
2. separate the costs for service from the cost of the reagents
3. lower the price for Genotype MTBDRplus (version 2) to a level that
ensures access to this technology in poor countries
We commend Hain for developing a new version of the test. However, unless
the technology is affordable, it cannot make a difference in the lives of
people suffering from MDR-TB. The budgets of non-governmental
organisations and national TB programs simply cannot afford this price. We
hope that Hain reconsiders its approach to pricing.
Best regards,
Manica Balasegaram, Executive Director, MSF Access Campaign
For the Global Tuberculosis Community Advisory Board (TB CAB)
- Polly Clayden, United Kingdom
- Alberto Colorado, United States
- Colleen Daniels, United States
- Mike Frick, United States
- Sergey Golovin, Russian Federation
- Mark Harrington, United States
- Giselle Israel, Brazil
- Bactrin Killingo, Kenya
- Blessina Kumar, India (also on behalf of the India CAB)
- Erica Lessem, United States
- Lindsay McKenna, United States
- Natalia Sidorenko, Russia
- Khairunisa Suleiman, South Africa
- Ezio Tavora dos Santos Filho, Brazil
- Wim Vandevelde, South Africa
Nelson Otwoma, UNITAID board member representing Communities living with
the diseases, National Empowerment Network for People Living with HIV/AIDS
in Kenya (NEPHAK)
Prof. Brook Baker, Alternate NGO Board Member UNITAID, Health GAP,
Northeastern University School of Law
Dr Tido von Schoen-Angerer, NGO Board Member UNITAID, Health Action
International
Additional organisational endorsements:
Ethiopian Drug Information Network
Health GAP, US
National Empowerment Network of people living with HIV/AIDS in Kenya
PROCLADE Cameroon
Zimbabwe National Network of PLHIV
Joanna Keenan
Press Officer
Medecins Sans Frontieres - Access Campaign
P: +41 22 849 87 45
M: +41 79 203 13 02
E: joanna.keenan[at]geneva.msf.org