Farmacoeconomia dei COXIB nella patologia osteoarticolare: revisione della letteratura

A new class of anti-inflammatory agents, the selective inhibitors of cyclooxygenase-2 (COXIBs), has been recently introduced into the market for the treatment of osteoarthritis and reumatoid arthritis. Randomized and controlled clinical trials showed a similar efficacy and a better tolerability profile of COXIBs compared with conventional non-steroidal anti-inflammatory drugs (NSAIDs). The aim of this study was to perform a scientific literature review relating to the economic impact produced by COXIBs' introduction. The research of references included the following databases: MEDLINE, EMBASE and the NHS (Economic Evaluation Database) of the York University. A total of 67 in extenso pubblications have been extracted. Of these 13 papers having the specific objective to evaluate the economic implications of COXIBs in comparison to conventional NSAIDs was analysed. In ten cases (77%), cost-effectiveness analyses were performed. The European context was considered in eight cases (62%), while that of North America and Asia were investigated in four and one case, respectively. The analysis of costs took always into account direct costs of the management of arthritis exclusively (drugs, and resources associated with the treatment of gastrointestinal side effects). Indirect and intangible costs were never considered. The results of this review highlight that the higher tollerability profile of COXIBs may generate a cost-saving. This cost-saving seems to be basically due to the reduced frequency of gastroprotective agents coprescription and also to a lesser appearance of severe gastrointestinal side effects compared with conventional NSAIDs. Besides the disease management improving, the cost-saving associated with COXIBs can completely or partially offset the net increase of expense induced by their higher price of purchase

Clinical and economic impact of aliskiren in uncontrolled hypertensive patients

BACKGROUND: the majority of hypertensive patients do not achieve adequate blood pressure (BP) control and thus remain at risk of cardio-cerebrovascular events. Aliskiren, a novel antihypertensive drug acting as direct renin inhibitor, was authorized in Italy for the treatment of hypertension in patients who remain uncontrolled and at risk despite the use of at least two antihypertensive drugs. It was subject to an AIFA web-based monitoring registry. Results of the registry show a decrease of 20.8/9.2 mmHg in systolic/diastolic BP, within 6 months, when aliskiren is added to current therapy.OBJECTIVE: to evaluate the clinical and economic impact of such BP reduction in terms of avoidable cardio-cerebrovascular events.METHODS: an Excel-based Markov model compared aliskiren plus current antihypertensive treatment to current antihypertensive treatment alone over a 5-year horizon. Patients’ baseline characteristics and BP-reduction were taken from the AIFA registry and literature. Using Wilson and Anderson risk equations, the model simulated patient’s transitions from Pre-Event to Post-Event and Death, calculating the number of those who experience an event. Unit costs were assigned to treatments, events and follow-up. Sensitivity analyses considered: efficacy variability and societal costs of events.RESULTS: 2.47% of patients treated with aliskiren added-on to their antihypertensive therapy were expected to avoid an event. As observed in the AIFA registry, 19.8% of patients remained treated only with aliskiren whereas others reduced the number of antihypertensive treatments, leading to a 38.6% reduction of monthly concomitant antihypertensive treatment cost. Considering events and follow-up cost reduction, the per-patient annual incremental cost of aliskiren is calculated at € 187 and generates 0.042 QALYs over 5 years. The ICER was € 22,062 per QALY (€ 16,845 to € 30,771 for an efficacy range of ± 25%). Considering societal costs ICER was € 20,094 per QALY.Conclusions: AIFA registry real-world data confirmed aliskiren’s efficacy in uncontrolled hypertensive patients. Together with reaching their BP goals, patients consumed less medication from other antihypertensive drug classes and are expected to avoid cardio-cerebrovascular events. The ICER remained within acceptable thresholds, confirming that aliskiren represents a good investment in terms of health benefit

Achievement of therapeutic target in subjects on statin treatment in clinical practice. Results of the STAR (Statins Target Assessment in Real practice) study

The primary aim of the STAR Study (Statins Target Assessment in Real practice) was to determine the LDLcholesterol reduction and to analyse patient’s and therapeutic factors associated to LDL-cholesterol target attainment in newly treated subjects with statins in an unselected population in clinical practice setting. Administrative databases (including pharmaceutical prescriptions and hospital admissions) and laboratory test databases (including LDL-cholesterol values) of five Local Health Units, distributed in Emilia Romagna, Toscana and Umbria, were linked. A retrospective cohort study was conducted and all subjects aged ≥18 years with a first prescription for statins (newly treated subjects) between January 1st, 2007 and June 30th, 2008 were included. All statin prescriptions over a 12 months follow-up period were considered and used to calculate adherence to treatment. Baseline and follow-up LDL-cholesterol, respectively, were defined according to the nearest determination to the first prescription for statins and to the end of the follow-up period. A total of 3.232 subjects was included, 1.516 males (47%) and 1.716 females (53%), with an average age equal to 65,9 ± 11,3 years. Among included subjects, 22,6% had a gap to LDL-cholesterol target <10%, 30,0% between 10 and 29%, 20,7% between 30 and 49%, and 26,7% ≥50%. Among those with a gap to target ≥50%, 30-49%, and 10-29%, respectively, LDLcholesterol target was attained by 7,1%, 41,8%, and 62,3% of subjects. LDL-cholesterol target attainment was associated to gap to target, adherence with treatment, and type of statin

Farmacoepidemiologia e farmacoeconomia della terapia anti-ipertensiva: uno studio osservazionale della popolazione della Asl di Ravenna

The aim of the paper was to perform a pharmacoepidemiological and pharmacoeconomic analysis of antihypertensive drug treatment. An administrative database kept by the Local Health Unit of Ravenna listing patient baseline characteristics, drug prescriptions and hospital admissions was used to perform a population-based cohort study. The study included all new users of antihypertensive drugs, 20 years of age or over receiving a first prescription for diuretics, beta-blockers, calcium channel-blockers, ACE inhibitors or angiotensin II antagonists (AIIAs) between January 1st, 2000 and December 31st, 2000. All prescriptions for anti-hypertensive drugs filled during the 12-months follow-up period were considered. Patients were classified as continuers, switchers and discontinuers on the basis of their prescription dynamics. A total of 14.062 patients were included in the study of whom only 39,7% resulted persistent at 12 months. Patients initially prescribed for AIIAs were more likely to continue antihypertensive treatment than those started on other drug classes as well as those with older age, concurrent drug therapies and previous hospitalisation for cardiovascular diseases. The overall cost of the study cohort for antihypertensive drugs amounted to 1.238.752,37 euros of which 80,6% was used for persistent patients. The annual average cost for antihypertensive drugs was 171,73 euro for continuers, 205,10 euros for switchers and 28,29 euros for discontinuers. Factors associated to drug cost were age, pattern of persistence, number of prescribed drug classes, and class prescribed at enrolment. Nonpersistence with antihypertensive pharmacotherapy induced a high cost for the consumption of antihypertensive drug since discontinuers are responsible for a significant percentage of drug resources allocated on subjects exposed to therapy. A correlation between drug therapy cost and persistence with treatment is needed to evaluate the appropriateness of drug utilization and to perform cost-effectiveness analyses between alternative pharmacological agents

Adherence to treatment and anticoagulation control in vitamin K antagonists-treated patients: an administrative databases analysis in a large Italian population

Oral anticoagulant therapy is essential for the treatment and prevention of many thromboembolic disorders. The aim of the present study is to evaluate the level of anticoagulation intensity in patients treated with vitamin K antagonists (VKAs) in a clinical practice setting and to explore the relationship between anticoagulation intensity and adherence to VKA treatment. We conducted a retrospective cohort study using the administrative databases of three Italian Local Health Units. Patients were enrolled if they had filled at least one prescription for VKAs (ATC code B01AA) between January 1st, 2007 and June 30th, 2008. In the same period all determinations of the international normalised ratio (INR) were collected. The parameters evaluated were anticoagulation control and adherence to VKA treatment.The survey showed that only 47.9% and 56.3% of INR determinations, in VKA naïve and established patients respectively, were into the recommended range (2.0-3.0). Moreover, the percentage of INR determination below the recommended range was higher than the percentage of INR determination above the recommended range for both naïve and established patients. Moreover, adherence to VKA treatment was poor both in naïve and established patients and, consequently, anticoagulation control is poor. Also in patients with the highest adherence to VKA treatment, only about 60% of INR determinations were into the recommended range. Our findings evidence that the anticoagulation control in clinical practice settings is still unsatisfactory and it is necessary to evaluate interventions to increase the amount of time at which patients' INR are within the recommended range

La farmacoutilizzazione delle statine nella pratica clinica: risultati di uno studio di popolazione condotto su database amministrativi e di medici di medicina generale

In spite of findings of large-scale clinical trials which showed an overall reduction of morbidity and mortality from coronary heart disease in patients treated with 3-hydroxy-3-metylglutaryl coenzyme-A reductase inhibitors (statins), relatively little is still known about the real prevalence of treatment in general practice setting, particularly in patients with a high cardiovascular risk. The objective of this study was to investigate among patients with cardiovascular risk profile estimated according to the Framingham Heart Prediction Risk Study, the percentage of those exposed to statins, and the proportion of patients reaching total cholesterol (TC) target levels. A cross-sectional analysis was conducted on a large cohort of patients listed in the administrative databases of the Local Health Unit of Ravenna (total resident population of 356,000). In 2001, every single patient who received a prescription for a statin, and/or with a recorded plasma TC level, and/or with a hospital admission for cardiovascular reasons (identified by ICD-9 code), and/or with a clinical appraisal based on the presence of cardiovascular risk factors, was defined eligible. Sebsequently, pharmaceutical, and nosocomial databases, were cross-linked with that of 50 general practitioners in order to assess the pharmacoutilization of statins on a patient-by-patient basis. A cohort of 9,208 patients with a well documented cardiovascular risk profile were analyzed. The mean age of those patients was 57 (SD=17) years and 42% of them was male. On the basis of raised TC levels and cardiovascular risk profiles, patients for whom a statin treatment was suggested amounted to 7,233. However, the number of those who received statins was significantly lower (n = 1,343), corresponding to 18.6%. In those exposed to statins, just a small group of patients reached a level of TC below 190 mg/dl (n = 271), equivalent to 20.2%. In the group of treated who did not achieve recommended TC target levels, 31.7% (n = 340) of patients was at very high cardiovascular risk. Moreover, among all patients with high plasma TC levels (n=5,890), there was a 45.7% (n = 2,690) who did not received any lipid lowering drug even though they had a high cardiovascular risk profile. Results from large population-based administrative databases suggest a remarkable level of undertreatment among patients with cardiovascular risk factors. Furthermore, many patients did not achieve recommended TC target levels with their statin treatment. Pharmacoutilization of statins in general practice reveals the need of a more careful pursuing of therapeutic goals

Analisi della persistenza e delle risorse allocate nel trattamento farmacologico dell’ipertensione arteriosa

In this study, the persistence with treatment and resources allocated in antihypertensive pharmacotherapy has been evaluated. Administrative databases of the Local Health Unit of Ravenna listing patients baseline characteristics, drug prescriptions and hospital admissions were used to perform a population-based retrospective study. All new users 20 years old or over receiving a first prescription for diuretics, beta-blockers, calcium channel-blockers, ACE inhibitors or AII-Antagonists between January 1st, 1997 and December 31st, 1997 were included. A one-year follow-up for prescriptions of anti-hypertensive drugs were considered. According to duration of therapy, treated population was divided in persistent patients (continuers and switchers) and non-persistent patients. A total of 16,783 patients was included in the study of whom 64.9% were non-persistents. Persistence with treatment seems to be associated with the class of anti-hypertensive drug initially prescribed, and with patient-related factors. Patients initially prescribed for AII-Antagonists were more likely to persist than those starting on the other antihypertensive classes. Annual antihypertensive treatment cost accounted for • 1,076,053.55 of which 25.4% for non-persistent patients. An appropriate use of claims data may be considered as a powerful tool, providing detailed epidemiological and economic information concerning the antihypertensive treatment