[e-drug] Price reductions for drugs for leishmaniasis

["Margriet den Boer" <margriet.den.boer@amsterdam.msf.org>]

E-DRUG: Price reductions for drugs for leishmaniasis 
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Dear all,

WHO has announced that the prices of liposomal amphotericin B manufactured
by Gilead Sciences (AmBisome- Liposomal amphotericin B) and meglumine antimoniate
manufactured by Sanofi-Aventis (Glucantime) have been reduced for the treatment of leishmaniasis for public sector agencies of all developing countries. See below for WHO's messages and MSF's comments below the WHO messages about the significance of these reductions and about the place of the drugs in therapy .

Margriet den Boer
Campaign for Access to Essential Medicines
Medecins Sans Frontieres
mobile +31624661443
"Margriet den Boer" <margriet.den.boer@amsterdam.msf.org>

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WHO Message about price reduction of Ambisome:

Dear colleagues,

We have the pleasure to share with you that Gilead Sciences, Inc. has
announced offically WHO with the reduction of the price of AmBisome to
US$20 per vial  to Public Sector Agencies of all Developing Countries, for
the treatment of visceral and mucosal leishmaniasis. This important
achievement will have enormous impact worldover in the control of this
neglected tropical disease.

The reduction is effective from now. Public Sector Agencies interested can
enter directly in contact with:

Ms. Lorraine Fitzpatrick
AmBisome Access Programme
Gilead Sciences, Ltd
Unit 13, Stillorgan Industrial Park
Blackrock Co. Dublin, IRELAND

Tel:  +353-1-2952729
Fax: +353-1-2952449
Email: lorraine.fitzpatrick@gilead.com

Please, circulate this important information.
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WHO Message about price reduction of Glucantime:

Dear colleagues,

We have the pleasure to share with you that Sanofi-Aventis has announced
offically WHO with the reduction of a "no-profit, no-loss" price of
GLUCANTIME to  US$ 1,20 per vial + customs taxes + distribution cost  to
Public Sector Agencies of all Developing Countries, for the treatment of
leishmaniasis. This important achievement will have enormous impact in many
regions in the control of this neglected tropical disease.

The reduction is effective from now. Interested can enter in contact
directly with sanofi-Aventis commercials in each country. If you have any
question, contact WHO, please.

Please, circulate this important information.

Dr Jorge Alvar
Medical Officer (Leishmaniasis Control)
Control of Neglected Tropical Diseases
Innovative and Intensified Disease Management
Communicable Diseases Cluster
World Health Organization
20, Avenue Appia; CH-1211  Geneva 27
Tel.    +41 22 791 3870
Fax     +41 22 791 4877
e-mail: alvarj@who.int
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MSF comments:
The price of AmBisome (liposomal amphotericin B) is reduced to US$20 per 50 mg vial for the treatment of visceral and mucosal leishmaniasis. This is a significant and welcome reduction of the current private market price of  96.69 GBP (BNF 2006). However, treatment of VL with
L-AMB according to WHO is done with a total dose of 20 mg/kg, with a flexible dosing schedule but an initial dose of at least 5 mg/kg (1). 

With the reduced price, for a patient of 35 kg, a full course with a total dose of 20 mg/kg still costs US$280. This price is too high for implementation in treatment programmes in developing countries. The price of liposomal amphotericin B should come down further in order to make it accessible for VL patients. Combination therapy with another drug could bring the price per treatment down as well but there are very few data on combination therapies with L-AMB. 

MSF strongly encourages research into effective combination therapies for the treatment of VL. Also, other, cheaper lipid formulations of amphotericin B should be tested for their efficacy in leishmaniasis.

Place in therapy of liposomal amphotericin B:

Liposomal amphotericin B (L-AMB) is substantially less toxic (especially in terms of nephrotoxicity) compared to conventional amphotericin B (AMB) or other known lipid  formulations of AMB. L-AMB has compared to other antileishmanial drugs the highest therapeutical index for the treatment of
visceral leishmaniasis (VL) and it is less toxic than pentavalent antimonials, which are so far the mainstay of therapy, except in the West, where L-AMB is first line therapy (because there are no cost considerations). L-AMB is highly effective in India for VL (13 trials in India were done, and a single dose of 7,5 mg/kg gave a cure rate >90%). In Sudan, MSF has considerable experience and very good results with the use of L-AMB in moribund VL patients that do not tolerate
SSG.

(1)  Bern  Caryn  et  al:  Liposomal  amphotericin  B  for the treatment of
visceral  leishmaniasis.  Clinical  infectious  diseases,  43:7(2006),  p.
917-924.

The price of Glucantime (meglumine antimoniate) is reduced to US$1,20 per 5
ml vial of 85 mg/ml (+ customs taxes + distribution cost) for the treatment
of all forms of leishmaniasis. Meglumine antimoniate is a pentavalent
antimonial, as is sodium stibogluconate. Glucantime is now significantly
cheaper than sodium stibogluconate produced by GSK (Pentostam), which costs
66.43 GBP/100 ml vial of 100 mg/ml (BNF 2006), but is still more expensive
than generic sodium stibogluconate.The treatment protocol is 20 mg/kg/day
for 30 days for VL. With the reduced price, a treatment of a patient of 35
kg with Glucantime costs US$49. The same treatment with Pentostam costs
US$155, and US$27 with generic sodium stibogluconate. The prices of both
Pentostam and Glucantime should be further reduced to be equivalent to the price of
generic SSG.

Place in therapy:
Pentavalent antimonials are the mainstay of treatment and have been for over half a century, for all forms of cutaneous and mucocutaneous and visceral leishmaniasis. With pentavalent antimonials, initial cure rates for VL are >95% and failure rates <5% can be expected. Resistance to pentavalent antimonials is seen in India in 30-65% of cases.