This systematic review assesses the current status of anti-cyclic citrullinated peptide (anti-CCP) and rheumatoid factor (RF) tests in the diagnosis and prognosis of rheumatoid arthritis (RA). We reviewed publications on tests and biomarkers for early diagnosis of RA from English-language MEDLINE-indexed journals and non-MEDLINE-indexed sources. 85 publications were identified and reviewed, including 68 studies from MEDLINE and 17 non-MEDLINE sources. Anti-CCP2 assays provide improved sensitivity over anti-CCP assays and RF, but anti-CCP2 and RF assays in combination demonstrate a positive predictive value (PPV) nearing 100%, greater than the PPV of either of the tests alone. The combination also appears to be able to distinguish between patients whose disease course is expected to be more severe and both tests are incorporated in the 2010 ACR Rheumatoid Arthritis Classification Criteria. While the clinical value of anti-CCP tests has been established, differences in cut-off values, sensitivities and specificities exist between first-, second- and third-generation tests and harmonization efforts are under way. Anti-CCP and RF are clinically valuable biomarkers for the diagnosis and prognosis of RA patients. The combination of the two biomarkers in conjunction with other clinical measures is an important tool for the diagnosis and management of RA patients.

The episodic data of our pilot study in the UK contributes further evidence that TGC protocols may be arduous to maintain and constitute a substantial investment of nursing time.

BackgroundTreatment for patients with breast cancer (BC) is guided by human epidermal growth factor receptor 2 (HER2) status. The patient’s HER2 status is assessed using US Food and Drug Administration-approved in vitro diagnostic (IVD) immunohistochemical (IHC) tests and laboratory-developed IVD tests. We analysed HER2 testing accuracy using data from the Nordic Immunohistochemistry Quality Control (NordiQC) HER2 IHC programme; results were used in an economic BC treatment model.MethodsData were obtained from NordiQC HER2 BC surveys performed from 2008 to 2012. False-negative (FN) and false-positive (FP) rates for approved and laboratory-developed IVDs were used to estimate direct costs, loss of survival, productivity benefit and quality-adjusted life-years. In the absence of consistent and accessible clinical and economic data from countries participating in the NordiQC programme, United States productivity data, healthcare costs and patient numbers were used as a surrogate in order to estimate the potential impact of selecting an approved or laboratory-developed IVDs.ResultsIn total, 1703 tests were performed. Pooled FN rates were 11 % for approved IVDs and 25 % for laboratory-developed IVDs; FP rates were 0 % and 5 %, respectively. Using these FP and FN rates in the economic model and applying them to the United States BC population, approved IVD tests would result in better clinical outcomes, i.e., better survival and fewer disease recurrences/progressions, and lower costs, i.e., total direct costs and lost productivity, versus laboratory-developed IVD tests. Every $1 saved by laboratories by using cheaper reagents could potentially result in approximately $6 additional costs to the healthcare system.ConclusionsThe results of this analysis suggest that incorrect HER2 test results have far-reaching clinical and economic consequences.

A475take into account confidential discounts under patient access schemes. Finally, the threshold probability of cost effectiveness seems to lie between 30% and 60%. PHP134 Parameter Uncertainty in ValUe Based mUlti criteria decision analysis: a systematic reView of metHods

The number of eligible patients for each drug (141 -214,000) tends to correlate with the negotiated rebate. ConClusions: An additional benefit is necessary for a reimbursement beyond the reference group price. Despite the small number of observations it might be concluded, that the reimbursed price inversely correlates with disease incidence. The highest rebate on reimbursement price resulted from the decision of the arbitration board.