Impatto sul budget di un trattamento personalizzato dell'epatite B cronica HBeAg-negativa in Italia mediante peg-interferone alfa-2a associato allastopping-rulealla 12a settimanaBudget impact of an individualized treatment for HBeAg-negative chronic hepatitis B in Italy with peg-interferon alpha-2a combined to 12 weeks' stopping-rule

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Background and objectiveTreatment options for chronic hepatitis B (CHB) are the direct inhibition of viral replication by continuous administration of nucleoside analogues (NUCs) or a finite 48-week course of peg-interferon (PEG). PEG can induce the off-therapy immune control of CHB leading to HBsAg loss/anti-HBs seroconversion, but with a low success rate. On the other hand life-long treatment with NUCs is expensive. Currently in Italy, around 67% of naïve patients receive treatment with NUCs. However, exploiting the early identification of PEG-non-responders by combined HBV-DNA and HBsAg quantification at week 12 (stopping-rule) is a new sequential therapeutic strategy that may benefit both patients and third payers. We measured the impact on the Italian National Health Service (NHS) budget of the strategy PEG-week-12-stopping-rule in the treatment of HBeAg-negative CHB.MethodsA Markov model, developed over a 5 year time horizon, comprises the following states: CHB, virologic response, relapse, HBsAg clearance, compensated and decompensated cirrhosis, hepatocarcinoma, liver transplant, post-liver transplant and death. The target population (treatment-naïve CHB patients) was determined based on Italian national population projections and epidemiological data. The current mix of treatment with NUCs (entecavir, tenofovir, adefovir, lamivudine and telbivudine) and PEG (without stopping-rule) was compared with a mix based on a hypothetical adoption of PEG (with stopping-rule). The percentage of patients adopting PEG instead of NUCs started at 25% of current NUCs patient share, increasing over time.ResultsThe estimated impact on the Italian NHS budget, over a 5 year treatment, resulted in savings of approximately €19.3 million, of which drug cost accounted for more than 99%. The beneficial impact of the stopping-rule became clear from the second year, when the break-even point was reached.ConclusionThe large estimated savings in drug costs following the adoption of PEG + stopping-rule in the treatment of HBeAg-negative CHB patients, together with previously published cost-effectiveness results, demonstrate a potentially advantageous profile of this strategy, that could enable a more efficient use of health care resources.

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