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PAPERS: A H Miners, Martina Garau, Dogan Fidan, and A J Fischer Comparing estimates of cost effectiveness submitted to the National Institute for Clinical Excellence (NICE) by different organisations: retrospective study BMJ 2005; 330: 65 [Abstract] [Full text]

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Negotiating the price of innovative treatments based on cost-effectiveness techniques

Andrea Messori, Sabrina Trippoli, and Benedetta Santarlasci   (14 January 2005)

Negotiating the price of innovative treatments based on cost-effectiveness techniques 14 January 2005
Andrea Messori, Coordinator Laboratorio SIFO di Farmacoeconomia, Azienda Careggi, Viale Morgagni 85, 50134 Firenze, Italy, Sabrina Trippoli, and Benedetta Santarlasci Send response to journal: Re: Negotiating the price of innovative treatments based on cost-effectiveness techniques	Miners et al. (1) have examined the cost-effectiveness appraisals submitted to the National Institute for Clinical Excellence and have shown that the cost-effectiveness ratios calculated by manufacturers tend to be more favourable to the relevant technology than those determined by university-based assessment groups. In the framework of national health-care systems, national committees exist in some countries (e.g. in Italy) that negotiate (based on cost-effectiveness) the price of innovative treatments with the respective manufacturers (Figure 1). In the case of Italian drugs, these negotiations are conducted soon after granting the marketing authorisation to the new products and are generally completed before the introduction of the product in the health-care market. In particular, the negotiations regulate the decision of whether or not the new product is reimbursed by the public funds of our national health system (2). Negotiating the cost-effectiveness price of a drug (or health-care intervention) before its availability on the market is, by definition, better than assessing its degree of cost-effectiveness after the drug (or intervention) has already been marketed at a certain price. In the current scenario of application of cost-effectiveness techniques, Miners et al. (1) have only considered the case where the price has already been decided for the technology under examination (and so the economic analysis is restricted to determining whether the cost of the health-care intervention is high or average or low from a societal viewpoint in comparison with the clinical benefit that it produces). The case where price negotiations (based on cost-effectiveness benchmarks) take place before the marketing of a new product has not been mentioned by Miners et al. (1). In our view, pre-marketing appraisals of cost-effectiveness are likely to be more effective to appropriately allocating health-care resources than post-marketing appraisals.   REFERENCES 1. Miners AH, Garau M, Fidan D, Fischer AJ. Comparing estimates of cost effectiveness submitted to the National Institute for Clinical Excellence (NICE) by different organisations: retrospective study. BMJ 2005;330:65 2. Messori A, Santarlasci B, Trippoli S, Vaiani M. Beneficio clinico e prezzo dei farmaci. Pharmacoeconomics, Italian Research Articles 2003; 5:53-67.             Figure 1. Methodological process for pricing new health-technology interventions based on their respective clinical benefits (see reference 2 for details). One QALY (QALY = quality-adjusted life year) is currently valued between 1000 and 5000 Euros according to standard cost-effectiveness benchmarks.     Analysing pertinent clinical trials             Estimating the incremental clinical benefit produced by the new technology in comparison with the reference treatment                 Converting this incremental clinical benefit (e.g. QALYs gained per patient) into an economic value (e.g. treatment cost per patient) using cost-effectiveness benchmarks                                                   Determining an "appropriate" economic cost for the new technology (based on the number of therapeutic interventions needed to administer the new technology, e.g. number of vials to cover an entire therapeutic course)                         Competing interests: From 1999 to 2004, AM has been a member of the CIPE group for national drug price negotiations at the Ministry of Health. ST is currently a member of the national cost-effectiveness appraisal group that evaluates medical devices at the Ministry of Health. This letter reports the personal views of AM and ST that do not necessarily reflect the official position of these two national regulatory organisms