Timothy Arnaut

Responsible for payer evidence strategy and long-term evidence planning for Wegovy® and CKD therapeutic area:

• Determine payer evidence strategy and tactics, support market access preparation for products in development and for launch
• Set evidence direction for Global Market Access team members, regions, and affiliates
• Lead payer-relevant real-world evidence (RWE) studies (incl. costed patient pathways, treatment patterns, patient preferences, and burden of illness)
• Perform descriptive and statistical analyses from secondary data sources and manage ad-hoc evidence requests from affiliates to support payer dialogues and HTA submissions
• Represent the payer view and Portfolio Strategy, Access and Pricing in cross-functional fora and processes, e.g. Integrated Evidence Strategy (IEP)
• Anticipate and shape payer/HTA evidence requirements via publications and external engagement
• Lead internal and/or external training and presentations on Payer Evidence to disseminate and communicate research findings cross the organization
• Act as counsellor to less senior colleagues

Global lead regarding evidence generation and health economic modelling at the Roche Diabetes Care (RDC) HQ Market Access department:

• Ensure integration of the payer perspective into RDC evidence plans and studies based on affiliate payer insights and payer landscape assessments (SLRs etc.). Coordinate and guide the local teams to ensure alignment with global market access strategy and best practices in terms of real word evidence.
• Execute payer relevant evidence programs with the quality of collection and statistical analysis expected by payers (PICO, MCID etc.) including identification, collection, synthesis and analysis of real-world datasets and designing and executing real world pilot studies in partnership with affiliates and their payers and the impactful publication of the results.
• Act as a role-model for Agile Leadership behaviors, and be a strong advocate of RDC's culture, mindset & behaviors.
• Building health economic models strategically and early to help identify evidence development opportunities and priorities in order to support convincing payer value messages.
• Quantify the value of RDC product solutions by employing tailor-made best practice burden of illness, cost-effectiveness analysis and budget impact models and methods acceptable to targeted payer segments. Coordinate and ensure correct roll out of these economic models in relevant countries.
• Work closely with low- to middle-income markets to generate evidence that help to improve patient access to self-monitoring of blood glucose (SMBG) solutions

• Leading the development and execution of a global, comprehensive and scientifically rigorous HEOR program that is aligned with the commercial and market access strategies for the brand(s) and with the must-win countries
• Be responsible for driving the collaborative generation of a payer evidence strategy, plan, the evidence deliverables
• Ensuring that the market access and payer perspective is integrated in the target product profile, the clinical development program(s), the Real Life Evidence development program(s), and in the commercial strategy of the brand(s)
• Providing timely strategic recommendations to early clinical development programs by identifying appropriate comparators, target patient populations, and end-points (clinical, economic, patient reported outcomes) aimed at ensuring differentiation for the purpose of relative value demonstration, and by giving input to HPRs
• Coordinating a common global strategy and package for submissions to health technology assessment (HTA) agencies in securing reimbursement Developing together with the Access Core Team value propositions and proactively identifying evidence requirements to support relative value demonstration and product differentiation
• Representing the HEOR function, managing effective communications with various internal global/regional team(s), as well as appropriate external forums and meetings

Global Health Economics & Outcomes Research (GHEOR) lead for Eylea and early ophthalmology pipeline within the Global Market Access Structure:

• Focus on marketed products and early assets. Support to prepare HTA processes and P&R re-evaluations from a Global and country perspective
• Co-development of the real-world evidence and data generation strategies (including patient reported outcomes), value message development, defining MACS/HEOR publication strategy
• Provide input regarding early clinical development, early economic modeling and stakeholder management.

Aim to increase the value of Pharma's development and marketed portfolio by calculating the Budget Impact (BI) for health authorities and generating Cost-effectiveness (CE) Evidence, ensuring and maintaining market access by:

• Performing epidemiological research to estimate the eligible/target patient population and associated flow.
  
• Creating/adapting CE and BI models and reports based on sound economic, statistic and scientific data to reflect local medical practice (therapeutic areas: oncology, cardiology, ophthalmology and hematology).
  
• Developing innovative (oncology) HE/BI models, including designing and implementing the parametric survival regression data.
  
• Planning proactively CE processes and ensure high quality data collection by working with external vendors, surveys, Delphi panels, F2F contacts and other projects.
• Creating/adapting BI files in line with strategy and prepare sound business forecast early onward to enable business creation of optimized brand plans.
• Providing support during P&R procedures and listing negotiations to guarantee an optimal outcome, in cross-departmental collaboration.
• Providing, after full internal alignment, support in HE, BI & price-related activities to external stakeholders (RIZIV, APB, EA, …) to assure correct prices & notifications of sales.
  
• Additional Global assignment July 2020-March 2021 (part-time) : Main responsible in the development of the global payer value proposition (PVP), global value dossier (GVD) and CE model of a new asset, including collaborating with the global team and external vendor working on the project.
  

• Establish and maintain a local functions network, i.e. representatives from each of the R&D functions, with others as relevant.
• Pinpoint the need for new Quality System Documents and coordinate the writing process in collaboration with the Local Process Owners.
• Liaise with representatives from Headquarters to ensure alignment with Global SOPs whilst safeguarding the local relevance.
• Monitor SOP compliance and implementation of Quality System Documents: Ensure training regarding medical-quality processes and follow-up on post-audit activities.

• Manage, coordinate and execute observational studies within Belgium and Luxembourg as part of the Real Life Evidence Projects Unit:-Write study protocol according to local needs (e.g. Market Access) and participate in cross-departmental discussions with relevant stakeholders.
• Management of observational studies and other RLE projects: contract negotiations and budget forecasting, site initiation and training, query management, remuneration of study-related activities and close-out.
• Monitor compliance of site activities with study protocol and Bayer SOPs (eg. quality review for local studies)
• Liaise with investigators to maintain productive relationships and ensure relevance of study outcomes.
• Develop Data Entry Tool in light of observational studies to facilitate data entry for participating HCPs. Ensure a smooth data extraction of the study data.
  
• Analyze the results of local studies and write the study report. Coordination of publication process with external vendor if applicable.

• Pharmacovigilance department: Receiving, documenting, preparing, medically reviewing and timely transferring spontaneous and solicited reports to headquarters. Ensuring the patient's safety and compliance with global and local pharmacovigilance requirements by PV training.
• Real Life Evidence Projects Unit: As Local Project Manager of two observational studies, tasks included initiating and closing studies, data management and monitoring, communication with stakeholders, achieving important milestones of the study in time and payment of the investigators.