1. PHARMACEUTICAL
STRATEGIC PRICING
OCTOBER 5-6, 2015 | PHILADELPHIA, PA
Adapting To Changing Payer Expectations, New Government Regulations and the
Increased Focus on Product Innovation to Develop Optimal Pricing Strategies that
Ensure Greater Patient Access while Maximizing a Pharmaceutical Company’s Profitability
DISTINGUISHED PRESENTERS INCLUDE:
PHARMACEUTICAL INDUSTRY PERSPECTIVES
PAYERS, PHARMACY BENEFIT MANAGERS AND ACCOUNTABLE CARE ORGANIZATIONS
ADDITIONAL PRICING EXPERTS
CONFERENCE SPONSOR:
500 N. DEARBORN STREET, SUITE 500 CHICAGO, IL 60654 (P) 312.822.8100 (F) 312.602.3834 www.q1productions.com
Michael Paas
VP, Market Access & Pricing
REGENERON PHARMACEUTICALS
Sean McElligott
Director
JANSSEN
Leonard Fairfield
Senior Director Pricing & Contracts
DEPOMED *pending confirmation
Jonathan Connell
Senior Counsel
BRISTOL MYERS SQUIBB
2nd Semi-Annual
John Alter
Vice President, Global Health & Value,
Global Established Pharma Business Unit
PFIZER
Jennifer English
Director, Contracts & Pricing
ACORDA THERAPEUTICS
Juan Camilo Roman
Senior Director, Market Access
ABBVIE
William Hillmer
Senior Director, Strategic Pricing &
Contracts
MALLINCKRODT
J’Aime Conrod
National Director, Federal & Government
Accounts, Market Access & Pricing
UCB
Lisa McNair
Manager, Contracting and
Reimbursement
INVIDIOR
Ed Pezalla, MD, MPH
National Medical Director for
Pharmacy Policy and Strategy
AETNA
Kimberly Gwiazdzinski
Senior Director, Pharmaceutical Trade
Relations,
PRIME THERAPEUTICS
F.Michael White, PharmD CSP
Director, Clinical Pharmacy Services,
Interim VP
BLUECROSS BLUESHIELD TENNESSEE
Megan Woosley
Team Leader of Case Management
OWENSBORO HEALTH ACO
Crystal Kuntz
VP Policy and Regulatory Affairs
AMERICA’S HEALTH INSURANCE
PLANS (AHIP)
Rene Acker, R.Ph.
Chief Operating Officer
MERIDIANRX
Trevor Wear
Partner
SIDLEY AUSTIN
Donna Yesner
Partner
MORGAN LEWIS
Matthew Fornataro
Associate
ARNOLD & PORTER LLP
Robert Field, PhD, MPH, JD
Professor, Health Management & Policy
DREXEL UNIVERSITY
Anne Hance
Partner
MCDERMOTT, WILL & EMERY
Andrew Peterson, PharmD, PhD
John Wyeth Dean, Professor of Clinical
Pharmacy and Health Policy
UNIVERSITY OF THE SCIENCES
2. 8:00 REGISTRATION & MORNING COFFEE
8:50 OPENING REMARKS
9:00 KEYNOTE PRESENTATION: EVOLUTION OF HEALTHCARE AND
IMPACT ON PHARMACEUTICAL PRICING
The continually evolving healthcare landscape throughout the US has a
constant impact on pharmaceutical pricing, as consumers, physicians and
health plans change priorities and requirements. Robust healthcare reforms
across the country have also placed an increased focus and awareness relat-
ed to the price of pharmaceutical therapies, resulting in considerable chang-
es for pharmaceutical executives. Compounded by external scrutiny of the in-
dustry, executives must continually evaluate and re-evaluate pricing models,
forecasts, and structures to ensure the future growth and viability of the in-
dustry. The focus of this talk will be on the how each of the major stakehold-
ers in the drug supply chain price their products and how the market place,
government requirements and other forces influence pricing decisions.
Andrew Peterson, PharmD, PhD
John Wyeth Dean Professor of Clinical Pharmacy and Professor of Health
Policy- Mayes College of Healthcare Business and Policy
UNIVERSITY OF THE SCIENCES
9:45 PANEL DISCUSSION: REVISED PRICING STRATEGIES IN LINE
WITH 340B OMNIBUS GUIDANCE
Many uncertainties exist surrounding the proposed changes to the 340B
Drug Pricing Program, with the Health Resources & Services A sdministra-
tion (HRSA) having submitted new guidance to the Office of Management
and Budget on May 6th, 2015. Although a comment period as well as imple-
mentation phase will be provided once the guidance is final, many organiza-
tions are preparing for changes and the impact on pricing structures. With
legal, financial and operational ramifications, understanding the anticipated
revisions will ensure corporations are ready to move forward within a restruc-
tured 340B framework.
• Impact on revenue, rebates and price
• Reporting and compliance considerations
• Effective internal restructuring to comply
Jonathan Connell, Senior Counsel, BRISTOL MYERS SQUIBB
Donna Yesner, Partner, MORGAN LEWIS
Trevor Wear, Partner, SIDLEY AUSTIN
10:30 COFFEE & NETWORKING BREAK
11:00 PRICING TRANSPARENCY REPORTING AND REQUIREMENTS
IN LIGHT OF 340B DRUG PRICING CHANGES
While pharmaceutical manufacturers are currently submitting data to CMS
related to the average manufacturer’s price, unit rebate amount, package
size and national drug code, the proposed changes to 340B include addi-
tional reporting requirements with an aim of providing even greater price
transparency. Revisions to the 340B regulations indicate new requirements
including collection of previously stated drug pricing, as well as calculated
340B ceiling price for each National drug code. Pricing executives require a
firm understanding of proposed changes in order to ensure data is available
for reporting based on finalized regulations.
• Impact of increased transparency on pricing
• Ensuring data is accessible for reporting
• Forecasting additional 340B transparency requirements
Donna Yesner, Partner, MORGAN LEWIS
11:45 IDENTIFYING THE IMPACT OF GENERIC AND BIOSIMILAR
ENCROACHMENT ON PHARMACEUTICAL PRICING
Across the pharmaceutical and biotechnology industries, pricing executives
are continually planning and evaluating strategies related to maximizing
product exclusivity provided by patents, and are concerned regarding the
launch of generic and biosimilar products. Uncertainties exist throughout the
industry related to the timelines of generic and biosimilar approvals by FDA,
with the first biosimilar product only recently receiving clearance, after con-
siderable delays. For pricing executives, balancing the optimization of reve-
nue alongside strategies for maintaining profitability post-generic launch is
essential in preserving the growth and development of the industry.
• Impact on pricing as a result of generic and biosimilar approval
• Maximizing revenue through final periods of exclusivity
• Maintaining sales through creative pricing post-generic launch
Sean McElligott, Director
JANSSEN
Robert Field, PhD, MPH, JD, Professor, Health Management & Policy
DREXEL UNIVERSITY
12:45 LUNCHEON FOR ALL DELEGATE, SPEAKERS AND SPONSOR
ATTENDEES
1:45 COMMUNICATING PRODUCT VALUE TO COMMERCIAL PAYERS
TO SUPPORT PRICING STRUCTURES
In an increasingly competitive marketplace, pharma pricing executives must
provide clear and comprehensive value propositions to gain support for new
and existing therapies with commercial payers. While effectively communi-
cating the health and economic value of a product is essential to gaining sup-
port, it is increasingly difficult to do so, as payers shift priorities and continue
to place more focus on cost in addition to effectiveness. Having a robust dos-
sier prepared for payers and successfully leveraging information gathered
throughout the organization will ensure pricing structures are maintained.
• Utilizing HEOR data to support value proposition
• Lessons learned from successful negotiations
• Trends in payer landscape focused on cost
John Alter, Vice President, Global Health & Value, Global Established
Pharma Business Unit, PFIZER
2:30 PANEL: PAYER PERSPECTIVES ON THE EVOLVING HEALTHCARE
LANDSCAPE AND EFFECT ON PHARMACEUTICAL PRICING
Private payers throughout the US play a pivotal role in the healthcare system,
ensuring millions of individuals have access to healthcare. As the cost of
healthcare across the country has continued to rise, health insurers have
looked to support products with high levels of effectiveness, as well as prod-
ucts that have the ultimate levels of cost-effectiveness. With pharmaceuti-
cal and biotechnology companies increasingly developing more expensive,
niche products that serve unmet medical needs but carry higher prices, the
two industries have come to a cross-road and must work in tandem to con-
tinue serving patients across the country.
• Models for assessing pharmaceutical price v. effectiveness
• Review processes for new and existing product formularies
• Payer perspective on optimal dossier inclusions
Michael Paas, VP, Market Access & Pricing
REGENERON PHARMACEUTICALS
Rene Acker, R.Ph., Chief Operating Officer, MERIDIANRX
F. Michael White, PharmD, CSP, Director, Clinical Pharmacy Services,
Interim VP, BLUECROSS BLUE SHIELD TENNESSEE
Ed Pezalla, MD, MPH, National Medical Director for Pharmacy Policy and
Strategy, AETNA
Crystal Kuntz, VP Policy and Regulatory Affairs
AMERICA’S HEALTH INSURANCE PLANS (AHIP)
3:30 COFFEE & NETWORKING BREAK
4:00 PRICING COLLABORATION AND COHESION WITH PHARMACY
BENEFIT MANAGERS
For Pharmacy Benefit Managers (PBMs) throughout the nation, working with
pharmaceutical pricing executives is a crucial step in reducing the per capita
spend of clients enrolled in the varied programs supported by the PBM. Nego-
tiations are increasingly centered around product health benefits, and ensur-
ing funds directed to pharmaceutical therapies provide the highest possible
medical benefit. With rising prices across the specialty drug segment apply-
ing pressure across the entire system, it is more critical than ever to establish
strong working relationships between PBMs and life sciences corporations.
• Trends in the PBM market for the next several years
• Challenges caused by increasing pharmaceutical prices
• Establishing mutually beneficial partnerships
Rene Acker, R.Ph., Chief Operating Officer, MERIDIANRX
Kimberly Gwiazdzinski, Senior Director, Pharmaceutical Trade Relations
PRIME THERAPEUTICS
5:00 IMPACT OF BUNDLED PAYMENTS ON PHARMACEUTICAL
PRICING AND REIMBURSEMENT
As public and private payers continue to reduce the overall cost of care while
providing the most advantageous possible outcome, the growing trend of
utilizing bundled payments for treatment will continue. Bundled payments
are becoming increasingly prevalent, especially in light of the shift toward
integrated care, and bundled reimbursement methodologies provide hospi-
tals and healthcare professionals with an opportunity to bill per procedure
or episode-of-care -- rather than based on itemized costs. In order to react
to this emphasis on bundled payments, pharmaceutical pricing executives
must consider the impact of bundling when developing overall pricing and
contracting structures, and companies must grapple with the complex legal
and regulatory framework governing bundled sales arrangements.
• Overview of bundled payments in pharmaceutical and biotech industry
• Developing a bundled price and cost benefits for patients and providers
• Anti-Kickback Statute overview and discount “safe harbor”
• Current enforcement trends and performance-based rebates
Matthew Fornataro, Associate, ARNOLD & PORTER LLP
5:45 END OF DAY ONE
PHARMACEUTICAL STRATEGIC PRICING
DAY ONE | MONDAY, OCTOBER 5
500 N. DEARBORN STREET, SUITE 500 CHICAGO, IL 60654 (P) 312.822.8100 (F) 312.602.3834 www.q1productions.com
3. 500 N. DEARBORN STREET, SUITE 500 CHICAGO, IL 60654 (P) 312.822.8100 (F) 312.602.3834 www.q1productions.com
PHARMACEUTICAL STRATEGIC PRICING
DAY TWO | TUESDAY, OCTOBER 6
8:30 REGISTRATION & MORNING COFFEE
8:50 OPENING REMARKS
9:00 IMPACT OF STATE MEDICAID PROGRAMS ON
PHARMACEUTICAL PRICING STRATEGIES
Although much discussion surrounding pharmaceutical pricing is centered
on US Federal programs, there is increasing concern regarding individual
state Medicaid programs, especially in light of new coverage requirements
put into place through the Affordable Care Act. With some of the largest
states driving a high proportion of Medicaid utilization, it is important to un-
derstand the priorities and challenges faced at the state level in providing
cost-effective care. In a multi-part presentation, presenters will provide in-
sight into challenges with state Medicaid, followed by robust discussion with
the audience to answer questions and ensure clarification.
PART ONE: SHIFT OF STATE MEDICAID PATIENTS TO PRIVATE MAN-
AGED CARE
• State benefits of shifting patients to private managed care
• Impact of shifting patient base on pricing and formularies
• Preparing pricing strategies for state Medicare enrollees
J’Aime Conrod
National Director, Federal & Government Accounts, Market Access & Pricing
UCB
PART TWO: PANEL DISCUSSION: STATE-LEVEL MEDICAID
CHALLENGES
• Overview of significant state Medicaid programs
• Varied priorities based on population health and needs
• Budgetary constraints at the state Medicaid level
J’Aime Conrod
National Director, Federal & Government Accounts, Market Access & Pricing
UCB
Lisa McNair
Manager, Contracting and Reimbursement
INVIDIOR
10:30 COFFEE & NETWORKING BREAK
11:00 RISK SHARING, VALUE BASED, AND EXCLUSIVITY: TRENDS
WITHIN INNOVATIVE CONTRACTING TYPES
Ensuring product coverage and accessibility is essential for pricing teams
and as more high-cost products move up the pipeline, pricing leaders work
to develop innovative contracting types for these products that will be well-re-
ceived by private payers and managed care organizations. Unique contract-
ing types, such as risk sharing, value based and exclusivity agreements
may garner payer support and coverage of products, however they may be
challenging to implement due to legal restrictions, budgetary concerns, and
distribution of risk between both parties. This session will explore innovative
contracting types and the future growth of each contracting method and us-
ability for various therapeutic areas.
PART ONE: PANEL DISCUSSION ON VALUE BASED CONTRACTING
• Payer and managed care group preferences for a value-based contract
• Including clear and readable metrics on product value
• ACA impact on value-based contract usability
William Hillmer
Senior Director, Strategic Pricing & Contracts
MALLINCKRODT
Jennifer English
Director, Contracts & Pricing
ACORDA THERAPEUTICS
Jonathan Connell
Senior Counsel
BRISTOL MYERS SQUIBB
Kimberly Gwiazdzinski
Senior Director, Pharmaceutical Trade Relations
PRIME THERAPEUTICS
PART TWO: RISK SHARING AND EXCLUSIVITY AGREEMENTS
• Avoiding legal red tape to ensure that the contract moves forward
• Balancing the scale to ensure both parties truly share risk
• Advantages to utilizing an exclusivity agreement for new products
Trevor Wear
Partner
SIDLEY AUSTIN
12:30 LUNCHEON FOR ALL DELEGATE, SPEAKER AND SPONSOR
ATTENDEES
1:30 ENSURING COVERAGE OF SPECIALTY PHARMACEUTICALS
THROUGH EXCEPTIONAL CONTRACTS AND PRICING MODELS
With many pharmaceutical products in the pipeline targeted for rare diseas-
es, oncology and other specialty areas, pharmaceutical pricing teams are
tasked with balancing the return on investment for these products while en-
suring accessibility for patients. Understanding factors that are taken into
consideration by payers, such as patient outcomes, trial data, affordability
and risk, when deciding to cover a specialty product will help pricing leaders
better develop contractual agreements that provide usable information for
payers and pricing models that are mutually beneficial. As the development
of innovative and targeted therapies continues to grow, companies must
clarify the ways in which specialty products will be managed and covered in
order to develop sustainable pricing models for the future.
• Identifying usable contracting models for specialty products
• Predicting future trends of coverage in specialty pharma
• Pricing specialty pharmaceuticals to ensure product coverage
Juan Camilo Roman, Senior Director, Market Access
ABBVIE
2:15 REGULATORY ENVIRONMENT AND CONTRACTING TRENDS FOR
THE MEDICARE PART D PROGRAM
Through the implementation of the Affordable Care Act, Medicare Part D
has been greatly impacted as lowering drug costs for patients affects re-
bates and discounts expected. With more specialty products in the pipeline,
understanding the structure of specialty tier prices for Part D programs is
essential. This session will delve into current best practices in contracting
and pricing within the Medicare part D programs, identifying areas where
change may be imminent and enabling attendees to best prepare for upcom-
ing shifts in guidance.
• Reviewing proposed guidance: why it was revoked & what will be next
• Successful navigation of specialty tier pricing structures within Medicare
• Direct price negotiation with government groups vs managed care or PBMs
Anne Hance, Partner
MCDERMOTT, WILL & EMERY
3:00 COFFEE & NETWORKING BREAK
3:15 PANEL DISCUSSION: THE ROLE OF PRODUCT PRICING IN ACO
DECISION-MAKING
Based on provisions within the Affordable Care Act, Accountable Care Or-
ganizations have been tasked with the responsibility of lowering the overall
cost of treatment for patients while increasing the quality of care provided
to the general population. ACO executives must balance cost and quality
when deciding what products will be contracted and prescribed within their
hospitals and physician offices, prompting pharmaceutical pricing teams to
better understand the factors that are considered within these value analy-
sis discussions. This insightful panel discussion will provide attendees with
an inside look at how value analysis committees and ACO leadership evalu-
ate therapies based on pricing, product effectiveness and other elements.
William Hillmer Senior Director, Strategic Pricing & Contracts
MALLINCKRODT
Megan Woosley, Team Leader of Case Management
OWENSBORO HEALTH ACO
Matthew Fornataro, Associate
ARNOLD & PORTER LLP
4:00 PRICING CONSIDERATIONS FOR PHARMACEUTICAL PRODUCT
ACQUISITIONS
As pharma brands change ownership due to larger pharma re-focusing port-
folios and smaller pharma acquiring assets or consolidating, these brands
experience price decisions that impact commercial and government payers
in unplanned ways. These changes also require careful assessment, deci-
sion-making, planning, and implementation by the new pharma owner as
early as due diligence and far into the brand pricing lifecycle for successful
transition. Transition places at risk value position, market access, contin-
ued payer coverage, patient affordability, revenue stream, and government
reporting. Understanding, anticipating, and mitigating pricing risk in these
areas enable successful product transition or, for payers, insights into bal-
ancing continued access and costs.
• Assessing net price in due diligence
• Gauging strategic pricing opportunity in the competitive value mix
•Aligningpricingconsiderationswithpayercoverageandpatientaffordability
• Supporting product acquisition pricing through value and payer transition
• NDC pricing transition: rebate, chargeback and government reporting
Leonard Fairfield, Senior Director Pricing & Contracts
DEPOMED
4:45 CONCLUSION OF CONFERENCE ACTIVITIES
4. PHARMACEUTICAL STRATEGIC PRICING
OCTOBER 5-6, 2015 | PHILADELPHIA, PA
500 N. DEARBORN STREET, SUITE 500 CHICAGO, IL 60654 (P) 312.822.8100 (F) 312.602.3834 www.q1productions.com
Senior Manager, Strategic Pricing, ABBVIE
Director of Contracts and Pricing, ACORDA THERAPEUTICS
Vice President Patient & Market Access, AEGERION
Partner, ARTISAN HEALTHCARE CONSULTING
Senior Manager, Pricing & Contracting, AVANIR
Director, Managed Markets Marketing, AVANIR
Director, Global Market Access Strategies, BAXTER
Director of Strategic Pricing & Reimbursement, BAYER
Head, Strategic Pricing & Reimbursement, BAYER
Director, Business Strategies, BAYER
Director, BERKELEY RESEARCH GROUP
Associate Director of Managed Markets, BIOGEN IDEC
Associate Director, Sales Analysis, BMS
Market Access, BMS
Managed Care & Contracting, BMS
Director, Strategic Contracting & Analytics, BTG
Associate Pharmacy Director, CAREOREGON
Assoc. Dir. Global Pricing & Market Access, CELGENE
National Account Manager, CELGENE
Chief Commercial Officer, CLEMENTIA PHARMACEUTICALS
Senior Director, US Corporate Accounts, CSL BEHRING
Senior Manager of Government Programs, DAIICHI SANKYO
Associate Director, Strategic Pricing and Contracting, EISAI
Director, Pricing & Contracting, FERRING
Cross Portfolio Pricing & Contracting, GENENTECH
Senior Manager, Pricing & Contracting, GENENTECH
Director of Pricing & Contracting, HORIZON PHARMA
Associate Director, Payer & Trade Strategy, HYPERION
Vice President Customer Operations, IKARIA
Vice President of Payor & Pricing, IRONWOOD
Strategic Contract Management, JANSSEN
Director, National Accounts & Market Access, JANSSEN
Director, Offer Development, JOHNSON & JOHNSON
Director, Strategic Contracts, JOHNSON & JOHNSON
Senior Director, Managed Care & Trade Relations, MEDA
Director, Managed Markets, MEDAC PHARMA
Director of Pricing, ONYX PHARMACEUTICALS
Director of Payer Strategy, OTSUKA AMERICA
Director, Pricing; Home Healthcare, PHILIPS HEALTHCARE
Director, Marketing, PURDUE PHARMA
Director, Managed Markets Contracting, PURDUE PHARMA
Government Pricing, RB PHARMACEUTICALS
Director of Managed Markets, RECKITT BENCKISER
Senior DIrector, Contract Development & Analytics, SANOFI
Director, Managed Markets Analytics, SHIRE
Head, Contracts & Reporting, SHIRE
Senior Director, Contract Development & Analytics, SHIRE
Partner, SIDLEY AUSTIN LLP
Partner, SIMON-KUCHER & PARTNERS
Associate Director, Contract Development, SUNOVION
National Pricing Manager, TAKEDA PHARMACEUTICALS
Senior Director, Pricing & Contracting, TEVA
Associate Director, Contract Administration & Pricing, TEVA
US Head, Access & Reimbursement, THROMBOGENICS
National Account Executive, UCB PHARMA
National Account Manager, UNITED THERAPEUTICS
PREVIOUS ATTENDEES INCLUDE:
KEY SPEAKER HIGHLIGHT:
Professionals who have the most to gain from this program are those that de-
velop and manage pricing strategies and create contract agreements with pay-
ers and government agencies. Executives whose work is directly impacted by
the evolving healthcare market will find this program of great insight, including
Heads, Managers, Directors and Vice Presidents of:
• Pricing
• Pricing & Contracting
• Contracting
• Market Access
• Managed Markets
• Contract Development
At this time, there are a variety of sponsorship and exhibition opportunities
available for companies wishing to increase their visibility and participation in
the program, ranging from keynote speaking opportunities through to exhibitor
and documentation sponsors. Organizations most suitable for this type of expo-
sure on this program provide services and solutions including:
• Benchmarking
• Contract Management
• Forecasting
• Market Research
• Pharmaceutical Pricing Services
• Pricing Strategy Consultation
WHO SHOULD ATTEND:
SPONSORSHIP OPPORTUNITIES:
• Market Analytics
• National Accounts
John Alter
Vice President / Global Established Pharma
Business Unit Lead Global Health and Value
PFIZER INC
John Alter is currently VP Global Health & Value lead and member of the lead-
ership team of the Global Established Pharma Business Unit at Pfizer. Health
& Value functions include Pricing, Market Access, HEOR and Real World Data.
John joined Pfizer in 1998 and has held positions of increasing responsibilities
in several functions/divisions including Corporate Finance, Global Manufactur-
ing and Pharmaceutical Commercial Operations in North America, Latin Ameri-
ca, Europe, Africa, Middle East and Asia Pacific.
John earned his undergraduate degree from Villanova University and his MBA
from George Mason University and served as a U.S. Naval officer for six years
before joining industry. He is married with three children.