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IGES Pharma Italy

Local Insight. Global Impact.

"Italy offers exceptional opportunities for innovation, but navigating its system requires strategic thinking, stakeholder alignment, and detailed local expertise. At IGES Pharma Italy, we work with companies to shape market access strategies— and turn it into action to achieve timely and effective access."

Ilda Theka, General Manager Italy

Italy's Healthcare Landscape: A Key Market Requiring Integrated Access Strategies

Italy is an attractive, strategic and high-value market within the EU for pharmaceutical products. It consistently ranks among the top countries in terms of availability of EMA-approved medicines, including oncology treatments, orphan drugs, and combination therapies. However, achieving a successful launch requires more than regulatory approval — it demands a well-planned market access strategy that aligns with the expectations of multiple decision-makers across the system.
While AIFA (Italian Medicines Agency) is responsible for national-level pricing and reimbursement decisions, the 21 regional healthcare systems retain autonomy over formulary inclusion, distribution, and local funding. This dual structure means that early engagement with both regulatory authorities and regional stakeholders — including clinicians, HTA bodies, and payer networks — is essential for timely and consistent access.
Italy also offers robust mechanisms to support innovation, particularly for products targeting high unmet needs. Early access pathways such as Law 648/96 and the AIFA 5% Fund are actively used for orphan and life-saving therapies. In this context, an integrated, multistakeholder strategy becomes increasingly critical to ensure medicines reach patients efficiently and equitably across the country.

IGES Pharma Italy’s Approach: Turning Complexity into Access

IGES Pharma Italy is the Italian subsidiary of the IGES Pharma Group — a European market access provider supporting pharmaceutical and biotech companies across key EU markets. Based in Milan, we combine deep local expertise with cross-border coordination to deliver integrated pricing and market access strategies that are both country-specific and EU-aligned.

Navigating the Italian pharmaceutical landscape requires deep local insight, strategic foresight, and seamless execution. As part of the IGES Pharma Group, IGES Pharma Italy supports pharma and biotech companies in accelerating access through integrated services across market access strategy, pricing and reimbursement, launch execution, and regional lifecycle management.

Whether entering the market for the first time or expanding access across regions, we deliver tailored, cross-functional solutions that blend strategic planning, health economics, stakeholder engagement, and operational execution — turning strategy into measurable results.

As part of the IGES Pharma Group, our team in Italy collaborates closely with experts across Germany, France, Spain, UK and other EU countries. This pan-European presence allows us to align national strategies with evolving EU HTA requirements — including Joint Clinical Assessments (JCA) and cross-country pricing coordination — helping companies manage access challenges in a unified and strategic way.
From early market access strategy to lifecycle management and regional evidence generation, we help biopharma companies navigate the complex Italian market with clarity, efficiency, and impact.

Here is how we help companies building and turning strategy into access:

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Supporting early development decisions and access planning to maximize launch success.

1. Early Access & Opportunity Assessment

  • Evaluation of clinical and commercial potential in Italy
  • Unmet need and competitor landscape analysis
  • Assessment of target patient population, place in therapy and access hurdles

  • Stakeholders and decision-makers mapping
  • Advisory boards and early engagement planning
  • Tailored access roadmap aligned with the Italian system

  • Early HTA assessment aligned with AIFA and EU JCA
  • Recommendations for clinical trial design to support access
  • Integration of payer-relevant endpoints and comparators

  • Feasibility assessment for Early Access pathways (Law 648/96, 5% AIFA Fund, Compassionate Use)
  • Strategic planning and risk mapping
  • Stakeholder engagement and support for evidence pack preparation

End-to-end support for pricing and reimbursement in Italy, including AIFA dossier preparation and negotiation.

2. Product Launch: National Access

  • Evidence gap analysis for AIFA HTA and innovation status
  • KOL validation and value proposition optimization

  • Price scenario development based on precedents and discount benchmarks
  • Validation of pricing strategy and optimization of the value story in alignment with payer requirements

  • National AIFA dossier development and adaptation of global value dossiers
  • Development and adaptation of economic models: CEA, BIA
  • Feasibility support for innovation status application

  • Support with dossier submission
  • Mock negotiation preparation
  • Integration of JCA outcomes into the national access strategy

Ensuring broad and sustainable access beyond national approval.

3. Regional Access & Lifecycle Planning

  • Mapping and engaging regional payers, HTA bodies, and clinicians
  • Regional access strategy

  • Tailoring submission materials to regional requirements
  • Adapting clinical and economic evidence to the regional requirements

  • Stakeholder identification and mapping
  • Recommendations on cross-functional organizational setup

  • Risk management strategies for LoE, biosimilars, and competitor launches
  • Ongoing policy tracking and adaptation to regulatory changes

Why IGES Pharma

Let’s Make Access Happen
How to Contact Our Team:

pharma@iges.com

Milan Office: Piazza Gae Aulenti, 1 Torre B, 20154 Milano