1,721,022 research outputs found
Should we really worry about "launch delays" in OECD countries?
No full textThis is an editorial. The purpose is to point out the limits of the empirical literature linking launch delays of new drugs with the regulation of entry. We find four main problems related to the main conclusions of the literature. We think that these limits should be aknowledged in the international debate on the regulation of drugs approvals
Off patent drugs in Italy: a short sighted view?
No full textThe new Italian policy to off-patent prod ucts,
although similar to recent reforms in other
European countries, seems to use some
interesting instruments and has achieved
significant results in the past 2 years. In particular,
the prices of branded products have
been reduced for all active in gredients
where a generic version is available. However,
this strategy may raise some problems
in the longer term. Our analysis identified
two open issues that might limit the longterm
sustainability of the present scheme:
the limited diffusion of generics and the real
location of demand. The first stems from
the new regulatory schemes which equate
generics to brand ed off-patent products
and exploit their presence only to cut prices.
The second is favored by tough price competition that induces large companies to divert
demand towards more profitable “me-too
drugs.” Solutions exist, but they are not easy
to apply because so many difficulties arise
when certain aspects of a long-standing
equilibrium are modified
Health status, resource consumption, and costs of dysthymia. A multi-center two-year longitudinal study
No full textBackground: In this study we estimated the health status, resource consumption and costs of a large cohort of patients with early and late-onset dysthymia. Methods: The DYSCO (DYSthymia COsts) project is a multi-center observational study which prospectively followed for two years a randomly chosen sample of patients with dysthymia in the Italian primary health care system. Results: A total of 501 patients were followed for two years; 81% had early-onset dysthymic disorder. During the study, improvement was seen in most domains of the 36-Item Short Form Health Survey (SF-36) questionnaire. Comparison of the SF-36 scores for the two groups showed that only the physical health index significantly differed during the two years. The use of outpatient consultations, laboratory tests and diagnostic procedures was similar in the two groups, but patients with early-onset dysthymia were admitted significantly more than late-onset cases. Hospital admissions were almost entirely responsible for the higher total cost per patient per year of early-onset dysthymia. Limitations: A first limitation of this study is that general practitioners were selected on the basis of their willingness to participate, not at random; secondly, no information was collected on concomitant psychiatric comorbidities. Conclusions: The present study provides the first prospective, long-term data on service use and costs in patients with dysthymia. Differently from patients with early-onset dysthymia, patients with late-onset dysthymia were admitted less and cost less. © 2005 Elsevier B.V. All rights reserved
A comparative analysis of domiciliary oxygen therapy in five European countries
No full textThis comparative study analyses the domestic market of domiciliary oxygen therapy in five
European countries (Denmark, France, Germany, Italy, and the UK) according to a
common checklist of subjects. Domestic legislation, prescription procedures, delivery, and
the market situation concerning oxygen therapy were considered. The analysis involved (i)
reviewing the literature on oxygen therapy in national and international journals, and (ii)
interviewing a selected expert panel of market operators in each country (composed of at
least one civil servant, one physician, one distributor, and one oxygen manufacturer). The
analysis did not find any specific relationship between the health care system framework and
the oxygen therapy market, except for a greater inclination towards home care in national
health services. In all these countries oxygen therapy is reimbursed, but the type of supply
and its diffusion differ widely. The spread of domiciliary care has undermined the traditional
role of pharmacies in the oxygen distribution chain in all countries except Italy. The study
did not help identify any specific country that can be considered a benchmark for oxygen
therapy, each one dealing with oxygen therapy in a different way. An economic evaluation
of the different supply modalities could help improve decision making by public authorities
Italian Pharmaceutical Policy: Towards a Structural Change?
No full textItalian pharmaceutical policy has recently moved towards a “two lanes” approach, with regulation differing according to a
drug’s patent status. This study analyses the Italian regulatory framework, focusing on policies related to “off-patent” drugs.
Three main regulatory innovations have been examined: (i) generics, introduced in Italy for the first time in 1996; (ii) the reference
pricing (RP) scheme, under which consumers pay part of the cost of high-priced products; (iii) pharmacists’ right of substitution,
supported by a regressive margins system.
The recent reforms are already producing some worthwhile results, at least in terms of competitive pressure on the (few)
substances that run out of patent protection. However, further intervention could be required to achieve long-term sustainability
Direct costs of schizophrenia and related disorders in Italian community mental health services: a multicentre, prospective 1-year follow-up study
No full textThe behavior that accompanies schizophrenia and related disorders interferes with professional and social activities. As a result, schizophrenia is one of the most costly psychiatric illnesses. Direct medical costs associated with schizophrenia were estimated from the Italian National Health Service perspective. This was a multicenter observational 1-year study conducted in 14 Italian community mental health centers (CMHCs). Eligible patients were those with a diagnosis of schizophrenia or schizoaffective or schizophreniform disorder who had been followed by the CMHCs for at least 2 years at study entry. Exactly 643 patients were enrolled in the study. The mean direct cost per year was currency sign6,964 (currency sign27,025 for schizophrenia and currency sign6,587 for patients with related psychotic disorders) (1998 exchange rate U.S.$1 = currency sign1.121). The present study provides further estimates of the cost of schizophrenia treatment in Italian mental health services and highlights the variability in the single cost components across clinically defined subgroups of patients
Is EQ-5D a valid measure of HRQoL in patients with movement disorders?
No full textIn a pilot study, we assessed the desriptive part of the EQ-5D system in rehabilitation patients with severe moving disorders and compered it with FIM and SF-36 in a sample of 60 patients. The internal validity of the EQ-5D was good. However, most patients considered "moving on a wheelchair" as a good way of "getting about". The findings show possible problem of misinterpretation in the levels of mobility dimension
How do italian pharmacoeconomists evaluate indirect costs?
No full textObjectives: To investigate how indirect costs are evaluated in pharmacoeconomic studies in Italy and the attitude of Italian pharmacoeconomists toward indirect costs. Methods: A literature review was conducted, specifically focused on pharmacoeconomic studies including indirect costs carried out in Italy, and a suevey among Italian pharmacoeconomics experts. Results: Nineteen studies were available for review. Although the methods used to calculate the value of production loss due to morbidity were all based on the Human Capital Approach (HCA), there was a wide variability among studies in practical methods. The parameters used to value production losses varied widely too. Of the 25 survey responders, 20 considered it important to include indirect costs in pharmacoeconomic studies; 56% of those interviewed stated that health authorities should require indirect cost evaluations. Most of these experts would include indirect cost estimates in drug-pricing calculation. Conclusions: In Italy studies evaluating indirect costs are still only few, although there is evidence of an increase. Italian pharmacoeconomists are far from reaching any consensus on methods for evaluating these costs. Methods need to be standardized particularly with respect to the parameters used to quantify productive time lost in monetary terms
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