Market Access Strategy & Support
Translating innovative research to address a market need can be an intricate exercise with many potential pitfalls. Additionally, organizations require a dynamic strategy aligning the activities of commercial and medical affairs, driven by clinical outcomes and supported by real-world evidence (RWE).
From needs assessments to evidence generation, from preparing to obtain 510k clearance to leveraging a product’s recent approved 510k status, and from dossier compilation to effective health plan and provider communication strategies, Baker Tilly’s team of market access specialists help life sciences, medical device and pharmaceutical companies achieve commercial success. Our specialized and data-driven professionals understand the intricacies of navigating the complex demands of physicians, hospital systems and health plans to ensure patients’ fair and equitable access to novel therapies. These solutions take into account product pricing, reimbursement, life cycle management and RWE in developing global commercialization plans as well as enabling medical affairs platforms.
Our market access strategy and support services assist companies in balancing pricing, reimbursement and market demand decisions. Thoughtful program design and execution enables our clients to sustain market penetration throughout the product life cycle. Our approach includes:
Baker Tilly’s focus on being a Value Architect™ means our market access solutions and strategies are derived from evidence-driven insights and align with global priorities that maximize client value. Whether you’re looking to capitalize on your product’s recent 510k status, or if your organization is needing more robust market access assistance, Baker Tilly is here to help. We offer a comprehensive set of solutions to help clients achieve their unique market access goals, including:
Baker Tilly’s diverse and unique set of solutions seek to address all facets of life sciences, medical device and pharmaceutical companies’ market access requirements. Out team of Value Architects™ support our clients’ market access needs with:
In today’s highly competitive and rapidly evolving healthcare ecosystem, there are numerous challenges to obtaining unrestricted global market access, including increasing costs, declining approval rates and reducing product development pipelines. Through our proficiency and experience of understanding the life sciences industry, as well as the health plans and provider markets, we are able to work with our clients to define, prioritize and plan their road to lasting market success through:
There is a continued need for life science companies to identify the best clinical outcomes that speak to their products’ clinical and economic value and resonate with health plans, providers, and patient audiences, including short- and long-term clinical outcomes as well as physical, mental and quality of life impacts.
At Baker Tilly, we work with life sciences companies to assess and develop study measures that speak to the symptom, and functional and quality impacts of a product, as well as its efficacy at treating the condition through:
As the industry continues to shift toward the acceptance of RWE in lieu of randomized control trials (RCTs) for market access decision-making, there is a growing need for life science companies to demonstrate product value and gain competitive advantage through RWE insights. Companies still struggle and need assistance with selecting the appropriate RWE dataset for their therapeutic area and analytic needs, developing the appropriate analytic plan to generate RWE/HEOR insights and understanding necessary sample sizes for outcome significance.
At Baker Tilly, we enable life science companies to effectively utilized RWE to generate reliable evidence and insights in the economic and clinical outcomes of their products through:
Baker Tilly also has direct access to nationally recognized real-world healthcare data to meet the RWE/HEOR modeling needs, which encompasses both commercial and Medicare databases, totaling more than 60 million unique patients annually. Our datasets include:
This database represents final action Medicare fee-for-service claims data for inpatient, outpatient, skilled nursing facilities and home health agencies across five to seven years. Additionally, this dataset represents roughly 38 million Medicare fee-for-service patients who can be tracked longitudinally with diagnostics, procedurals and financials (both for providers and health plans).
IBM® MarketScan® Research Databases encompass medical and pharmaceutical drug data along with enrollment information from both employer groups and health plans across the U.S. The expansive commercial claims database includes diagnostic, procedural and financial data for nearly 25 million patients annually, covered by employer-sponsored private healthcare. Notably, longitudinal patient journeys of up to three years can be captured to assist all of our clients (i.e., pharma, medical technology (medtech), health plans and providers) with episode-of-care analyses consistent with market trends.
The NIS is a database of hospital inpatient stays derived from billing data submitted by hospitals to statewide data organizations across the U.S. This inpatient data includes clinical and resource use information typically available from discharge abstracts. Researchers and policymakers use the NIS to make national estimates of healthcare utilization, access, charges, quality and outcomes. The NIS also covers all patients, including individuals covered by Medicare, Medicaid or private insurance, as well as those who are uninsured.
While Baker Tilly has direct access to several large nationally recognized databases, depending upon the study question and design, other external datasets might provide a better option. Baker Tilly has worked with and is familiar with other large distributors of RWE such as Optum, Premier Health, Blue Health Intelligence, H1 and several others.
Administrative claims databases are robust sources of information to answer a number of research questions, but are limited to diagnostic and procedural coding when more specific clinical measures are needed. EMR analyses are beneficial to answering more specific clinical research questions. Baker Tilly has a comprehensive understanding of data available within EMRs, and how to capture and leverage that information through analytics to answer fundamental research questions.
Life science companies continue to struggle with streamlining outcomes to address economic product value, effectively communicating clinical and economic value to health plans and providers, growing industry presence ahead of product commercialization, and supporting product pricing with RWE analytics. As competition within the healthcare industry rises, the importance of product power through value and pricing positioning has never been higher.
Through our dedicated focus on market access, we support life science companies as they strengthen their industry presence and positioning, from value communication to pricing to market intelligence:
As the healthcare industry continues to become increasingly intertwined, product value has become a key factor in influencing coverage and market access. Many life science companies face challenges leveraging their value to drive health plan and provider conversations and decisions in coverage, engage in value-based agreements with health plans and providers, and broaden product access and utilization.
At Baker Tilly, we support life science companies throughout their product coverage journey from initial coverage to expanded coverage access through:
Baker Tilly’s RWE experience has led to peer-reviewed publications in premier outlets such as the American Journal of Managed Care (AJMC), Journal of Comparative Effectiveness (JCE), Surgical Endoscopy (SE) and Journal of American College of Cardiology (JACC).
Baker Tilly’s health economics expertise was a key part of our launch of Impella throughout the world. They are respected in the industry and really understand the drivers of growth for the medtech industry.Michael Minogue, CEO, Abiomed