The study wants to take a picture of the current epidemiological scenario regarding HCV infection in Italy. Studies used to estimate HCV burden of illness in Italy were so far local and performed a number of years ago, not mirroring the state of the art. EpaC wanted to provide a real number of diagnosed patients, eligible to new anti-HCV therapies. EpaC is the most important Italian NGO for hepatopathic patients. A number of source were cross-checked. Starting from all regional data regarding HCV-related exemptions, a correction/integration was performed with online questionnaire to associated patients (from which we derived patients cured and also other/no exemptions); survey to all prescribing centers in Italy (from which we derived the percentage of ineligible patients); prevalence of particular subpopulations was also collected (prisoners and HIV/HCV coinfected); calculations of new diagnosed, dead and cured patients in 2015. Excluded patients were illegal immigrants and active drug addicts (subpopulations currently rarely cured). A total of 221.549 patients were derived from regional exemptions databases and the mean national prevalence was 0,364%. Adding patients without exemptions/other exemptions, total was 308.624. We deducted the yearly deaths, cured and not eligible patients and, last, integrated with coinfected and prisoner special groups. Prevalence was also estimated at regional level, highlighting a reduction of the typical North-to-South prevalence gradient. Applying the abovementioned corrections/integrations, total diagnosed and eligible HCV patients in Italy who can be immediately cured are supposed to range 163.148 –187.756. This is a study aimed at filling an informative gap able to provide useful actual information in terms of HCV patients real life management and future resource allocation. These data may in fact be considered the basis for policy- and decision-makers to plan and manage patients ready to be cured. The study do not provide information on patients not yet diagnosed.
RA is a chronic inflammatory disorder leading to disability and reduced quality of life. Effective treatment with biologic DMARDs poses a significant economic burden. The Abatacept versus Adalimumab Comparison in Biologic-Naive RA Subjects with Background Methotrexate (AMPLE) trial was a head-to-head, randomized study comparing SC abatacept with SC adalimumab.1 Recent subgroup analyses showed improved efficacy for abatacept in serum anti-citrullinated protein antibody (ACPA)-positive patients, with increasing efficacy across ACPA quartile levels.2
Objectives
To evaluate the cost per response of abatacept relative to adalimumab in ACPA-positive patients with RA from the Italian, Spanish and Canadian societal perspectives.
Methods
A decision tree was designed to compare the cost per response of abatacept with adalimumab in a cohort of 1000 ACPA-positive patients (Q1: 28–235 AU/mL, Q2: 236–609 AU/mL, Q3: 613–1046 AU/mL, Q4: 1060–4894 AU/mL) over 2 years. Clinical inputs were based on the AMPLE trial, and response was based on ACR20/50/70/90 and HAQ-DI. Unit costs for direct medical costs of AEs were based on local tariffs for disease-related groups and the ex-manufacturer9s price, including mandatory reductions, payback and transparent discounts for drugs. Societal costs included patient costs, indirect costs of work absence and early retirement, according to HAQ functional capacity categories.
Results
The cost per response in ACPA-positive patients favoured SC abatacept compared with SC adalimumab for ACR20, ACR70, ACR90 and HAQ-DI across all countries (Table 1). When evaluating across ACPA quartiles, cost per ACR20, ACR50 and ACR70 favoured SC abatacept with increasing stringency of response criteria and serum ACPA levels. Cost per ACR90 and HAQ-DI response consistently favoured SC abatacept across all ACPA subgroups and countries. In terms of cost per remission across all countries, cost per DAS28 favoured SC abatacept in ACPA-negative patients, while cost per CDAI and SDAI favoured SC abatacept in ACPA-positive patients.SC abatacept was consistently favoured in ACPA-Q4 patients across all outcomes and countries.
Conclusions
The costs per responder were lower for SC abatacept than SC adalimumab in ACPA-Q4 patients across all countries. Cost savings were greater when more stringent response criteria were applied and also with increasing ACPA levels, which could lead to a lower overall healthcare budget impact with abatacept compared with adalimumab in Italy, Spain and Canada.
References
Schiff M, et al. Ann Rheum Dis 2014;73:86–94. Sokolove J, et al. Ann Rheum Dis. 2015 Sep 10. doi: 10.1136/annrheumdis-2015-207942.
Disclosure of Interest
J. Foo Consultant for: Bristol-Myers Squibb, F. Mennini: None declared, J. M. Rodriguez Heredia: None declared, D. Choquette Consultant for: Amgen, AbbVie, Bristol-Myers Squibb, Celgene, Pfizer, Merck, Janssen, Roche, G. Attina Employee of: Bristol-Myers Squibb, S. Jiménez Merino Employee of: Bristol-Myers Squibb, M. Mtibaa Shareholder of: Bristol-Myers Squibb, Employee of: Bristol-Myers Squibb, E. Alemao Shareholder of: Bristol-Myers Squibb, Employee of: Bristol-Myers Squibb, J. Gaultney Consultant for: Bristol-Myers Squibb
