Healthcare Decision Analysis courses and descriptions
HCDA 501 Fundamentals of Healthcare Insurance Design
Introduction to insurance payer types, functions, insurance product development, actuarial pricing methods, network design, employer requirements, and business operations impacting public and private benefits and reimbursement. An in-depth review of medical and drug policies including access determinations for retail and specialty products, formularies, and other utilization management tools and techniques impacting coverage of pharmaceuticals, biologics, and other specialty drugs and devices will be illustrated using real-world examples.
- How and why do private and public formularies determine coverage, copays and access
- What factors drive coverage and reimbursement under both the medical and pharmacy benefit
- Where are Payers likely to be in 3-5 years and how can the industry adjust today
- How can industry and providers better communicate with Payers to meet their needs
HCDA 502 Comparative International Healthcare Systems
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, and 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
HCDA 503 Competitive Healthcare Intelligence and Pricing
An overview of analysis and techniques used to evaluate marketplace opportunities and competition for value and pricing determinations for retail and specialty drug, biologics, devices, and diagnostics. New product launch and positioning strategies are profiled and modeled by payer type and national health systems, use of tools to improve primary & secondary intelligence gathering methods, decision testing, and planning. Included are strategic case examples and head-to-head war game decision practices.
- Strategic use of an integrated systematic approach to competitive intelligence gathering
- What role can CI play in new product development, marketing timing, and tactics
- How CI should play and active role in every aspect of product and account management
- Basic principles of new and mature product pricing and value determinations by market type
HCDA 506 Foundations of Insurance and Global Access
An overview and applied learning course covering material extracted from several core HCDA Payer and Coverage focus areas. HCDA 506 is part of a two-course Fundamentals suite including HCDA 507, featuring practical information aimed at students from: health sciences, economics and business. HCDA 506 is specifically focused on pharmaceutical/biotech coverage, pricing and reimbursement, payers and global access, product and technology assessment. This course will include hands-on learning, team based scenario based learning techniques, to ensure each student can apply and evaluate task specific examples and situations. Each student will be required to present and have their work reviewed by their faculty adviser and peers.
Material presented will include:
- Commercial and government insurance design, actuarial ratings, and product coverage
- US & EU Pharmacy & Therapeutics, Formulary structure, product evaluations (HTA)
- Global pricing, launch sequencing, discounting, and health agency standards
- Product and market penetration strategies to maximize access and reimbursement
HCDA 507 Foundations of Product Development and Commercialization
An overview and applied learning course covering material extracted from several core Product development and Pharma HCDA focus areas. HCDA 507 is part of a two-course Fundamentals suite including HCDA 506, including health sciences, economics and business. HCDA 507 is specifically focused on product development and step-by-step launch processes, go/no-go decision mapping, strategic intelligence search tools and war gaming, applied health economics and systematic review, critical literature evaluation, clinical trial design, product impact validation tools. This course will include hands-on learning, scenario based learning techniques, to ensure each student can apply and evaluate task specific examples and situations. Each student will be required to present and have their work reviewed by their faculty adviser and peers.
- Clinical to human trials design, post-launch outcomes research and data
- Industry & payer competitive intelligence, systematic assessment of medical literature
- Value strategy design, evidence demonstration, cost impact analysis and modeling
- Product lifecycle management, product marketing, and tactical launch planning
HCDA 510 Business Implications of Healthcare Reform
Overview of coverage, access, and reimbursement changes that have resulted from the Affordable Care Act and 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
HCDA 515 Medical Decision Analysis and Modeling
Improve and expand basic analytical skills in coordination with HCDA 520 and 525. Apply quantitative methods of evaluating resource allocation problems to business economics, health policy, and services. Evaluate pharmaceuticals and medical care tradeoffs 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
HCDA 520 Health Economics and Outcomes Methodology
Comprehensive review of core biostatistics principles and applications oriented to clinical and business professionals representing both payers and industry. Material presented using a practical problem solving approach and case studies oriented to specific applications of value, outcomes, and competitiveness. Topics: appropriate use of statistical methods, validation of data and outcomes research, identifying red flags and misuse of data, clinical trials 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 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
HCDA 525 Healthcare Literature Analysis and Applications
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 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 a “hands-on” practical knowledge of how research is designed and reviewed
HCDA 530 Total Product Development
A comprehensive overview of the major steps required to take a new pharmaceutical or biotech product from benchtop to launch. This course will introduce several of the critical milestones and regulatory requirements needed to manage a new product through pre and clinical trial design, government filings and product submissions, publication planning, channel and distribution, leading to marketing and launch execution. You will learn how to align business strategies and tactics into each go or no-go step in the product development life cycle for both US and European markets. Finally, you will build a simulated launch plan to illustrate your products potential market share, coverage profile and sales goals as a measure of future financial success.
- Understand the requirements, designs and stages of clinical trials
- Review the new role of Comparative Effectiveness in launch planning
- Learn product NDA, FDA, CMS, regulatory, coding, and safety requirements and tactics
- Discover the marketing and sales strategies for a successful launch
HCDA 535 Evidence Generation: Sources and Applications*
This course is intended to review and explain the growing sources and types of evidence used in critical thinking among the Pharmaceutical Industry, Biopharmaceuticals, Payers and other Institutional sources of product critique, relative value assessments, and recommendations for coverage and reimbursement, and will be a natural complement to other HCDA courses on Product Development, Pricing & Modeling, and Marketing.
Real World Evidence (RWE) will be presented to illustrate the evolution of data and information requirements beginning prior to product launch and entrance into the marketplace:
- Critical reasoning in determining “unmet need”, competitive therapeutic & product alternatives
- Commercial market opportunities, information flow, clinical trial & other outcome results
- Products “pros and cons”, virtual head-to-head assessment against competitive alternatives
- Review critical assessment of post-launch & RWE applications (“did we deliver on our promise”)
- Post-launch review vs measurable outcomes, use of natural user groups, category comparisons.
*course under development
HCDA 540 Executive Leadership and Healthcare Marketing
This course directly addresses the four pillars of successful core Business and Industry management skills: Leadership, Project Management, Communication and Marketing. This highly interactive course covers fundamental skill development through a unique blend of role playing, case studies and real world scenario management. 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 penetraation. 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
HCDA 550 Healthcare Innovation: Creativity to Value
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 revolution 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 tradition 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 systematic evolution of biotechnology to identify key inflection points and origins
- Review next generation of therapeutic options and impact on pharmaceutical industry
- Dissect the traditional measures of cost and value against novel approaches of care
HCDA 553 Advanced Pricing Strategies
Strategic principles will be demonstrated on 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 dugs, 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
HCDA 560 Managing Effective Partnerships and Mergers
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 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
HCDA 580 Seminars in Healthcare Decision Analysis
A discussion and research forum to examine and test ideas in a rigorous, systematic manner based on evidence and literature support. Students will challenge issues and principles related to particular topics and present different points-of-view, followed by an assigned research and evaluative project. 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 & Impact
- Payers, Insurance Benefits, and Coverage
- Pharmaceutical & Biotech: Value, Access, and Reimbursement
- Medical Devices & Diagnostics: Applications and Impact
HCDA 590 Directed Research
Individual research projects leading to the Master of Science degree in Healthcare Decision Analysis. These research projects are suited to three units of credit which will be applied to the HCDA degree in areas that support and enhance the student’s understanding of one or more of the core principles represented, pending approval by the program director. Students will be required to submit a formal research proposal, analysis plan, and final report.
- Note: Committee consisting of a minimum of three faculty members will be appointed by the Director of Graduate Studies in Healthcare Decision Analysis, after consultation with the student, to advise on research project design and execution
2-Year Curriculum Schedule: V 8.0 Semester Sched HCDA, 2 Yr Sched. 2019-2021