Papers by Lorenzo Pradelli
ClinicoEconomics and Outcomes Research: CEOR, 2021
Purpose This Lyme disease early detection economic model, for patients with suspected Lyme diseas... more Purpose This Lyme disease early detection economic model, for patients with suspected Lyme disease without erythema migrans (EM), compares outcomes of standard two-tier testing (sTTT), modified two-tier testing (mTTT) and the DiaSorin Lyme Detection Algorithm (LDA), a combination of both serology tests and Interferon-ɤ Release Assay. Patients and Methods A patient-level simulation model was built to incorporate effectiveness estimation from a structured focused literature review, and health-care cost inputs for the United States, Germany, and Italy. Simulated clinical outcomes were 1) percent of patients with timely and correct diagnosis, 2) patients appropriately treated and exposed to antibiotics therapy, and 3) patients with late Lyme disease manifestations. Expected health outcomes were expressed in terms of differences in quality-adjusted life years (QALYs) due to disseminated Lyme disease and persisting symptoms, and economic outcomes were analyzed from a third-party payer per...
Clinical Drug Investigation, 2021
Background and Objective In asthma, symptom control is a primary goal that is not consistently me... more Background and Objective In asthma, symptom control is a primary goal that is not consistently met with available treatment options. The first commercially available fixed-dose combination in a single inhaler of a long-acting beta-agonist (indacaterol, IND), an inhaled corticosteroid (mometasone furoate, MF) and a long-acting muscarinic antagonist (glycopyrronium, GLY) has shown promising clinical results in phase III trials. The aim of the present study is to evaluate the cost-utility of IND/ GLY/MF fixed-dose combination relative to a combination of salmeterol/fluticasone and tiotropium or salmeterol/fluticasone or IND/MF in adult patients with asthma, from the Italian Health Service (NHS) perspective. Methods A two-state and 4-week cycle Markov model was used to estimate lifetime clinical outcomes and costs. Patients entered the model in stable disease and could experience a non-fatal exacerbation event. The exacerbation rate is dependent upon the therapy a patient is receiving, as per the IND/GLY/MF clinical trials. The impact of each type of exacerbation is accounted by applying a utility decrement, obtained from the literature, and a treatment cost. Utility values were obtained from the EQ-5D questionnaires in the IND/GLY/MF clinical trials. Lifetime costs considered in the analysis were drugs and exacerbation management. Probabilistic sensitivity analyses were carried out, with the aim of evaluating the impact of uncertainty on input parameters. Results IND/GLY/MF is associated with a higher quality of life [+ 0.25 quality-adjusted life-year (QALY)] than salmeterol/ fluticasone plus tiotropium, with an incremental cost of −€3213.90. The incremental cost-utility ratio indicates dominance. At a threshold of €5000 per QALY, IND/GLY/MF has nearly a 100% probability of being cost effective. IND/GLY/MF is associated with a higher quality of life (+ 0.21 QALY) than salmeterol/fluticasone, with an incremental cost of €2547.76. Incremental cost-utility ratio results in €11,897 per QALY. At a threshold of €20,000 per QALY, IND/GLY/MF has nearly a 100% probability of being cost effective. IND/GLY/MF is associated with a higher quality of life (+ 0.34 QALY) than IND/MF, with an incremental cost of €4745.91. Incremental cost-utility ratio results in €14,088 per QALY. At a threshold of €20,000 per QALY, IND/GLY/MF has nearly a 100% probability of being cost effective. Conclusion The results indicate that IND/GLY/MF is cost effective against the considered comparators in a cohort representative of adult patients with asthma in Italy. Extended author information available on the last page of the article On the basis of the clinical results, a Markov model has been fed with local Italian economic inputs. Under the assumptions of the model, it is predicted that the new option is cost effective against existing alternatives.
Therapeutics and Clinical Risk Management, 2021
The aim of this document is to provide a set of indications on the national best practice managem... more The aim of this document is to provide a set of indications on the national best practice management of knee osteoarthritis based on an analysis of the existing literature and the contribution of experts in the field. During the first phase of the project, in agreement with the multidisciplinary panel of experts, the main guidelines on the topic were selected. Each guideline was assessed through the AGREEII system to identify their strong/weak points and a summary of the recommendations contained in the various documents was drawn up. The panel drew up a list of therapeutic options to be included in the document and some of these topics were selected for in-depth analysis and review. The search strategy for the required literature reviews was constructed using the PICOS approach. The results obtained from the literature reviews, the in-depth analyses conducted by the members of the scientific societies involved and the analysis of the existing guidelines enabled an initial draft of the consensus document to be elaborated. This document was examined at the consensus conference held on 28 May 2019, in the presence of a multidisciplinary group consisting of members of the various scientific societies involved. Single recommendations were discussed in work groups with a view to combining the indications given by the literature examined with the experience of the specialists involved. The recommendations discussed were then put to the vote in a plenary assembly. The final document contains 26 practice recommendations which leading specialists involved in the management of knee OA in Italy agree upon.
Farmeconomia. Health economics and therapeutic pathways, 2020
Type 2 diabetes (T2D) is a chronic disease associated with a high epidemiological and economic bu... more Type 2 diabetes (T2D) is a chronic disease associated with a high epidemiological and economic burden. It is associated with a high risk of developing both macrovascular and microvascular complications and cardiovascular diseases represent the main cause of mortality and morbidity in T2D patients. The economic impact of diabetes is primarily due to the cost and duration of treatment and secondary complications of diabetes and associated costs. Sodium-glucose co-transporter-2 (SGLT2) inhibitors are an effective therapy for providing a long-term improvement of glucose control, thus contributing to the long-term prevention of diabetic (particularly microvascular) complications. Furthermore, SGLT-2 inhibitors seem to lead to significant reductions in hospital admissions due to heart failure and progression of renal disease, regardless of baseline atherosclerotic risk category or history of heart failure. Evidence from randomized controlled trials, observational and pharmacoeconomic stud...
Farmeconomia. Health economics and therapeutic pathways, 2018
BACKGROUND: Enhanced pharmacokinetic profile of albutrepenonacog alfa allows to prolong the inter... more BACKGROUND: Enhanced pharmacokinetic profile of albutrepenonacog alfa allows to prolong the interdose period in prophylaxis, maintaining higher trough level, and to reduce dosage needed for bleeding. This improvement could lead to a better efficiency of the hemophilia B treatment.OBJECTIVES: To estimate the impact of this new drug on the Italian National Health System (NHS).METHODS: A model was developed from the NHS perspective to assess the budget impact of treating severe hemophilia B with reimbursed recombinant factor IX over 3 years in Italy. Target population was based on data from the National Registry of Congenital Coagulopathies, which collects data from 54 Hemophilia Treatment Centers. Treatment options were: albutrepenonacog alfa (Idelvion®), eftrenonacog alfa (Alprolix®) and nonacog alfa (BeneFIX®). Annual bleeding rate, dose and infusions needed to treat an episode based on clinical trials data were considered.RESULTS: Mean costs per patient were calculated for prophyla...
Human Vaccines & Immunotherapeutics, 2017
Pneumococcal diseases are associated with a significant clinical and economic burden. The 7-valen... more Pneumococcal diseases are associated with a significant clinical and economic burden. The 7-valent pneumococcal conjugate vaccine (PCV-7) has been used for the immunization of newborns against invasive pneumococcal diseases (IPD) in Italy while now, the pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) and the 13-valent pneumococcal conjugate vaccine (PCV-13) are available. The aim of this analysis was to compare the estimated health benefits, cost and cost-effectiveness of immunization strategies vs. non-vaccination in Italy using the concept of overall vaccine effectiveness. A published Markov model was adapted using local data wherever available to compare the impact of neonatal pneumococcal vaccination on epidemiological and economic burden of invasive and non-invasive pneumococcal diseases, within a cohort of newborns from the Italian National Health Service (NHS) perspective. A 18-year and a 5-year time horizon were considered for the base-case and scenario analysis, respectively. PHiD-CV and PCV-13 are associated with the most important reduction of the clinical burden, with a potential marginal advantage of PHiD-CV over PCV-13. Compared with no vaccination, PHiD-CV is found on the higher limit of the usually indicated willingness to pay range (30,000-50,000€/quality-adjusted life year [QALY] gained), while the incremental cost-effectiveness ratio (ICER) for PCV-13 is slightly above. Compared with PCV-13, PHiD-CV would provide better health outcomes and reduce costs even at parity price, solely due to its differential effect on the incidence of NTHi acute otitis media (AOM). The analysis on a shorter time horizon confirms the direction of the base-case.
Farmeconomia. Health economics and therapeutic pathways, 2008
The estimation of real-world pharmaceutical costs in a given setting is one of the crucial steps ... more The estimation of real-world pharmaceutical costs in a given setting is one of the crucial steps in pharmacoeconomic comparisons among drugs used in that setting. For the purpose of this estimation, information regarding available pharmaceutical forms, alongside price and market share, for every considered drug is needed. Furthermore, it’s necessary to know, at least approximately, drug quantities averagely consumed in each episode, in the case of acute therapies, or on a daily basis in chronic therapies. This data is difficult to measure in non-experimental settings, and is generally approximated using the statistical average of the drug quantity prescribed by physicians for a given condition. This paper will briefly review definitions and appropriate uses of DDDs (defined daily dose), and PDDs (prescribed daily dose), and then illustrate the expressed concepts on the basis of a practical example constructed on the analysis of last available 12 months of solid oral antipsychotics p...
ClinicoEconomics and Outcomes Research, 2017
Background/objectives: Parenteral nutrition (PN) incorporating omega-3 fatty-acid-enriched lipid ... more Background/objectives: Parenteral nutrition (PN) incorporating omega-3 fatty-acid-enriched lipid emulsions has been shown to be cost effective in Western populations. A pharmacoeconomic evaluation was performed within the Chinese intensive care unit (ICU) setting. This assessed whether the additional acquisition cost of PN with omega-3 fatty-acid-enriched lipid emulsion (SMOFlipid) vs standard PN was offset by improved clinical outcomes that can reduce subsequent costs. Materials and methods: A pharmacoeconomic discrete event simulation model was developed, based on an update to efficacy data from a previous international meta-analysis, with China-specific clinical and economic input parameters. Sensitivity analyses were undertaken to assess the effects of uncertainty around input parameters. Results: The model predicted that PN with an omega-3 fatty-acid-enriched lipid emulsion was more effective and less costly than PN with standard lipid emulsions for Chinese ICU patients, as follows: reduced length of overall hospital length of stay (19.48 vs 21.35 days, respectively), reduced length of ICU stay (5.03 vs 6.18 days, respectively), and prevention of 35.6% of nosocomial infections leading to a lower total cost per patient (¥47 189 [US $6937] vs ¥54 783 [US $8053], respectively). Additional treatment costs were offset by savings in overall hospital and ICU stay cost, and antibiotic cost, resulting in a mean cost saving of ¥7594 (US $1116) per patient. Sensitivity analyses confirmed the robustness of these findings. Conclusions: PN enriched with an omega-3 fatty-acid-containing lipid emulsion vs standard PN may be effective in reducing length of hospital and ICU stay and infectious complications in Chinese ICU patients, and also decreases overall treatment costs. This results in a favorable cost-effectiveness ratio. Thus, PN enriched with an omega-3 fatty-acid-containing lipid emulsion can be seen as a win-win situation for patients, hospital administration, and health insurance companies.
Clinical nutrition (Edinburgh, Scotland), Jan 25, 2017
The Swiss supplemental parenteral nutrition (SPN) study demonstrated that optimised energy provis... more The Swiss supplemental parenteral nutrition (SPN) study demonstrated that optimised energy provision combining enteral nutrition (EN) and SPN reduces nosocomial infections in critically ill adults who fail to achieve targeted energy delivery with EN alone. To assess the economic impact of this strategy, we performed a cost-effectiveness analysis using data from the SPN study. Multivariable regression analyses were performed to characterise the relationships between SPN, cumulative energy deficit, nosocomial infection, and resource consumption. The results were used as inputs for a deterministic simulation model evaluating the cost-effectiveness of SPN administered on days 4-8 in patients who fail to achieve ≥60% of targeted energy delivery with EN by day 3. Cost data were derived primarily from Swiss diagnosis-related case costs and official labour statistics. Provision of SPN on days 4-8 was associated with a mean decrease of 2320 ± 338 kcal in cumulative energy deficit compared wi...
Farmeconomia. Health economics and therapeutic pathways, 2005
Inhibition of platelet glycoprotein IIb/IIIa (GP IIb/IIIa) receptor prevents platelet aggregation... more Inhibition of platelet glycoprotein IIb/IIIa (GP IIb/IIIa) receptor prevents platelet aggregation by controlling its final common pathway, the cross-binding of fibrinogen, bridging across adjacent platelets. Three pharmacological agents capable of inhibiting GP IIb/IIIa are available for use in Italy: abciximab, eptifibatide and tirofiban. In this paper, some relevant studies on the pharmacology of GP IIb/IIIa inhibitors are summarized, as well as the main clinical trials assessing their use in the management of unstable angina (UA) and during percutaneous coronary interventions (PCI). Furthermore, the recommendations on their appropriate use in UA and PCI issued by authoritative scientific societies are presented. Finally, some of the pharmacoeconomic evidence published in the international literature is reviewed and implications in the Italian health care setting are discussed.
Clinical Management Issues, 2007
Recombinant growth hormone (rGH) administration is a cornerstone in the treatment of short statur... more Recombinant growth hormone (rGH) administration is a cornerstone in the treatment of short stature secondary to GH deficit. Since its introduction in the 80s, the population of short patients with an indication to rGH therapy has clearly broadened, probably because of increased awareness by patients and physicians. Since rGH therapy is demanding for patients and expensive, the Italian National Health Service, like other third payers and regulatory authorities, regulates its prescription according to criteria listed in the Nota AIFA 39. This paper illustrates pitfalls and difficulties paediatricians may encounter when assessing short stature patients in order to decide upon the opportunity and possibility to initiate rGH therapy through the exposition of four emblematic, though hypothetical, clinical histories. In the discussion, the Authors highlight some of the most critical points in the formulation of the Nota 39, among which are the lack of clear reference values, neglecting of ...
Farmeconomia. Health economics and therapeutic pathways, 2005
The formation and rupture of esophageal and gastric varices are severe but common complications o... more The formation and rupture of esophageal and gastric varices are severe but common complications of hepatic cirrhosis. They represent the cause underlying more than one forth of all deaths in cirrhotic patients and exact an impressive burden in terms of survival, quality of life and health care resource consumption. Therapeutic options for the control of active variceal hemorrhage comprise pharmacological agents, endoscopic techniques and surgery. Of these, the only options immediately available in the absence of highly specialized medical personnel are vasoactive drugs, namely vasopressin and derivatives and somatostatin and derivatives. Despite this clear advantage, the role of pharmacological treatment is still debated; furthermore, there’s no consensus on the drug of choice for variceal bleeding control. In this paper the main pharmacological and clinical features of terlipressin, a synthetic vasopressin analog, are outlined, as well as a frame for its pharmacoeconomical evaluati...
Farmeconomia. Health economics and therapeutic pathways, 2005
Until recently, pain therapy in Italy was conducted with largely sub-optimal standards, as reveal... more Until recently, pain therapy in Italy was conducted with largely sub-optimal standards, as revealed by one of the lowest mean morphine consumption values, an important indicator of pain therapy quality according to the WHO, among industrialized countries. The recognition of such a negative situation has led to an important effort to improvement, carried out by the law-maker, institutions and health professionals. As suggested by the WHO, these efforts aimed at three main objectives: reducing the cultural barriers to appropriate opioid use through targeted education and information, easing of analgesic drug prescription and availability, and improvement of the integration among hospital-based and domiciliar pain management and care-giving. In this article, the new legal framework concerning the prescription and administration of analgesics - regulatory innovations started in February 2001 - is presented and its practical implications for health professionals are discussed. Alongside ...
Farmeconomia. Health economics and therapeutic pathways, 2005
Sodium parnaparin is a low molecular weight heparin (LMWH). The introduction of this drug class h... more Sodium parnaparin is a low molecular weight heparin (LMWH). The introduction of this drug class has represented a medical advancement in the prevention and therapy of thromboembolic pathologies, as they maintain the same efficacy of unfractionated heparin, but with simplified dosing regimens and reduced side effects. Parnaparin has demonstrated its thromboprophylactic efficacy on both high- and moderate risk surgical patients, besides resulting effective in treating established deep vein thromboses and thrombosis-associated phlebopathies. Alongside these clinical advantages, parnaparin and other LMWHs allow outpatient or home-based therapy of a large number of subjects that should otherwise be treated in hospital, with important savings of health resources and enhanced quality of life for the patients. In Italy, parnaparin drug acquisition cost is among the lowest in its class for many applications, permitting marginal savings in health costs at the same efficacy level. In summary, ...
Clinical Management Issues, 2007
Vulvo-vaginal infections are the most common gynaecological pathologies seen in clinical practice... more Vulvo-vaginal infections are the most common gynaecological pathologies seen in clinical practice. While being predominantly benign, although disturbing, in non pregnant women, their presence during pregnancy has been associated with peri-natal and obstetric complications. The opportunity to prevent these adverse outcomes, especially prematurity and low birth weight, has to be cautiously balanced against the potential to induce fetal toxicity, inherently related to the continuous exchanges among maternal and fetal blood that occurs in the placenta. In this paper, a brief overview of the evidence regarding efficacy, safety and utility during pregnancy of topical clotrimazole and metronidazole, whose combined spectrum covers the great majority of the involved pathogens, is provided. These antimicrobials, especially when applied topically, are highly effective and have been used in pregnant women for many years without evidence of adverse outcomes; in conclusion it appears that they ho...
Farmeconomia. Health economics and therapeutic pathways, 2008
Sodium parnaparin is a low molecular weight heparin (LMWH). The introduction of this drug class h... more Sodium parnaparin is a low molecular weight heparin (LMWH). The introduction of this drug class has represented a medical advancement in the prevention and therapy of thromboembolic pathologies, as they maintain the same efficacy of unfractionated heparin, but with simplified dosing regimens and reduced side effects. Parnaparin has demonstrated its thromboprophylactic efficacy on both high- and moderate risk surgical patients, besides resulting effective in treating established deep vein thromboses and thrombosis-associated phlebopathies. Besides and independently from its antithrombotic activity, parnaparin possesses modulating effects on cells involved in inflammatory processes, which may explain its reported utility in phlebopathies other than DVT; among LMWHs available in Italy, parnaparin is the only approved for these indications. Alongside these clinical advantages, parnaparin and other LMWHs allow outpatient or home-based therapy of a large number of subjects that should oth...
Clinical Management Issues, 2015
Farmeconomia. Health economics and therapeutic pathways, 2005
Type II (non-insulin-dependent) diabetes is one of the most widespread chronic patologies in the ... more Type II (non-insulin-dependent) diabetes is one of the most widespread chronic patologies in the developed countries and its prevalence in Italy is about 2-3% of the population. Type II diabetes is also associated with several other metabolic abnormalities such as central obesity, hypertension, and dyslipidemia, which contributes to the very high rate of cardiovascular morbidity and mortality. Therefore Type II diabetes involves a significant financial burden on the health care system. The purpose of this paper is to explain the composition of the healthcare costs of managing people with Type II diabetes and the economic repercussions due to the adoption of an aggressive strategy against the pathology. To carry out this evaluation we considered the CODE-2 (The Cost of Diabetes in Europe - Type II) Study results, the American Diabetes Association Position Statement, the Diabetes Prevention Program and the UK Prospective Diabetes Study. Evidence exists to show that introducing prevent...
Farmeconomia. Health economics and therapeutic pathways, 2005
BACKGROUND: The dry eye sindrome refers to a group of disorders of the tear film due to reduced t... more BACKGROUND: The dry eye sindrome refers to a group of disorders of the tear film due to reduced tear production or excessive tear evaporation that is associated with symptoms of ocular discomfort and may cause disease of the ocular surface. Dry eye syndrome varies in severity, duration and etiology. The cornerstone of dry eye syndrome therapies includes the intraocular gel or ophthalmic solutions instillation, reaching correct artificial lubrication. Molecules that can produce a stable lubricating film are the carbomers. METHODS: In the first step of our work we reviewed the data from literature reporting about carbomers’ characteristics in respect to other lacrimal substitutes. Then, a pharmacoeconomical analysis has been performed on ophtalmic gels derived from carbomers 974P and PVA. RESULTS: Dry eye sindrome, if not adequately treated, determines a deterioration of the patient’s quality of life, other than high secondary costs. CONCLUSION: The high therapeutical index of carbome...
Value in Health, 2007
Severity of pain (BPI-item-3) was statistically associated with total annual health costs; €1255 ... more Severity of pain (BPI-item-3) was statistically associated with total annual health costs; €1255 (932), €1473 (1198) and €1950 (1391) for mild, moderate and severe pain respectively, p = 0.017. Walking (FIQ1g) and work/domestic (BPI5d) interference were positive predictors for per patient annual drug costs, while pain problems and 12-month health state change (EQ-5D items 4 and 6) were negative predictors (R2 = 0.283, p < 0.001). CONCLUSION: In the primary care setting, annual per patient total direct health cost of Fibromyalgia showed weak but statistically significant association with patient disease interference and severity of pain. Less drug costs could be associated with poorer outcomes in term of health state change and level of pain.
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Papers by Lorenzo Pradelli