[e-drug] MSF calls AMFm to endorse FDCs of ACT

E-DRUG: MSF calls AMFm to endorse FDCs of ACT
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AMFm: Affordable Medicines Facility malaria

Dear e-druggers,

In view of the imminent launch of the AMfm, MSF has written to the Global
Fund to ask that the AMfm endorse the exclusive use of fixed-dose
combinations of artemisinin-based combination therapies (ACT).

The text of the letter has been pasted below, or to download MSF's letter
to the Global Fund click on the following link:
http://www.msfaccess.org/fileadmin/user_upload/diseases/other_diseases/msfletter_FDC_jan09.pdf

January 27, 2009

Dear Dr. Kazatchkine,

Medecins Sans Frontieres (MSF) welcomes the imminent launch of the
Affordable Medicines Facility for malaria (AMFm).

We would like to take this opportunity to recommend that the AMFm
exclusively endorses fixed-dose combinations (FDCs) of artemisinin-based
combination therapies (ACT).

The advantages of using FDCs have been well documented in several disease
areas, including tuberculosis and HIV/AIDS. 1 2 3 An FDC can benefit
patients by reducing the pill burden, thereby increasing adherence.
Additionally, combining therapies within a fixed-dose prevents the risk of
medication being taken as monotherapy. FDCs are thus useful both when
considering a patient's needs, as well as on the broader spectrum of
reducing the risk of resistance development. As you may know, the WHO Roll
Back Malaria (WHO/RBM) recommends the use of FDCs for malaria treatment.

To date, there are two WHO prequalified (WHO-PQ) co-formulations of
arthemeter/lumefantrine (Novartis, Ajanta) and others are under assessment.
There is only one WHO-PQ artesunate/amodiaquine FDC (sanofi-aventis) but
three further products are under assessment. Two FDCs containing
artesunate/mefloquine are under assessment by the WHO-PQ programme.

One can therefore assume that in the near future there will be two or more
WHO pre-qualified FDCs for each of these key ACTs. The growing number of
manufacturers of artemisinin-containing FDCs thus provides a viable way for
the AMFm to use FDCs exclusively from the outset while ensuring sufficient
generic competition.

Furthermore, the AMFm technical proposal has already outlined its
acceptance, under certain conditions 4, of non-WHO PQ products for a period
of two years. In addition, if the situation arises where there are not
enough FDC formulations available, a time-limited acceptance of
co-blisters, similar to the time-limited acceptance of non WHO-PQ products,
could be considered.

We believe that by endorsing the exclusive use of FDCs, the AMFm will give
a clear message to manufacturers to invest in the development of such
formulations, including all necessary quality, safety and efficacy
elements.

Such a move would also encourage the WHO Prequalification Programme to
consider the review of FDCs as a priority.

An acceptance of co-blisters beyond a limited timeframe, however, would
only discourage potentially interested manufacturers from developing FDCs.

We hope these comments make a constructive contribution to the AMFm and
look forward to discussing the issue further with you.

Yours sincerely,

Tido von Schoen-Angerer, MD
Executive Director
Campaign for Access to Essential Medicines
Medecins Sans Frontieres International

1. Connor J, Rafter N, Rodgers A: Do fixed-dose combination pills or
unit-of-use packaging improve adherence? A systematic review. Bull World
Health Organ 2004;82:935-9

2. Moulding T, Dutt AK, Reichman LB. Fixed-dose combinations of
antituberculous medications to prevent drug resistance. Ann Intern Med
1995;122:951-954

3. Laurent C: Effectiveness and safety of a generic fixed-dose combination
of nevirapine, stavudine and lamivudine in HIV-1-infected adults in
Cameroon: open-label multicentre trial. Lancet 2004; 364:29-34

4. If there are < 2 or 3 products already WHO-PQ or authorized for use by
a Stringent Regulatory Authority (SRA), if such products are manufactured
in a site GMP compliant certified after inspection by WHO or by a SRA for
the formulation concerned, and the product dossier accepted for review by
WHO-PQ or SRA, and recommended for use by an ad-hoc expert review panel
(ERP).
Information from: AMFm Taskforce of the Roll Back Malaria Partnership:
Interim report on progress against outstanding AMFm implementation
challenges. (February 2008)

Leyla Pope
Communications Officer
Medecins Sans Frontieres
Campaign for Access to Essential Medicines
Tel. + 41(0) 22 849 89 88