Stefano Capri

Guidelines for Economic Evaluations in Italy: Recommendations from the Italian Group of Pharmacoeconomic Studies:

Since 1997, in order for a new drug to obtain its price and reimbursement in Italy, the negotiation between authorities and the pharmaceutical industry must include an economic evaluation. The economic evaluation study leads to price and reimbursement negotiations together with such other requirements as the price of the new drug in other countries, the impact on the domestic market in terms of public pharmaceutical expenditure, and the effects on the national economy (employment and investments). In response to the need to set methodological standards for the economic evaluation of drugs a group of about 40 experts (the Italian Group for Pharmacoeconomic Studies) made up of representatives of the regulatory authorities and ministries, academia, and the industry prepared recommendations concerning the methodology and the presentation of pharmacoeconomic studies. The principles were intensively reviewed and discussed during a number of workshops and meetings throughout one year, and then finally and officially presented to the regulatory authorities. The elements which must be contained in each study submitted to the authorities are briefly described in this paper, considering the main theoretical and regulatory contributions found in the literature. In particular, the economic analyses suggested are cost-effectiveness and cost-utility, and they must be applied from the points of view of both society and the Italian National Health Service. Even though pragmatic economic-clinical trials are preferred, given the difficulties in releasing these kinds of studies for drugs which have just been authorized, the use of models is suggested when satisfying a series of requirements (the reproducibility of the results by the regulatory commission, detailed description of the methodology and the intermediate results, etc.). Preference is given to microcosting, that is, cost measurement performed at the health care provider level (eg, hospitals), from which representative data at the national level can be obtained. In terms of the presentation of an economic evaluation, a synthesis of the study must be prepared on the basis of a detailed list of issues in order to facilitate evaluation of the study by the regulatory authorities. The approach followed by the Italian Group for Pharmacoeconomic Studies is based on the belief that only the recommendations prepared with the active contributions of all subjects interested in the economic evaluation of drugs are likely to be efficiently applied and disseminated.

Comparison of detailed and succinct cohort modelling approaches in a multi-regional evaluation of cervical cancer vaccination

Mathematical models have been used extensively in the evaluation of chronic diseases and in exploring the health economics of vaccination. In this study, we examine the value of having two different cohort models based on similar assumptions, one comprehensive and one simplified, which can be used to evaluate the impact of cervical cancer vaccination. To compare models, we ran cost-effectiveness analyses in four geographical regions (Italy, the UK, Taiwan and Canada). We show that the models produce comparable results and therefore can be used independently. However, as they require different complexities of data inputs, they are more suited to different circumstances depending on the level of data inputs available or the complexity of the research question asked.

Valutazione economica di erlotinib, docetaxel e pemetrexed nel trattamento di seconda linea del carcinoma polmonare non a piccole cellule

SummaryObjectiveThe purpose of this study was to compare the costs of the drugs, drug administration and managing of adverse events (AEs) using erlotinib, docetaxel and pemetrexed as second line therapy in non-small cell lung cancer, in the Italian hospital setting.MethodsSince a clinical study comparing the three therapies is not available, the major clinical findings from randomized trials of each drug were used showing that all three chemotherapies have comparable efficacy results. Therefore a cost-minimization analysis was performed. Costs from the hospital perspective were calculated according to Italian clinical practice. Consumption of each chemotherapy was based on respective clinical trials, while to estimate the resources used in the AEs and for the drug administration a Delphi panel of experts was structured. In order to allow a comparison between an oral daily therapy (erlotinib) and infusion therapies administered every 21 days (docetaxel and pemetrexed), costs were computed on a monthly base.ResultsThe total per-patient cost for erlotinib was € 1,669, for docetaxel € 2,569 and for pemetrexed € 3,324 for one month therapy from the hospital perspective. Costs of AEs represent 8%, 18%, and 3% of the total costs for erlotinib, docetaxel, and pemetrexed, respectively. Sensitivity analysis showed that no reasonable changes in the quantity and cost of services reduced the savings associated with erlotinib by more than 33%.ConclusionsA cost-minimization analysis was performed to assess the costs of three second line chemotherapies in non-small cell lung cancer. The less costly alternative was erlotinib, which could produce savings between 40% and 50% of total hospital costs in Italy.

Drug Pricing and Risk Sharing Agreements

In the the recent past some forms of risk sharing agreements have been used in some countries in drug pricing. In this note we present a specific risk sharing agreement on effectiveness and show how such mechanism is going to affect the market in the long run. In particular, we will show how the regulator may create a trade off between expected efficacy and the number of patients to be treated using the pricing formula.

Shifting the Risk in Pricing and Reimbursement Schemes? A Model of Risk-Sharing Agreements for Innovative Drugs

Risk sharing is becoming an increasingly popular instrument to regulate the price of new drugs. In the recent past, forms of risk-sharing agreements between the public regulator and the industry have been proposed and implemented, but their effects on price and profits are still controversial. in this paper we propose a model aimed at studying the effects on price and expected profit of several risk-sharing agreements between a regulator and the industry, based on the ex post effectiveness of the drug (i.e. the efficacy resulted in the real medical practice). We assume that the probability of being listed (approved and reimbursed) depends on the relative performance of the new drug in terms of effectiveness and budget required. The price is set according to the declared efficacy of the new drug, but if ex post the effectiveness falls short of what declared, several forms of penalties may be used by the regulator. We show that the number of patients that are treated is not necessarily affected by risk-sharing/risk-shifting mechanisms; the price for which the drug is listed may be higher than without risk-sharing, but the expected profit of the industry is: a) always lower for risk-shifting schemes; b) for true risk-sharing it depends on the bargaining power of the company. This result is however valid only if the listing process is not affected by risk sharing. If this is not the case, risk sharing mechanisms may increase the expected profit of the industry.

International Price Regulations in the Pharmaceutical Sector: A Common Model to Sharing the Benefits

In this article we analyse the market for drugs in health care markets where third payers (an insurance company or a government agency) bear the cost and we suggest a common and transparent methodology to set the price for new drugs as well as active principles for which an alternative already exists. We argue that in this context a bargaining approach is the most suitable instrument to describe the price setting procedure and we show how this approach can be implemented. We argue that many of the systems that are used by western countries are in fact simplified application of our model, the main difference usually being that the actual price setting procedure is not as transparent as the one we propose.

Pricing policies in the pharmaceutical sector

In this article we analyze the problem of determining the price for new drugs in a market where stringent budget constraints on public expenditure exists and we suggest an innovative methodology to set drug prices. The market is characterized by asymmetry of information and a high proportion of investment in research and development, an element that must be taken into account because it is only through research that it is possible to obtain better drugs. Our proposed method allows one to set the price of new drugs in different market contexts, that is, where less effective alternatives are already sold or in new markets. We also propose a unified methodology to evaluate the social value of drugs in different markets through the definition of a function of the cost per quality adjusted life year that society is willing to pay.

Drug Pricing in a Regulated Market

In this article we analyse the problem of determining the price for new drugs in a market where a stringent budget constraint on public expenditure exists and we suggest an innovative methodology to set their prices. The market is characterised by asymmetry of information and a high proportion of investment in R&D, an element that has to be taken into account because it is only through research that it is possible to obtain better drugs. Our proposed method allows to set the price of new drugs in different market contexts, i.e. where less effective alternatives are already sold or in new markets. We also propose a unified methodology to evaluate the social value of drugs in different markets through the definition of a function of the cost per QALY that society is willing to pay.

Razionalizzazione della spesa farmaceutica: farmaci costo efficaci in malattie cardiovascolari

The study presented in this paper applies the principles of economic evaluation to the allocation of pharmaceutical expenditure among different drugs. The analysis stems from the definition of cost effective drugs and the type of disease under study is cardivascular problems. This sector accounts for 25% of total expenditure, the drugs mostly come in the same format and belongs to group A, i.e. those drugs that are fully paid by the State. The work is structured in three different steps: the first one consists of a review of the literature to compare the effectiveness of the different drug principles, the second step is the comparison of the costs of the different principles and the determination of the cost effective ones. The third step consists of the substitution of the most cost effective one with those used at the moment in order to determine expenditure savings. The work presented here has mainly methodological goals for two main reasons: the studies considered are mainly of American origin and costs are often referred to this context, furthermore for some drugs we could not determine the expenditure due to the limitations imposed on the use of data. In any case the analysis proposed shows that there is scope for this type of analysis.