Advances in scientific and technological research are opening new, promising treatments for previously difficult to treat diseases, increasing the demand on already constrained healthcare budgets. The challenging economic and political environment is leading Health Technology Assessment (HTA) agencies and payers to demand better outcomes at lower cost to the overall health system.  

In 2021, the European Commission adopted the EU HTA regulation with the key objective of accelerating patient access to innovative treatments by harmonizing methodologies, establishing predictability and avoiding duplications. For AbbVie, this provides a unique opportunity to demonstrate the value attributes of our assets & strengthen affiliate position in country Pricing & Reimbursement (P&R) appraisals. Joint Clinical Assessment (JCA) is the key component of the EU HTA regulation and comprises the EU HTA dossier that will need to be submitted to the Member State Coordination Group on HTA, in which the evidence of relative effectiveness and relative safety is summarized within a single submission. For AbbVie, JCA will enable better planning of market access strategies across Europe, driving the perception of value, removing redundancies with repetitive dossiers, saving time and ultimately resulting in smoother P&R negotiations, aiming to achieve faster and broader access for patients.

To succeed in this environment, we (AbbVie) need to fully understand market value drivers, identify the evidence required for Pricing, Reimbursement and Access (PRA), and work with the evidence generating functions to ensure that evidence generated will support successful JCA and HTA outcome along with PRA negotiations.  

The International HTA Strategy team was established to realize the full value of our assets by strategically informing drug development, evidence generation and HTA submissions, aligned with HTA/payer needs. The primary goals of the function are to ensure HTA evidence requirements are considered early in the development of AbbVie assets and implement a robust and aligned HTA strategy including EUHTA across the organization for the successful launch of Abbvie assets. The International HTA Strategy team oversees EU HTA Regulation implementation for AbbVie and leads Join Scientific Consultation (JSC) and JCA strategy development and execution.

AbbVie is currently looking for an Associate Director/Lead within the International HTA Strategy team to support the EU HTA process for our new Specialty assets

• Develop HTA insights collaborating with key affiliates to understand Access Evidence requirements for specific diseases and assets in Specialty
• Supports early affiliate engagement (Early Touchpoint process) on behalf of International Market Access and Pricing (IMAP) to help inform (registrational) clinical development programs. This includes early Large Business Units (LBUs) PICOs development.
• Consult HTA reimbursement Databases, develop HTA /payer engagement plans and gather insights from early scientific advice from HTA agencies and other external experts
• Internal stakeholders include IMAP; Global Health Economics and Outcomes Research; Affiliates; Areas; R&D; Commercial; Medical and Regulatory; Governance bodies
• Support the development of global Payer evidence deliverables, working in close collaboration with global colleagues and external vendors.
• Lead the strategy development and execution of JCA dossier.
• Lead external advocacy plan working with patient groups and external experts to shape the JCA strategy
• Lead the preparation of Market Access and Analysis Plan (MAAP) and post hoc analysis plan
• Support areas/affiliates on local HTA submissions by providing strategic guidance and coordinating across evidence generation functions at global level (Medical Affairs, HEOR and Clinical Development) to answer questions from HTA agencies.
• Support establishing the new framework and capabilities needed for successful EUHTA Regulation implementation.
• Develop and execute contingency / risk mitigation planning