The sPCMA Business Forum hosts payer-aligned specialty pharmacies and their business partners – payers, PBMs, drug manufacturers, and others.  Speakers are among the specialty pharmacy industry’s top thought leaders and the Business Forum hosts the most specialty drug management decision makers of any industry conference.

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sPCMA Business Forum 2016 Agenda

Monday, February 8
9:00 am – 9:30 am

Breakout Session 1 of 2

Indication-Based Pricing in Oncology

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Mary Dorholt, Senior Director & Specialty Clinical Practice Lead, Express Scripts

In 2014, the Express Scripts prescription drug trend was 13.1% — the highest it’s been in more than 10 years. With hepatitis C and cancer products leading the way, analysis shows that specialty drug trend more than doubled from 2013 to 2014 and reached nearly 31%. During this period of industry-wide innovation, all stakeholders are struggling to adapt to the growing demand to justify the value of products or services. As payers, PBMs, and specialty pharmacies look to reward and create headroom for more pharmaceutical and biotech innovation, they are developing new and unique management tools and patient care strategies. During this session, Mary will discuss indication-based pricing for oncology drugs as well as other specialty pharmacy programs aimed at providing unique cost and management solutions designed to respond to the recent wave of high-priced products.

By attending this session, you should be able to:

  • Describe current medication spend and trend drivers in oncology;
  • Outline how management and patient care, using a variety of techniques and approaches including indication-based pricing, are critical to maximizing care and minimizing trend; and
  • Explain how these programs are clinically supported and tie into existing patient support services.

9:00 am - 9:30 am

Breakout Session 2 of 2

PBMs Prepare for Biosimilars — How PBMs are Preparing for an Expansion of the Biosimilar Market

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Steve Avey, Vice President, Specialty Pharmacy, MedImpact

Patient advocates and payers anticipate that biosimilars will foster competition — enabling negotiated discounts — and that interchangeable biosimilars may compete in the same way generic drugs compete with brand-name small molecule drugs. Without active PBM management of the growing specialty drug market, these discounts will not be realized.

Since the introduction of the first biosimilar to the market, PBMs have been adding programs and services to better support plan sponsors and their beneficiaries. By relying on P&T Committee recommendations, encouraging increased plan sponsor utilization of biosimilars, and establishing partnerships with network pharmacies to conduct post-launch surveillance for adverse events and biosimilar effectiveness, PBMs are focused on preparing clients and their members to adapt to this changing environment. This session will also address the evolution of contracting processes, formulary management, and the continued encouragement of competition in the biosimilar space.

By attending this session, you should be able to:

  • Describe the key elements of a biosimilar product adoption policy;
  • List the steps a PBM should take to improve biosimilar utilization; and
  • Outline the pitfalls that can still hamper the utilization of biosimilars as they become available.

9:45 am – 10:15 am

Breakout Session 1 of 2

Strategic Changes in Medicare Part D

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Michael Anderson, Chief Pharmacy Officer, UnitedHealthcare Medicare & Retirement

The Medicare Part D program is ten years old and continues to evolve. During this session, Mike will review ten significant changes that are now impacting the program, including changes to the benefit design, program funding, regulatory environment, and competitive landscape.

By attending this session, you should be able to:

  • Explain key benefit design changes that are impacting the Part D program, including those driven by the government and by plan sponsors;
  • Describe the funding challenges that Part D sponsors are now facing;
  • Summarize changes to the Star Rating and MTM programs that impact pharmacy benefits; and
  • Describe emerging trends in the Part D competitive landscape

 

9:45 am – 10:15 am

Breakout Session 2 of 2

An Analyst’s Perspective on Market Dynamics — Future of the Formulary, Biosimilars, and Specialty Pharmacies

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Ronny Gal, Senior Analyst, Global Specialty Pharmaceuticals, Sanford Bernstein

Due to their unique vantage point, Wall Street analysts offer a highly informed and distinctive perspective of our industry. During this session, Ronny will discuss biosimilars, a topic for which he is a frequent speaker, and how these products will start to penetrate the U.S. market. He will also address the future of the formulary and why commercial markets are expanding their exclusion lists, and other imminent topics and their implications for the specialty pharmacy industry.

By attending this session, you should be able to:

  • Identify two issues Ronny sees to be impactful for the specialty pharmacy industry in the next year;
  • Describe profitability and margin expectations for biosimilars; and
  • List at least two reasons why drug exclusion lists are growing, and the implications this growth will have on the market.

10:30 am – 11:15 am

General Session

Drug Pricing and Affordability Challenges for Payers and Policymakers

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Everett Neville, Senior Vice President, Supply Chain, Express Scripts

Steve Pearson, President, Institute for Clinical and Economic Review

Moderator: Sam Nussbaum, Former Executive Vice President, Clinical Health Policy & Chief Medical Officer, Anthem

What is a drug worth? This is the question at the heart of the debate that rages around the price of prescription drugs today. Payers and policymakers find the pricing strategies of drug makers to be problematic. The projected growth of drug costs is unsustainable and necessitates PBMs, payers, and manufacturers working together to identify solutions that provide affordable, high value medications to patients.

During the session Steve Pearson will provide an overview of the ICER value-based price benchmark model, which calculates cost-effectiveness and potential budget impact under different utilization assumptions. The session will also address how the payer community is responding to these challenges, and how imperative the lowering of drug costs is to the future of our respective industries.

Questions to be addressed during the panel discussion include:

  • How do PBMs use ICER data in determining the value, appropriate price, and formulary placement for a product? What other factors are involved?
  • How are cost offsets factored into the value of a drug?
  • How will payers deal with incremental innovation that does not justify a price?
  • Where have PBMs been successful in reducing prices to acceptable levels, and where is there still an opportunity for savings?
  • How can pharma and payers work together sooner in the development and commercialization of a product?

11:15 am – 12:00 pm

General Session

Defining and Differentiating Specialty Pharmacies

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Bill Martin, Vice President, Accredo Specialty Trade Relations, Express Scripts

Michael Zeglinski, Senior Vice President, Specialty Pharmacy, OptumRx

Moderator: Adam Fein, President, Pembroke Consulting

Pharmaceutical industry revenues will continue shifting from traditional brand name drugs to specialty drugs over the next few years. By 2018, specialty drugs will account for 50% of total U.S. drug spend. Pharmacies owned by a diverse set of organizations compete to dispense these specialty therapies. As with specialty drugs, there is no universal definition of a “specialty pharmacy.” Unlike other outpatient dispensing formats, state boards of pharmacy lack distinct regulatory requirements that define a “specialty pharmacy.” Thus, any pharmacy can designate itself as a “specialty pharmacy” if its business focus is self-administered specialty pharmaceuticals covered under a patient’s pharmacy benefit.

This session will help clarify the marketplace and its dynamics. The panel will:

  • Identify the services and definitions of specialty pharmacy;
  • Assess the various organizations that compete to dispense specialty medications;
  • Evaluate the network strategies used by pharmaceutical manufacturers and payers to manage specialty therapies; and
  • Provide the outlook for the market’s evolution.

1:30 pm – 2:00 pm

Breakout Session 1 of 2

The Role of Copay Coupons in Specialty

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Pat Gleason, Director, Health Outcomes, Prime Therapeutics

Growth in the development and spending for specialty drugs has important implications to a number of stakeholders including patients, employers, insurers, and manufacturers. With the drug manufacturers spending an estimated $7 billion on coupons and discount cards annually, it is important to understand how much is going toward specialty drug and the potential value. This session will examine trends in the specialty drug market, including member cost sharing, prevalence of coupons, employers’ specialty management goals, and the role of coupons. At the end of this session, participants should have a better understanding of employers’ and PBMs’ specialty pharmacy benefit management tools and the role of coupons/drug discount cards.

By attending this session, you should be able to:

  • Describe the trends and evolution of the specialty drug market and coupon use;
  • Outline the implications of increases in specialty drug spending and utilization on health insurance benefits and coverage decisions;
  • List employers’ and PBMs’ specialty pharmacy tools and how they will be implemented in the near future;
  • Describe the value of specialty coupons.

1:30 pm – 2:00 pm

Breakout Session 2 of 2

The Intersection of Oncology Pathways and Value Measures — The Impact on Payers, Providers, Pharma, and Patients

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Debbie Stern, Senior Vice President, Strategy and Business Development, Medical Oncology and Specialty Pharmacy, eviCore Healthcare

The rate at which health care costs are growing is of concern to all stakeholders in the health care system: providers, payers, manufacturers, and patients. The cost of targeted oncology drug therapy in particular is at the forefront of this discussion, with annual treatment costs exceeding $100,000. At the same time that these costs are growing, there is concern that this high-cost care does not necessarily translate into high quality care or improved outcomes.

With all the focus on health care costs, the topic of value has been raised: identifying outcomes relative to cost. The growing focus on value and quality are driving greater use of oncology clinical pathways by payers. Although a minority of U.S. payers have implemented oncology pathways, multiple industry surveys expect the use to increase over the next few years. During this session, Debbie will discuss how oncology pathways are influencing treatment selections and how various value models may impact drug treatment.

By attending this session, you should be able to:

  • Describe the role oncology clinical pathways play in ensuring evidence based treatment;
  • Outline the various value-based models currently available for cancer treatment;
  • Understand key drivers impacting drug product selection; and
  • Identify methods for pharma to bring value into oncology management.

2:15 pm – 2:45 pm

Breakout Session 1 of 2

The 340B Program’s Impact on the Specialty Pharmacy Industry

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Stephanie Hales, Partner, Sidley Austin LLP

HRSA published its proposed omnibus guidelines (or “mega guidance”) for the 340B Drug Discount Program in August. The proposed guidelines, which followed closely on the heels of a major proposed rule from HRSA regarding ceiling price calculations and civil monetary penalties, address many components of the 340B Program, including a number of key issues affecting the specialty pharmacy industry. HRSA’s proposals seek to clarify and modify several aspects of the 340B Program, but many questions still remain as we wait for the final rule and final guidelines to be published — likely this spring or summer. Moreover, CMS just released its long-awaited Medicaid Covered Outpatient Drugs Final Rule, which speaks to important 340B-related questions, including best price exclusion issues, duplicate discounts, and requirements for state Medicaid agencies to describe their payment methodology for drugs dispensed by 340B covered entities and contract pharmacies.

During this session, Stephanie will discuss some of the most significant implications of HRSA’s proposed rule and guidelines and the newly issued CMS final rule that are relevant to the specialty pharmacy industry. In particular, she will address regulatory impacts such as contract pharmacy guidance, civil monetary penalties, distribution considerations, and audit activity, and what these proposals and policies might suggest is the federal government’s view on specialty pharmacy models. Outside of regulatory implications, Stephanie will also introduce some by-products of the 340B Program, such as the growth of ACO and IDN specialty pharmacies, and increasing government and commercial interest in shared savings arrangements.

By attending this session, you should be able to:

  • Outline at least three of the main impacts that HRSA’s proposed rule and proposed guidelines will have on the specialty pharmacy industry;
  • Compare and contrast payer and manufacturer perspectives about 340B prices being offered in specialty pharmacy distribution networks; and
  • List at least two potential by-products of the proposed rule.

2:15 pm – 2:45 pm

Breakout Session 2 of 2

2015 Specialty Pharmacy Patient Satisfaction Survey Results

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Jason Rucker, Director, Trade Research, Zitter Health Insights

Over the past year, Zitter Health Insights has conducted patient satisfaction research every quarter across ten of the major specialty disease states. The research encompasses results from more than 9,000 specialty pharmacy patients from the top twenty specialty pharmacies. Major pharmaceutical manufacturers and payers are using this information to understand how patients perceive their specialty pharmacies, and to help their organization and network of specialty pharmacies improve operational excellence.

This survey, the largest ever conducted on the specialty pharmacy industry, focuses on such key metrics as time to therapy, adherence/compliance, reimbursement services, net promoter score, and the drivers of pharmacy switching. During his presentation, Jason will explore beyond the traditional patient surveys and see how the top 20 specialty pharmacies rank overall and by disease states.

By attending this session, you should be able to:

  • Outline key influencers of patient perceptions of their specialty pharmacies and the care they receive;
  • Describe at least three drivers for patient satisfaction; and
  • List the top-rated specialty pharmacies for at least three disease states

3:00 pm – 3:30 pm

Breakout Session 1 of 1

Separating Facts and Myths with Specialty Drug Management Under the Medical Benefit — An Integrated PBM/Specialty Pharmacy Perspective

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Thom Stambaugh, Vice President, Cigna Specialty Pharmacy Services

Payment and operating models for specialty drugs covered through the medical and pharmacy benefits differ. The pharmacy benefit is carefully managed by payers and PBMs, and the medical benefit is carefully and primarily managed by health plans. Confusion often exists as to which benefit coverage approach — medical or pharmacy — and under what conditions provides the best affordability, outcomes, and customer experience. Simply put, even after many years, separating “fact from myth” remains difficult for plan sponsors. During this session, Thom will discuss why a whole view cost approach can bring important insights to plan sponsors so they pursue specialty management strategies that drive to the best affordability, outcomes, and customer experience.

By attending this session, you should be able to:

  • Outline how select specialty drugs are managed by health plans under the medical benefit;
  • Summarize which benefit, pharmacy or medical, optimizes affordability for key drug classes — and under what situations; and
  • Describe the customer service experience differences in carve-out versus carve-in models.

3:45 pm – 4:15 pm

Breakout Session 1 of 1

Pipeline Data, Modeling and Clinical Information – Evolving Payer Considerations

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Farrah Wong, Manager, Pipeline and Drug Surveillance, OptumRx

This presentation goes beyond your typical pipeline session by offering a glimpse into how PBMs analyze health plan data and model for future expenses. The first part of the presentation will include an overview of the “high impact” products coming to market in the next few years and why some of these products are being labeled “buzz drugs.” Farrah will also outline how OptumRx has enhanced their data, modeling, and clinical programs over the past year, and what this means for monitoring the drug pipeline and drug prices moving forward.

By attending this session, you should be able to:

  • Identify at least two high impact pipeline drug trends;
  • Define industry “buzz drugs” according to the presenter; and
  • Outline how health plan data and clinical modeling influence formulary decisions.

Tuesday, February 9
9:00 am – 9:30 am

General Session

Opening Remarks

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Mark Merritt, President & Chief Executive Officer, PCMA

PBM Industry Keynote Address:

State of the Industry — New Challenges for All of Us

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Tim Wentworth, President, Express Scripts

A vast array of challenges, opportunities, and solutions exist for the future of the prescription drug marketplace. Tim’s keynote address will review the state of the industry landscape today by highlighting the positive and negative breakthroughs for all stakeholders.

9:30 am – 10:15 am

General Session

Evolving Oncology Drug Management Programs — Prior Authorization, Comparative Effectiveness Displays, Performance Contracting, and a New Episode Payment Program

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Lee Newcomer, Senior Vice President, Oncology, Genetics and Women’s Health, UnitedHealthcare

In a move to streamline the payment and delivery of injectable chemotherapy drugs administrated in an outpatient setting, payers are beginning to launch online prior authorization (PA) programs. National insurers have long used guidelines published in the National Comprehensive Cancer Network (NCCN) Drugs and Biologics Compendium to determine coverage for chemotherapy drugs used in outpatient settings. By automating the NCCN guideline-based PA process, payers are able to reduce the number of post-service denials, collect clinical treatment information, and build databases that may shed light on the relative effectiveness of chemotherapy treatments.

During this session, Lee will share insights on performance contracting for oncology drugs. Specifically, UHC’s total care provider reimbursements tied to value-based arrangements have nearly tripled since 2011 to $36 billion, and are expected to reach $65 billion by the end of 2018. Rewarding physicians for patient health improvement moves physician incentives closer to the values and needs of patients. Previously, performance-based payments have been insignificant compared to the total revenue of an oncology clinic. Therefore, payers are working to transform the industry into a true value-based system that compensates providers for better outcomes and lower costs. By linking reimbursement to these outcomes, and not just the process of care, payers hope to better align all parties to do what is in the best interest of the patient.

By attending this session, you should be able to:

  • Describe the value online prior authorization tools provide for patients, providers, and payers;
  • Explain how comparative effectiveness displays will help physicians categorize patients for the purpose of monitoring and assessing the success rates of regimens;
  • List the main components of performance and value-based contracting programs; and
  • Compare the benefits of episode payment programs versus the predominant “fee-for-service” approach.

10:15 am – 11:00 am

General Session

The Latest Trends in Drug Product Utilization

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Doug Long, Vice President, Industry Relations, IMS Health

This session will address the current and future state of the U.S. pharmaceutical market. Topics addressed will include current growth, top class performance, top product performance, top company performance, biosimilar impact, and cost containment efforts.

By attending this session, you should be able to:

  • Outline where the U.S. pharmaceutical market growth has been and near-term forecast for growth;
  • Describe the performance of the various sectors of the dispensing side;
  • Describe the performance of brand, generic and specialty products; and
  • Identify which factors will affect future growth.

11:15 am – 12:00 pm

Breakout Session 1 of 2

The Value of Specialty Drugs Across the Health Care Continuum

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Martin Zagari, Vice President, Global Health Economics, Amgen

Stakeholders in the health care system are increasingly invoking good value as a highly desirable aspect of care decisions and resource allocation. In fact, some have used the phrase “from volume to value” to describe a health care system that rewards effective high value care rather than merely activity. But although everyone can generally agree that value should drive an increasingly large proportion of health care decisions, there is not alignment about what value actually is, how it is measured, how such ascertainment should be used in decision making, and what changes might need to occur in the complex health care ecosystem to encourage value based decision making versus more one-dimensional cost-based decisions. In this discussion, Martin will talk about the concept of value, how it is measured, and how it might help health care decision makers partner around health care reform that incentivizes and creates the most value for all participants in our system.

By attending this session, you should be able to:

  • Discuss the definition of value across the health care continuum and how QALY measures can be considered;
  • Outline value considerations used in Europe; and
  • Describe how outcomes are playing a role on contract negotiations.

11:15 am – 12:00 pm

Breakout Session 2 of 2

The Role and Scope of IDN and ACO Specialty Pharmacies

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Bill Roth, Founding Partner, Blue Fin Group

There is a growing trend amongst health systems and integrated delivery networks (IDNs) to open their own specialty pharmacies. As these health systems seek to gain ground, payers and manufacturers question the value these new specialty pharmacies bring to the market. Yet as these are the sites in which many clinical trials are conducted and physicians and health systems insist that they cannot be held accountable for care without allowing their practices access to treat the patients, the question remains, what should payers and manufacturers do with access?

This session will provide a look into the role and scope of these health system specialty pharmacies. Central questions that will be addressed include 1) should payers grant them network coverage and 2) should manufacturers provide them with preferred programs and access to drug?

By attending this session, you should be able to:

  • Describe why health systems are spending the time and investment to develop their own specialty pharmacy capabilities and the value they are offering to the industry;
  • List the key challenges facing IDN-owned specialty pharmacies, and how payers and manufacturers could consider criteria for network inclusion;
  • Outline how these health systems specialty pharmacies might continue to evolve with the onset of greater data sets such as behavioral and genetic information; and
  • Describe potential scenarios if the payers or manufacturers restrict access to these specialty pharmacies moving forward.

1:30 pm – 2:00 pm

Breakout Session 1 of 2

Personalized Medicine in Oncology Care

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Mike Kolodziej, National Medical Director, Oncology Solutions, Office of the Chief Medical Officer, Aetna

The understanding of the molecular basis of cancer has transformed cancer treatment. From the humble beginnings of targeting the estrogen receptor through HER2-directed therapies for breast cancer to the present day molecular subtyping of lung cancer, the treatment of adult solid tumors has evolved from a discussion of dose-intensive cytotoxic chemotherapy to one of very precise molecularly-driven therapy. In fact, there is now discussion around reclassifying malignancies based on molecular profile rather that anatomic origin. Yet, despite the intellectual attractiveness and preliminary promise of this approach, it remains far from being routinely implemented at the bedside. During this session, Mike will discuss the payer’s views regarding personalized medicine in oncology care and how we can overcome these hurdles.

By attending this session, you should be able to:

  • Outline challenges associated with complex molecular testing from the perspectives of analytic and clinical validity;
  • Describe incomplete data available around clinical utility; and
  • List at least two reasons why value is not yet established for this approach.

 

1:30 pm – 2:00 pm

Breakout Session 2 of 2

The Growing Importance and Impact of Fair Market Value in Specialty Pharmacy

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David Galardi, Vice President, Worldwide Managing Director, Apogenics

Payments made to specialty pharmacies for their services are growing and becoming a larger component of specialty pharmacy profitability. Such payments should be fair and legitimate and must meet special requirements when offered or paid by those participating in federal health care programs, which account for about 50% of drug spend in the U.S. As government drug spend grows, authorities are also expected to increase their scrutiny of service arrangements between buyers and sellers. These service programs create unique challenges for manufacturers and may influence drug pricing calculations, exposing manufacturers and their pharmacy service providers to compliance challenges. Fair market value (FMV) becomes a key element in maintaining compliance with many aspects of the law, as well as providing a sound basis for compensation and payment to service providers.

During this session, David will provide insight into how FMV analysis can be done, and how it can vary based on legal definitions (i.e. class of trade), operational services (i.e. adherence, data management, etc.), and the ownership structure of a servicing pharmacy. He will discuss the impact FMV considerations have on limited specialty pharmacy network decisions, how contract criteria must be adjudicated across the entire network, and how PBMs and specialty pharmacies might use these details to differentiation themselves as they compete in the market.

By attending this session, you should be able to:

  • Outline the criteria for fair market value;
  • Provide an overview of the valuation methods used;
  • Describe the importance of defining services and their business needs; and
  • Describe why FMV is a critical aspect of maintaining a compliance operation.

2:15 pm – 2:45 pm

Breakout Session 1 of 2

Value-Based Contracting — The Future for Specialty Survival in the U.S.

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Steve Clark, Vice President, Optum Life Sciences

Brian Solow, Chief Medical Officer, Optum Life Sciences

Value-based pharma contracting as a buzz phrase seems to be reaching new heights in 2016. Several organizations have already put their toes in the water and several more are close behind. Pharma companies will need to be ready to work with payers on these arrangements and be able to show the value they bring.

By attending this session, you should be able to:

  • Explain the definition of value-based pharma contracting;
  • Describe the history and perception of this concept; and
  • Outline the future outlook for value-based contracting.

2:15 pm – 2:45 pm

Breakout Session 2 of 2

Opposing Influences of Evidence and Market Forces in Pharmaceutical Pricing and Payer Net Cost

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Larry Blandford, Executive Vice President & Managing Partner, Precision for Value

Steve Carter, Vice President, Precision for Value

This session will outline the process often used by manufacturers to establish a price for a product and compare that to how payers assess how that price impacts perception of value. The presenters will outline how clinical and economic evidence, research, and market forces can shift price points through launch preparation. New research on how payers perceive a product based on price will be unveiled along with implications across different benefits plans, such as Medicare Part D and employer-funded. Lastly, evolving and future methods for alignment between these stakeholders will be shared.

By attending this session, you should be able to:

  • Outline a process and influences by which the price of pharmaceutical products may be established;
  • Explain how payers perceive the value of pharmaceutical products, based on price, evidence, and value added services on their overall net cost; and
  • Identify evolving and future methods for aligning pharmaceutical product price with payer value.