Therapies and treatments are becoming more specialized, and product adoption and coverage decisions are increasingly being tied to effective communication of the product’s value. With a growing pressure for commercial and medical affairs teams to execute their functions with greater precision, life sciences, medical device and pharmaceutical companies must continue to account for smaller patient populations and generate evidence that resonates with patients, physicians and health plans.

    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:

    • Evidence reviews
    • Observational research strategy
    • Patient recruitment and retention planning
    • Health technology assessment/reimbursement strategy
    • Post-market evidence plan
    • Clinical development plan
    • Early asset prioritization review
    • Comparative effectiveness/meta-analysis
    • Risk assessment strategy

    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:

    • Expertise in patient-reported outcomes (PROs), clinician-reported outcomes (ClinROs), observer-reported outcomes (ObsROs) and performance-reported outcomes (PerfROs)
    • Clinical protocol and endpoint review and development
    • Clinical outcome assessment (COA) implementation
    • COA instrument review/gap analysis
    • COA instrument development and enhancement
    • COA instrument validation

    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:

    • RWE mapping and assessment
    • RWE analyses (safety, long-term effectiveness and cost of illness)
    • Due diligence assessment
    • HEOR models and analysis
    • Electronic medical records (EMR) review and analysis
    • Cost effectiveness/utility models
    • Budget impact models
    • Sample size review

     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:

    Medicare fee-for-service standard analytic files

    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

    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, medtech, health plans and providers) with episode-of-care analyses consistent with market trends.

    • A sampling of the most recent year of commercial data includes the following:
    • 3.4 million hypertensive patients
    • 2 million overweight patients
    • 1.4 million diabetic patients
    • 340,000 coronary artery disease patients

    Healthcare Cost and Utilization Project (HCUP) National Inpatient Sample (NIS)

    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:

    • Global pricing and market access strategy
    • Modeling pricing and revenue
    • Early health technology assessment (HTA) and health plan engagement
    • Evidence optimization
    • Value communication
    • Market sizing
    • Stakeholder engagement
    • Market intelligence
    • Competitor intelligence
    • Dossier review and development
    • Scientific publication development and dissemination

    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:

    • Health plan and provider outreach
    • Self-insured employer strategy
    • Feasibility analyses
    • Value-based care (VBC) outcome assessment and development
    • High-value interactions with health plans
    • VBC road map development and strategy
    • Strategic partnerships
    • Expanded access coverage strategy

    Baker Tilly professionals have been published in peer-reviewed and other medical journals 

    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
    Market Access Life Sciences