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

Capri, Stefano; Ceci, Adriana; Terranova, Lorenzo; Merlo, Domenico Franco; Mantovani, Lorenzo Giovanni

doi:10.1177/009286150103500122

Cited by 99 publications

(91 citation statements)

References 31 publications

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“…Even though these would be duly quantified, they should not be included. Being intangible, costs represented by psychological and physical discomfort associated with the state of the disease, they are usually already adequately measured in effectiveness, for example, by faster healing or decreased side-effects, as well as by greater quality of life (utility) associated with the condition [15]. The number of economic evaluations of pharmaceuticals is rapidly growing, and so is their relevance.…”

Section: Intangible Costsmentioning

confidence: 99%

“…According to Capri et al [15], for the estimation of paid productivity losses the Human Capital approach [18] should be used. Human Capital approach assumes that the value to society of productivity losses should…”

Section: Estimating Indirect Costsmentioning

confidence: 99%

“…Unpaid work is the production of goods and services that are not sold on a conventional market [19]. In Capri et al [15] it is suggested to use the Proxy Good approach to estimate unpaid productivity losses. With this approach, the monetary value of unpaid work is based on the value of the closest market substitute.…”

Section: Indirect Costsmentioning

confidence: 99%

“…Hence, initial productivity levels can be restored after a "friction period". Both because this approach is less straightforward to apply -it requires further assumptions and estimates of the length of the friction period -and because Human Capital is suggested in Capri et al [15], the model estimates lost paid production according to this last approach. In addition, the absence of a validated measurement instrument -such as the Health and Labor Questionnaire (HLQ) or the iMTA Productivity Cost Questionnaire (iPCQ) or the Valuation of Lost Productivity (VOLP) -to collect data regarding both paid and unpaid production and informal care can be seen as a limitation.…”

Section: Reduced Ability: Productivity Loss and Informal Carementioning

confidence: 99%

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A General Model for The Estimation of Societal Costs of Lost Production and Informal Care In Italy

Pradelli

Ghetti

2016

Value in Health

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We developed a general model for estimating and comparing disease-and treatment-specific lost paid/unpaid production (due to premature death and reduced ability) and informal care received (due to reduced ability) in Italy, starting from survival, demographic and Health-Related Quality of Life (HRQoL) data. Assuming the disease is not selecting a systematically different population in terms of mean wage than the general public, age-and gender-specific yearly production values are estimated combining data from the last Italian Time-Use-Survey on time dedicated to paid and unpaid (household, caring and volunteering) activities, with a) the last Italian Wage-Structure-Survey, for paid activities (Human Capital approach), and b) market prices for an equivalent service, for unpaid production (Proxy Good approach). To avoid double counting, age-and gender-specific maximum care needs are approximated with time dedicated to eating and personal care, reported in TUS. Present monetary values of future productivity and informal care are estimated applying a 3.5% annual discount rate. Lost life years due to a particular condition/treatment are estimated by comparison of its survival curve with the corresponding age-and gender-normalized survival curve of the general Italian population. The degrees of reduced productivity and need for informal care for remaining life years are estimated by comparison of condition-/treatment-specific reported HRQoL data with demographically matched Italian norms. Our results will be useful for cost-effectiveness and budget impact analyses conducted from the perspective of the Italian society and we encourage the inclusion of these costs in economic evaluations to allow decision makers to be fully informed about the costs and consequences of their decisions on healthcare interventions.

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Section: Intangible Costsmentioning

confidence: 99%

Section: Estimating Indirect Costsmentioning

confidence: 99%

Section: Indirect Costsmentioning

confidence: 99%

Section: Reduced Ability: Productivity Loss and Informal Carementioning

confidence: 99%

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A General Model for The Estimation of Societal Costs of Lost Production and Informal Care In Italy

Pradelli

Ghetti

2016

Value in Health

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“…È stata infine condotta un'analisi volta a identificare il prezzo soglia di atorvastatina che determinasse il medesimo costo per i due trattamenti in studio [9][10][11].…”

Section: Sensibilitàunclassified

Valutazione economica dello studio PROVE-IT

Mantovani

Montella

Citarella

et al. 2007

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Introduction: the PROVE-IT ("Intensive versus moderate lipid lowering with statins after acute coronary syndromes") was a comparison of pravastatin 40 mg/die versus atorvastatin 80 mg/die in patients with an acute coronary syndrome (ACS). Aim: our aim was to investigate the economic consequence of high dose of atorvastatin vs usual-dose of pravastatin in Italian patients with a history of acute coronary syndrome. Methods: the analysis is conducted on the basis of clinical outcomes of the PROVE-IT study. We conducted a cost-effectiveness analysis, comparing high dose of atorvastatin (80 mg/die) versus usual-dose of pravastatin (40 mg/die) in the perspective of the Italian National Health Service. We identified and quantified medical costs: drug costs according to the Italian National Therapeutic Formulary and hospitalizations were quantified based on the Italian National Health Service tariffs (2006). Effects were measured in terms of mortality and morbidity reduction (number of deaths, life years gained and frequency of hospitalizations). We considered an observation period of 24 months. The costs borne after the first 12 months were discounted using an annual rate of 3%. We conducted one and multi-way sensitivity analyses on unit cost and effectiveness. We also conducted a threshold analysis. Results: the cost of pravastatin or atorvastatin therapy over the 2 years period amounted to approximately 1.3 millions euro and 870,000 euro per 1,000 patients respectively. Atorvastatin was more efficacious compared to pravastatin and the overall cost of care per 1,000 patients over 24 months of follow-up was estimated at 3.2 millions euro in the pravastatin and 2.5 millions euro in the atorvastatin group, resulting into a cost saving of about 700,000 euro that is 27% of total costs occurred in the pravastatin group. Discussion: this study demonstrates that high does atorvastatin treatment leads to a reduction of direct costs for the National Health System. Atorvastatin therapy is dominant since it is both less costly and more effective than pravastatin. Results of sensitivity analysis showed that atorvastatin therapy remains dominant even in the most unfavourable hypotheses.

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Patient‐reported outcomes and health‐related quality of life in effectiveness studies: pros and cons

Marquis

Arnould

Acquadro

et al. 2006

Drug Development Research

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The importance of patient perspectives on disease impact and response to therapy is increasingly recognized. Patient-reported outcomes (PROs), including health-related quality of life (HRQL), provide information on the effectiveness of medical interventions that cannot be obtained using objective clinical measures. For drug development, PROs such as symptom questionnaires are accepted by the European Medicines Agency (EMEA) and US Food and Drug Administration (FDA) in the approval process. HRQL assessments can help to establish the niche for a new product to support marketing efforts. Utilities can also be derived from health outcomes measures for cost-effectiveness analyses required by health plans for granting drug reimbursement. Because they more closely reflect routine clinical care, effectiveness studies are often a superior setting than traditional randomized controlled trials (RCTs) for conducting comprehensive PRO assessments to determine the real-world impact of therapy on symptoms and other aspects of everyday life. Screening, quality of care, self-reported adherence to treatment, and patient monitoring are important potential applications of PROs in effectiveness studies. However, well-known limitations of effectiveness studies also apply to PROs; these sometimes include a lack of randomization, controls, and blinding. It may be difficult to obtain patient compliance and clinician assistance with PRO assessments in a real-world setting. PRO data may be biased by nonrandom patient dropout, errors in timing of PRO assessments, and the environment in which questionnaires are administered. Additionally, the drug development schedule often requires outcomes results before effectiveness studies can be conducted. Addressing these difficulties during study design and the use of short and targeted questionnaires will improve the usefulness and feasibility of PRO measures in effectiveness studies. Drug Dev.

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

Cited by 99 publications

References 31 publications

A General Model for The Estimation of Societal Costs of Lost Production and Informal Care In Italy

A General Model for The Estimation of Societal Costs of Lost Production and Informal Care In Italy

Valutazione economica dello studio PROVE-IT

Patient‐reported outcomes and health‐related quality of life in effectiveness studies: pros and cons

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