Courses

A comparison of national and private health coverage and funding across multiple industrial countries, with an examination of variances and similarities in healthcare outcomes by region and population mix vs. stated policy. We will discuss different payment mechanisms across Europe and emerging regions including the Middle East, Africa, South America and how to improve access to key regional decision-makers. Understanding critical elements in introducing a product for coverage and assessment will be presented by selected countries and regions and how formulary inclusion can be influenced. Patient access and coverage determination for products and services will be individually examined for drugs & biologics, hospitals, devices, and physician services.

• Better understand how regulatory and value determinations vary by country
• Profile directions for future drug and device coverage across the European Union and the developing markets of the Middle East, Africa, and South America
• Critical pathways for access & reimbursement among global health systems & providers
• Best practice examples for new product introductions by both region and product category

An overview of competitive analysis techniques used to evaluate healthcare marketplace opportunities including primary & secondary intelligence-gathering methods, decision testing, and head-to-head wargaming  with strategic cases.

• Strategic use of an integrated systematic approach to competitive intelligence gathering
• What role competitive intelligence can play in new product development, marketing timing, and tactics
• How competitive intelligence should play an active role in every aspect of product and account management
• Basic principles of new and mature product analysis and value determinations by market type

A comprehensive overview of the organization of healthcare markets, insurance coverage and benefits, reimbursement, and access to healthcare and biopharmaceuticals.

• Discuss commercial and government insurance designs and its impact on access to innovative treatments

• Discuss reimbursement and payment of health systems and providers for patient services

• Describe evidence needs for value assessments of products for drug formularies and health technology assessments (HTA)

• Analyze product market access strategies to maximize access and reimbursement

A comprehensive review of the key management decisions and milestones in developing and advancing a new product from bench-top to clinical trials to market authorization and commercial market launch.

• Describe key elements of clinical development and regulatory requirements for new products.
• Describe the role of marketing throughout the product development process to optimize market success of new products.
• Evaluate critical milestones and go/no go decision mapping throughout the product development process.
• Discuss and analyze marketing and value strategies from product development to commercial launch.

Overview of coverage, access, and reimbursement changes that have resulted from healthcare reform that will impact payers, employers, healthcare industry, state and federal agencies, and consumers. Topics will include implications and consequences of individual and employer-mandated benefits, risk transfer, medical loss ratio, and ongoing payer business model adjustments, along with a detailed view of healthcare exchanges and coverage by individual state and premium structures.  Impact of comparative effectiveness review (CER) on new methods of determining value and expansion of current research methodology.

• Review the basic goals and principles of the Affordable Care Act and access to care

• How will reform impact future insurance coverage, risk models, and reimbursement decisions

• Impact of CER on clinical trial design & scope, new product development, and liability

• Future impact of healthcare reform on emerging commercial products and services

Apply quantitative methods of evaluating resource allocation problems to business economics, health policy, and services. Evaluate pharmaceuticals and medical care trade-offs between treatment strategies. Measure risks and benefits by treatment alternatives relative to uncertainty.

• Cost-effectiveness, utility, and benefit analysis

• Budget and cost impact tools and analysis

• Decision tree analysis and Markov modeling

• Discrete event and Monte Carlo modeling
• Critical evaluation of data, tools, and techniques

A demonstration of how drug value is formally assessed using health economics and outcomes research, clinical trials, and epidemiologic study designs. Students will develop an understanding of these core research methodologies, their applications to generate and synthesize different types of value evidence, and the relative strengths and limitations of the different approaches.Topics: appropriate use of statistical methods, validation of data and outcomes research, identifying red flags and misuse of data, clinical trial design and limitations, business consequences, future implications of new measures of value.

• Improve your skills in using analytic techniques and tools in daily business and marketing decisions
• Apply basic analytical techniques to measure the validity and applicability of data and outcomes
• Learn to quickly identify well-designed research and models offering efficiency and value-added
• Build your comfort in designing and managing research projects targeting value and access

A practical approach to systematic review and critique of health economics, outcomes, and product literature ranging from randomized control trials, observational to phase IV, and comparative effectiveness research.  Core biostatistical measures are used to deconstruct, rate, and evaluate all aspects of published and promotional research focusing on accurate representation of results and outcome implications.  Each student will be required to complete a project from areas including pharmaceuticals, biologics, diagnostics, and testing, utilizing applied real-world case studies, methods in research design and planning, and development and presentation of a practical research proposal.

• Learn to efficiently and quickly review and grade research and outcomes publications
• Understand the basic rules that identify and define good vs. bad research results
• Understand unique research requirements across different therapeutic categories
• Gain perspective into CER, new value measures impacting access & reimbursement
• Gain hands-on practical knowledge of how research is designed and reviewed

HCDA 540 develops critical principles of leadership, communication, project management techniques, marketing best practices, and strategy. This class will cover healthcare product marketing and development through the eyes of the healthcare business executive. Learn principles of leadership, product evaluation and marketing strategies, and how to drive effective product leadership in a diverse corporate culture. We will evaluate the healthcare industry, innovations that are coming to bear, and leadership principles that will help position yourself within the healthcare construct.

Students completing this course will learn how to design, build, and present a launch and marketing plan, as well as other applied critical sales management skills.  Applications and examples will range from Pharma and Biotech to managed care and health systems to ultimately clinical efficacy and market penetration. Specific topics of instruction include:

• Strategic innovation and product forecasting and financial (launch) planning
• Business vs. scientific communication principles of market planning and tools
• Developing the best teams, coaching and mentoring
• Product branding, risk mitigation, stakeholder analysis and messaging

A systematic review of how creativity and innovation within the healthcare industry can lead to both economic and therapeutically important measures of value. This course will review the basic principles and tools for creating novel and breakthrough thinking within healthcare research. The evolution of the pharmaceutical industry into biotechnology and beyond will be evaluated for the key processes and methods that have led to today’s newest research and therapies. Biotechnology, biosimilars, specialty drugs, genetic engineering, biomarkers will all be discussed in the context of understanding the trends and evolution within healthcare. These key advances will then be evaluated using both traditional economic measures of value along with comparative effectiveness to better understand the intersection of efficiency and outcome.

• Examine the techniques we can all use to improve creative thinking
• Follow the systematic evolution of biotechnology to identify key inflection points and origins
• Review the next generation of therapeutic options and impact on the pharmaceutical industry
• Dissect the traditional measures of cost and value against novel approaches of care

Strategic principles will be demonstrated on the effective use of product attributes, guarantees, and discounts to attain advantaged global market positioning for new products while protecting mature product market positioning. Market share targets and rate or attainment, payer value across different payer categories and demographic groupings, product lifecycle, and launch techniques to maximize future opportunities along with structured tools and techniques for formulary positioning & reimbursement will be covered for traditional drugs, biotech & specialty drugs, devices, and diagnostics.

• Product positioning and uptake at launch in competitive categories and closed markets
• Defending established global product positioning from generic and follow-on biologics
• Changing role of shifting global sales forecasts on creating new measures of value
• Profiling future value, proof of concept requirements and pricing strategies to consumers

Applied and operational view of M&A and partnering in the healthcare industry examining why changes are likely to continue.  Systematically review the operational effectiveness of new relationships to examine successful and failed collaborations and to measure identifiable patterns of strengths and weaknesses. Fundamentals and case studies will be oriented to comprehensive healthcare services along with the retail drug, biotech and device industry professionals including legal, due diligence, contracts, research alliances, structured agreements, global partners, and tactical business strategies.

• Manager’s role in advising the company on the operational implications of new partnerships
• The key measures and steps needed to assess the likelihood of clinical and business success
• Impact of a new class of partnerships in shaping which products will come to market
• Global M&A and strategic partnerships role in shaping coverage and reimbursement by region

In-depth review and comparison of China, India, Japan, and Korea. Analyze and compare regional pharmaceutical industries in the areas of research and development, manufacturing, partnerships and licensing, and patient access to treatments.

• Evaluate comparisons of insurance coverage and patient access to drugs and healthcare services across the region
• Discuss how regulatory and value determinations vary by country
• Identify critical pathways for access & reimbursement among health systems and providers

This course will introduce students to methods for working with large health data sets, including developing an analytic plan and selecting an appropriate data source, as well as practical skills needed to manage and use large health data sets to accomplish an analytic goal. By the end of the course students should be able to develop and execute an analytic plan, use SAS or RStudio, create a database from disparate data sources, explore data for problems and suitability, run appropriate data cleansing and sanitation for accurate analysis, describe the data, and run analysis.

A discussion and research forum to examine and test ideas in a rigorous, systematic manner and develop critical thinking skills. Initial discussion-based seminars serve as guides to critical thinking skills and will lead each student into their own research project design, execution and presentation to the faculty. Each student will be required to demonstrate an organized approach to addressing and solving healthcare questions, using applied tools and techniques.

Students may select from critical healthcare areas with faculty permission such as:

• Health policy and government payment implications
• Payers, insurance benefits, and coverage
• Pharmaceutical & biotech: value, access, and reimbursement
• Medical devices & diagnostics: applications and impact

The Enterprise Team Project (ETP) course is designed to provide students with an opportunity to work on consulting team project. Students and a faculty advisor work closely with leading healthcare companies on real-work consulting projects. Students are able to successfully apply all their knowledge and skills learned in the classroom to real-world consulting projects at healthcare companies.

Individual research projects in one or more of the core domains of the Healthcare Decision Analysis curriculum. These research projects are suited for one t0 three units of credit based on the scope of the research project, pending approval by the program director.  Students will be required to submit a formal research proposal, analysis plan, and final report.