Inclusion of cost effectiveness in licensing requirements of new drugs: the fourth hurdleBMJ 2004; 329 doi: https://doi.org/10.1136/bmj.329.7472.972 (Published 21 October 2004) Cite this as: BMJ 2004;329:972
All rapid responses
If one excludes English speaking countries, the rest of the world is generally unfamiliar with the word QALY. i.e. quality adjusted life year (1-3). To non English speaking people this acronym sounds somewhat esoteric, but apart from linguistic reasons there are also objective reasons limiting its use. For example, the typical incremental benefit found in studies employing QALYs is less than 1 QALY and quite frequently less than 0.20 QALYs (4-6). Even for people with some expertise in this area, an immediate understanding of a gain of, say, 0.167 QALYs or 0.0417 QALYs is not straightforward, and so the very small numbers that generally express this parameter raise some objective problems. Anyhow, one consequence is that the poor understanding of this concept hampers the application of both cost-effectiveness analysis and health technology assessment, particularly in non-English-speaking countries.
Basing the definition of quality adjusted survival on months as opposed to years is increasingly being thought to be helpful. In fact, understanding an incremental benefit of 2 months (or 2 quality adjusted months or 2 QALMs) is easier than understanding 0.167 QALYs (2 QALMs = 0.167 QALYs); likewise, understanding a gain of 0.5 QALMs is easier than understanding 0.0417 QALYs (0.5 QALMs = 0.0147 QALYs).
In this framework, some authors (7) have advocated using QALMs rather than QALYs as a partial solution to facilitate the application of these concepts. Indeed, launching a PUBMED query based on the keyword <<"quality adjusted life month" OR QALM>> already extracts a total of 12 studies (search run on 18 December 2011).
In the Italian context, the familiarity with the QALY by most health care professionals remains very poor despite the recent educational efforts of experts in health economics. In a joint meeting of three national scientific societies (oncologists, hospital pharmacists, pharmacologists, and experts in health technology assessment), the awareness that the QALY continues to receive a poor comprehension and acceptance in Italy has led to the proposal to discourage the use of the QALY (mainly because of the small numbers related to its yearly interval basis) and encourage the use of parameters based on a monthly interval, like the QALM. In addition, since in the Italian language the acronym QALM sounds esoteric as well as the QALY does, the proposal has been to favour an easier-to-understand word, and the Italian term "mese pesato" (translation into English: weighted month) has been chosen to accomplish this task. Clearly, this proposal has a merely formal purpose, and the substance of the problem remains unchanged. Nonetheless, although the advantage in using the new term might be purely cosmetic, our hope is that this choice can facilitate the comprehension of cost-effectiveness studies by Italian health-care professionals.
1) Rodriguez JM, Paz S, Lizan L, Gonzalez P. The use of quality-adjusted life-years in the economic evaluation of health technologies in Spain: a review of the 1990-2009 literature. Value Health. 2011;14(4):458-64.
2) Simbula S, Burchini G, Caccese E, Orsi C, Santarlasci B, Trippoli S, Messori A. Definizione del prezzo dei farmaci e dei dispositivi medici innovativi sulla base del rapporto costo-efficacia. Bollettino SIFO 2007;53:211-15.
3) Messori A. Exports from Britain (Rapid Response). eBMJ URL http://www.bmj.com/rapid-response/2011/11/01/exports-britain , published 26 August 2007.
4) Wright JC, Weinstein MC. Gains in life expectancy from medical interventions--standardizing data on outcomes. N Engl J Med. 1998;339(6):380-6.
5) Messori A, Santarlasci B, Trippoli S. Guadagno di sopravvivenza dei nuovi farmaci. Pharmacoeconomics - Italian Research Articles 2004;6(2):95-104.
6) McNamee P. What difference does it make? The calculation of QALY gains from health profiles using patient and general population values. Health Policy. 2007 Dec;84(2-3):321-31.
7) Messori A, Maratea D, Nozzoli C, Bosi A. The role of bortezomib, thalidomide and lenalidomide in the management of multiple myeloma. Pharmacoeconomics 2011;29:1-17.
Competing interests: No competing interests
Kamran Abbasi is probably correct to suggest that less than half of
the articles on pharmaceuticals published in this weeks BMJ are ghost
written by the wicked pharmaceutical industry, but this should not be a
source of complacency. Indeed, this issue of the BMJ does contain one
glaring error concerning transparency (although probably not trust). The
article by Taylor et al  is an edited version of a chapter in a book
published by BMJ books and was commissioned by the Journal on that
basis, although this is not made clear anywhere in the article or
1. Abbasi K. Editors Choice, BMJ 2004; 329 (23 October),
2. Taylor RS, Drummond MF, Salkeld G, Sullivan SD. Inclusion of cost
effectiveness in licensing requirements of new drugs: the fourth hurdle.
3. Freemantle N, Hill S (Eds). Evaluating pharmaceuticals for health
policy and reimbursement. London, BMJ Books, 2004.
Competing interests: No competing interests