E-drug: Is Coartem an essential drug? (cont'd)
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Further to Dr Jansen's comments on artemether-lumefantrine, we
should like to make the following clarifications/points:
Lumefantrine is the International Nonproprietary Name (INN) for
benflumetol, which is combined with artemether in the product
manufactured and marketed by Novartis as Coartem in a number of
malaria-endemic countries. The combination of artemether with
lumefantrine allows for a lower dose of artemether to be used
compared to the use of artemether as a monotherapy. This product is
marketed in some European countries as Riamet and in malaria endemic
countries as Coartem.
The artemether-lumefantrine combination was listed on the 12th
WHO Model List of Essential Medicines - EML (previously known as
the WHO Model list of Essential Drugs) after undergoing a new
procedure for including medicines on the EML.
http://www.who.int/medicines/organization/par/edl/procedures.shtml
It should be noted that the listing of artemether-lumefantrine on the
EML did not mean that the product replaced other essential medicines
for malaria treatment that are on the list. The new procedure requires
that applications of products for inclusion into the list, as well as
all material supporting the applications be posted on the web page of
WHO Department of Essential Drugs and Medicines Policy prior to the
meeting of the WHO Expert Committee on the Selection and Use of
Essential Medicines (EML Expert Committee). During this period, it is
expected that all those who have comments to make with regard to
either the product application itself or its supporting and/or
opposing material are able to do so. This opportunity for
communication with the Expert Committee, through its Secretary exists
before the review of an application as well as after a decision has
been made on an application.
The WHO Expert Committee on the Selection and Use of Essential
Medicines has approved the following definition: "essential medicines
are those that satisfy the priority health care needs of the
population. They are selected with due regard to public health
relevance, evidence on efficacy and safety, and comparative
cost-effectiveness. Essential medicines are intended to be available
within the context of functioning health systems at all times in
adequate amounts, in the appropriate dosage forms, with assured
quality and adequate information, and at a price the individual and
the community can afford. The implementation of the concept of
essential drugs is intended to be flexible and adaptable to many
different situations; exactly which drugs are regarded as essential
remains a national responsibility".
The Committee noted that the prevalence of drug resistant falciparum
malaria has increased so that, in some countries, resistance to all of
the available antimalarial drugs, except artemisinin and its
derivatives, exists. For patients with falciparum malaria resistant to
chloroquine, sulfadoxine/ pyrimethamine, mefloquine and quinine, the
use of artemisinin and its derivatives is essential.
The process of development of WHO global guidance on product
selection should be viewed as a distinct process from that of drug
registration at the national level. While both processes review and
consider the evidence-base for safety and efficacy, at the national
level, regulatory authorities may weigh the risk and benefits
associated with granting of market authorization of a product against
other available therapeutic options.
WHO through the Malaria Control Department has evaluated the
available treatment options and has recommended
artemether-lumefantrine for uncomplicated malaria. WHO has
recommended a six-dose regimen to be given over three days of
treatment. The drug is available as tablets only and is not
recommended for use in severe and complicated malaria, because
these patients require parenteral treatment. Pre-registration studies
did not include sufficient number of children of less than 10kg body
weight and, for this reason, the drug could not be recommended for use
in this group. Studies have now been completed that will enable the
extension of the labelling to include children of less than 10 kg body
weight, and a peadiatric preparation is under development.
Like for all newly developed drugs, pre-registration studies also did
not include pregnant women, and the safe use of artemether and
lumefantrine has not been established. Ongoing studies and
pharmacovigilance activities will provide more evidence of drug safety
for this population group.
A differential price for artemether-lumefantrine is available for
supplies ordered by public sector and NGOs through WHO:
http://158.232.12.19/cmc_upload/0/000/015/789/CoA_website5.pdf
In a recently concluded external audit of this pricing, it was
concluded that the price offered through WHO did not exceed production
costs. The results of this audit are to be published shortly.
Finally, it is critical that all of us who contribute to the E-drug
forum are transparent with regard to affliations as potential conflict
of interest may obscure the real nature of the exchange of message
which provides quality continuous dialogue between interested parties
through E-drug . Dr Jansen should therefore have informed the
audiance, accordingly, that he has specific interests in the
manufacture and/or marketing of artemisinin-based products which are
competitors in the market.
Dr Clive Ondari
Technical Officer
Policy, Access and Rational Use (PAR)
Essential Drugs and Medicines Policy (EDM)
World Health Organization
20, Avenue Appia
CH-1211 Geneva 27
Switzerland
Tel. +41 22 791 3676
Fax. +41 22 791 4167
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