Generic Pricing and Contract Analytics

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1 Generic Pricing and Contract Analytics May 2017 Tom Evegan

2 2 Agenda I. Analytics: Keys to Accuracy and Compliance a) Roadmap and Work Steps b) Dashboards and Big Data II. Pricing, Rebates, Discounts and Recent Developments a) Generic Price Inflation Penalty b) Medicaid Reporting and Expansion c) ACA Repeal/Replace

3 3 Analytics for Compliance and Accuracy - Analysis Road Map - Dashboards and Big Data Analyses

4 Contract Price (FSS/PHS) Utilization Contract Price Direct Sales, Credit/Funding, Master Data Utilization Flow of the Dollar Wholesaler WAC Manufacturer Contract Price End Customer Funding Request GPO Membership Rosters Admin Fee Reports & Payment Gross to Net Distribution Gov Programs Managed Care Chargebacks Rebate Reports & Payment Invoice, Utilization, Plan Lists PBM/MCO RX Strategic Pricing Final Pricing VA, PHS, CMS Medicaid, Tricare, Part D

5 5 Analysis Roadmap Transactional Data Evaluation Evaluate source systems, GP calculation models and systems, and analytics applications utilize a consistent data set. Master Data Updates Partner with pricing and contracting teams to identify and classify new contracts, pricing strategies, products, and rebates programs. Pricing Review Communicate pricing results to appropriate stakeholders to level set on outcomes and ensure no other data points are needed. Key Activities - Financial Reconciliation (i.e. GL Reconciliation) - Gross-to-net walkthrough - Month-end reconciliation - Pricing Committee Participation - Contract Walkthrough - Pricing Review Sessions Gross-to-Net Education Component Analyses Document and Archive Collaborate with finance and accounting teams to understand sales, rebates, and fees projections for current quarter. 2 Implement a grossto-net component review to identify transactional data anomalies and inconsistencies 4 Memorialize, communicate, and archive findings and assumptions utilized for current calculations. 6

6 Understanding Payer Mix Throughout Product Lifecycle What is the estimated mix of patients/units shipped per program? How can Payer Mix shift over time, and how do we account for changes in the market place? *Payer Mix shift one year after launch

7 7 Dashboards and Big Data Gross-to-Net Dashboards Application of a gross-to-net analysis in dashboard formats provides a comprehensive and concise views of immense data volumes Analysis Mechanics - Key component review - Comparison of actuals to benchmarks - Validation of projections

8 8

9 9 Recent Developments: Medicaid Reporting and Analysis Generic Price Inflation Penalty Rebates and Chargebacks Medicaid and PHS liability Territory Expansion

10 10 Generic Pricing Landscape Gross to Net Inventory 852/867 reporting Wholesaler DSA contracts and Fees Generic Pricing Strategy following Branded/Specialty ASP Contracting/Class of Trade Managed Care Hub Lite Programs Specialty Generics Distribution Models/Fees Bona Fide Service Fee/Fair Market Value Assessments Analyzing fee for service

11 New Regulatory Changes Generics Inflation Rule CMS Manufacturer Release 97: Additional Inflation-Adjusted Rebate Requirements for Generic Products a) Part of the Bipartisan Budget Act of Nov 2015 b) Release of the regulation was c) Manufacturers required to calculate additional rebates Q d) FROM THE RULE: In general, for N drugs marketed on or before April 1, 2013, the Base AMP is equal to the AMP for the third quarter of 2014 and the Base CPI-U is the CPI-U for September For N drugs marketed after April 1, 2013, the Base AMP is equal to the AMP for the fifth full calendar quarter after which the drug is marketed as a drug other than a single source or innovator multiple source drug and the Base CPI-U is equal to the CPI-U for the last month of the Base AMP quarter (refer to the table below)

12 12 Generic Price Inflation Penalty

13 13 Medicaid and PHS Liability Medicaid Analytics - Define impact of inflation by state - Understand projected impact of Territory expansion

14 14 Medicaid Expansion Decisions as of April 2017

15 15 ACA Repeal and State Decisions: Impact on Analytics Roll back expansion of Medicaid programs Estimated 14MM lives no longer eligible for program Could Medicaid/Medicare Supplemental/RFP requests become more egregious? Insurance plans looking for more rebate dollars Utilization move from Paid Date to Dispense date in 2016 Impact to Accrual Modeling and Analytics NY State and Prop 61 CA SMAC and VA pricing caps California no longer scrubbing 340B claims from Medicaid utilization Trend to analyze more Medicaid data program by program Claims level detail when necessary

16 Distribution Models Distribution Model Open Open (Managed) Controlled Restricted What it means No Purchasing Restrictions, Full Line Wholesale Hybrid Network (Branded and Specialty Sell direct to a controlled network, Dual Accounts (e.g. Walgreens SP and Retail Store) Manufacturer sells to end customers, No wholesaler access, REMS/Blackbox warning

17 Alignment Between Distributors, Pharmacies and PBMs Life Sciences Practice

18 18 CHARGEBACKS Considerations and Challenges Availability and specificity of customer-specific pricing information. Consider impact of growing complexity of contract terms and sales agreements. Availability and reliability of customer inventory levels (852 data). Time period between the date of the original sale of the product and the date that chargeback claim is processed by the pharmaceutical company is generally 3-4 weeks. Evaluate lag time by product as some products may be slow moving and require larger reserves. Reduction of the Pipeline reserve for anticipated returns directly from wholesaler. Ability of organization to predict future Demand sales by the wholesaler and sufficient historical experience and data: Demand Sales of Product (sold by wholesaler) Chargebacks (X% of Product demand sales to Hospitals, etc) Rebates (X% of Product demand sales to retailers, etc)

19 19 CHARGEBACKS Calculation Methods Method 1 (complex method) Monthly: Portion of current month s sales projected to be sold to CB entities x Weighted Average Contract Price (ACP) = monthly accrual Rate calculation: Weighted Average Contract Price (ACP) Uses historical chargeback and sales data to estimate the Hospital/Clinic/Etc. utilization and product mix to weight the contracted rates. Quarterly: Calculate pipeline estimate Units of product at wholesalers (852 inventory data) less estimated direct returns from wholesaler. Compare reserve balance to pipeline estimate. Recalculate estimate of product/entity utilization/mix. Evaluate lag time by product periodically. Chargebacks (X% of Product demand sales to Hospitals, etc) GPO Entity 1 (contracted rate = 5%) Wholesaler Inventory Demand Sales of Product (sold by wholesaler) Chargebacks (X% of Product demand sales to Hospitals, etc) Potential Returns Rebates (X% of Product demand sales to retailers, etc) GPO Entity 2 (contracted rate = 10%) x ACP = Pipeline

20 20 CHARGEBACKS Calculation Methods Method 2 (simplified method) Monthly: Expense recorded is estimated based on actual processed chargeback claims during that month. Rate calculation: Determined by taking the most recent 12 months of actual chargebacks paid and dividing by the historical sales for the related 12 months (using lag period by product). TTM Chargeback claims processed (by product) TTM Gross sales (by product) Accrual = Rate for pipeline Quarterly: Calculate pipeline estimate Multiplying an estimate of inventory on-hand at the wholesalers by accrual rate Evaluate lag time by product periodically. Example: Wholesalers turnover inventory of Product A every 3 weeks. Average Weekly Gross Sales (Product A) 3 Accrual x weeks x Rate = Pipeline

21 Managed Care Analytics 2 User GP Medicaid Chargebacks Managed Care

22 22 REBATES Considerations and Challenges Complexity of contracts (performance based contracts, price protection provisions, rate changes, etc.). Increasing variability in utilization of rebate programs. Utilization data should be analyzed prior to issuing payments to the health plans for rebates. Time period between the date of the original sale of the product and the date that the rebate is paid to the commercial insurance company/health plan can range from 3 months to 6 months. Ability of organization to predict future Demand sales by the wholesaler and sufficient historical experience and data as well as predicting share of Demand sales between different Rebated health plans: Demand Sales of Product (sold by wholesaler) Chargebacks (X% of Product demand sales to Hospitals, etc) Rebates (X% of Product demand sales to retailers, etc)

23 23 REBATES Accrual Rates Method 1 (utilization) Rate calculation: Weighted Average Rebate Rate: Based on management s estimate of product utilization/mix and the respective contracted rebate rate associated with that respective program. Often uses historical utilization levels. Commercial Rebates (X% of rebated sales to Commercial only) Caremark (contract rate X%) Rebates (X% of Product demand sales to retailers, etc) Express Scripts (contract rate X%) Other Rebates (X% of rebated sales to Medicare, Medicaid, etc.) Optum (contract rate X%) Method 2 (historical) Rate calculation: Historical invoiced claims received from Managed Care divided by historical gross sales. Based on the Company s experience and actuals paid on a rolling four quarter basis using a one quarter lag. Q1 - Q4 FY1 Invoiced rebates Q1 - Q4 FY1 Gross product sales Q2 FY2 = Accrual Rate

24 24 REBATES Reserve Calculation Methods Method 2 (income statement method) EXAMPLE Calculate Estimated Reserve for current QTR Compare to current balance Rebate Type Product Q1-Q Gross Sales Q1-Q Rebates Paid Historical % Q Gross Sales Q Reserve Estimate Current Net Balance QTRLY Accrual Adjustments Commercial Product 1 8,000, , % x 2,000,000 = (100,000) - (100,000) = - Commercial Product 2 2,000, , % x 500,000 = (25,000) - (65,000) = 40,000 Commercial Product 3 15,000,000 1,200, % x 5,000,000 = (400,000) - (317,500) = (82,500) Total 25,000,000 1,700,000 7,500,000 (525,000) (482,500) (42,500) Rebate Type Product Beginning Balance Monthly Accrual Rebates Paid Net Balance QTRLY Accrual Adjustments Ending Balance Commercial Product 1 (120,000) (30,000) 50,000 (100,000) - (100,000) Commercial Product 2 (60,000) (15,000) 10,000 (65,000) 40,000 (25,000) Commercial Product 3 (350,000) (87,500) 120,000 (317,500) (82,500) (400,000) Total (530,000) (132,500) 180,000 (482,500) (42,500) (525,000)

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