important). More than half (64%) perceived a gap between available and needed post-approval HCEI. A gap between available and needed PIE was noted by 45% of respondents. The majority of payers (80%) reported that they sometimes/rarely received HCEI communications; receipt of PIE was also uncommon (64% rarely or never). An increase in HCEI and PIE communication over the past year was noted by 43% and 39% of respondents, respectively. Regarding type of PIE, payers considered indication sought (82%), clinical trial results (84%), anticipated timeline for FDA approval (80%), and product pricing (86%) as very or extremely important. Almost all (95%) respondents would prefer to receive PIE within 1 year of the product's anticipated approval. Further, 47% of respondents would most prefer that a medical science liaison communicate PIE. ConCluSionS: New legislation and regulations pertaining to the proactive communication of HCEI and PIE may have prompted an increase in such communication by manufacturers in the past year. More frequent and relevant communications between manufacturers and population health decision makers may be helpful to improve formulary decision making and ultimately treatment decisions for patients in need of therapy.

Objectives: The German healthcare system introduced an early benefit assessment for new active ingredients and successive price negotiations with payers in 2011. This paper analyzes how the assessment is in accordance with Porter's concept of value-based healthcare and which specific value-based starting points pharmaceutical companies possess during drug development and benefit assessment. It is further investigated which importance patient benefits possess for pharmaceutical companies and how the benefit assessment led to changes in strategies and structures. Future tendencies for development are discussed. MethOds: A literature review established the linkages between the value-based healthcare concept (Michael Porter) and the German market-access process. Seven in-depth, qualitative interviews were conducted with German executives from the research-driven pharmaceutical industry in May 2016 according to a semi-structured interview guideline. The data was coded and analyzed. Results: The market-access process and the value-based healthcare concept mainly match in aspects of clinical outcome measures, pricing approaches and cost-benefit-assessments. All pharmaceutical companies interviewed act patient-oriented. This influences study design by increasingly gathering quality of life data. Several companies are open to new healthcare models as well as new pricing models (f.i. outcome-based pricing; capitation). However, major challenges exist both internally and externally: discrepancies with payers about payback period (short-term financial planning of statutory health insurances), inconsistencies in the study design, marketing authorization and HTA requirements between different countries, and implicit as well as explicit organizational change on different hierarchy levels and departments. Market-access/HEOR departments are gaining importance while marketing/sales departments remain important (with changes in certain task areas). cOnclusiOns: The results reveal an increasing shift towards value-based elements in healthcare for pharmaceutical companies, payers and public authorities. However, major obstacles and methodological challenges still exist. More appreciation and respect for each other need to be developed in order to establish successful initiatives jointly which are focusing stronger on treatment outcomes of patients.