A Cross-Functional Formula: Operationalizing the Broader Role of Access

Access has become the front and center topic for the biopharmaceutical industry. The majority of biopharma companies now have explicit goals and commitments related to patient access at the executive level and in their mission statements. The role of the access function is rapidly evolving and access objectives are shared across multiple functions. The access function orchestrates these objectives across the organization to ensure timely, equitable, and sustainable patient access, expanding beyond the traditional focus on technical issues like health economic models, evidence synthesis, and pricing research.

The evolving role of “access” requires us to rethink how companies can operationalize the broader role of global access in this new environment. This report provides a joint perspective of the BCG Market Access Roundtable members. In this joint perspective, we seek to lay out three topics:

How have access objectives evolved? Description of the evolution of access objectives and measures reflecting today’s expanded scope of access.

What is the ideal access contribution toward these objectives? Outlines key elements of how access can contribute at the enterprise level.

What are activities of access functions to deliver on these contributions? Articulation of key considerations around operationalizing the broader role of access.

Convening power

The BCG Market Access Roundtable is a forum that brings together senior market access leaders and serves as a platform for interactive discussion on industry-level topics. Roundtable members collectively select topics that are relevant but not handled in other forums, and which can have either near- and/or long-term relevance. Members work in smaller working groups on specific topics to develop thought pieces, relevant frameworks, or policy-related publications, which are collectively ratified by the Roundtable on a biannual basis. The Boston Consulting Group (BCG) hosts the roundtable and facilitates these forums and the working groups. As of this year, 28 companies are full-time members of the BCG Market Access Roundtable (see list below).

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Access objectives have evolved

Several key developments within and beyond the healthcare system have impacted patient access and the role of access functions within biopharma companies, which are summarized in more detail in “Access in the New World.”¹ As the role of access is expanding, key outcomes for access have also evolved. Objectives have shifted from a functional focus to shared outcomes with other functions, such as medical, regulatory, commercial, and their respective stakeholder counterparts in the healthcare ecosystem.

Historically, access objectives were price achieved, time to reimbursement, or breadth of coverage. Success or progress toward these objectives can be measured or tracked with key performance indicators (KPIs), such as production of key deliverables on time and budget (e.g., value dossier, health economics models, pricing strategy, etc.) or number and quality of interactions with internal and external stakeholders.

The scope of access today has expanded beyond reimbursement to “getting drugs in the hands of patients” and ultimately adoption. State-of-the-art access outcomes are patients treated, patients with choice to benefit from the medicine, or measures of health equity.² Relevant KPIs have also changed to joint efforts such as the co-creation of a NHS National Cancer Plan; resolution on pressing health issues like antimicrobial resistance; the Memorandum of Understanding for access with the Ministry of Health in Ontario Canda; or concrete steps to increase the value, affordability, and capacity for innovative drug treatment.

We anchor the discussion on these joint outcomes at the healthcare ecosystem level, summarized as “access to optimal care in a sustainable fashion.” Several contributions from access are required at the enterprise level to achieve these joint outcomes. The different contributions address internal and external stakeholders, and need to happen at and above the product level. From these types of contribution, we derive implications for operationalizing access activities and deliverables at a functional level. In “Building Access Competencies for the future,”³ we further provide an overview of new and advanced access competencies required to enable functional operationalization and delivery.

Internal and external access contributions required

To enable successful delivery of the shared outcome “access to optimal care in a sustainable fashion” at the healthcare ecosystem level, the access function has a critical role along four internal and four external dimensions. Contributions can further be split into product level and above product/portfolio level. In the following section, we aim to provide an overview of the various elements and examples of what a meaningful or impactful contribution could be.

Internal access contribution

Access leaders have a key role to drive organizational decision-making and steer strategic discussions at the executive level. This becomes particularly critical when interdependencies exist between decisions of access stakeholders and other stakeholders, which are traditionally seen to be the sole remit of other functions. Key contributions from an internal perspective can be summarized along the four themes ahead.

1. Provide the voice of health technology assessment (HTA), payer, and policy stakeholders at and above the product level for pipeline and business development investments

What is a meaningful or impactful contribution?

• Understanding of policy, healthcare system, and other relevant health system stakeholders and their needs, and articulating implications across the organization.
• Anticipating and creating action plans for environmental risks and scenarios where the access landscape can
  rapidly shift.

2. Champion integrated evidence and commercial strategies that define, demonstrate, and capture the broad value of a product

What is a meaningful or impactful contribution?

• Ensuring integrated evidence planning considers the value of a product, including regulatory approval.
• Establishing access priorities and objectives as a formal part of action plans and objectives of key internal
  team members.
• Promoting a solid understanding of access considerations around evidence and value across relevant internal functions—relevance beyond regulatory approval is widely acknowledged.

3. Drive societal and health system considerations on value, affordability, and health outcomes within a broader environmental, social, and governance (ESG) agenda

What is a meaningful or impactful contribution?

• Truly integrated activities ensure delivery of timely and equitable access as part of the broader societal and healthcare system value.
• Cross-functional plans recognize distinct and dedicated access objectives—any downstream implications are fully articulated by the access function, and broader impact on longer-term access, utilization, and patient benefit is considered appropriately.
• Health policy activities drive measurable improvements in healthcare financing, capacity, and value recognition.
• The company articulates a clear strategy on access to medicines and health equity as part of a broader ESG agenda—given the rising importance of ESG, ensure the “S” remains relevant in board discussions.

4. Frame strategic access trade-offs across pipeline, portfolio, franchise, and products

What is a meaningful or impactful contribution?

• The organization makes trade-off decisions under consideration of all elements of health system value.
• Access considerations inform early portfolio investment decisions (e.g., during late-stage research and early development).
• Therapeutic area and brand strategies consider access hurdles and complex trade-offs (e.g., multi-indication-/combination-therapy considerations).

External access contribution

The roundtable identified four additional areas where access leaders can contribute and steer decision-making in forums with external stakeholder groups. Understanding and co-creating the environment with these stakeholders is crucial to achieve joint outcomes with a positive impact at the healthcare ecosystem level.

1. Advocate change in health systems to ensure timely and equitable patient access

What is a meaningful or impactful contribution?

• The company (e.g., individually or jointly with peers) advocates and partners for effective policy change toward value-based healthcare, informing overall healthcare budgets across all of government, and addressing practices that erode value (e.g., international reference pricing).
• Organizational leaders demonstrate a deep understanding of barriers to access (e.g., financing, capacity, value recognition) and take action toward strategically addressing these.

2. Co-create sustainable access, funding, and value-assessment mechanisms leveraging real-world evidence (RWE) and patient experience

What is a meaningful or impactful contribution?

• RWE studies and patient experience data are used as input into negotiations with key external stakeholders to secure funding and support the value assessment of a product over time.⁴
• External stakeholders are engaged as true partners to facilitate patient access as a mutual goal.
• The organization demonstrates a deep understanding of, and ability to, manage stakeholder expectations.

3. Ensure value of diagnostics, drugs, and devices is consistently communicated

What is a meaningful or impactful contribution?

• The broad value of a product and innovation is proactively communicated and effectively supported by evidence and value-based prices.
• HTA body expectations are understood and effectively managed such that full recognition of the broad value of a therapeutic product (beyond health economic value considerations) by healthcare system stakeholders is achieved.
• Evidence generation effectively demonstrates the unmet need, burden of disease, and achievement of health
  policy objectives.

4. Contribute to financial incentives and price realization for commercial success and sustained investment in innovation

What is a meaningful or impactful contribution?

• Value definition, demonstration, and pricing are successful in achieving the broader access outcomes of today and ensuring the ability to continue to invest in innovation.
• Prices are aligned with value delivered to patients and healthcare systems as defined by the access function.
• Where reasonable, performance of the products is tracked and is able to link payment to outcomes, building on the growing availability of RWE.

Implications on operationalization considerations

When thinking about how to operationalize delivery of the contributions outlined, four key concepts need to be embedded in the functional setup and processes of the access function. To ensure structured discussions on value, access, and evidence can happen early and with the relevant decision-makers, access needs to have a “seat at the table” from early development across the entire life cycle. In these cross-functional decision fora, the access function is required to provide access enterprise leadership and formalize shared objectives in integrated disease area and brand strategies. Elevating the mandate of access by establishing access as a key function at the executive level and appointing a single point of contact with full accountability⁵ represent critical measures to operationalize access as a corporate objective within a broader ESG agenda and communication strategy.

Given access is essentially local in nature, close collaboration with key countries for early strategy development and operational support during and after product launch is key to achieve shared objectives in the local healthcare ecosystem. In the following paragraphs, we seek to lay out some key exemplary activities or process measures for how the four concepts can be implemented successfully in an organization.

Approach to operationalize an earlier focus of access involvement

• Investment templates at key stage transitions (e.g., first-in-human, transition to pivotal) consider key access drivers and access evidence requirements.
• Access leaders provide formal input to commercial trade-offs for indication sequencing, trial design, and product formulation and administration.
• Access is a key member of policy committees to identify broader access barriers and empowered to co-develop plans to facilitate necessary policy change.

Approach to operationalize shared access objectives between functions

• Access is considered for key trade-offs across the life cycle in disease area and brand strategies, e.g., fast-to-market vs. best-in-class, indication sequencing, and target product profiles (TPP) decisions such as dosing, administration, patient selection, comparisons, and statistical plans.
• TPPs include specification of a “target benefit rating” to formalize access contribution to joint outcomes and provide right incentives for commercial, medical, regulatory, and clinical science.
• Input from and co-decision-making with the access function is seen as a critical driver of integrated evidence planning, commercial strategy development, and associated funding requirements ensuring sufficient resources to support local access and RWE needs.

Approach to operationalize integration of access at enterprise leadership level

• Ensure access is at the executive table when key access-related decisions are being made.
• “Access enterprise leadership” is formalized as a core capability in learning and development plans for key functions that contribute to access.
• Corporate-wide access ambition and metrics are established as part of a broader ESG and health equity agenda.
• A clear access point-of-contact represents the company perspective and drives thought leadership within industry associations, global health, and civil societies.
• “Corporate access report” is produced regularly to articulate access objectives and facilitate communication within and beyond the company.
• Pricing- and access-related risks are systematically considered in the corporate risk assessment.

Approach to drive country operationalization

• Ensure early and consistent engagement of key countries through co-creation of value and access strategies (e.g., in joint teams, rather than through multiple layers of contact).
• Provide hands-on operational guidance for access in launch plans, including policy engagement, pricing corridors, and the adaptation of key health economic models.
• Allocate sufficient resources to support countries in their access ambitions (e.g., through appropriate stakeholder engagement plans, value communication materials, and negotiation trainings).
• Set up a steering committee, with access as a key member, to review business cases for exceptions from global
  pricing guidance.

Framework fundamentals

These operationalization elements aim to support articulation of the value and unique contribution of access as a strategic partner to the business. They should represent a set of guiding principles rather than a structural blueprint—as the structural setup of organizations is individually tailored toward their needs (as it should be). Buy-in of senior company leadership outside the access function is essential to enable the operationalization of the broader role of access.

Within the access function, department leaders need to take further steps to detail what is required and how to achieve the outlined operating model principles within their specific biopharma organization.

The following guiding questions can help to define these steps, while acknowledging that there is no single right answer.

• When are the activities required in order to be impactful?
• Who needs to be engaged, and who are the stakeholders and contributors?
• How do we work, take decisions, and collaborate internally and externally?

Finally, the purpose of any operating model is to translate strategy into a functioning organization and to serve as the foundation for execution and achieving measurable results. As the context in which we operate continues to evolve, regular reassessments of the shared objectives, their evolution, and the progress toward them are crucial to enable the organization to deliver value in the long run.

References

1. https://www.pharmexec.com/view/access-in-the-new-world
2. Availability and ability to access medicines across social determinants of health
3. https://www.pharmexec.com/view/building-market-access-competencies-future
4. RWE and patient experience as inputs become more relevant after launch for a marketed product, given access is required to generate RWE
5. e.g., appointing a Chief Value and Access Officer