Farmeconomia. Health economics and therapeutic pathways
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Entecavir (Baraclude) in patients with chronic hepatitis B virus (HPV) infection
Get PDFHepatitis B is the most common serious liver infection in the world, with about 350 million people who are infected with the hepatitis B virus (HBV) and about 1 million deaths annually.Hepatitis B is characterized by an acute and a chronic phase, if the subject fails to produce adequate immune response. About 5-10% of adults infected with HBV go on to develop chronic infection and become chronic carriers (CHB); moreover, the liver damage, if not stopped, continues until cirrhosis or hepatocellular carcinoma. In the natural history of HBV infection, the most important event is HBeAg seroconversion, characterized by loss of HBeAg (a specific antigen of the virus) and development of Anti-HBe antibodies (HBeAg-positive patients). If the seroconversion has occurred early (when liver damage is not yet significant) and is maintained,long-term prognosis is excellent. The disease can follow a more aggressive course if active viral replication persists despite anti-HBe positivity. This state, characterized by continuing viral replication, has been termed as HBeAg-negative CHB, and is the most prevalent form in Italy. At the moment, there are 4 approved antiviral drug classes, with different antiviral efficacy, for the treatment of chronic hepatitis B: interferons, nucleoside analogues, nucleotide analogues, and cyclopents. The primary target of the treatment is a prolonged suppression of viral replication, in order to avoid long term complications and increase survival
Maraviroc (Celsentri) in HIV treatment
Get PDFSince 1996, the prognosis of people living with immunodeficiency virus (HIV) and acquired immunodeficiency syndrome (AIDS) has improved significantly, due to highly active antiretroviral therapies (HAART) based on a combination of 3-4 anti-HIV drugs; the use ofthese drugs can achieve a durable suppression of HIV viraemia, turning HIV infection into a chronic illness. The three first licensed classes of antiretroviral agents are nucleoside reverse transcriptase inhibitors (NRTIs), non-nucleoside reverse transcriptase inhibitors (NNRTIs) and protease inhibitors (PIs). Until recently, treatment options for individuals developing resistanceto these drugs have been limited, but new drugs in existing classes (second generation NNRTIs and novel PIs) and novel classes of drugs (integrase inhibitors, CCR5 antagonists and fusion inhibitors) have become clinically available
PROVE-IT trial: economic analysis
No full textIntroduction: 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 (2008). Effects were measured in terms of morbidity reduction (number of deaths 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. Results: the cost of pravastatin or atorvastatin therapy over the 2 years period amounted to approximately 664.684 millions euro and 909.006 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 2.58 millions euro in the pravastatin and 2.57 millions euro in the atorvastatin group, resulting into a cost saving of about 11.000 euro. Discussion: this study demonstrates that high dose 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 were sensitive to either clinical or economic variables
Sartans: differences, similitudes and costs
No full textThe search for a more specific and complete blockade of the hypertensive effects of angiotensin and of better tolerability than ACE-inhibitors has led to the development of angiotensin II receptor blockers (ARBs), which were introduced about 10 years ago. During this period they have been evaluated in several large studies in terms of efficacy and safety in reducing blood pressure, as well as for cardiovascular and renal protection. In patients with heart failure, valsartan, candesartan and, partially, losartan have been shown to be associated with positive outcomes both as monotherapy, when ACE-inhibitors are contraindicated or not tolerated, and in combination with ACE-inhibitors standard therapy. Among ARBs, valsartan is the only that is also approved for treatment of patients with both heart failure and recent myocardial infarction. In light of the high costs related to cardiovascular disorders, agents that reduce cardiovascular risk, like ARBs, represent a potential long-term health cost saving strategy, if used according to guidelines in approved indications. Valsartan has a daily cost which is lower than the mean cost of the class. Furthermore, this drug shows one of the lowest costs for patient brought to blood pressure goals in its class. In this paper, economic evaluations conducted on the results of large trials were reviewed. Their results add economic rationale to the therapeutic algorithms recommended by clinical guidelines on heart failure management; using valsartan, or other evaluated ARBs, in heart failure patients who are intolerant or contraindicated to ACE-inhibitors therapy, is expected to be highly cost/effective. In combination with ACE-inhibitors in those patients not on beta-blocker therapy, its cost/effectiveness is somewhat worse, but still acceptable, with an estimated cost of 15,000 USDs for life year saved. In summary, when used for approved indications, valsartan offers attractive economic features for the healthcare provider and has a positive impact on the cardiovascular morbidity and health-related quality of life of these patient populations
Peg-interferon plus ribavirin in chronic hepatitis C: cost-efficacy and pharmacoutilization in clinical practice
No full textThe current standard of care for the treatment of chronic hepatitis C virus (HCV) infection is combination therapy with Peg-interferon (IFN) alpha-2a or alpha-2b type plus ribavirin (RBV). This antiviral schedule can in fact avoid the three fold mortality rates associated to untreated cases with HCV infection, by inducing viral eradication and liver damage regression, so as to define the patients “definitively cured” from liver disease. This analysis describes the modalities of antiviral treatment in the Veneto region, in particular the therapy-schedule mainly used and compares the cost-effectiveness of treatment with the 2 available Peg-IFNs with strategies proposed as in the every day practice. Twelve on line hepatologic units, centralized by a network program on “Surveillance and Control of HCV Infection in the Veneto Region”, prospectively collected data and, of these, we evaluated 450 subjects that underwent antiviral therapy for chronic hepatitis or cirrhosis. A post hoc retrospective analysis of cases treated from January 2003 to December 2005 was performed, grouping the study population in 166 cases treated with Peg-IFN alpha-2a (Pegasys®, Roche, fixed-dose of 180 μg/weekly) and 284 that received Peg-IFN alpha-2b (Peg-Intron®, Schering-Plough, weight-adjusted-dose from 50 to 150 μg/weekly), both in combination therapy with ribavirin (Copegus®, Roche, or Rebetol®, Schering-Plough, weight-adjusted-dose of 15 mg/kg/daily). Epidemiological characteristics and cumulative rate of end-of-therapy response and Sustained Virological Response (SVR) were similar in the 2 groups, but 78% of cases treated with Peg-IFN alpha-2b and RBV received a significantly lower dose with respect to the weight-adjusted dose. This event conditioned efficacy to therapy as demonstrated in cases that received a < 1 μg/kg dose with respect to those treated with > 1 μg/kg (respectively SVR: 49% vs 66%, p < 0,01), particularly in genotype HCV-1 (SVR: 29% vs 51%, p = 0,01), known to be more resistant to IFN-therapy. The overall cost of antiviral therapy in this study population was about € 3,528,000/450 treated cases and considering the 269 that reached SVR (98 and 171, respectively by Peg-IFN alpha-2a or 2b and RBV therapy), the cost/SVR was € 15,632 and € 11,672 in the 2 groups. In conclusion, the optimization of Peg-IFN therapy, that is the use of the full dose, particularly in cases treated with a weight-adjusted Peg-IFN alpha-2b and RBV, at the standard of care dosage of 1.5 μg/kg/week and 15 mg/kg/day respectively, will allow a better efficacy, especially in genotype HCV-1 with an increase of 11% in SVR (43% to 54%) at a lower cost
Veneto
Get PDFIn Veneto region 72,8% of women (aged 25-64) are screened regularly, meaning every 3 years.
Considering regional tariffs and vaccine acquisition cost, the vaccination of 12-year-old girls with a 90% coverage could prevent 72 cases of cervicocarcinoma and 31 related deaths and thus results to be cost-effective (29.052 €/QALY). When the vaccination programme is extended to 16-year-old girls a further 67 cancer cases and 28 deaths could be prevented, with a very similar cost-effectiveness ratio. In Veneto region, the net cost for woman vaccinated is 184 € for the single cohort and 188 € for the multiple cohort
Telbivudine (Sebivo) in patients with hepatitis B virus (HBV) chronic infection
Get PDFHepatitis B is the most common serious liver infection in the world, with about 350 million people who are infected with the hepatitis B virus (HBV) and about 1 million deaths annually.Hepatitis B is characterized by an acute and a chronic phase, if the subject fails to produce adequate immune response.About 5-10% of adults infected with HBV go on to develop chronic infection and become chronic carriers (CHB); moreover, the liver damage, if not stopped, continues until cirrhosis or hepatocellular carcinoma. In the natural history of HBV infection, the most important event is HBeAg seroconversion, characterized by loss of HBeAg (a specific antigen of the virus) and development of anti-HBe antibodies (HBeAg-positive patients). If the seroconversion has occurred early (when liver damage is not already significant) and is maintained, long-term prognosis is excellent. The disease can follow a more aggressive course if active viral replication persists despite anti-HBe positivity. This state, characterized by continuing viral replication, has been termed as HBeAg-negative CHB, and is the most prevalent form in Italy. At the moment, there are 4 approved antiviral drug classes, with different antiviral efficacy, for the treatment of chronic hepatitis B: interferons, nucleoside analogues, nucleotide analogues, and cyclopents.The primary target of the treatment is a prolonged suppression of viral replication, in order to avoid long term complications and increase survival
Bolzano
Get PDFIn Bolzano province 84,8% of women (aged 25-64) are screened regularly, meaning every 3 years. Considering local tariffs and vaccine acquisition cost, the vaccination of 12-year-old girls with a 90% coverage could prevent 7 cases of cervicocarcinoma and 3 related deaths and thus results to be cost-effective (40.541 €/QALY). When the vaccination programme is extended to 16-year-old girls a further 6 cancer cases and 3 deaths could be prevented, with a very similar cost-effectiveness ratio. In Bolzano province, the net cost for woman vaccinated is 216 € for the single cohort and 218 € for the multiple cohort