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Background: In the increasingly complex environment of MS there is a need for better cross-talk and communication between the different stakeholders who each address MS according to their own perspective. Objective & Methods: The first and second Pan-European MS Multi-stakeholder Colloquia were specifically set-up for this. Results: In May 2014 and May 2015, the different stakeholders in MS (patients, healthcare professionals, regulators, payers and pharmaceutical industry professionals) met to present and discuss each other’s perspective, formulate 10 integrated Calls to Actions (first Colloquium) and discuss guidance propositions/recommendations developed by working groups for the Calls to Action (second Colloquium). Conclusion: The perspectives of the different stakeholders and the 10 integrated Calls to Action are summarised in this supplement.

ObjectiveTo assess the value of best clinical judgment (BCJ) and the prostate cancer gene 3 (PCA3) assay in guiding the decision to perform a repeat prostate biopsy (PBx) after a previous negative PBx.Materials and MethodsUsing the RAND/UCLA Appropriateness Method, 12 European urologists established recommendations (BCJ) for the appropriateness of PBx according to the prostate-specific antigen level, digital rectal examination findings, number of previous negative PBxs, prostate volume, and life expectancy, with and without consideration of the PCA3 scores. These recommendations were applied to 1024 subjects receiving placebo in the Reduction by Dutasteride of Prostate Cancer Events trial, including men with a previous negative PBx, a baseline prostate-specific antigen level of 2.5-10 ng/mL, and a PCA3 test performed before the protocol-mandated 2- and 4-year repeat PBxs. Three scenarios (ie, BCJ alone, BCJ with PCA3, and the PCA3 score alone) were tested for their ability to reduce the repeat PBx rate versus missing Gleason sum ≥7 prostate cancer (PCa).ResultsBCJ with PCA3 would have avoided 64% of repeat PBxs compared with 26% for BCJ alone and 55% for PCA3 alone (cutoff score 20). Of 55 PCa cases (Gleason sum ≥7), 13 would have been missed using BCJ alone compared with 7 using PCA3 (cutoff score 20) alone and 8 using BCJ plus PCA3. The diagnostic accuracy for Gleason sum ≥7 PCa of the BCJ with PCA3 scenario was superior to that of the other scenarios, with a negative predictive value of 99%.ConclusionApplication of the BCJ together with PCA3 testing can reduce the number of repeat PBxs while maintaining the sensitivity to detect Gleason sum ≥7 PCa.

Background: The first and second Pan-European MS Multi-stakeholder Colloquia were set up to increase cross-talk and communication between the different stakeholders in MS and developed joint Calls to Action to improve (equal) access to quality care and treatment for MS in Europe. Objective & Methods: To summarise the 10 integrated and interrelated Calls to Action developed. Results & Conclusion: Call 1: increase awareness in the European community about the burden MS places on patients, caregivers and society. Call 2: improve communication towards the European community on the direct and indirect cost burden of MS. Call 3: perform patient research to (re)define treatment goals/endpoints from a humanistic/patient perspective point of view. Call 4: develop new tools to better capture the total clinical burden of MS. Call 5: develop a protocol for standardisation of MRI for optimising its use as a marker of disability progression in MS. Call 6: support research to find other (molecular) biomarkers which can predict long-term disability progression and (monitor) individual treatment response. Call 7: align CHMP/EMA and HTA decision-making process. Call 8: develop separate EMA guidelines for evaluating follow-on products of non-biological complex drugs. Call 9: support people with MS remaining (physically) active and at work and stimulate the implementation of specialised care centres. Call 10: support the continuation of multi-stakeholder colloquia.

111 Background: 10-35% of men with a negative initial biopsy (Bx) have prostate cancer (PCa) found on repeat Bx (rBx). Fear of missing significant cancer frequently results in, often negative, rBx. As Bx is associated with pain, anxiety and complications, a better individualization of the decision for rBx to reduce the number of rBx and overdiagnosis of indolent PCa is needed. Recently, we used the RAND Appropriateness Method (RAM) to develop a model for rBx patient selection, based on expert recommendations and including the PROGENSA PCA3 Assay (Tombal B, et al. World J Urol 2011;doi:10.1007/s00345-011-0721-0). PCA3 has been shown to predict the probability that a rBx will be positive and may be indicative of PCa significance (Aubin SMJ, et al. J Urol 2010;184:1947-52). In the current analysis, we tested the expert recommendations model on the placebo cohort of the REDUCE study. Methods: The RAM expert recommendations were applied to the placebo cohort of the REDUCE study in which 1073 men with a baseline PSA 2.5-10 ng/mL and a prior negative Bx had a PCA3 test before the planned 2-year and 4-year rBx2. For each scenario (with and without PCA3), the number of rBx and the number of missed high-grade (Gleason sum ≥ 7) cancers were assessed. Results: Data from 1024 subjects were available for analysis. In the scenario without PCA3 consideration (reflecting the experts’ recommendations using PSA, DRE, number of previous negative Bx, prostate volume and life expectancy), 267 (26%) of study-mandated rBx were considered inappropriate and the number of missed high-grade cancers was 14. The scenario including also PCA3 consideration led to a reduction of the number of rBx (656 or 64%), while the number of missed high-grade cancers was decreased to 8. The diagnostic accuracy was superior in the model with PCA3: sensitivity for high-grade cancer was 85% vs. 75%, specificity 67% vs. 26%, positive predictive value PPV 13% vs. 5%, NPV 99% vs. 95%. Conclusions: Application of RAM expert recommendations for rBx that include the PCA3 Score can reduce the number of rBx for men with an elevated PSA while maintaining the sensitivity to detect high-grade cancer.