ANALYSIS OF ECONOMIC EVALUATIONS OF PHARMACOLOGICAL CANCER TREATMENTS IN SPAIN BETWEEN 1990 and 2010.

Clin Transl Oncol. 2013 Jan;15(1):9-19.

Sanz-Granda A1, Hidalgo A2, Del Llano JE3, Rovira J4

(1): Weber Economía y Salud, Pharmacoeconomics Department, Madrid; (2): Universidad de Castilla-La Mancha; (3): Gaspar Casal Foundation, Madrid; (4): Universidad de Barcelona

 

Abstract:

OBJECTIVES: To analyze the main characteristics of the economic evaluations of pharmacological cancer treatment in Spain published between 1990 and 2010.

METHODS: A systematic review of the literature was performed.

RESULTS: 29 complete economic analyses were identified. The pathology most frequently evaluated was non-small cell lung cancer (31%). Cost-effectiveness analyses (69%) were the most frequent analyses carried out. The reviewed cost-utility studies presented a wide range of incremental cost-effectiveness values (295-160.667 Euros/ QALY). For the most part these studies were developed from the perspective of the National Health System (65.5%). None of the studies estimated the indirect costs.

CONCLUSIONS: The absence of regulations concerning the application of the efficiency criterion in decision-making on the subject of price, financing and, most importantly, the fact it is are not included in Spanish hospitals forms, makes it difficult to analyze the real impact of economic evaluations of cancer treatments on such decisions.

 

Supplements

Cancer is one of the diseases with the biggest health impact due to its high rates of incidence, prevalence and mortality. Data on Spain from GLOBOCAN 2008, a World Health Organization project, estimated an incidence of 196.902 cases for all types of cancer (nonmelanoma skin cancers excepted), with higher rates of prostate, lung and colorectal cancers in men, and of breast, colorectal and gynecological tumors in women. Cancer management involves enormous health resources. In Spain, direct costs associated with colorectal, prostate, breast and cervical cancer rose were estimated to 2.154 million Euros while indirect cost thereofe rose to 3.824 million Euros (costs related to 2003).

A systematic review which describes the main features of economic evaluation studies of pharmacological treatments of cancer in Spain between 1990 and 2010 was performed (Medline, Embase, Índice Médico Español (IME), red Yriss, NHS EDD, Medicina en Español (MEDES) and Elsevier. The main variables were analyzed, taking into account the recommendations included in the proposed guideline for the application of economic evaluation to health technologies.

Analyzed variables Expected values
First author affiliation Pharmaceutical industry, National Health, System, University, Consultant or other
Journal National or international and year of publication
Pathology Cancer type
Type of analysis Cost-minimization, cost-effectiveness, cost-utility and cost-benefit
Perspective of the analysis Society, National Health System, hospital,Unknown
Drug Evaluated drug and its comparators
Benefit source Clinical trial, meta-analysis, systematic, review, selection of literature, patients´ database
Result variables Objective response, LYG, QALY,  progression-free time, other
Type of cost considered Direct, indirect and intangible
Time frame Shorter, equal or longer than a year
Discount rate Applied (%), not applied (horizon shorterthan a year), not applied
Use of models Decision trees, Markov models,simulation of discreet events
Analysis of sensitivity Performed – deterministic, probabilistic ornon-performed
Incremental cost-effectiveness (or utility) ratio In monetary units for additional benefit
Financing source Public, private, non-specified
Recommendation from the authors If they exist, and what they are

 

Of the initially selected articles, 29 met inclusion/exclusion criteria. The most-analyzed cancer types correlated, with some cancer types accounting for the highest incidence: non-small cell lung (31.0%), breast (20.7%) and colorectal (13.8%) cancers. It was observed that hospitals’ medical staff had an important participation as authors of the articles included: they appear as first authors in 65.5% of the works. Of 24 effectiveness studies they have relied economic analysis included in the study had an efficiency level of type 1.

The cost-effectiveness analysis was the most used (69.0%). Most studies were developed from the perspective of the National Health System (65.5%). In most cases (75.9%), the comparator was the alternative usually used in clinical practice. The medications that were most frequently taken as reference for economic studies were cisplatin and docetaxel and the combination 5-fluorouracil/folinic acid (5-FU/FA). Excluding the cost-minimization analyses, the efficacy data were mainly obtained from randomized clinical trial results (37.9%).

In the first decade analyzed, the economic results of cost-effectiveness analyses were expressed by means of clinical variables such as the objective response or the survival measures, mainly total survival. The use of quality-adjusted survival measures, such as the quality-adjusted life years, was used in the cost-utility analyses performed exclusively during the last decade studied.

Even if all the studies incorporated direct costs associated with the evaluated treatment (drugs and administration costs), 20.7% of those studies did not incorporate other relevant direct costs, such as those derived from the management of observed adverse effects.

In the first half of the analyzed period there is only one study which uses the Markov model. However, 60% of the studies performed in the second decade used such methodology. The structure of the model used is quite similar in all cases with inclusion of a progression–free state, another one of disease progression, and one of death; in some cases the model is designed in a more complex way.

Overall, the methodology is comparable to the one observed in other countries; likewise, a clear improvement is observed among the studies published during the last period analyzed. Recent years have witnessed an increase in the use of probabilistic methods to perform sensitivity analyses. The use of models is also increasing.

The mere cost estimate cannot assume the acceptance or rejection criteria of a drug. It is necessary to relate the cost incurred with the health outcome obtained to estimate the level of efficiency, which is made with respect to a threshold. In Spain, notwithstanding the absence of an officially accepted efficiency limit, it has been suggested that 30.000 Euros per life-year gained could be considered an acceptable figure.

The British NICE has adopted, for cancer and other terminal diseases, a criterion other than the one usually used with other pathologies, and some criteria have been included to classify life-extending, end-of-life treatment interventions.

The absence of regulations for the application of the efficiency criterion about price, financing and, above all, about inclusion in Spanish hospital forms, make the analysis of the actual impact of economic evaluations on such decisions difficult. The results of this review reinforce the idea that the limited use of economic evaluation studies in decision making in Spain is not caused by the lack of ability to perform quality studies but by the lack of willingness on the part of managing organizations and by the lack of regulations intended for their application.

 

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