4th Annual Passport to Proficiency on Rx Drug Pricing & Rebate Fundamentals - DS

EARN CLE/CPE CREDITS

4th Annual 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 340B • VA • DOD Updates on IRA Reforms and Proposed Revisions to MDRP CALENDAR-ALT October 30 to November 29, 2023

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

4 weeks, 2x weekly

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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

Register Now

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Practical sessions on pricing and rebate considerations for new products

resource File-Alt Substantive materials for your daily work Certificate of completion + CLE credits

VIRTUAL SERIES

MASTER key pricing and rebate concepts and how they are applied including: Check AMP

Check CPIU

Check AWP

Check ASP

Check WAC

Check FCP

Check BP

Check FAMP and

Check WAMP

non-FAMP

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

AmericanConference.com/Proficiency-DrugPricing • 888 224 2480

Part of ACI’s PROFICIENCY SERIES

Master the essentials of key pricing and rebate concepts and methodologies, including IRA reforms and Proposed Revisions to the MDRP. 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. We have refreshed our course agenda to include in-depth sessions on changes to the pricing and rebate system under the Inflation Reduction Act (IRA) as well as proposed changes to the Medicaid Drug Rebate Program under CMS’s newly Proposed Rule: Medicaid Program; Misclassification of Drugs, Program Administration and Program Integrity Updates Under the Medicaid Drug Rebate Program.

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 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 Monday and Wednesday afternoon over the course of four weeks and examine:

WEEK 1 Oct 30 & Nov 1

WEEK 2 Nov 6 & 8

WEEK 3 Nov 13 & 15

WEEK 4 NOV 27 & 29

• Drug Pricing and Rebate Essentials and Introduction to Medicaid

• PHS 340B, VA and DOD Rx Pricing and Rebates

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

• Pricing and Reimbursement for New Products and Therapies

This intensive training program will 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 MAKE sense of complex pricing and rebate calculations that go beyond the essentials EXAMINE the latest developments impacting government drug pricing and rebate programs, from reforms instituted under the IRA to CMS’s newly Proposed Rule which would significantly amend the MDRP

COMPREHEND pricing strategies and key considerations for new products and therapies 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.

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Fast Track Your Learning with Guidance from a Renowned Faculty of Masters in Rx Drug Pricing and Rebates Kirsten Axelsen Senior Policy Advisor DLA Piper LLP

Joseph Metro Partner Reed Smith LLP

Jeff Blake Partner Federal Compliance Solutions

Erika Moreno Chief, Pharmaceutical Division, National Contract Service National Acquisition Center, U.S. Department of Veterans Affairs

Craig Bleifer Partner Akin Gump Strauss Hauer & Feld LLP Claire Castles Partner Jones Day Merle DeLancey Partner Blank Rome LLP Stefanie Doebler Partner Covington & Burling LLP Margaux Hall Partner Ropes & Gray LLP Mary Hendrickson Partner Foley & Lardner LLP James Kim Partner Arnold & Porter Kaye Scholer LLP Dennis Kim Senior Engagement Manager Syneos Health Consulting Katie Lapins Trujillo Executive Director The Pricing Group Jennifer Lospinoso Managing Director & Consulting Lead Riparian LLC Ross Margulies Partner Foley Hoag LLP Juliet McBride Partner King & Spalding LLP Scott A. Memmott Partner Morgan Lewis & Bockius LLP

Andrew Ruskin Partner K & L Gates LLP Chris Schott Partner Latham & Watkins LLP Sharon Small Director, Counsel – Market Access Govt. Pricing and Policy Novartis T. Reed Stephens Partner Winston & Strawn LLP Joy Sturm Partner Hogan Lovells LLP Keren Tenenbaum US General Counsel and Chief Compliance Officer Ascendis Pharma Stephanie Trunk Partner Arent Fox Schiff LLP

Register Now

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

Trevor Wear Partner Sidley Austin LLP

• Financial Analysts

Matthew Wetzel Partner Goodwin Procter LLP

• Corporate Counsel/General Counsel

Constance Wilkinson Member of Team Epstein Becker & Green, P.C. Melissa Wong Partner Holland & Knight LLP

quote-left All encompassing overview of government program and current issues. quote-right

This Rx Drug Pricing and Rebate Proficiency Series is for:

GOVERNMENT AFFAIRS

PHARMACIES

• 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

– Director of Pricing and Contracts at Horizon Pharmaceuticals

AmericanConference.com/Proficiency-DrugPricing • 888 224 2480

Part of ACI’s PROFICIENCY SERIES

WEEK 1: Drug Pricing and Rebate Essentials and Introduction to Medicaid Monday, October 30 • Eastern Standard Time 1:00pm

Analysis of the National Rebate Agreement and the Mechanics of the Rx Drug Rebate System Dennis Kim Senior Engagement Manager Syneos Health Consulting

Chris Schott Partner Latham & Watkins 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

The National Drug Rebate Agreement

Mechanics of the Medicaid Drug Rebate System

• Understanding the agreement’s terms and purpose

• Survey of applicable drug pricing legislation such as the MMA, DRA, and ACA

• What is required to participate in the agreement?

• Overview of Medicaid, Medicare, and PHS Programs relative to prescription drug coverage

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

• How is price established?

• How is the PHS program linked to Medicaid?

• How does the rebate system work?

• What relation does the agreement have to Medicare benefits? (i.e., Medicare Part B and Part D)

• Under which of the payor systems are rebates available? » Medicare • Medicaid • PHS • VA • DOD

2:00pm

AWP (Average Wholesale Price) and WAC (Wholesale Acquisition Cost): What You Need to Know Stephanie Trunk Partner Arent Fox Schiff LLP

• How is AWP calculated?

• When is AWP still used?

• What is included in WAC, and when?

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

2:30pm

Break

2:45pm

Medicaid Pricing and Rebate 1.0: Key Terminology Stefanie Doebler Partner Covington & Burling LLP • Analysis of the Medicaid rebate system’s components:

» Defining “retail community pharmacy” class of trade » what are the variables in AMP price calculation?

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

• CPIU: what is it and how is it calculated

• Best Price: what is it and how is it calculated?

» When is it triggered?

• How are the calculations different for generic products?

» Does it ever reset?

• recent court and regulatory developments

» Nominal Pricing: when is relevant to calculating URA?

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

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WEEK 1: Drug Pricing and Rebate Essentials and Introduction to Medicaid Monday, October 30 • Eastern Standard Time 3:45pm

Medicaid Pricing and Rebate 2.0: Complexities and Challenges Juliet McBride Partner King & Spalding LLP • 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

» Free goods — same product, other Medicaid product, and other items » 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 sales and concessions

» Commercial rebates — when and how are they included?

• Employing the 5(i) alternate AMP calculation

» Rebates for drugs reimbursed through federal government programs » Rebates for drugs reimbursed through SPAPs

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

» Manufacturer coupons, vouchers and Patient Assistance Programs (PAPs)

• URA calculations for line extension products

• Calculating AMP and identifying Best Price for Authorized Generics

4:45pm

Recap and Q & A 5:15pm

End of Monday Session

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AmericanConference.com/Proficiency-DrugPricing • 888 224 2480

Part of ACI’s PROFICIENCY SERIES

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

1:00pm

Analysis of Key Aspects of CMS’ Finalized MDRP Rule 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.

Ross Margulies Partner Foley Hoag LLP Among the topics covered will be: • PBM accumulator programs • Impact on price reporting for MA Plans 1:45pm

• Value-based purchasing arrangements » Reporting multiple BPs • Line extensions, and Authorized Generics

Break

2:00pm

Analysis of Proposed Changes to the MDRP Under CMS’s Recently Proposed Rule Trevor Wear Partner Sidley Austin LLP

Joseph Metro Partner Reed Smith LLP

In May 2023, CMS issued a Proposed Rule that would radically alter the Medicaid Drug Rebate Program. This session will provide an in-depth analysis of several key portions under the proposed Rule and their implications for drug manufacturers. Point of discussion will include: • Analysis and overview of the Medicaid Program; Misclassification of Drugs, Program Administration and Program Integrity Updates Under the Medicaid Drug Rebate Program Proposed Rule • Examining the proposed new definition for misclassification • Exploring how proposals for aggregation or stacking of concessions would change how best price is set • Analyzing proposed new definitions for CODs, manufacturer, and market date

• Understanding how the proposed new annual drug price verification survey would impact reporting obligations • Contemplating the effect of proposed time limits on manufacturer audits and drug cost transparency requirements with certain managed care contracts • Assessing the probability of possible suspension from National Drug Rebate Agreement (NDRA) for late reporting • Reviewing comment submissions and what we can glean from them

3:15pm

Compendium of State Drug Transparency Laws Scott A. Memmott Partner Morgan Lewis & Bockius LLP

Merle DeLancey Partner Blank 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.

• Identifying states with current and pending drug pricing transparency laws » 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

4:00pm

Recap and Q & A 4:20pm

End of Wednesday Session

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WEEK 2: PHS 340B, VA and DOD Rx Pricing and Rebates Monday, November 6 • Eastern Standard Time 1:00pm

PHS 340B 1.0 – Pricing and Reimbursement Under the Public Health Service 340B Program and The Link to Medicaid Rebate Jennifer Lospinoso Managing Director & Consulting Lead Riparian LLC • What is a PHS 340B covered entity and why do they receive special pricing on drugs?

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

• Who qualifies as a 340B covered entity and for 340B pricing?

• What impact do GPO arrangements have on covered entities access to 340B prices?

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

• When must 340B pricing be offered on orphan drugs?

• How do discounts to customers affect 340B prices?

2:00pm

Break

2:15pm

PHS 340B 2.0 Constance Wilkinson Member of Team Epstein Becker & Green, P.C. Operational Challenges: • Examining the implications of the Supreme Court’s decision discontinuing reimbursement cuts to 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 » Penny pricing

» 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?

» Limited distribution drugs

Legal Challenges: • Restrictions for participating covered entities

• Protecting against duplicate discounts

» The anti-diversion provisions • Exploring HRSA’s limited authority to enforce the 340B program » Examining manufacturers’ obligation, or lack thereof, to offer 340B pricing on drugs dispensed by contract pharmacies SQUARE

Implications of recent cases

• Assessing the considerations around using rebates in the 340B program pros and cons of turning 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 developments

3:30pm

Recap and Q and A 4:00pm

End of Monday Session

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AmericanConference.com/Proficiency-DrugPricing • 888 224 2480

Part of ACI’s PROFICIENCY SERIES

WEEK 2: PHS 340B, VA and DOD Rx Pricing and Rebates Wednesday, November 8 • Eastern Standard Time 1:00pm

A Guide to the Essentials of FSS Contracting for Pharmaceuticals with the VA and DOD James Kim Partner Arnold & Porter Kaye Scholer LLP

T. Reed Stephens Partner Winston & Strawn LLP » PHS – 340B

• 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)

• How is non-FAMP (non-Federal Average Manufacturer Price) calculated? » How do you calculate the FSS price from non-FAMP?

» Tricare 2:15pm

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

» Which entities are eligible?

Break

2:30pm

Advanced VA and DOD Pricing and Contracting Joy Strum Partner Hogan Lovells LLP

Merle DeLancey Partner Blank Rome LLP

Erika Moreno Chief, Pharmaceutical Division, National Contract Service National Acquisition Center, U.S. Department of Veterans Affairs

» Automatic substitution by Pharmaceutical Prime Vendor

• Specialized arrangements for personalized medicines • Reviewing criteria for a drug to be eligible for consideration under the FSS

» Changes with pricing for other drugs in the class • Examining the contracting process

» Standardization versus therapeutic interchange contracts • Analyzing how target drugs are chosen by VA/DOD/IHS/BOP for joint national contract targets

» Pre-solicitation

• What are the general requirements for issuing a drug contract?

» Post-Solicitation discussions

» Package size considerations

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

» Bottle caps

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

» Safety seals

» Supply considerations and challenges

» 30% up front requirement for VA mail order • Understanding the factors for creating the requirements in the estimated volume of purchase » Formulary status changes

» Comparative pricing • Understanding the differences in the processes used by the VA National Acquisition Center and Defense Logistics Agency

3:45pm

Recap and Q & A 4:15pm

End of Wednesday Session

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WEEK 3: Medicare Pricing and Rebate Essentials and Advanced CMS Pricing and Rebate Topics Monday, November 13 • Eastern Standard Time 1:00pm

The Inflation Reduction Act (IRA): An In-Depth Review of Changes to Medicare Pricing under the IRA Matthew Wetzel Partner Goodwin Procter LLP

Matthew Wetzel Partner Goodwin Procter LLP

The Inflation Reduction Act (IRA) marked a monumental shift in Medicare and to some extent Medicaid drug pricing policy. The drug pricing provisions set out in the IRA are complex and include a slate of new obligations and considerations for pharmaceutical manufacturers, most notably mandatory pricing negotiations on the costliest drugs. This session will provide a timely analysis of drug pricing provisions under the IRA as well as current and projected impacts on drug manufacturers and the pharmaceutical industry at large. Key points of discussion include: • Break down the Inflation Reduction Act » Determining the impact of IRA on Medicare drug pricing » Examining concerns from Medicaid and dual-eligible • Understanding CMS’s negotiation of maximum fair prices under Medicare Parts B and D • Examining Inflation rebates payable under Part B and D • Analysis of Part D re-design, including new manufacturer discounts • Examining what has currently been implemented under the IRA • Anticipating what’s ahead and what will be implemented • Dissecting the misconceptions of the IRA • Examining key provisions in the IRA for manufacturers to consider 2:15pm

» Identifying what drugs will be subject to negotiation » Negotiation timelines and process » Enforcement provisions • Analysis of the implications for drug manufacturers » Examining how the negotiation provisions will impact product prices SQUARE Maximum fair price calculations » Understanding the mechanics of inflation rebate calculations for Medicare Part B and D • Understanding of how drug pricing reforms will be applied in the real word through hypothetical examples

Break

2:30pm

Medicare Part B: Coverages and Rebate and Pricing Essentials Andrew Ruskin Partner K & L Gates LLP

Mary Hendrickson Partner Foley & Lardner LLP • Identifying drug coverages under Medicare Part B • Understanding Part B reimbursement 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 » How late filed ASPs are dealt with when calculations are done?

• Bundling • Reimbursement under Part B • Congressional changes the reimbursement for Part B drugs » Reimbursement of generic specialty drugs » Biosimilars • Analyzing the Medicare Part B Drug Wastage Rule • Exploring the interplay between the IRA and the Drug Wastage Rule

3:30pm

Medicare Part D: Coverages and Rebate Pricing Essentials Melissa Wong Partner Holland & Knight LLP • 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 4:15pm

Recap and Q & A 4:30pm

End of Monday Session

• 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

WEEK 3: Medicare Pricing and Rebate Essentials and Advanced CMS Pricing and Rebate Topics Wednesday, November 15 • Eastern Standard Time 1:00pm

Understanding How Co-Pay Coupons, Accelerators, and Maximizers Impact Medicaid and Medicare Pricing and Rebates Ross Margulies Partner Foley Hoag LLP

Andrew Ruskin Partner K & L Gates LLP

• Defining coupons, accelerators and maximizers and examining their similarities and differences

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

» How are the parameters for such discount mechanisms set?

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

• Reviewing these mechanisms as a whole and understanding how they are were supposed to affect Medicaid best price liability » In what ways do these mechanisms impact out of pocket expenses?

• Exploring the process for working with a coupon vendor

• How do these mechanisms effect specialty products?

• Reviewing recent litigation surrounding the use of co-pay coupons

2:15pm

How to Negotiate the Maximum Fair Price Under Medicare Part B and D Margaux Hall Partner Ropes & Gray LLP • Identifying selected drugs which will fall under the maximum fair price requirement category • Analyzing the fair pricing requirement

• Understanding the significance of the shift in responsibility to identify MFP • Calculating maximum fair pricing and why it is important to the negotiation requirement

• Detailing the HHS negotiation process and timeline 2:45pm

Break

3:00pm

Simplifying Inflation Rebate Penalties Under Medicare Part B and D Trevor Wear Partner Sidley Austin LLP

Katie Lapins Trujillo Executive Director The Pricing Group

• Understanding IRA inflation rebate requirements for Part B drugs and its relationship to ASP

• Evaluating what utilization is and is not subject to the rebate requirements

• Examining the IRA inflation rebate requirement for Part D drugs and its relationship to AMP

• Exploring penalties for manufacturers who do not comply with new rebate provisions

• Analyzing the benchwork periods for evaluating inflation for both existing and new drugs

• Working through the mechanics of precisely how the rebates are calculated

• Looking at the impact and interplay of the IRA inflation rebates on commercial sales

4:00pm

LAB – Learn, Apply, and Benchmark: Pricing and Rebate Exercise Under Medicaid, Medicare, and 340B Trevor Wear Partner Sidley Austin LLP 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.

4:45pm

Recap and Q & A 5:00pm

End of Wednesday Session

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WEEK 4: Pricing and Reimbursements for New Products and Therapies Monday, November 27 • Eastern Standard Time 1:00pm

Will Your Product Be Eligible for Reimbursement? Pre-Commercialization Concerns in New Therapeutic Development Keren Tenenbaum US General Counsel and Chief Compliance Officer Ascendis Pharma New considerations: • Understanding the distinction between FDA approval and commercial viability

• Assessing the competition landscape and articulating a compelling value composition

• Planning to secure appropriate coding, coverage and reimbursement for new products

Questions to ask now: • When should you start talking to payors about coding, coverage and reimbursement?

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

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

• What regulatory and commercial impediments are preventing these companies from pursuing the development of the desired product?

• How can you stay compliant when marketing a new product in light of those restrictions?

2:15pm

» Will the product/technology be covered through government payor/ pricing methodologies?

Break

2:30pm

New Product Launch – Government Pricing and Contracting Considerations Jeff Blake Partner Federal Compliance Solutions

Claire Castles Partner Jones Day • 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? 3:45pm

Recap and Q&A Session 4:15pm

End of Monday Session

quote-left Very good information. The slides are helpful to follow along and have to come back to for a refresh. quote-right – Senior Manager, Price Forecasting & Optimization at Takeda

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AmericanConference.com/Proficiency-DrugPricing • 888 224 2480

Part of ACI’s PROFICIENCY SERIES

WEEK 4: Pricing and Reimbursements for New Products and Therapies Wednesday, November 29 • Eastern Standard Time

1:00pm

Value of Therapy to Value Proposition: Sources and Uses of Pricing Data in Prescription Drug Advertising and Promotion Kirsten Axelsen Senior Policy Advisor DLA Piper LLP • Understanding key variables in the determination of value to key stakeholders

• Identifying databases of pharmaceutical benchmark prices for economic analyses

• What is a value proposition?

• Communicating why your medical product is worth paying for in quantitative terms

2:15pm

Break

2:30pm

Delving Deeper into Critical Drug Pricing-Related Pre-Launch Considerations Craig Bleifer Partner Akin Gump Strauss Hauer & Feld LLP

Sharon Small Director, Counsel – Market Access Govt. Pricing and Policy Sidley Austin LLP

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: • FDA considerations (e.g., approval pathway, special designations, or patient populations)

• Payor program (dis)alignment, including formulary and prior authorization considerations as part of market access strategy

• Method and setting of administration

• Targeted patient population

• Unit of measure/dosage form

• Likely customer type(s) and channel partners and types of common pricing arrangements with these partners

• Billing codes 3:30pm

Recap and Q & A 4:00pm

End of Wednesday Session and Series

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

• EnvisionRx

• Lowenstein Sandler

• Sanofi

• Almirall SA

• Epstein Becker & Green PC

• McDermott Will & Emery LLP

• Scilex Pharmaceuticals Inc

• Analysis Group

• Genfit

• Sidley Austin LLP

• Ani Pharmaceuticals Inc

• Greenwich Biosciences

• MN Department of Administration

• Arent Fox LLP

• Grifols

• Astellas Pharma Inc

• Hercules Pharmaceuticals Inc

• Bristol-Myers Squibb Company

• Hyman Phelps & McNamara PC

• Buchanan Ingersoll & Rooney PC

• Incyte Corporation

• Covington & Burling LLP • CSL Behring • DRUGHUB

• Intercept Pharmaceuticals Inc • Invictus Pharmacy • King & Spalding

• Morgan Lewis & Bockius LLP • Office of the US Attorney • Otsuka Pharmaceutical • PhillyCooke Consulting

• Sunovion Pharmaceuticals Inc • Therapeuticsmd • Theravance • Tolmar Pharmaceuticals Inc

• PhRMA

• U.S. Department of Health and Human Services

• Reed Smith LLP

• UCB Inc

• Ropes & Gray LLP

• US Attorney's Office for the District of Massachusetts

• R-Pharm US

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

• EnvisionRx

• Lowenstein Sandler

• Sanofi

• Almirall SA

• Epstein Becker & Green PC

• McDermott Will & Emery LLP

• Scilex Pharmaceuticals Inc

• Analysis Group

• Genfit

• MN Department of Administration

• Sidley Austin LLP

• Ani Pharmaceuticals Inc

• Greenwich Biosciences

• Morgan Lewis & Bockius LLP

• Sunovion Pharmaceuticals Inc

• Arent Fox LLP

• Grifols

• Office of the US Attorney

• Therapeuticsmd

• Astellas Pharma Inc

• Hercules Pharmaceuticals Inc

• Otsuka Pharmaceutical

• Theravance

• Bristol-Myers Squibb Company

• Hyman Phelps & McNamara PC

• PhillyCooke Consulting

• Tolmar Pharmaceuticals Inc

• Buchanan Ingersoll & Rooney PC

• Incyte Corporation

• PhRMA

• Intercept Pharmaceuticals Inc

• Reed Smith LLP

• U.S. Department of Health and Human Services

• Invictus Pharmacy

• Ropes & Gray LLP

• King & Spalding

• R-Pharm US

• Covington & Burling LLP • CSL Behring • DRUGHUB

EARN CLE CREDITS

Continuing Legal Education 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 the New York State Continuing Legal Education Board.

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

• UCB Inc • US Attorney's Office for the District of Massachusetts

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-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

- Government Programs

- Contracts and Reimbursement

- Finance/Accounting/Audit

- Medicaid/Medicare Rebates

- Managed Markets

- Government Affairs

- Managed Care • Compliance Officers

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

• 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

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

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

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.

Field of Study: Business Law Prerequisite: None.

Level of knowledge: Basic Advanced Preparation: None

Mark Parrish, American Conference Institute

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Daniel Manganiello, American Conference Institute

Use Registration Code: B00-999-MPH23

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Register & Pay by August 26, 2022

Register & Pay by September 30, 2022

Register & Pay after September 30, 2022

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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.

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, 2022

CONFERENCE CODE:

124L23-VRT

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