Entry-Level Module or Experienced Module

This module explores the business side of oncology and may include the following topics:

• Introduction & Overview
• The New World Oncologist
• Increasing Gaps in the Front Lines
• Market Consolidation
• The Patient Challenge
• Where will we be 3 to 5 years from now?

Entry-Level Module or Experienced Module

This module can include customized disease-state training at an entry or experienced level.

This module provides an overview of clinical oncology and may include the following topics:

• Main classifications of cancer, principles of oncogenesis, histology, diagnosis, grading and staging, predictive and prognostic factors, local and systemic treatment, and supportive care
• Major diagnostic strategies and treatment modalities and their coordination in multidisciplinary care for optimal control of disease
• The relative toxicity of a regimen that is tolerated in the context of therapeutic index, as related to the different goals of care at various intervals in the disease trajectory
• The transition from active treatment to palliative care as a continuing process.

Entry-Level Module

This module explores “hot topics” in policy areas that will affect the use of drugs, biologics, and diagnostics in the near future. Understand how the implementation (or the degree of implementation) of the following initiatives would be likely to impact practice and policy decisions about access to, availability of, and utilization of drugs, biologics, and diagnostics. The following topics may be included:

• Quality measures, quality evaluation, pay for performance
• Patient co-pays, value-based insurance, oncology formularies
• Specialty pharmacy, BioSimilars
• Outcomes research, comparative effectiveness, cost, and cost-effectiveness
• Molecular testing

Entry-Level Module or Experienced Module

This module reviews the impact of scientific advances on clinical practice, payor programs, and patient decisions and may include the following topics:

• Patient management issues associated with the increasing use of oral drugs, the chronic administration of less toxic biologics, and the decision-driving impact of biomarkers
• The impact of these developments on the utilization and policy for use of drugs and biologics

Entry-Level Module or Experienced Module

This module illustrates cancer care in the community setting and the utilization of the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines^®) in this environment. The following topics may be included:

• Implications and applications of NCCN Guidelines^® and other information products in clinical treatment decisions for patients in community cancer centers
• Definition of how differing administrative structures among academic centers, community centers, and private practices lead to different paths for institutional decision-making
• The role of oncologists, mid-level providers and other advanced practitioners in managing decisions about patient care within the context of different care delivery settings
• Faculty perspectives on the interactions between community cancer centers and pharma/biotech

Entry-Level Module

This module focuses on a fundamental area that must be understood in order to appreciate how centers and practices make decisions about clinical interventions and may include the following topics:

• The integration of information into decision-assist tools designed for use by clinicians, patients, or payors
• The role of informatics tools such as EMR and CPOE in oncology, with a particular emphasis on how these tools may influence the use of drugs and biologics in clinical settings

Entry-Level Module or Experienced Module

This module focuses on academic and community cancer center approaches to pharmacy management in cancer care, including supportive care and may include the following topics:

• Justification for purchases within budgets
• The revenue cycle and authorizations
• Least-costly alternatives
• Patient system support programs
• Collaboration models for effective working relationships with pharma/biotech professionals
• Selection of regimens, the process and influence of P & T Committees, internal guidelines/ pathways, standardized orders, pharmacy budget development, purchase agreements, and disease management all in the context of decision-making within oncology institutions
• Risk Evaluation Mitigation Strategies (REMS)

Additionally, a mock Pharmacy and Therapeutics Committee meeting can be added to present the decision-making methods used by cancer centers and to illustrate the discussion process and influence of P & T Committees.

Entry-Level Module and Experienced Module

This module discusses the effects that personalized medicine has on treatment methods, payor decision-making, and market impact and may include the following topics:

• Assessment of the evolving area of personalized medicine in the treatment of various tumor types, with attention to:
  • Biomarkers
  • Diagnosis, prognosis, and evaluation of therapeutic effects
  • Product development effects
• Considerations regarding the information that payors now use and will use in the future in coverage and precertification decisions
• Market implications for the use of drugs, biologics, or diagnostics

Entry-Level Module and Experienced Module

This module provides expert insights into the consideration and decision-making processes that result in the recommendations of the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines^®) and may include the following topics:

• Review of the type and level of data needed for submissions to NCCN Guidelines Panels; methodological considerations
• Views of the experts on data and studies that are convincing
• NCCN Guidelines Categories of Evidence and Consensus for recommendations and assignment by panels to recommendations
• Panel considerations of payor implications for NCCN Guidelines recommendations
• Public transparency and panel discussions

Entry-Level Module or Experienced Module

This module discusses NCCN history, goals, and future directions, as well as the development processes for the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines^®) and associated resources and may include the following topics:

• NCCN Guidelines Panels: member nomination and conflict of interest disclosure policy
• NCCN Guidelines: development and categorization of treatment recommendations
• NCCN Drugs & Biologics Compendium (NCCN Compendium™): implementation in practice; recognition
• NCCN Chemotherapy Order Templates (NCCN Templates™): use; patient safety

Entry-Level Module

This module addresses programs and information products and their influence on decisions that impact access to and availability of drugs, devices, and procedures to patients. Programs and products from patient (patient advocacy), provider (such as ASCO and NCCN), and other groups may be incorporated into the discussion and may include the following topics:

• The influence of the above groups in the legislative, regulatory, informational, and educational arenas
• The interaction or lack thereof, among governmental agencies such as the FDA, CMS, NCI, AHRQ, NIHCR, and others
• The decision-making processes for oncology policy in the United States as briefly contrasted with European Union countries, Canada, Australia, and large emerging markets

Entry-Level Module or Experienced Module

This module reviews the use of coverage policy, reimbursement levels, preauthorization, patient co-pay, disease management, specialty pharmacy, and other payor trends with an eye to the types of data and information needed to achieve positive reviews and decisions from oncology payors. The following topics may be included:

• The structure, processes, and programs used by payors to manage and control the use of drugs, devices, procedures, and techniques
• Inherent differences and “pressure points” between public and private payors
• Specific national payors and other stakeholder organizations, including United Healthcare, FDA, CMS, TEC, ECRI, Hays, AMCP, DOD, AHRQ, and NIHCR, with respect to their impact and influence on payor policies and decisions
• The role of both insured and self-insured employers in benefit design and coverage policy

Experienced Module

This module addresses trends impacting the delivery of cancer care, cost, reimbursement, and policy, and may include the following topics:

• Review of trends from the clinician, payor, and manufacturer points-of-view, including:
  • Guidelines for clinical practice and pathways
  • Compendia, oncology formularies, precertification
  • Patient co-pays, value-based insurance, episode-based payments
  • Specialty pharmacy, BioSimilars, oral therapies
  • Outcomes research, comparative effectiveness, cost, and cost-effectiveness
  • Quality measures, quality evaluation, Pay for Performance, coverage with evidence development, NICE
  • The type and quanta of data needed to influence decisions
  • Risk Evaluation Mitigation Strategies (REMS)

Entry-Level Module

This module describes the structure of and decision-making process for the delivery of care in the United States and may include the following topics:

• The significance of national designations for oncology programs such as NCI and NCCN, as well as how differing administrative structures among academic centers, community centers, and private practices lead to different paths for institutional decision-making
• The role of oncologists, mid-level providers and other advanced practitioners in managing decisions about patient care, in the context of different care delivery settings, and the concept of multidisciplinary care in academic centers
• The intersection of clinical decision-making with financial issues along with the roles and issues faced by billing managers and practice managers

Experienced Module

This module highlights specific cases illustrating the types and amounts of data needed to influence provider and payor organizations and may include the following topics:

• Analysis of the value of specific clinical outcomes, the design, size, and publication status of studies, and the influence and type of cost data used in decisions
• Crucial issue of use of drugs and biologics beyond the FDA-approved label, with a particular emphasis on practice guidelines and drug compendia
• Candid discussion on the "dos" and "don'ts" of interacting with organizations that develop information products
• The integration of information into decision-assist tools designed to be used by clinicians, patients, or payors
• The role of information products in clinical treatment decisions and the design of disease management programs
• The role of informatics tools such as EMR and CPOE in oncology, with a particular emphasis on how these tools may influence the use of drugs and biologics in clinical settings
• New programs which may impact use of agents in the foreseeable future
• The process of new agent incorporation into NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines^®)

Entry-Level Module or Experienced Module

This module emphasizes how these clinical points impact the selection and use of drugs and biologics in various care delivery settings and may include the following topics:

• A concise overview of the clinical course of patients from the detection of a suspicious lesion, to diagnosis, treatment, surveillance, and follow-up care
• Discussion among expert clinicians regarding common terminology, important distinctions, such as clinical versus pathological staging, principles of staging, and the variety of treatment options (surgery, radiation, drugs and biologics)
• Description, comparison, and contrast of cancer care delivery settings including academic cancer centers, community cancer centers, and community practices. This session will also focus on the issue of the type and quanta of data needed to support the establishment of an indication for clinical use of an agent. The clinical interpretation of clinical trial data (Phases I, II, and III) in oncology will be discussed and contrasted with that in other areas of medicine.

Experienced Module

This module provides insights into cancer center decision-making structures and illustrates working examples of effective partnerships with cancer centers and may include the following topics:

• Definition of the key decision-makers in protocol development and acceptance
• Definition of how decisions are promulgated and managed in clinical settings along with the roles of oncologists, advance practice nurses, physician assistants, pharmacists, etc.
• Roles and issues faced by billing managers and practice managers (drug and biologic focused)
• Insight into an institution’s decision to become involved in major research studies and/or to approve and seek investigator initiated studies
• Industry view on some of the issues and opportunities
• M2Gen as an example of successful collaborations between cancer centers and industry
  • Initiation of relationship and decision to partner
  • Value of M2Gen to Moffitt Cancer Center
• Current and emerging center views on some of those issues and opportunities
• Views on medical education functions (e.g., grand rounds, institution needs, specific projects, institution rules and constraints, potential for collaborations in general)
• Impact of state regulations on collaborations and programs
• The role and application of Risk Evaluation Mitigation Services (REMS)
• Impact of Conflict of Interest policies on clinicians, industry, and patients

Experienced Module

This module addresses trends impacting the delivery of evaluative information and the influence on decision-making about the use of diagnostics, biomarkers, drugs and biologics. This module may include the following topics:

• Review of issues, programs, and trends in informatics and information systems from the provider, payor, and informatics perspectives including:
  • Systems in development and available for decision-support for clinicians in oncology
  • Integration of key information to support system recommendations
  • Views of academic and community clinicians regarding information and system needs
  • Strategic views of payors, including PBMs, on use of decision-support tools in management of drug/biologic use
  • Strategies of companies in marketing systems for use in precertification, pay for performance, quality evaluation, etc
  • Perspectives of major companies in acquisition mode for informatics companies

Experienced Module

This module provides insight into the information needs and applications for those making decisions in the investment community about diagnostics, biomarkers, drugs and biologics. This module may include the following topics:

• Discuss with investment and business thought leaders how the information needs of Wall Street are viewed and fulfilled
  • Where do analysts and investors go for scientific and clinical information to meet their needs?
  • What is the mix of information that is required when one is making a decision or call about investment and business?
  • Opportunities: scientific, clinical, regulatory, coverage, and reimbursement, etc.
  • How do pharma/biotech companies integrate the need to address Wall Street's information needs into their research strategies?
  • How is pricing of health care technologies factored into the decisions made by experts on Wall Street?
  • Is the fast pace of advances in oncology a challenge for all involved in information collection and analysis?