Preliminary Agenda

Day One - Monday, February 5, 2018

Morning Workshop Registration and Coffee

Pre-Summit Morning Workshop- Oncology Market Access & Commercialization

UNCOVER PATHWAY DEVELOPMENT UTILIZATION FROM PATHWAYS TO PROVIDERS TO ENHANCE MARKET ACCESS STRATEGY

Today’s clinical pathways are an increasingly prevalent factor in the access of cancer treatments as patients, providers, and payers look to minimize the cost of cancer care. Exploring the use, the trends and the future of pathways will allow market access executives to align pricing and reimbursement strategies as they look forward to the next generation of cancer care.

• Uncover how and who authors the pathways
• Discuss the perspective of the creator of the pathways in defining transparency
• Learn the processes around pathway development and data
• Examine if there’s a way to incorporate more real time data into pathways
• Explore how to achieve more multi-disciplinary pathway development
• Uncover methods of getting more involved in practical uses of medical evidence for pathway decisions
• Uncover the next steps in clinical pathways
  • Determine who is regulating, monitoring, and accountable for these pathways
• Discuss top pathway initiatives with key stakeholders from FL Cancer Centers, VIA, TN Cancer Care and other leading groups to uncover physician group, pharma manufacturer, and industry best practices to working with pathways and access to cancer care.
• Hear compare and contrast of what the customers are looking for, what the GPOs and IDNs delivery, and partnership best practices for manufacturers in order to manage gross to net and reimbursement.  

There is a 30 minute refreshments and networking break from 10:00 am – 10:30 am

Lunch for Morning Workshop Attendees; Afternoon Workshop Registration

EXPLORE SPECIALTY PHARMACY DELIVERY MODELS IN AN INCREASINGLY COMPLEX HEALTHCARE SYSTEM

Specialty pharmacies are very involved in the distribution of many oncology drugs as manufacturers develop more complex drugs for rare disease and cancer care, including, new-to-market cell and gene therapies. Understanding the evolution of the specialty pharmacy and the different functions they provide as well as their role in becoming vertically integrated with GPOs is top of mind for those in market access.

• Discuss the role of the specialty pharmacy and the different functions provided to ensure the proper use and placement of assistance functions.
• Explore manufacturer’s role in building out their own patient on-boarding, patient education and patient assistance programs.
• Discuss financial implications of specialty pharmacy partnerships to ensure allocation of appropriate funds between pharmacy, payers, and assistance programs.
• Uncover best models for distribution of rare, specialty, and cell and gene therapies: how do you distribute this product, what is the role of different stakeholders?

There is a 30 minute refreshments and networking break from 3:00 pm – 3:30 pm

Day One Concludes

Day Two - Tuesday, February 6, 2018

Morning Registration and Coffee

SHARED PLENARY SESSIONS FOR ALL FOUR DELEGATIONS

Chairperson's Opening Remarks

FDA KEYNOTE: REGULATORY GUIDANCE ON INITIATIVES TO INCREASE DEVELOPMENT AND AVAILABILITY OF ORPHAN DRUGS, BIOSIMILARS, AND NOVEL ONCOLOGY THERAPIES

• Gain insight into the FDA’s approval of the first oncology biosimilar
• Hear about efforts to clear the backlog of orphan drug submissions and profile the Orphan Drug Act
• Examine the possibilities of cell and gene therapy and pinpoint regulatory hurdles

KEYNOTE PANEL DISCUSSION: BIG PICTURE STRATEGY TO ENSURE MARKET ACCESS AND COMMERCIALIZATION SUCCESS IN A HEALTHCARE SYSTEM WITH INCREASING COSTS AND COMPLEX THERAPIES

In an era of increasing interest around evolving market access and commercialization models, pharmaceutical and biotech manufacturers continue to work towards successful strategies in an evolving healthcare ecosystem. This informative keynote will empower manufacturers with the knowledge they need to prepare strategies for evolving market access and commercialization models to optimize strategy and ensure evolution with the future of healthcare. Through a high-level keynote discussion with a stakeholder from each role within the pharma organization, uncover strategies used to achieve a streamlined approached oncology, cell and gene therapy, rare disease, and biosimilars.

Networking & Refreshment Break

PAYER PANEL DISCUSSION: GAIN PAYER INSIGHT INTO MARKET ACCESS BEST PRACTICES FOR REIMBURSEMENT OF SPECIALTY PRODUCTS IN A VALUE-BASED HEALTHCARE LANDSCAPE

• Hear from multiple stakeholders, including private payers, PBMs, and IDNs on how “value” is defined when approached by manufacturers
• Profile the data sets and outcomes required to appropriately evaluate the effectiveness of a therapy and how a decision is made to add to a formulary
• Examine pricing and reimbursement challenges surrounding single-dose therapies

EXAMINE PRAGMATIC PAYMENT MODELS AROUND CELL & GENE THERAPY AND THE AFFECT ON THE HEALTHCARE ECHOSYSTEM

The next decade promises breakthroughs in regenerative medicine as cell and gene therapy innovation promises new hope for patients with devastating and rare diseases. With over 750 companies globally in the regenerative medicine market, the cell and gene therapy industry is a key space that pharmaceutical companies are looking at as an area for growth. However, manufacturers, payers, and leaders in regulatory organizations must come together to discuss the well-known challenge around the cost of producing and providing such therapies.

• Discuss the top barriers in terms of legal issues that need to be tackled with cell and gene therapies
• Uncover the top benefits to producing cell and gene therapies to ensure continued research and development
• Explore the top payment models around cell and gene therapies which can be curative or life-long therapies

Networking Luncheon

DIVULGE PRICE TRANSPARNECY AND THE FUTURE OF PHARMACEUTICAL PRICING AS BIOSIMILARS ENTER THE MARKET

From top officials at the White House to increasingly informed patients, and experts providing healthcare and healthcare solution, pricing is an area of top concern. There is no question that the cost of healthcare in America is of top concern and price transparency is critical to drug pricing solutions. Discussing some of the macro approaches for US healthcare system and examining ways to increase clarity as to the pricing structure of pharmaceuticals.

• Explore the ways in which pharma is responding to the increasing pressures around drug pricing and availability
• Examine Biosimlars entering the market and what that means to pharmaceutical pricing
• Discuss direct and indirect fees that the PPOs are now including in pricing in order to gain transparency on the use and distribution of the fees

PANEL: OVERHAUL MARKET ACCESS & COMMERCIALIZATION THROUGH THE USE OF VALUE-BASED CONTRACTING

• Assess the construction and implementation of the first wave of publicly disclosed value based contracts, including challenges, outcomes, and payer requirements
• Determine the necessary data requirements, specifically Real World Evidence (RWE), to initiate a value-based contract
• Analyze the current shift to value-based care, as well as the healthcare landscape, and determine how outcomes-based contracts could replace or supplement traditional reimbursement models
• Profile examples of value-based contracts and similar pricing models used in the EU and assess their feasibility in the US

Afternoon Networking & Refreshments Break

EXAMINE THE IMPACT OF INTEGRATED DELIVERY NETWORKS AND CARE CONSOLIDATION ON MARKET ACCESS

There are now a multitude of care models that are popping up due to this increase in a need for access and price controls. From IDNs to GPOs and personalized medicine as well as new clinical pathways which serve as alternative payment methods and strategies focusing more around cost. Decreasing reimbursements and increasing administrative cost are leading hospital systems and large physician groups to join GPOs and IDNs to gain bargaining power with payers and manufacturers of cancer drugs. Through this session hear the perspective from Super Groups such as TN oncology and FL oncology as well as GPOs such as ION to discuss the value of these partnerships and expectations for partnerships moving forward.

• Define the relationship between GPOs and super groups such as TN oncology and FL oncology in order to move forward with successful partnerships
• Examine the value these partnerships bring to healthcare in the arenas of cancer care and rare disease to ensure success for both pharmaceutical therapies and patient access
• Uncover top priorities from the organizations around the future of partnerships with pharmaceutical manufacturers to ensure manufacturers fit into future strategies of contracts and pricing

MARKET ACCESS 2020: FORECAST THE FUTURE OF MARKET ACCESS IN THE CURRENT HEALTHCARE LANDSCAPE

• Analyze policy and healthcare changes since the 2016 Presidential Election and specific initiatives to enhance pharmaceutical development
• Assess shifts in global policy, such as Brexit, and its effect on both U.S. and international product launches
• Examine the potential use of an Executive Order to reduce scrutinized drug pricing and its relationship with value-based contracting

Cocktail & Networking Reception

Day Three - Wednesday, February 7, 2018

Morning Coffee

Oncology Market Access & Commercialization Summit Track

Chairperson’s Opening Remarks & Recap of Day Two

CMS KEYNOTE: DISCUSS PRICING AND ACCESS WITHIN THE ONCOLOGY CARE MARKET

• Uncover CMS’ view on pricing and payment models for oncology therapies
• Discuss CMS partnership with payers to enact the Oncology Care Model committed to enhance services for Medicare beneficiaries
• Examine CMS view on quality measures to ensure market access strategy aligns with value and quality standards set by top stakeholders

VALUE KEYNOTE: GAIN FURTHER UNDERSTANDING OF LEADING VALUE MODELS AND POTENTIAL IMPLICATIONS ON REIMBURSEMENT AND MARKET ACCESS

There is no question that the health care industry is greatly shifting to focus on value. In moving from FFS to value-based care, pharmaceutical organizations are facing greater demand demonstrate the value of their therapies. Through a panel discussion with leading organizations Oncology Market Access executives have the opportunity to discuss and better understand ASCO’s Value Framework, ICER Value-Based Pricing, and NCCN Evidence Blocks.

• Uncover objective frameworks for assessing pharmaceutical products
• Discuss new metrics make an impact on market access for oncology drugs
• Discover how value metrics are being used by payers
• Discuss ways to demonstrate value to both physicians and payers
• Understand the value points highlighted by each value framework
• Discuss the adoption and impact of the value framework on oncology care

INDUSTRY KEYNOTE: EXPLORE THE INDUSTRY SHIFT FROM VALUE ASSESSMENT IN US vs XUS

Manufacturers are noticing a shift in attention in the market access arena as the US starts to parallel Europe in terms of access challenges. Many pharmaceutical manufacturers are looking towards experts in global markets to gain insight on best practices in access and commercialization strategies. Through high-level presentation, uncover methods of bringing successful global strategies to the US market.

• Bringing Access learnings closer and sharing the expertise, the trend within the industry
• Review of global value frameworks
• Review of emerging US value frameworks
• Discuss similarities, disparities and indications of success and lessons learned around multiple frameworks

OVERCOME PRICING AND ACCESS HURDLES WITH COMBINATION THERAPEIS AND IMMUNO-ONCOLOGY

There is increased interest in the combination therapy and immuno-oncology (IO) market as it provides non-invasive, non-toxic, and less painful ways to deliver care. With the promise of better outcomes, increased life-span, and less-evasive therapies, many pharmaceutical manufacturers are looking at entering into the combination-IO realm of therapy. However, with increased combinations comes increased price as well as a multitude of side effects that may now have to be taken into consideration. Hear the challenges and opportunities for manufacturers, as well as emerging trends seen as payers, providers, and patients respond to new immuno-therapies in the market.

• Discuss new strategies for communicating the value proposition of immuno -oncology products
• Discover how immuno-oncology therapies are influencing clinical pathway decisions
• Discuss the clinical benefits of combination / IO therapies to increase visibility around the success of each treatment
• Uncover top concerns of the industry and ways to overcome hurdles with increased price and side effects of combination therapies

Morning Networking & Refreshments Break

LEVERAGE BIG DATA AND THE VALUE OF ONCOLOGY SUCCESS TO INCREASE ACCESS TO INNOVATIVE THERAPIES

Over the past five years and through the next five years, there has been and continues to be a success trend in the wave of fantastic oncology innovation. However, pharmaceutical manufacturers have yet to uncover the best practices in utilizing this data to show the value of these therapies. In order to drive innovation and encourage policy change for innovative therapies such as IO and genomics, it is imperative to proactively organize data, improving access and lowering costs.

PATIENT & PROVIDER VIEW: UNCOVER PROVIDER AND PATIENT VIEWS AROUND VALUE TO ENHANCE DEVELOPMENT, PRICING, AND COMMERCIALIZATION STRATEGIES AROUND CANCER THERAPIES

There is a new era in the wave of patient care as patients become increasingly involved in their healthcare education and the burden of healthcare costs continues to rise. Progressively, hospitals are looking to the manufacturer to assist in understanding the budgetary impact their therapies will have on both the hospital and the patients they serve. A successful market access strategy should address the growing power of patients and the top concerns of providers to determine treatment options and the best ways in which to partner with each stakeholder to ensure access, affordability, education, and adherence to therapies.

• Discuss the top challenges and victories in the provider healthcare systems to better understand the provider landscape
• Uncover top thought processes in choosing therapies for cancer patients based on pricing, combination, education, availability, and other considerations
• Examine patient affordability in a world where their cost burden is increasing particularly in oncology especially and how is the industry and society going to react to that and handle that
• Uncover the goals of advocacy groups and how they work in partnership with pharma on policy objectives
• Learn how pharma is partnering with patient advocacy to ensure patient access and adherence

DISCUSS TOP REGULATIONS IMPACTING ONCOLOGY MARKET ACCESS AND COMMERCIALIZATION

• Identify key drivers of insurance regulations to ensure market access strategy adheres with top regulations moving into the future
• Explore areas of coverage expansion how manufacturers can prepare for new and impending regulations
• Examine the implications of payment reform and the steps manufacturers should take to ensure compliance

Close of Summit