Value, Access & Outcomes

The value and access landscape is complex and ever-changing. We can identify unmet needs, understand evidence requirements, and craft a strategy that will enable optimal access and uptake. We can help you:

• Understanding stakeholder (payer, regulator, patient, provider, and policymakers) needs and requirements via expert elicitation services
• Understanding current management, standards of care, and unmet needs
• Understanding the available evidence and reimbursement pathway and restrictions of existing technologies
• Evaluating the burden of disease, including the patient perspective and journey

A compelling and integrated value story, developed early, supported by evidence, and expertly communicated to all relevant stakeholders, will set your product apart, and position it for commercial success. We can help you to:

• Define a value story and payer requirements for a Target Product Profile
• Develop a payer-ready evidence generation plan and gap assessment (trial- and non-trial based)
• Inform commercial launch planning and forecast assumptions

Evidence needs are increasing as HTA bodies and payers conduct more thorough and sophisticated evaluations of your health technology. Demonstrating your product’s value requires clear and powerful evidence, generated in the most efficient way possible, to support both global needs and local implementation. We can help you to:

• Conduct literature reviews and indirect treatment comparisons to synthesize the available evidence
• Develop and support HTA and reimbursement submissions and dossiers
• Assess clinical and economic burden
• Design and build economic models to establish cost-effectiveness and budget impact
• Complete early modeling from phase 2 through HTA submissions
• Conduct qualitative research to elicit expert opinion

At the core of any drug development program are patients with an underlying health condition or disease that are in need of novel therapeutic advances. Among stakeholders in the drug development process, patients are the core group that sponsors must address when making decisions about investing and developing new treatments. We can help you to:

• Identify, modify, or develop and validate clinical outcomes assessment (COA) measures for use in clinical trials, including: patient-reported outcome (PRO), clinician-reported outcome (ClinRO), observer-reported outcome (ObsRO), and performance outcome (PerfO) measures
• Leverage clinical trials, in entry and exit interviews, to talk to patients about their experience to inform a measurement strategy and endpoint selection for future clinical studies
• Examine the natural history of a disease from its inception through all of its clinical stages via survey and/or interview research
• Utilize survey research as a cost-effective and time-efficient means to collect information from large or hard-to-reach samples
• Develop an endpoint strategy from phase I to phase IV to ensure product differentiation at the time of market launch
• Help to navigate communication with regulatory authorities, including when and what to communicate in terms of patient benefit

Your product’s commercial success depends on a variety of stakeholders. We can help extract and synthesize expert opinions, understand the evidence needs of key decision makers, develop high impact payer engagement strategies, and execute communication plans to ensure that your product’s key messages are conveyed throughout its access journey. This involves:

• Defining pricing and reimbursement models and opportunities
• Communicating value to all stakeholders through appropriate channels
• Operationalizing coverage and reimbursement
• Provide resources and training to optimize payer engagement and negotiation

New data, evidence, competitors, and other factors can affect the access you’ve gained. We can help monitor the value and access health of your product to ensure it is continually positioned for success. We do this by:

• Generating continuous real world evidence (RWE) to provide an ongoing demonstration of product benefits and value
• Repositioning appropriately as the therapy area and competitive environment evolves
• Continuing to use data-driven approaches to enhance access, reimbursement, and adoption
• Optimizing contracting, including value-based agreements