Human league

In an era where healthcare consumer roles are evolving from recipients to proactive participants, a growing number of stakeholders have employed a patient-centric approach in shaping healthcare access and delivery.

Empowered by an unprecedented level of access to information, patients are increasingly influencing decisions that affect their care, including therapeutic use.

This paradigm shift of the consumer’s role means manufacturers that integrate a patient perspective throughout the drug life cycle can better ensure that evidence generation focuses on endpoints important to patients and that market access strategies are tailored to patient needs, preferences and priorities.

Manufacturers that engage directly with patients across the product development cycle can leverage direct insights into patient needs and design access strategies based on what patients value.

Patient-centric market access represents a holistic approach that places the patient’s voice at the forefront. This commitment is manifested through active patient collaboration at every stage, from drug development and pre-launch strategy, through post-launch commercialisation.

This perspective acknowledges patients not merely as recipients of healthcare but as indispensable contributors. When manufacturers engage patients early in the product life cycle, they can understand specific perspectives on health outcomes most relevant to patients as well as desired improvements in quality of life.

In the process of bringing therapies to market, manufacturers should maintain a sharpened focus on delivering value that authentically resonates with patients.
Patient needs or preferences regarding mechanism of action, dosing regimens, financial support, care coordination and insurance navigation, among others, are central to developing manufacturer market access strategies that enable access to treatment in a meaningful way.

Digital health technologies play a pivotal role in expanding how patients engage and collaborate with the healthcare system and provide options for more systematic data collection on the patient experience.

The integration of digital tools has not only revolutionised how stakeholders engage with patients, but has also opened novel avenues in market access development.

This includes clinician-patient collaboration during clinical trials, virtual engagement with patient focus groups, broader range of research participation across geographical regions and affordability support resources.

As life sciences companies adopt a patient-centric approach, they should leverage these digital technologies to expand the patient population included in product life cycle development.

Digital engagement proves especially useful in reaching vulnerable patient populations, including those traditionally hard to access, ensuring that their input and experiences are considered when shaping market access strategy and design during treatment development, pre-launch and post-launch.

Incorporating the patient perspective in therapy development
Patient-centricity in drug development through direct engagement with patients ensures clinical trials and other data collection frameworks are aligned with the actual patients’ needs and preferences.

In therapeutic development, identifying unmet needs, burden of illness and treatment gaps through the lens of the patient is foundational.

Clinical study design benefits from patient input. Trials crafted with patient convenience and concerns in mind tend to achieve faster recruitment and better performance. Engaging patients throughout the clinical study process encourages participation and adherence.

Specifically, patient centricity in the design of clinical trials and protocols, as well as consent materials and feedback collection mechanisms as part of market access strategy, can enable manufacturers to develop therapies that address an unmet need.

It also supports quality of life through the patient lens, thus supporting future uptake and adherence.

Beyond patient-centricity in clinical trials, market access strategies can benefit from patient preference studies to assess factors patients consider when selecting a treatment and how that impacts their decision-making.

Conducting primary market research with patients (e.g. surveys, interviews, focus groups) to understand potential challenges they may face when accessing care can help identify unique needs that may not be seen through clinical trial studies.

Manufacturers can leverage this information to refine therapy development (e.g., re-prioritising endpoints) as well as future trial design as they prepare for the next phase - pre-launch activities.

Pre-market launch strategy – shifting the paradigm
Manufacturers can strengthen pre-market launch strategies by ensuring that value messaging directly addresses patient-articulated needs and priorities.

Similar to the development phase, manufacturers can incorporate patient engagement in their pre-market launch strategy, where a nuanced understanding of the patient’s perspective may elevate a product’s value position.

Manufacturers can establish patient-centric value messaging via established frameworks that prioritise patient voice. One example is the Patient Perspective Value Framework (PPVF), which assesses healthcare options from the patient’s viewpoint, incorporating patient-centred domains, criteria and measures for a comprehensive evaluation.

It provides a framework for patient-centred value assessments by focusing on preferences, outcomes, costs and evidence quality, and ensuring healthcare evaluations align with patient priorities.

Value messaging should communicate how a manufacturer’s product specifically solves patient challenges, such as adherence, financial needs (e.g., patient willingness to pay), access and quality of life limitations, among other clinical, economic and social challenges.

Leveraging research findings on patient needs from therapeutic product development, manufacturers can further refine value messaging to articulate how their product aligns with patient preferences.

This research can also be used to build patient- and provider-facing tools (e.g., shared decision-making aids, site of care locators, care navigation resources) that consider the individual goals and preferences.

Communicating to payers, providers and even patients that the patient perspective and data were engrained in the pre-launch strategies demonstrates a robust understanding of unmet need and can help establish competitive differentiation.

By integrating the patient perspective pre-launch, manufacturers can ease the transition to post-launch and commercialisation, enhancing product interest and uptake.

Post-launch – sustaining engagement and access
In the post-launch phase, establishing feedback loops with both patients and stakeholders facilitates the continuous improvement of access strategies.

Assessing patient access barriers including payer coverage gaps, provider access restrictions and financial limitations utilising a patient data-driven approach (e.g., patient and caregiver interviews or roundtables) can highlight areas for improvement across the patient journey.

For example, understanding delays in treatment access due to prior authorisation challenges, out-of-pocket costs, travel limitations and other difficulties navigating the care continuum from the patient’s perspective can help manufacturers refine their market access priorities and may provide competitive leverage.

Additionally, the integration of patient-reported outcomes (PROs) into post-launch strategies can enable systematic tracking and collection of patient feedback.
PROs provide insights into the real-world impact of treatments on patients’ lives, empowering companies to fine-tune their strategies based on direct experiences and enhance the overall effectiveness of healthcare interventions.

Real-world evidence/real-world data (RWE/RWD) can also provide a holistic view of the patient perspective.

These data sources can range from data captured in electronic health records to social media platforms where patients exchange information regarding their health. Digital tools can help streamline and aggregate these sources of data, which can be used to assess patient behaviour, feelings toward treatment, and the impact of socio-economic drivers on their treatment experience, among other effects.

Collaborative efforts with advocacy groups can further enhance the care experience by bridging community-based resources with treatment and establishing trust within the community.

These partnerships leverage the expertise of these community-based groups in the true needs of the patient community. Manufacturer adoption of these integrated approaches can help solidify the continuity of patient engagement and access.

While the benefits of a patient-centric market access strategy are clear, its implementation is not without challenges. It requires a cultural shift within organisations, fostering an environment that builds patient engagement into every aspect of a product’s life cycle.

Moreover, it demands a commitment to transparency and ethical considerations, especially in collecting and utilising patient perspectives and insights.

Implementing a patient-centric strategy effectively requires forging partnerships across various stakeholders. Moreover, meaningful patient engagement may require specific data-collection methods to ensure patient input is accurately captured and valued.

In placing patients at the heart of market access strategies, companies can not only enhance drug development and commercialisation but could also contribute to a more equitable and responsive healthcare ecosystem.

By listening to and learning from patients throughout the drug life cycle, companies can ensure that the therapies they bring to market are not only innovative, but also accessible and aligned with real-world data points on patient needs.

This approach will likely lead to more effective therapies, improved patient outcomes, and ultimately, a healthcare system that truly serves those at its centre - the patients.

Brigit Kyei-Baffour is a principal at Avalere. Go to avalere.com