José A. Vidal

ACCESS TO HEALTH, MEDICINE, BIOLOGY & DIGITAL TECHNOLOGY

EN

360º Methodology: from Molecule to Patient

This is my proven framework, designed to reduce uncertainty and maximize opportunities at each stage of your product's life cycle. We unite regulatory strategy, value evidence, and commercial execution into a cohesive action plan.

Phase 1 - Government & Public Affairs

Building the Favorable Environment

Commercial success begins long before launch. In this phase, we focus on creating a receptive ecosystem for your innovation. It’s not just about complying with regulations, but about shaping them.

  • Drive the Conversation: Design and execution of institutional relations strategies to position your vision in parliamentary forums and key committees.
  • Lobby: Development of socioeconomic impact reports and strategic alliances to build bridges with decision-making stakeholders.
  • Awareness: Proactive management of corporate reputation to generate an environment of trust and leadership.
  • Regulatory: Monitoring and analysis of the political-regulatory environment, with special focus on the new EU HTA regulation, to anticipate changes and turn them into opportunities.

Phase 2 - Pricing & Reimbursement

Demonstrating Value

Once the environment is favorable, we must communicate the value of your innovation clearly, rigorously, and convincingly to payers and evaluators. This phase is critical to obtaining a fair price and adequate funding.

  • New HTA EU Regulation: Adaptation and strategic preparation for the new Health Technology Assessment (HTA) and the Joint Clinical Assessments (JCA).
  • Global Value Dossiers: Creation of global and local Value Dossiers that articulate the clinical and economic value proposition.
  • Payer Value Tools: Design of customized tools for payers, budget impact calculators (BIM), and cost-effectiveness models.
  • Objection Handler & AI Tools: Development of solid arguments and use of AI tools to anticipate and manage evaluator objections.

Phase 3 - Market Access & Execution

Ensuring Adoption

With approval and pricing secured, the real work begins: ensuring that patients have real access to treatment. This phase focuses on operational excellence and tactical execution at the national and regional level.

  • Regional Access by Archetypes: Design of regional access plans based on the archetypes and care pathways of each autonomous community.
  • Healthcare Routes & Position Papers: Mapping of patient routes and development of position papers to facilitate inclusion in guidelines and protocols.
  • Tender Strategy: Development of winning strategies for public tenders and bidding processes.
  • Commercial Operations: Alignment and training of field teams (X-Teams) for impeccable execution of the access strategy.

Ready to accelerate your market access?

Let’s talk about your challenges and how my experience can become your greatest strategic asset.

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