Our internal self-assessment identified five areas for growth, categorized into two focused priority areas and three additional modules requiring improvement. The two primary priorities consisted in the development of Innovative Value Strategies (IVS)/Payer Evidence (area 5) and the refinement of an actionable plan regarding RWD Vision and Strategy (area 2). These areas were selected for their critical importance in supporting payer decision-making, fostering value-based healthcare collaborations, and establishing the frameworks necessary for evidence-based decision-making within the local context.

In addition to these focused priorities, the assessment highlighted three key areas for further development. The first was Evidence Planning and Value Team Implementation (area 1), to align cross-functional evidence-planning processes more effectively with strategic objectives. The second was Research/Evidence Partnerships (area 3), recognized for their potential to foster external collaborations and drive innovative evidence-generation projects. Finally, PROM/Patient-Centric Evidence (area 8) emerged as a priority due to its critical role in enriching evidence through direct patient insights and fostering patient-centered initiatives.

These five areas were prioritized based on their alignment with AZ Spain’s strategic goals and their relevance to the evolving needs of the local healthcare ecosystem. Collectively, they represent significant opportunities to enhance AZ Spain’s evidence-generation capacity, strengthen external partnerships, and effectively address unmet healthcare challenges.

3.1 Focused Priority Areas3.1.1 IVS/Payer Evidence (Area/Module 5)

Reimbursement negotiations with payers are evolving towards an increased emphasis on agreements based on product value. This shift underscores the need for internal cross-functional structures and processes capable of assessing whether OBAs will be required early in the product lifecycle. Furthermore, these structures are tasked with identifying evidence gaps that must be addressed to effectively define success criteria for OBA constructs.

The action planning for this module was designed to ensure that payer evidence generation is a systematic, strategic, and scalable process. The capability gap development in this area followed a structured timeline of short-term (6–12 months), mid-term (12–24 months), and long-term (24+ months) objectives, with a clear focus on defining systematic processes, enhancing collaboration, and leveraging data-driven insights (Table 2). The plan aimed to proactively assess OBA needs, strengthen engagement with global reimbursement teams and regulatory bodies, and integrate technological frameworks in the hospital systems to support decision-making. By implementing these strategies, AZ Spain sought to align its evidence-generation efforts with the evolving demands of payers, ensuring robust preparation for OBAs and strengthening its position in value-based healthcare negotiations.

Table 2 IVS/payer evidence action planning

To address this challenge, AZ Spain undertook several tangible actions. A local procedure was developed that included working processes and established a cross-functional team to evaluate OBA needs early in the planning cycle and, where needed, to generate the necessary evidence and define its use in OBAs. The procedure was intended to ensure the timely generation of required evidence and to define the strategy to develop OBAs, taking into account interactions with key stakeholders, including global teams, regulators, and hospitals. Another tangible action was the creation of payer-focused evidence strategies using local case studies to contextualize and tailor the approach to local market needs. Furthermore, the ATLAS platform, a recently in production proprietary tool containing public and private local RWE data on disease state, treatment patterns, and health system burden, is expected to play a critical role in supporting payer evidence discussions in the future.

3.1.2 RWD Vision and Strategy (Area/Module 2)

AZ Spain identified critical needs and opportunities for improving its RWD vision and strategy. The current landscape of data sources in Spain is characterized by significant regional variability in data availability, quality, and industry access. Addressing this fragmentation was essential to refining and expanding existing evidence-based strategies and leveraging RWD to support decision-making across the product lifecycle. In line with the Clinical Evidence 2030 framework proposed by the EMA [5], AZ Spain's strategy emphasizes the need to enhance RWD integration, ensuring its evidentiary value across different research questions.

To this end, AZ Spain supported the establishment of a “FarmaIndustria” Working Group in 2023, dedicated to advancing RWE strategies. Efforts were also directed towards enhancing knowledge of existing data sources, such as national public databases (e.g., CMBD/Ministerio de Sanidad [8], utilized for the ATLAS platform) and regional sources (e.g., Andalusia, Valencia), to maximize their potential use. Furthermore, RWE initiatives were aligned with our ongoing transforming care efforts to identify opportunities for practice change, including perception research and other potential RWE-linked projects [7, 9]. AZ also began integrating sustainability outcomes into its RWE initiatives, reflecting their growing importance to decision-makers. Additionally, partnerships with innovative organizations such as technological companies and startups resulted in projects exploring advancements in artificial intelligence (AI), machine learning (ML), and natural language processing (NLP), such as Diabetic@ [10] and FAITHFUL [11].

The action planning for this module was designed to enhance RWD accessibility, integration, and strategic application over short-term (6–12 months), mid-term (12–24 months), and long-term (24+ months) phases. The plan prioritized early access to local RWD, the development of federated data models, and strengthening governance around data quality and privacy (Table 3). Over time, efforts were focused on advancing AI-driven analytics, improving collaboration with regulatory bodies, and fostering partnerships for government-to-government data discussions. Through this structured approach, AZ Spain aimed to overcome regional disparities, optimize the use of RWE, and support impactful healthcare decisions that drive meaningful practice change across the product lifecycle.

Table 3 RWD Vision and Strategy action planning3.2 Modules for Improvement3.2.1 Evidence Planning and Value Team Implementation (Area/Module 1)

AZ Spain identified the need for earlier alignment of evidence plans with brand strategies to enhance integration and improve decision-making throughout the product lifecycle. This need was addressed in the context of a broader initiative simultaneously taking place in the company, aimed at accelerating AZ Spain’s transformation. This initiative used a combination of external and internal assessments, including aspects related to evidence generation [9].

The external assessment, conducted to identify market trends and stakeholder needs, emphasized the increasing complexity of market access due to tightening budgets and a shift towards consultative selling over traditional commercial approaches. Stakeholders now expect value-added services beyond the pharmaceutical product and are often willing to only pay for value, which may require generating evidence to show that the drug provides the expected benefits (outcome-based funding models). This underscores the need for more comprehensive evidence strategies.

The inside assessment identified opportunities for improvement in key organizational areas, highlighting the potential for greater systematization and end-to-end traceability in core processes related to launching and marketing new drugs. It also revealed areas where stronger collaboration between national and regional levels could enhance operational efficiency, ensuring more seamless execution of core processes and optimized resource allocation. Additionally, the engagement model presented an opportunity to become more integrated and responsive to stakeholder needs, fostering a holistic customer view and shared organizational objectives. Feedback from internal surveys of Brand Teams further underscored the value of refining team structures and work processes to strengthen alignment between central teams and in-field roles. Enhancing planning, coordination, and execution was recognized as a key step toward achieving greater synergy in evidence-planning efforts, ultimately driving more effective and cohesive strategies.

Tangible actions were undertaken to address these needs, including the systematization and standardization of cross-functional teams along the product lifecycle (Fig. 1). These changes in the way AZ Spain MA operates within the Spanish context ensured evidence generation became a key contributor across all model phases, starting as early as 12–18 months before phase 3 readouts. These teams included the Early Asset Strategy Team, the Launch Readiness Team, the Core Value Team, and the aforementioned Brand Team, each designed to address specific needs across the product lifecycle. The Early Asset Strategy Team focuses on early positioning and engagement strategies to ensure an optimal time to market. The Launch Readiness Team ensures early positioning of the assets by aligning product value strategies with customer feedback during the pre-launch phase. Finally, the Brand Team and Core Value Team prepare the ground for a successful launch and executes strategic and tactical initiatives post-launch.

Fig. 1.

Implication of MA and evidence generation in cross-functional teams during the product’s development lifecycle in Spain. BEX Business Excellence, EAL Early Asset Lead, EMA European Medicines Agency, EU European Union, HEOR Health Economics and Outcomes Research, MA Medical Affairs, MC3 Marketing Company Consultation and Communication, P&L Profit and Loss, P&R Pricing and Reimbursement, TA therapeutic area

Product lifecycle teams are aligned with all stages of product development, ensuring that each phase has a dedicated expert team for oversight. Strategic tactical planning is developed to define comprehensive plans for each team throughout the product’s lifecycle, following a pre-established work methodology. Operational execution and monitoring forums are held periodically to ensure that teams’ activities align with strategic goals and continuously track the progress to adapt to changing healthcare ecosystem conditions and stakeholder needs.

All these efforts enhanced the anticipation and preparation of information and dossiers required to adapt and fully comply with the latest national and European regulatory changes in scientific consultations on medicinal products and technologies. The new European regulation European Union (EU) Regulation 2021/2282 on Health Technology Assessment [12] establishes a structured framework for joint clinical assessments at the EU level, emphasizing early and continuous dialogue between regulatory agencies and industry stakeholders. This regulation demands a higher degree of alignment in evidence-generation strategies across multiple markets, requiring pharmaceutical companies to adopt a proactive and standardized approach to data collection and submission. Additionally, it reinforces the need for robust RWE to support value-based assessments and market access decisions.

At the national level, Spain is advancing new legislation on Health Technology Assessment and evidence-based decision-making [13], which will increase the focus on regional and national scientific consultations. The draft regulation introduces a more structured and transparent evaluation process, requiring pharmaceutical companies to engage earlier with regulatory authorities and demonstrate the clinical and economic impact of their therapies more rigorously. This shift underscores the growing importance of integrating health economic evaluations and RWE into the regulatory and reimbursement landscape.

By refining its evidence planning model, AZ Spain has positioned itself ahead of these regulatory changes, ensuring that data generation efforts are aligned with both national and European requirements. The systematization of cross-functional teams, the development of structured evidence-planning tools such as "one-pagers," and the integration of brand strategies with early evidence generation, have strengthened the company’s ability to meet evolving compliance expectations. These efforts not only enhance regulatory preparedness but also improve strategic engagement with health authorities, reinforcing AZ Spain’s role in shaping the future of evidence-based healthcare decision-making.

3.2.2 Research/Evidence Partnerships (Area/Module 3)

We identified the opportunity to expand our collaborative efforts beyond traditional database owners and study-specific site engagements. By broadening the scope of partnerships, AZ Spain sought to establish long-term collaborations that could generate impactful RWE. Recognizing the potential of such partnerships, we implemented a series of tangible actions to address these needs.

An Innovation Hub was established to foster collaboration between internal departments and external institutions. This initiative aimed to integrate diverse expertise and promote innovative research endeavors. Strategic partnerships were also forged with key research institutions and consortia by leveraging European funding opportunities. Notable collaborations include the following: the FAITHFUL project [11], which focuses on AI solutions for early heart failure detection, supported by EIT Health (2023-SUD-3860); the PRECISEU initiative [14], which seeks to advance personalized medicine by connecting innovation ecosystems across Europe, funded under the HORIZON-EIE-2023-CONNECT-03-01 program; and the UMBRELLA project [15], which aims to create a comprehensive framework for holistic and patient-centric stroke management, supported by the Innovative Health Initiative Joint Undertaking (grant agreement No. 101172825).

These strategic initiatives have enabled AZ Spain to engage in cutting-edge research, enhance its evidence-generation capabilities, and contribute meaningfully to the broader scientific community.

3.2.3 PROM/Patient-Centric Evidence (Area/Module 8)

We recognized the need to increase the integration of patient-centric methodologies into our evidence-generation processes, moving beyond reliance on quality-of-life questionnaires. Several key initiatives were implemented to address this need and ensure that patient perspectives were central to evidence development.

Ethnographic studies using semi-structured interviews were introduced to capture deeper insights into patient experiences. Collaborations with patient associations were established to co-develop evidence frameworks and lead large-scale macro-surveys, ensuring that patient voices directly informed research initiatives. Furthermore, AZ Spain emphasized the creation of plain-language summaries and patient-authored publications to enhance accessibility and engagement. For example, publications by Rubio et al. [16] and Galindo Izquierdo et al. [17], which involved patients and patient associations in their preparation and authorship, have provided critical insights into patient experiences in heart failure and lupus, respectively, and have demonstrated the organization’s commitment to this approach.

These efforts represent a significant step forward in embedding patient-centric methodologies into AZ Spain's evidence-generation strategy, ensuring that the outcomes are directly aligned with patients' needs and priorities.