The complexity and external scrutiny around gross-to-net continues to rise. Gross-to-net is impacted by significant volatility, high risk exposure, and material true-up adjustments.

The interactive 2020 Gross-to-Net (GTN) Workshop is designed to enhance your knowledge of GTN key concepts including developing accurate estimates of accruals for commercial & government rebates, chargebacks, 340B programs, co-pay cards and returns. The workshop provides best practices for well-designed GTN processes supported by a sound methodology to enhance financial reporting accuracy and reduce volatile material true-up adjustments. Workshop incorporates an analysis of market access challenges and dynamics. The Senate Finance Committee’s Drug Pricing Package and other proposed legislation will be reviewed to provide an assessment of the financial implications.

Learning Objectives:

  • Understand the key components of gross to net revenue adjustments
  • Assess market access challenges and payer dynamics
  • Illustrate Medicaid and Medicare Part D key concepts including coverage gap liability
  • Determine impact of copay programs & copay accumulators on GTN and patient out-of-pocket costs
  • Review complexities and nuances inherent in determining the reserve for returns
  • Review and understand key considerations for new product launches, price increases, outcomes-based pricing, indication-based pricing and specialty pharmaceuticals
  • Understand variations in GTN by customer channel and across your product portfolio
  • Evaluate payer contracting scenarios and GTN implications
  • Assess implications of proposed legislation

Gross-to-net training workshop is comprised of four parts:

Part 1 – Gross-to-Net Key Concepts
Part 2 – Gross-to-Net Considerations – New Product Launch (numerical example)
Part 3 – HCV Product Launch Case Study – Strategy, Execution & Key Learnings
Part 4 – Payer Role Play Negotiation (optional)

Following is a description of the four parts of the one-day gross-to-net training workshop:

Part 1: Gross-to-Net Key Concepts

Workshop is designed to provide an understanding of the dynamics inherent in developing gross-to-net forecasts, accruals and subsequent adjustments. Methodologies to establish accurate gross to net reserves and minimize risk will be addressed. Following are the major topics designed to enhance your knowledge and understanding of gross-to-net concepts:

  • Developing key assumptions to estimate gross sales
  • Impact of prior authorization and patient abandonment on gross sales
  • Overview of components of gross-to-net revenue adjustments
  • Developing product-specific GTN channel summaries
  • Documenting and refining GTN accrual rate assumptions
  • Pressures from pharmacy benefit managers to increase rebates and reduce utilization
  • Commercial rebates
  • Prior authorization & step edits
  • Price protection
  • Medicare Part D rebates
  • Medicare Part D Coverage Gap (Donut Hole)
  • Medicaid rebates and best price implications
  • 340B Drug Pricing Program & potential abuses
  • Chargebacks
  • Vouchers
  • Co-pay cards, co-pay accumulators, and co-pay maximizers
  • Product returns (before and after loss of exclusivity)
  • GTN demand liability for rebates and chargebacks – key considerations
  • GTN pipeline for wholesale & retail channel inventory
  • GTN true-up adjustments
  • Outcomes-based contracts
  • Specialty pharmacies
  • Implications of proposed legislation
  • Fundamentals of payer contracting & market access challenges
  • ROI of alternative payer contracting scenarios
  • GTN considerations for the long-term plan (“LRP”)

Part 2: Gross-to-Net Considerations – New Product Launch

A comprehensive case study with numerical examples illustrating the challenges associated with a new product launch. Key considerations to improve accuracy of accruals and minimize unexpected volatility will be addressed.

Following are the major topics designed to enhance your knowledge of gross-to-net considerations for new product launches:

  • Preparing a realistic gross sales forecast and alternative scenarios
  • Developing a new product launch channel summary reflecting business mix and accrual rates by estimating:
    • Gross sales & related rebates for private and public payers
    • Chargebacks
    • Vouchers
    • Co-pay cards subsidizing patients’ out-of-pocket costs
    • Returns
    • Wholesaler fees
  • Estimating demand and pipeline liability
  • Truing-up gross-to-net liabilities to reflect:
    • Differences between actual and projected rebates
    • Revisions of accrual rates
    • Modifications of pipeline liability
  • Modifying GTN fourth quarter pipeline liability by incorporating:
    • New contracts and rebates/chargeback rates effective first quarter of ensuing year
    • Forecasted changes in channel mix next year based on new contracts
    • Impact of higher patient cost reduction subsidies in the first quarter of next year

Part 3: HCV Product Launch Case Study – Go-to-Market Strategy, Execution & Key Learnings

The case study focuses on the launches of new innovative products transforming the HCV market. Key elements of the go-to-market strategy, payer dynamics and financial investments are evaluated. Methodology to develop the forecast for the new product launch and underlying assumptions are reviewed. The case study concludes with an analysis of the launch execution and lessons learned.

Following are the major topics designed to enhance your knowledge of key new product launch considerations:

  • Market overview
  • Profile of products competing for market access
  • Addressing challenges in the payer environment
  • Developing a go-to-market strategy
  • Behavioral biases
  • Forecasting NBRx, market size, gross-to-net and net sales
  • Developing sensitivity analysis
  • Assessing risks and opportunities
  • Understanding key factors impacting performance
  • Analyzing the impact of subsequent launches of new competitive products
  • Managing expectations
  • Lessons learned and suggestions

Part 4 (optional): Payer Negotiation Role Play

The negotiation role play is a unique case study focusing on the payer dynamics after a competitive product with comparable efficacy enters the marketplace. Two teams representing the incumbent and new company negotiate with the PBM to determine the rebate rate, access (exclusive, second tier, parity, third tier, or excluded), prior authorization and a step edit. Financial implications related to impact of alternative proposals on gross-to-net sales and payer costs will be assessed.

  • Illustration of the GTN funnel
  • Commercial payers
  • Key factors impacting rebates
  • Utilization restrictions – Prior authorization, step edits, tiers & formulary exclusions
  • Payer cost controls – Using leverage to extract higher rebates & price protection
  • Impact of co-pay cards and co-pay accumulators
  • Payer contracting formulary options and related rebates
  • Contracting scenarios – Measuring ROI
  • Understanding market access dynamics
  • Hands-on payer negotiation exercise (incumbent, new entrant and payer)
  • Accessing key terms to be negotiated and financial implications
  • Developing SWOT analysis for the incumbent company, new entrant & PBM
  • Evaluating financial implications of tradeoffs between access and higher rebates
  • Assessing the impact of negotiation on patients’ access and affordability
  • Debrief on negotiation outcomes
  • Summary of key learnings