incremental to AR10-based treatment. Methods: A microsimulation version of the CVD Policy Model, a decision-analytic state-transition model, was employed. The model estimated health and cost outcomes for a cohort of CVD-free individuals, accounting for outcomes and costs associated with statin treatment and CVD events. Individual demographic and risk factor profiles were randomly drawn from U.S. National Health and Nutrition Examination Surveys 1999-2010, producing a cohort of 50,000 CVD-free individuals (50% women) who were simulated from ages 40-80 years. Moderate-intensity statin therapy was simulated first for those with AR10≥ 7.5% (standard of care) and was then extended to those with ARR10≥ 2.3% (the minimum ARR10 at the 7.5% AR10 threshold). ARR10 was assigned using a formula that accounted for LDL and AR10. AR10 was assigned using the 2013 U.S. Pooled Cohorts CVD Risk Score. Effectiveness was quantified in quality-adjusted life years (QALYs), costs were quantified in 2017 $U.S., and both were discounted at an annual rate of 3%. The primary outcome was the incremental cost-effectiveness ratio (ICER). Results: Incremental to treating all AR10≥ 7.5%, adding treatment of remaining ARR10≥ 2.3% yielded an ICER of $15,783/QALY. Treating remaining ARR10≥ 2.3% would prevent 1,223 lifetime CVD events in the cohort. Women benefited most (68% of 1,245 QALYs gained). In scenario analyses, results were sensitive to treatment adherence (ICER: Dominant-$52,598/QALY) and efficacy (ICER: $4,984-70,628/QALY) inputs. ConClusions: Statin treatment based on ARR10 is cost-effective and would yield significant lifetime health gains in U.S. adults. Women would gain most from ARR10-based statin treatment when AR10< 7.5%.
A 3 3 5 -A 7 6 6 A521 current regulation and practices; (4) Lack of an ICER threshold. The likely future of health economic assessment of drugs in France will imply the expansion of health economic assessment scope, the implementation of an impactful ICER threshold, the generalisability of coverage with evidence, and eventually the possible merge of the CEESP and the CT. ConClusions: Major steps in French HTA are expected to occur in the near future. Empowerment of the CEESP (merged or not with the CT) is expected, and it may become the unique or leading committee addressing the HTA of pharmaceuticals in France. However, it is likely that the robust and wellestablished methodology developed by the CT (SMR, ASMR) to assess comparative efficacy or effectiveness will remain in force. PHP41Are tHe IrIsH slower tHAn tHey tHInk? A systemAtIc AnAlysIs of All recent ncPe APPrAIsAls Macaulay R, Tan H PAREXEL, London, UK objeCtives: The National Centre for Pharmacoeconomics (NCPE) reviews the cost effectiveness of new medicines following an application for reimbursement in Ireland. All medicines are subjected to a preliminary rapid review (RR, stated to take ~2 weeks) with only high cost products and those with significant budget impact subjected to formal pharmacoeconomic assessments (PEA, stated to be completed in < 3 months). This research aims to review all recent NCPE appraisals to determine what proportion of drugs require a full appraisal, the review times and rates of approvals. Methods: Publically available decision summaries from the NCPE were identified (from 1st January 2013 to 31st May 2015) and the outcome, date, indication, and whether a full PEA was needed were extracted. Results: 110 appraisals were identified with 43% (47/110) approved following RR. Of these, only 21% (10/47) were reviewed within < 2 weeks; the rest taking on average > 2x longer than stated (29 days). Of the 57% (63/111) appraisals deemed to require a full PEA, 62% (39/63) were initiated, on average, > 5 months post-RR. Only 33% (13/39) of full PEAs were eventually recommended, adding another 5 months (average 152 days) to the process. 27% (30/110) appraisals were for oncology medicines; 90% (27/30) of which required a full PEA. Only 15 were NCPE-appraised, almost all of which were not recommended (87%, 13/15). ConClusions: The total average length of time between start of the RR to final PEA recommendation is up to a year (12 months), which is substantially longer than what is claimed. If companies can convince the NCPE that their medicine is not high cost, nor has a significant budget impact, the RR process can enable rapid reimbursement within 1-2 months. However, if a full PEA is required, this significantly delays reimbursement decisions, with positive recommendations being difficult to achieve, especially for oncology medicines.
s197 important implication that the new treatment sarilumab (KEVZARA) may be more cost-effective when compared to adalimumab (HUMIRA) for treating patients with rheumatoid arthritis.
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