PPD Evidera Market Access
Demonstrating product value to optimize patient access and uptake
The importance of a proper market access strategy cannot be overstated. Not having a well-constructed and implemented evidence-generation plan may result in market access delays and unfavorable commercial outcomes. Regulatory approval is only the first step toward success in the real world. Without a strong value proposition and evidentiary support, even the most innovative and needed intervention may never reach its intended user—the patient.
The creation of a successful market access strategy requires navigating complex global payer, regulatory and health technology assessment (HTA) requirements, often across product classes and therapeutic areas. In today’s competitive environment, you need actionable strategies to drive and demonstrate payer value throughout the development life cycle to maximize your product’s success.
Common challenges in innovative health technology development include:
- Garnering insights to reduce risk
- Robust evidence plan expectations from regulatory and HTA bodies
- Competitive threats and pressures
- Growing and changing regulatory, HTA and payer restrictions
Leveraging deep relationships with HTA bodies, regulators and payers in established and emerging markets, our market access team remains current on the factors used by these stakeholders in their decision-making process. Our clients can apply these insights to overcome payer challenges and ensure optimal pricing and access.
Market access consulting
The process of gaining market access can be lengthy and requires extensive research, including clinical trials to provide evidence of efficacy and safety and real-world studies to demonstrate evidence of product value beyond efficacy—such as economic impact, patient outcomes and long-term safety and effectiveness.
Early planning allows companies to assess the market landscape, anticipate potential challenges and identify mitigation strategies, develop effective pricing and reimbursement plans and reduce time to market.
Achieve strong, optimized strategic planning by partnering with the PPD Evidera Market Access team for solutions focused on long-term success, including:
- An integrated evidence generation plan that creates a road map for clinical and real-world evidence generation, addressing knowledge gaps and outlining evidence needs at every stage of development to optimize timely, successful market access
- Integrated scientific advice that provides feedback from regulatory and HTA stakeholders to guide your development plans and decisions and allows for adjustments to meet stakeholder needs
- Strategic planning across the access continuum to meet global and local stakeholder requirements and expectations
Strategic market access solutions to move you forward, faster
Patients are waiting for new, accessible therapeutic interventions, and drug and technology developers are working hard to bring those new life-changing products to the market. Our real-world evidence and market access teams design and conduct studies that enable companies to deliver new treatments to patients.
Enhance your evidence planning and generation through every phase of development to optimize your investment and resources, ultimately achieving successful market access.
Global pricing and access strategy
Acquire optimal pricing and market access with comprehensive strategies, including:
- Pricing and reimbursement
- Value and access
- Value and evidence generation
- Stakeholder insights and engagement
- Launch excellence
- Global pricing and access training
Global health technology assessment strategy
Attain favorable recommendations from health technology assessment bodies with robust planning and insights focused on HTA priorities, including:
- HTA landscape and assessment
- Value proposition payer testing
- Integrated scientific advice
- HTA policy consulting
- HTA life cycle needs
- HTA critical review and training
Local access strategy
Achieve local and regional formulary use adoption with tailored evidence generation strategies focused on meeting local requirements for successful market access, including:
- Local pricing and access
- Payer negotiations
- Innovative contracting
- Formulary coverage
- Product value demonstration
- Local access training
Global market access
Global market access is often the goal of manufacturers to maximize the reach of their products to patients in need around the world. However, various regulations, systems and processes present their own set of challenges, including the new HTA process in the European Union (EU), country-specific requirements and varying levels of complexity across geographies. Companies must navigate these diverse landscapes by understanding regulatory frameworks, meeting clinical data requirements and adapting to region-specific market dynamics.
Let’s partner to answer these key questions and define your value proposition needs:
- What are the unmet needs and value drivers from a payer and provider perspective?
- I have a product with many indications—which has the greatest commercial potential?
- How well does my target product profile and clinical trial stand up to provider and payer scrutiny?
- What endpoints will increase the pricing and access potential?
- What evidence supports pricing and access assumptions in forecasting or partnering discussions?
- What is the optimal launch sequence of global markets, considering local pricing and reimbursement decision-making processes?
- How does international reference pricing affect the launch?
By staying informed, collaborating with stakeholders and employing tailored strategies, companies can overcome challenges, answer questions and seize opportunities for successful global market access to improve patient outcomes and drive health care innovation.
Navigating the complexity of U.S. market access
While many countries have a single-payer system and a more centralized approach, the United States (U.S.) has a multi-payer system, with a combination of private insurance companies, employer-sponsored plans and government-funded programs like Medicare and Medicaid. In this system, there is no consolidated process; rather, each payer negotiates pricing and reimbursement independently, leading to fragmented pricing structures.
Medicare’s coverage and reimbursement process was significantly impacted by the 2022 U.S. Inflation Reduction Act, which implemented new pricing negotiations not previously available. Initial price changes take effect on Jan. 1, 2025, with new drugs to be identified each year for negotiation. The implications of this change are significant for biopharmaceutical companies.
Prepare for new product or indication launch success in the U.S. by partnering with a team that understands how to get you there. Ensuring patients have access to the interventions they need drives our Evidera Market Access team to continuously refine and enhance our solutions to reach that goal. We enable our clients to optimize their resources and strategies at every phase of development. Trust us to guide you through:
Early payer engagement and landscape assessment
- Market access landscape assessment and due diligence support
- Clinical trial design optimization, with payer engagement for validating study designs
Commercial launch planning
- Treatment journey mapping and pain points
- Payer market research, including value and evidence needs, management, pricing and message testing
- Patient services strategy and partner selection
- Distribution and dispensing strategy and partner selection
Evidence generation
- Evidence generation plan
- Value proposition development
Optimizing access and uptake
- Access defense strategies
- Patient journey optimization
- Channel optimization
Communicating your value story
Positioning your product for success requires an effective and well-designed communication strategy. Various stakeholders require different information, often in different formats. Understanding what and how to disseminate compelling, payer-tested evidence of value is crucial to advance your product through the stages of stakeholder validation.
We enable our clients to disseminate specific payer-tested evidence of product value in a compelling format to each stakeholder. By simplifying the complex and creating persuasive visuals that tell the story of your product’s value, we enable you to deliver effective and engaging content to solidify your ability to move forward, faster.
Drive stakeholder engagement with customized visuals and content geared toward each decision maker. Our team of market access specialists has been creating best-in-class communications for more than 25 years. We’ll work with you to develop and test your value messages and communicate them convincingly through:
- Global value dossiers
- Health technology assessment submissions
- Country-specific submissions
- Academy of Managed Care Pharmacy (AMCP) dossiers
- Payer communications
- Objection handlers
- iValue Suite, our array of interactive tools for communicating product value to both internal and external stakeholders
- House your value communication materials on a secure web-based platform that can easily be updated, shared and communicated
- Turn your slides into a living presentation of your value story
- Dynamically present your economic model using a customizable, interactive interface
- Extract country-specific content from your more than 200-page global value dossier
Draw on expansive market access experience
Our dedicated market access team brings more than two decades of leadership and deep experience to every client interaction. When you partner with us, you can be confident knowing you are benefiting from:
Market access is much more than just getting your product on the market, but rather getting safe and effective products to the patients who need them at a price that works for everyone. Regulatory approval is a giant step in the journey; however, ensuring your product gets reimbursed is also a critical step in improving health outcomes and positively impacting patients around the world.
Let’s work together to make an impact.
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