Recent developments in the specialty pharmaceutical marketplace merit distinct attention from manufacturers. Multiple drivers of change are affecting the pharmaceutical industry, including major policy changes (e.g., anti-kickback statue safe harbor rebate reform), the integration and formation of large or mega customers, the rise of copay accumulators and maximizers and more restrictive benefit designs, and the increasing focus on patient access and affordability to groundbreaking medicines. Additionally, clinical advancements are outpacing current regulatory and reimbursement mechanisms, which will need to adapt to account for the value of specialty drugs and biologics.

These changes present a unique opportunity for life science companies to reexamine their relationships with external stakeholders. For manufacturers to properly navigate the future landscape, they will need to act in conjunction with outside parties to improve continuity of care for patients, align their service offerings, and add and measure value contribution to the healthcare ecosystem. Manufacturers who think radically, and selectively identify and diversify their stakeholder affiliations will be better positioned to tackle these changes and ensure higher quality and affordable care for patients is delivered in a rapidly evolving market.

Biopharmaceutical leaders will set the pace through redesigned commercial approaches leveraging essential partnerships with healthcare stakeholders. Key focus areas that companies are evaluating as they advance their commercial model include the following:

1. Optimizing commercial model for innovative therapies
2. Maximizing access under evolving policy landscape
3. Ensuring patient access and affordability
4. Enhancing patient support care across the care continuum

Avalere, with nearly 20 years as a central and essential voice in US healthcare, is positioned to assist life science companies in understanding the evolving market, approaching relationships with outside stakeholders with new perspectives, and improving patient access and affordability to innovative care. Avalere delivers strategy, ideas, and answers to complex challenges as it works with all stakeholders across the healthcare spectrum. To assist biopharmaceutical companies with the decisions needed to inform their commercial footprint and to redefine and build essential partnerships, Avalere highlights the following as core competencies in our work and in our approach to supporting you:

• Our people, with vast experiences and new, vetted ideas that are proven and reliable
• Policy and regulatory strategy to inform commercialization strategy
• Real-time intelligence and analytics to monitor a rapidly changing policy environment
• Data generation to evaluate, build, assimilate, and measure quality and value in healthcare
• Market access strategy from product development to point-of-care delivery
• Integrated health economics and advanced analytics to predict and prepare for market entrance, access and uptake, and commercialization trajectory
• Deep experience in pricing and payment across all benefit designs and across all settings of care
• Navigation between various stakeholders in the healthcare space
• Patient-focused approaches to ensure patient engagement strategies are advancing to account for the needs of patient support with clinical care journeys, access and affordability to care, and the appropriate quality and outcomes patients experience through innovative treatments

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