Rx Drug Pricing & Rebate Fundamentals

CHEVRON-RIGHT

Building Blocks for Success on the Job: A new, immersive virtual series for mastering the essentials of Rx drug pricing and rebates

EARN CLE/CPE CREDITS

Passport to Proficiency on

Rx Drug Pricing & Rebate Fundamentals Intensive training in essential pricing and rebate concepts, methodologies, and strategies for key government payor programs Medicaid • Medicare • PHS • VA • DOD CALENDAR-ALT November 10 to December 10, 2020

VIRTUAL SERIES

Your 1-Month Passport to Rx Drug Pricing and Rebate Proficiency: CALENDAR-ALT clock

4 weeks, 2x weekly

PENCIL-ALT

5 hours of in-depth instruction on the key terminology of and calculations for MDRP and Medicare Parts B and D

CALCULATOR

28 hours of interactive learning and professional development

6 hours of instruction on advanced and complex pricing and rebate scenarios

video 8 class recordings for future

Check AMP

Check CPIU

reference

Check AWP

Check ASP

lightbulb

4 Think Tank-style sessions on pricing and rebate considerations for new products

Check WAC

Check FCP

Check BP

Check FAMP and

Substantive resource materials for your daily work

File-Alt

MASTER key pricing and rebate concepts and their interrelation, including:

Certificate of completion + CLE credits

AmericanConference.com/Proficiency-DrugPricing • 888 224 2480

Check WAMP

non-FAMP

APPLY all you will learn through ACI's Exclusive LAB — Learn, Apply, and Benchmark Exercise on Drug Pricing and Reimbursement

Part of ACI’s PROFICIENCY SERIES

Master the essentials of key pricing and rebate concepts and methodologies Welcome to ACI’s Passport to Proficiency on Rx Drug Pricing and Rebate Fundamentals. We have designed this course to make you proficient in essential pricing and rebate concepts under Medicaid, Medicare, and other related government payor programs, including those under the auspices of PHS 340B, the VA, and DoD.

This intensive training program will give novices and experienced practitioners alike a thorough understanding of core pricing competencies and applicable changes in the reimbursement structures of key payor programs.

Gain exclusive and unparalleled access to an in-depth guide on navigating the legal and regulatory maze of prescription drug pricing and rebates.

ACI’s goal is to provide you with a live glossary of essential pricing terminology, in addition to updates on the recent Proposed Rule and Executive Orders affecting drug pricing and reimbursement under the Medicaid and Medicare programs. We will provide a complete course of study for foundational elements, as well as a strategy guide for tackling complex challenges that will benefit the industry novice and the veteran.

Let us help you master the basics and prepare for the complexities.

We will meet each Tuesday and Thursday afternoon over the course of four weeks and examine:

WEEK 1 Nov. 10 & 12

WEEK 2 Nov. 17 & 19

WEEK 3 Dec. 1 & 3

WEEK 4 Dec. 8 & 10

Drug Pricing and Rebate Essentials and Introduction to Medicaid

Medicare Pricing and Rebate Essentials and Advanced CMS Pricing and Rebate Topics

PHS 340 B, VA and DoD Rx Pricing and Rebates

Pricing and Reimbursement for New Products and Therapies

We will help you: Angle-Right Adopt a holistic view of key pricing and rebate concepts and methodologies Angle-Right Understand how pricing and rebate terms and calculations intersect, how they are related, and how they may be impacted by new regulations and policy initiatives Angle-Right Ensure comprehension of essential concepts and their application to more complex scenarios A renowned faculty of experienced counsel and consultants will present these key concepts to ensure you have a well-rounded understanding of the current pricing and rebate environment. Built in networking breaks and Q&A sessions in our new interactive virtual platform will also allow for you to benchmark with colleagues to confirm that best practices are in place.

Register now to ensure you don't miss this unique and important course.

2|

BUSINESS INFORMATION IN A GLOBAL CONTEXT #DrugPricingProficiency twitter: @ACI_Pharma

linkedin: ACI: Pharmaceuticals / Biotech / Medical Device – Legal, Regulatory, IP and Compliance Professionals

Learn from a Renowned Faculty of Masters in Rx Drug Pricing and Rebates Trevor Wear Partner Sidley Austin LLP (Chicago, IL) Constance Wilkinson Member Epstein Becker & Green PC (Washington, DC) Robert Hill Partner Reed Smith LLP (Washington, DC) Pamela Politis Executive Director – U.S. Legal Incyte Corporation (Wilmington, DE) Andrew Ruskin Partner K&L Gates (Washington, DC) Stephanie Trunk Partner Arent Fox LLP (Washington, DC) Judith Waltz Partner Foley & Lardner LLP (San Francisco, CA) Lorraine Campos Partner Crowell & Moring LLP (Washington, DC) Merle DeLancey Partner Blank Rome LLP (Washington, DC) Elizabeth Lindquist Partner King & Spalding LLP (Denver, CO) Christopher Schott Partner Hogan Lovells US LLP (Washington, DC) William von Oehsen Partner Powers Pyles Sutter & Verville PC (Washington, DC)

Christopher Jackson Managing Member The Law Office of Christopher S. Jackson LLC (Whitehouse Station, NJ) Nneka Onwudiwe Former PRO-PE Regulatory Review Officer U.S. Food and Drug Administration (Silver Spring, MD) Jennifer Razor Founder Razor Legal Solutions (Chicago, IL) Keren Tenenbaum VP and Assistant General Counsel, Head of Legal, Salix Bausch Health Companies Inc. (Bridgewater, NJ) Allan Thoen Partner Troutman Pepper (Philadelphia, PA) Partha Chatterjee Partner Akara Group LLC (Morristown, NJ) James Kim Partner McDermott Will and Emery (Washington, DC) Jesse Mendelsohn Vice President Model N (Chicago, IL) Cheryl Nagowski Vice President & Head - Federal Markets D2 Consulting (Burlington, MA) Gregory Madden Managing Member Orlaithe Consulting LLC (Aurora, IL)

This Rx Drug Pricing and Rebate Proficiency Series is for: PHARMACEUTICAL COMPANIES • Corporate Counsel/General Counsel • Vice Presidents, Officers, Directors and Managers for: - Pricing, Pricing Strategy, Pricing Analytics - Contracts and Reimbursement - Managed Markets - Managed Care - Government Programs - Medicaid/Medicare Rebates - Finance/Accounting/Audit - Government Affairs • Compliance Officers LAW FIRMS • Attorneys with practice areas in: - Government Contracts and Managed Markets - Pharmaceuticals - Healthcare - Food & Drug PBMs • Corporate Counsel/General Counsel • Vice Presidents, Officers, Directors and Managers for: - Contract Management - Network Pharmacy - Retail Pharmacy Operations - Government Programs - Pricing and Operations - Clinical Operations - Industry Relations GOVERNMENT AFFAIRS • Financial Analysts PHARMACIES

Real-Life Benefits of Attending: CHEVRON-RIGHT UNDERSTAND how price is established and how the rebate system works CHEVRON-RIGHT DEFINE key pricing terms under Medicaid, Medicare, PHS 340 and other key government payor programs

• Corporate Counsel/General Counsel

• Vice Presidents, Officers, Directors and Managers for:

- Pricing - Business Development

CHEVRON-RIGHT MAKE sense of confusing pricing calculations

PLANS

CHEVRON-RIGHT MASTER key pricing and rebate concepts under the main government payor programs and their interrelation, including:

• Corporate Counsel/General Counsel

Check AMP

Check BP

Check ASP

Check AWP

Check WAMP

Check FCP

Check WAC

Check CPIU

Check FAMP and non-FAMP

CHEVRON-RIGHT TACKLE pricing and rebate complexities that go beyond the essentials

• Vice Presidents, Officers, Directors and Managers for: - Pharmacy Networks - Pharmaceutical Contracting - Clinical - Pharmacy Services

CHEVRON-RIGHT COMPREHEND pricing strategies for new products and therapies

AmericanConference.com/Proficiency-DrugPricing • 888 224 2480

Part of ACI’s PROFICIENCY SERIES

WEEK 1: Drug Pricing and Rebate Essentials and Introduction to Medicaid Tuesday, November 10 • Eastern Standard Time Trevor Wear Partner Sidley Austin LLP (Chicago, IL)

Partha Chatterjee Partner Akara Group LLC (Morristown, NJ)

Constance Wilkinson Member Epstein Becker & Green PC (Washington, DC)

1:00

Analysis of the National Rebate Agreement and the Mechanics of the Rx Drug Rebate System The Medicaid Drug Rebate Program (MDRP) is a program that requires a drug manufacturer to enter into, and have in effect, a national rebate agreement with the Secretary of the Department of Health and Human Services (HHS) in exchange for state Medicaid coverage of most of the manufacturer’s drugs.…

Manufacturers are required to report all covered outpatient drugs under their labeler code to the MDRP. Manufacturers may not be selective in reporting their National Drug Code's (NDC) to the program. Manufacturers are then responsible for paying a rebate on those drugs for which payment was made under the state plan. These rebates are paid by drug manufacturers on a quarterly basis to states and are shared between the states and the Federal government to offset the overall cost of prescription drugs under the Medicaid Program.

In addition to signing a national rebate agreement, drug manufacturers are required to enter into agreements with two other Federal programs in order to have their drugs covered under Medicaid: a pricing agreement for the Section 340B Drug Pricing Program, administered by the Health Resources and Services Administration, and a master agreement with the Secretary of Veterans Affairs for the Federal Supply Schedule.

– Medicaid Drug Rebate Program, cms.gov

The National Rebate Agreement • Understanding the agreement’s terms and purpose • What is required to participate in the agreement?

• Why is participation in the Medicaid outpatient drug program contingent on participation in the PHS 340B and VA programs?

• How is the PHS program linked to Medicaid?

• What relation does the agreement have to the Medicare Drug benefit? (i.e., Medicare Part D)

Mechanics of the Rx Drug Rebate System • Survey of applicable drug pricing legislation such as the MMA, DRA, and ACA • Overview of Medicaid, Medicare, and PHS Programs relative to prescription drug coverage • How is price established?

• How does the rebate system work?

• Under which of the payor systems are rebates available? » Medicare

» PHS

» Medicaid

» VA

» DOD

2:10

AWP (Average Wholesale Price) and WAC (Wholesale Acquisition Cost): What You Need to Know • How is AWP calculated?

• When is AWP still used?

• Defining the relationship between AWP and WAC » What are their roles in the calculation of Medicaid Rebates?

• What is included in WAC, and when?

2:30

Break

3:00

Medicaid Pricing and Rebate 1.0: Key Terminology • Analysis of the Medicaid rebate system’s components: » Reimbursements vs. volume discounts º What are they?

» How are the calculations different for generic products?

• AMP: what is it and how is it calculated? » What are the variables in AMP price calculation?

º When is each used?

• URA: what is it and how is it calculated?

º To whom are they given?

• Status of additional rebate under CPIU

• Medicaid Rebate terminology: Best Price; AMP » Defining “retail community pharmacy” class of trade (COT) for AMP calculations • Best Price: what is it and how is it calculated?

• Is there a nominal price exception to the reporting requirements under Medicaid? » How is this exception determined?

• What is the overall effect of nominal pricing on the rebate system?

4:00

Recap and Q & A 4:30

4|

End of Tuesday Session

BUSINESS INFORMATION IN A GLOBAL CONTEXT #DrugPricingProficiency twitter: @ACI_Pharma

linkedin: ACI: Pharmaceuticals / Biotech / Medical Device – Legal, Regulatory, IP and Compliance Professionals

WEEK 1: Drug Pricing and Rebate Essentials and Introduction to Medicaid Thursday, November 12 • Eastern Standard Time 1:00

Medicaid Pricing and Rebate 2.0: Complexities and Challenges • Validating transactional data » Ensuring the completeness of direct sales, indirect sales, price concession (rebates, discounts, etc.), fee, returns, and adjustment data • Analyzing AMP and BP included and excluded transaction types

» Patient transactions — coupons, vouchers and patient assistance programs » Sales at nominal prices » Invoice adjustments: Returns, price corrections and order corrections

» Customary Prompt Pay Discounts (CPPD)

• Understanding what constitutes a bundle arrangement and developing an unbundling methodology

» Chargebacks

• Developing a smoothing methodology for lagged price concessions

» Commercial rebates — when and how included?

• Employing the 5(i) alternate AMP calculation

» Rebates for drugs reimbursed through federal government programs

• AMP calculation for non-5(i) products not generally sold to the retail community pharmacy COT

» Rebates for drugs reimbursed through SPAPs » Manufacturer coupons, vouchers and Patient Assistance Programs (PAPs) » Free goods — same product, other Medicaid product, and other items

• Calculating AMP for Authorized Generics (AGs) AMP and URA calculations for line extension products » Accounting for the entry of authorized generics and biosimilars

1:45

Analysis of Key Aspects of The CMS’ MDRP Proposed Rule The panel will discuss and analyze those aspects of CMS’ June 2020 MDRP proposed rule that are likely to have the greatest impact if finalized. Highlights will include the background for these proposals, the challenges which they present, and how these proposals might affect price reporting and business operations.

Among the topics covered will be those proposals aimed at: • PBM accumulator programs, • Value-based purchasing arrangements, • Line extensions, and • Authorized generics

2:45

Break

3:15

What You Should Know About State Drug Transparency Laws This session will explore the rise of state transparency laws across the country and how they are working in conjunction with government payor programs.

• Identifying states with current and pending drug pricing transparency laws » Manufacturer notifications and justifications requirements from the manufacturer • Addressing challenges with and finding solutions for reporting under non-uniform and sometimes conflicting state laws

» Can a state request supplemental rebates within these models? » If the rebate is denied, can the state exclude the drug from Medicaid coverage?

• Developing a system to keep track of these laws as well as a compliance program to address them • Impact of transparency laws on Medicaid pricing

4:00

Recap and Q & A 4:30

End of Thursday Session

About us:

BUSINESS INFORMATION IN A GLOBAL CONTEXT The C5 Group, comprising American Conference Institute, The Canadian Institute and C5 in Europe, is a leading global events and business intelligence company.

For over 35 years, C5 Group has provided the opportunities that bring together business leaders, professionals and international experts from around the world to learn, meet, network and make the contacts that create the opportunities.

Our new Proficiency Series continues to be guided by our unifying philosophy: we believe that growth and success occur when the power of people and the power of information come together.

AmericanConference.com/Proficiency-DrugPricing • 888 224 2480

Part of ACI’s PROFICIENCY SERIES

WEEK 2: Medicare Pricing and Rebate Essentials and Advanced CMS Pricing and Rebate Topics Tuesday, November 17 • Eastern Standard Time Robert Hill Partner Reed Smith LLP (Washington, DC)

Andrew Ruskin Partner K&L Gates (Washington, DC)

Pamela Politis Executive Director – U.S. Legal Incyte Corporation (Wilmington, DE)

Stephanie Trunk Partner Arent Fox LLP (Washington, DC)

Judith Waltz Partner Foley & Lardner LLP (San Francisco, CA) Constance Wilkinson Member Epstein Becker & Green PC (Washington, DC)

1:00

Medicare Part B: Coverage and Pricing Essentials • Identifying drug coverages under Medicare Part B • Understanding Part B pricing methodologies, coverage and coding

» Patient assistance • Submission of ASP data: timing

» Average Sales Price (ASP) » Recognizing the differences in coverage, pricing and coding among various outpatient settings • Calculation of ASP

» OIG and state AG efforts to obtain data » How late filed ASPs are dealt with when calculations are done?

• Bundling

» Inclusions and exclusions

• Special concerns for radiopharmaceuticals

» Exempt and non-exempt sales

• Reimbursement of biosimilars under Part B

» Smoothing

» Managing coding protocols and a hybrid payment model

» The three-quarter lag 2:15

» Free goods

Break

2:45

Medicare Part D: Coverages and Rebate Contracting Essentials • Identifying formulary and coverage requirements under Part D • Developing rebate contracting strategies under Part D • Understanding the mechanics of Part D

• Assessing CGDP payment disputes • Conducting CGDP audits

» Implications of the Part D benefit structure » What subsidies and payments do Part D plans receive?

• Evaluating 340B duplicate discounts and new manufacturer approaches • Addressing Part D fraud and abuse concerns

• Understanding requirements under the Part D Coverage Gap Discount Program (CGDP)

• Anticipating potential legislative and regulatory changes » Replacing rebates with point-of-sale discounts » Changes to the Part D benefit and mandatory manufacturer discounts

4:00

Recap and Q & A 4:30

End of Tuesday Session

HANDSHAKE Global Sponsorship Opportunities

With conferences in the United States, Europe, Asia Pacific, and Latin America, the C5 Group of Companies: American Conference Institute, The Canadian Institute, and C5 Group, provides a diverse portfolio of conferences, events and roundtables devoted to providing business intelligence to senior decision makers responding to challenges around the world.

Don’t miss the opportunity to maximize participation or showcase your organization’s services and talent. For more information please contact us at: SponsorInfo@AmericanConference.com

6|

BUSINESS INFORMATION IN A GLOBAL CONTEXT #DrugPricingProficiency twitter: @ACI_Pharma

linkedin: ACI: Pharmaceuticals / Biotech / Medical Device – Legal, Regulatory, IP and Compliance Professionals

WEEK 2: Medicare Pricing and Rebate Essentials and Advanced CMS Pricing and RebateTopics Thursday, November 19 • Eastern Standard Time 1:00

Understanding How Co-Pay Coupons, Accelerators, and Maximizers Impact Medicaid and Medicare Pricing and Rebates • Defining coupons, accelerators and maximizers and examining their similarities and differences » How are the parameters for such discount mechanisms set?

• Reviewing these mechanisms as a whole and understanding how they are affecting Medicare and Medicaid pricing » In what ways do these mechanisms impact out of pocket expenses? » How do they relate to the Medicare “donut hole”?

• How do these mechanisms affect patients in the public payor realm

• What are the types of pharmaceuticals and biologics sold under these mechanisms?

• How do these mechanisms s effect specialty products?

• Reviewing recent litigation surrounding the use of co-pay coupons • Examining the HHS blueprint as to whether coupons are considered a discount » Can the removal of safe harbors be considered in the future relative to these mechanisms?

• Exploring the process for working with a coupon vendor 2:00

Break

2:30

Post-Election Analysis: New Legislative, Regulatory and Enforcement Trajectories for Drug Manufacturers Under a New Administration On July 24th, President Trump signed four Executive Orders aimed at lowering drug prices. Four months later, on November 7th, Joe Biden was declared the winner of the presidential election vowing to undo all executive orders signed by the soon-to-be former president. This panel will analyze what the Biden administration will mean for the pharmaceutical industry from a legislative, regulatory and enforcement perspective. The discussion will touch on trends seen thus far and what the trajectory looks like going forward in an administration that may face roadblocks pushing legislation through Congress given the uncertainty surrounding the makeup of the Senate.

3:30

Medicaid/Medicare Recap and Q & A 4:30

End of Thursday Session

quote-left Excellent and very capable list of speakers.

Not always this good and comprehensive at other programs. quote-right – VP, Us Commercial Legal Lundbeck LLC

AmericanConference.com/Proficiency-DrugPricing • 888 224 2480

Part of ACI’s PROFICIENCY SERIES

WEEK 3: PHS 340 B, VA, and DoD Rx Pricing and Rebates Tuesday, December 1 • Eastern Standard Time Lorraine Campos Partner Crowell & Moring LLP (Washington, DC)

Christopher Schott Partner Hogan Lovells US LLP (Washington, DC)

Merle DeLancey Partner Blank Rome LLP (Washington, DC)

William von Oehsen Partner Powers Pyles Sutter & Verville PC (Washington, DC)

Elizabeth Lindquist Partner King & Spalding LLP (Denver, CO)

James Kim Partner McDermott Will and Emery (Washington, DC)

Trevor Wear Partner Sidley Austin LLP (Chicago, IL) Andrew Ruskin Partner K&L Gates (Washington, DC) Cheryl Nagowski Vice President & Head – Federal Markets D2 Consulting (Burlington, MA) Gregory Madden Managing Member Orlaithe Consulting LLC (Aurora, IL)

1:00

PHS 340B 1.0 – Introduction to the 340B Program and the Link to Medicaid Rebate • Understand the fundamentals of the 340B program, including program background, rationale, and operation • Introduction to the key stakeholders and their obligations and contributions under the program: » Which “covered entities” are entitled to the 340B ceiling price, and what are their related compliance obligations? » What are the obligations of participating manufacturers?

• Links to the Medicaid drug rebate program: » Calculation of the 340B ceiling price » “Covered outpatient drug” definition » Duplicate discount prohibition • Contract pharmacies and the replenishment model • Orphan drug exclusion

» What role do wholesalers play?

2:00

PHS 340B 2.0 • Examining continuing reimbursement cuts to 340B hospitals and understanding how this impacts manufacturers

• Restrictions for participating covered entities

• Analyzing important amendments to PHS 340B under the CMP final rule and how they affected pricing and rebates

• Exploring HRSA’s limited authority to enforce the 340B program

» Penny pricing » Distribution systems » Calculation of the 340B price • Validating the eligibility of purchasers • Developing best practices for monitoring HRSA data • Distinguishing 340B sales from non-340B sales made to entities that fill both types of prescriptions » What data sources can manufacturers look to when attempting to make these distinctions?

3:15

» The anti-diversion provisions • Examining manufacturers’ obligation, or lack thereof, to offer 340B pricing on drugs dispensed by contract pharmacies • Protecting against duplicate discounts • Assessing the pros and cons of turning 340B into a rebate program • Examining current trends and updates on recent developments and whether agency guidance is enforceable • Reassessing covered entities under the Genesis case • Evaluating the likelihood of future government audits of covered entities • Contract pharmacy

Break

3:30

LAB — Learn, Apply, and Benchmark: Pricing and Rebate Exercise Under Medicaid, Medicare, and 340B This hands-on session will draw from hypothetical examples to show how the pricing and reimbursement concepts you have just learned about fit together in the real world.

4:30

8|

End of Tuesday Session

BUSINESS INFORMATION IN A GLOBAL CONTEXT #DrugPricingProficiency twitter: @ACI_Pharma

linkedin: ACI: Pharmaceuticals / Biotech / Medical Device – Legal, Regulatory, IP and Compliance Professionals

WEEK 3: PHS 340 B, VA and DoD Rx Pricing and Rebates Thursday, December 3 • Eastern Standard Time 1:00

A Guide to the Essentials of FSS Contracting for Pharmaceuticals with the VA and DOD » How do you calculate the FSS price from non-FAMP?

• Examining overall obligations when contracting with the federal government with respect to: » General Services Administration (GSA) Federal Supply Schedule (FSS): what are the requirements? » VA (Veteran’s Affairs)/ DOD (Department of Defense) » Tricare

» Which entities are eligible?

• Modifying the FSS contract to incorporate 2021 pricing updates for covered products • Resolving open disputes » Getting Non-FAMP methodology changes approved by VA

» PHS – 340B

» Requesting FCP relief

• Understanding the significance of bifurcated tracks and when they are used

» Proposing appropriate 2021 pricing » Finalizing the paperwork with VA

• How is non-FAMP (non-Federal Average Manufacturer Price) calculated?

2:15

Break

2:45

Advanced Pricing and Contracting – National Contracts National Contract Overview

• Key Requirements / Pre and Post award

• Program introduction

» FCP cap

• Current scope of drug standardization

» TAA considerations

• Future opportunities - VA program goals

» Supply issues

Operational Considerations • National Contract Roadmap

» Prime Vendor participation » Price changes

» Candidates for drug standardization

Strategic Considerations

» Solicitation Process

• Risks & Best Practices

» Evaluation Process

• Analogs of Success

» Award

• FAQ

» Timeline » Termination / Renewal 4:15

Recap and Q & A 4:45

End of Thursday Session

quote-left All encompassing overview of government program and current issues. quote-right – Director of Pricing and Contracts Horizon Pharmaceuticals

AmericanConference.com/Proficiency-DrugPricing • 888 224 2480

Part of ACI’s PROFICIENCY SERIES

WEEK 4: Pricing and Reimbursement for New Products and Therapies Tuesday, December 8 • Eastern Standard Time Christopher Jackson Managing Member The Law Office of Christopher S. Jackson LLC (Whitehouse Station, NJ) Nneka Onwudiwe Former PRO-PE Regulatory Review Officer U.S. Food and Drug Administration (Silver Spring, MD)

Jennifer Razor Founder Razor Legal Solutions (Chicago, IL)

Allan Thoen Partner Troutman Pepper (Philadelphia, PA)

Keren Tenenbaum VP and Assistant General Counsel, Head of Legal, Salix Bausch Health Companies Inc. (Bridgewater, NJ)

Jesse Mendelsohn Vice President Model N (Chicago, IL)

1:00

Will Your Product Be Eligible for Reimbursement?: Pre-Commercialization Concerns in New Therapeutic Development New considerations: • Understanding the distinction between FDA approval and commercial viability • Planning to secure appropriate coding, coverage and reimbursement for new products

• What regulatory and commercial impediments are preventing these companies from pursuing the development of the desired product? » will the product/technology be covered through government payor/ pricing methodologies?

2:15

Break

2:45

New Product Launch – Government Pricing and Contracting Considerations • Procedural approaches to set a launch price for a new drug

• Assessing the competition landscape and articulating a compelling value composition

• Understanding the role of the pricing committee

Questions to ask now:

• Ensuring transparency for the pricing process

• When should you start talking to payors about coding, coverage and reimbursement?

• Considering the role of traditional and non-traditional functions in setting price

• What are the limitations on discussing coding, coverage, and reimbursement with prescribers?

• How can you compliantly market a new product in light of those restrictions?

• What types of products are drug, biotech, and biopharmaceutical companies seeking to develop now and why?

• Involving leadership in pricing sign off

• Accessing government programs 4:00

Recap and Q & A 4:30

End of Tuesday Session

Thursday, December 10 • Eastern Standard Time 1:00

3:00

From Value of Therapy to Value Proposition: Sources and Uses of Pricing Data in Prescription Drug Advertising and Promotion

Delving Deeper into Critical Drug Pricing-Related Pre-Launch Considerations

• Understanding key variables in the determination of value to key stakeholders

This session will cover the many pre-launch drug pricing related considerations that can either help smooth the path to a successful launch or cause ongoing challenges. In particular, this session will address the role the following elements play in drug pricing:

• What is a value proposition?

• Approval pathway

• Targeted patient population

• Identifying databases of pharmaceutical benchmark prices for economic analyses

• Dosage form

• Likely customer type(s) and channel partners

• How to communicate in advertising and promotion why your medical product is worth paying for in quantitative terms – a regulatory perspective

• Billing codes

• Communicating value to different audiences and related considerations 2:30

Break

• Unit of measure • Payor program (dis)alignment 4:00

Recap and Q & A 4:30

10 |

• Possible channel partners

End of Thursday Session and Series

BUSINESS INFORMATION IN A GLOBAL CONTEXT #DrugPricingProficiency twitter: @ACI_Pharma linkedin: ACI: Pharmaceuticals / Biotech / Medical Device – Legal, Regulatory, IP and Compliance Professionals

Past Rx Drug Pricing and Rebates attendees came from: • Alkermes

• EnvisionRx

• Lowenstein Sandler

• Sanofi

• Almirall SA

• Epstein Becker & Green PC

• Scilex Pharmaceuticals Inc

• Analysis Group

• Genfit

• McDermott Will & Emery LLP

• Ani Pharmaceuticals Inc

• Greenwich Biosciences

• Arent Fox LLP

• Grifols

• Astellas Pharma Inc

• Hercules Pharmaceuticals Inc

• Bristol-Myers Squibb Company

• Hyman Phelps & McNamara PC

• Buchanan Ingersoll & Rooney PC

• Incyte Corporation

• CSL Behring • DRUGHUB

EARN CLE CREDITS

• Office of the US Attorney

• Theravance

• Otsuka Pharmaceutical

• Tolmar Pharmaceuticals Inc

• PhillyCooke Consulting

• UCB Inc

• Invictus Pharmacy

• Ropes & Gray LLP

• King & Spalding

• R-Pharm US

• US Attorney's Office for the District of Massachusetts

Continuing Professional Education Credits

ACI certifies this activity has been approved for CLE credit by the New York State Continuing Legal Education Board.

ACI certifies this activity has been approved for CLE credit by the State Bar of California.

ACI has a dedicated team which processes requests for state approval. Please note that event accreditation varies by state and ACI will make every effort to process your request.

To learn more about how to apply, please visit www.AmericanConference.com/accreditation-instructionsfor-virtual-attendance/ or email ACI-CLE@AmericanConference.com for further information.

American Conference Institute (ACI) will apply for Continuing Professional Education credits for all conference attendees who request credit. There are no pre-requisites and advance preparation is not required to attend this conference.

Course objective: Instruction on pricing and rebates for pharmaceutical products for the Medicare, Medicaid, PHS, VA, and DoD programs. Prerequisite: None. Level of knowledge: Beginner/Intermediate. Teaching Method: Group-live. Advanced Preparation: None. Delivery method: Group-live presented online due to COVID-19.

Please refer to the information in this brochure for outline, course content and objectives. Final approval of a course for CPE credits belongs with each states’ regulatory board. Recommended CPE Credit: 11/10–11/17 & 12/3–12/10: 3.0 CPE; 11/19: 2.0 CPE; 12/01: 3.50 CPE ACI is registered with the National Association of State Boards of Accountancy (NASBA) as a sponsor of continuing professional education on the National Registry of CPE Sponsors. State boards of accountancy have final authority on the acceptance of individual courses for CPE credit. Complaints regarding registered sponsors may be addressed to the National Registry of CPE Sponsors, 150 Fourth Avenue North, Suite 700, Nashville, TN, 37219-2417 or by visiting the web site: www.learningmarket.org.

ONLINE:

AmericanConference.com/Proficiency-DrugPricing

All Inclusive (4 weeks, 2x weekly)

• Therapeuticsmd

• Reed Smith LLP

Accreditation will be sought in those jurisdictions requested by the registrants which have continuing education requirements.

This course is identified as nontransitional for the purposes of CLE accreditation.

PRICING

• Sunovion Pharmaceuticals Inc

• U.S. Department of Health and Human Services

Continuing Legal Education Credits

3 Ways to Register 

• Morgan Lewis & Bockius LLP

• Sidley Austin LLP

• PhRMA

• Intercept Pharmaceuticals Inc

• Covington & Burling LLP

• MN Department of Administration



EMAIL:



CustomerService@AmericanConference.com

Register & Pay by October 9, 2020

Register & Pay by November 2, 2020

Register & Pay after November 2, 2020

$1595

$1695

$1795

PHONE:

1-888-224-2480

REGISTRATION CODE:

B00-124-124L21.WEB CONFERENCE CODE:

124L21-VRT

Bringing a Team?

All program participants will receive an online link to access the conference materials as part of their registration fee.

Additional copies of the Conference Materials available for $199 per copy.

To update your contact information and preferences, please visit https://www.AmericanConference.com/preference-center/.

Refund and cancellation policies can be found at https://AmericanConference.com/company/faq/.

© American Conference Institute, 2020

3-4

10% Conference Discount

5+

Call 888-224-2480

Special Discount

ACI offers financial scholarships for government employees, judges, law students, non-profit entities and others. For more information, please email or call customer service.

C5 GROUP’S VIRTUAL EVENTS

Re-imagining the way we deliver professional development Collaboration is more vital than ever and for that, you can still rely on ACI to bring the industry together but in a different way. We are transforming quickly to ensure you can now connect virtually and continue to gain unparalleled access to market leading intelligence and to the facilitation of a global exchange of expertise.

Our new virtual events continue to be guided by our unifying philosophy: we believe that growth and success occurs when the power of people and the power of information come together. We may not be able to gather in person, but nothing stops connection and innovation.

What you can expect at this virtual series This new virtual series delivers the same access to a community of industry leaders we have spent decades building and nurturing. We invite you to be part of this community.

PLAY VIEW DEMO

Expand your network to a global audience.

Immerse yourself in live presentations, panel discussions, specialized breakout sessions and networking opportunities.

Engage in meaningful dialogue with attendees and speakers in an interactive format.

Meet 1-on-1 with attendees you select and exchange contact information for lasting connections and true engagement.

To view the complete list of our events, please visit:

Visit solution providers and learn about the latest technologies, services and products.

PIGGY-BANK

Eliminate the costs and stress of travel.

Hand-holding-seedling

Reduce waste and carbon footprint through this environmentally friendly platform.

AmericanConference.com/conferences/proficiency/