Passport to Proficiency on RX Drug Pricing & Rebate Fundamentals - WEB by C5Group

Part of ACI’s PROFICIENCY SERIESRegister Now AmericanConference.com/Proficiency-DrugPricing • 888 224 2480 Rx Drug Pricing & Rebate Fundamentals Intensive training in essential pricing and rebate concepts, methodologies, and strategies for key government payor programs Medicaid • Medicare • PHS 340B • VA • DOD CALENDAR-ALT November 1 to December 1, 2022 VIRTUAL SERIES EARN CLE/CPE CREDITS Passport to Proficiency on Your 1-Month Passport to Rx Drug Pricing and Rebate Proficiency: CALENDAR-ALT 4 weeks, 2x weekly clock 28 hours of interactive learning PENCIL-ALT 6+ hours of instruction on advanced and complex pricing and rebate scenarios video Class recordings for future reference lightbulb Practical sessions on pricing and rebate considerations for new products File-Alt Substantive resource materials for your daily work Certificate of completion + CLE credits MASTER key pricing and rebate concepts and how they are applied including: Check AMP Check AWP Check WAC Check BP Check WAMP Check CPIU Check ASP Check FCP Check FAMP and non-FAMP APPLY all you will learn through ACI's Exclusive LAB — Learn, Apply, and Benchmark Exercise on Drug Pricing and Reimbursement

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, as well as analysis of the latest developments affecting Rx drug pricing and rebates including the CMS final rule on MDRP, actions on PHS 340B pricing and co-pays and more…

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:

This intensive training program will

MAKE

EXAMINE

COMPREHEND

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

help you: UNDERSTAND how price is established and how the rebate system works DEFINE key pricing terms under Medicaid, Medicare, PHS 340B and other key government payor programs

sense of complex pricing and rebate calculations that go beyond the essentials

the latest developments impacting the drug pricing and rebate programs, from the CMS final rule on MDRP and 340 B litigation to the most favored nation model and more…

pricing strategies and key considerations for new products and therapies

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.

now to ensure you don't miss this unique and important course. WEEK 1 Nov. 1 & 3 • Rx Drug Pricing and Rebate Essentials and Introduction to Medicaid WEEK 2 Nov. 8 & 10 • Medicare Pricing and Rebate Essentials • VA and DOD Rx Pricing and Rebates WEEK 3 Nov. 15 & 17 • PHS 340B • Advanced CMS Pricing and Rebate Topics WEEK 4 Nov. 29 & Dec. 1 • Pricing and Reimbursement for New Products and Therapies

Fast Track Your Learning with Guidance from a Renowned Faculty of Masters in Rx Drug Pricing and Rebates

Craig Bleifer Principal

Akin Gump Strauss Hauer & Feld LLP (New York, NY)

Merle Delancey Partner

Blank Rome LLP (Washington, DC)

Stefanie Doebler Partner

Covington & Burling LLP (Washington, DC)

Margaux Hall Partner

Ropes & Gray LLP (Washington, DC)

Christopher Jackson Managing Member

The Law Office of Christopher S. Jackson LLC (Stanton, NJ)

Brett Kelly

Senior Director Contract Operations and Pricing Strategy

Vifor Pharma (Redwood City, CA)

Dennis Kim Senior Engagement Manager

Syneos Health Consulting (New York, NY)

James Kim Partner

Arnold & Porter LLP (Washington, DC)

Annamarie Lee Director Advisory Services IntegriChain (Philadelphia, PA)

Partha Chatterjee Partner

Akara Group LLC (Morristown, NJ)

Miree Lee Principal M. Lee Consulting LLC (Scottsdale, AZ)

This Rx Drug Pricing and Rebate Proficiency Series is for:

Jennifer Lospinoso

Managing Director & Consulting Lead Riparian LLC (New York, NY)

Andrew Ruskin Partner

K & L Gates LLP (Washington, DC)

Christopher Schott Partner

Latham and Watkins LLP (Washington, DC)

T. Reed Stephens Partner

Winston & Strawn LLP (Washington, DC)

Joy Sturm Partner

Hogan Lovells (Washington, DC)

Keren Tenenbaum

VP, Assistant General Counsel Vifor Pharma (Redwood City, CA)

Stephanie Trunk Partner

Arent Fox LLP (Washington, DC)

Trevor Wear Partner

Sidley Austin LLP (Chicago, IL)

Melissa Wong Partner

Holland & Knight LLP (Boston, MA)

Robert Hill Partner

Reed Smith LLP (Washington, DC)

Judith Waltz Partner

Foley & Lardner LLP (San Francisco, CA)

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

• Corporate Counsel/General Counsel

• Vice Presidents, Officers, Directors and Managers for:

- Pricing - Business Development

PLANS

• Corporate Counsel/General Counsel

• Vice Presidents, Officers, Directors and Managers for:

- Pharmacy Networks

- Pharmaceutical Contracting

- Clinical - Pharmacy Services

Part of ACI’s PROFICIENCY SERIESRegister Now AmericanConference.com/Proficiency-DrugPricing • 888 224 2480

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

Drug Pricing and Rebate Essentials and Introduction to Medicaid

Analysis of the National Rebate Agreement and the Mechanics of the Rx Drug Rebate System

Trevor Wear Partner Sidley Austin LLP

Merle DeLancey Partner Blank Rome LLP

The Medicaid Drug Rebate Program (MDRP) is a program that includes Centers for Medicare & Medicaid Services (CMS), state Medicaid agencies, and participating drug manufacturers that helps to offset the Federal and state costs of most outpatient prescription drugs dispensed to Medicaid patients. ….

The program 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

(Average Wholesale Price) and WAC (Wholesale

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 340B 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 » Medicaid

• What is included in

» PHS 340B

» VA » DOD

What You Need to Know

• Defining the relationship between

WAC

» What are their roles in the calculation of Medicaid

Doebler

» How are

• AMP: what is

» What are

how is

• URA: what is it and how is it

• Status of additional rebate under CPIU

• Is there a

» How is this

exception to the

requirements under

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

4 | BUSINESS INFORMATION IN A GLOBAL CONTEXT #DrugPricingProficiency twitter: @ACI_Conferences linkedin: ACI: Pharmaceuticals / Biotech / Medical Device – Legal, Regulatory, IP and Compliance Professionals WEEK 1:

Tuesday, November 1 • Eastern Standard Time 1:00

2:00 AWP

Acquisition Cost):

Stephanie Trunk Partner Arent Fox LLP • How is AWP calculated? • When is AWP still used?

WAC, and when?

AWP and

Rebates? 2:30 Break 3:00 Medicaid Pricing and Rebate 1.0: Key Terminology Miree Lee Principal M. Lee Consulting, LLC Stefanie

Partner Covington & Burling LLP • Analysis of the Medicaid rebate system’s components: » Reimbursements vs. volume discounts º What are they? º When is each used? º To whom are they given? • 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?

the calculations different for generic products?

it and

it calculated?

the variables

AMP price calculation?

calculated?

nominal price

reporting

Medicaid?

exception determined?

4:00 Recap and Q & A 4:30 End of Tuesday Session

Introduction to Medicaid

• Validating

» Ensuring

• Analyzing

» Customary

» Commercial rebates

» Rebates

» Rebates for

» Manufacturer coupons, vouchers and

» Free goods —

Challenges

Trevor Wear

» Patient transactions — coupons,

» Sales at nominal prices

and patient assistance

» Invoice adjustments: Returns, price corrections and order corrections

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

• Developing a smoothing methodology for lagged price concessions

• Employing the 5(i) alternate AMP calculation

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

• Calculating AMP for Authorized Generics (AGs) AMP and URA calculations for line extension products

» Accounting for the entry of authorized generics and biosimilars

Analysis of Key Aspects of the CMS Finalized MDRP Rule

Schott

Analysis of State Drug Transparency Laws

Kim

Engagement

Merle Delancey

Blank

•

• Value-based

•

Part of ACI’s PROFICIENCY SERIESRegister Now AmericanConference.com/Proficiency-DrugPricing • 888 224 2480 WEEK 1: Drug Pricing and Rebate Essentials and

Thursday, November 3 • Eastern Standard Time 1:00 Medicaid Pricing and Rebate 2.0: Complexities and

Miree Lee

Principal Partner M. Lee Consulting, LLC Sidley Austin LLP

transactional data

the completeness of direct sales, indirect sales, price concession (rebates, discounts, etc.), fee, returns, and adjustment data

AMP and BP included and excluded transaction types

Prompt Pay Discounts (CPPD)

Chargebacks

— when and how included?

for drugs reimbursed through federal government programs

drugs reimbursed through SPAPs

Patient Assistance Programs (PAPs)

same product, other Medicaid product, and other items

vouchers

programs

1:45

Chris

Partner Latham & Watkins LLP The panel will analyze developments coming out of the CMS’ MDRP rule that was finalized in December 2020. Highlights will include the background for these proposals, the challenges which they present, and how the rule could affect price reporting and business operations. Among the topics covered will be:

PBM accumulator programs

Impact on price reporting for MA Plans

purchasing arrangements » Reporting multiple BPs • Line extensions, and Authorized generics 2:45 Break 3:15

Dennis

Senior

Manager Syneos Health Consulting

Partner

Rome LLP This session will explore the rise of state transparency laws across the country and how they are working in conjunction with government payor programs. • Manufacturer notifications and justifications requirements from the manufacturer » Enforcement and actions taken under existing laws • 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

Andrew Ruskin Partner

K & L Gates LLP

Melissa Wong Partner

Holland & Knight LLP

Judith Waltz Partner

Foley & Lardner LLP

•

Stephanie Trunk Partner

Arent Fox LLP

•

6 | BUSINESS INFORMATION IN A GLOBAL CONTEXT #DrugPricingProficiency twitter: @ACI_Conferences linkedin: ACI: Pharmaceuticals / Biotech / Medical Device – Legal, Regulatory, IP and Compliance Professionals WEEK 2: Medicare Pricing and Rebate Essentials Tuesday, November 8 • Eastern Standard Time 1:00 Medicare Part B: Coverages and Rebate and Pricing Essentials

• Identifying drug coverages under Medicare Part B • Understanding Part B pricing methodologies, coverage and coding » Average Sales Price (ASP) » Recognizing the differences in coverage, pricing and coding among various outpatient settings • Calculation of ASP » Inclusions and exclusions » Exempt and non-exempt sales » Smoothing » The three-quarter lag » Free goods » Patient assistance

Submission of ASP data: timing

OIG and state AG efforts to obtain data

How late filed ASPs are dealt with when calculations are done?

Impact of COVID relief fund provisions on reporting

Bundling

Implications of the Inflation Reduction Act

Pricing for selected Part B drugs subject to negotiation

Mandatory rebate for all Part B drugs

Timing considerations associated with the new law

Biosimilars 2:15 Break 2:45 Medicare Part D: Coverages and Rebate Pricing Essentials

• Identifying coverages under Part D • Understanding the mechanics of Part D » What subsidies and payments do Part D plans receive? » Interaction with 28% Retiree Drug Subsidy and commercial rebates • Reporting of Part D rebates and PBM administrative fees • Reviewing Part D fraud and abuse concerns • Examining Part D formulary requirements • Developing rebate contracting strategies under Part D

Taking advantage of plan Star Ratings

Accounting for specialty pharmaceuticals • Assessing potential legislative changes • Understanding the CMS program design relative to the Part D Coverage Gap Discount

Managing the logistics of payments to multiple plan sponsors • Assessing CGDP payment disputes • Conducting CGDP audits 4:00 Recap Q & A 4:30 End of Tuesday Session JOIN OUR EMAIL LIST TO STAY CONNECTED SIGN UP TO RECEIVE EXCLUSIVE DISCOUNTS, OFFERS AND PROGRAM UPDATES AmericanConference.com/join-our-email-list/

•

Reed Stephens

and

Merle Delancey

Blank Rome LLP

• Reviewing criteria for a

» Standardization

Annamarie Lee Directory Advisory Services IntegriChain

• Understanding the significance of bifurcated

• How is non-FAMP (non-Federal Average Manufacturer

» how do you calculate the FSS

are eligible?

from

when

used

Pricing and Contracting

Joy Sturm Partner Hogan Lovells

• Analyzing how target drugs are chosen by VA/DOD/IHS/BOP for joint

• What are the general requirements for issuing a drug

» Package size considerations

caps

» 30% up front requirement for VA mail order

• Understanding the factors for creating the requirements in the estimated

of purchase

» Formulary

• Examining the contracting process

» Pre-solicitation

» Solicitations

» Post-Solicitation discussions

• What is the process for having the contract for a drug renewed?

• Identifying the factors considered by the agencies when a drug is up for renewal

» Supply considerations and challenges

» Comparative pricing

• Understanding the differences in the processes used by the VA National Acquisition Center and Defense Logistics A

Part of ACI’s PROFICIENCY SERIESRegister Now AmericanConference.com/Proficiency-DrugPricing • 888 224 2480 WEEK 2: VA and DOD Rx Pricing and Rebates Thursday, November 10 • Eastern Standard Time 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 HANDSHAKE Global Sponsorship Opportunities 1:00 A Guide to the Essentials of FSS Contracting for Pharmaceuticals with the VA and DOD T.

Partner Winston & Strawn LLP

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

PHS – 340B

tracks and

they are

Price) calculated?

price

non-FAMP?

which entities

2:00 Break 2:30 Advanced VA

DOD

Partner

drug to

eligible for consideration under the FSS

versus therapeutic interchange contracts

national contract targets

contract?

Bottle

Safety seals

volume

status changes » Automatic substitution by Pharmaceutical Prime Vendor » Changes with pricing for other drugs in the class

4:00 Recap and Q & A 4:30 End of Thursday Session

PHS 340B

PHS 340B 1.0 - Pricing and Reimburement Under the Public Health Service 340B Program and the Link to Medicaid Rebade

Jennifer Lospinoso Partner

Riparian LLC

• What is a PHS 340B entity and why do they receive special pricing on drugs?

• PHS 602: navigating the complexities of determining who qualifies for 340B

T. Reed Stephens Partner Winston & Strawn LLP

within the PHS 340B context?

• Repackaging and re-labeling: understanding how they affect pricing in the context of PHS 340B

• What steps does a PHS 340B entity need to take to qualify for the program’s benefits?

• Discounts to wholesalers – how do they affect Best Price/AWP

2:00

PHS 340B 2.0

Joy Sturm Partner Hogan Lovells

• Understanding how bundling, tying, and GPO arrangements impact PHS 340B

• When do orphan drugs qualify for a PHS 340B discounting arrangement?

James Kim Partner Arnold & Porter LLP

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

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

Pricing

» Distribution Systems

» Calculation of the PHS 340B price

• Validating the eligibility of purchasers

• Developing best practices for monitoring HRSA data

• Distinguishing PHS 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?

• Restrictions for participating

» The anti-diversion provisions

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

» Examining manufacturers’ obligation, or lack thereof, to offer PHS 340B pricing on drugs dispensed by contract pharmacies

• Implications of recent cases

• Protecting against duplicate discounts

» Analyzing claims data

• Assessing the pros and cons of turning PHS 340B into a rebate program

• Examining current trends and updates on recent developments and whether agency guidance is enforceable

• Evaluating the likelihood of future government audits of covered entities

• Contract pharmacy

Chris Schott Partner Latham & Watkins LLP

Jennifer Lospinoso Managing Director & Consulting Lead Riparian LLC

8 | BUSINESS INFORMATION IN A GLOBAL CONTEXT #DrugPricingProficiency twitter: @ACI_Conferences linkedin: ACI: Pharmaceuticals / Biotech / Medical Device – Legal, Regulatory, IP and Compliance Professionals WEEK 3:

Tuesday, November 15 • Eastern Standard Time 1:00

Penny

covered entities

3:15 Break 3:30 LAB - Learn, Apply, and Benchmark: Pricing and Rebate Exercise Under Medicaid, Medicare, and PHS 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 End of Tuesday Session

Andrew Ruskin Partner K&L Gates LLP

•

• How do

•

• What are the types of pharmaceuticals

• 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?

• Inflation

Part D redesign,

Implications for

Part of ACI’s PROFICIENCY SERIESRegister Now AmericanConference.com/Proficiency-DrugPricing • 888 224 2480 quote-left Very good information. The slides are helpful to follow along and have to come back to for a refresh. quote-right – Rhonda Borgman, Senior Manager, Price Forecasting & Optimization at Takeda WEEK 3: Advanced CMS Pricing and RebateTopics Thursday, November 17 • Eastern Standard Time 1:00 Understanding How Co-Pay Coupons, Accelerators, and Maximizers Impact Medicaid and Medicare Pricing and Rebates

Trevor Wear Partner Sidley Austin LLP

• 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

they relate to the Medicare “donut hole”?

these mechanisms affect patients in the public payor realm

Exploring the process for working with a coupon vendor

and biologics sold under these mechanisms?

2:00 Break 2:30 Legislative Update: Inflation Reduction Act Drug Pricing Changes and their Implications

Dennis Kim Senior Engagement

Manager Syneos Health Consulting

James Kim Partner Arnold & Porter LLP Robert Hill Partner Reed Smith LLP

The panel will analyze the groundbreaking changes made by the Inflation Reduction Act, and their implications for manufacturers. Topic addressed will includes: • CMS “negotiation” of “maximum fair prices” under Medicare Parts B and D » What drugs will be subject to negotiation, and what are the ways to avoid it? » How will negotiations work, and where might prices be set?

rebates payable under Parts B and D •

including new mandatory manufacturer discounts •

manufacturer pricing, rebate contracting and market access 3:30 Medicaid/Medicare Recap and Q & A 4:30 End of Thursday Session

Chatterjee

Group

Jackson

Member

Margaux Hall Partner

•

Brett Kelly

Director

Pharma

Operations and

Thursday, December 1 • Eastern Standard Time WEEK 4: Pricing and Reimbursement for New Products and Therapies Tuesday, November 29 • Eastern Standard Time 1:00 Will Your Product Be Eligible for Reimbursement?: Pre-Commercialization Concerns in New Therapeutic Development Keren Tenenbaum Partha

VP, Assistant General Counsel Partner Vifor Pharma Akara

LLC New considerations: • Understanding the distinction between FDA approval and commercial viability • Planning to secure appropriate coding, coverage and reimbursement for new products • Assessing the competition landscape and articulating a compelling value composition Questions to ask now: • When should you start talking to payors about coding, coverage and reimbursement? • 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? • 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 Christopher

Managing

The Law Office of Christopher Jackson LLP

Ropes & Gray LLP • Identifying the steps generally involved in setting a launch price for a new drug • Understanding the role of the pricing committee and other key stakeholders • Understanding legal, policy, and reputational risks around price setting Exploring the uses of list prices versus other pricing metrics in supply chain agreements

What is the role of pricing in connection with drug reimbursement under the Medicaid Drug Rebate Program, Medicare Program, 340B program, and the VA/FSS? 4:00 Recap and Q & A 4:30 End of Tuesday Session 1:00 Value of Therapy to Value Proposition: Sources and Uses of Pricing Data in Prescription Drug Advertising and Promotion Keren Tenenbaum VP, Assistant General Counsel Vifor Pharma

Senior

Contract

Pricing Strategy Vifor

• Understanding key variables in the determination of value to key stakeholders • What is a value proposition? • Identifying databases of pharmaceutical benchmark prices for economic analyses • Communicating why your medical product is worth paying for in quantitative terms 2:30 Break 3:00 Delving Deeper into Critical Drug Pricing-Related Pre-Launch Considerations

Craig Bleifer Principal Akin Gump Strauss Hauer & Feld LLP Margaux Hill Partner Ropes & Gray LLP

This session will delve into pre-launch drug pricing related considerations that can either help smooth the path to a successful launch or cause ongoing challenges. This session will focus on the following aspects: • FDA considerations (e.g., approval pathway, special designations, or patient populations) • Method and setting of administration • Unit of measure/dosage form • Billing codes • Payor program (dis)alignment, including formulary and prior authorization considerations as part of market access strategy • Targeted patient population • Likely customer type(s) and channel partners and types of common pricing arrangements with these partners 4:00 Recap and Q & A 4:30 End of Thursday Session and Series

Past Rx Drug Pricing and Rebates attendees came from:

• Alkermes

• Almirall SA

• Analysis Group

• Ani Pharmaceuticals Inc

• Arent Fox LLP

• Astellas Pharma Inc

• Bristol-Myers Squibb Company

• Buchanan Ingersoll & Rooney PC

• Covington & Burling LLP

• CSL Behring

• DRUGHUB

• EnvisionRx

• Epstein Becker & Green PC

• Genfit

• Greenwich Biosciences

• Grifols

• Hercules Pharmaceuticals Inc

• Hyman Phelps & McNamara PC

• Incyte Corporation

• Intercept Pharmaceuticals Inc

• Invictus Pharmacy

• King & Spalding

Continuing

Education

• Lowenstein Sandler

• McDermott Will & Emery LLP

• MN Department of Administration

• Morgan Lewis & Bockius LLP

• Office of the US Attorney

• Otsuka Pharmaceutical

• PhillyCooke Consulting

• PhRMA

• Reed Smith LLP

• Ropes & Gray LLP

• R-Pharm US

ACI

the New York State

Continuing Professional Education Credits

American Conference Institute (ACI) is registered with the National Association of State Boards of Accountancy (NASBA) as a sponsor of Continuing Professional Education (CPE) 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 submitted to the National Registry of CPE Sponsors through its website: www. nasbaregistry.org

Course objective: To provide instruction in core prescription drug pricing and rebate competencies as well as applicable changes in the reimbursement structures of key government payor programs, including Medicare, Medicaid, PHS 340B, VA, and DOD.

• Understand how price is established and how the rebate system works Define key pricing terms under Medicaid, Medicare, PHS 340B and other key government payor programs

• Make sense of complex pricing and rebate calculations that go beyond the essentials

• Examine the latest developments impacting the drug pricing and rebate programs, from the CMS final rule on MDRP and PHS 340B litigation to the most favored nation model and more

• Comprehend pricing strategies and key considerations for new products and therapies

Field of Study: Business Law Prerequisite: None. Level of knowledge: Basic Advanced Preparation: None

• Sanofi

• Scilex Pharmaceuticals Inc

• Sidley Austin LLP

• Sunovion Pharmaceuticals Inc

• Therapeuticsmd

• Theravance

• Tolmar Pharmaceuticals Inc

• U.S. Department of Health and Human Services

• UCB Inc

• US Attorney's Office for the District of Massachusetts

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

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-instructions-for-virtual-attendance/ or email ACI-CLE@AmericanConference.com for further information.

WHO SHOULD ATTEND:

For Pharmaceutical Companies, PBMs, Pharmacies, and Health Insurance Plans: 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

TEACHING METHOD: Group Internet Based DELIVERY METHOD: Group Internet Based Group Internet Based Participants will earn up to 21.0 CPE credits.

To be awarded full credits, you must actively participate in activities (such as polling) and submit the verification codes presented in the chat. For more information and to submit your CPE request visit: CPE for Livestream

Refunds and Cancellations: Requests for refunds less the cancellation fee must be received in writing by October 22, 2021. For more information regarding refund, complaint, and/or program cancellation policies please contact our offices at 1-888-224-2480.

All Inclusive (Includes all modules + recordings) PRICING $1595 Register & Pay by August 26, 2022 $1795 Register & Pay after September 30, 2022 $1695 Register & Pay by September 30, 2022 © American Conference Institute, 2022 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. Bringing a Team? 3-4 10% Conference Discount 5+ Call 888-224-2480 REGISTRATION CODE: B00-124-124L23.WEB CONFERENCE CODE: 124L23-VRT 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/. All program participants will receive an online link to access the conference materials and recordings as part of their registration fee. Additional copies of the Conference Materials available for $199 per copy. 3 Ways to Register ONLINE: AmericanConference.com/Proficiency-DrugPricing EMAIL: CustomerService@AmericanConference.com  PHONE: 1-888-224-2480

Legal

Credits 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. ACI certifies this activity has been approved for CLE credit by

Continuing Legal Education Board.

certifies

event accreditation

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