Jorge Mestre-Ferrándiz, Ana Becerro de Bengoa, Paloma González y Carme Pinyol, part of ISPOR Spanish Chapter.
An international overview of drug pricing, evaluation and financing systems, within the program “ISPOR’s Wednesdays”, organized by the Spanish Chapter of ISPOR.
I am convinced that the reader of these lines will agree that we are at a key moment in the world of ‘market access’. This access depends on many variables, it is a (very) complex issue, but the price, evaluation and financing of medicines are key to when, in what way, and for which patients, medicines are used. And here it is important to note that there is no ‘typical’ drug, nor is there a ‘standard model’, that gives us the magic solution because pricing and financing decisions depend on many factors.
Considering the changes that have occurred and those that are in process in Spain in relation to the evaluation of medicines to determine their price and financing, it is relevant to analyze how it is done in neighboring countries, or similar ones, in order to learn and improve our system. But without ‘cherry-picking’, as the English say; that is to say, to take a piece of the system of another country and to use it without further ado in our system because in that country it has worked well.
Returning to the three variables (price, evaluation and financing), first, various price regulation systems have been used, or are being used and to different extents, to directly or indirectly control prices. The most traditional models would include international reference prices, benefit control and cost-plus. The first are used in many countries, the second sporadically and the third, almost never. On the other hand, we would have newer and/or more flexible models, where the price could not only reflect the value of the medicine (giving rise to the famous ‘value-based prices’ or value-based pricing), but also be dynamic and vary according to the evolution of its value with the use of clinical practice. In addition, it is possible to pay only if the medicine ‘works’ and in this case, we would have the so-called shared risk agreements, or controlled entry agreements, among other terms. Likewise, it is true that to date, and perhaps excepting the US (and that is for other reasons), in most countries, prices have been declining, regardless of their value or health outcomes.
Regarding evaluation, the ‘cost per QALY’ model continues to have a lot of traction, perhaps more and more. But there are also countries that are still very reluctant to use this metric and advocate evaluation systems with a clinical perspective, normally associated with a ranking of ‘(relative) therapeutic or clinical utility’ and where this ranking is a key parameter to determine the price. But we must not forget that the new therapies that are coming may require different evaluation models than the ‘cost per QALY’ or ranking model, thinking of costs and benefits beyond the therapeutic effect of the treatment on the patient. Thus, we find orphan drugs for rare or minority diseases, gene therapies that offer the possibility of ‘curing’ the disease with a single use or antibiotics for when antimicrobial resistance appears, where the most classic evaluation models (and where the evidence of efficacy usually comes from a single randomized clinical trial with few patients) must be adapted. In fact, international experience shows how these evaluation models have been adapting.
Regarding financing, several decades ago the concept of selective financing was established in Spain. It is not the place to analyze whether we spend a lot or a little on medicines, because in part, that also depends on how much we spend on health or on other items covered by public budgets (education, pensions,…). What concerns us is evaluating whether we spend well or badly and how we could obtain better results. Therefore, the price, evaluation and financing systems should pursue an efficient investment in medicines, yes, being very clear that ‘efficiency’ must be one of the criteria, but by no means the only one, to determine the investment in medicines.