Farmeconomia. Health economics and therapeutic pathways
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Budget impact analysis of the use of rituximab in the treatment of rheumatoid arthritis in Italy
No full textObjective: a Budget Impact analysis was performed to evaluate cost implications for the Italian National Health Service (NHS) of the introduction of rituximab (RTX) in the treatment of rheumatoid arthritis (RA). Methods: RA patients eligible to treatment with a second-line biologic DMARD (Disease Modifying Antirheumatic Drugs) were identified and quantified and available strategies for their management were explored. Costs associated with the different alternatives were estimated, and the impact on the NHS budget was estimated using a cohort simulation based on a Markov chain with a time horizon of 5 years and 1-year cycles. Seven alternative strategies were analyzed, each of them starting after the failure of a first anti-TNFα: 1) the use of a second and a third anti-TNFα; 2) the use of a second anti-TNFα followed by RTX; 3) the use of a second anti-TNFα followed by abatacept (ABAT); 4) the use of RTX as a second biological line, followed by an anti-TNFα; 5) the use of ABAT as a second biological line, followed by an anti-TNFα; 6) the use of RTX as a second biological line, followed by ABAT; 7) the use of ABAT as a second biological line, followed by RTX. Only direct medical costs were considered: drug acquisition, administration, incidental premedication and monitoring exams. Results: Italian patients eligible to second biological line therapies (RA patients refractory or intolerant to at least one anti-TNFα therapy) were estimated in about 650 per year. The adoption of RTX as a second line therapy produced a substantial saving in total costs (-33% at the fifth year) with respect to the strategy with RTX as third line and the one with only anti-TNFα (the last two resulting substantially cost-equivalent). The number of patients in active treatment (biologic DMARD) per unit cost resulted of about 8.1 patient-years/100,000 € with the strategy based only on anti-TNFα and increased of 10% with RTX as a third line. The strategy of RTX as a second line provided a further 41% increase (with respect to RTX as a third line). Conclusions: the introduction of RTX in the treatment of Italian RA patients represents a valuable new therapeutic option for this population especially if anticipated after a first anti-TNFα failure; it can also induce a reduction in health resources consumption for the NHS
The use of corticosteroids in patients with chronic obstructive pulmonary disease: epidemiological and economic aspects
No full textObjective: this study aimed at assessing the level of compliance to GOLD guidelines regarding the use of ICS containing drugs for the treatment of patients with COPD in the GPs setting in Italy and at evaluating the economic consequences that the use of corticosteroids may have, specifically in mild and moderate COPD patients where it is inappropriate. Methods: the retrospective GPs database study has analyzed patients with at least one diagnosis of COPD during the period January 2005 – December 2008 who had a report of VEMS and at least one prescription of a drug from ATC R03 class within two months from the date of spirometric exam, who were 40 years or older and that have been followed for at least 9 months. Patients were classified in four disease severity groups according to GOLD (2008). Compliance to GOLD guidelines regarding the use of corticosteroids was evaluated on the basis of the first treatment prescribed after spirometric exam. The analysis evaluated exacerbations as well, assuming their occurrence when one prescription of either antibiotic, oxygen or systemic corticosteroid was found. The cost of the first prescription of treatments containing ICS in mild and moderate patients was calculated. Then the “Hypothetic cost” was built for those patients in order to estimate the cost that would have been created in case the considered treatments had been ICS free. The difference between these two costs represents inappropriate cost that could have been avoided by using an ICS free treatment, more appropriate according to GOLD. Results: a cohort of 2,103 Italian patients with the diagnosis of COPD, followed by 700 GPs all over Italy was analyzed. An ICS-containing treatment was prescribed to more than 50% of patients within each disease severity group. The percentage of patients who experienced an exacerbation within 6 months from the first prescription was not found to be different among patients prescribed with an ICS-free treatment and those treated with an ICS-containing treatment and was independent of the disease severity. In mild and moderate COPD patients respectively, 53% and 48% of the cost generated by the ICS containing prescriptions represent the inappropriate cost for the Health Care System. Moreover, patients are unnecessarily exposed to the risk of inadequate therapy.
Costs of diabetes in Italy
No full textAmong chronic diseases, diabetes is one of the most impacting on healthcare expenditures. This impact is expected to continue growing over time, because of increasing prevalence and earlier diagnosis, with subsequent longer duration of the disease. A review of the main Italian cost of illness studies has been conducted, with a focus on papers addressing the cost structure of diabetes care and those exploring the resources determining the expenditure difference between diabetic and non-diabetic patients. According to different sources, in Italy the yearly average direct cost for diabetes management ranges from € 2,340 to 2,990 per patient. Drugs account for 22-34% of this burden, while 52-60% is due to hospitalization. Of the pharmaceutical expenditure, only 10-11% is related to oral hypoglycemic drugs. Complications account for a large share of diabetes costs: vascular complications induce a 70-100% cost increase. Several studies compared health care expenditures for diabetic patients with those for matched control patients without diabetes. These studies point out that diabetic patients have higher health costs due to an increase in the prevalence of use of health care resources and/or an increase in their prescribed amount. As expected, this gap is mainly due to the treatment of diabetes complications, as opposed to routine disease management; furthermore, some evidence showed that cost increases related to diabetes diagnosis are also caused by drugs, hospitalizations and specialist consultations required for managing disorders traditionally considered not related to diabetes. Consistently with international literature data, our review suggests that the improvement of therapy adherence, together with the adoption of strategies specifically prescribed in order to prevent or delay complications, may be able to ameliorate long term clinical and quality of life outcomes, with a marginal increment of health expenditures
Effectiveness and cost of treatment with maraviroc in HIV infection
No full textSince 1995, life expectancy and quality of life of HIV patients improved significantly due to the use of Highly Active Anti-Retroviral Therapy (HAART), consisting of different combinations of three classes of antiretroviral agents, nucleoside and non-nucleoside reverse transcriptase inhibitors, and protease inhibitors. Recently, new treatment options for individuals developing resistance to these drugs have become available, with the appearance of new drug classes like integrase inhibitors, fusion inhibitors and CCR5 antagonists. Maraviroc is the first antiretroviral agent belonging to the latter drug class approved for clinical use. CCR5 receptor antagonists act by blocking the interaction of the HIV virus with the CCR5 chemokine receptor, a co-receptor essential to the entry process of R5-tropic viruses. The drug is indicated, in combination with other antiretroviral products, for treatment-experienced adult patients infected with only CCR5-tropic HIV-1 detectable virus strains. Results of main phase III clinical trials indicate that maraviroc, in combination with optimized background therapy (OBT), causes significantly greater reductions in viral load and increases in CD4+ cell count, as compared to OBT alone in this kind of patients. In Italy, the monthly cost of maraviroc therapy is about € 780. A number of economic evaluations, performed for different settings, demonstrate that the therapy including maraviroc is cost-effective if compared to OBT alone, determining an ICER generally below the threshold of three times the GDP per capita. In the Italian context, the ICER determined by OBT + maraviroc vs OBT alone is approximately 45,000 €/LYG
Trends in prescribing and persistence with antihypertensive therapy: results of the study PAPEETE (Population-based Analysis of Persistence and Economics of treatment with telmisartan) study
No full textThis paper summarizes the results of the PAPEETE study (Population-based Analysis of PErsistence with treatment and Economics of TElmisartan) that assessed trends in prescriptions, determinants and timing of treatment discontinuation and/or changes in antihypertensive drug therapy in a cohort of hypertensive patients living in Pavia. In the study were included all new users 18 years old or over receiving a first prescription for diuretics, beta-blockers, calcium channel-blockers, ACE inhibitors (ACEi) or angiotensin receptor blockers (ARBs) between 1 January 2003 and 31 December 2006. The follow-up period for each patient was 12 months starting from enrolment date. Based in the presence of continuous therapy, patients were defined as persistent and non-persistent users. A total of 61,493 patients was included in the study of whom 11.2% were persistent. Persistence with the treatment seems to be associated with patient-related factors and with the class of anti-hypertensive drug initially prescribed with the lowest persistence to antihypertensive treatment with diuretics (3.0%) and the highest with ARBs (18.8%)
Economic evaluation of temsirolimus on the basis of the results of the ARCC (Advanced Renal-Cell Carcinoma) study
No full textIntroduction: metastatic renal cell carcinoma (mRCC) is highly resistant to chemotherapeutics, rendering limited antitumor effect. Temsirolimus, a specific inhibitor of the mammalian target of rapamycin kinase, may benefit patients with this disease. The Global ARCC Trial (Temsirolimus, Interferon Alfa, or Both for Advanced Renal-Cell Carcinoma) compared temsirolimus alone or temsirolimus plus interferon alfa with interferon alfa alone in mRCC. It has demonstrated that, as compared with interferon alfa, temsirolimus improved overall survival among patients with metastatic renal-cell carcinoma and a poor prognosis while the addition of temsirolimus to interferon did not improve survival. Aim: the objective of our study was to investigate the pharmacoeconomic impact in the Italian context of temsirolimus vs interferon alfa in patients with metastatic renal-cell carcinoma and a poor prognosis. Methods: economic evaluation is based on clinical outcome data from the ARCC trial and was carried out conducting a cost/effectiveness analysis, comparing economic and clinical consequences of temsirolimus (25 mg weekly) vs interferon alfa (18 MU 3 times weekly) in the perspective of the Italian National Health Service. Direct medical costs included in the analysis were drug costs, costs associated with the management of treatment-related serious adverse events (grade 3 and 4), cost related to progression and best supportive care. Effects were measured in terms of overall survival. A sensitivity analysis was performed. Results: the cost of temsirolimus or interferon alfa therapy amounted to approximately € 14,000 and € 2,000 patient respectively. The cost of hospitalization related to drug toxicity was about € 1,500 for temsirolimus and € 2,100 for interferon alfa. Temsirolimus shows an incremental cost per patient per month saved of € 3,767. Sensitivity analysis demonstrates that cost consequences parameters are sensitive to fluctuation. Discussion: this study is the first economic evaluation of ARCC trial based on the Italian context. This evaluation found that temsirolimus therapy in patients with metastatic renal-cell carcinoma and a poor prognosis is cost-effective
Sugammadex in antagonism of neuromuscular block in anesthesia: a clinical and economic profile
No full textSugammadex is a modified cyclodextrin which acts by encapsulating and inactivating the neuromuscular blocking agents (NMBAs) rocuronium and vecuronium, used to induce relaxation of skeletal muscles during surgery and to facilitate endotracheal intubation. The procedure of reversal of the block at the end of surgery can influence the time to discharge from the operating room and post-operative residual curarization (PORC) incidence, which is related to an increased rate of adverse respiratory events in the post-anaesthesia care unit. Cholinesterase inhibitors are frequently used to reverse neuromuscular block, but their use is associated with potential cardiovascular and respiratory side-effects. The recommended dose-range for sugammadex is 2-16 mg/kg, depending on the level of block: the dose is approximately 2 mg/kg for reversal of moderate blockade, 4 mg/kg for deep blockade and 16 mg/kg for the immediate reversal of a neuromuscular blockade as early as 3 minutes after 1-1.2 mg/kg of rocuronium. Four pivotal, phase III trials studied sugammadex in routine reversal of moderate, deep neuromuscular block and in the immediate reversal of rocuronium-induced block. In all the cases the drug demonstrated of being significantly more efficient than other reversal strategies, providing a faster reversal than the most used anticholinesterase comparator neostigmine. Sugammadex also appeared to have an acceptable safety profile. Acquisition cost of sugammadex is greater than that of neostigmine, but cost-savings related to the reduced theatre time and to the reduced incidence of PORC episodes can offset it. A Budget Impact analysis in the perspective of the hospital has been conducted for the Italian setting resulting in a total cost-save of 7,420 € for one year of activity. In conclusion, sugammadex appears to be a valuable innovation in anesthesiology. This drug represents a safe and effective alternative to anticholinesterase agents
Budget impact analysis of use of aliskiren in hypertension on the Italian Health Care System
No full textCardiovascular (CV) disease management and prevention has been the leading cost driver in health care expenditures of industrialized Countries for many years, and this trend is not expected to change in the next future. Although drugs used for the treatment of arterial hypertension and heart failure account for three fourths of the total Italian pharmaceutical expenditures in this disease area, population studies indicate that only about half of all hypertensive patients are treated for this condition, and that, among treated individuals, only a minority achieves a satisfactory and stable blood pressure control. A complementary observation is that drug expenditures, as high as they seem to be, actually account for only about a fourth of the total direct cost of CV illness, as they are exceeded by costs of hospitalizations required for the acute management of the clinical events that should be, at least partially, prevented by the same cardiovascular drugs. An often pointed out corollary to these findings is that an increase in the rate of controlled hypertension in the population, although surely linked to a further increase in pharmaceutical expenditures, carries the potential to reduce overall health care costs for the management of CV patients. As far as drug treatment is concerned, there seem to be three applicable strategies capable of increasing blood pressure control rates, i.e. interventions directed toward the increase of the treated population, interventions aimed at improving compliance, and the introduction of innovative drugs to cover unmet needs. Aliskiren is the first agent of the new direct renin inhibitors drug class, and has been recently approved in Italy under strict reimbursement restrictions. In this paper, the Authors present a budget impact analysis in the perspective of the National Health Service, conducted by estimating eligible populations according to reimbursement limitations, calculating differential costs by patient subgroups and possible strategies (addition to vs substitution of ACE-Is or ARBs), and finally by applying expected market shares to the identified population. The low forecast market penetration (0.2% and 0.6% of eligible patients, in the first and second year, respectively) drives the results: the treatment of 3,274-9,821 patients induces a yearly increase of 1.5 to 4.5 million € with aliskiren added to ACE-Is or ARBs, and of 917,000 to 2,751,000 € in the substitution scenario