Strategic Solutions Tailored to Your Biopharma Needs

Crafting Your Value Narrative: A Step-by-Step Journey

In the rapidly evolving biopharmaceutical landscape, articulating the value of a new product early in its development is crucial. This initial step is not just about understanding the potential impact of the product, but about aligning this potential with the evidence that will be required to support it. At Apex Market Access, we recognize that a well-structured value proposition and value story are fundamental to this alignment, setting the stage for effective communication with payers and other stakeholders down the line.

Our approach emphasizes the importance of laying a solid foundation right from the outset. By establishing a clear value proposition and value story early in the clinical development process, we create a roadmap for the necessary health economic evidence generation. This proactive approach ensures that at the time of FDA clearance, or ideally 12 months prior, marketing teams are equipped with robust data to support their materials through the medical-legal-regulatory (MLR) review process, enabling them to articulate the product’s value in a scientifically substantiated manner.

Embarking on this journey with a clear vision and strategic foresight not only facilitates smoother regulatory navigation but also maximizes the potential for market success. Explore the steps that encapsulate our comprehensive process, driving seamless transitions from initial value proposition creation to achieving supported value messages by FDA clearance.

1. Value Proposition and Value Story Development

Light bulb illuminating a medical cross symbol

Crafting a Compelling Narrative

The journey begins with developing a compelling Value Proposition and Value Story for your product. This narrative outlines the problem, the clinical and economic burden of the disease, limitations of current solutions, the opportunity offered by your modality, and the unique value of your product. This step is crucial for laying a solid foundation for all subsequent activities, ensuring alignment across all teams and stakeholders.

 

2. Testing and Refinement of Value Proposition/Story

Magnifying glass focusing on a document with a medical cross symbol

Fine-Tuning the Message
Once the initial narrative is crafted, it’s imperative to test and refine it through qualitative research with payers and other customers. Their feedback provides invaluable insights that help in fine-tuning the message to ensure it resonates well with the ultimate decision-makers and aligns with market realities.

 

3. Targeted Literature Review (TLR)

Stack of books with microscope in foregroundIdentifying Evidence Gaps
A targeted literature review helps in identifying existing evidence supporting your value messages and uncovering gaps where new evidence is needed. By reviewing the available literature and benchmarking against market standards, we’re able to pinpoint areas where additional evidence can significantly bolster the value narrative.

 

4. Value Evidence Generation Plan (VEGP) Development

Blueprint roll with medical cross symbol on itStrategizing Evidence Generation
Based on the insights gained from the TLR, we develop a Value Evidence Generation Plan. This plan outlines a series of studies and activities aimed at generating the necessary data to fill identified evidence gaps. It provides a clear roadmap for both internal teams and external resources, ensuring alignment in efforts to support the desired value messages.

 

5. Execution & Evidence Generation

Gear in motion with a medical cross symbol

Bringing the Plan to Life
With a clear plan in place, the next step is execution. This phase involves undertaking the prioritized studies and activities to generate the required evidence. Though led by the company’s internal team, external collaborators and partnerships often play a crucial role in executing the plan efficiently and effectively.

 

6. Ready for Regulatory Scrutiny

Ready for ReviewPrepared for Success
As the evidence generation activities conclude, value marketing teams are now armed with robust data to support their messages. This preparedness facilitates smoother navigation through internal review processes, ensuring that the product’s value is well articulated and substantiated as it steps into the market.

Data-Driven Pricing Strategy

Navigating the intricate pathways of drug pricing demands a blend of thorough market understanding, rigorous research, and seasoned expertise. At Apex, we meticulously craft pricing strategies that not only withstand the test of market dynamics but also align with the broader value narrative of your innovative solutions. Our approach entails a multi-dimensional exploration, ensuring your pricing decisions are grounded in solid, actionable intelligence.

Chessboard illustrating competitive strategy among pharmaceutical products

1. Understanding the Market Landscape

Before delving into pricing specifics, it’s imperative to grasp the existing market landscape. Our journey begins with an analysis of the price structures of analogous drugs or treatments within the same therapeutic or disease area. We evaluate the modalities and intents of treatment whether curative, management, or otherwise, laying a robust foundation for subsequent explorations.

 

2. Secondary Research and Identifying Direct Cost Offsets

Equipped with a robust understanding of the market, we delve into meticulous secondary research. This phase encompasses the collection of historical pricing data, reimbursement trends, and the evaluation of pricing strategies of similar drugs. Simultaneously, we probe into potential cost offsets as depicted in clinical data or literature, focusing on ‘direct’ cost offsets that resonate with US payer decision making, thus, framing a clearer picture of the pricing latitude.

Illustration of primary qualitative research

3. Primary Research with Payers and Providers

Primary research forms the cornerstone of our pricing strategy development. Through tailored methodologies like monic pricing or a modified van Westendorp approach, we engage with payers and providers to gauge price sensitivity and acceptance levels. This engagement elucidates pivotal insights that sharpen our pricing acumen, aligning it closely with market receptivity.

 

4. Competitive Intelligence and Sanity Checking

With a rich reservoir of competitive intelligence experience, we delve into a comprehensive analysis of competitors’ potential pricing strategies. This sanity checking against the competitive environment and patient out-of-pocket (OOP) costs ensures that our pricing proposals are not only competitive but also grounded in market reality.

Interconnected gears on white background

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5. Engaging Stakeholders and Executives

Effective pricing strategies are a product of collaborative effort. We work in tandem with executives across Commercial and Marketing organizations within your biopharma company, ensuring a seamless alignment on pricing strategies and addressing any emergent concerns, fostering a conducive environment for strategic pricing decisions.

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6. Measuring Outcomes and Payer Acceptance

Post-launch, we meticulously measure the outcomes of our pricing strategies, evaluating the acceptance levels among payers and the broader market. This phase also encompasses an analysis of any media and public relations impacts related to pricing, ensuring a well-rounded understanding of the pricing strategy’s performance.

Infographic on historical pricing data and identified cost offsets

7. Continuous Evaluation and Adaptation

The pricing landscape is ever-evolving. We engage in a continuous cycle of evaluation and adaptation, tuning the pricing strategy based on market feedback, competitive actions, and other external factors. This iterative process ensures your pricing remains competitive and acceptable to payers, anchoring your market position amidst the dynamic market currents.

Optimizing Provider Revenue through Precision Mapping and Strategic Product Integration

Tailored solutions to identify economic leverage points and integrate your product seamlessly into the in-office patient journey, enhancing uptake and asset valuation

Discover how Apex employs a meticulous approach to map economic leverage points onto the in-office patient journey in outpatient settings. By understanding the nuances of care delivery and patient interactions, we help integrate your product strategically to improve cost recovery for HCP practices.

In-Office Patient Journey with Economic Leverage Points
Illustration of the in-office patient journey highlighting key interaction points and potential areas for cost recovery improvement.

Solution Overview

  • Identifying Economic Leverage Points

Analysis of care delivery dynamics, including HCP roles and patient interactions, to pinpoint areas where the product can alleviate operational and economic pressures.

  • Code Stack Development

Creating a comprehensive code stack overview that details the CPT/HCPCS codes for typical encounters, coupled with national-level average reimbursement rates and practice cost metrics.

Snapshot of an illustrative code stack overview showing the economic metrics of integrating the product into the community practice workflow.
  • Engaging Provider Accounts

Compliant, collaborative engagement with community practices to ensure a mutual understanding of the economic benefits and operational ease brought about by the product.

  • Revenue Cycle Management Alignment

Aligning the product integration with the existing revenue cycle management processes to enhance cost recovery and improve the overall economic outlook for practices.

Outcome

Harnessing the insights derived from the in-office patient journey and code stack analysis, we facilitated a smoother integration of the product into practice workflow. This strategic approach led to increased uptake, empowering end-customers to better manage patient interactions, enhance quality metrics, and ultimately improving the asset valuation for our client.

Long-Term Buildout Planning: Your Guided Path to Multi-Year Success

Embarking on the journey of penetrating the US market or expanding operations is an exciting venture that requires meticulous planning and foresight. At Apex, we leverage our extensive experience across the biotech, pharmaceutical, and medical device sectors to craft tailored roadmaps that outline a clear path toward your goals.

Our planning process is comprehensive and flexible, designed to evolve with your needs. It spans across pivotal Commercial functions including Access & Reimbursement, Marketing, Sales, Medical Affairs, and more. Our roadmaps are structured to provide a clear timeline of deliverables, staffing requirements, and budget allocations, tailored to your phase of development and long-term objectives.

Our Approach

Functional AnalysisIcon illustrating functional analysis for long-term buildout planning

Delve into a deep analysis of your current capabilities, identifying the essentials for a robust roadmap that aligns with your operational and financial objectives.

 

Icon illustrating industry benchmarking in roadmap planningBenchmarking

Utilizing industry benchmarks to inform the roadmap, ensuring alignment with best practices and realistic expectations.

 

De-identified roadmap image for long-term planningCustomized Roadmapping

Development of a detailed roadmap outlining quarterly milestones, staffing plans, and budget allocations across key functions, aligning every step with your long-term goals.

 

Icon illustrating adaptation in long-term buildout planningCollaborative Evolution

Periodic review and adjustments to the roadmap as your needs evolve and budget comes into focus, ensuring continued alignment and forward momentum.

 

Icon illustrating support and teamwork in execution phaseExecution Support (Optional)

Our team is equipped to provide support in the execution phase, leveraging a broad network to address project needs across all functional areas.

 

Real-world Experience

Our team’s diverse experience, from startups to large biotech firms and multi-company trade associations, ensures that we understand the unique challenges and opportunities at every stage of your journey. The tailored roadmaps we develop are informed by real-world insights and a deep understanding of trade-offs essential in resource allocation, ensuring a pragmatic and actionable plan.

De-identified illustrative roadmap image for long-term planning
An illustrative roadmap showing activities by quarter ahead of launch

Ready to Embark on Your Journey?

Our long-term buildout planning service is a cornerstone for companies aspiring to meticulously plan their journey towards successful market entry or expansion. Engage with us to navigate the intricacies and propel your operations forward with a well-orchestrated plan.